dalimumab Products Non-preferred

Non-preferred adalimumab product(s)1 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming ONE of the following diagnoses:
1. moderate to severe rheumatoid arthritis
2. moderate to severe polyarticular juvenile idiopathic arthritis (PJIA)
3. active psoriatic arthritis
4. moderate to severe chronic plaque psoriasis
5. Ankylosing spondylitis
6. moderate to severe Crohn's disease
7. moderate to severe ulcerative colitis
8. moderate to severe hidradenitis suppurative (i.e., Hurley stage II or III)
9. non-infectious intermediate, posterior, or panuveitis; and
2. Submission of medical records (e.g., chart notes) confirming ONE of the following:
1. BOTH of the following:
1. Member has had an inadequate response to ONE preferred adalimumab product1 for a period sufficient to determine clinical response as outlined in the clinical trial4 for the indication requested; and
2. Details on why the preferred adalimumab product1 has not been effective is provided; or
2. BOTH of the following:
1. Member has an inability to tolerate ONE preferred adalimumab product1; and
2. Details of intolerability is provided; and
3. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
4. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Authorization duration: 12 months

Ustekinumab Products Non-preferred

Non-preferred ustekinumab product(s)2 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming ONE of the following diagnoses:
1. Active psoriatic arthritis
2. Moderate to severe chronic plaque psoriasis
3. Moderate to severe Crohn's disease
4. Moderate to severe Ulcerative colitis; and
2. Submission of medical records (e.g., chart notes) confirming ONE of the following:
1. BOTH of the following:
1. Member has an inadequate response to ONE preferred ustekinumab product2 for a period sufficient to determine clinical response as outlined in the clinical trial4 for the indication requested; and
2. Details on why the preferred ustekinumab product2 has not been effective is provided; or
2. BOTH of the following:
1. Member has an inability to tolerate ONE preferred ustekinumab product2; and
2. Details of intolerability is provided; and
3. For ustekinumab (Stelara by Janssen Biotech) only, one of the following:
1. BOTH of the following:
1. Member has an inadequate response to BOTH ustekinumab-ttwe (Pyzchiva by Sandoz) AND ustekinumab-aauz (Otulfi by Fresenius Kabi) for a period sufficient to determine clinical response as outlined in the clinical trial4 for the indication requested; and
2. Details on why ustekinumab-ttwe (Pyzchiva by Sandoz) AND ustekinumab-aauz (Otulfi by Fresenius Kabi) have not been effective is provided; or
2. BOTH of the following:
1. Member has an inability to tolerate BOTH ustekinumab-ttwe (Pyzchiva by Sandoz) AND ustekinumab-aauz (Otulfi by Fresenius Kabi); and
2. Details of intolerability is provided; and
4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Authorization duration: 12 months

Tocilizumab Products Non-preferred

Non-preferred tocilizumab product(s)3 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming ONE of the following diagnoses:
1. Moderate to severe rheumatoid arthritis
2. Moderate to severe polyarticular juvenile idiopathic arthritis
3. Giant cell arteritis
4. Active systemic juvenile idiopathic arthritis
5. Systemic sclerosis-associated interstitial lung disease; and
2. Submission of medical records (e.g., chart notes) confirming ONE of the following:
1. BOTH of the following:
1. Member has an inadequate response to ONE preferred tocilizumab product3 for a period sufficient to determine clinical response as outlined in the clinical trial4 for the indication requested; and
2. Details on why the preferred tocilizumab product3 has not been effective is provided; or
2. BOTH of the following:
1. Member has an inability to tolerate ONE preferred tocilizumab product3; and
2. Details of intolerability is provided; and
3. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
4. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Authorization duration: 12 months

4. Clinical trial supporting indication approval as described in the drug Prescribing Information, or in accordance with criteria outlined in the Off-Label Use policy.

Rheumatoid Arthritis (RA)

INITIAL CRITERIA Preferred adalimumab product1 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe rheumatoid arthritis (RA); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response of inability to tolerate ONE of the following disease-modifying anti-rheumatic drugs (DMARDS) at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Certolizumab (Cimzia®), golimumab (Simponi®), etanercept (Enbrel®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe rheumatoid arthritis (RA); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response of inability to tolerate ONE of the following disease-modifying anti-rheumatic drugs (DMARDS) at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and
5. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Tofacitinib (Xeljanz [XR]® tablets/extended-release tablets) or upadacitinib (Rinvoq®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe rheumatoid arthritis (RA); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response of inability to tolerate ONE of the following disease-modifying anti-rheumatic drugs (DMARDS) at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and
5. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
6. Member has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab); and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Anakinra (Kineret®), sarilumab (Kevzara®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe rheumatoid arthritis (RA); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response of inability to tolerate ONE of the following disease-modifying anti-rheumatic drugs (DMARDS) at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and
5. ONE of the following:
1. Both of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. certolizumab (Cimzia®)
3. golimumab (Simponi®)
4. etanercept (Enbrel®)
5. tofacitinib (Xeljanz [XR]® tablets/extended-release tablets)
6. upadacitinib (Rinvoq®); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate BOTH of the following: abatacept (Orencia® SQ) and preferred tocilizumab product3; or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Baricitinib (Olumiant®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe rheumatoid arthritis (RA); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response of inability to tolerate ONE of the following disease-modifying anti-rheumatic drugs (DMARDS) at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and
5. ONE of the following:
1. Both of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. certolizumab (Cimzia®)
3. golimumab (Simponi®)
4. etanercept (Enbrel®)
5. tofacitinib (Xeljanz [XR]® tablets/extended-release tablets)
6. upadacitinib (Rinvoq™); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate BOTH of the following: abatacept (Orencia® SQ) and preferred tocilizumab product3; or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
6. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
7. Member has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab); and
8. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Abatacept (Orencia® SQ) or preferred tocilizumab product3 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe rheumatoid arthritis (RA); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate ONE of the following disease-modifying anti-rheumatic drugs (DMARDS) at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and
5. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following: 
1. One preferred adalimumab product1
2. certolizumab (Cimzia®)
3. golimumab (Simponi®)
4. etanercept (Enbrel®)
5. tofacitinib (Xeljanz [XR]® tablets/extended-release tablets)
6. upadacitinib (Rinvoq®); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Methotrexate injection (i.e., Otrexup™, Rasuvo®, Reditrex™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of severe, active rheumatoid arthritis (RA); and
2. Prescribed by or in consultation with a rheumatologist; and
3. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate oral methotrexate; and
4. For Otrexup™ and Reditrex™ only: paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate Rasuvo®; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Preferred adalimumab product1, certolizumab (Cimzia®), golimumab (Simponi®), tofacitinib (Xeljanz [XR]® tablets/extended-release tablets), upadacitinib (Rinvoq™), anakinra (Kineret®), etanercept (Enbrel®), sarilumab (Kevzara®), baricitinib (Olumiant®), abatacept (Orencia® SQ), preferred tocilizumab product3 or methotrexate injection (i.e., Otrexup™, Rasuvo®, Reditrex™) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by at least one of the following:
1. Reduction in total active (swollen and tender) joint count from baseline; or
2. Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline; and
2. For sarilumab (Kevzara®) only, paid claim or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate one preferred tocilizumab product3; and
3. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Ankylosing Spondylitis (AS)

INITIAL CRITERIA: Preferred adalimumab product1 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of ankylosing spondylitis (AS); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate two different NSAIDS at maximally tolerated doses; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Certolizumab (Cimzia®), etanercept (Enbrel®), or golimumab (Simponi®), Ixekizumab (Taltz®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of ankylosing spondylitis (AS); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate two different NSAIDS at maximally tolerated doses; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Secukinumab (Cosentyx®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active ankylosing spondylitis (AS); and
2. Member is 18  years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate two different NSAIDS at maximally tolerated doses; and
5. One of the following:
1. Both of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. certolizumab (Cimzia®)
3. golimumab (Simponi®)
4. etanercept (Enbrel®)
5. tofacitinib (Xeljanz [XR]® tablets/extended-release tablets)
6. upadacitinib (Rinvoq™); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate BOTH ixekizumab (Taltz®) and bimekizumab (Bimzelx) or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Bimekizumab (Bimzelx®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active ankylosing spondylitis (AS); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate two different NSAIDS at maximally tolerated doses; and
5. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. certolizumab (Cimzia®)
3. golimumab (Simponi®)
4. etanercept (Enbrel®)
5. tofacitinib (Xeljanz [XR]® tablets/extended-release tablets)
6. upadacitinib (Rinvoq™)
7. ixekizumab (Taltz®); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Tofacitinib (Xeljanz [XR]® tablets/extended-release tablets) or upadacitinib (Rinvoq®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active ankylosing spondylitis (AS); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate two different NSAIDS at maximally tolerated doses; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming inadequate response or intolerance to one of more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab); and
6. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA: Preferred adalimumab product1, certolizumab (Cimzia®), golimumab (Simponi®), Etanercept (Enbrel®), secukinumab (Cosentyx®), tofacitinib (Xeljanz [XR]® tablets/extended-release tablets), ixekizumab (Taltz®), upadacitinib (Rinvoq®), or bimekizumab (Bimzelx®) is medically necessary when BOTH of the following are met:

1. There is documentation of positive clinical response to therapy as evidence by improvement from baseline by at least one of the following:
1. Disease activity (e.g., pain, fatigue, inflammation, stiffness); or
2. Lab values (erythrocyte sedimentation rate, C-reactive protein level); or
3. Axial status (e.g., lumbar spine motion, chest expansion); or
4. Total active (swollen or tender) joint count; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

INITIAL CRITERIA: Preferred adalimumab product1 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis (PJIA); and
2. Member is 2 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate ONE of the following DMARDs at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and

4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Etanercept (Enbrel®), certolizumab pegol (Cimzia®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis (PJIA); and
2. Member is 2 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate ONE of the following DMARDs at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Sarilumab (Kevzara®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active polyarticular juvenile idiopathic arthritis (PJIA); and
2. Member weighs at least 63 kg; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate ONE of the following DMARDs at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and
5. One of the following:
1. Both of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. tofacitinib (Xeljanz® tablets and oral solution)
3. etanercept (Enbrel®)
4. upadacitinib (Rinvoq/Rinvoq LQ®)
5. certolizumab pegol (Cimzia®); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate BOTH of the following:
1. preferred tocilizumab product3; and
2. Abatacept (Orencia®); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: preferred tocilizumab product3, abatacept (Orencia® SQ) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis (PJIA); and
2. Member is 2 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate ONE of the following DMARDs at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and
5. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1 
2. tofacitinib (Xeljanz® tablets and oral solution)
3. etanercept (Enbrel®)
4. Upadacitinib (Rinvoq®/Rinvoq LQ)
5. Certolizumab pegol (Cimzia®); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Tofacitinib (Xeljanz® tablets and oral solution), Upadacitinib (Rinvoq®, Rinvoq LQ®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis (PJIA); and
2. Member is 2 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate ONE of the following DMARDs at maximally tolerated doses: methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine; and
5. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
6. Member had an inadequate response or inability to tolerate one or more TNF inhibitors (e.g., adalimumab, etanercept, certolizumab pegol); and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Methotrexate injection (i.e., Otrexup™, Rasuvo®, Reditrex™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of polyarticular juvenile idiopathic arthritis (PJIA); and
2. Prescribed by or in consultation with a rheumatologist; and
3. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate oral methotrexate; and
4. For Otrexup™ and Reditrex™ only: paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate Rasuvo®; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Preferred adalimumab product1, preferred tocilizumab product3, abatacept (Orencia® SQ), tofacitinib (Xeljanz® tablets and oral solution), Upadacitinib (Rinvoq®, Rinvoq LQ®), etanercept (Enbrel®), Sarilumab (Kevzara®), certolizumab pegol (Cimzia®) or methotrexate injection (i.e., Otrexup™, Rasuvo®, Reditrex™) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by at least one of the following:
1. Reduction in the total active (swollen and tender) joint count from baseline; or
2. Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline; and
2. For sarilumab (Kevzara®) only, paid claim or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate one preferred tocilizumab product3; and
3. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Psoriatic Arthritis (PsA)

INITIAL CRITERIA: Preferred adalimumab product1 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Certolizumab (Cimzia®), golimumab (Simponi®), ixekizumab (Taltz®), deucravacitinib (Sotyktu®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Guselkumab (Tremfya®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. Member is 6 years of age or older and weighs at least 40kg; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Apremilast (Otezla®, Otezla XR®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. Member is 6 years of age or older and weighs at least 20kg; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Etanercept (Enbrel®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. Member is 2 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Preferred ustekinumab product2, risankizumab (Skyrizi® SQ) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. Member is 6 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Upadacitinib (Rinvoq®, Rinvoq LQ®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. Member is 2 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming the member has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab); and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Tofacitinib (Xeljanz® tablet and oral solution, Xeljanz® XR tablets) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. One of the following:
1. For Xeljanz XR, member is 18 years of age or older; or
2. For Xeljanz tablet and oral solution, member is 2 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming the member has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab); and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Abatacept (Orencia® SQ) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. Member is 2 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming the member has had an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. certolizumab (Cimzia®)
3. One preferred ustekinumab product2
4. golimumab (Simponi®)
5. etanercept (Enbrel®)
6. guselkumab (Tremfya®)
7. risankizumab (Skyrizi™)
8. tofacitinib (Xeljanz® tablet and oral solution, Xeljanz® XR tablets)
9. upadacitinib (Rinvoq/Rinvoq LQ®)
10. ixekizumab (Taltz®)
11. apremilast (Otezla®, Otezla XR®)
12. deucravacitinib (Sotyktu®); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Secukinumab (Cosentyx®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. Member is 2 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. One of the following:
1. All of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming the member has had an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1 
2. certolizumab (Cimzia®)
3. golimumab (Simponi®)
4. One preferred ustekinumab product2
5. etanercept (Enbrel®)
6. guselkumab (Tremfya®)
7. risankizumab (Skyrizi™)
8. tofacitinib (Xeljanz® tablet and oral solution, Xeljanz® XR tablet)
9. upadacitinib (Rinvoq/Rinvoq LQ®)
10. apremilast (Otezla®, Otezla XR®)
11. deucravacitinib (Sotyktu®); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming the member has had an inadequate response or inability to tolerate BOTH of the following: ixekizumab (Taltz®) AND abatacept (Orencia® SQ) or bimekizumab (Bimzelx®); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: bimekizumab (Bimzelx®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active psoriatic arthritis; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist or dermatologist; and
4. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming the member has had an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. certolizumab (Cimzia®)
3. golimumab (Simponi®)
4. One preferred ustekinumab product2
5. etanercept (Enbrel®)
6. guselkumab (Tremfya®)
7. risankizumab (Skyrizi™)
8. tofacitinib (Xeljanz® tablet and oral solution, Xeljanz® XR tablets)
9. upadacitinib (Rinvoq/Rinvoq LQ®)
10. ixekizumab (Taltz®)
11. apremilast (Otezla®, Otezla XR®)
12. deucravacitinib (Sotyktu®); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Methotrexate injection (i.e., Otrexup®, Rasuvo®, Reditrex™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of psoriatic arthritis (PsA); and
2. Prescribed by or in consultation with a rheumatologist or dermatologist; and
3. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate oral methotrexate; and
4. For Otrexup™ and Reditrex™ only: Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate Rasuvo®; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA: Preferred adalimumab product1, certolizumab (Cimzia®), Preferred ustekinumab product2, apremilast (Otezla®, Otezla XR®), golimumab (Simponi®), guselkumab (Tremfya®), abatacept (Orencia® SQ), tofacitinib (Xeljanz® tablet and oral solution, Xeljanz® XR tablets), Ixekizumab (Taltz®), etanercept (Enbrel®), secukinumab (Cosentyx®), methotrexate injection (i.e., Otrexup®, Rasuvo®, Reditrex™), upadacitinib (Rinvoq™®, Rinvoq LQ®), risankizumab (Skyrizi® SQ), deucravacitinib (Sotyktu®) or bimekizumab (Bimzelx®) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by at least one of the following:
1. Reduction in the total active (swollen and tender) joint count from baseline; or
2. Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline; or
3. Reduction in the body surface area involvement from baseline; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Plaque Psoriasis (PsO)

INITIAL CRITERIA: Preferred adalimumab product1 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe chronic plaque psoriasis; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response of inability to tolerate ONE of the following: topical calcipotriene containing products, topical anthralin, topical steroids, topical immune modulators (Elidel®, Protopic®), topical retinoids; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Certolizumab (Cimzia®), deucravacitinib (Sotyktu™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe chronic plaque psoriasis; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response of inability to tolerate ONE of the following: topical calcipotriene containing products, topical anthralin, topical steroids, topical immune modulators (Elidel®, Protopic®), topical retinoids; and
5. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Guselkumab (Tremfya®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe chronic plaque psoriasis; and
2. Member is 6 years of age or older and weighs at least 40kg; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following: topical calcipotriene containing products, topical anthralin, topical steroids, topical immune modulators (Elidel®, Protopic®), topical retinoid; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Apremilast (Otezla®, Otezla XR®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of plaque psoriasis; and
2. Both of the following:
1. Member is 6 years of age or older; and
2. Member weighs at least 20 kg; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response of inability to tolerate ONE of the following: topical calcipotriene containing products, topical anthralin, topical steroids, topical immune modulators (Elidel®, Protopic®), topical retinoids; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Risankizumab (Skyrizi® SQ), preferred ustekinumab product2 or ixekizumab (Taltz™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe chronic plaque psoriasis; and
2. Member is 6 years of age or older; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response of inability to tolerate ONE of the following: topical calcipotriene containing products, topical anthralin, topical steroids, topical immune modulators (Elidel®, Protopic®), topical retinoids; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Secukinumab (Cosentyx™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe chronic plaque psoriasis; and
2. Member is 6 years of age or older; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following: topical calcipotriene containing products, topical anthralin, topical steroids, topical immune modulators (Elidel®, Protopic), topical retinoids; and
5. One of the following:
1. BOTH of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following:
1. certolizumab (Cimzia®)
2. One preferred adalimumab product1
3. One preferred ustekinumab product2
4. etanercept (Enbrel®)
5. guselkumab (Tremfya®)
6. risankizumab (Skyrizi™)
7. apremilast (Otezla®, Otezla XR®)
8. icotrokinra (Icotyde™)
9. deucravacitinib (Sotyktu®); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate BOTH ixekizumab (Taltz®) and bimekizumab (Bimzelx®); or
2. BOTH of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
2. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate BOTH ixekizumab (Taltz®) and bimekizumab (Bimzelx®); and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Etanercept (Enbrel®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe chronic plaque psoriasis; and
2. Member is 4 years of age or older; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following: topical calcipotriene containing products, topical anthralin, topical steroids, topical immune modulators (Elidel®, Protopic), topical retinoids; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Methotrexate injection (i.e., Otrexup™, Rasuvo®, Reditrex™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of severe psoriasis; and
2. Member is age 18 years or older; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response to ALL other standard therapy (e.g., oral methotrexate, all topical therapy modalities, phototherapy, etc.); and
5. For Otrexup™ and Reditrex™ only: Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate Rasuvo®; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Bimekizumab (Bimzelx®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe chronic plaque psoriasis; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following: topical calcipotriene containing products, topical anthralin, topical steroids, topical immune modulators (Elidel®, Protopic), topical retinoids; and
5. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following:
1. certolizumab (Cimzia®),
2. One preferred adalimumab product1
3. One preferred ustekinumab product2
4. etanercept (Enbrel®)
5. guselkumab (Tremfya®)
6. risankizumab (Skyrizi™)
7. apremilast (Otezla®, Otezla XR®)
8. ixekizumab (Taltz®)
9. icotrokinra (Icotyde™)
10. deucravacitinib (Sotyktu®); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: icotrokinra (Icotyde™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe chronic plaque psoriasis (PsO); and

2. Both of the following:
1. Member is 12 years of age or older; and
2. Member weighs at least 40kg; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate a minimum 30-day supply (14-day supply for topical corticosteroids) of one of the following topical therapies:
1. corticosteroids (e.g., betamethasone, clobetasol); or
2. vitamin D analogs (e.g., calcitriol, calcipotriene); or
3. tazarotene; or
4. calcineurin inhibitors (e.g., tacrolimus, pimecrolimus); and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Preferred adalimumab product1, guselkumab (Tremfya®), certolizumab (Cimzia®), risankizumab (Skyrizi® SQ), apremilast (Otezla®, Otezla XR®), Preferred ustekinumab product2, secukinumab (Cosentyx™), ixekizumab (Taltz™), etanercept (Enbrel®), deucravacitinib (Sotyktu™), bimekizumab (Bimzelx®), icotrokinra (Icotyde™) or methotrexate injection (i.e., Otrexup™, Rasuvo®, Reditrex™) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by one of the following:
1. Reduction in body surface area (BSA) involvement from baseline; or
2. Improvement in symptoms (e.g., pruritus, inflammation) from baseline; and
2. For secukinumab (Cosentyx) only, paid claim or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate BOTH ixekizumab (Taltz) and bimekizumab (Bimzelx®); and
3. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

INITIAL CRITERIA Brodalumab (Siliq™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe chronic plaque psoriasis; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a dermatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following: topical calcipotriene containing products, topical anthralin, topical steroids, topical immune modulators (Elidel®, Protopic®), topical retinoids; and
5. One of the following:
1. BOTH of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. One preferred ustekinumab product2
3. certolizumab (Cimzia®
4. etanercept (Enbrel®)
5. risankizumab (Skyrizi)
6. guselkumab (Tremfya®)
7. apremilast (Otezla®, Otezla XR®)
8. icotrokinra (Icotyde™)
9. deucravacitinib (Sotyktu®); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate BOTH bimekizumab (Bimzelx) and ixekizumab (Taltz®); or
2. BOTH of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
2. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate BOTH bimekizumab (Bimzelx) and ixekizumab (Taltz®); and
6. Member has been evaluated for depression and suicidal ideations using the Patient Health Questionnaire (PHQ)-9; and
7. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
8. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 16 weeks

REAUTHORIZATION CRITERIA Brodalumab (Siliq™) is medically necessary when ALL of the following are met:

1. Member has positive response to therapy with brodalumab (Siliq®) as evidenced by one of the following:
1. Reduction of the body surface area (BSA) involvement from baseline; or
2. Improvement in symptoms (e.g., pruritus, inflammation) from baseline; and
2. Paid claim or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate bimekizumab (Bimzelx) and ixekizumab (Taltz); and
3. Member has been evaluated for depression and suicidal ideations using the Patient Health Questionnaire (PHQ)-9; and
4. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Crohn’s Disease (CD)

INITIAL CRITERIA: Preferred adalimumab product1 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe Crohn's disease; and
2. Member is 6 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate the following conventional therapy: one corticosteroid (e.g., budesonide (Entocort® EC), prednisone, hydrocortisone, methylprednisolone); and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Certolizumab (Cimzia®), Preferred ustekinumab product2, guselkumab (Tremfya® SQ), mirikizumab (Omvoh® SQ) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe Crohn's disease; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate the following conventional therapy: one corticosteroid (e.g., budesonide (Entocort® EC), prednisone, hydrocortisone, methylprednisolone); and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Risankizumab (Skyrizi® SQ) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe Crohn's disease; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming ONE of the following:
1. Member had inadequate response or inability to tolerate the following conventional therapy: one corticosteroid (e.g., budesonide (Entocort® EC), prednisone, hydrocortisone, methylprednisolone); or
2. Risankizumab (Skyrizi® SQ) will be used as a maintenance dose following the intravenous induction doses; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Upadacitinib (Rinvoq®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe Crohn's disease; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate the following conventional therapy: one corticosteroid (e.g., budesonide (Entocort® EC), prednisone, hydrocortisone, methylprednisolone); and
6. One of the following:
1. Member has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, golimumab); or
2. If treatment is inadvisable (i.e., contraindication) with a TNF inhibitor, member has had a trial of a systemic therapy approved for CD (e.g., guselkumab, mirikizumab-mrkz, risankizumab-rzaa, ustekinumab); and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Methotrexate injection (i.e., Otrexup™, Rasuvo®, Reditrex™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe Crohn's disease; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. For Otrexup™ and Reditrex™ only: Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate Rasuvo®; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Infliximab (Zymfentra™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderately to severely active Crohn's disease; and
2. Member is 18 years of age or older; and
3. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
4. ONE of the following:
1. BOTH of the following:
1. Paid claims of submission of medical records (e.g., chart notes) confirming that the member had Inadequate response or inability to tolerate the following conventional therapy: one corticosteroid (e.g., budesonide (Entocort® EC), prednisone, hydrocortisone, methylprednisolone); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. Certolizumab (Cimzia®)
3. Risankizumab (Skyrizi®)
4. Upadacitinib (Rinvoq®)
5. One preferred ustekinumab product2
6. Guselkumab (Tremfya® SQ)
7. Mirikizumab (Omvoh® SQ); or
2. Submission of medical records (e.g., chart notes) confirming that the member has achieved a clinical response following a minimum of 10 weeks of IV infliximab; and
5. Prescribed by or in consultation with a gastroenterologist; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Vedolizumab (Entyvio®) SQ is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderately to severely active Crohn's disease; and
2. Member is 18 years of age or older; and
3. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
4. ONE of the following:
1. BOTH of the following:
1. Paid claims of submission of medical records (e.g., chart notes) confirming that the member had Inadequate response or inability to tolerate the following conventional therapy: one corticosteroid (e.g., budesonide (Entocort® EC), prednisone, hydrocortisone, methylprednisolone); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. Certolizumab (Cimzia®)
3. Risankizumab (Skyrizi®)
4. One preferred ustekinumab product2
5. Upadacitinib (Rinvoq®)
6. Guselkumab (Tremfya® SQ)
7. Mirikizumab (Omvoh® SQ); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming ONE of the following:
1. Will be used as maintenance dose following two doses of Entyvio IV for induction; or
2. Member is currently established on Entyvio IV; and
5. Prescribed by or in consultation with a gastroenterologist; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Preferred adalimumab product1, certolizumab (Cimzia®), Preferred ustekinumab product2, risankizumab (Skyrizi® SQ), infliximab (Zymfentra™), vedolizumab (Entyvio®), methotrexate injection (i.e., Otrexup™, Rasuvo®, Reditrex™), upadacitinib (Rinvoq®), guselkumab (Tremfya® SQ), mirikizumab (Omvoh® SQ) is medically necessary when BOTH of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following:
1. Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline; or
2. Reversal of high fecal output state; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Ulcerative Colitis (UC)

INITIAL CRITERIA: Preferred ustekinumab product2 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe ulcerative colitis (UC); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following conventional therapies: corticosteroids, azathioprine; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Golimumab (Simponi®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe ulcerative colitis (UC); and
2. Member weighs at least 15kg*; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following conventional therapies: corticosteroids, azathioprine; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

*The weight listed is only applicable to the pediatric population.

INITIAL CRITERIA: Risankizumab (Skyrizi® SQ), guselkumab (Tremfya® SQ), mirikizumab (Omvoh® SQ) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe ulcerative colitis (UC); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming ONE of the following:
1. member had inadequate response or inability to tolerate ONE of the following conventional therapies: corticosteroids, azathioprine; or
2. Risankizumab-rzaa (Skyrizi® SQ), guselkumab (Tremfya® SQ), mirikizumab (Omvoh® SQ) will be used as a maintenance dose following the intravenous induction doses; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Preferred adalimumab product1 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe ulcerative colitis (UC); and
2. Member is 5 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following conventional therapies: corticosteroids, azathioprine; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Ozanimod (Zeposia®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe ulcerative colitis (UC); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following conventional therapies: corticosteroids, azathioprine; and
5. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. One preferred ustekinumab product2
3. golimumab (Simponi®)
4. upadacitinib (Rinvoq®)
5. Risankizumab (Skyrizi®)
6. tofacitinib (Xeljanz®/Xeljanz® XR)
7. guselkumab (Tremfya® SQ)
8. Mirikizumab (Omvoh® SQ)
9. Etrasimod (Velsipity®); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Etrasimod (Velsipity™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe ulcerative colitis (UC); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following conventional therapies: corticosteroids, azathioprine; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Tofacitinib (Xeljanz®/Xeljanz® XR tablets/extended-release tablets), or upadacitinib (Rinvoq®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe ulcerative colitis (UC); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ONE of the following conventional therapies: corticosteroids, azathioprine; and
5. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate ONE of more TNF inhibitors (e.g., adalimumab, golimumab); or
2. If treatment is inadvisable (i.e., contraindication) with a TNF inhibitor, member has had a trial of a systemic therapy approved for UC (e.g., etrasimod, guselkumab, mirikizumab-mrkz, risankizumab-rzaa, ustekinumab); or
3. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
6. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Vedolizumab (Entyvio®) SQ is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe Ulcerative colitis (UC); and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a gastroenterologist; and
4. ONE of the following:
1. BOTH of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had Inadequate response or inability to tolerate ONE of the following conventional therapies: corticosteroids, azathioprine; and
2. Paid claims or submission of medical records (e.g., chart notes) confirming inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. One preferred ustekinumab product2
3. Golimumab (Simponi®)
4. Upadacitinib (Rinvoq®)
5. Risankizumab (Skyrizi®)
6. Tofacitinib (Xeljanz®/Xeljanz® XR)
7. Guselkumab (Tremfya® SQ)
8. Mirikizumab (Omvoh® SQ)
9. Etrasimod (Velsipity®); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming ONE of the following:
1. Will be used as a maintenance dose following two doses of Entyvio IV for induction; or
2. Member is currently established on Entyvio IV; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Infliximab (Zymfentra™) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderately to severely active ulcerative colitis; and
2. Member is 18 years of age or older; and
3. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
4. ONE of the following:
1. BOTH of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had Inadequate response or inability to tolerate ONE of the following conventional therapies: corticosteroids, azathioprine; and
2. Paid claims or submission of medical records (e.g., chart notes) confirming inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1
2. One preferred ustekinumab product2
3. Golimumab (Simponi®)
4. Upadacitinib (Rinvoq®)
5. Risankizumab (Skyrizi®)
6. Tofacitinib (Xeljanz®/Xeljanz® XR)
7. Guselkumab (Tremfya® SQ)
8. Mirikizumab (Omvoh® SQ)
9. Etrasimod (Velsipity®); or
2. Submission of medical records (e.g., chart notes) confirming that the member has achieved a clinical response to therapy following a minimum of 10 weeks of IV infliximab; and
5. Prescribed by or in consultation with a gastroenterologist; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Preferred adalimumab product1, Preferred ustekinumab product2, golimumab (Simponi®), tofacitinib (Xeljanz® /Xeljanz® XR tablets/extended-release tablets), upadacitinib (Rinvoq®), ozanimod (Zeposia®), mirikizumab (Omvoh™), etrasimod (Velsipity™), vedolizumab (Entyvio®) SQ, infliximab (Zymfentra™), Risankizumab (Skyrizi® SQ), guselkumab (Tremfya® SQ) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by at least one of the following:
1. Improvement in intestinal inflammation (e.g., mucosal healing, improvement in lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline; or
2. Reversal of high fecal output state; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Cryopyrin-Associated Periodic Syndrome (CAPS)

INITIAL CRITERIA: Anakinra (Kineret®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of Neonatal-Onset Multisystem Inflammatory Disease (NOMID); and
2. Prescribed by or in consultation with a rheumatologist or other appropriate specialist; and
3. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
4. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Anakinra (Kineret®) is medically necessary when ALL of the following are met:

1. Documentation of positive clinical response to therapy; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

INITIAL CRITERIA: Rilonacept (Arcalyst®) is medically necessary when there ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS) including Familial cold Auto-Inflammatory Syndrome (FCAS) and/or Muckle-Wells Syndrome (MWS); and
2. Prescribed by or in consultation with an immunologist, allergist, dermatologist, rheumatologist, neurologist, or other medical specialist; and
3. Member is 12 years of age or older; and
4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA rilonacept (Arcalyst®) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by one of the following:
1. Improvement in rash, fever, joint pain, headache, or conjunctivitis; or
2. Decreased number of disease flare days; or
3. Normalization of inflammatory markers (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], serum amyloid A [SAA]); or
4. Corticosteroid dose reduction; or
5. Improvement in MD global score or active joint count; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Hidradenitis Suppurativa

INITIAL CRITERIA: Preferred adalimumab product1 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe hidradenitis suppurativa (i.e., Hurley stage II or III); and
2. Prescribed by or in consultation with a dermatologist; and
3. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
4. Member is 12 years of age or older; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: bimekizumab-bkzx (Bimzelx®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe hidradenitis suppurativa (i.e., Hurley stage II or III); and
2. Member is 18 years of age or older; and
3. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate ONE preferred adalimumab product1; or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than 45 days gap in therapy; and
4. Prescribed by or in consultation with a dermatologist; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Secukinumab (Cosentyx®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of moderate to severe hidradenitis suppurativa (i.e., Hurley stage II or III); and
2. Member is 12 years of age or older; and
3. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate TWO of the following:
1. One preferred adalimumab product1; and
2. Bimekizumab-bkzx (Bimzelx®); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
4. Prescribed by or in consultation with a dermatologist; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Preferred adalimumab product1, bimekizumab-bkzx (Bimzelx®), Secukinumab (Cosentyx®) is medically necessary when BOTH ALL of the following are met:

1. There is documentation of positive clinical response to therapy; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Uveitis

INITIAL CRITERIA: Preferred adalimumab product1 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of non-infectious intermediate, posterior, or panuveitis; and
2. Prescribed by or in consultation with an ophthalmologist or rheumatologist; and
3. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate ophthalmic and oral corticosteroids; and
4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. Member is 2 years of age or older; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Preferred adalimumab product1 is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Giant Cell Arteritis

INITIAL CRITERIA: upadacitinib (Rinvoq), preferred tocilizumab product3 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of Giant Cell Arteritis; and
2. Prescribed by or in consultation with a rheumatologist; and
3. Member is 18 years of age or older; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had inadequate response or inability to tolerate a glucocorticoid (i.e., prednisone); and
5. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested 

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA upadacitinib (Rinvoq), preferred tocilizumab product3 is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Systemic Juvenile Idiopathic Arthritis

INITIAL CRITERIA: preferred tocilizumab product3 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active systemic juvenile idiopathic arthritis (SIJA); and
2. Prescribed by or in consultation with a rheumatologist; and
3. Member is 2 years of age or older; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate ONE of the following conventional therapies at maximally tolerated doses:
1. Non-steroidal anti-inflammatory drug (NSAID) (e.g., ibuprofen); or
2. Systemic glucocorticoid (e.g., prednisone)
3. DMARDs (e.g., leflunomide, methotrexate); and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA preferred tocilizumab product3 is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by at least one of the following:
1. Reduction in the total active (swollen and tender) joint count from baseline; or
2. Improvement in clinical features or symptoms (e.g., pain, fever, inflammation, rash, lymphadenopathy, serositis) from baseline; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Non-radiographic axial spondyloarthritis (nr-axSpA)

INITIAL CRITERIA: Certolizumab (Cimzia®), Ixekizumab (Taltz®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation; and
2. Member has objective signs of inflammation (e.g., C-reactive protein [CRP] levels above the upper limit of normal and/or sacrolitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints); and
3. Member is 18 years of age or older; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming inadequate response or inability to tolerate two different NSAIDs (e.g., diclofenac, meloxicam, naproxen) at maximally tolerated doses; and
5. Prescribed by or in consultation with a rheumatologist; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA Upadacitinib (Rinvoq®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation; and
2. Member has objective signs of inflammation (e.g., C-reactive protein [CRP] levels above the upper limit of normal and/or sacrolitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints); and
3. Member is 18 years of age or older; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming inadequate response or inability to tolerate two different NSAIDs (e.g., diclofenac, meloxicam, naproxen) at maximally tolerated doses; and
5. Prescribed by or in consultation with a rheumatologist; and
6. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
7. Member has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., certolizumab pegol); and
8. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Secukinumab (Cosentyx®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation; and
2. Member has objective signs of inflammation (e.g., C-reactive protein [CRP] levels above the upper limit of normal and/or sacrolitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints); and
3. Member is 18 years of age or older; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming inadequate response or inability to tolerate two different NSAIDs (e.g., diclofenac, meloxicam, naproxen) at maximally tolerated doses; and
5. Prescribed by or in consultation with a rheumatologist; and
6. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate ALL of the following: certolizumab (Cimzia®), Upadacitinib (Rinvoq™), Ixekizumab (Taltz®), and bimekizumab (Bimzelx®); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than a 45-day gap in therapy; and
7. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
8. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Bimekizumab (Bimzelx®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation; and
2. Member has objective signs of inflammation (e.g., C-reactive protein [CRP] levels above the upper limit of normal and/or sacrolitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints); and
3. Member is 18 years of age or older; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming inadequate response or inability to tolerate two different NSAIDs (e.g., diclofenac, meloxicam, naproxen) at maximally tolerated doses; and
5. Prescribed by or in consultation with a rheumatologist; and
6. One of the following:
1. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO of the following:
1. certolizumab (Cimzia®),
2. Upadacitinib (Rinvoq™),
3.  Ixekizumab (Taltz®); or
2. Paid claims or submission of medical records (e.g., chart notes) confirming a continuation of therapy with the requested product, defined as no more than 45-day gap in therapy; and
7. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
8. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Certolizumab (Cimzia®), upadacitinib (Rinvoq™), ixekizumab (Taltz®), secukinumab (Cosentyx®) or Bimekizumab (Bimzelx®) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following:
1. Disease activity (e.g., pain, fatigue, inflammation, stiffness); or
2. Lab values (erythrocyte sedimentation rate, C-reactive protein level); or
3. Function; or
4. Axial status (e.g., lumbar spine motion, chest expansion); or
5. Total active (swollen and tender) joint count; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Ulcer of the mouth associated with Behcet's syndrome

INITIAL CRITERIA: Apremilast (Otezla®, Otezla XR®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of ulcer of the mouth associated with Behcet's syndrome; and
2. Member has active oral ulcers; and
3. Member is 18 years of age or older; and
4. Prescribed by or in consultation with a rheumatologist or dermatologist; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate systemic corticosteroids, topical corticosteroids or topical sucralfate; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Apremilast (Otezla®, Otezla XR®) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by ONE of the following:
1. Reduction in pain from oral ulcers from baseline; or
2. Reduction in number of oral ulcers from baseline; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

INITIAL CRITERIA: Rilonacept (Arcalyst®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes) confirming the use for the maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA); and
2. Member is currently in remission (e.g., no fever, skin rash, and bone pain; no radiological evidence of active bone lesions; C-reactive protein [CRP] less than 5 mg/L); and
3. Member weights at least 10kg; and
4. Prescribed by or in consultation with a rheumatologist or pediatric specialist; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Anakinra (Kineret®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA); and
2. Prescribed by or in consultation with a rheumatologist or pediatric specialist; and
3. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
4. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Rilonacept (Arcalyst®) or anakinra (Kineret®) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Recurrent pericarditis

INITIAL CRITERIA: Rilonacept (Arcalyst®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming use for the treatment of recurrent pericarditis as evidenced by at least 2 episodes that occur a minimum of 4 to 6 weeks apart and reduction in risk of recurrence; and
2. Member is 12 years of age or older; and
3. Submission of medical records (e.g., chart notes) confirming inadequate response or inability to tolerate at least one of the following:
1. NSAID (e.g., ibuprofen, naproxen, aspirin) in combination with colchicine; or
2. Corticosteroids (e.g., prednisone); and
4. Prescribed by or in consultation with a cardiologist; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Rilonacept (Arcalyst®) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

INITIAL CRITERIA: Anakinra (Kineret®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming use for the treatment of recurrent pericarditis as evidenced by at least 2 episodes that occur a minimum of 4 to 6 weeks apart and reduction in risk of recurrence; and
2. Member is 18 years of age or older; and
3. Submission of medical records (e.g., chart notes) confirming inadequate response or inability to tolerate at least one of the following:
1. NSAID (e.g., ibuprofen, naproxen, aspirin) in combination with colchicine; or
2. Corticosteroids (e.g., prednisone); and
4. Prescribed by or in consultation with a cardiologist; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA Anakinra (Kineret®) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Systemic sclerosis-associated interstitial lung disease 

INITIAL CRITERIA: preferred tocilizumab product3 is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) confirmed by a High-Resolution CT scan or biopsy; and
2. Member is 18 years of age or older; and
3. Prescribed by or in consultation with a pulmonologist or rheumatologist; and
4. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
5. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA preferred tocilizumab product3 is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Active enthesitis-related arthritis 

INITIAL CRITERIA: Secukinumab (Cosentyx®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of active enthesitis-related arthritis (ERA); and
2. Member is 4 years of age or older; and
3. Prescribed by or in consultation with a rheumatologist; and
4. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen) at maximally tolerated doses; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested 

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA: Secukinumab (Cosentyx®) is medically necessary when ALL of the following are met:

1. There is documentation of positive clinical response to therapy as evidenced by at least one of the following:
1. Reduction in the total active (swollen and tender) joint count from baseline; or
2. Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Atopic dermatitis 

INITIAL CRITERIA: Upadacitinib (Rinvoq™) is medically necessary when ALL of the following are met:

1. Diagnosis of refractory, moderate to severe atopic dermatitis; and
2. One of the following:
1. Involvement of at least 10% body surface area (BSA); or
2. SCORing Atopic Dermatitis (SCORAD) index value of at least 25; and
3. Member is 12 years of age or older; and
4. Prescribed by or in consultation with a dermatologist, allergist or immunologist; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response to a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication (e.g., safety concern, not indicated for member’s age/weight), or inability to tolerate ONE of the following:
1. Topical steroids, medium potency or higher; or
2. Topical tacrolimus; or
3. Topical pimecrolimus; or
4. Eucrisa; or
5. Opzelura; or
6. Vtama; or
7. Zoryve 0.15% cream; and
6. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate ONE systemic drug product for the treatment of atopic dermatitis (example include, but are not limited to Adbry [tralokinumab-Idrm], Dupixent [dupilumab], etc.); and
7. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
8. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Abrocitinib (Cibinqo™) is medically necessary when ALL of the following are met:

1. Diagnosis of refractory, moderate to severe atopic dermatitis; and
2. One of the following:
1. Involvement of at least 10% body surface area (BSA); or
2. SCORing Atopic Dermatitis (SCORAD) index value of at least 25; and
3. Member is 12 years of age or older; and
4. Prescribed by or in consultation with a dermatologist, allergist or immunologist; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response to a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication (e.g., safety concern, not indicated for member’s age/weight), or inability to tolerate ONE of the following:
1. Topical steroids, medium potency or higher; or
2. Topical tacrolimus; or
3. Topical pimecrolimus; or
4. Eucrisa; or
5. Opzelura; or
6. Vtama; or
7. Zoryve 0.15% cream; and
6. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response or inability to tolerate ONE systemic drug product for the treatment of atopic dermatitis (examples include, but are not limited to Adbry [tralokinumab-Idrm], Dupixent [dupilumab], etc.); and
7. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
8. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Tralokinumab-idrm (Adbry®) is medically necessary when ALL of the following are met:

1. Member is 12 years of age or older; and
2. Diagnosis of moderate-severe atopic dermatitis; and
3. One of the following:
1. Involvement of at least 10% body surface area (BSA); or
2. SCORing Atopic Dermatitis (SCORAD) index value of at least 25; and
4. Prescribed by or in consultation with a dermatologist, allergist or immunologist; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response to a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication (e.g., safety concern, not indicated for member’s age/weight), or inability to tolerate ONE of the following:
1. Topical steroids, medium potency or higher; or
2. Topical tacrolimus; or
3. Topical pimecrolimus; or
4. Eucrisa; or
5. Opzelura; or
6. Vtama; or
7. Zoryve 0.15% cream; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Nemolizumab-ilto (Nemluvio®) is medically necessary when ALL of the following are met:

1. Member is 12 years of age or older; and
2. Diagnosis of moderate-severe atopic dermatitis; and
3. One of the following:
1. Involvement of at least 10% body surface area (BSA); or
2. SCORing Atopic Dermatitis (SCORAD) index value of at least 25; and
4. Prescribed by or in consultation with a dermatologist, allergist or immunologist; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response to a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication (e.g., safety concern, not indicated for member’s age/weight), or inability to tolerate ONE of the following:
1. Topical steroids, medium potency or higher; or
2. Topical tacrolimus; or
3. Topical pimecrolimus; or
4. Eucrisa; or
5. Opzelura; or
6. Vtama; or
7. Zoryve 0.15% cream; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Lebrikizumab-lbkz (Ebglyss™) is medically necessary when ALL of the following are met:

1. Member is 12 years of age or older; and
2. Diagnosis of moderate-severe atopic dermatitis; and
3. One of the following:
1. Involvement of at least 10% body surface area (BSA); or
2. SCORing Atopic Dermatitis (SCORAD) index value of at least 25; and
4. Prescribed by or in consultation with a dermatologist, allergist or immunologist; and
5. Paid claims or submission of medical records (e.g., chart notes) confirming an inadequate response to a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication (e.g., safety concern, not indicated for member’s age/weight), or inability to tolerate ONE of the following:
1. Topical steroids, medium potency or higher; or
2. Topical tacrolimus; or
3. Topical pimecrolimus; or
4. Eucrisa; or
5. Opzelura; or
6. Vtama; or
7. Zoryve 0.15% cream; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA: Upadacitinib (Rinvoq™), abrocitinib (Cibinqo™), tralokinumab-idrm (Adbry™), lebrikizumab-lbkz (Ebglyss™), nemolizumab-ilto (Nemluvio®) is medically necessary when ALL of the following are met:

1. Documentation of positive clinical response to therapy (e.g., reduction in body surface area involvement, reduction in pruritus severity); and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Multiple sclerosis 

INITIAL CRITERIA: Ozanimod (Zeposia®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions); and
2. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA: Ozanimod (Zeposia®) is medically necessary when ALL of the following are met:

1. Documentation of positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression); and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Alopecia Areata 

INITIAL CRITERIA: Baricitinib (Olumiant®) is medically necessary when all of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of alopecia areata; and
2. Member is 18 years of age or older; and
3. Member has at least 50% scalp hair loss; and
4. Other causes of hair loss have been rules out (e.g., androgenetic alopecia, trichotillomania, tinea capitis, psoriasis); and
5. Prescribed by or in consultation with a dermatologist; and
6. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: Ritlecitinib (Litfulo™) is medically necessary when all of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of alopecia areata; and
2. Member is 12 years of age or older; and
3. Member has at least 50% scalp hair loss; and
4. Other causes of hair loss have been rules out (e.g., androgenetic alopecia, trichotillomania, tinea capitis, psoriasis); and
5. Prescribed by or in consultation with a dermatologist; and
6. No concurrent therapy with any other biologic DMARD or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

INITIAL CRITERIA: deuruxolitinib (Leqselvi™) is medically necessary when all of the following are met:

1. Submission of medical records (e.g., chart notes, lab values) confirming a diagnosis of alopecia areata; and
2. Member is 18 years of age or older; and
3. Member has at least 50% scalp hair loss; and
4. Other causes of hair loss have been rules out (e.g., androgenetic alopecia, trichotillomania, tinea capitis, psoriasis); and
5. Prescribed by or in consultation with a dermatologist; and
6. Inadequate response or inability to tolerate one previous treatment for alopecia areata (e.g., topical, intralesional, or systemic corticosteroids [e.g., triamcinolone acetonide, prednisone], topical immunotherapy [e.g., diphenylcyclopropenone]); and
7. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
8. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA: Baricitinib (Olumiant ®), Ritlecitinib (Litfulo™), deuruxolitinib (Leqselvi™) is medically necessary when ALL of the following are met:

1. Documentation of positive clinical response to therapy; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Polymyalgia Rheumatica 

INITIAL CRITERIA: Sarilumab (Kevzara®) is medically necessary when ALL of the following are met:

1. Submission of medical records (e.g., chart notes) confirming a diagnosis of polymyalgia rheumatica (PMR); and
2. Paid claims or submission of medical records (e.g., chart notes) confirming that the member had an inadequate response or inability to tolerate corticosteroids (e.g., prednisone); and
3. Prescribed by or in consultation with a rheumatologist; and
4. Member is 18 years of age or older; and
5. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
6. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA: Sarilumab (Kevzara®) is medically necessary when ALL of the following are met:

1. Documentation of positive clinical response to therapy as evidenced by at least one of the following:
1. Improvement in symptoms (e.g., pain, stiffness) or lab values (e.g., C-reactive protein) from baseline; or
2. Reduced need for corticosteroids (e.g., Prednisone), and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months

Prurigo Nodularis

INITIAL CRITERIA: Nemolizumab-ilto (Nemluvio®) is medically necessary when ALL of the following are met:

1. Submission of documentation (e.g., chart notes) confirming a diagnosis of Prurigo Nodularis (PN); and
2. Member is 18 years of age or older; and
3. Member has at least 20 nodular lesions; and
4. Paid claims or submission of documentation (e.g., chart notes) confirming inadequate response or inability to tolerate one previous PN treatment (e.g., topical corticosteroids, topical calcineurin inhibitors, topical capsaicin); and
5. Prescribed by or in consultation with allergist, immunologist or dermatologist; and
6. No concurrent therapy with any other biologic DMARD, or with a JAK inhibitor; and
7. Dosing and frequency does not exceed maximum FDA recommendation per indication requested

Initial authorization duration: 12 months

REAUTHORIZATION CRITERIA: Nemolizumab-ilto (Nemluvio®) is medically necessary when ALL of the following are met:

1. Documentation of a positive clinical response to therapy as evidenced by at least ONE of the following:
1. Reduction in the number of nodular lesions from baseline; or
2. Improvement in symptoms (e.g., pruritus, inflammation) from baseline; and
2. ONE of the following:
1. Dosing and frequency does not exceed maximum FDA recommendation per indication requested; or
2. Member is continuing on the established dose and frequency previously approved

Reauthorization duration: 12 months