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Risankizumab-rzaa (Skyrizi®) for intravenous use
MA08.153c

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member's medical needs and condition.

MEDICALLY NECESSARY

Ulcerative Colitis

Risankizumab-rzaa (Skyrizi) for intravenous use is considered medically necessary and, therefore, covered for moderately to severely active Ulcerative Colitis when all of the following criteria, including dosing and frequency, are met:

  • The individual is 18 years of age or older
  • There is documentation of Inadequate response, contraindication, or intolerance to conventional (non-advanced) and/or advanced therapies of at least one of the following: 
    • Corticosteroids (e.g., budesonide, prednisone, hydrocortisone, methylprednisolone)
    • Biologic therapy (e.g., infliximab [Remicade]), adalimumab [Humira], golimumab [Simponi Aria], vedolizumab [Entyvio])
    • Immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate)
    • JAK Inhibitors (e.g., tofacitinib [Xeljanz], Upadacitinib [Rinvoq])
    • S1P receptor modulators (e.g., ozanimod [Zeposia])
  • Prescribed by or in consultation with a gastroenterologist 
  • No concurrent use with any other biologic therapy (i.e., tumor necrosis factor antagonists) 
  • Dosing and frequency: Induction dosage is 1,200 mg administered by intravenous infusion at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. ​
Crohn's Disease ​
Risankizumab-rzaa (Skyrizi) for intravenous use is considered medically necessary and, therefore, covered for moderately to severely active Crohn's disease when all of the following criteria, including dosing and frequency, are me​t​:
  • The individual is 18 years of age or older​
  • ​There is documentation of failure, contraindication, or intolerance to a trial of at least one of the following:       
    • ​Corticosteroids (e.g., budesonide [Entocort EC], prednisone, hydrocortisone, methylprednisolone)
    • Immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate)
    • Biologic therapy (e.g., certolizumab [Cimzia], adalimumab [Humira], infliximab [Remicade]), ustekinumab (Stelara), vedolizumab [Entyvio]) ​
  • Prescribed by or in consultation with a gastroenterologist 
  • No concurrent use with any other biologic therapy (i.e., tumor necrosis factor antagonists) 
  • Dosing and frequency: 600 mg administered by intravenous infusion at Weeks 0, 4, and 8. (Maintenance doses are administered by subcutaneous injection.)​
​EXPERIMENTAL/INVESTIGATIONAL

All other uses for risankizumab-rzaa (Skyrizi) for intravenous use are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics. 
​
DOSING AND FREQUENCY REQUIREMENTS

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this policy to ensure consistency with the most recently published recommendations for the use of risankizumab-rzaa (Skyrizi)​. Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) to request coverage for an amount of risankizumab-rzaa (Skyrizi) outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia, view our policy on off-label coverage for prescription drugs and biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the utilization management activities. The Company reserves the right to conduct postpayment review and audit procedures for any claims submitted for risankizumab-rzaa (Skyrizi)​.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.​

When coverage of risankizumab-rzaa (Skyrizi)​ is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.​

Guidelines

There is no Medicare coverage determination addressing risankizumab-rzaa (Skyrizi) for intravenous use; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the applicable Evidence of Coverage, risankizumab-rzaa (Skyrizi) for intravenous use is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria and Dosing and Frequency Requirements l​isted in this medical policy are met.

​For Medicare Advantage members, certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances risankizumab-rzaa (Skyrizi) for intravenous use is covered under a member's medical benefit (Part B benefit). It does not address instances when risankizumab-rzaa (Skyrizi) for intravenous use is covered under a member’s pharmacy benefit (Part D benefit).​

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Risankizumab-rzaa (Skyrizi) for intravenous use was approved by the US Food and Drug Administration (FDA) on June 16, 2022, for the treatment of moderately to severely active Crohn's disease in adults.

Supplemental approvals for risankizumab-rzaa (Skyrizi) have since been issued by the FDA.​

PEDIATRIC USE
The safety and effectiveness in pediatric individuals have not been established.​

Description

ULCERATIVE COLITIS AND CROHN'S DISEASE 

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract of unknown etiology. IBD has two major categories: ulcerative colitis (UC) and Crohn's disease (CD). The most common symptoms in UC and CD are diarrhea, rectal bleeding, urgency to have bowel movements, abdominal cramps, pain, fever, and weight loss. Although UC and CD have similar clinical presentations, they differ in the body areas affected. UC primarily causes inflammation of the mucosal lining and is generally limited to the colon and rectum, whereas CD affects the entire digestive system and can produce ulcers that extend deep into the intestinal wall. For the treatment of Crohn's disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline, and during induction at least up to 12 weeks of treatment. Monitor thereafter according to routine patient management.​

The treatment of UC and CD is focused on stopping the inflammation and preventing flare-ups. The type of treatment depends on the type and severity of symptoms. Mild symptoms may respond to an antidiarrheal medicine such as loperamide (e.g., Imodium). Treatment for individuals who may be having mild-to-moderate symptoms include aminosalicylates and antibiotics, whereas individuals with severe symptoms may be treated with corticosteroids, immunomodulators, or biologics.

RISANKIZUMAB-RZAA (SKYRIZI)

Risankizumab-rzaa (Skyrizi) is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds to the p19 subunit of human interleukin-23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Risankizumab-rzaa inhibits the release of proinflammatory cytokines and chemokines. Risankizumab-rzaa (Skyrizi) was first approved in the United States in April 2019 as a subcutaneous injection to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; supplemental approvals for this formulation have since been issued by the US Food and Drug Administration (FDA).​ Risankizumab-rzaa (Skyrizi) for intravenous (IV) use was approved by the FDA on June 16, 2022, for the treatment of moderately ​to severely active Crohn's disease in adults.​ 

The recommended induction dosage is 600 mg administered by intravenous infusion over a period of at least 1 hour at Week 0, Week 4, and Week 8.​ The recommended maintenance dosage is 180mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage needed to maintain therapeutic response.

ULCERATIVE COLITIS PEER-REVIEWED LITERATURE  
Summary
 
The approval for risankizumab-rzaa (Skyrizi) for IV use is based on 12-week, phase 3, double-blind, randomized, placebo-controlled induction study. INSPIRE (n=650) evaluated the efficacy and safety of risankizumab-rzaa (Skyrizi) 1200 mg IV at weeks 0,4, and 8 compared with a placebo as induction therapy for with moderately to severely active ulcerative colitis (defined as adapted Mayo score of 5-9 and endoc subscore of 2-3 (central review) with biopsy confirmed diagnosis ≥3 months prior to baseline) who had an intolerance or inadequate response to conventional (non-advanced) and/or advanced therapies (e.g., infliximab, adalimumab, golimumab, vedolizumab, tofacitinib, filgotinib, upadacinib, ozanimod). At Week 12, the treatment difference of clinical remission between risankizumab-rzaa (Skyrizi) 1200 mg IV at Weeks 0, 4, 8, and placebo was 14%, which is statistically significant (P<0.001). The treatment difference of endoscopic response was >24% increase from baseline between risankizumab-rzaa (Skyrizi) and placebo at Week 12 (risankizumab-rzaa (Skyrizi) 36.5%, placebo 12.1%, P<0.001).

Adverse event rates were consistent with the known safety profile of risankizumab-rzaa (Skyrizi) across inflammatory bowel syndrome and other indications. No new safety risks were observed. Adverse event rates were similar among groups, and the most frequently reported adverse events in all treatment groups were worsening ulcerative colitis, COVID-19, and anemia.

A total of 584 participants who achieved clinical response after 12 weeks of induction treatment  enrolled in the maintenance study (COMMAND), based on 52-week, phase 3, multicenter, randomized, double-blind, placebo-controlled, maintenance studies evaluating the efficacy and safety of risankizumab-rzaa (Skyrizi) 180mg and 360mg SC compared to the withdrawal from risankizumab-rzaa (Skyrizi) IV induction only treatment as the control group), as maintenance therapy for participants with moderately to severely active Ulcerative Colitis who responded to induction treatment. Participants were randomly assigned to receive a maintenance regimen of risankizumab-rzaa (Skyrizi) 180 mg or 360 mg subcutaneously or placebo at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks. At Week 52, the treatment difference of clinical remission between risankizumab-rzaa (Skyrizi)  and placebo was 20% at the 180 mg dose and 16% at the 360mg dose (p<0.001). The treatment difference of endoscopic response between risankizumab-rzaa (Skyrizi) and placebo at Week 12 was 20.1% at the 180mg dose and 17.4 % at the 360mg dose (p<0.001).​

​​
CROHN'S DISEASE PEER-REVIEWED LITERATURE  
Summary

The approval for risankizumab-rzaa (Skyrizi) for IV use is based on two 12-week, phase 3, multicenter, double-masked, randomized, placebo-controlled induction studies: ADVANCE (n=931) and MOTIVATE (n=618). Participants who had moderately to severely active Crohn's disease (defined as Crohn’s Disease Activity Index [CDAI] of 220 to 450 and Simple Endoscopic Score for Crohn’s disease [SES-CD] ≥6 [or ≥4 for isolated ileal disease]) and had inadequate response, loss of response, or intolerance to oral aminosalicylates, corticosteroids, immunomodulators, and/or biologic therapy. All participants in the MOTIVATE study and approximately half of the participants in the ADVANCE study had previously tried at least one biologic; approximately half of the participants in both studies had prior therapy with an anti-TNF agent. At Week 12, the treatment difference of clinical remission (defined as CDAI <150) between risankizumab-rzaa (Skyrizi)​ 600 mg IV at Weeks 0, 4, 8, and placebo was 21% (ADVANCE) and 22% (MOTIVATE) (P<0.001). The treatment difference of endoscopic response (defined as a >50% decrease in SES-CD from baseline [or for isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline]) between risankizumab-rzaa (Skyrizi)​ and placebo at Week 12 was 28% (ADVANCE) and 18% (MOTIVATE) (P<0.001). 
​
A total of 542 participants who achieved clinical response (defined as a reduction in CDAI of at least 100 points from baseline) after 12 weeks of induction treatment​ enrolled in the the maintenance study (FORTIFY), a phase 3 multicenter, randomized, double-blind, placebo-controlled, maintenance withdrawal ​study. Participants were randomly assigned to receive a maintenance regimen of risankizumab-rzaa (Skyrizi) 360 mg subcutaneously or placebo at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks. At Week 52, the treatment difference of clinical remission between risankizumab-rzaa (Skyrizi)​ and placebo was 14%. The treatment difference of endoscopic response between risankizumab-rzaa (Skyrizi)​ and placebo at Week 12 was 31% (​P<0.05). Adverse event rates were similar among groups, and the most frequently reported adverse events in all treatment groups were worsening Crohn's disease, arthralgia, and headache.
​
OFF-LABEL INDICATION

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.​

References

American Hospital Formulary Service–Drug Information (AHFS-DI). Risankizumab. [LexiComp Web site]. 03/10/2024. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 26, 2024.


Barberio B, Gracie DJ, Black CJ, Ford AC. Efficacy of biological therapies and small molecules in induction and maintenance of remission in luminal Crohn's disease: systematic review and network meta-analysis. Gut. 2023 Feb;72(2):264-274.


D'Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030.


Elsevier's Clinical Pharmacology Compendium. Risankizumab . 03/08/2024. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/  [via subscription only]. Accessed August 26, 2024.


Ferrante M, Panaccione R, Baert F, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046.


Feuerstein JD, Ho EY, Shmidt E, et al.; American Gastroenterological Association Institute Clinical Guidelines Committee. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021;160(7):2496-508. Available at: https://gastro.org/clinical-guidance/medical-management-of-moderate-to-severe-luminal-and-perianal-fistulizing-crohns-disease/. Accessed August 26, 2024.


Feuerstein JD, Isaacs KL, Schneider Y, Siddique SM, Falck-Ytter Y, Singh S; AGA Institute Clinical Guidelines Committee. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020 Apr;158(5):1450-1461.


Lexi-Drugs Compendium. Risankizumab . 02/29/2024. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 26, 2024.


Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG Clinical Guideline: Management of Crohn's Disease in Adults. Am J Gastroenterol. 2018;113(4):481-517.


Louis E, Schreiber S, Panaccione R, Bossuyt P, Biedermann L, Colombel JF, Parkes G, Peyrin-Biroulet L, D'Haens G, Hisamatsu T, Siegmund B, Wu K, Boland BS, Melmed GY, Armuzzi A, Levine P, Kalabic J, Chen S, Cheng L, Shu L, Duan WR, Pivorunas V, Sanchez Gonzalez Y, D'Cunha R, Neimark E, Wallace K, Atreya R, Ferrante M, Loftus EV Jr; INSPIRE and COMMAND Study Group. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. 2024 Sep 17;332(11):881-897. doi: 10.1001/jama.2024.12414. PMID: 39037800; PMCID: PMC11264075.


Louis E, Schreiber S, Panaccione R, et al. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. 2024;332(11):881–897. doi:10.1001/jama.2024.12414.


Novitas Solutions, Inc. Article (A53127) Self-Administered Drug Exclusion List [Novitas Medicare Services Web site]. Original 10/01/2015. Revised 03/17/2024. Available at: Article - Self-Administered Drug Exclusion List: (A53127) (cms.gov). Accessed August 26, 2024.


Risankizumab-rzaa [prescribing information]. North Chicago, IL: AbbVie Inc. 03/2024. Available at: https://www.skyrizi.com/. Accessed August 26, 2024.


Singh S, Murad MH, Fumery M, et al. Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2021;6(12):1002-1014.


Singh, S., Loftus, E. V., . Limketkai, B. N., Haydek, J. P., Agrawal, M., Scott, F. I., & Ananthakrishnan, A. N. (n.d.). AGA LIVING GUIDELINES: PHARMACOLOGICAL MANAGEMENT OF MODERATE-TO[1]2 SEVERE ULCERATIVE COLITIS.


Terdiman JP, Gruss CB, Heidelbaugh JJ, et al.; AGA Institute Clinical Practice and Quality Management Committee. American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. Gastroenterology. 2013;145(6):1459-1463.


Truven Health Analytics. Micromedex® DrugDex® Compendium. Risankizumab-rzaa . 03/20/2024. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed August 26, 2024.


US Food and Drug Administration (FDA). Risankizumab-rzaa [prescribing information]. [FDA Web site]. 03/2024. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed August 26, 2024.

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)

K50.00Crohn's disease of small intestine without complications
K50.011Crohn's disease of small intestine with rectal bleeding
K50.012Crohn's disease of small intestine with intestinal obstruction
K50.013Crohn's disease of small intestine with fistula
K50.014Crohn's disease of small intestine with abscess
K50.018Crohn's disease of small intestine with other complication
K50.019Crohn's disease of small intestine with unspecified complications
K50.10Crohn's disease of large intestine without complications
K50.111Crohn's disease of large intestine with rectal bleeding
K50.112Crohn's disease of large intestine with intestinal obstruction
K50.113Crohn's disease of large intestine with fistula
K50.114Crohn's disease of large intestine with abscess
K50.118Crohn's disease of large intestine with other complication
K50.119Crohn's disease of large intestine with unspecified complications
K50.80Crohn's disease of both small and large intestine without complications
K50.811Crohn's disease of both small and large intestine with rectal bleeding
K50.812Crohn's disease of both small and large intestine with intestinal obstruction
K50.813Crohn's disease of both small and large intestine with fistula
K50.814Crohn's disease of both small and large intestine with abscess
K50.818Crohn's disease of both small and large intestine with other complication
K50.819Crohn's disease of both small and large intestine with unspecified complications
K50.90Crohn's disease, unspecified, without complications
K50.911Crohn's disease, unspecified, with rectal bleeding
K50.912Crohn's disease, unspecified, with intestinal obstruction
K50.913Crohn's disease, unspecified, with fistula
K50.914Crohn's disease, unspecified, with abscess
K50.918Crohn's disease, unspecified, with other complication
K50.919Crohn's disease, unspecified, with unspecified complications​
K51.00Ulcerative (chronic) pancolitis without complications
K51.011Ulcerative (chronic) pancolitis with rectal bleeding
K51.012Ulcerative (chronic) pancolitis with intestinal obstruction
K51.013Ulcerative (chronic) pancolitis with fistula
K51.014Ulcerative (chronic) pancolitis with abscess
K51.018Ulcerative (chronic) pancolitis with other complication
K51.019Ulcerative (chronic) pancolitis with unspecified complications
K51.20Ulcerative (chronic) proctitis without complications
K51.211Ulcerative (chronic) proctitis with rectal bleeding
K51.212Ulcerative (chronic) proctitis with intestinal obstruction
K51.213Ulcerative (chronic) proctitis with fistula
K51.214Ulcerative (chronic) proctitis with abscess
K51.218Ulcerative (chronic) proctitis with other complication
K51.219Ulcerative (chronic) proctitis with unspecified complications
K51.30Ulcerative (chronic) rectosigmoiditis without complications
K51.311Ulcerative (chronic) rectosigmoiditis with rectal bleeding
K51.312Ulcerative (chronic) rectosigmoiditis with intestinal obstruction
K51.313Ulcerative (chronic) rectosigmoiditis with fistula
K51.314Ulcerative (chronic) rectosigmoiditis with abscess
K51.318Ulcerative (chronic) rectosigmoiditis with other complication
K51.319Ulcerative (chronic) rectosigmoiditis with unspecified complications
K51.40Inflammatory polyps of colon without complications
K51.411Inflammatory polyps of colon with rectal bleeding
K51.412Inflammatory polyps of colon with intestinal obstruction
K51.413Inflammatory polyps of colon with fistula
K51.414Inflammatory polyps of colon with abscess
K51.418Inflammatory polyps of colon with other complication
K51.419Inflammatory polyps of colon with unspecified complications
K51.50Left sided colitis without complications
K51.511Left sided colitis with rectal bleeding
K51.512Left sided colitis with intestinal obstruction
K51.513Left sided colitis with fistula
K51.514Left sided colitis with abscess
K51.518Left sided colitis with other complication
K51.519Left sided colitis with unspecified complications
K51.80Other ulcerative colitis without complications
K51.811Other ulcerative colitis with rectal bleeding
K51.812Other ulcerative colitis with intestinal obstruction
K51.813Other ulcerative colitis with fistula
K51.814Other ulcerative colitis with abscess
K51.818Other ulcerative colitis with other complication
K51.819Other ulcerative colitis with unspecified complications
K51.90Ulcerative colitis, unspecified, without complications
K51.911Ulcerative colitis, unspecified with rectal bleeding
K51.912Ulcerative colitis, unspecified with intestinal obstruction
K51.913Ulcerative colitis, unspecified with fistula
K51.914Ulcerative colitis, unspecified with abscess
K51.918Ulcerative colitis, unspecified with other complication
K51.919Ulcerative colitis, unspecified with unspecified complications​​
HCPCS Level II Code Number(s)
J2327 Injection, risankizumab-rzaa, intravenous, 1 mg
Revenue Code Number(s)
N/A

​

Coding and Billing Requirements

​

Policy History

Revisions From MA08.0153c:​

​11/26/2025
​This policy has been reissued in accordance with the Company's annual review process​​
10/21/2024

This version of the policy will become effective 10/21/2024​​.

This policy has been updated to communicate the Company's coverage criteria for risankizumab-rzaa (Skyrizi) for intravenous use for the treatment of ulcerative colitis. ​​

The following ICD-10 code has been added to this policy:

K51.00, K51.011, K51.012, K51.013, K51.014, K51.018, K51.019, K51.20, K51.211, K51.212, K51.213, K51.214, K51.218, K51.219, K51.30, K51.311, K51.312, K51.313, K51.314, K51.318, K51.319, K51.40, K51.411, K51.412, K51.413, K51.414, K51.418, K51.419, K51.50, K51.511, K51.512, K51.513, K51.514, K51.518, K51.519, K51.80, K51.811, K51.812, K51.813, K51.814, K51.818, K51.819, K51.90, K51.911, K51.912, K51.913, K51.914, K51.918, K51.919​


Revisions From MA08.153​b:

06/03/2024

This version of the policy will become effective 06/03/2024.


​The following ICD-10 CM code has been added to this policy:

K50.00 Crohn's disease of small intestine without complications


Revisions From MA08.153a:

​01/01/2024

​Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.​
​04/19/2023​
​This policy has been reissued in accordance with the Company's annual review process.
01/01/2023

This version of the policy will become effective 01/01/2023​.

The following HCPCS code has been added to this policy:
​J2327 Injection, risankizumab-rzaa, intravenous, 1 mg


​The following HCPCS codes have been removed from this policy:

C9399 Unclassified drugs or biologicals

J3590 Unclassified biologics


Revisions From MA08.153:

10/24/2022

This version of the policy will become effective 10/24/2022​.


The following new policy has been developed to communicate the Company's coverage criteria for risankizumab-rzaa (Skyrizi) for intravenous use.


10/21/2024
10/21/2024
11/26/2025
MA08.153
Medical Policy Bulletin
Medicare Advantage
No
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