Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Infliximab and Related Biosimilars

Policy #:08.00.34l

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, 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. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Infliximab (Remicade®) and related biosimilars (e.g., infliximab-dyyb [Inflectra™], infliximab-abda [Renflexis™], infliximab-qbtx [Ixifi™]) are considered medically necessary and, therefore, covered when the dosing and frequency requirements listed in Attachment A and the following indications and all the criteria (including the statement below) are met:
    Biosimilars Note: If the individual has not previously received a biologic DMARD to treat the indication requested for coverage, biosimilars of infliximab (e.g, infliximab-dyyb [Inflectra™], infliximab-abda [Renflexis ™], infliximab-qbtx [Ixifi™]) are only eligible for coverage when the individual has a documented failure, contraindication, or intolerance to infliximab (Remicade®), or there is a clinical reason that a trial of infliximab (Remicade®) would be otherwise inappropriate for the member.

RHEUMATOLOGIC CONDITIONS
  • Ankylosing spondylitis(See Biosimilars Note above)
    • When all of the following criteria are met:
      • Individual is over 18 years of age with evidence of active disease (increasing inflammation, pain, disability, and decreased function)
      • Documentation of an adequate therapeutic trial* of at least two nonsteroidal anti-inflammatory drugs (NSAIDs) which have failed to control symptoms
          *An adequate therapeutic trial is defined as: Treatment with NSAIDS for at least 3 months at maximum recommended or tolerated anti-inflammatory dose unless treatment is discontinued due to lack of response, intolerance, toxicity or contraindication
    • If the above criteria are not met, there must be documentation both of very severe disease and that the clinician considers infliximab or related biosimilars the best initial drug of choice with appropriate justification (severe pain, disability, and inability to perform activities of daily living, or severe impact on quality of life)
  • Autoimmune collagen vascular disease(See Biosimilars Note above)
    • Consideration may be given for individuals with an autoimmune collagen vascular disease that is refractory to conventional therapies.
  • Granulomatosis with polyangiitis (Wegener’s granulomatosis)(See Biosimilars Note above)
    • When all the following criteria are met:
      • Individual at least 18 years of age with evidence of severe, active disease (increased disease activity evidenced by signs and symptoms such as, but not limited to: pulmonary inflammation, infiltrates, hemorrhage, or nodules; active nephritis with renal failure; sinus/nasal inflammation; serious eye lesions, such as scleritis and peripheral ulcerative keratitis; mononeuritis multiplex; stroke; gastrointestinal bleeding
      • Documentation of failure, contraindication or intolerance to a 3-month trial of a standard regimen of corticosteroids and immunosuppressive agents (e.g., cyclophosphamide, methotrexate, azathioprine)
      • Infliximab or related biosimilars will be used in combination with corticosteroids, unless intolerant or contraindicated
    • If the above criteria are not met, there must be documentation both of very severe disease and that the professional provider considers infliximab or related biosimilars to the best initial drug of choice with appropriate justification (disability, and inability to perform activities of daily living, or severe impact on quality of life)
  • Inflammatory bowel disease arthritis(See Biosimilars Note above)
    • When all of the following criteria are met:
      • Individual is over 18 years of age with evidence of active disease (increased disease activity evidenced by increasing inflammation, pain, disability, and decreased function
      • Documented failure, contraindication or intolerance to a 3-month trial of any of the disease modifying antirheumatic drugs (DMARDs) (e.g., sulfasalazine, azathioprine, cyclophosphamide, other anti-tumor necrosis factor agents)
    • If the above criteria are not met, there must be documentation of very severe disease and the clinician considers infliximab or related biosimilars the best initial drug of choice with appropriate justification (severe pain, disability, and inability to perform activities of daily living, or severe impact to quality of life)
  • Polyarticular juvenile idiopathic arthritis (JIA)(See Biosimilars Note above)
    • When all of the following criteria are met:
      • Individual is 4 years of age and older with moderate-to-severe polyarticular JIA with evidence of active disease (increased disease activity evidenced by increasing inflammation, pain, disability, and decreased function)
      • Documented failure, contraindication, or intolerance to a 3-month trial of any of the non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., methotrexate, sulfasalazine, leflunomide)
      • Documented failure, contraindication, or intolerance to a 3-month trial of any of the FDA-approved biologic DMARDs (e.g., anti-tumor necrosis factor agents, T-cell costimulation modulators)
      • Infliximab or related biosimilars will be used in combination with methotrexate, or as a monotherapy when the individual is intolerant of, or has a contraindication to, methotrexate
    • If the above criteria are not met, there must be documentation of both very severe disease and that the clinician considers infliximab or related biosimilars the best initial drug of choice with appropriate justification (severe pain, disability, and inability to perform activities of daily living, or severe impact on quality of life)
  • Psoriatic arthritis(See Biosimilars Note above)
    • When all the following criteria are met:
      • Individual is over 18 years of age with evidence of active disease (increased disease activity evidenced by increasing inflammation, pain, disability, and decreased function)
      • Documented failure, contraindication or intolerance to a 3-month trial of any of the disease-modifying antirheumatic drugs (DMARDs) (e.g., sulfasalazine, azathioprine, cyclosporine, methotrexate, other anti-tumor necrosis factor agents)
    • If the above criteria are not met, there must be documentation both of very severe disease and that the clinician considers infliximab or related biosimilars the best initial drug of choice with appropriate justification (severe pain, disability, and inability to perform activities of daily living, or severe impact to quality of life)
  • Reactive arthritis (Reiter's disease)(See Biosimilars Note above)
    • When all the following criteria are met:
      • Individual is over 18 years of age with evidence of active disease (increased disease activity evidenced by increasing inflammation, pain, disability, and decreased function)
      • Documented failure, contraindication, or intolerance to a 3 month trial of any of the disease modifying antirheumatic drugs (DMARDs) (e.g., sulfasalazine, azathioprine, cyclophosphamide, cyclosporine, methotrexate, other anti-tumor necrosis factor agents)
    • If the above criteria are not met, there must be documentation of very severe disease and the clinician considers infliximab or related biosimilars the best initial drug of choice with appropriate justification (severe pain, disability, and inability to perform activities of daily living, or severe impact to quality of life)
  • Rheumatoid arthritis (RA)(See Biosimilars Note above)
    • When all the following criteria are met:
      • Individual is over 18 years of age with moderate-to-severe rheumatoid arthritis with evidence of active disease (increased disease activity evidenced by increasing inflammation, pain, disability, and decreased function)
      • Documented failure, contraindication or intolerance to a 3-month trial of any of the disease-modifying antirheumatic drugs (DMARDs) (e.g., hydroxychloroquine, leflunomide, sulfasalazine, methotrexate, other anti-tumor necrosis factor (TNF) agents or non-TNF biologics [abatacept, rituximab, tocilizumab])
      • Infliximab or related biosimilars will be used in combination with methotrexate, or as a monotherapy when the individual is intolerant of, or has a contraindication to, methotrexate
    • If the above criteria are not met, there must be documentation both of very severe disease and that the clinician considers infliximab or related biosimilars the best initial drug of choice with appropriate justification (severe pain, disability, and inability to perform activities of daily living, or severe impact on quality of life)
  • Sarcoidosis, chronic pulmonary(See Biosimilars Note above)
    • When both criteria are met:
      • Individual at least 18 years of age
      • Documentation of failure, contraindication or intolerance to a 3-month trial of a standard regimen of corticosteroids and immunosuppressive agents (e.g., methotrexate, azathioprine)
    • If the above criteria are not met, there must be documentation both of very severe disease and that the professional provider considers infliximab or related biosimilars to the best initial drug of choice with appropriate justification (disability, and inability to perform activities of daily living, or severe impact on quality of life)
  • Uveitis, non-infectious, due to Behcet’s disease(See Biosimilars Note above)
    • Documented diagnosis of Behcet’s disease with vision-threatening uveitis
  • Uveitis, non-infectious, not due to Behcet’s syndrome(See Biosimilars Note above)
    • Documented failure, contraindication or intolerance to corticosteroids and at least one immunosuppressive drug (e.g., azathioprine, cyclosporine, methotrexate, mycophenolate, tacrolimus, or other tumor necrosis factor [TNF] inhibitors)

GASTROINTESTINAL INDICATIONS
  • Crohn's disease: non-fistualizing(See Biosimilars Note above)
    • Presence of moderately to severely active Crohn's disease (CD) in adults or pediatric individuals 6 years of age or older when all the following criteria are met:
      • The individuals has active Crohn's disease (CD) as indicated by any of the following signs or symptoms: gastrointestinal bleeding, weight loss, diarrhea, perianal disease, internal fistula(ae), intestinal obstruction, megacolon or extraintestinal manifestations, such as arthritis or spondylitis
      • The individual has had an inadequate response to at least 3 months of conventional therapy (unless intolerant or contraindicated) which include, but are not limited to: (antibiotics, 5-aminosalicylates (e.g., mesalamine), immunosuppressants (e.g., 6-mercaptopurine, azathioprine, corticosteroids
    • There is the presence of severe inflammatory disease involving the distal small bowel and/or large bowel in an individual who is having symptoms of gastrointestinal bleeding, diarrhea, profound anemia, and poor nutritional intake associated with weight loss and abdominal pain.
  • Crohn's disease: fistualizing(See Biosimilars Note above)
    • When both criteria are met:
      • An adult or pediatric individual 6 years of age or older whose presentation of Crohn's disease involves the formation of a fistula(ae)
      • An adult or pediatric individual 6 years of age or older with diffuse inflammatory disease involving the distal small bowel and/or large bowel who is having symptoms of profound anemia, gastrointestinal bleeding, poor nutritional intake associated with weight loss, and abdominal pain
  • Ulcerative colitis: adults(See Biosimilars Note above)
    • When all the following criteria are met:
      • In individuals 18 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy, including a documented 3-month failure, contraindication, or intolerance to at least two of the following:
        • Aminosalicylates: (e.g., mesalamine [Apriso, Asacol, Canasa, Lialda, Pentasa, Rowasa], sulfasalazine [Azulfidine], olsalazine [Dipentum])
        • Systemic corticosteroids: (e.g., prednisone, prednisolone)
        • Immunomodulators: 6 mercaptopurine (6-MP), azathioprine (Imuran), methotrexate (e.g., Rheumatrex, Trexall), or cyclosporine (e.g., Neoral, Gengraf)
OR
    • When either of the following criteria are met:
      • In individuals 18 years of age or older, when there is a clinical presentation that requires an intervention with a more immediate effect to resolve the colitis; examples include:
        • Symptoms of profound anemia, poor nutritional intake associated with weight loss, and abdominal pain
        • Individuals who have the potential for adverse events to the other, more common treatment regimens or who have contraindication to the use of these treatment regimens (e.g., individuals with underlying diabetes may have worsening control with the addition of prednisone)
    • If the above criteria are not met, there must be documentation of the individual's rapidly-worsening disease as indicated by increasing disability, poorly controlled symptoms, and increasing quality of life concerns (cannot perform ADLs without great difficulty) and there is inadequate response to more conventional agents.
  • Ulcerative colitis: children(See Biosimilars Note above)
    • When all of the following criteria are met:
      • Child is at least 6 years of age
      • Has moderately to severely active ulcerative colitis (see Policy Guidelines section)
      • Has had an inadequate response to conventional therapy (i.e., use of immunomodulators such as azathioprine [AZA, eg Imuran], 6-mercaptopurine [6-MP], methotrexate [MTX, e.g., Rheumatrex, Trexall] or corticosteroids [prednisone equivalents])

DERMATOLOGIC INDICATIONS
  • Plaque psoriasis(See Biosimilars Note above)
    • When all the following criteria are met:
      • The individual is over the age of 18 with chronic, severe psoriasis who is a candidate for systemic therapy but other systemic therapies are less medically appropriate (e.g., presence of other factors such as hypertension, alcohol consumption, the condition of pregnancy, non-melanoma skin cancers).
      • Individual is affected with plaque psoriasis covering more than 10 percent of body surface area (BSA) or a lesser percentage if psoriasis affects sensitive body areas, such as hands, feet, face, or genitals.
      • Documentation of failure, contraindication, or intolerance to a trial of at least 3 months with at least one of the following:
        • Phototherapy: either UVB, PUVA
        • Methotrexate (e.g., Trexall®, Rheumatrex®)
        • Retinoids (e.g., acitretin [Soriatane®])
        • Cyclosporine (e.g., Neoral®, Gengraf®)
    • If the above criteria are not met, there must be documentation of severe psoriasis (greater than 10 percent body surface area [BSA]) or a lesser percentage if psoriasis affects sensitive body areas, such as hands, feet, face, or genitals and is very symptomatic (e.g., pain, pruritus, burning, scaling), the symptoms significantly hinder the quality of life, and the use of other systemic therapy is not appropriate due to other factors (e.g., history of hypertension, alcohol consumption, the condition of pregnancy, non-melanoma skin cancers).
  • Pyoderma gangrenosum(See Biosimilars Note above)
    • In individuals 18 years of age or older with documentation of pyoderma gangrenosum that is refractory to a 3-month trial of conventional treatments, such as local steroid injections, topical tacrolimus, and conservative wound care, including oral antibiotics
    • If the above criterion is not met, there must be documentation of rapidly worsening disease process as indicated by increasing disability, poorly controlled symptoms, and increasing quality of life concerns (cannot perform ADLs without great difficulty) and who is not adequately responding to more conventional agents.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for infliximab and related biosimilars are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics.

The use of infliximab and related biosimilars with other tumor necrosis factor (TNF) inhibitors (e.g., adalimumab [Humira], etanercept [Enbrel] or interleukin-1 (IL-1) inhibitors (e.g., anakinra [Kineret®]) is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this regimen cannot be established by a review of the available published peer-reviewed literature.

DOSING AND FREQUENCY REQUIREMENTS

Refer to Attachment A for dosing and frequency requirements for infliximab and related biosimilars.

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 infliximab and related biosimilars. 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) in order to request coverage for an amount of infliximab and related biosimilars 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 precertification process. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for infliximab and related biosimilars.

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 drug.

When coverage of infliximab and related biosimilars are 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

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

THE PEDIATRIC ULCERATIVE COLITIS ACTIVITY INDEX (PUCAI)

The Pediatric Ulcerative Colitis Activity Index, published in 2007 in Gastroenterology,** analyzes data which has been obtained from the child through noninvasive means during the previous 48 hours. Elements of this data assessment include the presence of abdominal pain, rectal bleeding, stool consistency, number of stools in 24 hours, presence or absence of nocturnal stools, and the child's activity level.

The Pediatric Ulcerative Colitis Activity Index (PUCAI)
Maximum score is 85
Remission <10
Mild-to-moderate disease 11 to 30
Moderate-to-severe disease 30 to 65
Severe >65
**Turner D, Otley AR, Mack D, et al. Development, Validation, and Evaluation of a Pediatric Ulcerative Colitis Activity Index: A Prospective Multicenter Study. Gastroenterology. 2007;133(2):423-432.

For complete information on the parameters evaluated in the PUCAI and how it is scored, please see the following table: http://download.lww.com/wolterskluwer_vitalstream_com/PermaLink/MPG/A/MPG_2011_04_25_LEE_201708_SDC1.pdf

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, infliximab and related biosimilars are covered under the medical benefits of the Company’s products when the medical necessity criteria and dosing and frequency requirements listed in this medical policy are met.

INFORMATION FROM THE MANUFACTURER AND THE FDA LABELING

PEDIATRIC USE
Infliximab and related biosimilars have not been studied in children with Crohn's disease or ulcerative colitis younger than 6 years of age. The long-term (duration greater than one year) safety and effectiveness of infliximab and related biosimilars in the treatment of Crohn's disease or ulcerative colitis for the pediatric population have not been established in clinical trials.

CONTRAINDICATIONS
Infliximab and related biosimilars at doses greater than 5 mg/kg should not be administered to individuals with moderate to severe heart failure. In a randomized study evaluating infliximab and related biosimilars in individuals with moderate to severe heart failure (New York Heart Association [NYHA] Functional Class III/IV), treatment at 10 mg/kg was associated with an increased incidence of death and hospitalization due to worsening heart failure.

USE WITH ANAKINRA (KINERET®) OR ABATACEPT (ORENCIA®)
The combination of infliximab or related biosimilars with anakinra (Kineret®) or abatacept (Orencia®) is not recommended.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA initially approved infliximab (Remicade®) on August 24, 1998. Supplemental approvals have since been issued.

Infliximab-dyyb (Inflectra™) was approved by the FDA on April 5, 2016 for adults with ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and adults and children with Crohn’s Disease.

Infliximab-abda (Renflexis ™) was approved by the FDA on April 21, 2017 for adults with ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and adults and children with Crohn’s Disease.

Infliximab-qbtx (Ixifi™) was approved by the FDA on December 13, 2017 for adults with ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and adults and children with Crohn’s Disease.

Description

Infliximab (Remicade®) was initially approved by the US Food and Drug Administration (FDA) on August 24, 1998 for rheumatoid arthritis and Crohn's Disease. Supplemental approvals have since been issued. The most recent FDA approval for infliximab Remicade®) is for use in the pediatric patient 6 years of age or older with moderately to severely active ulcerative colitis (UC) who has had an inadequate response to conventional therapy.

Infliximab-dyyb (Inflectra™), infliximab-abda (Renflexis ™), and infliximab-qbtx (Ixifi™) are biosimilars of infliximab that were approved by the FDA on April 5, 2016 and April 21, 2017, respectively for adults with ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and adults and children with Crohn’s Disease.

According to the US Food and Drug Administration (FDA), "a biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products."

Infliximab and related biosimilars are chimeric immunoglobulin monoclonal antibodies that bind to and neutralize the effects of tumor necrosis factor-alpha (TNF-α), a naturally occurring cytokine that plays a role in inflammatory and immune responses. Increased concentrations of TNF-α have been found in the affected tissues of individuals with certain anti-inflammatory disease, such as rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Infliximab and related biosimilars are supplied as a sterile, white, lyophilized powder for intravenous (IV) infusion, which is prepared and administered by a professional provider.

Infliximab and related biosimilars contain anti-TNF-α antibodies that reduce infiltration of inflammatory cells and TNF-α production in affected areas (e.g., the inflamed joints in RA, the inflamed intestines in Crohn's disease). Infliximab and related biosimilars also initiate healing in areas of erosion and inflammation caused by diseases such as ulcerative colitis and Crohn's disease. Decreased concentrations of TNF-α may be associated with decreased disease activity; however, the full mechanism of action of infliximab is not thoroughly understood.

Several categories of drugs are used to treat some rheumatic joint diseases that produce chronic inflammation. For many rheumatologic conditions, treatment typically begins with over-the-counter (OTC) drugs referred to as non-steroidal anti-inflammatory drugs (NSAIDs); these drugs are analgesic, antipyretic, relieve pain without impairing consciousness, and, when given in higher doses, have anti-inflammatory effects. The term "non-steroidal" distinguishes these agents from those that contain steroids whose action is also anti-inflammatory. NSAIDs include, but are not limited to, aspirin, ibuprofen, and naproxen, which are available without a prescription at local retail pharmacies.

Disease-modifying antirheumatic drugs (DMARDs) act to slow down disease progression, and some act with mild chemotherapeutic action, causing immunosuppression. Furthermore, DMARDs can be subdivided into drugs which are the traditional small molecular mass, chemically synthesized non-biologic DMARDs, such as, but not limited to, methotrexate, sulfasalazine, azathioprine, leflunomide, hydroxychloroquine sulfate, cyclosporine, and the newer biologic DMARDs. Examples of biologic DMARDs include, but are not limited to, etanercept (Enbrel®), adalimumab (Humira®), anakinra (Kineret®), abatacept (Orencia®), rituximab (Rituxan®), and infliximab (Remicade®). DMARDs are only available with a prescription.

For gastrointestinal or dermatologic manifestations of inflammatory disease, other types of initial treatments are indicated, depending on severity of symptom presentation and degree of disability.

OFF-LABEL INDICATIONS

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 professional clinical guidelines issued by leading professional organizations and government entities.
References


Alhusayen R, Shear NH. Pharmacologic interventions for hidradenitis suppurativa: what does the evidence say? Am J Clin Dermatol. 2012;13(5):283-91.

American Gastroenterological Association Institute. Technical Review on Corticosteroids, Immunomodulators, and Infliximab in Inflammatory Bowel Disease. Gastroenterology. 2006;130:940-987.

American Hospital Formulary Service (AHFS). Drug Information 2017. Infliximab (Remicade), infliximab-dyyb (Inflectra). Bethesda, MD: American Society of Health-System Pharmacists. updated 07/24/17. Available at: http://online.lexi.com/lco/action/doc/retrieve/docid/complete_ashp/413044 [via subscription only]. Accessed September 1, 2017.

Baughman RP, Costabel U, Du Bois RM. Treatment of sarcoidosis. Clin Chest Med. 2008;29:533-548.

Baughman RP, Drent M, Kavuru M, et al. Infliximab therapy in patients with chronic sarcoidosis and pulmonary involvement. Am J Respir Crit Care Med. 2006;174(7):795-802.

Baughman RP, Lower EE. Treatment of Sarcoidosis. Clin Rev Allergy Immunol. 2015;49(1):79-92. doi: 10.1007/s12016-015-8492-9.

Beukelman T, Patkar N, Saag K. 2011 American College of Rheumatology Recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care & Research. 2011;63(4):465-482.

Boulous P, Dougados M, MacLeod SM, Hunsche E. Pharmacological treament of ankyosing spondylitis: A systematic review. Drugs. 2005;65:2111-2127.

Bradley GM, Oliva-Hemker M. Pediatric ulcerative colitis: current treatment approaches including role of infliximab. Biologics. 2012;6:125-34.

Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011 Jun;70(6):896-904.

Cantini F, Niccoli L, Nannini C, et al. Efficacy of infliximab in refractory Behçet's disease-associated and idiopathic posterior segment uveitis: a prospective, follow-up study of 50 patients. Biologics. 2012;6:5-12.

Colombel JF, Sandborn WJ, Reinisch W, et al; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95.

Combe B, Landewe R, Daien CI, et al. 2016 update of the EULAR recommendations for the management of early arthritis. Ann Rheum Dis. 2016 Dec 15.

Dahl MV. Hidradenitis suppurativa (acne inversa): Treatment. [UpToDate Web Site]. 02/27/2017. Available at: https://www.uptodate.com/contents/hidradenitis-suppurativa-acne-inversa-treatment?source=search_result&search=hidradenitis%20suppurativa%20treatment&selectedTitle=2~50 . Accessed May 18, 2017.

Danese S, Colombel JF, Peyrin-Biroulet L, Rutgeerts P, Reinisch W. Review article: the role of anti-TNF in the management of ulcerative colitis -- past, present and future. Aliment Pharmacol Ther. 2013;37(9):855-66.

DeRidder L, Benninga MA, Tamniau JA, et al. Infliximab use in children and adolescents with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2007;45(1):3-14.

Doty JD, Mazur JE, & Judson MA: Treatment of sarcoidosis with infliximab. Chest 2005; 127(3):1064-1071.

Elsevier's Clinical Pharmacology Compendium. infliximab. [Clinical Pharmacology Web site]. 09/21/17. Available at: https://www.clinicalkey.com/pharmacology/monograph/2284?sec=monindi&n=Remicade [via subscription only]. Accessed October 2, 2017.

Falk RJ. Maintenance immunosuppressive therapy in granulomatosis with polyangiitis and microscopic polyangiitis. Jan 13, 2016. Available at: https://www.uptodate.com/contents/maintenance-immunosuppressive-therapy-in-granulomatosis-with-polyangiitis-and-microscopic-polyangiitis?source=search_result&search=wegener%20granulomatosis&selectedTitle=3~150#H627221684 Accessed February 13, 2017.

Falk RJ. Treatment-resistant granulomatosis with polyangiitis and microscopic polyangiitis. Feb 03, 2016. https://www.uptodate.com/contents/treatment-resistant-granulomatosis-with-polyangiitis-and-microscopic-polyangiitis?source=search_result&search=wegener%20granulomatosis&selectedTitle=4~150 . Accessed February 13, 2017.

Feldman SR. Treatment of psoriasis. 08/10/17. Available at: https://www.uptodate.com/contents/treatment-of-psoriasis?source=search_result&search=Plaque%20psoriasis&selectedTitle=1~66 . Accessed September 11, 2017.

Fernandes-Vozmediano JM, Armario-Hita JC. Infliximab for the treatment of hidradenitis suppurativa. Dermatology. 2007; 215(1);41-44.

Fitzgerald O. Psoriatic arthritis. In: Firestein GS, Budd RC, Gabriel IB, O’Dell JR, eds. Kelley’s Textbook of Rheumatology. 9th ed. Philadelphia, PA: Elsevier Saunders; 2013: 1246-1247.

Flores D, Marquez J, Garza M, Espinoza LR. Reactive arthritis: newer developments. Rheum Dis Clin North Am. 2003;29(1):37-59, vi.

Foeldvari I, Nielsen S, Kummerle-Deschner J, et al. Tumor necrosis factor-alpha blocker in treatment of juvenile idiopathic arthritis-associated uveitis refractory to second-line agents: results of a multinational survey. J Rheumatol. 2007;34(5):1146-50.

Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(4):644-59, quiz 660.

Gallagher M, Quinones K, Cervantes-Castaneda RA, et al. Biological response modifier therapy for refractory childhood uveitis. Br J Ophthalmol. 2007; 91(10):1341-1344.

Gerloni V, Pontikaki I, Gattinara M, et al. Efficacy of repeated intravenous infusions of an antitumor necrosis factor alpha monoclonal antibody, infliximab, in persistently active, refractory juvenile idiopathic arthritis: results of an open-label prospective study. Arthritis Rheum. 2005;52(2):548-53.

Gerloni V, Pontikaki I, Gattinara M, Fantini F. Focus on adverse events of tumour necrosis factor alpha blockade in juvenile idiopathic arthritis in an open monocentric long-term prospective study of 163 patients. Ann Rheum Dis. 2008;67(8):1145-52. Epub 2007 Nov 2.

Gladman DD, Ritchlin C. Treatment of psoriatic arthritis. 09/28/16. Available at: https://www.uptodate.com/contents/treatment-of-psoriatic-arthritis?source=search_result&search=psoriatic%20arthritis&selectedTitle=2~145#H133947948 . Accessed February 15, 2017.

Hill Gaston JS. Reactive arthritis and undifferentiated spondyloarthritis. In: Firestein GS, Budd RC, Gabriel IB, O’Dell JR, eds. Kelley’s Textbook of Rheumatology. 9th ed. Philadelphia, PA: Elsevier Saunders; 2013: 1227-1228.

Ingram JR, Woo PN, Chua SL, et al. Interventions for hidradenitis suppurativa. Cochrane Database Syst Rev. 2015 Oct 7;(10):CD010081.

Jackson JM. Pyoderma Gangrenosum: Treatment and Medication. [medicine Web site]. 07/18/17. Available at: http://emedicine.medscape.com/article/1123821-treatment. Accessed October 2, 2017.

Jois RN, Leeder J, Gibb A, et al. Low-dose infliximab treatment for anklyosing spondylitis clinically-and-cost effective. Rheumatol.2006;45:1566-1569.

Josselin L, Mahr A, Cohen P, et al. Infliximab efficacy and safety against refractory systemic necrotizing vasculides: Long-term follow-up of 15 patients. Ann Rheum Dis. 2008;67:1343-1346.

Kahn P, Weiss M, Imundo LF, Levy DM. Favorable response to high-dose infliximab for refractory childhood uveitis. Ophthalmology. 2006 May;113(5):860-4 e2.

Kaufman WS, Kaufman McNamara E, Jorizzo JL. Behcet’s Disease. In: Firestein GS, Budd RC, Gabriel IB, O’Dell JR, eds. Kelley’s Textbook of Rheumatology. 9th ed. Kelley’s Textbook of Rheumatology. 9th ed. Philadelphia, PA: Elsevier Saunders; 2013:1525-1532.

Keystone EC. The utility of tumor necrosis factor blockade in orphan diseases. Ann Rheum Dis (Supp II). 2004;ii79-ii83.

King TE. Treatment of pulmonary sarcoidosis: Disease refractory to glucocorticoid therapy. last updated: Jan 25, 2017. UpToDate Web Site. Available at: https://www.uptodate.com/contents/treatment-of-pulmonary-sarcoidosis-disease-refractory-to-glucocorticoid-therapy?source=search_result&search=sarcoidosis%20treatment&selectedTitle=2~150 . Accessed February 10, 2017.

Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23; quiz 524. Epub 2010 Jan 12. Erratum in: Am J Gastroenterol. 2010 Mar;105(3):500.

Lahdenne P, Vahasalo P, Honkanen V. Infliximab or etanercept in the treatment of children with refractory juvenile idiopathic arthritis: an open label study. Ann Rheum Dis. 2003;62:245-247.

Lee RW, D'Cruz DP. Novel therapies for anti-neutrophil cytoplasmic antibody-associated vasculitis. Drugs.2008;68:747-770.

Levy-Clarke G, Jabs DA, Read RW, Rosenbaum JT, Vitale A, Van Gelder RN. Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders. Ophthalmology. 2014 Mar;121(3):785-96.e3.

Lexi-Drugs Compendium. infliximab (Remicade), infliximab-abda (Renflexis), infliximab-dyyb (Inflectra). [Lexicomp Online Web site]. 08/25/17. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed September 29, 2017.

Lichtenstein GR, Hanauer SB, Sandborn WJ; Practice Parameters Committee of American College of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2009 Feb;104(2):465-83; quiz 464, 484.

Lichtenstein L, Ron Y, Kivity S, et al. Infliximab-Related Infusion Reactions: Systematic Review. J Crohns Colitis. 2015 Sep;9(9):806-15.

Mayberry JF, Lobo A, Ford AC, Thomas A. NICE clinical guideline (CG152): the management of Crohn's disease in adults, children and young people. Aliment Pharmacol Ther. 2013 Jan;37(2):195-203.

Mekkes JR, Bos JD. Long-term efficacy of a single course of infliximab in hidradenitis suppurativa. Br J Dermatol. 2008;158(2):370-374.

Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2007;56(1):31.e1-15.

Merkel PA, Kaplan AA, Falk RJ. Initial immunosuppressive therapy in granulomatosis with polyangiitis and microscopic polyangiitis. Jan 04, 2017. Available at: https://www.uptodate.com/contents/initial-immunosuppressive-therapy-in-granulomatosis-with-polyangiitis-and-microscopic-polyangiitis?source=search_result&search=wegener%20granulomatosis&selectedTitle=2~150#H3090274 . Accessed February 13, 2017.

Molloy ES, Langford CA, Clark TM, et al. Anti-tumor necrosis factor therapy in patients with refractory Takayasu arteritis: Long-term follow-up. Ann Rheum Dis.
2008;67:1567-1569.

Moschella SL. Is there a role for infliximab in the current therapy of hidradenitis suppurativa? A report of three treated cases. Int J Dermatol. 2007;46(12):1287-1291.

National Clinical Guideline Centre. Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2012 Oct. 61 p. (Clinical guideline; no. 153).

Pipitone N, Savarani C. Improving therapeutic options of patients with giant acell arteritis. Curr Opin Rheumatol. 2008;20:17-22.

Pritchard C, Nadarajah K. Tumour necrosis factor alpha inhibitor treatment for sarcoidosis refractory to conventional treatments: A report of five patients. Ann Rheum Dis. 2004:63(3):318-320.

Putgeerts P, Vermiere S, Van Assche G. Biological therapies for inflammatory bowel disease. Gastroenterology. 2009;136:1182-1197.

Rajaraman RT, Kimura Y, Li S, Haines K, Chu DS. Retrospective case review of pediatric patients with uveitis treated with infliximab. Ophthalmology. 2006;113(2):308-14.

Reich K, Nestle FO, Papp K, Ortonne JP, Evans R, Guzzo C, Li S, Dooley LT, Griffiths CE; EXPRESS study investigators. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005;366(9494):1367-74.

Remicade (Infliximab) [package insert]. Horsham, PA. Janssen Biotech. Revised October 2017. Available at: http://www.remicade.com/ . Accessed October 30, 2017.

Ringold S, Weis PF, Beukelman T, et al. 2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile
Idiopathic Arthritis. Arthritis Rheum. 2013;65(10):2499-2512.

Rosenbaum JT. The eye and rheumatic diseases. In: Firestein GS, Budd RC, Gabriel IB, O’Dell JR, eds. Kelley’s Textbook of Rheumatology. 9th ed. Kelley’s Textbook of Rheumatology. 9th ed. Philadelphia, PA: Elsevier Saunders; 2013:617-623.

Rosenbaum JT. Uveitis: treatment. Updated 08/14/17. Available at: http://www.uptodate.com/contents/uveitis-treatment?source=search_result&search=uveitis&selectedTitle=2~150 [via subscription only]. Accessed November 3. 2017.

Ruperto N, Lovell DJ, Cuttica R, et al. A randomized, placebo-controlled trial of infliximab plus methotrexate for treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2007; 56:3096-106.

Ruperto N, Lovell DJ, Cuttica R, et al. Paediatric Rheumatology INternational Trials Organization (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: Findings from an open-label treatment extension. Ann Rheum Dis. 2010;69(4):718-722.

Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology. 2008 Recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in Rheumatoid Arthritis. Arthritis Rheum. 2008;59(6):762-84.

Saleh S, Ghodsian S, Yakimova V, et al. Effectiveness of infliximab in treating selected patients with sarcoidosis. Respir Med. 2006;100(11):2053-2059.

Saurenmann RK, Levin AV, Rose JB, et al. Tumour necrosis factor alpha inhibitors in the treatment of childhood uveitis. Rheumatology (Oxford). 2006;45(8):982-9.

Schadt C. Pyoderma Gangrenosum: treatment and prognosis. 12/22/16. Available at: https://www.uptodate.com/contents/pyoderma-gangrenosum-treatment-and-prognosis?source=search_result&search=Pyoderma%20gangrenosum&selectedTitle=2~71#H1797000 [via subscription only]. Accessed January 31, 2017.

Seko Y. Giant cell and Takayasu arteritis. Curr Opin Rheumatol. 2007; 9:39-43.

Simonini G, Zannin ME, Caputo R, et al. Loss of efficacy during long-term infliximab therapy for sight-threatening childhood uveitis. Rheumatology (Oxford). 2008;47(10):1510-4.

Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012;64(5):625-39.

Singh JA, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology guidelines for the treatment of rheumatoid arthritis. Arthritis Care Res.2016;68:1-26.

Smith EL, Yazici Y. Treatment of Behcet’ s Syndrome. 12/08/16. Available at: https://www.uptodate.com/contents/treatment-of-behcets-syndrome?source=search_result&search=behcet's%20uveitis&selectedTitle=2~150 [via subscription only]. Accessed November 3. 2017.

Subramaniam K, Tymms K, Shadbolt B, Pavli P. Spondyloarthropathy in inflammatory bowel disease patients on TNF inhibitors. Intern Med J. 2015;45(11):1154-60.

Suhler EB, Smith JR, Giles TR, et al. Infliximab therapy for refractory uveitis: 2-year results of a prospective trial. Arch Ophthalmol. 2009;127(6):819-822.

Sullivan TP, Welsh E, Kerdel FA, et al. Kirsner RS. Infliximab for hidradenitis suppurativa. Br J Dermatol. 2003;149(5):1046-1049.

Tallouzi MO,Barry RJ,Bucknall N,et al. Anti-tumour necrosis factor biological therapies for the treatment of uveitic macular oedema (UMO) for non-infectious uveitis (Protocol). Cochrane Database of Systematic Reviews 2017, Issue 4.Art. No.: CD012577.

Terdiman JP, Gruss CB, Heidelbaugh JJ, Sultan S, Falck-Ytter YT; AGA Institute Clinical Practice and Quality Management Committee. American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-á biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. Gastroenterology. 2013;145(6):1459-63.

Truven Health Analytics. DrugDex®. Infliximab-abda (Renflexis). 09/11/17. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed September 29, 2017.

Truven Health Analytics. DrugDex®. infliximab-dyyb (Inflectra). 09/11/17. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed September 29, 2017.

Truven Health Analytics. DrugDex®. infliximab (Remicade). 09/19/17. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed September 29, 2017.

Truven Health Analytics. Micromedex Solutions. Inflammatory Bowel Disease - Drug Therapy. Drug Consults. 05/11/16. Available at: http://www.micromedexsolutions.com/micromedex2/librarian/CS/95B56B/ND_PR/evidencexpert/ND_P/evidencexpert/DUPLICATIONSHIELDSYNC/FDF237/ND_PG/evidencexpert/ND_B/evidencexpert/ND_AppProduct/evidencexpert/ND_T/evidencexpert/PFActionId/evidencexpert.IntermediateToDocumentLink?docId=4544&contentSetId=50&title=Inflammatory+Bowel+Disease+-+Drug+Therapy&servicesTitle=Inflammatory+Bowel+Disease+-+Drug+Therapy . Accessed October 31, 2017.

Turner D, Otley AR, Mack D, et al. Development, Validation, and Evaluation of a Pediatric Ulcerative Colitis Activity Index: A Prospective Multicenter Study. Gastroenterology. 2007;133(2):423-432.

Tynjala P, Lindahl P, Honkanen V, et al. Infliximab and etanercept in the treatment of chronic uveitis associated with refractory juvenile idiopathic arthritis. Ann Rheum Dis. 2007;66(4):548-550.

Tynjälä P, Vähäsalo P, Tarkiainen M, et al. Aggressive combination drug therapy in very early polyarticular juvenile idiopathic arthritis (ACUTE-JIA): a multicentre randomised open-label clinical trial. Ann Rheum Dis. 2011;70(9):1605-12. Epub 2011 May 28.

US Food and Drug Administration (FDA). infliximab-abda (Renflexis™) prescribing information & approval letter. [FDA Web site]. 04/21/2017. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed September 1, 2017.

US Food and Drug Administration (FDA). infliximab-dyyb (Inflectra) prescribing information & approval letter. [FDA Web site]. 04/05/2016. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm . Accessed September 29, 2017.

US Food and Drug Administration (FDA). infliximab-qbtx (Ixifi™) prescribing information & approval letter. [FDA Web site]. 12/13/2017. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm . Accessed December 14, 2017.

US Food and Drug Administration (FDA). infliximab (Remicade) prescribing information & approval letter. [FDA Web site]. 10/25/2017. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103772&elqTrackId=734010c9bcbc407cbe782453b9c970e2&elq=c8fa255411e54806be49fb293a726248&elqaid=1098&elqat=1&elqCampaignId=611 . Accessed October 30, 2017.

US Food and Drug Administration (FDA). Information on Biosimilars. Last Updated: 05/10/2016. Available at:http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm. Accessed September 29, 2017.

Vader JP, Froehlich F, Juillerat P, et al. Appropriate treatment of Crohn's disease: methodology and summary results of a multidisiplinary international expert panel approach. Digestion. 2006;73;(4): 237-248.

Van Den Bosch F, Kruithof E, Baeten D, et al. Randomized double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor alpha (infliximab) versus placebo in active spondylarthropathy. Arthritis Rheum. 2002;46(3):755-765.

Van der Kooij SM, et al. Patient-reported outcomes in a randomized trial comparing four different treatment strategies in recent-onset rheumatoid arthritis. Arthritis Rheum. 2009;61:4-12.

Van der Linden SM, Baeten D, Maksymowych WP. Ankylosing spondylitis. In: Firestein GS, Budd RC, Gabriel IB, O’Dell JR, eds. Kelley’s Textbook of Rheumatology. 9th ed. Philadelphia, PA: Elsevier Saunders; 2013: 1213-1220, 1246-1247.

Ward MM, Deodhar A, Akl EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2016;68(2):282-98.

Weiss PF. Polyarticular juvenile idiopathic arthritis: Treatment. UpToDate. Updated 09/29/15. Available at: http://www.uptodate.com/contents/polyarticular-juvenile-idiopathic-arthritis-treatment [via subscription only]. Accessed October 2, 2017.

Wung PK, Stone JH. Therapeutics of Wegener's granulomatosis. Nature Clinical Practice Rheumatology. 2006;2:192-200.

Yu DT. Assessment and treatment of ankylosing spondylitis in adults. 04/21/16. [UpToDate Web Site]. Available at: http://www.uptodate.com/contents/assessment-and-treatment-of-ankylosing-spondylitis-in-adults?source=search_result&search=ankylosing+spondylitis&selectedTitle=2%7E150#H24895511 [via subscription only]. Accessed October 2, 2017.

Yu D. Reactive arthritis. 07/21/16. Available at: https://www.uptodate.com/contents/reactive-arthritis?source=search_result&search=spondyloarthritis&selectedTitle=7~150#H28 (via subscription only). Accessed January 23, 2017.

Zochling J. Assessment and treatment of ankylosing spondylitis. Current status and future directions. Curr Opin Rheumatol. 2008;20:398-403.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment B


HCPCS Level II Code Number(s)


J1745 Injection, infliximab, excludes biosimilar, 10 mg

Q5103 Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg

Q5104 Injection, infliximab-abda, biosimilar, (renflexis), 10 mg

Q5109 Injection, infliximab-qbtx, biosimilar, (ixifi), 10 mg



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A : Infliximab and Related Biosimilars
Description: Dosing and Frequency Requirements for Infliximab and Related Biosimilars

Attachment B: Infliximab and Related Biosimilars
Description: ICD-10-CM Codes and Narratives




Policy History

Revisions from 08.00.34l
01/01/2019This policy has been identified for the HCPCS code update, effective 01/01/2019.

The following HCPCS codes have been added to this policy:
Q5109 Injection, infliximab-qbtx, biosimilar, (ixifi), 10 mg

Revisions from 08.00.34k:
04/01/2018This policy has been identified for the ICD-10 code update, effective 04/01/2018.

The following HCPCS code has been deleted from this policy:
Q5102 Injection, infliximab, biosimilar, 10 mg

The following HCPCS codes have been added to this policy:
Q5103 Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg
Q5104 Injection, infliximab-abda, biosimilar, (renflexis), 10 mg

Revisions from 08.00.34j:
12/27/2017This Policy has undergone a routine review, and the medical necessity criteria have been revised as follows:
  • New Biosimilars: infliximab-abda (Renflexis ™) and infliximab-qbtx (Ixifi™)
  • Medical Necessity criteria and Dosing and Frequency Information for the coverage of non-infectious uveitis
  • Minor updates to the following indications due to updates to Standards of Care.
    • Inflammatory bowel disease arthritis
    • Psoriatic arthritis
    • Rheumatoid arthritis (RA)
    • Crohn's disease: non-fistualizing
    • Plaque psoriasis


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 01/02/2019
Version Reissued Date: N/A

Connect with Us        


© 2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.