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Inflectra (infliximab-dyyb)

Policy Number: PH-0275

infliximab-dyyb

Last Review Date: 07/01/2019

Date of Origin: 04/26/2016

Dates Reviewed: 04/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 04/2019, 07/2019

 

I.      Length of Authorization

        Coverage will be provided for 6 months and may be renewed

        Therapy for the management of Immune-Checkpoint Inhibitor related toxicity may not be renewed.

II.     Dosing Limits

        A.  Quantity Limit (max daily dose) [Pharmacy Benefit]:

Loading Dose:

Inflectra 100 mg single-use vial: 6 vials at weeks 0, 2, 6 (18 vials total)

Maintenance Dose:

Inflectra 100 mg single-use vial: 10 vials every 4 weeks

       B.  Max Units (per dose and over time) [Medical Benefit]:

Loading Dose:

Rheumatoid Arthritis (RA)

  • 40 billable units at weeks 0, 2, 6

All other indications (except management of immune checkpoint inhibitor toxicity)

  • 60 billable units at weeks 0, 2, 6

Management of immune checkpoint inhibitor toxicity

  • 60 billable units at weeks 0, 2

Maintenance Dose:

Rheumatoid Arthritis (RA)

  • 100 billable units every 4 weeks

Crohn’s Disease/Ulcerative Colitis

  • 100 billable units every 8 weeks

Ankylosing spondylitis

  • 60 billable units every 6 weeks

All other indications (except management of immune checkpoint inhibitor related toxicity)

  • 60 billable units every 8 weeks

III.     Initial Approval Criteria

Remicade is preferred over biosimilar infliximab products. Patients must have failed, or have a contraindication, or intolerance to Remicade prior to consideration of another infliximab product. Patients who have been receiving a biosimilar infliximab product may continue therapy with that product.

         Coverage is provided in the following conditions:

  • Patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment; AND
  • Patient has been evaluated and screened for the presence of hepatitis B virus (HBV) prior to initiating treatment; AND
  • Patient does not have an active infection, including clinically important localized infections; AND
  • Must not be administered concurrently with live vaccines; AND
  • Patient is not on concurrent treatment with another TNF-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib); AND
  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND

         Crohn’s Disease †

  • Must be prescribed by, or in consultation with, a specialist in gastroenterology; AND
  • Adult patient (18 years or older); AND
  • Documented moderate to severe disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate)

Requirement for a 3 month trial of traditional therapies is waived if ONE of the following applies:

  • Patients with severe disease presenting with any of the following: recent surgery or hospitalization, anemia requiring blood transfusion, significant weight loss, fever, malnutrition, extraintestinal symptoms
  • Patients with first presentation requiring surgery
  • Patients with severe disease and unresponsive to high dose steroids OR immunosuppressive medications after 2 weeks
  • Patients unable to attain remission without continuous corticosteroids.

         Pediatric Crohn’s Disease †

  • Must be prescribed by, or in consultation with, a specialist in gastroenterology; AND
  • Patient is at least 6 years of age; AND
  • Documented moderate to severe disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g., azathioprine, etc.)

Requirement for a 3 month trial of traditional therapies is waived if ONE of the following applies:

  • Patients with severe disease presenting with any of the following: recent surgery or hospitalization, anemia requiring blood transfusion, significant weight loss, fever, malnutrition, extraintestinal symptoms
  • Patients with first presentation requiring surgery
  • Patients with severe disease and unresponsive to high dose steroids OR immunosuppressive medications after 2 weeks
  • Patients unable to attain remission without continuous corticosteroids.

         Ulcerative Colitis †

  • Must be prescribed by, or in consultation with, a specialist in gastroenterology; AND
  • Adult patient (18 years or older); AND
  • Documented moderate to severe disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate)

Requirement for a 3 month trial of traditional therapies is waived if ONE of the following applies:

  • Patients with severe disease presenting with any of the following: recent surgery or hospitalization, anemia requiring blood transfusion, significant weight loss, fever, malnutrition, extraintestinal symptoms
  • Patients with first presentation requiring surgery
  • Patients with severe disease and unresponsive to high dose steroids OR immunosuppressive medications after 2 weeks
  • Patients unable to attain remission without continuous corticosteroids.

          Pediatric Ulcerative Colitis ‡

  • Must be prescribed by, or in consultation with, a specialist in gastroenterology; AND
  • Patient is at least 6 years of age; AND
  • Documented moderate to severe disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g., azathioprine, etc.)

Requirement for a 3 month trial of traditional therapies is waived if ONE of the following applies:

  • Patients with severe disease presenting with any of the following: recent surgery or hospitalization, anemia requiring blood transfusion, significant weight loss, fever, malnutrition, extraintestinal symptoms
  • Patients with first presentation requiring surgery
  • Patients with severe disease and unresponsive to high dose steroids OR immunosuppressive medications after 2 weeks
  • Patients unable to attain remission without continuous corticosteroids.

          Fistulizing Crohn’s Disease †

  • Must be prescribed by, or in consultation with, a specialist in gastroenterology; AND
  • Adult patient (18 years or older); AND
  • Patient has at least one or more draining fistulas (i.e., enterovesical, enterocutaneous, enteroenteric, or enterovaginal fistulas) for at least 3 months

Requirement for a 3 month trial of traditional therapies is waived if ONE of the following applies:

  • Patients with severe disease presenting with any of the following: recent surgery or hospitalization, anemia requiring blood transfusion, significant weight loss, fever, malnutrition, extraintestinal symptoms
  • Patients with first presentation requiring surgery
  • Patients with severe disease and unresponsive to high dose steroids OR immunosuppressive medications after 2 weeks
  • Patients unable to attain remission without continuous corticosteroids.

         Rheumatoid Arthritis (RA) †

  • Must be prescribed by, or in consultation with, a specialist in rheumatology; AND
  • Adult patient (18 years or older); AND
  • Documented moderate to severe disease; AND
  • Patient has had at least a 3 month trial and failed previous therapy with ONE oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, or leflunomide; AND
  • Used in combination with methotrexate (MTX) unless contraindicated

          Psoriatic Arthritis †

  • Must be prescribed by, or in consultation with, a specialist in dermatology or rheumatology; AND
  • Adult patient (18 years or older); AND
  • Documented moderate to severe active disease; AND
  • For patients with predominantly axial disease OR active enthesitis and/or dactylitis, an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs), unless use is contraindicated; OR
  • For patients with peripheral arthritis, a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, or hydroxychloroquine

          Ankylosing Spondylitis †

  • Must be prescribed by, or in consultation with, a specialist in rheumatology; AND
  • Adult patient (18 years or older); AND
  • Documented active disease; AND
  • Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs), unless use is contraindicated

          Plaque Psoriasis †

  • Must be prescribed by, or in consultation with, a specialist in dermatology or rheumatology; AND
  • Adult patient (18 years or older); AND
  • Documented moderate to severe plaque psoriasis for at least 6 months with at least one of the following:
    • Involvement of at least 10% of body surface area (BSA); OR
    • Psoriasis Area and Severity Index (PASI) score of 10 or greater; OR
    • Incapacitation due to plaque location (i.e. head and neck, palms, soles or genitalia); AND
  • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of topical agents (i.e., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, retinoic acid derivatives, and/or vitamin D analogues); AND
  • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of at least one systemic agent (i.e., immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND
  • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of phototherapy (i.e., psoralens with UVA light (PUVA) or UVB with coal tar or dithranol)

     Uveitis Associated with Behçet’s Syndrome ‡

  • Must be prescribed by, or in consultation with, a specialist in rheumatology or ophthalmology; AND
  • Patient’s disease is refractory to immunosuppressive therapy (e.g., corticosteroids, etc.); AND
  • Patient had an inadequate response to a self-administered biologic therapy (e.g., adalimumab)

    Management of Immune Checkpoint Inhibitor related Toxicity ‡

  • Patient has been receiving therapy with an immune checkpoint inhibitor (e.g. nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, ipilimumab, etc.); AND
  • Patient has one of the following toxicities related to their immunotherapy:
        • Moderate (grade 2) to severe (grade 3-4) diarrhea or colitis
        • Severe (grade 3-4) pneumonitis refractory to methylprednisolone after 48 hours of therapy
        • Severe (grade 3) or life-threatening (grade 4) renal failure or elevated serum creatinine that is refractory to at least 1 week of therapy with corticosteroids
        • Uveitis (grade 3-4) that is refractory to high-dose systemic corticosteroids
        • Life-threatening (grade 4) myocarditis, pericarditis, arrhythmias or impaired ventricular function if no improvement within 24 hours of starting pulse-dose methylprednisolone
        • Severe inflammatory arthritis as additional disease-modifying therapy refractory to high-dose corticosteroids after 14 days of treatment

FDA Approved Indication(s); Compendia recommended indication(s)

IV.     Renewal Criteria

Remicade is preferred over biosimilar infliximab products. Patients must have failed, or have a contraindication, or intolerance to Remicade prior to consideration of another infliximab product. Patients who have been receiving a biosimilar infliximab product may continue therapy with that product.

         Coverage can be renewed based upon the following criteria:

  • Patient continues to meet criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe hypersensitivity reactions, malignancy, significant hematologic abnormalities, serious infections, cerebrovascular accidents, cardiotoxicity/heart failure, neurotoxicity, hepatotoxicity, lupus like syndrome, demyelinating disease, etc.; AND
  • Patient is receiving ongoing monitoring for presence of TB or other active infections; AND

         Crohn’s Disease

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra intestinal complications, use of anti-diarrheal drugs, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score.]

          Pediatric Crohn’s Disease

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra intestinal complications, use of anti-diarrheal drugs, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Pediatric Crohn’s Disease Activity Index (PCDAI) score or the Harvey-Bradshaw Index score.]

         Ulcerative Colitis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, and/or endoscopic activity, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score or the Mayo Score].

    Pediatric Ulcerative Colitis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, and/or endoscopic activity, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Pediatric Ulcerative Colitis Activity Index (PUCAI) score or the Mayo Score].

          Fistulizing Crohn’s Disease

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as a reduction in number of enterocutaneous fistulas draining upon gentle compression, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score].

           Psoriatic Arthritis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts and/or an improvement on a disease activity scoring tool [e.g. defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria.]

          Rheumatoid Arthritis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Disease Activity Score-28 (DAS28) of 1.2 points or more or a ≥20% improvement on the American College of Rheumatology-20 (ACR20) criteria]

           Ankylosing Spondylitis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, morning stiffness, and/or an improvement on a disease activity scoring tool (e.g. ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) or an improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

            Plaque Psoriasis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement (a total BSA involvement ≤1%), and/or an improvement on a disease activity scoring tool [e.g. a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and a four-point reduction in the DLQI from when treatment started.]

    Uveitis Associated with Behçet’s Syndrome

  • Disease response as indicated by an improvement in signs and symptoms compared to baseline [e.g. reduction in inflammation and/or lesions, dose reduction of oral glucocorticoids and/or immunosuppressive agents, improvement in vitreous haze, improvement in best corrected visual acuity (BCVA), disease stability and/or reduced rate of decline]

    Management of Immune Checkpoint Inhibitor related Toxicity ‡

  • May not be renewed.

V.       Dosage/Administration

Indication

Loading Doses

Maintenance Dosing

Maximum Dose & Frequency

Rheumatoid Arthritis

3 mg/kg at weeks 0, 2, & 6

3 mg/kg every 8 weeks thereafter

Up to 10 mg/kg every 4 weeks

Ankylosing Spondylitis

5 mg/kg at weeks 0, 2, & 6

5 mg/kg every 6 weeks thereafter

5 mg/kg every 6 weeks

Crohn’s Disease & Ulcerative Colitis

5 mg/kg at weeks 0, 2, & 6

5 mg/kg every 8 weeks thereafter

Up to 10 mg/kg every 8 weeks

Psoriatic Arthritis, Plaque Psoriasis, Behçet’s Uveitis

5 mg/kg at weeks 0, 2, & 6

5 mg/kg every 8 weeks thereafter

5 mg/kg every 8 weeks

Management of Immune Checkpoint Inhibitor Related Toxicity

5 mg/kg at weeks 0,2

N/A

N/A

  • Dose escalation (up to the maximum dose and frequency specified above) may occur upon clinical review on a case by case basis provided that the patient has:
    • Shown an initial response to therapy; AND
    • Received the three loading doses at the dose AND interval specified above; AND
    • Received a minimum of one maintenance dose at the dose AND interval specified above; AND
    • Responded to therapy (by treatment week 16) with subsequent loss of response; AND
    • Dose escalation may either increase the dose OR decrease the interval provided it does not exceed the following limits:
      • Dose increase by no more than 2.5 mg/kg; OR
      • Interval decrease by no more than 2 weeks

          Note:

  • Prior to escalating doses a patient's neutralizing IFX-antibodies should be assessed and addition of a DMARD (e.g, thiopurine or MTX), if not already on such therapy, should be considered.
  • Criteria for disease-specific response to therapy are noted in section IV. Patients with moderate to severe heart failure (NYHA Functional Class III/IV; LVEF ≤35%) should not receive doses in excess of 5 mg/kg.

VI.     Billing Code/Availability Information

JCode:

  • Q5103 – injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg

NDC:

  • Inflectra 100 mg single-use vial: 00069-0809-xx

VII.    References

  1. Inflectra [package insert]. Yeonsu-gu, Incheon, Republic of Korea; CELLTRION, Inc; July 2018. Accessed June 2019.
  2. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov 6. doi: 10.1002/acr.22783.
  3. 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. 2015 Sep 24. doi: 10.1002/art.39298.
  4. 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;56:31e1-15.
  5. Lichtenstein GR, Loftus EV, Isaacs KL, et al. American College of Gastroenterology. Clinical Guideline: Management of Crohn’s disease in adults. Am J Gastroenterol. 2018;113:481-517.
  6. 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.
  7. Terdiman JP, Gruss CB, Heidelbaugh JJ, et al. 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 Dec;145(6):1459-63. doi: 10.1053/j.gastro.2013.10.047.
  8. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
  9. Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May;58(5):851-64.
  10. National Institute for Health and Clinical Excellence (NICE). Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Aug. 73 p. (Technology appraisal guidance; no. 195)
  11. Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2015 Dec 7. pii: annrheumdis-2015-208337. doi: 10.1136/annrheumdis-2015-208337.
  12. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Mar 6. pii: annrheumdis-2016-210715.
  13. Van Der Heijde D, Ramiro S, Landewe R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis doi:10.1136/annrheumdis-2016-210770.
  14. Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jan 28. doi: 10.1093/ecco-jcc/jjx009.
  15. Jabs DA, Rosenbaum JT, Foster CS, et al. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000 Oct;130(4):492-513.
  16. Levy-Clarke G, Jabs DA, Read RW, et al. 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. doi: 10.1016/j.ophtha.2013.09.048.
  17. Sieczkowska J, Jarzębicka D, Banaszkiewicz A, et al. Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations. J Crohns Colitis. 2016 Feb;10(2):127-32. doi: 10.1093/ecco-jcc/jjv233.
  18. Giardina A, Ferrante A, Ciccia F, et al. One year study of efficacy and safety of infliximab in the treatment of patients with ocular and neurological Behcet’s disease refractory to standard immunosuppressive drugs. Rheumatol Int 2011;31:33–37.
  19. Okada A, Goto H, Ohno S, et al. Multicenter study of infliximab for refractory uveoretinitis in Behcet disease. Arch Ophthalmol 2012;130(5):592-598.
  20. National Institute for Health and Care Excellence. NICE 2012. Crohn’s Disease: Management. Published 10 October 2012. Clinical Guideline [CG152]. https://www.nice.org.uk/guidance/cg152/resources/crohns-disease-management-pdf-35109627942085 .
  21. Lewis JD, Chuai S, Nessel L, et al. Use of the Non-invasive Components of the Mayo Score to Assess Clinical Response in Ulcerative Colitis. Inflamm Bowel Dis. 2008 Dec; 14(12): 1660–1666. doi: 10.1002/ibd.20520
  22. Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014 Aug; 2(3): 161–168.
  23. Walsh AJ, Bryant RV, Travis SPL. Current best practice for disease activity assessment in IBD. Nature Reviews Gastroenterology & Hepatology 13, 567–579 (2016) doi:10.1038/nrgastro.2016.128
  24. 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.
  25. National Institute for Health and Care Excellence. NICE 2017. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs. Published 24 May 2017. Technology Appraisal Guidance [TA445]. https://www.nice.org.uk/guidance/TA445/chapter/1-Recommendations. Accessed August 2017.
  26. National Institute for Health and Care Excellence. NICE 2009. Rheumatoid Arthritis in Adults: Management. Published 25 February 2009. Clinical Guideline [CG79]. https://www.nice.org.uk/guidance/cg79/resources/rheumatoid-arthritis-in-adults-management-pdf-975636823525.
  27. National Institute for Health and Care Excellence. NICE 2010. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after failure of a TNF inhibitor. Published 10 October 2012. Clinical Guideline [TA195]. https://www.nice.org.uk/guidance/ta195/resources/adalimumab-etanercept-infliximab-rituximab-and-abatacept-for-the-treatment-of-rheumatoid-arthritis-after-the-failure-of-a-tnf-inhibitor-pdf-82598558287813.
  28. Ward MM, Guthri LC, Alba MI. Rheumatoid Arthritis Response Criteria And Patient-Reported Improvement in Arthritis Activity: Is an ACR20 Response Meaningful to Patients”. Arthritis Rheumatol. 2014 Sep; 66(9): 2339–2343. doi: 10.1002/art.38705
  29. National Institute for Health and Care Excellence. NICE 2008. Infliximab for the treatment of adults with psoriasis. Published 23 January 2008. Technology Appraisal Guidance [TA134]. https://www.nice.org.uk/guidance/ta134/resources/infliximab-for-the-treatment-of-adults-with-psoriasis-pdf-82598193811141.
  30. Smith CH, Jabbar-Lopez ZK, Yiu ZK, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017 Sep;177(3):628-636. doi: 10.1111/bjd.15665.
  31. Jabs DA, Rosenbaum JT, Foster CS, et al. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000 Oct;130(4):492-513.
  32. Levy-Clarke G, Jabs DA, Read RW, et al. 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. doi: 10.1016/j.ophtha.2013.09.048.
  33. Minor DR, Chin K, Sashani-Sabet M, et al. Infliximab in the treatment of anti-CTLA4 antibody (Ipilimumab) induced immune-related colitis. Cancer Biotherapy & Radiopharmaceuticals. 2009 June; 24 (3). https://doi.org/10.1089/cbr.2008.0607
  34. Villadolid J, Amin A. Immune checkpoint inhibitors in clinical practice: update on management of immune-related toxicities. Translational Lung Cancer Research. 2015;4(5):560-575. doi:10.3978/j.issn.2218-6751.2015.06.06.Appendix 1 – Covered Diagnosis Codes
  35. Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27
  36. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis & Rheumatology. Vol. 0, No. 0, Month 2018, pp 1–28 DOI 10.1002/art.40726
  37. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019 Feb 13. pii: S0190-9622(18)33001-9. https://doi.org/10.1016/j.jaad.2018.11.057.
  38. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Infliximab. National Comprehensive Cancer Network, 2019. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2019.
  39. Wisconsin Physicians Service Insurance Corporation. Local Coverage Determination (LCD): Drugs and Biologics (Non-chemotherapy) (L34741). Centers for Medicare & Medicaid Services, Inc. Updated on 05/24/2018 with effective date 06/1/2018. Accessed March 2019.
  40. National Government Services, Inc. Local Coverage Article: Infliximab, Infliximab-dyyb (e.g., Remicade™, Inflectra™) – Related to LCD L33394 (A52423). Centers for Medicare & Medicaid Services, Inc. Updated on 4/27/2018 with effective date 4/1/2018. Accessed March 2019.
  41. Palmetto GBA. Local Coverage Determination (LCD): Drugs and Biologicals: Infliximab (L35677). Centers for Medicare & Medicaid Services, Inc. Updated on 02/01/2019 with effective date 02/07/2019. Accessed March 2019.
  42. First Coast Service Options, Inc. Local Coverage Determination (LCD): Infliximab (Remicade™) (L33704). Centers for Medicare & Medicaid Services, Inc. Updated on 01/04/2019 with effective date 01/01/2019. Accessed March 2019.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

H30.891

Other chorioretinal inflammations, right eye

H30.892

Other chorioretinal inflammations, left eye

H30.893

Other chorioretinal inflammations, bilateral

H30.899

Other chorioretinal inflammations, unspecified eye

H30.90

Unspecified chorioretinal inflammation, unspecified eye

H30.91

Unspecified chorioretinal inflammation, right eye

H30.92

Unspecified chorioretinal inflammation, left eye

H30.93

Unspecified chorioretinal inflammation, bilateral

I30.8

Other forms of acute pericarditis

I30.9

Acute pericarditis, unspecified

I40.8

Other acute myocarditis

I40.9

Acute myocarditis, unspecified

I50.9

Heart failure, unspecified

J70.2

Acute drug-induced interstitial lung disorders

J70.4

Drug-induced interstitial lung disorders, unspecified

K50.00

Crohn’s disease of small intestine without complications

K50.011

Crohn’s disease of small intestine with rectal bleeding

K50.012

Crohn’s disease of small intestine with intestinal obstruction

K50.013

Crohn’s disease of small intestine with fistula

K50.014

Crohn’s disease of small intestine with abscess

K50.018

Crohn’s disease of small intestine with other complication

K50.019

Crohn’s disease of small intestine with unspecified complications

K50.10

Crohn’s disease of large intestine without complications

K50.111

Crohn’s disease of large intestine with rectal bleeding

K50.112

Crohn’s disease of large intestine with intestinal obstruction

K50.113

Crohn’s disease of large intestine with fistula

K50.114

Crohn’s disease of large intestine with abscess

K50.118

Crohn’s disease of large intestine with other complication

K50.119

Crohn’s disease of large intestine with unspecified complications

K50.80

Crohn’s disease of both small and large intestine without complications

K50.811

Crohn’s disease of both small and large intestine with rectal bleeding

K50.812

Crohn’s disease of both small and large intestine with intestinal obstruction

K50.813

Crohn’s disease of both small and large intestine with fistula

K50.814

Crohn’s disease of both small and large intestine with abscess

K50.818

Crohn’s disease of both small and large intestine with other complication

K50.819

Crohn’s disease of both small and large intestine with unspecified complications

K50.90

Crohn’s disease, unspecified, without complications

K50.911

Crohn’s disease, unspecified, with rectal bleeding

K50.912

Crohn’s disease, unspecified, with intestinal obstruction

K50.913

Crohn’s disease, unspecified, with fistula

K50.914

Crohn’s disease, unspecified, with abscess

K50.918

Crohn’s disease, unspecified, with other complication

K50.919

Crohn’s disease, unspecified, with unspecified complications

K51.00

Ulcerative (chronic) pancolitis without complications

K51.011

Ulcerative (chronic) pancolitis with rectal bleeding

K51.012

Ulcerative (chronic) pancolitis with intestinal obstruction

K51.013

Ulcerative (chronic) pancolitis with fistula

K51.014

Ulcerative (chronic) pancolitis with abscess

K51.018

Ulcerative (chronic) pancolitis with other complication

K51.019

Ulcerative (chronic) pancolitis with unspecified complications

K51.20

Ulcerative (chronic) proctitis without complications

K51.211

Ulcerative (chronic) proctitis with rectal bleeding

K51.212

Ulcerative (chronic) proctitis with intestinal obstruction

K51.213

Ulcerative (chronic) proctitis with fistula

K51.214

Ulcerative (chronic) proctitis with abscess

K51.218

Ulcerative (chronic) proctitis with other complication

K51.219

Ulcerative (chronic) proctitis with unspecified complications

K51.30

Ulcerative (chronic) rectosigmoiditis without complications

K51.311

Ulcerative (chronic) rectosigmoiditis with rectal bleeding

K51.312

Ulcerative (chronic) rectosigmoiditis with intestinal obstruction

K51.313

Ulcerative (chronic) rectosigmoiditis with fistula

K51.314

Ulcerative (chronic) rectosigmoiditis with abscess

K51.318

Ulcerative (chronic) rectosigmoiditis with other complication

K51.319

Ulcerative (chronic) rectosigmoiditis with unspecified complications

K51.50

Left sided colitis without complications

K51.511

Left sided colitis with rectal bleeding

K51.512

Left sided colitis with intestinal obstruction

K51.513

Left sided colitis with fistula

K51.514

Left sided colitis with abscess

K51.518

Left sided colitis with other complication

K51.519

Left sided colitis with unspecified complications

K51.80

Other ulcerative colitis without complications

K51.811

Other ulcerative colitis with rectal bleeding

K51.812

Other ulcerative colitis with intestinal obstruction

K51.813

Other ulcerative colitis with fistula

K51.814

Other ulcerative colitis with abscess

K51.818

Other ulcerative colitis with other complication

K51.819

Other ulcerative colitis with unspecified complications

K51.90

Ulcerative colitis, unspecified, without complications

K51.911

Ulcerative colitis, unspecified with rectal bleeding

K51.912

Ulcerative colitis, unspecified with intestinal obstruction

K51.913

Ulcerative colitis, unspecified with fistula

K51.914

Ulcerative colitis, unspecified with abscess

K51.918

Ulcerative colitis, unspecified with other complication

K51.919

Ulcerative colitis, unspecified with unspecified complications

K52.1

Toxic gastroenteritis and colitis

L40.0

Psoriasis vulgaris

L40.50

Arthropathic psoriasis, unspecified

L40.51

Distal interphalangeal psoriatic arthropathy

L40.52

Psoriatic arthritis mutilans

L40.53

Psoriatic spondylitis

L40.59

Other psoriatic arthropathy

M05.10

Rheumatoid lung disease with rheumatoid arthritis of unspecified site

M05.111

Rheumatoid lung disease with rheumatoid arthritis of right shoulder

M05.112

Rheumatoid lung disease with rheumatoid arthritis of left shoulder

M05.119

Rheumatoid lung disease with rheumatoid arthritis of unspecified shoulder

M05.121

Rheumatoid lung disease with rheumatoid arthritis of right elbow

M05.122

Rheumatoid lung disease with rheumatoid arthritis of left elbow

M05.129

Rheumatoid lung disease with rheumatoid arthritis of unspecified elbow

M05.131

Rheumatoid lung disease with rheumatoid arthritis of right wrist

M05.132

Rheumatoid lung disease with rheumatoid arthritis of left wrist

M05.139

Rheumatoid lung disease with rheumatoid arthritis of unspecified wrist

M05.141

Rheumatoid lung disease with rheumatoid arthritis of right hand

M05.142

Rheumatoid lung disease with rheumatoid arthritis of left hand

M05.149

Rheumatoid lung disease with rheumatoid arthritis of unspecified hand

M05.151

Rheumatoid lung disease with rheumatoid arthritis of right hip

M05.152

Rheumatoid lung disease with rheumatoid arthritis of left hip

M05.159

Rheumatoid lung disease with rheumatoid arthritis of unspecified hip

M05.161

Rheumatoid lung disease with rheumatoid arthritis of right knee

M05.162

Rheumatoid lung disease with rheumatoid arthritis of left knee

M05.169

Rheumatoid lung disease with rheumatoid arthritis of unspecified knee

M05.171

Rheumatoid lung disease with rheumatoid arthritis of right ankle and foot

M05.172

Rheumatoid lung disease with rheumatoid arthritis of left ankle and foot

M05.179

Rheumatoid lung disease with rheumatoid arthritis of unspecified ankle and foot

M05.19

Rheumatoid lung disease with rheumatoid arthritis of multiple sites

M05.20

Rheumatoid vasculitis with rheumatoid arthritis of unspecified site

M05.211

Rheumatoid vasculitis with rheumatoid arthritis of right shoulder

M05.212

Rheumatoid vasculitis with rheumatoid arthritis of left shoulder

M05.219

Rheumatoid vasculitis with rheumatoid arthritis of unspecified shoulder

M05.221

Rheumatoid vasculitis with rheumatoid arthritis of right elbow

M05.222

Rheumatoid vasculitis with rheumatoid arthritis of left elbow

M05.229

Rheumatoid vasculitis with rheumatoid arthritis of unspecified elbow

M05.231

Rheumatoid vasculitis with rheumatoid arthritis of right wrist

M05.232

Rheumatoid vasculitis with rheumatoid arthritis of left wrist

M05.239

Rheumatoid vasculitis with rheumatoid arthritis of unspecified wrist

M05.241

Rheumatoid vasculitis with rheumatoid arthritis of right hand

M05.242

Rheumatoid vasculitis with rheumatoid arthritis of left hand

M05.249

Rheumatoid vasculitis with rheumatoid arthritis of unspecified hand

M05.251

Rheumatoid vasculitis with rheumatoid arthritis of right hip

M05.252

Rheumatoid vasculitis with rheumatoid arthritis of left hip

M05.259

Rheumatoid vasculitis with rheumatoid arthritis of unspecified hip

M05.261

Rheumatoid vasculitis with rheumatoid arthritis of right knee

M05.262

Rheumatoid vasculitis with rheumatoid arthritis of left knee

M05.269

Rheumatoid vasculitis with rheumatoid arthritis of unspecified knee

M05.271

Rheumatoid vasculitis with rheumatoid arthritis of right ankle and foot

M05.272

Rheumatoid vasculitis with rheumatoid arthritis of left ankle and foot

M05.279

Rheumatoid vasculitis with rheumatoid arthritis of unspecified ankle and foot

M05.29

Rheumatoid vasculitis with rheumatoid arthritis of multiple sites

M05.30

Rheumatoid heart disease with rheumatoid arthritis of unspecified site

M05.311

Rheumatoid heart disease with rheumatoid arthritis of right shoulder

M05.312

Rheumatoid heart disease with rheumatoid arthritis of left shoulder

M05.319

Rheumatoid heart disease with rheumatoid arthritis of unspecified shoulder

M05.321

Rheumatoid heart disease with rheumatoid arthritis of right elbow

M05.322

Rheumatoid heart disease with rheumatoid arthritis of left elbow

M05.329

Rheumatoid heart disease with rheumatoid arthritis of unspecified elbow

M05.331

Rheumatoid heart disease with rheumatoid arthritis of right wrist

M05.332

Rheumatoid heart disease with rheumatoid arthritis of left wrist

M05.339

Rheumatoid heart disease with rheumatoid arthritis of unspecified wrist

M05.341

Rheumatoid heart disease with rheumatoid arthritis of right hand

M05.342

Rheumatoid heart disease with rheumatoid arthritis of left hand

M05.349

Rheumatoid heart disease with rheumatoid arthritis of unspecified hand

M05.351

Rheumatoid heart disease with rheumatoid arthritis of right hip

M05.352

Rheumatoid heart disease with rheumatoid arthritis of left hip

M05.359

Rheumatoid heart disease with rheumatoid arthritis of unspecified hip

M05.361

Rheumatoid heart disease with rheumatoid arthritis of right knee

M05.362

Rheumatoid heart disease with rheumatoid arthritis of left knee

M05.369

Rheumatoid heart disease with rheumatoid arthritis of unspecified knee

M05.371

Rheumatoid heart disease with rheumatoid arthritis of right ankle and foot

M05.372

Rheumatoid heart disease with rheumatoid arthritis of left ankle and foot

M05.379

Rheumatoid heart disease with rheumatoid arthritis of unspecified ankle and foot

M05.39

Rheumatoid heart disease with rheumatoid arthritis of multiple sites

M05.40

Rheumatoid myopathy with rheumatoid arthritis of unspecified site

M05.411

Rheumatoid myopathy with rheumatoid arthritis of right shoulder

M05.412

Rheumatoid myopathy with rheumatoid arthritis of left shoulder

M05.419

Rheumatoid myopathy with rheumatoid arthritis of unspecified shoulder

M05.421

Rheumatoid myopathy with rheumatoid arthritis of right elbow

M05.422

Rheumatoid myopathy with rheumatoid arthritis of left elbow

M05.429

Rheumatoid myopathy with rheumatoid arthritis of unspecified elbow

M05.431

Rheumatoid myopathy with rheumatoid arthritis of right wrist

M05.432

Rheumatoid myopathy with rheumatoid arthritis of left wrist

M05.439

Rheumatoid myopathy with rheumatoid arthritis of unspecified wrist

M05.441

Rheumatoid myopathy with rheumatoid arthritis of right hand

M05.442

Rheumatoid myopathy with rheumatoid arthritis of left hand

M05.449

Rheumatoid myopathy with rheumatoid arthritis of unspecified hand

M05.451

Rheumatoid myopathy with rheumatoid arthritis of right hip

M05.452

Rheumatoid myopathy with rheumatoid arthritis of left hip

M05.459

Rheumatoid myopathy with rheumatoid arthritis of unspecified hip

M05.461

Rheumatoid myopathy with rheumatoid arthritis of right knee

M05.462

Rheumatoid myopathy with rheumatoid arthritis of left knee

M05.469

Rheumatoid myopathy with rheumatoid arthritis of unspecified knee

M05.471

Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot

M05.472

Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot

M05.479

Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot

M05.49

Rheumatoid myopathy with rheumatoid arthritis of multiple sites

M05.50

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified site

M05.511

Rheumatoid polyneuropathy with rheumatoid arthritis of right shoulder

M05.512

Rheumatoid polyneuropathy with rheumatoid arthritis of left shoulder

M05.519

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified shoulder

M05.521

Rheumatoid polyneuropathy with rheumatoid arthritis of right elbow

M05.522

Rheumatoid polyneuropathy with rheumatoid arthritis of left elbow

M05.529

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified elbow

M05.531

Rheumatoid polyneuropathy with rheumatoid arthritis of right wrist

M05.532

Rheumatoid polyneuropathy with rheumatoid arthritis of left wrist

M05.539

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified wrist

M05.541

Rheumatoid polyneuropathy with rheumatoid arthritis of right hand

M05.542

Rheumatoid polyneuropathy with rheumatoid arthritis of left hand

M05.549

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hand

M05.551

Rheumatoid polyneuropathy with rheumatoid arthritis of right hip

M05.552

Rheumatoid polyneuropathy with rheumatoid arthritis of left hip

M05.559

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hip

M05.561

Rheumatoid polyneuropathy with rheumatoid arthritis of right knee

M05.562

Rheumatoid polyneuropathy with rheumatoid arthritis of left knee

M05.569

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified knee

M05.571

Rheumatoid polyneuropathy with rheumatoid arthritis of right ankle and foot

M05.572

Rheumatoid polyneuropathy with rheumatoid arthritis of left ankle and foot

M05.579

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified ankle and foot

M05.59

Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites

M05.60

Rheumatoid arthritis of unspecified site with involvement of other organs and systems

M05.611

Rheumatoid arthritis of right shoulder with involvement of other organs and systems

M05.612

Rheumatoid arthritis of left shoulder with involvement of other organs and systems

M05.619

Rheumatoid arthritis of unspecified shoulder with involvement of other organs and systems

M05.621

Rheumatoid arthritis of right elbow with involvement of other organs and systems

M05.622

Rheumatoid arthritis of left elbow with involvement of other organs and systems

M05.629

Rheumatoid arthritis of unspecified elbow with involvement of other organs and systems

M05.631

Rheumatoid arthritis of right wrist with involvement of other organs and systems

M05.632

Rheumatoid arthritis of left wrist with involvement of other organs and systems

M05.639

Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems

M05.641

Rheumatoid arthritis of right hand with involvement of other organs and systems

M05.642

Rheumatoid arthritis of left hand with involvement of other organs and systems

M05.649

Rheumatoid arthritis of unspecified hand with involvement of other organs and systems

M05.651

Rheumatoid arthritis of right hip with involvement of other organs and systems

M05.652

Rheumatoid arthritis of left hip with involvement of other organs and systems

M05.659

Rheumatoid arthritis of unspecified hip with involvement of other organs and systems

M05.661

Rheumatoid arthritis of right knee with involvement of other organs and systems

M05.662

Rheumatoid arthritis of left knee with involvement of other organs and systems

M05.669

Rheumatoid arthritis of unspecified knee with involvement of other organs and systems

M05.671

Rheumatoid arthritis of right ankle and foot with involvement of other organs and systems

M05.672

Rheumatoid arthritis of left ankle and foot with involvement of other organs and systems

M05.679

Rheumatoid arthritis of unspecified ankle and foot with involvement of other organs and systems

M05.69

Rheumatoid arthritis of multiple sites with involvement of other organs and systems

M05.70

Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems involvement

M05.711

Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems involvement

M05.712

Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems involvement

M05.719

Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems involvement

M05.721

Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems involvement

M05.722

Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems involvement

M05.729

Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems involvement

M05.731

Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems involvement

M05.732

Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems involvement

M05.739

Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems involvement

M05.741

Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement

M05.742

Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems involvement

M05.749

Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems involvement

M05.751

Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems involvement

M05.752

Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement

M05.759

Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement

M05.761

Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement

M05.762

Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement

M05.769

Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement

M05.771

Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement

M05.772

Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement

M05.779

Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement

M05.79

Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement

M05.80

Other rheumatoid arthritis with rheumatoid factor of unspecified site

M05.811

Other rheumatoid arthritis with rheumatoid factor of right shoulder

M05.812

Other rheumatoid arthritis with rheumatoid factor of left shoulder

M05.819

Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder

M05.821

Other rheumatoid arthritis with rheumatoid factor of right elbow

M05.822

Other rheumatoid arthritis with rheumatoid factor of left elbow

M05.829

Other rheumatoid arthritis with rheumatoid factor of unspecified elbow

M05.831

Other rheumatoid arthritis with rheumatoid factor of right wrist

M05.832

Other rheumatoid arthritis with rheumatoid factor of left wrist

M05.839

Other rheumatoid arthritis with rheumatoid factor of unspecified wrist

M05.841

Other rheumatoid arthritis with rheumatoid factor of right hand

M05.842

Other rheumatoid arthritis with rheumatoid factor of left hand

M05.849

Other rheumatoid arthritis with rheumatoid factor of unspecified hand

M05.851

Other rheumatoid arthritis with rheumatoid factor of right hip

M05.852

Other rheumatoid arthritis with rheumatoid factor of left hip

M05.859

Other rheumatoid arthritis with rheumatoid factor of unspecified hip

M05.861

Other rheumatoid arthritis with rheumatoid factor of right knee

M05.862

Other rheumatoid arthritis with rheumatoid factor of left knee

M05.869

Other rheumatoid arthritis with rheumatoid factor of unspecified knee

M05.871

Other rheumatoid arthritis with rheumatoid factor of right ankle and foot

M05.872

Other rheumatoid arthritis with rheumatoid factor of left ankle and foot

M05.879

Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot

M05.89

Other rheumatoid arthritis with rheumatoid factor of multiple sites

M05.9

Rheumatoid arthritis with rheumatoid factor, unspecified

M06.00

Rheumatoid arthritis without rheumatoid factor, unspecified site

M06.011

Rheumatoid arthritis without rheumatoid factor, right shoulder

M06.012

Rheumatoid arthritis without rheumatoid factor, left shoulder

M06.019

Rheumatoid arthritis without rheumatoid factor, unspecified shoulder

M06.021

Rheumatoid arthritis without rheumatoid factor, right elbow

M06.022

Rheumatoid arthritis without rheumatoid factor, left elbow

M06.029

Rheumatoid arthritis without rheumatoid factor, unspecified elbow

M06.031

Rheumatoid arthritis without rheumatoid factor, right wrist

M06.032

Rheumatoid arthritis without rheumatoid factor, left wrist

M06.039

Rheumatoid arthritis without rheumatoid factor, unspecified wrist

M06.041

Rheumatoid arthritis without rheumatoid factor, right hand

M06.042

Rheumatoid arthritis without rheumatoid factor, left hand

M06.049

Rheumatoid arthritis without rheumatoid factor, unspecified hand

M06.051

Rheumatoid arthritis without rheumatoid factor, right hip

M06.052

Rheumatoid arthritis without rheumatoid factor, left hip

M06.059

Rheumatoid arthritis without rheumatoid factor, unspecified hip

M06.061

Rheumatoid arthritis without rheumatoid factor, right knee

M06.062

Rheumatoid arthritis without rheumatoid factor, left knee

M06.069

Rheumatoid arthritis without rheumatoid factor, unspecified knee

M06.071

Rheumatoid arthritis without rheumatoid factor, right ankle and foot

M06.072

Rheumatoid arthritis without rheumatoid factor, left ankle and foot

M06.079

Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot

M06.08

Rheumatoid arthritis without rheumatoid factor, vertebrae

M06.09

Rheumatoid arthritis without rheumatoid factor, multiple sites

M06.4

Inflammatory polyarthropathy

M06.80

Other specified rheumatoid arthritis, unspecified site

M06.811

Other specified rheumatoid arthritis, right shoulder

M06.812

Other specified rheumatoid arthritis, left shoulder

M06.819

Other specified rheumatoid arthritis, unspecified shoulder

M06.821

Other specified rheumatoid arthritis, right elbow

M06.822

Other specified rheumatoid arthritis, left elbow

M06.829

Other specified rheumatoid arthritis, unspecified elbow

M06.831

Other specified rheumatoid arthritis, right wrist

M06.832

Other specified rheumatoid arthritis, left wrist

M06.839

Other specified rheumatoid arthritis, unspecified wrist

M06.841

Other specified rheumatoid arthritis, right hand

M06.842

Other specified rheumatoid arthritis, left hand

M06.849

Other specified rheumatoid arthritis, unspecified hand

M06.851

Other specified rheumatoid arthritis, right hip

M06.852

Other specified rheumatoid arthritis, left hip

M06.859

Other specified rheumatoid arthritis, unspecified hip

M06.861

Other specified rheumatoid arthritis, right knee

M06.862

Other specified rheumatoid arthritis, left knee

M06.869

Other specified rheumatoid arthritis, unspecified knee

M06.871

Other specified rheumatoid arthritis, right ankle and foot

M06.872

Other specified rheumatoid arthritis, left ankle and foot

M06.879

Other specified rheumatoid arthritis, unspecified ankle and foot

M06.88

Other specified rheumatoid arthritis, vertebrae

M06.89

Other specified rheumatoid arthritis, multiple sites

M06.9

Rheumatoid arthritis, unspecified

M35.2

Behçet’s disease

M45.0

Ankylosing spondylitis of multiple sites in spine

M45.1

Ankylosing spondylitis of occipito-atlanto-axial region

M45.2

Ankylosing spondylitis of cervical region

M45.3

Ankylosing spondylitis of cervicothoracic region

M45.4

Ankylosing spondylitis of thoracic region

M45.5

Ankylosing spondylitis of thoracolumbar region

M45.6

Ankylosing spondylitis lumbar region

M45.7

Ankylosing spondylitis of lumbosacral region

M45.8

Ankylosing spondylitis sacral and sacrococcygeal region

M45.9

Ankylosing spondylitis of unspecified sites in spine

N17.8

Other acute kidney failure

N17.9

Acute kidney failure, unspecified

R19.7

Diarrhea, unspecified

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

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