In April of 2017, Renflexis (infliximab-abda), the second FDA-approved biosimilar to Remicade was approved for all Remicade-approved indications, except pediatric ulcerative colitis. It can be used for treating patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease.

In December of 2017, the FDA approved Ixifi (infliximab-qbtx), another biosimilar to Remicade for the treatment for all Remicade-approved indications. This includes the treatment of rheumatoid arthritis, ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease.

In December 2016, the FDA approved Avsola (infliximab-axxq), the 4th biosimilar to Remicade for the treatment of all Remicade-approved indications. This includes the treatment of rheumatoid arthritis, ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease.

[INFORMATIONAL NOTE: The FDA-approved Remicade (infliximab), Inflectra (infliximab-dyyb), Renflexis(infliximab-abda), Ixifi (infliximab-qbtx), and Avsola (infliximab-axxq) package inserts have the following:

BLACK BOX WARNINGS:

• Patients treated with Remicade, Inflectra, Renflexis, Ixifi or Avsola are at increased risk for developing serious infections that may lead to hospitalization or death). Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Remicade, Inflectra, Renflexis, Ixifi or Avsola should not be administered during an active infection. It should be discontinued if a patient develops a serious infection or sepsis.
• Reported infections include:
  • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Remicade, Inflectra, Renflexis, Ixifi or Avsola use and during therapy. Treatment for latent infection should be initiated prior to Remicade, Inflectra , Renflexis, Ixifi or Avsola use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
  • The risks and benefits of treatment with Remicade, Inflectra, Renflexis, Ixifi or Avsola should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection..
  • Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Remicade, Inflectra, Renflexis, Ixifi or Avsola, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
• Malignancies – the incidence of malignancies including lymphoma was greater in Remicade, Inflectra, Renflexis, Ixifi or Avsola treated patients than in controls. Due to the risk of hepatosplenic t-cell lymphoma carefully assess the risk/benefit especially if the patient has Crohn’s disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment.
• Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Remicade, Inflectra, Renflexis, Ixifi or Avsola.
• Rare postmarketing cases of hepatosplenic T-cell lymphoma have been reported in adolescent and young adult patients with Crohn’s disease or ulcerative colitis treated with Remicade, Inflectra, Renflexis, Ixifi or Avsola. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. All of these hepatosplenic T-cell lymphomas with Remicade, Inflectra, Renflexis, Ixifi or Avsola have occurred in patients on concomitant treatment with azathioprine or 6-mercaptopurine.]

The requirements of the Horizon BCBSNJ Infliximab (Remicade), infliximab-dyyb (Inflectra), infliximab-abda (Renflexis), infliximab-qbtx (Ixifi) and infliximab-axxq (Avsola) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).

I. Please refer to a separate policy on Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) under the Drug Section.

II. Prior to starting therapy with infliximab, infliximab-dyyb, infliximab-abda, infliximab-qbtx or infliximab-axxq the following must be documented:

• Member has been tested for latent tuberculosis (TB) AND if positive the patient has begun therapy for latent TB; AND
• The prescriber is a specialist (e.g. rheumatologist, gastroenterologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
[INFORMATIONAL NOTE: As per the FDA approved package insert, prior to initiating therapy, patients should be evaluated for Hepatitis B virus (HBV) risk, and if appropriate, HBV infection should be ruled out or treatment initiated.]

A. Crohn's Disease (CD)
• Moderately to severely active Crohn's Disease - for reduction of signs and symptoms, and induction and maintenance of clinical remission in adult and pediatric (6 years of age and older) members when:
  • Member has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, aminosalicylates, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], mesalamine, methotrexate, sulfasalazine) used in the treatment of CD for at least 3-months or has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate, sulfasalazine) used in the treatment of CD; OR
  • Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of Crohn's disease
• Fistulizing Crohn's disease - for reduction in the number of draining enterocutaneous and rectovaginal fistulas and for maintenance of fistula closure in adult members with fistulizing Crohn’s disease for at least 3 months duration

B. Rheumatoid Arthritis (RA) - for reduction of signs and symptoms, inhibition of progression of structural damage, and improvement of physical function in members with moderately to severely active rheumatoid arthritis, when all of the following are met
• prescribed concomitantly with methotrexate unless the member has contraindication or intolerance to methotrexate, AND
• member has tried and failed at least a 3 month trial of ONE conventional agent such as methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine or has an intolerance or contraindication to ALL of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) OR
• Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of RA

[INFORMATIONAL NOTE: The ACR 2015 recommendations on use of biological DMARDs in RA patients are based on duration, severity and prior exposure to non-biologic DMARDs.
In order to assess if a patient is a candidate for biologic DMARD therapy, RA disease activity should be measured as per the tests below:




Table 2. Disease activity cutoffs for each American College of Rheumatology-recommended disease activity measure*
Disease activity measure	Scale	Remission	Low/Minimal	Moderate	High/severe
Patient-driven composite tools
PAS	0-10	0.00-0.25	0.26-3.70	3.71 to <8.0	8.00-10.00
PAS-II	0-10	0.00-0.25	0.26-3.70	3.71 to <8.0	8.00-10.00
RAPID-3	0-10	0-1.0	>1.0 to 2.0	>2.0 to 4.0	>4.0 to 10
Patient and provider composite tool
CDAI	0-76	≤2.8	>2.8 to 10.0	>10.0 to 22.0	>22.0
Patient, provider, and laboratory composite tools
DAS28 (ESR or CRP)	0-9.4	<2.6	≥2.6 to <3.2	≥3.2 to ≤5.1	>5.1
SDAI	0-86	≤3.3	>3.3 to ≤11.0	>11.0 to ≤26	>26
*PAS= Patient Activity Scale; RAPID-3= Routine Assessment of Patient Index Data with 3 measures; CDAI= Clinical Disease Activity Index; DAS28= Disease Activity Score with 28-joint counts; ESR= erythrocyte sedimentation rate; CRP= C-reactive protein; SDAI= Simplified Disease Activity Index


Algorithm 1 - Once RA disease severity has been measured, they can be stratified in different treatments algorithms depending on the duration of the disease:
• Patients with Early RA (disease duration <6 months)
  • Low disease activity or remission
    • DMARD monotherapy is recommended
    • DMARD monotherapy is recommended for those who are DMARD naïve
    • If there is continued disease activity with DMARD therapy, consider combination of traditional DMARDs and TNF inhibitor or non TNF biologics
• Patients with established RA (disease duration ≥6 months or meeting the 1987 ACR RA classification criteria)
  • 1987 ACR RA classification criteria:
    · Morning stiffness
    · Arthritis of 3 or more joint areas
    · Arthritis of hand joints
    · Symmetric arthritis
    · Rheumatoid nodules
    · Serum rheumatoid factor
    · Radiographic changes
  · Consider DMARD monotherapy for all patients of low, moderate, or high disease activity who are DMARD naïve
  · For patients who do not respond adequately on DMARD monotherapy, consider combination therapy of traditional DMARD, or TNF inhibitor with or without MTX, or non TNF biologic with or without MTX, or tafacitinib with or without MTX
  · If patients continue to have moderate or high disease activity, consider switching to a different agent within the drug class of TNF inhibitors, or non TNF biologics (with or without MTX) or tafacitinib with or without MTX

C. Psoriatic Arthritis (PsA) – for reduction of signs and symptoms of active moderate to severe arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis when:
• Member has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive OR
• Member has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) OR
• Member has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, hydroxychloroquine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months OR member has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) OR
• Member's medication history indicates use of another biologic immunomodulator agent or Otezla that is FDA labeled or supported by compendia for the treatment of PsA
  
D. Ankylosing Spondylitis (AS) – reduction of signs and symptoms in members with active ankylosing spondylitis when:

• Member has tried and had an inadequate response to two different non-steroidal anti-inflammatory drugs (NSAIDs) used in the treatment of AS for at least a 4-week total trial or member has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL NSAIDs used in the treatment of ankylosing spondylitis OR
• Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of AS
E. Ulcerative Colitis (UC) –
• Adult - for reduction of signs and symptoms, achievement of clinical remission and mucosal healing, and elimination of corticosteroids use in members with moderately to severely active ulcerative colitis who have:
  • had inadequate response to one conventional agent (e.g., oral corticosteroids, 6 –mercaptopurine, azathioprine, balsalazide, cyclosporine, mesalamine, metronidazole, steroid suppositories, sulfasalazine) or has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., oral corticosteroids, 6 –mercaptopurine, azathioprine, balsalazide, cyclosporine, mesalamine, steroid suppositories, sulfasalazine) OR
  • Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of UC
• Pediatric - for reduction of signs and symptoms and inducing and maintaining clinical remission in pediatric members 6 years of age and older with moderately to severely active ulcerative colitis who have:
  • had inadequate response to one conventional agent (e.g., oral corticosteroids, 6 –mercaptopurine, azathioprine, balsalazide, cyclosporine, mesalamine, metronidazole, steroid suppositories, sulfasalazine) or has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., oral corticosteroids, 6 –mercaptopurine, azathioprine, balsalazide, cyclosporine, mesalamine, steroid suppositories, sulfasalazine) OR
  • Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of UC

F. Plaque Psoriasis (PS)- for the treatment of adult patients with moderate to severe chronic disease when member meets ONE of the following:
• Member has tried and had an inadequate response to ONE conventional agent (i.e., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least 3-months OR has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents used in the treatment of PS; OR
• Member has severe active PS (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences); OR
• Member has concomitant severe psoriatic arthritis (PsA) (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive; OR
• Member's medication history indicates use of another biologic immunomodulator agent or Otezla that is FDA labeled or supported by compendia for the treatment of PS

[Please refer to policy statement IV for off-label use of infliximab (REMICADE) for moderate-chronic plaque psoriasis.]
[INFORMATIONAL NOTE: According to the product's FDA-approved package insert, patients treated with REMICADE, INFLECTRA, RENFLEXIS, IXIFI or AVSOLA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Administration of REMICADE, INFLECTRA, RENFLEXIS, IXIFI or AVSOLAshould be discontinued if a patient develops a serious infection or sepsis. Treatment with REMICADE, INFLECTRA, RENFLEXIS, IXIFI or AVSOLA should not be initiated in patients with active infections including chronic or localized infections.]

A. Crohn's Disease -
· For adults with moderately to severely active Crohn's disease or Fistulizing Crohn’s disease - 5 mg/kg given as an induction regimen at weeks 0, 2, and 6 followed by a maintenance regimen of 5 mg/kg every 8 weeks. For members who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. Members who do not respond by week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue Remicade, Inflectra, Renflexis, Ixifi or Avsola in these members.
· For children (6 years of age and older) with moderately to severely active Crohn's disease - 5 mg/kg given as an induction regimen at weeks 0, 2, and 6 followed by maintenance regimen of 5 mg/kg every 8 weeks.

B. Rheumatoid arthritis - 3 mg/kg doses at weeks 0, 2, and 6 then every 8 weeks thereafter. For members who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks.

C. Psoriatic Arthritis – 5 mg/kg doses at weeks 0, 2, 6 and then every 8 weeks thereafter.

D. Ankylosing Spondylitis – 5 mg/kg for weeks 0, 2, 6 and then every 6 weeks thereafter.

E. Adult and pediatric (6 years and older) Ulcerative Colitis - 5 mg/kg doses at weeks 0, 2, 6 and then every 8 weeks thereafter.

F. Plaque Psoriasis - 5 mg/kg doses at weeks 0, 2, 6 and then every 8 weeks thereafter.

• Crohn's disease in adults and pediatrics
  • Member had disease response 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, tapering or discontinuation of corticosteroid therapy and use of anti-diarrheal drugs; AND
  • Patient continues to meet initial review criteria; AND
  • Absence of unacceptable toxicity from the drug (e.g.: serious infection, tuberculosis, malignancy, cytopenia, lupus-like syndrome, cerebrovascular accidents, cardiotoxicity/heart failure, neurotoxicity, hepatotoxicity, demyelinating disease, etc.)
• Fistulizing Crohn’s disease
  • Member had disease response indicated by improvement in signs and symptoms compared to baseline such as a reduction in number of enterocutaneous fistulas draining upon gentle compression; AND
  • Patient continues to meet initial review criteria; AND
  • Absence of unacceptable toxicity from the drug (e.g.: serious infection, tuberculosis, malignancy, cytopenia, lupus-like syndrome)
• Adult rheumatoid arthritis
  • Disease response 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
  • Patient continues to meet initial review criteria; AND
  • Absence of unacceptable toxicity from the drug (e.g.: serious infection, tuberculosis, malignancy, cytopenia, lupus-like syndrome, cerebrovascular accidents, cardiotoxicity/heart failure, neurotoxicity, hepatotoxicity, demyelinating disease, etc.)
• Psoriatic arthritis
  • Member had disease response indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts; AND
  • Patient continues to meet initial review criteria; AND
  • Absence of unacceptable toxicity from the drug (e.g.: serious infection, tuberculosis, malignancy, cytopenia, lupus-like syndrome, cerebrovascular accidents, cardiotoxicity/heart failure, neurotoxicity, hepatotoxicity, demyelinating disease, etc.)
• 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); AND
  • Patient continues to meet initial review criteria; AND
  • Absence of unacceptable toxicity from the drug (e.g.: serious infection, tuberculosis, malignancy, cytopenia, lupus-like syndrome, cerebrovascular accidents, cardiotoxicity/heart failure, neurotoxicity, hepatotoxicity, demyelinating disease, etc.)
• Ulcerative colitis in adults and pediatrics
  • Member had 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
  • Patient continues to meet initial review criteria; AND
  • Absence of unacceptable toxicity from the drug (e.g.: serious infection, tuberculosis, malignancy, cytopenia, lupus-like syndrome, cerebrovascular accidents, cardiotoxicity/heart failure, neurotoxicity, hepatotoxicity, demyelinating disease, etc.)
• 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; AND
  • Patient continues to meet initial review criteria; AND
  • Absence of unacceptable toxicity from the drug (e.g.: serious infection, tuberculosis, malignancy, cytopenia, lupus-like syndrome, cerebrovascular accidents, cardiotoxicity/heart failure, neurotoxicity, hepatotoxicity, demyelinating disease, etc.)

A. Severe, refractory Granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis), in combination with corticosteroids.

[ INFORMATIONAL NOTE: On June 3, 2008, the FDA issued an Early Warning Communication About an Ongoing Safety Review involving the association of Tumor Necrosis Factor (TNF) blockers and the development of lymphomas and other cancers among children and young adults. Over a ten-year interval using the FDA’s Adverse Event Reporting System, reports have been described cancer occurring in children using TNF blockers when they were 18 years of age or less to treat juvenile idiopathic arthritis, Crohn’s disease, and other diseases. Until the evaluation is complete and further long term studies have been conducted, caution should be advised in the use of TNF blockers in children and young adults.]

Medicare Coverage

There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for these drugs. Therefore, Medicare Advantage will follow the Horizon Policy. See generally: Local Coverage Article: Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents (A53049). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/LcdSearch?_afrLoop=90769712476969#!%40%40%3F_afrLoop%3D90769712476969%26centerWidth%3D100%2525%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D63y7eftob_46.

**Note: Bullet 1 of the policy section referring to Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) does not apply for Medicare Advantage Products.

Medicaid Coverage

For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf

________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Infliximab
Remicade
Inflectra
Renflexis
Ixifi
Avsola

References:

1. 2004 Physician's Desk Reference. 58th Edition. Medical Economics Publishing Company.

2. Horizon Blue Cross and Blue Shield of New Jersey Pharmacy and Therapeutics Committee (February 1, 2000) on Remicade (Infliximab).

3. Ogilvie A, Antoni C, Dechant C, et al. Treatment of psoriatic arthritis with antitumour necrosis factor-alpha antibody clears skin lesions of psoriasis resistant to treatment with methotrexate. Br J Dermatol. 2001;144:587-589.

4. Kirby B, Marsland AM, Carmichael AJ, et al. Successful treatment of severe recalcitrant psoriasis with combination infliximab and methotrexate. Clin Dermatol. 2001;26:27-29.

5. Oh CJ, Das KM, Gottlieb AB. Treatment with anti-tumor necrosis factor alpha monoclonal antibody dramatically decreases the clinical activity of psoriasis lesions. J Am Acad Dermatol. 2000;42:829-830.

6. Brandt J, Haibel H, Cornely D, et al. Successful treatment of active ankylosing spondylitis with the anti-tumor necrosis factor alpha monoclonal antibody infliximab. Arthritis Rheum. 2000;43(6):1346-1352.

7. Lipsky PE, van der Heijde D, St Clair E, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med. 2000;343:1594-1602.

8. Farrell RJ, Shah SA, Lodhavia PJ, et al. Clinical Experience with Infliximab Therapy in 100 Patients with Crohn's Disease. The American Journal of Gastroenterology. 2000;95(12):3490-3497.

9. Cohen RD, Tsang JF, Hanauer SB. Infliximab in Crohn's Disease: First Anniversary Clinical Experience. The American Journal of Gastroenterology. 2000;95(12):3469-3477.

10. Van den Bosch F, Kruithof E, Baeten D, et al. Effects of a loading dose regimen of three infusions of chimeric monoclonal antibody to tumour necrosis factor alpha (infliximab) in spondyloarthropathy: an open pilot study. Am Rheum Dis. 2000;59:428-433.

11. Rutgeerts P, D'Haens G, Targan S, et al. Efficacy and Safety of Retreatment with Anti-Tumor Necrosis Factor Antibody (Infliximab) to Maintain Remission in Crohn's Disease. Gastroenterology. 1999;117:761-769.

12. Maini RN, St Clair EW, Breedveld F, et al. Infliximab versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. Lancet. 1999;354:1932-1939.

13. FDA website (www.fda.gov).

14. Janssen Biotech, Inc., Remicade® (infliximab) prescribing information. Horsham, PA. May 2020.

15. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet 2002 May;359:1541-1549.

16. Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Eng J Med 2001 Oct;345(15):1098-1104.

17. Lim WS, Powell RJ, Johnston ID. Tuberculosis and treatment with infliximab. N Engl J Med 2002 Feb;346(8):623-624.

18. Fam AG. Recent advances in the management of adult myositis. Expert Opin Investig Drugs 2001 Jul;10(7):1265-1277.

19. Tateyama M, Nagano I, Yoshioka M, et al. Expression of tumor necrosis factor –alpha in muscles of polymyositis. J Neurol Sciences 1997;146:45-51.

20. Shimizu T, Tomita Y, Son K, et al. Elevation of serum soluble tumour necrosis factor receptors in patients with polymyositis and dermatomyositis. Clin Rheumatol 2000;19(5):352-359.

21. Kuru S, Inukai A, Liang Y, et al. Tumor necrosis factor-alpha expression in muscles of polymyositis and dermatomyositis. Acta Neuropathologica 2000;99(5):585-588.

22. Lundberg I, Ulfgren AK, Nyberg P, et al. Cytokine production in muscle tissue of patients with idiopathic inflammatory myopathies. Arthritis Rheum 1997;40:865-874.

23. Tews DS, Goebel HH. Cytokine expression profile in idiopathic inflammatory myopathies. J Neuropathol Exp Neurol 1996;55:342-347.

24. Lundberg I, Brengman JM, Engel AJ. Analysis of cytokine expression in muscle inflammatory myopathies, Duchenne dystrophy, and non-weak controls. J Neuroimmunol 1995;63:9-16.

25. Hengstman G, van der Hoogen, van Engelen, et al. Anti-TNF blockade with infliximab (REMICADE) in polymyositis and dermatomyositis. American College of Rheumatology 64th Annual Scientific Meeting, Philadelphia, PA, October 30-November 2, abstract no. 758.

26. Wada H, Saito K, Kanda T, et al. Tumor Necrosis Factor-alpha (TNF-alpha) Plays a Protective Role in Acute Viral Myocarditis in Mice. Circulation 2001;103:743-749.

27. Mann DL. Tumor Necrosis Factor and Viral Myocarditis. Circulation 2001;103:626-629.

28. Hanauer SB, Feagan BG, Lichtenstein GR et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomized trial. Lancet 2002 May 4;359(9317):154-9.

29. FDA Supplemental Approval. Updated 4/3/2003. http://www.fda.gov/cber/products/inflcen040103.htm (accessed 5/21/2003)

30. Clark W, Raftery J, Song F, et al. Systematic review and economic evaluation of the effectiveness of infliximab for the treatment of Crohn’s disease. Health Technology Assessment 2003 April;7(3)

31. Blue Cross and Blue Shield Association. Medical Policy Reference Manual: Off-Label Uses of Infliximab. 4:2004: Policy #5.01.15 (and its associated references).

32. Lam EC, Bailey RJ. Infliximab salvage therapy after cyclosporine in an acute flare of chronic ulcerative colitis. Can J Gastroenterol 2003 Mar;17(3):198-200.

33. Su C, Salzberg BA, Lewis JD, et al. Efficacy of anti-tumor necrosis factor therapy in patients with ulcerative colitis. Am J Gastroenterol 2002 Oct;97(10):2577-84.

34. Cohen RD. Evolving medical therapies for ulcerative colitis. Curr Gastroenterol Rep 2002 Dec;4(6):497-505.

35. Actis GC, Bruno M, Pinna-Pintor M, et al. Infliximab for treatment of steroid-refractory ulcerative colitis. Dig Liver Dis 2002 Sep;34(9):631-4.

36. Kohn A, Prantera C, Pera A, et al. Anti-tumour necrosis factor alpha (infliximab) in the treatment of severe ulcerative colitis: result of an open study on 13 patients. Dig Liver Dis 2002 Sep;34(9):626-30.

37. Rutgeerts P. A critical assessment of new therapies in inflammatory bowel disease. J Gastroenterol Hepatol 2002 Feb;17 Suppl:S176-85.

38. Sfikakis PP, Theodossiadis PG, Katsiari CG et al. Effect of infliximab on sight-threatening panuveitis in Behcet’s disease. Lancet. 2001 Jul 28;358(9278):295-6.

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Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

J1745