Remicade (infliximab)

Transcription

1 Remicade (infliximab) Line(s) of Business: HMO; PPO; QUEST Integration Akamai Advantage Original Effective Date: 11/18/2003 Current Effective Date: 10/01/2015 POLICY A. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. FDA-Approved Indications Moderately to severely active Crohn s disease Moderately to severely active ulcerative colitis Moderately to severely active rheumatoid arthritis in combination with methotrexate Active ankylosing spondylitis Active psoriatic arthritis Chronic severe plaque psoriasis Compendial Uses Axial spondyloarthritis Behçet s syndrome Granulomatosis with polyangiitis (Wegener s granulomatosis) Hidradenitis suppurativa Juvenile idiopathic arthritis Pyoderma gangrenosum Sarcoidosis Takayasu s arteritis Uveitis B. REQUIRED DOCUMENTATION The following information is necessary to initiate the prior authorization review: Current and previous therapies documented in member s chart or medical record Pretreatment tuberculosis (TB) screening with TB skin test or an interferon gamma release assay (e.g., QFT-GIT, T-SPOT.TB) and TB treatment status (if applicable) documented in member s chart or medical record For Crohn s disease, documentation in member s chart or medical record supporting the presence of fistulizing disease For Crohn s disease and ulcerative colitis, documentation supporting an inadequate response to conventional therapy (if applicable)

2 Remicade 2 For rheumatoid arthritis, disease activity measure o Clinical Disease Activity Index (CDAI) o Disease Activity Score (DAS28-ESR or DAS28-CRP) o Patient Activity Scale (PAS) or PAS-II o Routine Assessment of Patient Index Data with 3 measures (RAPID-3) o Simplified Disease Activity Index (SDAI) For psoriasis, the following documentation is required: o Documentation supporting a history of plaque psoriasis for longer than 6 months o Percent of body surface area involvement o Results of treatment with methotrexate (MTX) such as ineffective treatment or intolerance, or documentation that MTX is contraindicated o For continuation of therapy, documentation in member s chart or medical record supporting a decrease in percent of body surface area involvement when compared to baseline must be submitted For psoriatic arthritis, the following documentation is required: o Documentation in member s chart or medical record supporting the presence of active enthesitis/dactylitis, and/or predominant axial disease; or o Documentation in member s chart or medical record supporting severely active disease For continuation of therapy, positive response to Remicade therapy documented in member s chart or medical record C. EXCLUSIONS Untreated latent TB infection o Treatment must be initiated prior to starting Humira. Active tuberculosis infection o Treatment must be completed prior to starting Humira. D. CRITERIA FOR APPROVAL 1. Moderately to severely active Crohn s disease (CD) Authorization for 12 months may be granted for members who meet EITHER of the following criteria: i. Member has fistulizing disease ii. Member has either of the following: a. Inadequate response to conventional therapies for CD (e.g. mesalamine, sulfasalazine, ciprofloxacin, metronidazole, azathioprine, mercaptopurine, methotrexate, methylprednisolone, prednisone) b. Intolerance or contraindication to ALL conventional therapy options Contraindications to conventional therapy Examples History of intolerance or adverse event Alcoholic liver disease or other chronic liver disease Elevated liver transaminases Interstitial pneumonitis or clinically significant pulmonary fibrosis Renal impairment Pregnancy or planning pregnancy (female) Pregnancy or planning pregnancy (male) Breastfeeding Blood dyscrasias (eg, thrombocytopenia, leukopenia, significant anemia)

3 Remicade 3 Myelodysplasia Uncontrolled hypertension or diabetes Hypersensitivity Significant drug interaction 2. Moderately to severely active ulcerative colitis (UC) Authorization for 12 months may be granted for members with either of the following: i. Inadequate response to conventional therapies for UC (e.g. mesalamine, sulfasalazine, azathioprine, mercaptopurine, methylprednisolone, prednisone, cyclosporine, or tacrolimus (or antibiotics for pouchitis only) ii. Intolerance or contraindication to ALL conventional therapy options 3. Moderately to severely active rheumatoid arthritis (RA) Authorization for 24 months may be granted for members who meet ALL of the following criteria: i. Member has a definite diagnosis of RA as defined by the 2010 ACR/EULAR Classification Criteria for RA. (See G. APPENDIX.) ii. Member has moderately to severely active disease as evidenced by at least one of the following disease activity measures: a) CDAI > 10.0 b) DAS28-ESR or DAS28-CRP 3.2 c) PAS or PAS-II 3.71 d) RAPID-3 > 2.0 e) SDAI > 11.0 iii. Remicade must be prescribed in combination with methotrexate (MTX) or leflunomide unless the member has a clinical reason not to use MTX or leflunomide iv. Member has at least one of the following: a) Inadequate response to at least a 3-month trial of MTX despite adequate dosing (i.e., titrated to mg/week) b) Intolerance or contraindication to MTX Contraindications to MTX Examples: History of intolerance or adverse event Alcoholic liver disease or other chronic liver disease Elevated liver transaminases Interstitial pneumonitis or clinically significant pulmonary fibrosis Renal impairment Pregnancy or planning pregnancy (male or female) Breastfeeding Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia) Myelodysplasia Hypersensitivity Significant drug interaction c) Inadequate response to at least a 3-month trial of a prior biologic DMARD or a targeted synthetic DMARD (e.g., Xeljanz) d) Intolerance to a prior biologic or targeted synthetic DMARD e) Severely active RA that warrants a biologic DMARD as first-line therapy

4 Remicade 4 4. Moderate to severe chronic plaque psoriasis Authorization of 6 months may be granted for members who meet ALL of the following criteria: i. Treatment with Remicade was recommended by a dermatologist ii. Member has been diagnosed with moderate to severe chronic plaque psoriasis defined as the following a) At least 10% of body surface area (BSA) is affected, or crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected, and b) History of psoriasis for 6 months or longer iii. Plaque psoriasis is characterized by well-defined patches of red and raised skin iv. Member has tried MTX for at least 3 months at a therapeutic dose and found it to be ineffective, or the member exhibited intolerance or allergy, or the use of MTX is contraindicated. a) Ineffective treatment is defined as symptoms and/or signs that are not resolved after completion of treatment at the recommended therapeutic dose and duration. If there is no recommended treatment time, the member must have had a meaningful trial. b) Intolerance is defined as having a recognized and reproducible or repeated adverse reaction that is clearly associated with taking the medication. c) Allergy is defined as a state of hypersensitivity produced by exposure to a particular antigen resulting in harmful immunologic reactions on subsequent exposures. The most common symptoms are skin rash or anaphylaxis. v. Continuation of therapy is covered when initial therapy has been approved and there is a decrease in percent of body surface area involvement when compared to baseline. 5. Active psoriatic arthritis (PsA) Authorization of 24 months may be granted for members who meet ANY of the following criteria: i. Member has experienced an inadequate response to at least a 3-month trial of MTX, sulfasalazine, or leflunomide. ii. Member has intolerance or contraindication to MTX, sulfasalazine, or leflunomide. Contraindications to MTX, sulfasalazine, or leflunomide Examples: History of intolerance or adverse event Alcoholic liver disease or other chronic liver disease Elevated liver transaminases Interstitial pneumonitis or clinically significant pulmonary fibrosis Renal impairment Pregnancy or planning pregnancy Breastfeeding Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia) Myelodysplasia Hypersensitivity Significant drug interaction Intestinal obstruction Urinary obstruction Porphyria iii. Member has experienced an inadequate response to at least a 3-month trial of a prior biologic DMARD. iv. Member has experienced intolerance to a prior biologic DMARD.

5 Remicade 5 v. Member s condition is severely active as evidenced by ANY of the following: a) Multiple swollen joints b) Structural damage in the presence of inflammation c) Clinically relevant extra-articular manifestations Extra-articular manifestations of psoriatic arthritis Examples: Cutaneous involvement: o Psoriasis o Erythema nodosum o Keratoderma blenorrhagicum o Circinate balanitis o Pyoderma gangrenosum Bowel involvement o Crohn s disease (CD) o Ulcerative colitis(uc) o a specific colitis (in presence of inflammatory bowel disease (IBD) that cannot be classified as CD or UC) o Severe and persistent diarrhea Ocular involvement o Uveitis o Conjunctivitis Cardiovascular involvement o Aortic insufficiency o Conduction disturbances (e.g., atrioventricular blocks, bundle branch blocks, and intraventricular blocks) o Thrombosis o Phlebitis Urogenital involvement o Urethritis o Prostatitis o Balanitis o Vaginitis o Cervicitis amyloidosis (AA type) o IgA nephropathy Pulmonary involvement: Apical pulmonary fibrosis vi. Member has active enthesitis and/or dactylitis (i.e., sausage digit). vii. Member has predominant axial disease (i.e., extensive spinal involvement). 6. Active ankylosing spondylitis (AS) and axial spondyloarthritis Authorization of 24 months may be granted for members who meet ALL of the following criteria: i. Member has experienced an inadequate response to at least two non-steroidal antiinflammatory drugs (NSAIDs) over a 4-week period in total at maximum recommended or tolerated anti-inflammatory dose, OR has intolerance or contraindication to 2 or more NSAIDs. ii. Member has at least one of the following: a) Predominant axial disease (i.e., extensive spinal involvement) b) Inadequate response to a synthetic DMARD (e.g., sulfasalazine) c) Intolerance or contraindication to a synthetic DMARD

6 Remicade 6 d) Inadequate response to at least a 3-month trial of a prior biologic DMARD e) Intolerance to a prior biologic DMARD 7. Juvenile idiopathic arthritis Authorization of 24 months may be granted for members who meet ANY of the following criteria: i. Member has experienced an inadequate response to at least a 3-month trial of a selfinjectable TNF inhibitor (e.g., Enbrel or Humira). ii. Member has experienced an intolerable adverse event (e.g., hypersensitivity reaction) to a self-injectable TNF inhibitor iii. Member has developed antibodies against Enbrel or Humira. 8. Hidradenitis suppurativa Authorization of 24 months may be granted for members who meet the following criteria: i. Condition is severe and refractory to standard first-line treatment 9. Behçet s syndrome treatment of Behçet s syndrome. 10. Granulomatosis with polyangiitis (Wegener s granulomatosis) treatment of granulomatosis with polyangiitis. 11. Pyoderma gangrenosum treatment of pyoderma gangrenosum. 12. Sarcoidosis treatment of sarcoidosis. 13. Takayasu s arteritis treatment of Takayasu s arteritis. 14. Uveitis treatment of uveitis. E. CONTINUATION OF THERAPY For indications other than Crohn s disease, ulcerative colitis, and chronic plaque psoriasis, authorization of 24 months may be granted for all members (including new members) who meet ALL initial authorization criteria and achieve or maintain positive clinical response with Humira as evidenced by low disease activity (e.g., CDAI 10.0, DAS28 < 3.2, PAS or PAS 3.70, RAPID or SDAI 11.0 for RA) or improvement in signs and symptoms of the condition. For Crohn s disease and ulcerative colitis, authorization of 12 months may be granted for all members (including new members) who meet ALL initial authorization criteria and achieve or

7 Remicade 7 maintain positive clinical response with Humira as evidenced by low disease activity or improvement in signs and symptoms. To receive authorization for an additional 6 months of therapy for chronic plaque psoriasis, documentation supporting a decrease in percent of body surface area involvement when compared to baseline must be submitted. Thereafter, authorization of 12 months may be granted. F. DOSAGE AND ADMINISTRATION Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. G. APPENDIX The 2010 ACR-EULAR Classification Criteria for RA is a score-based algorithm. A score of at least 6 out of 10 is necessary for classification of a patient as having definite RA. Classification Criteria for RA (score-based algorithm: add score of categories A-D) Score A. Joint Involvement 1 large joint* large joints small joints (with or without involvement of large joints)** small joints (with or without involvement of large joints) 3 >10 joints (at least one small joint) # 5 B. Serology (at least 1 test result is needed for classification) Negative RF and negative ACPA 0 Low-positive RF or low-positive ACPA 2 High-positive RF or high-positive ACPA 3 C. Acute-phase reactants (at least 1 test result is needed for classification) Normal CRP and normal ESR 0 Abnormal CRP or abnormal ESR 1 D. Duration of symptoms <6 weeks 0 6 weeks 1 * Large joints refers to shoulders, elbows, hips, knees, and ankles. ** Small joints refers to the metacarpophalangeal joints, proximal interphalangeal joints, second through fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists. # In this category, at least 1 of the involved joints must be a small joint; the other joints can include any combination of large and additional small joints, as well as other joints not specifically listed elsewhere (e.g., temporomandibular, acromioclavicular, sternoclavicular, etc.). Negative refers to IU values that are less than or equal to the upper limit of normal (ULN) for the laboratory and assay; low-positive refers to IU values that are higher than the ULN but 3 times the ULN for the laboratory and assay; high-positive refers to IU values that are >3 times the ULN for the

8 Remicade 8 laboratory and assay. Where rheumatoid factor (RF) information is only available as positive or negative, a positive result should be scored as low-positive for RF; ACPA = anti-citrullinated protein antibody Normal/abnormal is determined by local laboratory standards. CRP = C-reactive protein; ESR = erythrocyte sedimentation rate. Duration of symptoms refers to patient self-report of the duration of signs or symptoms of synovitis (e.g., pain, swelling, tenderness) of joints that are clinically involved at the time of assessment, regardless of treatment status. H. IMPORTANT REMINDER The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii s Patients Bill of Rights and Responsibilities Act (Hawaii Revised Statutes 432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA s determination as to medical necessity in a given case, the physician may request that CVS/caremark reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. I. REFERENCES 1. Remicade [package insert]. Horsham, PA: Janssen Biotech, Inc.; November van der Heijde D, Sieper J, Maksymowych WP, et al Update of the international ASAS recommendations for the use of anti-tnf agents in patients with axial spondyloarthritis. Ann Rheum Dis. 2011;70: DRUGDEX System (electronic version). Truven Health Analytics, Ann Arbor, MI. Available at Accessed September 24, Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S 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): Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73: Singh JA, Furst DE, Bharat A, et al 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 2012;64(5): Aletasha D, Neogi T, Silman AJ, et al Rheumatoid Arthritis Classification Criteria. An American College of Rheumatology/European League Against Rheumatism Collaborative Initiative. Arthritis Rheum. 2010;62:

9 Remicade 9 9. Anderson J, Caplan L, Yazdany J, et al. Rheumatoid Arthritis Disease Activity Measures: American College of Rheumatology Recommendations for Use in Clinical Practice. Arthritis Rheum. 2010;64: Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1): Gossec L, Smolen JS, Gaujoux-Viala C, et al. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis 2012;71: Gladman DD, Antoni C, P Mease, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 2005;64(Suppl II):ii14 ii Peluso R, Lervolino S, Vitiello M, et al. Extra-articular manifestations in psoriatic arthritis patients. Clin Rheumatol May 8. [Epub ahead of print]. 14. Braun J, van den Berg R, Baraliakos X, et al update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011;70: Beukelman T, Patkar NM, Saag KG, et al 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 Res. 2011;63(4): Ringold S, Weiss PF, Beukelman T, et al Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis: Recommendations for the Medical Therapy of Children With Systemic Juvenile Idiopathic Arthritis and Tuberculosis Screening Among Children Receiving Biologic Medications. Arthritis & Rheumatism. 2013;65: