Drug Therapy Guidelines

Transcription

1 Simponi, Simponi Aria Applicable Medical Benefit x Effective: 2/13/18 Pharmacy- Formulary 1 x Next Review: 12/18 Pharmacy- Formulary 2 x Date of Origin: 7/2010 Pharmacy- Formulary 3/Exclusive x Review Dates: 3/10, 1/11, 3/11, 3/12, 3/13, 12/13, 9/14, 12/15, Pharmacy- Formulary 4/AON x 12/16, 12/17 I. Medication Description Golimumab is a monoclonal antibody that binds specifically to soluble and transmembrane bioactive forms of tumor necrosis factor (TNF). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. II. Position Statement Coverage is determined through a prior authorization process with supporting clinical documentation for every request. III. Policy Medical: See Section A Formulary 1: See Sections B and C Formulary 2: See Sections B and C Formulary 3/Exclusive: See Sections B and C Formulary 4/AON: See Sections B and C A. Coverage of Simponi and Simponi Aria under the medical benefit is provided for the following conditions when the listed criteria are met: Ankylosing spondylitis (active disease): o The member has had inadequate results with at least two NSAIDs (unless NSAIDs are contraindicated) Psoriatic arthritis (active disease): o Prescribed by a rheumatologist or dermatologist AND Member has tried therapy with at least one non-biologic DMARD with either treatment failure after 12 weeks or intolerable side effects (unless DMARDs are If predominantly axial disease is documented, the member has experienced treatment failure with at least two oral NSAIDs (unless NSAIDs are contraindicated) Rheumatoid arthritis (moderate to severe disease): o Member has tried therapy with at least one non-biologic DMARD with either treatment failure after 12 weeks or intolerable side effects (unless DMARDs are contraindicated) AND o Medication is used in combination with methotrexate (unless contraindicated) Page 1 of 5

2 Coverage of Simponi under the medical benefit is provided for the following condition when the listed criteria are met: Ulcerative colitis (moderate to severe disease): o Prescribed by a gastroenterologist AND The member has experienced treatment failure or intolerable side effects with an immune modulator such as azathioprine, 6MP, methotrexate (unless The severity of the condition requires rapid improvement not attainable with immune modulators B. Coverage of Simponi under the pharmacy benefit is provided for the following conditions when the listed criteria are met: Ankylosing spondylitis (active disease): o The member has had inadequate results with at least two NSAIDs (unless NSAIDs are contraindicated) AND (Cosentyx, Enbrel, or Humira) Psoriatic arthritis (active disease): o Prescribed by a rheumatologist or dermatologist AND Member has tried therapy with at least one non-biologic DMARD with either treatment failure after 12 weeks or intolerable side effects (unless DMARDs are If predominantly axial disease is documented, the member has experienced treatment failure with at least two oral NSAIDs (unless NSAIDs are contraindicated) AND (Cosentyx, Enbrel, Humira, or Stelara SC) Rheumatoid arthritis (moderate to severe disease): o Member has tried therapy with at least one non-biologic DMARD with either treatment failure after 12 weeks or intolerable side effects (unless DMARDs are contraindicated) AND o Medication is used in combination with methotrexate (unless contraindicated) AND (Actemra SC, Enbrel, Humira, or Xeljanz/XR) Ulcerative colitis (moderate to severe disease): o Prescribed by a gastroenterologist AND The member has experienced treatment failure or intolerable side effects with an immune modulator such as azathioprine, 6MP, methotrexate (unless Page 2 of 5

3 o The severity of the condition requires rapid improvement not attainable with immune modulators AND The member has tried therapy with plan-preferred medication (Humira) C. Step therapy criteria outlined in B apply unless the following criteria have been met: When requesting coverage of a brand medication for which an A/B rated generic is available, there is sufficient evidence that the use of the A/B rated generic equivalent has resulted in inadequate results AND At least one of the following is met: o The plan-preferred medications are contraindicated or will likely cause an adverse reaction by or physical or mental harm to the member. o The plan-preferred medications are expected to be ineffective based on the known clinical history and conditions of the member and the member s prescription drug regimen. o The member has tried the plan-preferred medications or another prescription drug in the same pharmacologic class or with the same mechanism of action and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event. o The member is stable on the medication selected by their healthcare professional for the medical condition under consideration (where stable is defined as receiving the medication for an adequate period of time, have achieved optimal response, and continued favorable outcomes are expected UNLESS the medication was initially selected due to the availability of a drug sample or a coupon card). o The plan-preferred medication is not in the best interest of the member because it will likely cause a significant barrier to the member s adherence or to compliance with the member s plan of care, will likely worsen a comorbid condition of the member, or will likely decrease the member s ability to achieve or maintain reasonable functional ability in performing daily activities. IV. Quantity Limitations SC formulation (RA, PsA, AS): 50mg every 4 weeks SC formulation (UC): o Induction: 300mg in the first 3 weeks o Maintenance: 100mg every 4 weeks IV formulation: o Induction: up to 2mg/kg at weeks 0 and 4 o Maintenance: up to 2mg/kg every 8 weeks V. Coverage Duration Coverage is provided for 12 months and may be renewed. VI. Coverage Renewal Criteria Page 3 of 5

4 Coverage can be renewed based upon the following criteria: Clinical response or remission of disease is maintained with continued use AND Absence of unacceptable toxicity from the drug VII. Billing/Coding Information Simponi 100mg /ml and 50mg/0.5ml prefilled syringe (J3590 currently unassigned) Simponi 100mg/ml and 50mg/0.5ml SmartJect auto injector (J3590 currently unassigned) Simponi Aria TM 50mg/4ml single use vial (J billable unit = 1mg) VIII. Summary of Policy Changes 4/1/11: Clarified Enbrel and Humira are the preferred self-injectable biologic medications 6/1/11: Clarified that coverage under the pharmacy benefit requires failed trials with both preferred medications (Enbrel and Humira ) first 6/15/12: Specific criteria for specialists, concurrent/past medication trials, etc. outlined for each diagnosis 6/15/13: Renewal criteria modified to review for symptom control and adverse reactions 7/1/13: Medical, Commercial Rx, and Medicaid/FHP Rx criteria differentiated 9/15/13: o criteria for coverage of Simponi for the treatment of ulcerative colitis added o Simponi Aria added to policy 3/15/14: no policy changes 1/1/15: o PsA guidelines updated to include recommendations for axial disease o requirements for one non-biologic DMARD in RA setting clarified 7/1/15: formulary distinctions made, removal of need for Tb testing on members not at high risk 3/15/16: no policy changes 1/1/17: o step therapy rules updated on the pharmacy benefit o combination use with methotrexate clarified for the treatment of RA 5/1/17: step therapy criteria added 2/13/18: criteria for coverage of Simponi Aria for the treatment of ankylosing spondylitis and psoriatic arthritis added IX. References 1. Simponi [golimumab]. Prescribing Information. Janssen Biotech Inc. Horsham, PA. Revised June Simponi Aria TM [golimumab]. Prescribing Information. Janssen Biotech, Inc. Horsham PA. Revised October American College of Rheumatology. Guidelines for the management of Rheumatoid Arthritis, 2012 Updated. Available from URL: Accessed November Page 4 of 5

5 4. Spondylitis Association of America. Guidelines for the use of anti-tnf therapy in patients with ankylosing spondylitis: breakdown of criteria. September Available at Accessed August 10, Simponi. Clinical Pharmacology. Accessed August Simponi. Micromedex. Accessed August Braun J, et. al update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011;70: Mentor A, et al. Guidelines of care for 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;58: Coates LC, et al. The 2012 BSR and BHPR guideline for the treatment of psoriatic arthritis with biologics. Rheumatology. 2013;52(10): Singh JA, 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 (Hoboken) May;64(5): The Plan fully expects that only appropriate and medically necessary services will be rendered. The Plan reserves the right to conduct pre-payment and post-payment reviews to assess the medical appropriateness of the above-referenced therapies. The preceding policy applies only to members for whom the above named pharmacy benefit medications are included on their covered formulary. Members with closed formulary benefits are subject to trying all appropriate formulary alternatives before a coverage exception for a non-formulary medication will be considered. The preceding policy is a guideline to allow for coverage of the pertinent medication/product, and is not meant to serve as a clinical practice guideline. Page 5 of 5