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Inflammatory Conditions – Ilaris® (Canakinumab for Subcutaneous Injection)

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Inflammatory Conditions – Ilaris® (Canakinumab for Subcutaneous Injection) Cigna National Formulary Coverage Policy Prior Authorization Inflammatory Conditions – Ilaris® (canakinumab for subcutaneous injection) Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 12878 Conditions Not Covered....................................... 4 Background .......................................................... 4 References .......................................................... 5 Revision History ................................................... 6 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. National Formulary Medical Necessity Cigna covers canakinumab (Ilaris®) as medically necessary when the following criteria are met for FDA Indications or Other Uses with Supportive Evidence: Prior Authorization is recommended for prescription benefit coverage of Ilaris. All approvals are provided for the duration noted below. In cases where the approval is authorized in months, 1 month is equal to 30 days. Because of the specialized skills required for evaluation and diagnosis of individuals treated with Ilaris as well as the monitoring required for adverse events and long-term efficacy, initial approval requires Ilaris to be prescribed by or in consultation with a physician who specializes in the condition being treated. All reviews for use of Ilaris for COVID-19 and/or cytokine release syndrome associated with COVID-19 will be forwarded to the Medical Director. FDA Indication(s) 1. Cryopyrin-Associated Periodic Syndromes (CAPS) [including Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, and Neonatal Onset Multisystem Inflammatory Disease {NOMID} Page 1 of 7 Cigna National Formulary Coverage Policy: PA Inflammatory Conditions – Ilaris or Chronic Infantile Neurological Cutaneous and Articular {CINCA} Syndrome]. Approve for the duration noted if the individual meets ONE of the following (A or B): A) Initial Therapy. Approve for 3 months if the individual meets the following conditions (i and ii): i. Individual is ≥ 4 years of age; AND ii. Ilaris is prescribed by or in consultation with a rheumatologist, geneticist, allergist/immunologist, or dermatologist. B) Individual is Currently Receiving Ilaris. Approve for 1 year if the individual has had a response, as determined by the prescriber. 2. Familial Mediterranean Fever. Approve for the duration noted if the individual meets ONE of the following (A or B): A) Initial Therapy. Approve for 4 months if the individual meets ALL of the following (i, ii, iii, iv, and v): i. Individual is ≥ 2 years of age; AND ii. Individual has tried colchicine, unless contraindicated; AND iii. Individual will be taking Ilaris in combination with colchicine, unless colchicine is contraindicated or not tolerated; AND iv. Prior to starting Ilaris, the individual meets both of the following (a and b): a) C-reactive protein level is ≥ 10 mg/L OR elevated to at least two times the upper limit of normal for the reporting laboratory; AND b) Individual has a history of at least one flare per month despite use of colchicine, OR was hospitalized for a severe flare; AND v. The medication is prescribed by or in consultation with a rheumatologist, nephrologist, geneticist, gastroenterologist, oncologist, or hematologist. B) Individual is Currently Receiving Ilaris. Approve for 1 year if the individual has experienced a reduction in the frequency and/or severity of attacks. 3. Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency. Approve for the duration noted if the individual meets ONE of the following (A or B): A) Initial Therapy. Approve for 4 months if the individual meets ALL of the following (i, ii, and iii): i. Individual is ≥ 2 years of age; AND ii. Prior to starting Ilaris, the individual meets both of the following (a and b): a) C-reactive protein level is ≥ 10 mg/L OR elevated to at least two times the upper limit of normal for the reporting laboratory; AND b) Individual has a history of at least three febrile acute flares within the previous 6-month period OR was hospitalized for a severe flare; AND iii. The medication is prescribed by or in consultation with a rheumatologist, nephrologist, geneticist, oncologist, or hematologist. B) Individual is Currently Receiving Ilaris. Approve for 1 year if the individual has experienced a reduction in the frequency and/or severity of attacks. 4. Stills Disease, Adult Onset. Approve for the duration noted if the individual meets ONE of the following (A or B): A) Initial Therapy. Approve for 3 months (which is adequate for three doses) if the individual meets ALL of the following conditions (i, ii, and iii): i. Individual is ≥ 18 years of age; AND Note: If the individual is < 18 years of age, refer to criteria for systemic juvenile idiopathic arthritis. ii. Individual meets ONE of the following conditions (a, b, or c): a) Individual has tried at least TWO other biologics; OR Note: Examples of biologics include Actemra (tocilizumab intravenous infusion, tocilizumab subcutaneous injection), Kineret (anakinra subcutaneous injection), Orencia (abatacept intravenous infusion, abatacept subcutaneous injection), an etanercept product, adalimumab product, or infliximab product. b) Individual meets BOTH of the following [(1) and (2)]: (1) Individual has features of poor prognosis, as determined by the prescriber; AND Page 2 of 7 Cigna National Formulary Coverage Policy: PA Inflammatory Conditions – Ilaris Note: Examples of features of poor prognosis include arthritis of the hip, radiographic damage, 6-month duration of significant active systemic disease, defined by: fever, elevated inflammatory markers, or requirement for treatment with systemic glucocorticoids. (2) Individual has tried Actemra or Kineret; OR c) Individual meets BOTH of the following [(1) and (2)]: (1) Individual has active systemic features with concerns of progression to macrophage activation syndrome, as determined by the prescriber; AND (2) Individual has tried Kineret; AND iii. Ilaris is prescribed by or in consultation with a rheumatologist. B) Individual is Currently Receiving Ilaris. Approve for 1 year if the individual has had a response as determined by the prescriber. Note: Examples of responses to therapy include resolution of fevers or rash, improvement in limitation of motion, less joint pain or tenderness, decreased duration of morning stiffness or fatigue; improved function or activities of daily living, and reduced dosage of corticosteroids. The individual may not have a full response, but there should have been a recent or past response to Ilaris. 5. Systemic Juvenile Idiopathic Arthritis (SJIA). Approve for the duration noted if the individual meets ONE of the following (A or B): A) Initial Therapy. Approve for 3 months (which is adequate for three doses) if the individual meets ALL of the following conditions (i, ii, and iii): i. Individual is ≥ 2 years of age; AND ii. Individual meets ONE of the following conditions (a, b, or c): a) Individual has tried at least TWO other biologics; OR Note: Examples of biologics for SJIA include Actemra (tocilizumab intravenous infusion, tocilizumab subcutaneous injection), Kineret (anakinra subcutaneous injection), Orencia (abatacept intravenous infusion, abatacept subcutaneous injection), an etanercept product, adalimumab product, or infliximab product. b) Individual meets BOTH of the following [(1) and (2)]: (1) Individual has features of poor prognosis, as determined by the prescriber; AND Note: Examples of features of poor prognosis include arthritis of the hip, radiographic damage, 6-month duration of significant active systemic disease, defined by: fever, elevated inflammatory markers, or requirement for treatment with systemic glucocorticoids. (2) Individual has tried Actemra or Kineret; OR c)
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