Kineret (anakinra) When Policy Topic is covered Kineret (anakinra) requires prior authorization through the pharmacy services area.

Transcription

1 Kineret (anakinra) Policy Number: Last Review: 3/2018 Origination: 3/2017 Next Review: 3/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Kineret (anakinra) when it is determined to be medically necessary because the criteria shown below are met. When Policy Topic is covered Kineret (anakinra) requires prior authorization through the pharmacy services area. 1. Rheumatoid Arthritis (RA) a. Initial Therapy. Approve for 3 months if the patient meets ALL of the following criteria (i, ii and iii): i. The patient has had a 3-month trial of a biologic disease-modifying antirheumatic drug (DMARD) OR targeted synthetic DMARD for this condition, unless intolerant (NOTE: examples of biologic DMARDs include: Actemra [tocilizumab for IV infusion, tocilizumab for SC injection], Orencia [abatacept for IV infusion, abatacept for SC injection], Rituxan [rituximab for IV infusion], tumor necrosis factor [TNF] antagonists [e.g., Humira, Cimzia, Enbrel, an infliximab product [e.g., Inflectra, Remicade], Simponi SC, or Simponi Aria]. Example of targeted synthetic DMARD: Xeljanz [tofacitinib tablets]). [NOTE: Conventional synthetic DMARDs such as methotrexate {MTX}, leflunomide, hydroxychloroquine, and sulfasalazine do not count.]; AND ii. Kineret is prescribed by or in consultation with a rheumatologist; AND iii. The patient has tried TWO of Actemra SC, Enbrel, Humira, and Xeljanz/XR [documentation required]. Note: Trial of either or both Xeljanz products (Xeljanz and Xeljanz XR) collectively counts as a trial of ONE product. A trial of Actemra IV, Cimzia, Orencia (IV or SC), an infliximab product (e.g., Inflectra, Remicade), and Simponi (Aria or SC) also counts [documentation required]. b. Patients Currently Receiving Kineret. Approve for 1 year if the patient meets BOTH of the following (i and ii): i. The patient has had a response (e.g., less joint pain, morning stiffness, or fatigue; improved function or activities of daily living; decreased soft tissue swelling in joints or tendon sheaths; improved laboratory values; reduced dosage of corticosteroids), as determined by the prescriber. The patient may not have a full response, but there should have been a recent or past response to Kineret; AND ii. The patient meets ONE of the following conditions (a or b): a. The patient has been established on Kineret at least 90 days and prescription claims history indicates at least a 90-day supply of Kineret was dispensed within the past 130 days [verification in prescription claims history required] or, if not available, [verification by prescribing physician required]. Note: In cases when 130 days of the patient s prescription claim history file is unavailable to be verified, an exception to this requirement is allowed if the prescriber has verified that the patient has

2 been receiving Kineret for at least 90 days AND the patient has been receiving Kineret via paid claims (e.g., patient has not been receiving samples or coupons or other types of waivers in order to obtain access to Kineret); OR b. The patient has tried TWO of Actemra SC, Enbrel, Humira, and Xeljanz/XR [documentation required]. Note: Trial of either or both Xeljanz products (Xeljanz and Xeljanz XR) collectively counts as a trial of ONE product. A trial of Actemra IV, Cimzia, Orencia (IV or SC), an infliximab product (e.g., Inflectra, Remicade), or Simponi (Aria or SC) also counts [documentation required]. 2. Cryopyrin-Associated Periodic Syndromes (CAPS) a. Initial Therapy. Approve for 3 months if the patient meets BOTH of the following criteria (i and ii): i. Kineret is being used for treatment of Neonatal Onset Multisystem Inflammatory Disease (NOMID), Familial Cold Autoinflammatory Syndrome (FCAS), Muckle- Wells Syndrome (MWS), and/or chronic infantile neurological cutaneous and articular (CINCA) syndrome; AND ii. Kineret is prescribed by or in consultation with a rheumatologist, geneticist, or a dermatologist. b. Patients Currently Receiving Kineret. Approve for 1 year if the patient has had a response, as determined by the prescriber. The patient may not have a full response, but there should have been a recent or past response to Kineret. 3. Systemic Juvenile Idiopathic Arthritis (SJIA) a. Initial Therapy. Approve for 3 months if the patient meets BOTH of the following criteria (i and ii): i. Patient meets ONE of the following conditions (a, b, or c): a. The patient has tried one other systemic agent for this condition (e.g., a corticosteroid [oral, IV]; a conventional synthetic disease-modifying antirheumatic drug [DMARD; e.g., methotrexate {MTX}, leflunomide, sulfasalazine]; a biologic DMARD such as Actemra IV, a tumor necrosis factor [TNF] inhibitor [e.g., Enbrel, Humira, or an infliximab product {e.g., Inflectra, Remicade}], or Ilaris [canakinumab for SC injection]; or a 1- month trial of a nonsteroidal anti-inflammatory drug [NSAID]). NOTE: NSAID trial must be at least 1-month duration to qualify; OR b. The patient has at least moderate to severe active systemic features of this condition (e.g., fever, rash, lymphadenopathy, hepatomegaly, splenomegaly, serositis) OR the patient has active systemic features with an active joint count of one joint or greater, according to the prescribing physician; OR c. The patient has active systemic features with concerns of progression to macrophage activation syndrome (MAS), as determined by the prescribing physician; AND ii. Kineret is prescribed by or in consultation with a rheumatologist b. Patients Currently Receiving Kineret. Approve for 1 year if the patient has responded (e.g., has improvement in limitation of motion; less joint pain or tenderness; decreased duration of morning stiffness or fatigue; improved function or activities of daily living; reduced dosage of corticosteroids), as determined by the prescriber. The patient may not have a full response, but there should have been a recent or past response to Kineret. 4. Still s Disease Approve for 1 year if the patient meets the following criteria (a, b, and c): a. The patient has tried one corticosteroid; AND

3 b. The patient has had an inadequate response to one conventional synthetic diseasemodifying antirheumatic drug (DMARD) such as methotrexate (MTX) given for at least 2 months or was intolerant to a conventional synthetic DMARD; AND c. Kineret is prescribed by or in consultation with a rheumatologist. 5. Patient has been Established on Kineret for 90 days. For conditions that do not have criteria for Patients Currently Receiving Kineret but are indications or conditions addressed as an approval in the Criteria section, approve Kineret for 1 year, if the patient is currently taking Kineret for 90 days When Policy Topic is not covered Kineret (anakinra) is considered not medically necessary if the criteria above are not met. Conditions Not Recommended for Coverage. Patients who meet any of the following criteria do not qualify for treatment with Kineret. (Note: for patients who do not meet one of the following criteria A through F, review using the appropriate criteria [1 through 5 above]: A) Ankylosing Spondylitis (AS); OR B) Concurrent Use with a Biologic or with a Targeted Synthetic Disease-Modifying Antirheumatic Drug (DMARD). Note: This does NOT exclude the use of conventional synthetic DMARDs (e.g., MTX, leflunomide, hydroxychloroquine, and sulfasalazine) in combination with Kineret.; OR C) Gout, Acute; OR D) Lupus Arthritis; OR E) Osteoarthritis (OA), Symptomatic; OR F) Other circumstances not listed in criterion 1 through 5 (above). Considerations This Blue Cross and Blue Shield of Kansas City policy Statement was developed using available resources such as, but not limited to: Food and Drug Administration (FDA) approvals, Facts and Comparisons, National specialty guidelines, Local medical policies of other health plans, Medicare (CMS), Local providers Description of Procedure or Service Anakinra (Kineret ) is a synthetic, injectable interleukin-1 (IL-1) receptor antagonist that blocks the effects of human IL-1. IL-1 is a protein produced by many cells in the body, but it is found in increased amounts within joints that are inflamed from rheumatoid arthritis (RA). IL-1 attaches to receptors on the tissues within and surrounding the joints, as well as to the cells that are responsible for inflammation (eg, white blood cells). The attachment of IL-1 to its receptors activates inflammation and the release of enzymes that destroy cartilage and bone, which contributes to joint pain and swelling. By binding to these receptors, anakinra (Kineret ) prevents the inflammatory and enzyme-releasing effects of IL-1, thereby reducing joint pain and swelling. Refer to the specific manufacturer's prescribing information for administration and dosage details, contraindications, and Black Box warnings. Rationale References: 1. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. 2. Guidelines for the management of rheumatoid arthritis: 2002 update. [American College of

4 Rheumatology Web site]. Available at: Accessed February 28, American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S Firestein GS, Boyle DL, Yu C, et al. Synovial interleukin-1 receptor antagonist and interleukin-1 balance in rheumatoid arthritis. Arthritis Rheum. 1994; 37: Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23(2): Gartlehner G, Hansen RA, Thieda P, Jonas B, Lohr KN, Carey T. Drug Class Review on Targeted Immunemodulators [Final Report] January Oregon Health & Science University. Drug Effectiveness Review Project [available at 7. Genant HK, Jiang Y, Peterfy C, Lu Y, Re dei J, Countryman PJ. Assessment of rheumatoid arthritis using a modified scoring method on digitized and original radiographs. Arthritis Rheum. 1998;41(9): Kineret (Anakinra) In: Facts and Comparisons [online through Facts and Comparisons Online]. Indy, IN: Walter Kluwer Health Inc. Accessed November 13, Kineret (Anakinra) In: Drugdex [online through Micromedex Healthcare Series]. Greenwood Village, CO: Thomson Micromedex. Accessed November 13, Kineret (Anakinra) [package insert]. Thousand Oaks, CA: Amgen ; Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum. 1983;26(11): Ries LAG, Eisner MP, Kosary CL, Hankey BF,Miller BA, Clegg L, Mariotto A, Feuer EF, Edwards BK (eds). SEER Cancer Statistics Review, , National Cancer Institute. Bethesda, MD, Van der Heijde DM, van Leeuwen MA, van Riel PL, et al. Biannual radiographic assessments of hands and feet in a three-year prospective follow-up of patients with early rheumatoid arthritis. Arthritis Rheum. 1992;35(1): Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998;51(11): Billing Coding/Physician Documentation Information NA This is a specialty pharmacy benefit Additional Policy Key Words

5 Policy Implementation/Update Information 03/2017 New policy titled Kineret (anakinra) 03/2018 Reviewed-no changes State and Federal mandates and health plan contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The medical policies contained herein are for informational purposes. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents Blue KC and are solely responsible for diagnosis, treatment and medical advice. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, photocopying, or otherwise, without permission from Blue KC.