Ajovy® (Fremanezumab-Vfrm) Subcutaneous Injection Last Review Date: August 18, 2020 Number: MG.MM.PH.182
Total Page：16
File Type：pdf, Size：1020Kb
Ajovy® (fremanezumab-vfrm) Subcutaneous Injection Last Review Date: August 18, 2020 Number: MG.MM.PH.182 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, (“EmblemHealth”) has adopted the herein policy in providing management, administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group Health Incorporated, GHI HMO Select, ConnectiCare, Inc., ConnectiCare Insurance Company, Inc. ConnectiCare Benefits, Inc., and ConnectiCare of Massachusetts, Inc. related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definitions Ajovy is indicated for the preventative treatment of migraine in adults. Ajovy is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. Guideline Ajovy is administered by the patient by subcutaneous injection and covered under the patient’s pharmacy benefit. Therefore, Ajovy is not considered a medical benefit. Injection, fremanezumab-vfrm, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered) Ajovy is considered medically necessary for the preventative treatment of migraine in adults when all of the following criteria are met: 1. Patient has clinically diagnosed episodic migraine as defined at least 4 migraine days per month; AND Ajovy® (fremanezumab-vfrm) Last review: August 18, 2020 Page 2 of 3 2. Patient has prior usage of at least TWO standard prophylactic pharmacologic therapies, each from a different pharmacologic class, used to prevent migraines or reduce migraine frequency including: a. Angiotensin receptor blockers; b. Angiotensin Converting Enzyme Inhibitors; c. Beta-blockers (i.e. propranolol, metoprolol, atenolol); d. Calcium Channel blockers (i.e. verapamil); e. Anti-epileptics (i.e. as topiramate or divalproex sodium); f. Antidepressants (venlafaxine OR a tricyclic antidepressant such as amitriptyline or nortriptyline); AND 3. The patient has had inadequate efficacy to both of those standard prophylactic pharmacologic therapies, according to the prescribing physician; OR 4. The patient has experienced adverse event(s) severe enough to warrant discontinuation of both of those standard prophylactic pharmacologic therapies, according to the prescribing physician; AND 5. Patient has prior usage in the last 18 months of at least one triptan therapy; OR 6. Patient is intolerant to or, has a contraindication to or, inadequate response from triptan therapy. Renewal Criteria Coverage may be renewed when all the following criteria are met: 1. Positive response to therapy demonstrated by a 50% reduction in monthly migraine days; AND 2. The use of acute migraine medications (i.e. NSAIDS, triptans) has decreased since start of therapy; AND 3. Patient has an overall improvement in function with therapy Limitations/Exclusions Ajovy is considered a covered pharmacy benefit for all FDA approved indications and is therefore not covered under the medical benefit. Applicable Procedure Codes C9040 Injection, fremanezumab-vfrm, 1 mg J3031 Effective 10/1/19, Injection, fremanezumab-vfrm, 1 mg Revision History 08/15/2019 Added code J3031, effective 10/1/19. 08/18/2020 Added following statement under guidelines: Injection, fremanezumab-vfrm, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered) Added in Clinical criteria, and renewal criteria for Medicare Line of Business Ajovy® (fremanezumab-vfrm) Last review: August 18, 2020 Page 3 of 3 References 1. Ajovy [package insert]. North Wales, PA; Teva; September 2018. 2. Headache Classification Committee of the International Headache Society (HIS). Cephalalgia. 2013; 33:629-808. 3. Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 2007; 68:343–349. Available at: http://n.neurology.org/content/68/5/343.long 4. Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the quality standards subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78(17): 1337–1345. 5. Dodick DW, Silberstein SD, Bigal ME, et al. Effect of fremanezumab compared with placebo for prevention of episodic migraine: A randomized clinical trial. JAMA. 2018 May 15; 319(19):1999- 2008. doi: 10.1001/jama.2018.4853. 6. Silberstein SD, Dodick DW, Bigal ME, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017 Nov 30; 377(22):2113-2122. doi: 10.1056/NEJMoa1709038. .