Ajovy® (fremanezumab-vfrm) Subcutaneous Injection Last Review Date: August 18, 2020 Number: MG.MM.PH.182

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Definitions

Ajovy is indicated for the preventative treatment of in adults. Ajovy is a humanized that binds to calcitonin gene-related (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 or reduce migraine frequency including: a. Angiotensin receptor blockers; b. Angiotensin Converting Enzyme Inhibitors; c. Beta-blockers (i.e. , metoprolol, atenolol); d. Calcium Channel blockers (i.e. ); e. Anti-epileptics (i.e. as or divalproex sodium); f. Antidepressants (venlafaxine OR a such as or ); 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 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, ) 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 . 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.