Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has authorization and coverage for Vyepti (eptinezumab-jjmr) 1 mg, 300 units infusion therapy every three months.According to the American Headache Society, Four injectable preventive therapies are available in the United States: onabotulinumtoxinA (Botox) and 3 monoclonal antibodies (mAbs) targeting calcitonin generelated peptide (CGRP) (fremanezumab, galcanezumab) or the CGRP receptor (erenumab). The authors state, CGRP mAbs are biologic agents that have demonstrated efficacy, safety, and tolerability for the preventive treatment of episodic and chronic migraine in phase 2 and phase 3 randomized, placebocontrolled trials. The authors concluded, All may achieve rapid treatment effects over days to weeks, and are effective in patients who have failed prior preventive treatment, as well as in those on concurrent oral preventive treatments.The AHS position statement noted that treatment with anti-CGRP mAbs is indicated when there is a diagnosis of International Classification of Headache Disorders third edition (ICHD-3) migraine with or without aura. Additionally, the patient must demonstrate an inability to tolerate (due to side effects) or inadequate response to a six-week trial of at least two of the following: topiramate, divalproex sodium/valproate sodium (Depakote), beta-blocker (metoprolol, propranolol, timolol, atenolol, nadolol), tricyclic antidepressant (amitriptyline, nortriptyline), and/or serotonin-norepinephrine reuptake inhibitor (venlafaxine, duloxetine). Alternatively, the patient may demonstrate an inability to tolerate or inadequate response to a minimum of two quarterly injection (six months) of onabotulinumtoxinA.In 2020, the U.S. Food and Drug Administration approved Vyepti, a CGRP antagonist administered intravenously and indicated for the preventive treatment of episodic and chronic migraines (CM) in adults. A study by Lipton and colleague provided Class I evidence that for patients with CM, a single dose of eptinezumab reduces monthly migraine days over 12 weeks of treatment.In this case, the patient has a history of chronic migraines and medication overuse headaches that have not responded to multiple oral preventive medications. The patient fits AHS criteria for initiation of CGRP monoclonal antibody therapy. The patient had adverse side effects to two injectable CGRP therapies. Vyepti is a newer CGRP therapy administered intravenously indicated for patients with chronic migraine. Therefore, the requested Vyepti (eptinezumab-jjmr) 1 mg, 300 units infusion therapy every three months is medically necessary for the treatment of the patients medical condition.Final Result: The reviewers determined that the requested medication is medically necessary for the treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in neurology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.