Is Vyepti (eptinezumab-jjmr) 300 mg IV medically necessary for the treatment of chronic migraine without aura?

Medical Necessity Determination for Vyepti (Eptinezumab-jjmr) 300 mg IV

Based on the Aetna criteria and available documentation, Vyepti 300 mg IV is NOT medically necessary for this patient at this time because there is no documentation of prior 3-month treatment with eptinezumab or evidence of clinical response to justify continuation therapy.

Critical Documentation Deficiencies

The case fails to meet Aetna's Clinical Policy Bulletin 0970 requirements on multiple fronts:

• No evidence of initial approval criteria being met: The policy requires documentation that the member "has not received at least 3 months of treatment with the requested medication" for initial approval, but there is no baseline documentation showing this is a first-time request 1
• No evidence of continuation criteria being met: For reauthorization, Aetna requires documentation of "at least 3 months of treatment with the requested medication" AND "a reduction in migraine days per month from baseline," neither of which is provided in the case summary 1
• Unclear treatment history: The case mentions prior onabotulinumtoxinA (Botox) treatment (J0585) but provides no information about whether Vyepti has been previously administered, making it impossible to determine if this is initial or continuation therapy 2

FDA-Approved Indication and Dosing

Vyepti is FDA-approved for preventive treatment of migraine in adults, with two dosing options:

• Standard dosing: 100 mg IV every 3 months is the recommended dose 1
• Higher dosing: 300 mg IV every 3 months may benefit some patients, but the FDA label does not specify which patients require the higher dose 1
• The diagnosis code G43.709 (chronic migraine without aura, not intractable, without status migrainosus) falls within the FDA-approved indication range (G43.001 - G43.E19) 1

Clinical Context: Appropriate Use of Vyepti

While the diagnosis is appropriate, several clinical considerations are relevant:

• CGRP monoclonal antibodies like eptinezumab are typically reserved for patients who have failed multiple oral preventive therapies due to cost considerations, though guidelines do not mandate a specific number of failures 2
• The patient appears to have received Botox previously, which is appropriate for chronic migraine (≥15 headache days per month) and represents a reasonable prior preventive attempt 2
• Eptinezumab demonstrates efficacy from day 1 and maintains consistent preventive effects through 1 year of treatment at both 100 mg and 300 mg doses 3, 4
• In patients with prior preventive treatment failures, eptinezumab showed ≥30% migraine responder rates of 65.9-70.4% (100 mg) and 71.0-74.5% (300 mg) versus 36.9-43.1% with placebo over 24 weeks 5

Required Documentation for Approval

To establish medical necessity, the following must be documented:

For Initial Approval:

• Confirmation this is the patient's first course of Vyepti treatment
• Baseline monthly migraine day frequency
• Documentation of prior preventive medication trials and reasons for discontinuation or inadequacy
• Clinical rationale for selecting 300 mg over 100 mg dose

For Continuation Therapy:

• Date and dose of previous Vyepti infusion(s)
• Baseline monthly migraine days before starting Vyepti
• Current monthly migraine days showing reduction from baseline
• Duration of treatment (must be ≥3 months)
• Clinical response justifying continuation

Common Pitfalls to Avoid

• Do not assume continuation therapy without documented prior treatment: The case shows Botox history but no clear Vyepti treatment history 2
• Do not approve based on diagnosis alone: While G43.709 is an appropriate diagnosis, payer criteria require specific documentation of treatment history and response 1
• Do not overlook the need for baseline and follow-up migraine frequency data: Objective measures of clinical response are essential for continuation approval 2
• Recognize that 300 mg dosing requires justification: The FDA label states "some patients may benefit" from 300 mg, but does not specify which patients, making clinical documentation of inadequate response to 100 mg important if this is continuation therapy 1

Safety Considerations

If approved, monitor for:

• Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, facial flushing, dyspnea, and rash, which can occur during infusion 1
• Most adverse events are mild, with nasopharyngitis, upper respiratory tract infections, and sinusitis being most common 3
• The medication has a favorable safety profile with no significant drug interactions 3