Aetna: Vyepti Payer Policy (Beta Access)

TABLE OF CONTENTS

Aetna: Vyepti Payer Policy (Beta Access)

• MEDICARE PART B
  • Other Pertinent Information:
  • Quantity Limits:
  • Exclusion(s):
  • Initial Approval Criteria:
  • Continuation Criteria:
  • Sources:
• COMMERCIAL
  • Other Pertinent Information:
  • Quantity Limits:
  • Exclusion(s):
  • Initial Approval Criteria:
  • Continuation Criteria:
  • Sources:

 MEDICARE PART B

Other Pertinent Information:

• National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) apply when available.
• In the absence of an NCD or LCD, Aetna Medicare Part B Drug Criteria will be used.
• Vyepti is a calcitonin gene-related peptide (CGRP) inhibitor.
• Should not be used concurrently with another CGRP inhibitor (Aimovig, Ajovy, Emgality, Qulipta, Nurtec ODT).

Quantity Limits:

• Approval is limited to dosing in accordance with FDA-approved guidelines.
• Initial approval duration: 6 months.
• Reauthorization period: 12 months.

Exclusion(s):

• Experimental or investigational uses outside migraine prevention.
• Acute treatment of migraine (Vyepti is only approved for prevention).
• Concurrent use with:
  • Another CGRP inhibitor for migraine prevention (Aimovig, Ajovy, Emgality, Qulipta).
  • Nurtec ODT (when used for migraine prevention).

Initial Approval Criteria:

Vyepti is medically necessary for patients who meet all the following criteria:

1. Patient is 18 years or older.
2. Diagnosis of migraine requiring preventive treatment, with one of the following:
   • Chronic migraine: 15 to 26 headache days per month, of which at least 8 are migraine days.
   • Episodic migraine: 4 to 14 headache days per month, of which at least 4 are migraine days.
3. Dosing aligns with FDA-approved guidelines.
4. Initial authorization period: 6 months.

Continuation Criteria:

For continued coverage, all the following must be met:

1. Patient is currently receiving therapy with Vyepti.
2. Vyepti is being used for an approved indication (migraine prevention).
3. Documented positive clinical response to treatment (e.g., reduction in migraine days per month from baseline).
4. Reauthorization period: 12 months.

Sources:

1. Vyepti [package insert]. Lundbeck; April 2022.
2. American Headache Society Consensus Statement (2021).
3. Aetna Medicare Part B Medical Benefit Drug Policy – Revised October 2023.

COMMERCIAL

Other Pertinent Information:

• Site of Care Utilization Management Policy applies.
• Vyepti is a calcitonin gene-related peptide (CGRP) inhibitor.
• Contraindications: Patients with serious hypersensitivity to eptinezumab-jjmr or its excipients.
• Common Adverse Reactions: Nasopharyngitis and hypersensitivity (≥2% incidence).
• Should not be used concurrently with another CGRP inhibitor (Aimovig, Ajovy, Emgality, Qulipta, Nurtec ODT).

Quantity Limits:

• Approval is limited to dosing in accordance with FDA-approved guidelines.
• Initial approval duration: 12 months.

Exclusion(s):

• Experimental or investigational uses outside migraine prevention.
• Acute treatment of migraine (Vyepti is only approved for prevention).
• Concurrent usewith:
  • Another CGRP inhibitor for migraine prevention (Aimovig, Ajovy, Emgality, Qulipta).
  • Nurtec ODT (when used for migraine prevention).

Initial Approval Criteria:

Vyepti is medically necessary for patients who meet all the following criteria:

1. Patient is 18 years or older.
2. Diagnosis of migraine requiring preventive treatment.
3. Has not previously received at least 3 months of Vyepti treatment.
4. Dosing aligns with FDA-approved guidelines.
5. Initial authorization period: Up to 12 months.

Continuation Criteria:

For continued coverage, all the following must be met:

1. Patient has received at least 3 months of Vyepti treatment.
2. Documented positive clinical response to treatment (e.g., reduction in migraine days per month from baseline).
3. Dosing remains in accordance with FDA labeling.
4. Reauthorization period: Up to 12 months.

Sources:

1. Vyepti [prescribing information]. Lundbeck; 2022.
2. American Headache Society (2024). CGRP-Targeting Therapies Position Statement Update.
3. Aetna Clinical Policy Bulletin – Effective 2024.