Cigna: Vyepti Payer Policy (Beta Access)

 MEDICARE PART B

Other Pertinent Information:

• Vyepti is a calcitonin gene-related peptide (CGRP) inhibitor.
• Not studied or approved for acute migraine treatment or cluster headaches.
• 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):

• Acute treatment of migraine (Vyepti is only approved for prevention).
• Cluster headache prevention or treatment (Not studied in this condition).
• Concurrent usewith:
  • Another CGRP inhibitor used 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. Patient has 4 or more migraine headache days per month (before starting preventive treatment).
3. Step therapy requirement met (see step therapy section).
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 previously received Vyepti.
2. Documented positive clinical response to treatment (e.g., reduction in monthly migraine days or severity).
3. Dosing remains in accordance with FDA labeling.
4. Reauthorization period: Up to 12 months.

Sources:

1. Vyepti [prescribing information]. Lundbeck; October 2022.
2. American Headache Society (2024). CGRP-Targeting Therapies Position Statement Update.
3. Cigna Healthcare Medical Benefit Drug Policy – Effective 07/15/2024.

COMMERCIAL

Step Therapy Requirements: 

• Employer Plans: The patient must have a failure, contraindication, or intolerance to two of the following:
  • Aimovig (erenumab-aooe)
  • Ajovy (fremanezumab-vfrm)
  • Emgality (galcanezumab-gnlm)
• Individual and Family Plans: The patient must have a failure, contraindication, or intolerance to Emgality (galcanezumab-gnlm).

Other Pertinent Information:

• Vyepti is a calcitonin gene-related peptide (CGRP) inhibitor.
• Not studied or approved for acute migraine treatment or cluster headaches.
• 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):

• Acute treatment of migraine (Vyepti is only approved for prevention).
• Cluster headache prevention or treatment (Not studied in this condition).
• Concurrent use with:
  • Another CGRP inhibitor used 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. Patient has 4 or more migraine headache days per month (before starting preventive treatment).
3. Step therapy requirement met (see step therapy section).
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 previously received Vyepti.
2. Documented positive clinical response to treatment (e.g., reduction in monthly migraine days or severity).
3. Dosing remains in accordance with FDA labeling.
4. Reauthorization period: Up to 12 months.

Sources:

1. Vyepti [prescribing information]. Lundbeck; October 2022.
2. American Headache Society (2024). CGRP-Targeting Therapies Position Statement Update.
3. Cigna Healthcare Medical Benefit Drug Policy – Effective 07/15/2024.