Priority Health: Vyepti Payer Policy

 MEDICARE PART B

Step Therapy Requirements

Yes, step therapy is required.

• Members must have tried and been unable to adequately reduce migraine headaches with at least two of the following for at least 3 months each:
  • Aimovig (erenumab-aooe)
  • Ajovy (fremanezumab-vfrm)
  • Emgality (galcanezumab-gnlm)

Other Pertinent Information:

• Must not be used in combination with another CGRP inhibitor (Aimovig, Ajovy, Emgality, Qulipta, Nurtec ODT).
• Patients must be evaluated for and determined not to have medication overuse headache (MOH) before starting therapy.

Quantity Limits:

• Approval is limited to dosing in accordance with FDA-approved labeling.
• Initial approval duration: 6 months.
• Reauthorization period: 2 years.

Exclusion(s):

• Combination therapy with another CGRP inhibitor for migraine prevention (Aimovig, Ajovy, Emgality, Qulipta, Nurtec ODT).
• Use for acute migraine treatment (Vyepti is only approved for prevention).

Initial Approval Criteria:

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

1. Diagnosis of migraine requiring preventive treatment.
2. Must not have medication overuse headache (MOH).
3. Tried at least two of the following CGRP inhibitors for at least 3 months each and did not achieve adequate migraine reduction:
   • Aimovig (erenumab-aooe)
   • Ajovy (fremanezumab-vfrm)
   • Emgality (galcanezumab-gnlm)
4. Dosing aligns with FDA-approved guidelines.
5. 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. Documented positive clinical response, defined as:
   • A reduction in monthly migraine days compared to baseline.
3. Dosing remains in accordance with FDA labeling.
4. Reauthorization period: 2 years.

Sources:

1. Vyepti [prescribing information]. Lundbeck; 2022.
2. Priority Health Medicare Part B References & Summary of Evidence Document.
3. Priority Health Medicare Part B Medical Benefit Drug Policy – Effective 2024
4. https://priorityhealth.stylelabs.cloud/api/public/content/Medical_Benefit_Drug_List_downloadOriginal?v=ebe3fbe9

MEDICAID

Step Therapy Requirements

Yes, step therapy is required.

• Members must have tried and failed at least one agent from two of the following groups for a minimum of 28 days each:
  • Blood pressure agents: Propranolol, timolol, or metoprolol
  • Antidepressant agents: Amitriptyline or nortriptyline
  • Antiepileptic drugs: Topiramate or valproic acid and its derivatives
• Members must also have tried and failed, or had intolerance to, the following CGRP inhibitors for at least 3 continuous months each:
  • Aimovig (erenumab-aooe)
  • Emgality (galcanezumab-gnlm)
  • Ajovy (fremanezumab-vfrm)

Other Pertinent Information:

• Must not be used in combination with another branded prophylactic CGRP inhibitor (Aimovig, Ajovy, Emgality, Qulipta, Nurtec ODT).

Quantity Limits:

• Approval is limited to dosing in accordance with FDA-approved labeling.
• Initial approval duration: 3 months.
• Reauthorization period: 12 months.

Exclusion(s):

• Combination therapy with another CGRP inhibitor for migraine prevention (Aimovig, Ajovy, Emgality, Qulipta, Nurtec ODT).
• Use for acute migraine treatment (Vyepti is only approved for prevention).

Initial Approval Criteria:

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

1. Diagnosis of migraine requiring preventive treatment.
2. Must experience 4 or more migraines per month.
3. Must have tried and failed at least one agent from two of the following prophylactic treatment groups for a minimum of 28 days each:
   • Blood pressure agents: Propranolol, timolol, or metoprolol
   • Antidepressant agents: Amitriptyline or nortriptyline
   • Antiepileptic drugs: Topiramate or valproic acid and its derivatives
4. Trial and failure, or intolerance to Aimovig, Emgality, and Ajovy for at least 3 continuous months each without achieving adequate migraine reduction.
5. Dosing aligns with FDA-approved guidelines.
6. Initial authorization period: 3 months.

Continuation Criteria:

For continued coverage, all the following must be met:

1. Patient is currently receiving therapy with Vyepti.
2. Documented positive clinical response, defined as:
   • A greater than 50% reduction in monthly migraine days compared to baseline.
3. Dosing remains in accordance with FDA labeling.
4. Reauthorization period: 12 months.

Sources:

1. Vyepti [prescribing information]. Lundbeck; 2022.
2. Priority Health Medicaid Medical Policy 91414 – Infusion Services and Equipment.
3. Priority Health Medicaid Medical Benefit Drug Policy – Effective 2024
4. https://priorityhealth.stylelabs.cloud/api/public/content/Medical_Benefit_Drug_List_downloadOriginal?v=ebe3fbe9

COMMERCIAL

Step Therapy Required?

Yes, step therapy is required.

• Preferred CGRP inhibitors (must be tried first):
  • Aimovig (erenumab)
  • Emgality (galcanezumab)
  • Ajovy (fremanezumab)
• Non-preferred CGRP inhibitors (require step therapy failure):
  • Vyepti (eptinezumab)
  • Qulipta (atogepant)

Other Pertinent Information:

• Must not be used in combination with another branded prophylactic CGRP inhibitor (Aimovig, Ajovy, Emgality, Qulipta, Nurtec ODT).
• Not covered in combination with Botox for migraine prevention.
• "Needle phobia" or "needle fatigue" is not considered an acceptable contraindication for bypassing step therapy requirements.

Quantity Limits:

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

Exclusion(s):

• Combination therapy with another CGRP inhibitor for migraine prevention (Aimovig, Ajovy, Emgality, Qulipta, Nurtec ODT).
• Use for acute migraine treatment (Vyepti is only approved for prevention).
• Use in combination with Botox for migraine prevention.

Initial Approval Criteria:

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

1. Patient is at least 18 years old.
2. Diagnosis of migraine requiring preventive treatment, with:
   • 4 or more migraine days per month.
3. Must have tried and failed at least a one-month trial of two of the following oral prophylactic treatment options:
   • Antidepressants: Amitriptyline or nortriptyline
   • Beta blockers: Propranolol, metoprolol, or timolol
   • Antiepileptics: Valproate or topiramate
4. Non-preferred drug requirement: Trial and failure, or intolerance/contraindication to Aimovig, Emgality, and Ajovy for at least 3 continuous months each without achieving adequate migraine reduction.
5. Dosing aligns with FDA-approved guidelines.
6. Initial authorization period: 12 months.

Continuation Criteria:

For continued coverage, all the following must be met:

1. Patient is currently receiving therapy with Vyepti.
2. Documented positive clinical response, defined as:
   • A greater than 50% reduction in monthly migraine days compared to baseline.
3. Dosing remains in accordance with FDA labeling.
4. Reauthorization period: 12 months.

Sources:

1. Vyepti [prescribing information]. Lundbeck; 2022.
2. Priority Health Commercial Medical Benefit Drug Policy – Effective 2024
3. https://priorityhealth.stylelabs.cloud/api/public/content/Medical_Benefit_Drug_List_downloadOriginal?v=ebe3fbe9