United Healthcare: Vyepti Payer Policy (Beta Access)

TABLE OF CONTENTS

• United Healthcare: Vyepti Payer Policy (Beta Access)
  • MEDICARE PART B
    • Initial Approval Criteria:
    • Continuation Criteria:
    • Sources:
  • MEDICAID
    • Other Pertinent Information:
    • Quantity Limits:
    • Exclusion(s):
    • Initial Approval Criteria:
    • Continuation Criteria:
    • Sources:
  • COMMERCIAL
    • Step Therapy Requirements
    • Other Pertinent Information:
    • Quantity Limits:
    • Exclusion(s):
    • Initial Approval Criteria:
    • Continuation Criteria:
    • Sources:

MEDICARE PART B

Step Therapy Required?

• Yes, patients must have a trial of at least 3 months each with two preferred CGRP inhibitors (e.g., Aimovig, Emgality) resulting in minimal clinical response to therapy or
• History of contraindication, intolerance, or adverse event(s) to two of the preferred drugs (e.g., Aimovig, Emgality) or
• Continuation of prior therapy within the past 365 days

Other Pertinent Information:

• Vyepti is a non-preferred CGRP receptor antagonist and is only covered under Medicare Part B after failing step therapy criteria.

Quantity Limits:

• 1 vial (100 mg) per 3 months.
• 300 mg dose may be approved if inadequate response to 100 mg dose.

Exclusion(s):

• Not covered in combination with another prophylactic CGRP agent (e.g., Aimovig, Ajovy, Emgality, Qulipta, or prophylactic use of Nurtec ODT).

Initial Approval Criteria:

• Diagnosis of episodic migraine (4-14 migraine days per month) or chronic migraine (≥15 headache days per month, of which ≥8 are migraine days).
• Trial and failure of two preferred CGRP inhibitors (Aimovig, Emgality, or Ajovy) unless contraindicated.
• Not used in combination with other CGRP inhibitors.
• Patient must be ≥18 years old.

Continuation Criteria:

• Demonstrate clinical benefit (e.g., 50% reduction in monthly migraine days or significant improvement in attack duration, severity, response to acute treatment, or quality of life).
• If using concurrently with botulinum toxin, must demonstrate further reduction in migraine days compared to monotherapy.
• Reauthorization period: 12 months.

Sources:

• UnitedHealthcare Medicare Advantage Drug Policy, Medicare Part B Step Therapy Programs, Effective 01/01/2025 
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf

MEDICAID

Note: This Medical Benefit Drug Policy does not apply to the states listed below; refer to the state-specific policy/guideline, if noted:

Other Pertinent Information:

• Must not be used in combination with another biologic CGRP inhibitor (Aimovig, Ajovy, Emgality, Qulipta, Nurtec ODT).
• Not approved for acute migraine treatment or episodic cluster headaches.

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).

Initial Approval Criteria:

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

1. Diagnosis of migraine requiring preventive treatment, with:
   • 4 to 7 migraine days per month, and either:
     • Less than 15 headache days per month, or
     • Provider attests that migraines are the predominant headache diagnosis.
   • OR 8 or more migraine days per month.
2. Trial and failure (at least 2 months each), contraindication, or intolerance to two of the following prophylactic therapies (see step therapy section).
3. Trial and failure (at least 3 months each), contraindication, or intolerance to two CGRP inhibitors (Aimovig, Ajovy, Emgality, Nurtec ODT, or Qulipta).
4. Medication will not be used in combination with another CGRP inhibitor.
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 has experienced a positive responseto therapy, demonstrated by:
   • A reduction in headache frequency and/or intensity.
2. Medication will not be used in combination with another CGRP inhibitor.
3. Dosing remains in accordance with FDA labeling.
4. Reauthorization period: 12 months.

Sources:

1. Vyepti [prescribing information]. Lundbeck; 2022.
2. UnitedHealthcare Community Plan Medical Benefit Drug Policy – Effective 09/01/2024

• Trial and failure (after at least 2 months), contraindication, or intolerance to two of the following prophylactic therapies:
  • Tricyclic antidepressants: Amitriptyline (Elavil) or nortriptyline (Pamelor)
  • Beta-blockers: Atenolol, metoprolol, nadolol, propranolol, or timolol
  • Angiotensin receptor blockers: Candesartan (Atacand)
  • Antiepileptic drugs: Divalproex sodium (Depakote/Depakote ER) or topiramate (Topamax)
  • Serotonin-norepinephrine reuptake inhibitors: Duloxetine (Cymbalta) or venlafaxine (Effexor/Effexor XR)
  • OnabotulinumtoxinA (Botox): Must have tried at least two quarterly injections (6 months) if applicable
• Trial and failure (after at least 3 months), contraindication, or intolerance to two CGRP inhibitors:
  • Aimovig (erenumab-aooe)
  • Emgality (galcanezumab-gnlm)
  • Nurtec ODT (rimegepant)
  • Qulipta (atogepant)

Other Pertinent Information:

• Must not be used in combination with another biologic CGRP antagonist or inhibitor (Aimovig, Emgality, Nurtec ODT, Qulipta).
• Not approved for acute migraine treatment or episodic cluster headaches.

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, Emgality, Nurtec ODT, Qulipta).
• 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, with:
   • 4 to 7 migraine days per month, and either:
     • Less than 15 headache days per month, or
     • Provider attests that migraines are the predominant headache diagnosis.
   • OR 8 or more migraine days per month.
2. Trial and failure (at least 2 months each), contraindication, or intolerance to two of the above-listed prophylactic therapies.
3. Trial and failure (at least 3 months each), contraindication, or intolerance to two CGRP inhibitors (Aimovig, Emgality, Nurtec ODT, or Qulipta).
4. Medication will not be used in combination with another CGRP inhibitor.
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 has experienced a positive responseto therapy, demonstrated by:
   • A reduction in headache frequency and/or intensity.
2. Medication will not be used in combination with another CGRP inhibitor.
3. Dosing remains in accordance with FDA labeling.
4. Reauthorization period: 12 months.

Sources:

1. Vyepti [prescribing information]. Lundbeck; 2022.
2. UnitedHealthcare Commercial Medical Benefit Drug Policy – Effective 08/01/2024