CurrentUnitedHealthcarePolicy N/A

Pharmacy prior authorization for migraine and cluster headache therapies (CGRP and oral agents) for North Carolina Medicaid

Prior authorization form and clinical criteria for initial and re-authorization of preventive and acute migraine/episodic cluster headache therapies (injectable CGRP monoclonal antibodies, intravenous Vyepti, oral agents Nurtec ODT and Qulipta) for North Carolina Medicaid beneficiaries and prescribers.

Policy Summary

PayerUnitedHealthcare

PolicyPharmacy prior authorization for migraine and cluster headache therapies (CGRP and oral agents) for North Carolina Medicaid

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, age, migraine day frequency, required prior medication trials, and pregnancy test when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial approval (most agents)

6 monthsAjovy quarterly approval

12 monthsre-authorization

4+/momin migraine frequency

300 mg

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Coverage and Medical Necessity Criteria

Initial Preventative Injectable CGRP Criteria

Covered when ALL of the following are met:

Injectable CGRP initial criteria: 1) Diagnosis of migraine with or without aura per International Classification of Headache Disorders; 2) Age >= 18 years; 3) No medication over‑use headache; 4) For beneficiaries who are women of childbearing potential, a negative pregnancy test at baseline; 5) ≥4 migraine days per month for at least 3 months; 6) Utilization of prophylactic intervention modalities (e.g., behavioral therapy, physical therapy, lifestyle modifications); 7) Trial and failure of at least a month‑long trial of medications from at least two different oral medication classes (antidepressants, beta blockers, anti‑epileptics, ACE inhibitor/ARB, calcium channel blockers).

Initial approvals up to 3 months (6 months for Ajovy quarterly dosing).

Initial Oral Agent Criteria

Covered when ALL of the following are met:

Oral agent initial criteria: 1) Diagnosis of migraine with or without aura per International Classification of Headache Disorders; 2) Age >= 18 years; 3) No medication over‑use headache; 4) ≥4 migraine days per month for at least 3 months; 5) Utilization of prophylactic intervention modalities (e.g., behavioral therapy, physical therapy, lifestyle modifications); 6) Has tried and failed at least 2 preferred injectable CGRPs (required for orals); 7) For Nurtec only: not concurrently using a strong CYP3A4 inhibitor and not having end‑stage renal disease with CrCl <15 ml/min (if applicable).

Initial approvals up to 3 months.

Initial Episodic Cluster Headache Criteria

Covered when ALL of the following are met:

Emgality cluster initial criteria: 1) Diagnosis of episodic cluster headache; 2) History of at least 2 cluster periods lasting 7 days to 1 year (when treated) and separated by pain‑free remission periods of at least 3 months; 3) Age >= 18 years; 4) For beneficiaries who are women of childbearing potential, a negative pregnancy test at baseline; 5) Utilization of prophylactic intervention modalities as applicable; 6) Dosing at onset of the cluster period not to exceed 300 mg administered as three consecutive 100 mg injections, then monthly until the end of the cluster period.

Initial approvals up to 3 months.

Re-authorization Criteria

Covered for re-authorization when ALL of the following are met:

Re-authorization criteria: 1) Documentation of a significant decrease in the number, frequency, and/or intensity of headaches and/or a decrease in the length of the cluster period; 2) Overall improvement in function with therapy; 3) Continued use of prophylactic intervention modalities (e.g., behavioral therapy, physical therapy, lifestyle modifications); 4) For beneficiaries who are women of childbearing potential, ongoing pregnancy monitoring (note: not required for Qulipta or Nurtec); 5) No unacceptable toxicity (e.g., intolerable injection site pain, constipation).

Re-authorizations can be approved for up to 12 months.

The prior authorization form explicitly asks whether the beneficiary has medication over-use headache (MOH). If MOH is present, the request is excluded from approval under the form logic and may be denied. This exclusion is applied for both injectable and oral preventative treatment pathways and is documented on the clinical information sections of the form.

Requests will be considered not medically necessary when required diagnostic, age, prior-treatment, or baseline testing criteria are not met. The form requires a diagnosis of migraine (or episodic cluster headache for Emgality) per the International Classification of Headache Disorders, an age of ≥18 years, documentation of required prior medication trials or step-therapy (including trials of oral medication classes or preferred injectable CGRPs as specified), and, for women of childbearing potential, a documented negative pregnancy test at baseline when applicable. Failure to meet any of these requirements may result in denial as not medically necessary.

Named Agents, Dosage Limits, and Key Thresholds

Covered medication agents named in formmixed

Aimovig	erenumab (injectable CGRP monoclonal antibody)
Ajovy	fremanezumab (injectable CGRP monoclonal antibody)
Emgality	galcanezumab (injectable CGRP monoclonal antibody)
Vyepti	eptinezumab (intravenous CGRP monoclonal antibody)
Nurtec ODT	rimegepant (oral)
Qulipta	atogepant (oral)

Migraine frequency threshold

Minimum frequency>= 4 migraine days per month

Minimum durationAt least 3 consecutive months

Combined requirement>= 4 migraine days/month for at least 3 months

Emgality cluster dosing limits

Onset dosing limitNo more than 300 mg at onset administered as three consecutive 100 mg injections

Maintenance dosingThen monthly dosing for remainder of cluster period

Applicable agent

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for specified migraine CGRP agents (Aimovig, Ajovy, Emgality, Vyepti) and oral migraine agents (Nurtec ODT, Qulipta). Initial approvals: injectable CGRPs — up to 3 months (monthly dosing) or up to 6 months for Ajovy quarterly dosing; oral agents — up to 3 months. Re-authorizations may be approved for up to 12 months.

Affected products: Aimovig, Ajovy, Emgality (120 mg/mL and 100 mg/mL for cluster), Vyepti, Nurtec ODT, Qulipta
Initial injectable approvals: up to 3 months (monthly dosing); Ajovy quarterly dosing up to 6 months
Initial oral approvals: up to 3 months
Re-authorization: up to 12 months

Documentation Required

Required Documentation

Requests must include completed beneficiary, prescriber, and drug information fields and documentation supporting the diagnosis and clinical criteria. For women of childbearing potential, baseline negative pregnancy test documentation is required where noted. Re-authorization requests must document clinical benefit (decrease in number/frequency/intensity of headaches and/or improved function) and ongoing monitoring for pregnancy status when applicable.

Policy Background and Scope

This form addresses prior authorization for preventive migraine therapies (injectable CGRP monoclonal antibodies and oral agents) and treatment of episodic cluster headache with Emgality. It applies to requests for Aimovig, Ajovy, Emgality, Vyepti, Nurtec ODT, and Qulipta and specifies initial authorization conditions, minimum migraine frequency (≥4 migraine days/month for at least 3 months), age requirement (≥18 years), assessment for medication-overuse headache, required prophylactic interventions, and required prior medication trials. Initial approvals are typically up to 3 months (with 6 months allowable for Ajovy quarterly dosing), and re-authorizations can be approved up to 12 months. For episodic cluster headache treated with Emgality, dosing at the start of a cluster period must not exceed 300 mg (three consecutive 100 mg injections), followed by monthly dosing until the end of the cluster period.

Key Definitions and Diagnostic Requirements

Diagnosis requirement (ICHD)

Required diagnosis standardDiagnosis of migraine with or without aura per International Classification of Headache Disorders (ICHD)

Diagnosis scopeApplies to initial authorization for both injectable and oral preventative therapies

DocumentationBeneficiary must have documentation confirming ICHD criteria on file

Emgality initial cluster-period dosing

Maximum initial cluster-period doseNo more than 300 mg administered as three consecutive 100 mg injections at onset

Subsequent dosingMonthly injections thereafter until the end of the cluster period