CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

CGRP receptor antagonist injectables — step therapy, quantity limits, and prior authorization

Defines initial step therapy, quantity limits, prior authorization triggers, and Duration of Approval for Aimovig, Ajovy, Emgality, and Vyepti for migraine prevention and episodic cluster headache under the prescription benefit administered by CVS Caremark.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCGRP receptor antagonist injectables — step therapy, quantity limits, and prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization when step therapy or quantity limits are not met and document prior therapy and clinical response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4brand drugs listed

730look-back days

3 monthsinitial DOA (migraine)

12 monthscontinuation DOA

Coverage Criteria

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inv-01: COVERAGE CRITERIA — Authorization for preventive treatment of migraine (initial therapy)

Authorization for preventive treatment of migraine (initial therapy)

Preventive Treatment of Migraine (Initial)

Requested drug: The request is for Aimovig, Ajovy, Emgality 120 mg, or Vyepti
Treatment history: The patient has NOT received at least 3 months of treatment with the requested drug3 months
Initial therapy criteria

Step Therapy Exception Note: If initial step therapy criteria are not met, the claim will reject and a prior authorization is required for review

See step therapy rules and look-back requirements

inv-02: COVERAGE CRITERIA — Authorization for preventive treatment of migraine (continuation)

Authorization for preventive treatment of migraine (continuation)

Preventive Treatment of Migraine (Continuation)

Requested drug: The request is for Aimovig, Ajovy, Emgality 120 mg, or Vyepti
Treatment history and response: The patient has received at least 3 months of treatment with the requested drug AND the patient had a reduction in migraine days per month from baseline3 months
Continuation requires documented clinical improvement

DOA Note: Continuation approvals are issued for a 12-month DOA per policy

See DOA rules

inv-03: COVERAGE CRITERIA — Authorization for episodic cluster headache (initial)

Authorization for episodic cluster headache (initial)

Episodic Cluster Headache (Initial)

Requested drug: The request is for Emgality 100 mg
Treatment duration: The patient has NOT received at least 3 weeks treatment with the requested drug3 weeks
Initial cluster headache trial period
Prior triptan failure/intolerance/contraindication: The patient experienced an inadequate response to sumatriptan (nasal or subcutaneous) OR zolmitriptan (nasal or oral) OR had intolerance/contraindication to these agents
One of these must be met

inv-04: COVERAGE CRITERIA — Authorization for episodic cluster headache (continuation)

Authorization for episodic cluster headache (continuation)

Episodic Cluster Headache (Continuation)

Requested drug: The request is for Emgality 100 mg
Treatment duration and response: The patient has received at least 3 weeks of treatment with the requested drug AND the patient had a reduction in weekly cluster headache attack frequency from baseline3 weeks
Continuation requires documented improvement

DOA Note: Continuation approvals for cluster headache are issued for a 12-month DOA per policy

See DOA rules

If the member does not meet the initial step therapy requirements for the requested CGRP receptor antagonist injectable, the claim will reject with a message indicating that a prior authorization (PA) is required. The PA criteria will then be applied to the submitted request for evaluation. If the member meets the step therapy requirements but the request exceeds the initial quantity limit, the claim will also reject with a message indicating that a PA is required.

Provider Actions & Authorization Guidance

Denial Risk

DOA-related denials

Requests exceeding the specified Duration Of Approval (DOA) without meeting continuation criteria may be at risk for denial. Providers should note the DOA for the requested agent and indication and submit documentation that meets continuation criteria prior to or with any request that would exceed the initial approval period.

DOA applies per agent and indication — confirm whether the request is initial or continuation.
Requests that exceed the initial or post-limit DOA without meeting continuation criteria may be denied.

Documentation Required

Required authorization information

Authorization must specify the indication (migraine prevention or cluster headache), the specific agent and dose requested, and whether the request is for initial or continuation therapy. Include clinical documentation demonstrating prior therapy, dates of fills (when step therapy applies), and objective evidence of response for continuation requests.

Specify indication: migraine prevention OR episodic cluster headache.
Specify agent & dose (e.g., Emgality 100 mg vs Emgality 120 mg).
Indicate whether request is initial therapy or continuation of therapy.
Include prior fill history or prior therapy trial details (e.g., sumatriptan, zolmitriptan, or specified oral preventive agents) with dates and durations.
For continuation, include evidence of clinical response (reduction in migraine days per month or reduction in weekly cluster headache attack frequency).

Prior Authorization

Prior authorization required when step therapy or quantity limits unmet

Prior authorization is required when initial step therapy criteria are not met or when requests exceed the initial or post-limit quantity/DOA limits. Claims will reject with a message indicating a PA is required; submit the PA with the required documentation per the criteria for the agent and indication.

If step therapy criteria are met, initial limit criteria apply; requests above the initial quantity limit will trigger a PA requirement.
For Emgality 100 mg cluster headache, required step therapy may include prior trial of sumatriptan or zolmitriptan unless contraindicated or intolerant.
When submitting PA, clearly state whether request is for a loading dose (new start) or maintenance dose (continuing therapy) where applicable.

Initial Therapy Criteria

inv-19: Initial therapy — Initial step therapy requirements and quantity limits

Initial step therapy requirements and quantity limits

Initial Step Therapy General: For Aimovig, Ajovy, Emgality (except 100 mg), Vyepti: patient must have filled at least a 56-day supply of specified oral preventive medications (e.g., divalproex sodium, topiramate, valproate/valproic acid, beta-blockers, candesartan, amitriptyline, venlafaxine) within the past 730 days under the CVS Caremark benefit; otherwise the claim will reject and a PA is required56 days; 730 days look-back

Specific medication list in policy

Emgality 100 mg Initial: For Emgality 100 mg: patient must have filled at least a 1 day supply of sumatriptan (nasal or subcutaneous) or zolmitriptan (nasal or oral) within the past 730 days; otherwise the claim will reject and a PA is required1 day supply; 730 days look-back

Triptan requirement specific to Emgality 100 mg

Initial Quantity Limits: Initial limit quantities vary by product and strength (see quantity limits): Aimovig: 1 mL/25 days or 3 mL/75 days; Ajovy: 4.5 mL/75 days; Emgality 100 mg: 2 mL/25 days (loading/maintenance distinctions apply) or 4 mL/75 days; Vyepti: 3 mL/75 days

Limits do not accumulate together; loading dose rules apply for Emgality

inv-20: Initial therapy durations — Initial therapy durations by product and indication

Initial therapy durations by product and indication

Initial DOA - migraine prevention: Aimovig, Ajovy, Emgality 120 mg, Vyepti: initial therapy DOA = 3 months

Initial DOA - cluster headache: Emgality 100 mg: initial therapy DOA = 1 month

Continuation Therapy Criteria

inv-21: Continuation therapy — Continuation therapy criteria and duration

Continuation therapy criteria and duration

Continuation for migraine prevention: Patient has received at least 3 months of treatment with the requested drug AND had a reduction in migraine days per month from baseline3 months

Continuation DOA: 12 months per policy 2761-E

inv-22: Cluster headache continuation — Continuation therapy criteria for episodic cluster headache

Continuation therapy criteria for episodic cluster headache

Continuation for episodic cluster headache: Patient has received at least 3 weeks of treatment with Emgality 100 mg AND had a reduction in weekly cluster headache attack frequency from baseline3 weeks

Continuation DOA: 12 months

inv-23: Continuation therapy durations — Continuation therapy durations for approved CGRP agents

Continuation therapy durations for approved CGRP agents

Continuation DOA - migraine prevention: Aimovig, Ajovy, Emgality 120 mg, Vyepti: continuation of therapy DOA = 12 months

inv-24: Continuation therapy durations (cluster headache) — Continuation therapy durations for cluster headache

Continuation therapy durations for cluster headache

Continuation DOA - cluster headache: Emgality 100 mg: continuation of therapy DOA = 12 months

Step Therapy Requirements

Step therapy requirement	Applicability / notes
Patient has filled ≥56-day supply of one of the following within the past 730 days: divalproex sodium, topiramate, valproate sodium, valproic acid, metoprolol, propranolol, timolol, atenolol, nadolol, candesartan, amitriptyline, or venlafaxine
Applies to Aimovig, Ajovy, Emgality (except 100 mg), and Vyepti. If met, the requested drug will be paid under the prescription benefit; if not met, claim will reject requiring prior authorization. If initial limit exceeded after meeting step, claim will also reject requiring PA.
Patient has filled ≥1 day supply of sumatriptan (nasal or subcutaneous) or zolmitriptan (nasal or oral) within the past 730 days
Applies specifically to Emgality 100 mg. If met, the requested drug will be paid under the prescription benefit; if not met, claim will reject requiring prior authorization. If initial limit exceeded after meeting step, claim will also reject requiring PA.

Quantity Limits by Product

Aimovig 70 mg, 140 mg (erenumab-aooe)

Dose forms/strengthsAimovig 70 mg and 140 mg (erenumab-aooe) — autoinjector, 1 mL per device

1‑month limit1 mL / 25 days (1 autoinjector)

3‑month limit3 mL / 75 days (3 autoinjectors)

Ajovy 225 mg (fremanezumab-vfrm)

Dose/strengthAjovy 225 mg (fremanezumab-vfrm) — autoinjector or syringe, 1.5 mL each

3‑month limit4.5 mL / 75 days (3 autoinjectors or 3 syringes x 1.5 mL)

NoteLimits do not accumulate; patient may receive maximum allowed per drug/strength

Emgality 100 mg (galcanezumab-gnlm)

Dose/strengthEmgality 100 mg (galcanezumab-gnlm) — syringe/pen, 1 mL each

1‑month (loading/maintenance) limits3 mL / 25 days (3 syringes)

3‑month limit9 mL / 75 days (9 syringes)

Vyepti 100 mg (eptinezumab-jjmr, IV)

Dose/strengthVyepti 100 mg (eptinezumab-jjmr) — intravenous, single‑dose vials 1 mL each

3‑month limit3 mL / 75 days (3 single‑dose vials)

Site of careAdministered via IV (infusion center setting referenced)

OpenPayer

CGRP receptor antagonist injectables — step therapy, quantity limits, and prior authorization

Coverage Criteria

Coding & Look-back Periods

Provider Actions & Authorization Guidance

Definitions

Initial Therapy Criteria

Continuation Therapy Criteria

Step Therapy Requirements

Quantity Limits by Product

Site of Care Considerations

Background