CurrentHealth NetPolicy CP PHAR.490

Clinical Policy: Rimegepant (Nurtec ODT)

Defines medical necessity, prior authorization, and coverage criteria for rimegepant (Nurtec ODT) for acute and preventive treatment of migraine for Health Net lines of business governed by this policy.

Policy Summary

PayerHealth Net

PolicyRimegepant (Nurtec ODT) coverage

Policy CodePolicy CP PHAR.490

Change TypeNo material change

Effective DateSep 1, 2020

Next Review DateN/A

Key ActionSubmit clinical documentation (office notes, lab results or other information) demonstrating the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

75 mgmaximum single dose

>=4 days/mopreventive threshold

6 moacute approval duration

3 moprophylaxis initial duration

hypersensitivitycontraindication

Coverage Criteria for Rimegepant (Nurtec ODT)

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inv-01: Initial Therapy — Acute

Covered when ALL of the following are met for acute treatment

Acute Migraine Initial: 1) Diagnosis of migraine headache; 2) Age >= 18 years; 3) Failure of ubrogepant (Ubrelvy) at up to maximally indicated doses unless contraindicated or intolerant; 4) Failure of at least TWO formulary generic triptan migraine medications (e.g., sumatriptan, rizatriptan, zolmitriptan) at up to maximally indicated doses unless contraindicated or intolerant; 5) Dose does not exceed 75 mg (1 ODT) per day; 6) Not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality, Qulipta, Ubrelvy, Vyepti, Zavzpret); 7) For dose increases to quantities >1 box per month, member must meet prophylaxis criteria in section B.

Approval duration: 6 months

inv-02: Initial Therapy — Prophylaxis (Episodic)

Covered when ALL of the following are met for preventive treatment

Prophylaxis Initial: 1) Diagnosis of episodic migraine; 2) Member experiences >=4 migraine days per month for at least 3 months; 3) Member does not have chronic migraine (>=15 headache days/month with >=8 migraine days/month for >=3 months); 4) Age > 18 years; 5) Prescribed by or in consultation with a neurologist, headache specialist, or pain specialist; 6) Failure of at least 2 oral migraine preventive therapies from different classes, each for 8 weeks unless contraindicated or intolerant (antiepileptics, beta-blockers, antidepressants); 7) Failure of Qulipta (atogepant) at up to maximally indicated doses unless contraindicated or intolerant; 8) Failure of a 3-month trial of at least ONE injectable CGRP therapy (Aimovig, Ajovy, Emgality, Vyepti) unless contraindicated or intolerant; 9) If concurrent use with Botox is requested (not switching), additional evidence required including continued >=4 migraine days/month despite Botox and prior positive response to Botox (>=30% reduction) after at least 2 quarterly injections (6 months); 10) Not prescribed concurrently with other CGRP inhibitors; 11) Dose does not exceed 75 mg every other day.

Approval duration: 3 months

inv-03: Continued Therapy — Acute

Covered when ALL of the following are met for continued acute therapy

Continued Acute: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria; 2) Member is responding positively to therapy; 3) Nurtec ODT is not prescribed concurrently with other CGRP inhibitors (exception for CA per policy if previously approved and stable on both oral and injectable CGRP inhibitors); 4) Dose increase requests must meet prophylaxis criteria in Section I.B; 5) If dose increase, new dose does not exceed 75 mg per day.

Approval duration: 12 months

inv-04: Continued Therapy — Prophylaxis

Covered when ALL of the following are met for continued prophylactic therapy

Continued Prophylaxis: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria; 2) Member has experienced and maintained positive response as evidenced by reduction in migraine days per month from baseline; 3) Nurtec ODT is not prescribed concurrently with other CGRP inhibitors (exception for CA per policy if previously approved and stable on both oral and injectable CGRP inhibitors); 4) If dose increase, new dose does not exceed 75 mg every other day.

Approval duration: 6 months

inv-05: Coverage criteria — dosing and preventive consideration

Coverage and dosing parameters indicated in document

Dosing for acute treatment: Single 75 mg PO as needed for acute migraine; maximum 75 mg in 24 hours; safety of >18 doses in 30 days not established.75 mg/day

supported by dosing section

Dosing for prophylaxis: 75 mg PO every other day for migraine prophylaxis; maximum dose 75 mg per dose.75 mg every other day

supported by dosing section

Indications for preventive therapy consideration: Preventive therapy considered when attacks significantly interfere with daily routines despite acute treatment OR frequent attacks (>=4 migraine days/month) OR contraindication/failure/overuse of acute treatments OR adverse effects with acute treatments OR certain uncommon migraine subtypes OR patient preference.

Coverage is not authorized for non‑FDA approved indications unless the provider supplies sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (e.g., CP.PA.09 for commercial, HIM.PA.154 for Marketplace, CP.PMN.53 for Medicaid) or submits other evidence of coverage that supports the requested indication.

Use of rimegepant (Nurtec ODT) is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, Nurtec ODT, or any component of the product.

Nurtec ODT should not be prescribed concurrently with other CGRP inhibitors (for example: Aimovig, Ajovy, Emgality, Qulipta, Ubrelvy, Vyepti, Zavzpret). Exceptions are limited to specific continuity‑of‑care or case‑by‑case situations outlined elsewhere in the policy.

Therapy that exceeds the recommended dosing limits is not supported. The single dose should not exceed 75 mg, and the maximum in any 24‑hour period is 75 mg. Additionally, the safety of administering more than 18 doses in a 30‑day period has not been established and such use will be considered not medically necessary.

Initial Therapy

inv-26: Initial Therapy — Initial therapy criteria summarized

Initial therapy criteria summarized

Initial Therapy Summary: See coverage.criteria_sets for detailed initial therapy requirements for both acute and prophylactic indications (diagnosis, age, prior therapy failures, prescriber specialty, dosing limits, and concurrent CGRP inhibitor restrictions).

inv-27: Initial therapy dosing

Initial dosing approaches for indication

Acute initial therapy: 75 mg PO as needed for acute migraine with maximum 75 mg per 24 hours; limit preventive/overuse per guidance.

Prophylaxis initial therapy: 75 mg PO every other day for episodic migraine prophylaxis.

Continuation / Renewal Criteria

inv-28: Continuation Therapy — Criteria for continued therapy

Criteria for continued therapy

Continued Therapy Nodes: Member currently receiving medication via Centene benefit or previously met initial approval criteria; member demonstrating positive response (reduction in migraine days); not prescribed concurrently with other CGRP inhibitors except noted CA exception; dose limits apply for any increases.

inv-29: Continuation therapy clarifications — Continuation/renewal notes included in annual reviews

Continuation/renewal notes included in annual reviews

Concurrent use with other CGRP inhibitors: Clarification added that requirement for concurrent use with other CGRP inhibitors does not apply to CA if member was previously approved via Centene benefit and is currently stable on therapy with both oral and injectable CGRP inhibitors.

Step Therapy and Prior Trials

Step	Requirement	Notes / Prior authorization
1	Failure of ubrogepant (Ubrelvy) at up to maximally indicated doses unless contraindicated or intolerant; failure of at least TWO formulary generic triptan agents (e.g., sumatriptan, rizatriptan, zolmitriptan) at up to maximally indicated doses unless contraindicated or intolerant; age ≥18; diagnosis of migraine	Prior authorization may be required for ubrogepant and for some listed agents; approval duration for acute use: 6 months

Step	Requirement	Redirection / Trial duration
1	For episodic migraine prophylaxis: failure of at least 2 oral preventive therapies (from different classes) each for 8 weeks, failure of Qulipta (atogepant) unless contraindicated or intolerant, and failure of at least ONE injectable CGRP therapy (Aimovig, Ajovy, Emgality, Vyepti) unless contraindicated or intolerant	Policy includes redirection to injectable CGRP agents for prophylaxis; prior authorization may be required for alternative CGRP redirections (per annual reviews)
2	If redirected to an alternative injectable CGRP for prophylaxis, a 3-month trial of that injectable CGRP is required unless contraindicated or intolerant	4Q2024 update added requirement for 3-month trial for injectable CGRP redirection and clarified redirection rules; PA may be required

What Providers Must Do

Prior Authorization

Prior Authorization May Be Required

Prior authorization may be required for some uses of rimegepant (Nurtec ODT) and for alternative oral or injectable CGRP agents referenced in the failure/step therapy criteria. Providers should verify PA requirements with the member's benefit plan prior to prescribing.

Prior authorization may be required for ubrogepant (Ubrelvy) and other specified agents referenced in failure criteria.
PA may be required for redirection to alternative CGRP therapies (oral or injectable) per payer guidance.

Documentation Required

Documentation Requirement

Provider must submit complete supporting documentation with the prior authorization request. Failure to provide adequate documentation may result in denial.

Acceptable documentation: office chart notes, medication trials and dates, specialist consultation notes, headache frequency diaries, and relevant lab or imaging results.
If documentation demonstrating failure, contraindication, or intolerance to required prior therapies is not provided, request may be denied.

Documentation Required

Required Clinical Documentation

Clinical documentation must specifically support the dosing regimen and indication requested, and the member's migraine history relative to the criteria.

For acute treatment requests: documentation of dosing (75 mg as needed), frequency of migraine/headache days, and prior trials of two formulary generic triptans and ubrogepant (Ubrelvy) unless contraindicated.
For prophylaxis requests: documentation of dosing (75 mg every other day), headache frequency to confirm non‑chronic episodic migraine, failure of ≥2 oral preventative therapies from different classes (each for ≥8 weeks), and failure of a 3‑month trial of at least one injectable CGRP therapy unless contraindicated.
If request is for concurrent use with Botox, provide evidence from at least two high‑quality published studies or clinical practice guidelines and documentation of positive response to Botox monotherapy and continued migraine burden.

Denial Risk

Contraindication‑Related Denials

Requests will be denied if the member has a contraindication to rimegepant or if required step‑therapy criteria are not met.

Contraindication: history of hypersensitivity to rimegepant, Nurtec ODT, or any of its components.
Non‑FDA indications without sufficient off‑label documentation per applicable off‑label policies may be denied.

Step Therapy

Step Therapy Requirement

Step therapy requirements apply for both acute and prophylactic indications; providers must document trials and outcomes of required prior therapies.

Acute treatment: failure of ubrogepant (Ubrelvy) at maximally indicated doses unless contraindicated, AND failure of at least two formulary generic triptans (e.g., sumatriptan, rizatriptan, zolmitriptan) at maximally indicated doses unless contraindicated.
Prophylaxis: failure of ≥2 oral migraine preventives from different therapeutic classes (each ≥8 weeks) AND failure of Qulipta unless contraindicated, AND failure of a 3‑month trial of at least one injectable CGRP therapy (Aimovig, Ajovy, Emgality, Vyepti) unless contraindicated.

Step Therapy

Step Therapy / Redirection Notes

Policy includes redirection notes and requirements when alternative CGRP agents are considered; prior authorization may be required for these redirections and additional trial durations may apply.

Redirection to injectable CGRP agents for prophylaxis requires a documented 3‑month trial of an injectable CGRP unless contraindicated.
For acute treatment, policy may redirect to ubrogepant (Ubrelvy) prior to approval of Nurtec ODT.
PA may be required for alternative CGRP redirections per plan-specific requirements.

Drug Codes and Key Values

Drug codes / referencesNDC

NDC	Nurtec ODT product NDC(s) referenced in prescribing information (NDCs not listed in this excerpt)

Frequency threshold for preventive consideration

Frequency threshold for preventive consideration>= 4 migraine days per month

Duration required at thresholdfor at least 3 months

Context for considerationConsider preventive therapy when attacks significantly interfere with daily routines despite acute treatment

Frequent migraine days

Definition of frequent migraine days>= 4 migraine headache days per month

Source guidanceAmerican Headache Society guidance referenced in Appendix D

Clinical implicationFrequent attacks may prompt offering preventive treatment

Quantity Limits and Formulation

Nurtec ODT (rimegepant) — 75 mg

Product and strengthNurtec ODT (rimegepant) — 75 mg

FormulationOrally disintegrating tablet (ODT), available in blister pack of 8

Approved uses notedDosing described for acute and prophylactic use in policy dosing section

rimegepant (Nurtec ODT) — packaging & dosing limits

PackagingBlister pack of 8 ODTs available

Daily maximumMaximum 75 mg per 24 hours (one 75 mg ODT)

Monthly safety limitSafety of using >18 doses in 30 days has not been established

Definitions and Abbreviations

CGRP, ODT definitions

CGRPCalcitonin gene-related peptide

ODTOrally disintegrating tablet

Class contextCGRP receptor antagonist (gepants) — Nurtec ODT is an oral ODT formulation

Chronic migraine

Chronic migraine definition>= 15 headache days/month with >= 8 migraine days/month for at least 3 months

Exclusion for prophylaxisMembers with chronic migraine are excluded from episodic prophylaxis criteria

Reference locationAppendix D and prophylaxis criteria in policy

Acute treatment overuse

Overuse definition — non-opioid analgesics/NSAIDs/acetaminophen>= 15 days per month

Overuse definition — ergot derivatives, triptans, opioids, combination analgesics>= 10 days per month

Clinical relevanceOveruse of acute treatments is an indication to consider preventive therapy

Background

Rimegepant (Nurtec ODT) is a calcitonin gene‑related peptide (CGRP) receptor antagonist available as an orally disintegrating tablet formulation. It is approved for the acute treatment of migraine and for preventive treatment of episodic migraine in adults. The recommended acute dosing is a single 75 mg PO as needed dose with a maximum of 75 mg per 24 hours. For episodic migraine prophylaxis the recommended dosing is 75 mg PO every other day. The product is available as an ODT blister pack (8 tablets); the safety of using more than 18 doses in 30 days has not been established.

Site of Care / Formulation

Note

Orally disintegrating tablet (ODT) for home use

Nurtec ODT is an orally disintegrating tablet intended for outpatient/home administration.

Product availability: ODT blister pack of 8, 75 mg per tablet.