CurrentCignaPolicy IP0029

Formulary Exceptions for Anti‑Migraine Products (Triptans, Ergotamines, DHE, Diclofenac)

Defines medical necessity criteria and authorization requirements for formulary exception requests for specified anti-migraine prescription products administered under Cigna benefit plans.

Policy Summary

PayerCigna

PolicyFormulary Exceptions for Anti‑Migraine Products (Triptans, Ergotamines, DHE, Diclofenac)

Policy CodePolicy IP0029

Change TypeOperational revision — preferred product step removed for select DHE nasal sprays

Effective DateJan 1, 2025

Next Review Date

Key ActionFor prior authorization, document trials of listed generic/bioequivalent products and evidence of failure, contraindication, or intolerance; initial and reauthorization approvals are each for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Removed preferred product step requirement for dihydroergotamine 4 mg/mL nasal spray, Elyxyb, Migranal, and Trudhesa.

~30products listed

≤12 moauthorization duration

4 alternativestypical prior-failure

12–17 yrsage-based approval

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Product-specific Medical Necessity Criteria

Products are considered medically necessary when the specified product-specific requirements are met.

Amerge (naratriptan) - Acute migraine: 1) Documentation the individual has tried naratriptan tablets (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Documentation of failure, contraindication, or intolerance to FOUR of: oral almotriptan; oral eletriptan; oral frovatriptan; oral rizatriptan; oral sumatriptan; oral zolmitriptan.2 conditions

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Amerge (naratriptan) - Menstrually‑associated migraine (MAM): 1) Documentation the individual has tried naratriptan tablets (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Documentation of failure, contraindication, or intolerance to BOTH: oral frovatriptan.2 conditions

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Cambia (diclofenac powder packet) - Acute migraine: 1) Individual is 18 years of age or older; AND 2) Documentation of failure, contraindication, or intolerance to BOTH: diclofenac tablets.2 conditions

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Diclofenac powder packet - Acute migraine: 1) Individual is 18 years of age or older; AND 2) Documentation of failure, contraindication, or intolerance to BOTH: diclofenac tablets and diclofenac delayed release tablets.2 conditions

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D.H.E. 45 (dihydroergotamine mesylate injection): 1) Documentation the individual has tried dihydroergotamine mesylate injection (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Documentation of failure, contraindication, or intolerance to sumatriptan injection (generic for Imitrex injection).2 conditions

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Ergomar (ergotamine sublingual tablet): Documentation of failure, contraindication, or intolerance to FIVE of: oral almotriptan; oral eletriptan; oral frovatriptan; oral naratriptan; oral rizatriptan; oral sumatriptan; oral zolmitriptan.5 of 7

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Frova (frovatriptan) - Acute migraine: 1) Documentation the individual has tried frovatriptan tablets (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Documentation of failure, contraindication, or intolerance to FOUR of: oral almotriptan; oral eletriptan; oral naratriptan; oral rizatriptan; oral sumatriptan; oral zolmitriptan.2 conditions

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Frova (frovatriptan) - MAM prevention: 1) Documentation the individual has tried frovatriptan tablets (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Documentation of failure, contraindication, or intolerance to BOTH: oral naratriptan.2 conditions

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Imitrex (sumatriptan injection or nasal spray): Documentation the individual has tried the bioequivalent generic product (sumatriptan injection or sumatriptan nasal spray) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction.1 condition

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Imitrex (sumatriptan tablets): 1) Documentation the individual has tried sumatriptan tablets (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) [additional failure requirements as specified per product where applicable].varies

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Maxalt / Maxalt MLT (rizatriptan): 1) Documentation the individual has tried the bioequivalent generic rizatriptan formulation (tablets or orally‑disintegrating tablets) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Documentation of failure, contraindication, or intolerance to FOUR of: oral almotriptan; oral eletriptan; oral frovatriptan; (additional alternatives vary by formulation and may include oral naratriptan and oral sumatriptan for MLT).2 conditions

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Onzetra Xsail (sumatriptan nasal): Documentation of failure, contraindication, or intolerance to sumatriptan nasal spray (generic for Imitrex nasal spray).1 condition

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Relpax (eletriptan): 1) Documentation the individual has tried eletriptan tablets (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Documentation of failure, contraindication, or intolerance to FOUR of: oral almotriptan; oral frovatriptan; oral naratriptan; oral rizatriptan; oral sumatriptan.2 conditions

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Tosymra (sumatriptan nasal spray): Documentation of failure or intolerance to sumatriptan nasal spray (generic for Imitrex nasal spray).1 condition

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Treximet (sumatriptan and naproxen): Documentation the individual has tried sumatriptan and naproxen sodium tablets (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction.1 condition

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Zembrace SymTouch (sumatriptan auto‑injector): Documentation of failure or intolerance to sumatriptan injection (generic for Imitrex injection).1 condition

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Zomig (zolmitriptan nasal spray): ONE of the following: 1) Individual is 12 to 17 years of age: approve; OR 2) Individual is 18 years of age or older: documentation of failure, contraindication, or intolerance to sumatriptan nasal spray (generic for Imitrex nasal spray).age‑based

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Zomig (zolmitriptan tablets) / Zomig ZMT: 1) Documentation the individual has tried zolmitriptan tablets or orally‑disintegrating tablets (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Documentation of failure, contraindication, or intolerance to FOUR of: oral almotriptan; oral eletriptan; oral frovatriptan; oral naratriptan; oral rizatriptan; oral sumatriptan.2 conditions

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Continuation Therapy

Continuation of therapy

Continuation of therapy: Continuation is medically necessary when the above medical necessity criteria are met AND beneficial response is demonstrated.all conditions

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Any use of the listed products outside the specific product‑level indications and medical necessity criteria in this policy is considered experimental, investigational, or unproven. The clinical criteria will be updated as new published data become available; until then, requests for unlisted indications may be denied.

Drug Listings, Codes, and Key Coding Rules

Listed anti-migraine drugs (brand/generic names)mixed

Amerge	naratriptan tablets
Cambia	diclofenac powder packet
D.H.E. 45	dihydroergotamine mesylate injection
Diclofenac powder packet	diclofenac powder packet
Ergomar	ergotamine 2 mg sublingual tablet
Frova	frovatriptan tablets
Imitrex (injection)	sumatriptan injection
Imitrex (nasal spray)	sumatriptan nasal spray
Imitrex (tablets)	sumatriptan tablets
Maxalt	rizatriptan tablets

1–10 of 19

1/2

Number of prior agent failures required (by product)

Typical requirementMany branded triptans require documentation of failure, contraindication, or intolerance to FOUR listed alternative oral triptans (e.g., almotriptan, eletriptan, frovatriptan, rizatriptan, sumatriptan, zolmitriptan).

Higher‑threshold agentsCertain products (e.g., ergotamine sublingual/Ergomar) require failure, contraindication, or intolerance to FIVE alternatives from the listed oral triptans.

Single‑agent thresholdSome formulations (e.g., sumatriptan nasal spray, injection, Onzetra Xsail, Tosymra, Zembrace SymTouch) require documentation of failure or intolerance to the equivalent generic formulation (often a single required agent).

Two‑agent requirementFor specific products (e.g., Cambia, diclofenac powder packet), criteria require failure/contraindication/intolerance to BOTH listed comparator formulations.

Variation by product formulationRequirements vary by product and formulation — tablet, nasal spray, orally‑disintegrating tablet, injection — and are specified per product in the criteria table.

Age threshold for zolmitriptan nasal spray

Age‑based automatic approvalZolmitriptan nasal spray (Zomig) is approved without prior‑failure documentation for individuals 12 to 17 years of age: approve.

Adult requirementFor individuals 18 years or older, zolmitriptan nasal spray requires documentation of failure, contraindication, or intolerance to sumatriptan nasal spray.

Related formulationsZolmitriptan orally‑disintegrating tablets (Zomig ZMT) have separate criteria requiring prior‑failure to four alternatives unless pediatric MAM exceptions apply.

Authorization, Documentation, and Operational Notes for Providers

Prior Authorization

Authorization duration and continuation

Initial and reauthorization approvals are each for up to 12 months. Continuation of therapy requires that the initial medical necessity criteria remain met and a beneficial response to the therapy is demonstrated.

Initial approval duration: up to 12 months
Reauthorization approval duration: up to 12 months
Continuation requires demonstration of beneficial response and that initial criteria remain met

Step Therapy

Preferred product step requirement removed for DHE nasal sprays

The preferred product step requirement for dihydroergotamine 4 mg/mL nasal spray products (Elyxyb, Migranal, Trudhesa) has been removed; providers do not need to document trial of a preferred product step for these DHE nasal sprays.

Revision: Removed preferred product step requirement for Dihydroergotamine 4 mg/mL nasal spray (Elyxyb, Migranal, Trudhesa)

Documentation Required

Trial and failure documentation required

Document that the individual has tried the bioequivalent generic formulation (when listed) and cannot take it due to a formulation difference in inactive ingredients causing a significant allergy or serious adverse reaction, and provide evidence of failure, contraindication, or intolerance to the specified number/list of alternative agents required for the requested product.

Evidence of trial of the bioequivalent generic product and reason why it cannot be taken (formulation difference causing significant allergy/serious adverse reaction)
Documentation of failure, contraindication, or intolerance to the product-specific number/list of alternatives (e.g., FOUR alternatives for many products; FIVE for Ergomar)

Documentation Required

MAM prevention: document trials/failures to required agents

For menstrually-associated migraine (MAM) prevention, provide documentation that the individual tried the specified smaller lists of agents and had failure, contraindication, or intolerance as required per product (for example, frovatriptan or naratriptan as listed per product-specific criteria).

Show trial and inability to take the bioequivalent generic due to formulation difference when applicable
Document failure/contraindication/intolerance to the BOTH-listed agents required for MAM prevention for the specific product

Denial Risk

Non‑covered uses may be denied

Requests for uses other than the listed indications are considered experimental, investigational, or unproven and may be denied.

Any indication not listed in the policy is treated as experimental/investigational/unproven

OpenPayer

Formulary Exceptions for Anti‑Migraine Products (Triptans, Ergotamines, DHE, Diclofenac)

Medical Necessity and Coverage Criteria

Drug Listings, Codes, and Key Coding Rules

Authorization, Documentation, and Operational Notes for Providers

Clinical Background

Key Definitions