CurrentCignaPolicy IP0029

Anti-migraine products medical necessity criteria

Defines medical necessity criteria, continuation, authorization duration, and excluded uses for a set of branded and generic anti-migraine products for Cigna benefit plans; supports formulary exception review and coverage determinations for listed agents.

Policy Summary

PayerCigna

PolicyAnti-migraine products medical necessity criteria

Policy CodePolicy IP0029

Change TypeAnnual Revision

Effective DateJan 1, 2025

Next Review Date

Key ActionDocument trials, failures, contraindications, or intolerance to the specified bioequivalent generic products and comparator agents when requesting formulary exceptions or prior authorization.

SourceLink

POLICY UPDATE CHANGES

Annual Revision: Removed preferred product step requirement for Dihydroergotamine 4 mg/mL nasal spray, Elyxyb, Migranal, and Trudhesa.

~30Listed products covered with criteria

12Initial approval duration (months)

12Reauthorization duration (months)

Coverage Summary

Defines medical necessity criteria, continuation, authorization duration, and excluded uses for a set of branded and generic anti-migraine products for Cigna benefit plans. Supports formulary exception review and coverage determinations for listed agents. Coverage Policy Number: IP0029. Effective date: 2025-01-01. Payer: Cigna Companies.

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Actions for Providers

Prior Authorization

Prior authorization required

Coverage policy supports medical necessity review for formulary exceptions and requires prior authorization for listed anti-migraine products. Note: receipt of sample product does not satisfy criteria.

Documentation Required

Document trials and formulation intolerance

Document prior use of the bioequivalent generic product(s) and that the patient cannot take them due to a formulation difference in inactive ingredient(s) that would result in a significant allergy or serious adverse reaction when required by product-specific criteria.

Documentation Required

Document failures/contraindications/intolerances

Document failures, contraindications, or intolerances to the specified number and list of comparator agents for each product (examples in policy include requirements to document failure/contraindication/intolerance to FOUR agents, FIVE agents, or BOTH of two agents as stated in the individual product criteria).

Note

Initial and reauthorization duration

Initial approvals and reauthorization approvals are up to 12 months.

Denial Risk

Non-covered uses / denial risk

Any use not meeting the listed criteria is considered experimental, investigational or unproven and may be denied.

Background and Definitions

Policy supports medical necessity review for multiple anti-migraine agents including triptans (e.g., sumatriptan, rizatriptan, zolmitriptan, naratriptan, frovatriptan, eletriptan, almotriptan), ergot derivatives (dihydroergotamine, ergotamine), diclofenac (Cambia/diclofenac powder packet), and combination agents (Treximet).

The policy aligns coverage with prior trials of the bioequivalent generic product for branded formulations — requiring documentation that the individual has tried the bioequivalent generic and cannot take it due to a formulation difference in inactive ingredient(s) that would cause a significant allergy or serious adverse reaction — and requires documentation of failure, contraindication, or intolerance to a specified number of comparator agents (e.g., four agents, five agents, or both agents depending on the product).

Background notes that some triptans have pediatric approvals (examples: almotriptan approved for ages 12–17, rizatriptan ≥6 years, treximet and zolmitriptan nasal spray ≥12 years) and that receipt of sample product does not satisfy criteria.

Continuation of therapy is allowed when criteria are met and a beneficial response is demonstrated. Initial and reauthorization approval durations are up to 12 months. The Annual Revision dated 1/1/2025 removed the preferred product step requirement for certain dihydroergotamine nasal sprays (Elyxyb, Migranal, Trudhesa).

Term	Definition
Receipt of sample product	Does not satisfy any criteria requirements for coverage.
Bioequivalent generic product	The generic equivalent of the branded product; trial of generic is required prior to brand unless inaccessible due to formulation-related allergy/serious adverse reaction.