CurrentUnitedHealthcarePolicy N/A

Ergotamine and Dihydroergotamine Step Therapy (Brekiya, Migranal, Trudhesa, Ergomar)

Step therapy program governing prior authorization for Brekiya (dihydroergotamine nasal spray), Migranal/Trudhesa (dihydroergotamine nasal sprays), and Ergomar (ergotamine) for acute migraine/cluster headache treatment in affected UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyErgotamine and Dihydroergotamine Step Therapy (Brekiya, Migranal, Trudhesa, Ergomar)

Policy CodePolicy N/A

Change TypeNew step therapy program

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization; approvals issued for 12 months when coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

New step therapy program created for ergotamine products including Brekiya, dihydroergotamine nasal spray, Ergomar, and Trudhesa.

12 monthsauthorization duration for approvals

>=3 eps + >=30drequired trial period for prior therapies

2failed triptans required (Brekiya/Ergomar)

1failed oral triptan required (Migranal/Trudhesa)

3/2025

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Coverage Criteria

Brekiya (initial therapy)

Covered when ALL of the following are met:

Brekiya approval: 1) History of failure (after at least 3 migraine episodes and a minimum of a 30-day trial), contraindication, or intolerance to dihydroergotamine (generic D.H.E.) injection.

Brekiya approval: 2) History of failure (after at least 3 migraine episodes and a minimum of a 30-day trial), contraindication, or intolerance to two of the following triptans (oral or nasal): almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan. Document drug names and duration of trial.

Authorization will be issued for 12 months.

Migranal / Trudhesa (initial therapy)

Covered when ALL of the following are met:

Dihydroergotamine nasal spray approval: 1) History of failure (after at least 3 migraine episodes and a minimum of a 30-day trial), contraindication, or intolerance to at least one oral triptan (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan). Document duration of trial.

Dihydroergotamine nasal spray approval: 2) History of failure (after at least 3 migraine episodes and a minimum of a 30-day trial), contraindication, or intolerance to both sumatriptan nasal spray (generic Imitrex nasal spray) AND zolmitriptan nasal spray (Zomig nasal spray).

Authorization will be issued for 12 months.

Ergomar (initial therapy)

Covered when ALL of the following are met:

Ergomar approval: History of failure (after at least 3 migraine episodes and a minimum of a 30-day trial), contraindication, or intolerance to two of the following oral triptans: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan. Document drug and duration of trial.

Authorization will be issued for 12 months.

Brekiya, Brand Migranal, and Trudhesa are typically excluded from coverage; brand exclusions may apply. This reflects the program’s standard formulary exclusions for these branded dihydroergotamine nasal spray products and should be verified against the member’s benefit plan and any applicable state or federal mandates.

Coding and Episode/Duration Requirements

Required trial episodes and duration

Required episode historyHistory of at least 3 migraine episodes required for each documented prior therapy trial

Minimum trial duration per prior therapyMinimum 30-day trial for each required prior therapy (document drug and duration)

Trial requirement for D.H.E. injection (Brekiya)History of failure, contraindication, or intolerance to dihydroergotamine (generic D.H.E.) injection after >=3 episodes and >=30-day trial

Triptan trial requirement (Brekiya/Ergomar)Failure, contraindication, or intolerance to two oral or nasal triptans (listed agents) after >=3 episodes and >=30-day trial

Triptan trial requirement (Migranal/Trudhesa)Failure, contraindication, or intolerance to at least one oral triptan plus failures to both sumatriptan nasal spray and zolmitriptan nasal spray after >=3 episodes and >=30-day trial

Initial Therapy Requirements

Initial therapy requirements

Initial authorization requires demonstration of prior trial failures as specified per product.

Brekiya initial: D.H.E. injection failure (after >=3 migraine episodes and >=30-day trial) AND failure (after >=3 migraine episodes and >=30-day trial), contraindication, or intolerance to two oral or nasal triptans (see product-specific list).>=3 episodes and >=30-day trial per prior therapy

Migranal/Trudhesa initial: Failure (after >=3 migraine episodes and >=30-day trial), contraindication, or intolerance to at least one oral triptan AND failures to both sumatriptan nasal spray and zolmitriptan nasal spray.>=3 episodes and >=30-day trial per prior therapy

Ergomar initial: Failure (after >=3 migraine episodes and >=30-day trial), contraindication, or intolerance to two oral triptans (see product-specific list).

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are issued for 12 months when coverage criteria are met.

Applies to Brekiya*, Dihydroergotamine Nasal Spray (Migranal*), Trudhesa*, and Ergomar (ergotamine) where criteria satisfied.

Step Therapy

Step Therapy Requirements

Step therapy: document failures, contraindications, or intolerances to required prior therapies before requesting approval.

For Brekiya*: documentation of failure/contraindication/intolerance to generic D.H.E. injection (after ≥3 migraine episodes and ≥30-day trial) and to two different triptans (oral or nasal).
For Migranal*/Trudhesa*: documentation of failure/contraindication/intolerance to one oral triptan (≥3 episodes, ≥30-day trial) and to both listed nasal triptans.
For Ergomar: documentation of failure/contraindication/intolerance to two oral triptans (≥3 episodes, ≥30-day trial).

Step Therapy Requirements and Table

Product	Prior agent requirements (number & specific agents)	Required trial documentation	Approval duration
Brekiya (dihydroergotamine nasal spray)	2 required prior triptan failures (oral or nasal): choose two from almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan; PLUS failure, contraindication, or intolerance to dihydroergotamine (D.H.E.) injection	Document drug names and duration of trial for D.H.E. injection and for each of the two triptans; prior history must include ≥3 migraine episodes and a minimum 30‑day trial per prior therapy	12 months
Migranal or Trudhesa (dihydroergotamine nasal sprays)	Failure, contraindication, or intolerance to 1 oral triptan (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan) AND to both sumatriptan nasal spray and zolmitriptan (Zomig) nasal spray	Document drug names and duration of trial for the oral triptan and for sumatriptan nasal spray and zolmitriptan nasal spray; prior history must include ≥3 migraine episodes and a minimum 30‑day trial per prior therapy	12 months
Ergomar (ergotamine)	2 required prior triptan failures (oral): choose two from almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan	Document drug names and duration of trial for each of the two oral triptans; prior history must include ≥3 migraine episodes and a minimum 30‑day trial per prior therapy	12 months

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization: Authorization will be issued for 12 months when initial criteria continue to be met or when approved based on prior claim/medication history and diagnosis code logic per program.

Quantity Limits

Supply limits

General statementSupply limits may apply.

Program-level discretionUnitedHealthcare may approve initial and reauthorization based on prior claim/medication history, diagnosis codes, and/or claim logic notwithstanding coverage criteria

Unit and per-period limitsSpecific quantity, unit, or per-period limits not specified in policy (refer to plan/program systems for numeric limits)

Site of Care and Claims Considerations

Note

Approvals/reauthorizations may be based on claim history and diagnosis codes

Approvals and reauthorizations may be determined using prior claim or medication history and diagnosis codes; no specific site-of-care restriction is specified.

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic.

Definitions

D.H.E. (dihydroergotamine) definition

TermD.H.E. (dihydroergotamine)

Formulations includedInjection formulations and nasal spray formulations (e.g., Brekiya, Migranal, Trudhesa)

Clinical roleUsed as a migraine-specific therapy for acute treatment of migraine (with or without aura); some nasal products indicated for cluster headaches (Brekiya)

Background

Dihydroergotamine (D.H.E.) nasal sprays — including Brekiya, Migranal, and Trudhesa — are approved for the acute treatment of migraine with or without aura; Brekiya and Trudhesa are also labeled for the acute treatment of cluster headache. These products are migraine-specific therapies used for moderate-to-severe or refractory attacks when prior first-line agents are ineffective or not tolerated.

Per the program, initial and continuation authorizations for these agents require documented prior treatment history (see coverage criteria). When criteria are met, approvals are issued for 12 months.