UnitedHealthcare ergotamine DHE Prior Auth Policy Update

Coverage Criteria

Initial Therapy - Brekiya

Brekiya (dihydroergotamine nasal spray) approved 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.after at least 3 migraine episodes and a minimum of a 30-day trial

Document drug name and duration of trial; provide documentation of contraindication or intolerance as applicable.

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.after at least 3 migraine episodes and a minimum of a 30-day trial

Document drug names and duration of trials; provide documentation of contraindication or intolerance as applicable.

Initial Therapy - Migranal/Trudhesa

Dihydroergotamine nasal spray (Migranal) or Trudhesa approved when ALL of the following are met:

Migranal/Trudhesa approval: 1) History of failure (after at least 3 migraine episodes and a minimum of a 30-day trial), contraindication, or intolerance to ONE oral triptan (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan).after at least 3 migraine episodes and a minimum of a 30-day trial

Document duration of trial or reason for contraindication/intolerance.

Migranal/Trudhesa approval: 2) History of failure (after at least 3 migraine episodes and a minimum of a 30-day trial), contraindication, or intolerance to BOTH of the following nasal triptans: sumatriptan nasal spray (generic Imitrex nasal spray) AND zolmitriptan nasal spray (Zomig nasal spray).after at least 3 migraine episodes and a minimum of a 30-day trial

Document duration of trials or reason for contraindication/intolerance for each agent.

Initial Therapy - Ergomar

Ergomar (ergotamine) approved when the following is 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.after at least 3 migraine episodes and a minimum of a 30-day trial

Document drug names and duration of trials or provide documentation of contraindication/intolerance.

Brand Brekiya, branded Migranal and Trudhesa are typically excluded from coverage per the member-specific formulary or benefit. Requests for these branded products may be denied when the benefit or formulary excludes the brand; generic or formulary-preferred alternatives and coverage rules should be checked prior to submission.

Use of these agents for prophylactic therapy of migraine or for hemiplegic or basilar migraine is not indicated. Brekiya, Migranal, and Trudhesa are approved for the acute treatment of migraine (with or without aura) and, for Brekiya, also acute cluster headache in adults; they are not intended for preventive therapy or treatment of hemiplegic or basilar migraine.

Coding and Trial Requirements

Prior trial episodes and duration — Failure after at least 3 migraine episodes and a minimum 30-day trial

Failure definitionHistory of failure (after at least 3 migraine episodes and a minimum of a 30-day trial), contraindication, or intolerance

Minimum migraine episodesAt least 3 migraine episodes

Minimum trial durationMinimum 30-day trial per comparator agent

Documentation requiredProvider must document drug names and duration of trials for required comparators

Provider Actions and Documentation

Step Therapy

Step therapy prior authorization — Prior authorization required with documented prior trials/contraindications/intolerances to specified comparator agents; approval issued for 12 months.

Prior authorization (step therapy) is required. Provider must document failure, contraindication, or intolerance to the specified comparator agents with drug names and duration of trials (after at least 3 migraine episodes and a minimum 30-day trial for each required agent). Approval, when criteria are met, will be issued for 12 months.

Brekiya: Require documented trial/contraindication/intolerance to generic D.H.E. injection AND two different oral or nasal triptans (document drug names and duration).
Migranal (D.H.E. nasal) or Trudhesa: Require documented trial/contraindication/intolerance to one oral triptan (document duration) AND to both sumatriptan nasal spray (generic Imitrex nasal spray) and Zomig nasal spray (zolmitriptan).
Ergomar (ergotamine): Require documented trial/contraindication/intolerance to two different oral triptans (document drug names and duration).
Authorization will be issued for 12 months when criteria are met.

Step Therapy

Step therapy requirements — Step therapy requires documented failure, contraindication, or intolerance to specified triptans and/or injectable D.H.E. depending on the product.

Background

Dihydroergotamine nasal sprays and ergotamine agents are approved for acute headache management. Dihydroergotamine (DHE) nasal sprays (Brekiya, Migranal, Trudhesa) are indicated for the acute treatment of migraine with or without aura; Brekiya is also indicated for acute cluster headache in adults. Ergomar (ergotamine) is indicated to abort or prevent vascular headache, including migraine and migraine variants, but should not be used for chronic daily administration. Clinical guidance (American Headache Society) recommends nonspecific analgesics for mild–moderate attacks and migraine-specific agents (triptans, DHE, gepants, lasmiditan) for moderate–severe or refractory attacks.

Definitions

DHE — dihydroergotamine (DHE)

TermDihydroergotamine (DHE)

IndicationsAcute treatment of migraine with or without aura; Brekiya also indicated for acute cluster headache in adults

Role in step therapyRequired comparator for Brekiya: failure/intolerance/contraindication to injectable D.H.E. is a prerequisite

triptans — triptans (serotonin 5-HT1B/1D agonists) used as migraine-specific agents

ClassTriptans (serotonin 5-HT1B/1D agonists)

Examples listedalmotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

Initial Therapy Criteria

Initial authorization — Initial authorization criteria by product

Initial authorization criteria by product

Brekiya initial: See Coverage criteria - Brekiya: approval requires failure/contraindication/intolerance to injectable D.H.E. plus TWO triptans (oral or nasal) after at least 3 migraine episodes and ≥30-day trials.see coverage criteria

Provide documentation of drug names and duration of trials; approval issued for 12 months when criteria met.

Migranal/Trudhesa initial: See Coverage criteria - Migranal/Trudhesa: approval requires failure/contraindication/intolerance to ONE oral triptan and to BOTH sumatriptan nasal spray and zolmitriptan nasal spray after at least 3 migraine episodes and ≥30-day trials.see coverage criteria

Document duration of trials; approval issued for 12 months when criteria met.

Continuation / Reauthorization Criteria

Reauthorization

Reauthorization: Authorization will be issued for 12 months when initial criteria are met.12 months

Supply limits may apply.

Step Therapy Progression

Comparator therapy	Required trial/failure before approval	Notes
{"text":"Injectable dihydroergotamine (generic D.H.E.)","status":""},{"text":"History of failure after at least 3 migraine episodes and a minimum 30-day trial, or documented contraindication/intolerance","status":""},{"text":"Required for Brekiya approval (must document drug name and duration of trial)","status":""}
{"text":"Oral triptans: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan","status":""},{"text":"Brekiya: failure/contraindication/intolerance to TWO of the listed triptans after ≥3 episodes and ≥30‑day trials; Migranal/Trudhesa: failure to ONE oral triptan after ≥3 episodes and ≥30‑day trial; Ergomar: failure to TWO oral triptans after ≥3 episodes and ≥30‑day trials","status":""},{"text":"Document specific drug names and duration of each trial","status":""}
{"text":"Sumatriptan nasal spray (generic Imitrex nasal spray) and zolmitriptan nasal spray (Zomig nasal spray)","status":""},{"text":"For Migranal or Trudhesa: history of failure to BOTH nasal sprays after at least 3 migraine episodes and a minimum 30‑day trial, or documented contraindication/intolerance","status":""},{"text":"Both nasal triptans must be tried (document duration)","status":""}

Quantity Limits

Supply limits may apply

Quantity limit noteSupply limits may apply

Authorization durationAuthorization issued for 12 months when criteria met (relevant to supply planning)

Program automationUnitedHealthcare may use prior claim/medication history, diagnosis codes, and/or claim logic for approval which may affect supply handling

Site of Care

Note

No explicit site‑of‑care restriction — approvals may use claim history/logic

No explicit site‑of‑care restriction is specified; UnitedHealthcare may use prior claim/medication history, diagnosis codes, or claim logic for approval decisions.

Program may approve initial or reauthorization based solely on previous claim/medication history or claim logic.
Supply limits or other program rules may still apply.

OpenPayer

Ergotamine and dihydroergotamine products step therapy