Pharmacy Prior Authorization Criteria

Ergot Alkaloids

Indications for Prior Authorization

D.H.E. 45 (dihydroergotamine mesylate) injection

• For diagnosis of Migraine
  Indicated for the acute treatment of migraine headaches with or without aura.

• For diagnosis of Cluster Headache
  Indicated for the acute treatment of cluster headache episodes.

Migranal (dihydroergotamine mesylate) nasal spray

• For diagnosis of Migraine
  Indicated for the acute treatment of migraine headaches with or without aura.

  Not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.

Cafergot (ergotamine tartrate and caffeine) tablet, Ergomar (ergotamine tartrate) sublingual tablet, Migergot (ergotamine tartrate and caffeine) suppository

• For diagnosis of Headache
  Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants, or so-called “histaminic cephalalgia”.

Trudhesa (dihydroergotamine mesylate) nasal spray

• For diagnosis of Migraine
  Indicated for the acute treatment of migraine with or without aura in adults.

  Limitations of Use: - Not indicated for the preventive treatment of migraine. - Not indicated for the management of hemiplegic or basilar migraine.

Criteria

Brand Cafergot tablet, Generic ergotamine tartrate/caffeine tablet, Brand D.H.E. 45 injection, Generic dihydroergotamine mesylate injection, Ergomar sublingual tablet, Migergot suppository, Brand Migranal nasal spray, Generic dihydroergotamine mesylate nasal spray, or Trudhesa nasal spray

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Migraines

• Diagnosis of migraine headaches with or without aura
AND
• Will be used for the acute treatment of migraine
AND
• Patient is 18 years of age or older [A]
AND
• One of the following: [3]
• Trial and failure or intolerance to two triptans (e.g., eletriptan, rizatriptan, sumatriptan)
• Contraindication to all triptans
AND
• If patient has 4 or more headache days per month, patient must be currently treated with one of the following: [B, 4]
• Elavil (amitriptyline) or Effexor (venlafaxine) unless there is a contraindication or intolerance to these medications
• Depakote/Depakote ER (divalproex sodium) or Topamax (topiramate) unless there is a contraindication or intolerance to these medications
• A beta-blocker (i.e., atenolol, propranolol, nadolol, timolol, or metoprolol) unless there is a contraindication or intolerance to these medications
• Atacand (candesartan) unless there is a contraindication or intolerance to this medication
• Generic lisinopril unless there is a contraindication or intolerance to this medication

Brand Cafergot tablet, Generic ergotamine tartrate/caffeine tablet, Brand D.H.E. 45 injection, Generic dihydroergotamine mesylate injection, Ergomar sublingual tablet, Migergot suppository, Brand Migranal nasal spray, Generic dihydroergotamine mesylate nasal spray, or Trudhesa nasal spray

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Migraines

• Patient has experienced a positive response to therapy (e.g., reduction in pain, photophobia, phonophobia, nausea)

Brand Cafergot tablet, Generic ergotamine tartrate/caffeine tablet, Brand D.H.E. 45 injection, Generic dihydroergotamine mesylate injection, Ergomar sublingual tablet, or Migergot suppository

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Cluster Headaches

• Diagnosis of cluster headache
AND
• Patient is 18 years of age or older [A]
AND
• Trial and failure, contraindication, or intolerance to sumatriptan injection [5]

Brand Cafergot tablet, Generic ergotamine tartrate/caffeine tablet, Brand D.H.E. 45 injection, Generic dihydroergotamine mesylate injection, Ergomar sublingual tablet, or Migergot suppository

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Cluster Headaches

• Patient has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity

P & T Revisions

2024-06-05, 2024-04-03, 2023-04-05, 2022-04-06, 2021-11-16, 2021-06-02, 2021-03-31, 2020-12-02, 2020-04-01

References

1. D.H.E. 45 Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. April 2022.
2. Migranal Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. September 2022.
3. AHS Consensus Statement. Update on integrating new migraine treatments into clinical practice. Headache. 2021 Jul;61(7):1021-1039.
4. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 May 10;86(19):1818-26.
5. Robbins MS, Starling AJ, Pringsheim TM, et al. Treatment of Cluster Headache: The American Headache Society Evidence-Based Guidelines. Headache. 2016 Jul;56(7):1093-106.
6. Cafergot Prescribing Information. Sandoz Inc. Princeton, NJ. May 2018
7. Ergomar Prescribing Information. TerSera Therapeutics LLC. Deerfield, IL. February 2020.
8. Migergot Prescribing Information. Cosette Pharmaceuticals, Inc.. South Plainfield, NJ. June 2020.
9. Trudhesa Prescribing Information. Impel Pharmaceuticals Inc. Seattle, WA. August 2023.

---

Revision History

• 2024-06-05: Removed prescriber requirement and updated background.
• 2024-04-03: Annual review: Updated criteria and background.
• 2023-04-05: Annual review: Updated migraine criteria and background.
• 2022-04-06: Annual review: Background updates.
• 2021-11-16: Added Trudhesa to the guideline and updated initial authorization criteria for migraine.
• 2021-06-02: Added Erogmar, Migergot, and Brand/Generic Cafergot to guideline and updated guideline name.
• 2021-03-31: Annual review: Background updates.
• 2020-12-02: Updated prescriber specialist criteria
• 2020-04-01: New program.

---