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Drug Category: Pain and Inflammation

Medication Class/Individual Agents: Butalbital Agents, Ergot Alkaloids, and Triptans

I. Prior-Authorization Requirements

 Headache Therapy – Butalbital-Containing Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

butalbital / aspirin / caffeine / codeine Fiorinal / Codeine PA  
butalbital / aspirin / caffeine capsule Fiorinal PA  
butalbital / aspirin / caffeine tablet PA   - < 18 years and PA > 20 units/month
butalbital 25 mg / acetaminophen 325 mg tablet PA  
butalbital 50 mg / acetaminophen 300 mg PA  
butalbital 50 mg / acetaminophen 300 mg / caffeine 40 mg PA  
butalbital 50 mg / acetaminophen 300 mg / caffeine 40 mg / codeine 30 mg PA  
butalbital 50 mg / acetaminophen 325 mg PA  
butalbital 50 mg / acetaminophen 325 mg / caffeine 40 mg / codeine 30 mg PA   - < 18 years and PA > 20 units/month
butalbital 50 mg / acetaminophen 325 mg / caffeine 40 mg capsule, tablet PA   - < 18 years and PA > 20 units/month
butalbital 50 mg / acetaminophen 325 mg / caffeine 40 mg solution PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

Contraindications to Triptans:

  • history, presence, symptoms, or signs of ischemic heart disease (e.g., angina, MI, stroke, TIA), coronary artery vasospasm, or other significant underlying cardiovascular disease
  • uncontrolled hypertension
  • concurrent use or use within 24 hours of ergotamine-containing products or ergot-type medications (e.g., dihydroergotamine, methysergide)
  • concurrent use with MAO inhibitor therapy or within two weeks of MAO inhibitor discontinuation
  • use within 24 hours of treatment with another triptan
  • management of hemiplegic or basilar migraine
  • hypersensitivity to the product or any of its ingredients

Do not exceed the maximum recommended dose per 24-hour period.

Orally Disintegrating Tablets:

  • Place tablet on tongue, where it will be dissolved and swallowed with saliva.
  • Inform phenylketonurics that tablets contain phenylalanine.

Migraine prophylaxis (e.g., amitriptyline, propranolol, timolol) may be considered for the following conditions:

  • migraine occurs ≥ twice monthly and produces disability lasting ≥ three days per month
  • contraindication to, or failure of, acute treatments
  • abortive medications are used > twice per week
  • other severe migraine conditions
 

 Headache Therapy – Calcitonin Gene-Related Peptide (CGRP) Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

erenumab-aooe Aimovig PA  
fremanezumab-vfrm Ajovy PA  
galcanezumab-gnlm Emgality PA  

 Headache Therapy – Ergot Alkaloids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

dihydroergotamine injection D.H.E. 45 PA  
dihydroergotamine nasal spray Migranal PA  
ergotamine PA  
ergotamine / caffeine suppository PA  
ergotamine / caffeine tablet PA  

 Headache Therapy – Triptans

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

almotriptan Axert PA  
eletriptan Relpax PA  
frovatriptan Frova PA  
naratriptan Amerge PA  
rizatriptan orally disintegrating tablet Maxalt MLT # PA   - > 18 units/month
rizatriptan tablet Maxalt # PA   - > 18 units/month
sumatriptan / naproxen Treximet BP PA  
sumatriptan injection-Imitrex Imitrex PA  
sumatriptan injection-Sumavel Sumavel PA  
sumatriptan injection-Zembrace Zembrace PA  
sumatriptan nasal powder Onzetra PA  
sumatriptan nasal spray Imitrex PA  
sumatriptan tablet Imitrex # PA   - > 18 units/month
zolmitriptan nasal spray Zomig PA  
zolmitriptan orally disintegrating tablet Zomig ZMT PA  
zolmitriptan tablet Zomig PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 

II. Therapeutic Uses

FDA-approved, for example:

  • acute treatment of migraine (all triptans, dihydroergotamine injection, dihydroergotamine nasal spray, ergotamine, ergotamine/caffeine tablet, ergotamine/caffeine suppository)
  • acute treatment of cluster headache episodes (dihydroergotamine injection, sumatriptan injection, Sumavel)
  • chronic tension-type headache (butalbital agents)
  • migraine prophylaxis (Aimovig, Ajovy, Emgality)
  • therapy to abort or prevent vascular headache (ergotamine, ergotamine/caffeine tablet, ergotamine/caffeine suppository)

Triptans are NOT intended for prophylactic therapy of migraines

Note: The above list may not include all FDA-approved indications.

Non-FDA-approved, for example:

  • migraine headache (butalbital agents)

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • Additional criteria may apply, depending upon the member's condition and requested medication (see below).

  

Aimovig

  • Documentation of all of the following is required:
    • an appropriate indication; and
    • member is ≥ 18 years of age; and
    • dose is appropriate for stated indication; and
    • prescriber is a neurologist or a neurology consult is provided; and
    • migraine frequency ≥ four days per month; and
    • inadequate response or adverse reaction to one of the following or contraindication to all of the following: atenolol, metoprolol, nadolol, propranolol, timolol; and
    • one of the following:
      • inadequate response or adverse reaction to two of the following: amitriptyline, Botox, topiramate, valproic acid, venlafaxine; or
      • contraindication to all of the oral prophylactic alternatives above.

   

Ajovy, Emgality

  • Documentation of all of the following is required:
    • an appropriate indication; and
    • member is ≥ 18 years of age; and
    • dose is appropriate for stated indication; and
    • prescriber is a neurologist or a neurology consult is provided; and
    • migraine frequency ≥ four days per month; and
    • inadequate response or adverse reaction to one of the following or contraindication to all of the following: atenolol, metoprolol, nadolol, propranolol, timolol; and
    • one of the following:
      • inadequate response or adverse reaction to two of the following: amitriptyline, Botox, topiramate, valproic acid, venlafaxine; or
      • contraindication to all of the oral prophylactic alternatives above; and
    • inadequate response, adverse reaction, or contraindication to Aimovig.

     

almotriptan (≤ 18 units/month), eletriptan (≤ 18 units/month), frovatriptan (≤ 18 units/month), naratriptan (≤ 18 units/month), or zolmitriptan tablets (≤ 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • one of the following:
      • if the request is for almotriptan, member's age ≥ 12 years; or
      • if the request is for any other agent, member's age ≥ 18 years; and
    • an inadequate response or adverse reaction to sumatriptan tablets; and
    • an inadequate response or adverse reaction to rizatriptan ODT or tablets.

SmartPA: Claims for ≤ 18 units/month of almotriptan tablets will usually process at the pharmacy if there is a history of paid claims for sumatriptan tablets and rizatriptan ODT or tablets and member is ≥ 12 years of age.

SmartPA: Claims for ≤ 18 units/month of eletriptan, frovatriptan, naratriptan, or zolmitripan tablets will usually process at the pharmacy if there is a history of paid claims for sumatriptan tablets and rizatriptan ODT or tablets and member is ≥ 18 years of age.

 

almotriptan (> 18 units/month), eletriptan (> 18 units/month), frovatriptan (> 18 units/month), naratriptan (> 18 units/month), or zolmitriptan tablets (> 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • an inadequate response or adverse reaction to sumatriptan tablets; and
    • an inadequate response or adverse reaction to rizatriptan ODT or tablets.
  • Requests will be evaluated on a case-by-case basis taking into account the member's headache frequency, documentation of neurologist consultation, and prophylactic regimen.

  

Brand name Imitrex and Maxalt MLT and tablets (≤ 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • medical records documenting an inadequate response or adverse reaction to the generic equivalent of the requested agent; and
    • inadequate response or adverse reaction to the other generic triptan (sumatriptan or rizatriptan).

 

Brand name Imitrex and Maxalt MLT and tablets (> 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • medical records documenting an inadequate response or adverse reaction to the generic equivalent of the requested agent; and
    • inadequate response or adverse reaction to the other generic triptan (sumatriptan or rizatriptan).
  • Requests will be evaluated on a case-by-case basis taking into account the member’s headache frequency, documentation of neurologist consultation, and prophylactic regimen.

  

butalbital/acetaminophen/caffeine solution (≤ 300 mL/month)

Please refer to additional criteria if request is for members < 18 years of age and/or for quantities exceeding 300 mL/month.

  • Documentation of the following is required:
    • an appropriate indication; and
    • medical condition in which member is not able to swallow solid oral dosage formulations; or
    • clinical rationale why conventional dosage forms cannot be used.

 

butalbital/aspirin/caffeine capsule (≤ 20 units/month)

Please refer to additional criteria if request is for members < 18 years of age and/or for quantities exceeding 20 units/month.

  • Documentation of the following is required:
    • an appropriate indication; and
    • an inadequate response, adverse reaction, or contraindication to butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg tablets.

  

butalbital-containing agents (formulations that require PA for all quantities, excluding solution formulations and butalbital/aspirin/caffeine capsule) (≤ 20 units/month)  

Please refer to additional criteria if request is for members < 18 years of age and/or for quantities exceeding 20 units/month.

  • Documentation of the following is required:
    • an appropriate indication; and
    • clinical rationale for the requested formulation over formulations covered within quantity limits.

 

butalbital-containing agents exceeding quantity limits (> 20 units/month or > 300 mL/month)

For all requests, individual drug PA criteria must be met first where applicable.

  • Documentation of the following is required for a diagnosis of tension headache:
    • an appropriate indication; and
    • headache frequency; and
    • current prophylactic regimen; and
    • prescriber is a neurologist or neurology consult notes are provided; and
    • an inadequate response or adverse reaction to at least three of the following, or contraindication to all of the following: NSAIDs, acetaminophen, aspirin, acetaminophen/caffeine, and acetaminophen/aspirin/caffeine.

 

  • Documentation of the following is required for a diagnosis of migraine headache:
    • an appropriate indication; and
    • headache frequency; and
    • current prophylactic regimen; and
    • prescriber is a neurologist or neurology consult notes are provided; and
    • an inadequate response or adverse reaction to two triptans or contraindication to all triptans; and
    • an inadequate response or adverse reaction to two of the following, or contraindication to all of the following: NSAIDs, acetaminophen, aspirin, acetaminophen/caffeine, acetaminophen/aspirin/caffeine, and ergot alkaloid.

 

butalbital-containing agents for members < 18 years old 

For all requests, individual drug PA criteria must be met first where applicable.

  • Documentation of the following is required for a diagnosis of tension headache:
    • an appropriate indication; and
    • headache frequency; and
    • current prophylactic regimen if member experiences more than four headaches per month or headaches that last longer than 12 hours; and
    • prescriber is a neurologist or neurology consult notes are provided that support the use of a butalbital-containing agent; and
    • an inadequate response, adverse reaction, or contraindication to all of the following:
      • NSAIDs; and
      • acetaminophen; and
      • aspirin; and
      • acetaminophen/caffeine; and
      • acetaminophen/aspirin/caffeine.

 

  • Documentation of the following is required for a diagnosis of migraine headache:
    • an appropriate indication; and
    • headache frequency; and
    • current prophylactic regimen if member experiences more than four headaches per month or headaches that last longer than 12 hours; and
    • prescriber is a neurologist or neurology consult notes are provided that support the use of a butalbital-containing agent; and
    • an inadequate response or adverse reaction to two triptans or contraindication to all triptans; and
    • an inadequate response, adverse reaction, or contraindication to all of the following:
      • NSAIDs; and
      • acetaminophen; and
      • aspirin; and
      • acetaminophen/caffeine; and
      • acetaminophen/aspirin/caffeine.

 

codeine-containing products for members < 12 years old

For all requests, individual drug PA criteria and/or butalbital-containing agents age restriction criteria must be met first where applicable.

  • Documentation of one of the following is required:
    • CYP2D6 genotyping confirms member is not an ultra-rapid CYP2D6 metabolizer; or 
    • member has previously utilized a codeine-containing product without adverse effect that prevents repeat use. 

 

dihydroergotamine injection

  • Documentation of the following is required:
    • an appropriate indication; and
    • clinical rationale for dosage form; and
    • an inadequate response, adverse reaction, or contraindication to sumatriptan injection.

 

dihydroergotamine nasal spray (≤ 8 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • an inadequate response, adverse reaction, or contraindication to intranasal sumatriptan; and
    • an inadequate response, adverse reaction, or contraindication to intranasal Zomig (zolmitriptan).

 

dihydroergotamine nasal spray (> 8 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • an inadequate response, adverse reaction, or contraindication to intranasal sumatriptan; and
    • an inadequate response, adverse reaction, or contraindication to intranasal Zomig (zolmitriptan); and
    • headache frequency; and
    • neurology consultation should be provided if headache frequency is > 15/month; and
    • member is currently on a prophylactic regimen (β Blocker, TCA, CCB, valproic acid, topiramate).

 

ergotamine and ergotamine/caffeine tablet

  • Documentation of the following is required:
    • an appropriate indication; and
    • an inadequate response, adverse reaction, or contraindication to sumatriptan tablets; and
    • an inadequate response, adverse reaction, or contraindication to rizatriptan ODT or tablets; and
    • requested quantity is within quantity limits (for ergotamine ≤ 20 tablets/month, for ergotamine/caffeine tablet ≤ 40 tablets/month).

 

ergotamine/caffeine suppository

  • Documentation of the following is required:
    • an appropriate indication; and
    • clinical rationale for dosage form; and
    • an inadequate response, adverse reaction, or contraindication to sumatriptan nasal spray; and
    • requested quantity is ≤ 18 suppositories/month.

 

Onzetra (≤ 32 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • clinical rationale for dosage form; and
    • an inadequate response or adverse reaction to sumatriptan nasal spray.

 

Onzetra (> 32 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • clinical rationale for dosage form; and
    • an inadequate response or adverse reaction to sumatriptan nasal spray.
  • Requests will be evaluated on a case-by-case basis taking into account the member’s headache frequency, documentation of neurologist consultation, and prophylactic regimen.

 

rizatriptan ODT and tablets, and sumatriptan tablets (> 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • requests will be evaluated on a case-by-case basis taking into account the member’s headache frequency, documentation of neurologist consultation, and prophylactic regimen.

     

sumatriptan nasal spray (≤ 18 units/month), sumatriptan injection (≤ 18 injections/month), Sumavel ( 18 injections/month), and Zomig nasal spray (≤ 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • clinical rationale for requested dosage form.

 

sumatriptan nasal spray (> 18 units/month), sumatriptan injection (> 18 injections/month), Sumavel (> 18 injections/month), and Zomig nasal spray (> 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • clinical rationale for requested dosage form.
  • Requests will be evaluated on a case-by-case basis taking into account the member’s headache frequency, documentation of neurologist consultation, and prophylactic regimen.

  

sumatriptan/naproxen (≤ 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • an inadequate response or adverse reaction to sumatriptan tablets; and
    • an inadequate response or adverse reaction to rizatriptan ODT or tablets; and
    • compelling clinical rationale (medical necessity) explaining why the combination product would offer a therapeutic advantage over the commercially available separate agents.

 

sumatriptan/naproxen (> 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • an inadequate response or adverse reaction to sumatriptan tablets; and
    • an inadequate response or adverse reaction to rizatriptan ODT or tablets; and
    • compelling clinical rationale (medical necessity) explaining why the combination product would offer a therapeutic advantage over the commercially available separate agents.
  • Requests will be evaluated on a case-by-case basis taking into account the member’s headache frequency, documentation of neurologist consultation, and prophylactic regimen.

  

Zembrace (≤ 36 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • clinical rationale for dosage form; and
    • an inadequate response or adverse reaction to generic sumatriptan injection; or
    • clinical rationale for necessity of lower sumatriptan dose.

 

Zembrace (> 36 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • clinical rationale for dosage form; and
    • an inadequate response or adverse reaction to generic sumatriptan injection; or
    • clinical rationale for necessity of lower sumatriptan dose.
  • Requests will be evaluated on a case-by-case basis taking into account the member’s headache frequency, documentation of neurologist consultation, and prophylactic regimen.

 

zolmitriptan orally disintegrating tablet (≤ 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • an inadequate response or adverse reaction to sumatriptan tablets and rizatriptan ODT or tablets; or
    • clinical rationale for dosage form and inadequate response or adverse reaction to rizatriptan ODT.

 

zolmitriptan orally disintegrating tablet (> 18 units/month)

  • Documentation of the following is required:
    • an appropriate indication; and
    • an inadequate response or adverse reaction to sumatriptan tablets and rizatriptan ODT or tablets; or
    • clinical rationale for dosage form and inadequate response or adverse reaction to rizatriptan ODT.
  • Requests will be evaluated on a case-by-case basis taking into account the member’s headache frequency, documentation of neurologist consultation, and prophylactic regimen.

 

 Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 03/2002

Last Revised Date: 03/2019


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Last updated 07/15/19