NURTEC ODT (rimegepant)

NURTEC ODT (rimegepant)

Self-Administration – Oral

Indication for Prior Authorization:

• Acute Treatment of Migraine-Indicated for the acute treatment of migraine with or without aura in adults. 
• Preventive Treatment of Episodic Migraine-Indicated for the preventive treatment of episodic migraine in adults.

Coverage Criteria: 

Acute Treatment of Migraine

• Dose does not exceed 75 mg per day (limit of 8 tablets per month); AND
• Patient is 18 years of age or older; AND 
• Documented trial and failure or intolerance to TWO triptan medications, or a contraindication to all triptan drugs (i.e., sumatriptan, rizatriptan, almotriptan, eletriptan, frovatriptan, naratriptan, zolmitriptan); AND
• Average number of migraine headaches experienced per month is confirmed by medical records; AND 
  • If patient experiences 4 or more migraine headaches days per month: Patient has experienced an inadequate response (minimum two-month trial) to at least TWO prophylactic medications used for migraine headaches, each from a different pharmacologic class supported by the American Academy of Neurology, American Headache Society (AAN/AHS), or a contraindication to all medications listed for migraine headache prophylaxis, OR is currently being treated with one of the following: 
    • Antiepileptic drugs (i.e., divalproex sodium, sodium valproate, topiramate, carbamazepine)
    • Beta-blockers (i.e., metoprolol, propranolol, timolol, atenolol, nadolol, nebivolol, pindolol)  
    • Antidepressants (i.e., amitriptyline, venlafaxine) 
    • Blood pressure drugs (i.e., lisinopril, candesartan)
    • Alpha-agonists (i.e., clonidine, guanfacine) 
    • Antihistamines (i.e., cyproheptadine); AND 
• Will not be used in combination with another oral CGRP inhibitor or 5-HT-1F agent
   

Preventive Treatment of Episodic Migraine

• Dose does not exceed 75 mg given once every other day (limit of 16 tablets per month); AND
• Patient is 18 years of age or older; AND
• Patient has an average of 4 to 18 migraine headaches per month as confirmed by medical records; AND
• Documented inadequate response (minimum two-month trial) to at least TWO prophylactic medications used for migraine headaches, each from a different pharmacologic class supported by the American Academy of Neurology, American Headache Society (AAN/AHS), or a contraindication to all medications listed for migraine headache prophylaxis:
  • Antiepileptic drugs (i.e., divalproex sodium, sodium valproate, topiramate, carbamazepine
  • Beta-blockers (i.e., metoprolol, propranolol, timolol, atenolol, nadolol, nebivolol, pindolol).
  • Antidepressants (i.e., amitriptyline, venlafaxine)
  • Blood pressure drugs (i.e., lisinopril, candesartan);
  • Alpha-agonists (i.e., clonidine, guanfacine)
  • Antihistamines (i.e., cyproheptadine); AND
• Will not be used in combination with an injectable CGRP inhibitor

Reauthorization Criteria: 

Acute Treatment of Migraine

• Dose does not exceed 75 mg per day (limit of 8 tablets per month); AND 
• Documentation of positive clinical response to therapy; AND 
• Not being used in combination with another oral CGRP inhibitor or 5-HT-1F agent. 

Preventive Treatment of Episodic Migraine

• Dose does not exceed 75 mg given once every other day (limit of 16 tablets per month); AND
• Documentation of positive clinical response to therapy (e.g., decrease in number of migraine headaches experienced per month compared to baseline); AND
• Not being used in combination with an injectable CGRP inhibitor.

Coverage Duration:  

• Initial: 3 months 
• Reauthorization: 1 year 

Authorization is not covered for the following: 

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee. 

Additional Information:  

• The maximum dose of Nurtec™ ODT in a 24-hour period is 75 mg. The safety of using more than 18 doses in a 30-day period has not been established. 
• Avoid use in patients with severe hepatic impairment or end-stage renal disease (CLcr <15 mL/min). 
• Avoid use with strong CYP3A4 inhibitors.  Avoid another dose of Nurtec™ ODT within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4. 
• Avoid use with strong or moderate inducers of CYP3A. 
• Avoid use with P-gp or BCRP inhibitors. 

Policy Updates: 

• 05/19/2020 – New policy approved by P&T for abortive treatment of migraine. 
• 10/19/2021–
  • Abortive migraine treatment updates: Prophylactic pharmacologic therapy trial and failure criteria updated; Combination CGRP inhibitor criteria updated; reauthorization criteria created; overage duration updated to initial 3 months
  • Preventive treatment of episodic migraine criteria created; quantity limits updated to include 16 per month for preventive treatment of migraine

References: 

• American Headache Society Consensus Statement. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59:1-18.
• Aimovig Prescribing Information. Amgen Inc. Thousand Oaks, CA. May 2021.
• Ajovy Prescribing Information. Teva Pharmaceuticals USA, Inc. North Wales, PA. May 2021.
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• ClinicalTrials.gov. A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies (LIBERTY). NCT03096834. Website. https://clinicaltrials.gov/ct2/show/NCT03096834?term=NCT03096834&rank=1. Accessed June 14, 2021.
• ClinicalTrials.gov. Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine. NCT02629861. Website. https://clinicaltrials.gov/ct2/show/NCT02629861?term=NCT02629861&rank=1. Accessed June 14, 2021.
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• Nurtec ODT Prescribing Information. Biohaven Pharmaceuticals, Inc. New Haven, CT. May 2021.
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