Rimegepant (Nurtec ODT) Form

Rimegepant (Nurtec® [orally disintegrating tablet] ODT) is a calcitonin gene-related peptide receptor (CGRP) antagonist. FDA Approved Indication(s) Nurtec ODT is indicated for the:
• Acute treatment of migraine with or without aura in adults • Preventive treatment of episodic migraine in adults. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Nurtec ODT is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acute Migraine Treatment (must meet all):

1. Diagnosis of migraine headache;
   2. Age ≥ 18 years;
   3. Failure of at least TWO formulary generic 5HT1B/1D-agonist migraine medications (e.g., sumatriptan, rizatriptan, zolmitriptan) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated; Prior authorization may be required.
2. Failure of Ubrelvy™ (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required.
3. For dose increase requests to quantities > 1 box of 8 ODTs per month, member must meet criteria in Section I, B below for migraine prophylaxis;
4. Nurtec ODT is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig®, Ajovy®, Emgality®, Qulipta™, Ubrelvy®, Vyepti™);

5. Dose does not exceed 75 mg (1 ODT) per day (one blister pack per month). Approval duration: 6 months B. Migraine Prophylaxis (must meet all):

   1. Diagnosis of episodic migraine;
   2. Member experiences ≥ 4 migraine days per month for at least 3 months; Page 1 of 10

   CLINICAL POLICY Rimegepant

6. Member does not have chronic migraine, defined as ≥ 15 headache days/month with ≥ 8 migraine days/month for at least 3 months;
7. Prescribed by or in consultation with a neurologist, headache, or pain specialist;
   
   5. Age ≥ 18 years;
   6. Failure of at least 2 of the following oral migraine preventative therapies, each for 8 weeks and from different therapeutic classes, unless clinically significant adverse effects are experienced or all are contraindicated: antiepileptic drugs (e.g., divalproex sodium, sodium valproate, topiramate), beta-blockers (e.g., metoprolol, propranolol, timolol), antidepressants (e.g., amitriptyline, venlafaxine);
8. Failure of at least 1 injectable CGRP therapy (e.g., Aimovig, Ajovy, Emgality, Vyepti), unless clinically significant adverse effects are experienced or all are contraindicated; Prior authorization may be required.
9. Failure of Qulipta (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required.
10. If currently receiving treatment with Botox® for migraine prophylaxis and request is for concurrent use of Botox and Nurtec ODT (i.e., not switching from one agent to another), all of the following (a, b, and c): a. Sufficient evidence is provided from at least two high-quality, published studies in reputable peer-reviewed journals or evidence-based clinical practice guidelines that provide all of the following (i – iv): Case studies or chart reviews are not considered high-quality evidence i. Adequate representation of the member’s clinical characteristics, age, and diagnosis;
    ii. Adequate representation of the prescribed drug regimen;
    iii. Clinically meaningful outcomes such as a reduction in monthly migraine or headache days; iv. Appropriate experimental design and method to address research questions (see Appendix E for additional information); b. Member has experienced and maintained positive response to Botox monotherapy as evidenced by a ≥ 30% reduction in migraine days per month from baseline following at least 2 quarterly injection (6 months) of Botox monotherapy; c. Despite Botox monotherapy, member continues to experience ≥ 4 migraine days per month and/or severe migraine headaches that result in disability and functional impairment;
11. Nurtec ODT is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality, Qulipta, Ubrelvy, Vyepti);
12. Dose does not exceed 75 mg (1 ODT) every other day (two blister packs per month). Approval duration: 3 months
    C. Other diagnoses/indications (must meet 1 or 2):

13. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: Page 2 of 10

    CLINICAL POLICY Rimegepant CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

14. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    II. Continued Therapy A. Acute Migraine Treatment (must meet all):
15. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
    2. Member is responding positively to therapy;
    3. For dose increase requests to quantities > 1 box of 8 ODTs per month, member must meet criteria in Section I, B above for migraine prophylaxis;
16. Nurtec ODT is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality, Qulipta, Ubrelvy, Vyepti);This requirement does not apply to CA if member was previously approved via Centene benefit and is currently stable on therapy with both oral and injectable CGRP inhibitors
17. If request is for a dose increase, new dose does not exceed 75 mg (1 ODT) per day (one blister pack per month) Approval duration: 12 months B. Migraine Prophylaxis (must meet all):
18. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
19. Member has experienced and maintained positive response to therapy as evidenced by a reduction in migraine days per month from baseline;
20. Nurtec ODT is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality, Qulipta, Ubrelvy, Vyepti);This requirement does not apply to CA if member was previously approved via Centene benefit and is currently stable on therapy with both oral and injectable CGRP inhibitors

21. If request is for a dose increase, new dose does not exceed 75 mg (1 ODT) every other day (two blister packs per month). Approval duration: 6 months Page 3 of 10

    CLINICAL POLICY Rimegepant C. Other diagnoses/indications (must meet 1 or 2):

22. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

23. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key 5-HT: serotonin AAN: American Academy of Neurology
    AHS: American Headache Society CGRP: calcitonin gene-related peptide
    FDA: Food and Drug Administration ODT: orally disintegrating tablet Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name
    Dosing Regimen Abortive Migraine Therapy Dose Limit/Maximum Dose Triptans naratriptan (Amerge®) One tablet (1 or 2.5 mg) PO at almotriptan (Axert®) frovatriptan (Frova®) onset; can be repeated in 4 hours 6.25 to 12.5 mg PO QD May repeat dose in 2 hours 2.5 mg PO QD May repeat dose in 2 hours 5 mg/day 25 mg/day 7.5 mg/day Page 4 of 10

    CLINICAL POLICY Rimegepant Drug Name
    Dosing Regimen Abortive Migraine Therapy sumatriptan (Imitrex® nasal spray)
    One spray (5 to 20 mg) at onset into one nostril; can be repeated in 2 hours sumatriptan (Imitrex®) One tablet (25 to 100 mg) PO at rizatriptan (Maxalt® /Maxalt MLT®) eletriptan (Relpax®) onset; can be repeated in two hours One tablet (5 or 10 mg) PO at onset of migraine headache; can be repeated in two hours 20 or 40 mg PO QD May repeat dose in 2 hours 1.25 or 2.5 mg PO QD May repeat dose in 2 hours zolmitriptan (Zomig®/Zomig® ZMT) Ubrelvy™ (ubrogepant) 50 or 100 mg PO, as needed. If needed, a second dose may be administered at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. Drug Name Dosing Regimen Prophylactic Migraine Therapy Migraine Prophylaxis Refer to prescribing information or Micromedex Dose Limit/Maximum Dose 40 mg/day 200 mg/day 30 mg/day 40 mg/dose 80 mg/day 5 mg/dose 10 mg/day 200 mg/day Dose Limit/Maximum Dose Refer to prescribing information or Micromedex Anticonvulsants such as: divalproex (Depakote®), topiramate (Topamax®), valproate sodium Beta-blockers such as: propranolol (Inderal®), metoprolol (Lopressor®), timolol, atenolol (Tenormin®), nadolol (Corgard®)
    Antidepressants/tricycli c antidepressants such as: amitriptyline (Elavil®), venlafaxine (Effexor®) Migraine Prophylaxis Refer to prescribing information or Micromedex Refer to prescribing information or Micromedex Migraine Prophylaxis Refer to prescribing information or Micromedex Refer to prescribing information or Micromedex Page 5 of 10

    CLINICAL POLICY Rimegepant Drug Name Dosing Regimen Prophylactic Migraine Therapy Qulipta™ (atogepant ) 10 mg, 30 mg, or 60 mg PO QD Dose Limit/Maximum Dose 60 mg/day Aimovig™ (erenumab- aooe) 70 mg SC once monthly 140 mg/month Ajovy® (fremanezumab-vfrm) Some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly 225 mg SC once monthly or 675 mg SC every three months 675 mg every 3 months Emgality® (galcanezumab-gnlm) Loading dose: 240 mg SC once Maintenance dose: 120 mg SC once monthly 120 mg/month Vyepti™ (eptinezumab- jjmr) The recommended dosage is 100 mg IV every 3 months.
    300 mg every 3 months Some patients may benefit from a dosage of 300 mg IV every 3 months. Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): history of hypersensitivity reaction to rimegepant, Nurtec ODT, or to any of its components.
    • Boxed warning(s): none reported Appendix D: General Information
    The American Headache Society (2018) provides the following migraine guidance:
    • Migraine patients who need to use acute treatments on a regular basis should be instructed to limit treatment to an average of 2 headache days per week, and patients observed to be exceeding this limit should be offered preventive treatment. Indications for preventive treatment: o Attacks significantly interfere with patients’ daily routines despite acute treatment o Frequent attacks (≥ 4 migraine headache days [per month]) o Contraindication to, failure, or overuse of acute treatments, with overuse defined as: Page 6 of 10

    CLINICAL POLICY Rimegepant  10 or more days per month for ergot derivatives, triptans, opioids, combination analgesics, and a combination of drugs from different classes that are not individually overused  15 or more days per month for non-opioid analgesics, acetaminophen, and nonsteroidal antiinflammatory drugs (NSAIDs [including aspirin])  Adverse effects with acute treatments  Patient preference o Prevention should also be considered in the management of certain uncommon migraine subtypes, including hemiplegic migraine, migraine with brainstem aura, migraine with prolonged aura, and those who have previously experienced a migrainous infarction, even if there is low attack frequency. Appendix E: Appropriate Experimental Design Methods • Randomized, prospective controlled trials are generally considered the gold standard; however:
    o In some clinical studies, it may be unnecessary or not feasible to use randomization, double-blind trials, placebos, or crossover. o Non-randomized prospective clinical trials with a significant number of subjects may be a basis for supportive clinical evidence for determining accepted uses of drugs. • Case reports and chart reviews are generally considered uncontrolled and anecdotal information and do not provide adequate supportive clinical evidence for determining accepted uses of drugs.
    V. Dosage and Administration
    Indication Dosing Regimen Migraine - acute treatment Migraine prophylaxis 75 mg PO every other day 75 mg PO as needed. The maximum dose 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.
    Maximum Dose 75 mg/day 75 mg/dose VI. Product Availability
    ODT (blister pack of 8): 75 mg VII.