Atogepant (Qulipta) Form

Atogepant (Qulipta™) is a calcitonin gene-related peptide receptor (CGRP) antagonist. FDA Approved Indication(s) Qulipta is indicated for the preventative 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 Qulipta is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Migraine Prophylaxis (must meet all):

1. Diagnosis of episodic migraine;
2. Member experiences > 4 migraine days per month for at least 3 months;
3. Member does not have chronic migraine, defined as > 15 headaches days/month with ≥ 8 migraine days/month for at least 3 months;
   4. Prescribed by or in consultation with a neurologist, headache, or pain specialist;
4. Age ≥ 18 years;

5. 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);

   7. 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;
   8. If currently receiving treatment with Botox® for migraine prophylaxis and request is for concurrent use of Botox and Qulipta (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 Page 1 of 7

   CLINICAL POLICY Atogepant
   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 D 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;

   9. Qulipta is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality, Nurtec ODT, Ubrelvy, Vyepti);
   10. Dose does not exceed 60 mg (1 tablet) per day. Approval duration: 3 months B. Other diagnoses/indications (must meet 1 or 2):
   11. 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
   12. 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. Migraine Prophylaxis (must meet all):
   13. 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);
   14. Member has experienced and maintained positive response to therapy as evidenced by a reduction in migraine days per months from baseline; Page 2 of 7

   CLINICAL POLICY Atogepant

   3. Qulipta is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality, Nurtec ODT, Ubrelvy, Vyepti);
   4. If request is for a dose increase, new dose does not exceed 60 mg (1 tablet) per day. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):
   5. 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
   6. 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 AAN: American Academy of Neurology AHS: American Headache Society CGRP: Calcitonin gene-related peptide
      FDA: Food and Drug Administration MHD: Monthly Headache Day
      MMD: Monthly Migraine Days
      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 Dose Limit/ Maximum Dose Refer to prescribing information or Micromedex Anticonvulsants such as: divalproex (Depakote®), topiramate (Topamax®), valproate sodium Migraine Prophylaxis Refer to prescribing information or Micromedex Page 3 of 7

   CLINICAL POLICY Atogepant
   Drug Name Dosing Regimen Beta-blockers such as: propranolol (Inderal®), metoprolol (Lopressor®), timolol, atenolol (Tenormin®), nadolol (Corgard®)
   Antidepressants/tricyclic antidepressants such as: amitriptyline (Elavil®), venlafaxine (Effexor®) Aimovig™ (erenumab- aooe) Ajovy® (fremanezumab- vfrm) Emgality® (galcanezumab-gnlm) Vyepti™ (eptinezumab- jjmr) Migraine Prophylaxis Refer to prescribing information or Micromedex Dose Limit/ Maximum Dose Refer to prescribing information or Micromedex Migraine Prophylaxis Refer to prescribing information or Micromedex Refer to prescribing information or Micromedex 70 mg SC once monthly 140 mg/month 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 Loading dose: 240 mg SC once Maintenance dose: 120 mg SC once monthly The recommended dosage is 100 mg IV every 3 months.
   Some patients may benefit from a dosage of 300 mg IV every 3 months. 675 mg every 3 months 120 mg/month 300 mg 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): None reported
   • Boxed warning(s): None reported Appendix D: 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.
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   CLINICAL POLICY Atogepant
   V. Dosage and Administration
   Indication Migraine prophylaxis
   VI. Product Availability
   Tablet: 10 mg, 30 mg, 60 mg
   Dosing Regimen 10 mg, 30 mg, or 60 mg PO QD Maximum Dose 60 mg/day VII.