ATOGEPANT TAB

Clinical Criteria Summary

Severe hepatic impairment (Child-Pugh C)
Uncontrolled hypertension
History of Raynaud’s phenomenon with ischemia (e.g., digital ulcers, tissue necrosis, or other critical ischemia)
Concurrent preventive therapy with another calcitonin gene related peptide (CGRP) targeting agent (including other gepants and CGRP targeting monoclonal antibodies)
Pregnancy

Completed comprehensive headache appointment prior to initiation
Episodic migraine defined as 4 to 14 monthly migraine days
Moderate to severe migraine intensity
Contraindication, intolerance, or lack of therapeutic response after at least 12 weeks each of a therapeutic dose of at least 3 of the following: beta blocker, topiramate, divalproex, SNRI or TCA, and ACE inhibitor or ARB
Contraindication, intolerance, or lack of therapeutic response after at least 12 weeks of a therapeutic dose of at least one CGRP-targeted monoclonal antibody (e.g., erenumab)

Discontinue therapy if signs or symptoms of Raynaud’s phenomenon develop
Monitor patients with a history of Raynaud’s phenomenon for recurrence/worsening and inform them of this possibility
Comprehensive headache assessment must include evaluation for medication overuse headache, other secondary headache types, adherence to prior therapies, urgent/emergent features, triggers, effective acute treatment, and nonpharmacologic interventions (board certification in headache medicine is not required)
Scheduled blood pressure check 2–4 weeks after therapy initiation
Therapeutic dose definitions for oral preventive agents: beta blocker (e.g., metoprolol 50-100 mg BID, propranolol 20-80 mg BID), topiramate 50-200 mg BID, divalproex 500-1000 mg daily, ACE inhibitor or ARB (e.g., lisinopril 20 mg daily, enalapril 10 mg daily, telmisartan 80 mg daily), SNRI or TCA (e.g., venlafaxine SA 75-150 mg daily, amitriptyline 25-100 mg daily)
Divalproex is not recommended in patients who can become pregnant
Erenumab is the designated national contract agent; if failure or intolerance occurs, an alternate non-formulary CGRP-targeted monoclonal antibody (e.g., fremanezumab, galcanezumab, eptinezumab) should be tried

Severe hepatic impairment (Child-Pugh C)
Creatinine clearance less than 30 mL/min
Uncontrolled hypertension
History of Raynaud’s phenomenon with ischemia (e.g., digital ulcers, tissue necrosis, or other critical ischemia)
Concurrent use with a strong or moderate CYP3A4 inducer (e.g., carbamazepine, efavirenz)
Concurrent preventive therapy with another calcitonin gene related peptide (CGRP) targeting agent (including other gepants and CGRP targeting monoclonal antibodies)
Pregnancy

Treatment initiated by a VA/VA Community Care neurologist or locally designated headache expert
Chronic Migraine defined as ≥15 headache days per month with ≥8 monthly migraine days
Contraindication, intolerance, or lack of therapeutic response after at least 12 weeks each of a therapeutic dose of at least 2 of the following: beta blocker, topiramate, divalproex, and ACE inhibitor or ARB
Contraindication, intolerance, or lack of therapeutic response after at least 12 weeks of a therapeutic dose of at least ONE CGRP-targeted monoclonal antibody (e.g., erenumab)

Discontinue atogepant if signs or symptoms of Raynaud’s phenomenon develop; monitor and inform patients with a history of Raynaud’s phenomenon about the possibility of recurrence and worsening.
Headache expert must perform a comprehensive headache assessment including evaluation for medication overuse headache, other secondary headache types, adherence to prior headache therapies, features requiring urgent/emergent evaluation, triggers, effective acute treatment, and nonpharmacologic interventions (board certification in headache medicine is not required).
Scheduled blood pressure check 2-4 weeks after initiation of therapy.
Botulinum toxin failure may be considered as one of the required oral prevention medication trials.
If erenumab failure or intolerance occurs, an alternate non-formulary CGRP-targeted monoclonal antibody (e.g., fremanezumab, galcanezumab, eptinezumab) should be tried.