RIMEGEPANT TAB,ORAL DISINTEGRATING

Clinical Criteria Summary

Diagnosis of migraine, with or without aura, per the International Classification of Headache Disorders (ICHD-3)
Moderate to severe migraine intensity
Currently receiving preventive therapy for migraine if indicated
Contraindication, intolerance, or lack of response to trial of two different triptans at a clinically effective dose
Treatment initiated by a VA/VA Community Care neurologist or locally designated headache expert

Concurrent therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin)
Concurrent therapy with inhibitors of P-gp
Concurrent therapy with strong and moderate CYP3A4 inducers
Patient has uncontrolled hypertension
Patient has a history of Raynaud’s phenomenon with ischemia (e.g., history of digital ulcers, tissue necrosis, or other critical ischemia)
If rimegepant is being requested for abortive therapy, concurrent therapy with a triptan or another gepant once rimegepant is initiated
Pregnancy

Veteran is transitioning care from Department of Defense to VHA and the medication is determined by a VA prescriber using shared decision making to be safe and clinically appropriate, or is needed for dose tapering / slowly discontinuing therapy

Patient must have a scheduled blood pressure check 2-4 weeks after initiation of therapy
Rimegepant should be discontinued if signs or symptoms of Raynaud’s phenomenon develop
Patients with a history of Raynaud’s phenomenon should be monitored for and informed about the possibility of recurrence and worsening
Locally designated headache expert performing assessment does not require board certification in headache medicine

If using rimegepant for abortive therapy in combination with a calcitonin gene related peptide (CGRP)-targeted monoclonal antibody for preventative therapy, patient has been evaluated and counseled on risks of concomitant therapy
Safety evidence of concomitant CGRP acting agents is limited; patients may be prone to CGRP-related adverse events including vasodilation, GI motor-stimulation, and prosecretory effects
Alternative therapies may benefit patients at high risk for adverse outcomes from this combination (e.g., high risk for ischemic events, severe constipation)
Vascular contraindications to triptans include ischemic coronary artery disease, previous stroke or transient ischemic attack, peripheral vascular disease, ischemic bowel disease, or uncontrolled hypertension; other contraindications may be drug interaction related such as concurrent use of a MAO inhibitor

Concurrent therapy with a strong CYP3A4 inhibitor
Concurrent therapy with inhibitors of P-gp
Concurrent therapy with strong and moderate CYP3A4 inducers
Uncontrolled hypertension
History of Raynaud’s phenomenon with ischemia (e.g., digital ulcers, tissue necrosis, or other critical ischemia)
For preventive therapy: concurrent preventative 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
Episodic Migraine defined as 4 to 14 monthly migraine days
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
Contraindication, intolerance, or lack of therapeutic response after at least 12 weeks of a therapeutic dose of atogepant

Discontinue rimegepant if signs or symptoms of Raynaud’s phenomenon develop
Monitor patients with a history of Raynaud’s phenomenon for and inform about the possibility of recurrence and worsening
Locally designated headache expert must perform a comprehensive headache assessment including evaluation for medication overuse headache, other secondary headache types, adherence to prior headache therapies, and features requiring urgent/emergent evaluation; review headache history to identify triggers, effective acute treatment, and nonpharmacologic interventions
Scheduled blood pressure check required 2-4 weeks after initiation of therapy
If failure or intolerance to erenumab occurs, an alternate non-formulary CGRP-targeted monoclonal antibody must be tried