RIMEGEPANT TAB,ORAL DISINTEGRATING
Clinical Criteria Summary
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Exclusion Criteria
- 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 abortive therapy: concurrent therapy with a triptan or another gepant once rimegepant is initiated
- Pregnancy
Inclusion Criteria
- Treatment initiated by a VA/VA Community Care neurologist or locally designated headache expert
- 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
Additional Inclusion Criteria
- 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
Clinical Monitoring & Safety Requirements
- Discontinue rimegepant if signs or symptoms of Raynaud’s phenomenon develop
- All 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 must perform a comprehensive headache assessment including evaluation for medication overuse headache, other secondary headache types, adherence to prior headache therapies, and features that require urgent/emergent evaluation; patient’s headache history should be reviewed to identify triggers, effective preventive treatment (if indicated), and nonpharmacologic interventions
- Patients started on rimegepant must have a scheduled blood pressure check 2-4 weeks after initiation of therapy
- Vascular contraindications to all triptans include ischemic coronary artery disease, previous stroke or transient ischemic attack, peripheral vascular disease, or ischemic bowel disease
- Other contraindications with triptans may be drug interaction related such as concurrent use of a MAO inhibitor
- Safety evidence of concomitant CGRP acting agents is limited; patients may be prone to CGRP-related adverse events involving vasodilation and GI motor-stimulation/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)
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Exclusion Criteria
- 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
Inclusion Criteria
- 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
Monitoring & Clinical Management Requirements
- 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