UBROGEPANT TAB
Clinical Criteria Summary
Continuity of Care Inclusion Criteria
- 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
Exclusion Criteria
- Concurrent therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin)
- 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)
- Concurrent therapy with a triptan agent once ubrogepant is initiated
- Concurrent therapy with another gepant prescribed for abortive treatment
- 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 a combination of a calcitonin gene related peptide (CGRP)-targeted monoclonal antibody for preventative therapy and ubrogepant for abortive therapy: patient has been evaluated and counseled on risks of concomitant therapy
Monitoring & Safety Requirements
- Ubrogepant should be discontinued 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 ubrogepant must have a scheduled blood pressure check 2-4 weeks after initiation of therapy