ERENUMAB-AOOE INJ

Clinical Criteria Summary

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 CGRP-targeting monoclonal antibodies and gepants)
Diagnosis of hemiplegic migraine or tension headache

Chronic Migraine defined as at least 15 headache days per month with at least 8 migraine days per month
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
If using a combination of a CGRP-targeted monoclonal antibody for preventive therapy and a CGRP receptor antagonist (gepant) for abortive therapy, patient must be evaluated and counseled on risks of concomitant therapy

Discontinue erenumab if signs or symptoms of Raynaud’s phenomenon develop; patients with a history of Raynaud’s phenomenon should be monitored and informed about the possibility of recurrence and worsening
Scheduled blood pressure check required 2-4 weeks after initiation of therapy
Botulinum toxin with demonstrated no response may be considered as one of the required prevention medication trials
Therapeutic dose definitions: 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)
Divalproex is not recommended in patients who can become pregnant
Safety evidence of concomitant CGRP acting agents is limited; patients may be prone to CGRP-related adverse events (vasodilation, GI motor-stimulation, prosecretory effects); alternative therapies may benefit patients at high risk for ischemic events or severe constipation

Treatment must be initiated by a VA/VA Community Care neurologist or locally designated headache expert
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 to meet the provider criterion

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 CGRP-targeting monoclonal antibodies and gepants)
Diagnosis of hemiplegic migraine or tension headache

Treatment initiated by a VA/VA Community Care neurologist or locally designated headache expert
Episodic migraine defined as 4 to 14 monthly headache 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

Scheduled blood pressure check required 2–4 weeks after initiation of therapy
Discontinue erenumab if signs or symptoms of Raynaud’s phenomenon develop
Monitor patients with a history of Raynaud’s phenomenon and inform them about the possibility of recurrence and worsening
Comprehensive headache assessment required by prescribing clinician (evaluation for medication overuse headache, other secondary headache types, adherence to prior therapies, features requiring urgent/emergent evaluation; review of headache history for triggers, effective acute treatment, and nonpharmacologic interventions)
If using a combination of a CGRP-targeted monoclonal antibody for preventive therapy and a CGRP receptor antagonist (gepant) for abortive therapy, patient must be evaluated and counseled on risks of concomitant therapy