Limited coverage criteria – galcanezumab

120 mg/mL pre-filled pen, pre-filled syringe

Initial

The patient has a confirmed diagnosis of episodic or chronic migraine defined as:

• Episodic migraine: Migraine headaches on at least 4 days per month and less than 15 headache days per month for more than 3 months
• Chronic migraine: Migraine headaches on at least 8 days per month and headaches for at least 15 days per month for more than 3 months

AND

The patient has experienced an inadequate response for a minimum three months trial at optimal dosing or intolerance to at least two oral prophylactic migraine medications from two different therapeutic classes. Required details of trial include: names, doses and durations of the previously tried prophylactic migraine medications¹. In cases of intolerance, also include details regarding the nature and severity of the intolerance(s) experienced

AND

The baseline number of headache and migraine days per month² at the time of initial request is provided

6 months

First renewal

The patient has had a minimum reduction of at least 50% in the average number of migraine days per month² compared to baseline

6 months

Second and subsequent renewals

The patient has maintained a minimum reduction of at least 50% in the average number of migraine days per month² compared to baseline

1 year

Anti-seizure medications:

• Divalproex sodium / valproic acid
• Topiramate
• Gabapentin

Serotonin and norepinephrine reuptake inhibitors:

• Duloxetine
• Venlafaxine

Beta-blockers:

• Atenolol
• Metoprolol
• Nadolol
• Propranolol
• Timolol

Tricyclic antidepressants:

• Nortriptyline
• Amitriptyline

Calcium channel blockers:

• Flunarizine
• Verapamil

Renin-angiotensin-aldosterone system inhibitors:

• Candesartan
• Lisinopril

Miscellaneous:

• Pizotifen