Limited coverage drugs – fremanezumab

Generic name

fremanezumab

Strength

225 mg in 1.5 mL (150 mg/mL)

Form

solution for subcutaneous injection

Special Authority criteria

Approval period

Initial:

  1. 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

  1. 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 medications. In cases of intolerance, also include details regarding the nature and severity of the intolerance(s) experienced.

AND

  1. The baseline number of headache and migraine days per month* 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 month* 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 month* compared to baseline.

1 year

Practitioner exemptions

  • No practitioner exemptions

Special notes

  • The patient should be under the care of a practitioner who has appropriate experience in the management of patients with migraine headaches
  • *Number of headache and migraine days should be calculated by averaging the past 3 months

Special Authority request form(s)