Good News! CADTH supports the reimbursement of Botox for Chronic Migraine

Botox was approved by Health Canada in 2011, but reimbursement by public payers was difficult to obtain. Following an updated recommendation from CADTH, access is likely to improve for Canadians with Chronic Migraine.

What is CADTH?

CADTH (Canadian Agency For Drugs And Technologies In Health) CADTH is an independent, not-for-profit organization responsible for providing health care decision-makers with objective evidence to help make informed decisions about the optimal use of health technologies.

CADTH reviews the evidence on different treatments to see if they bring value to Canadians and they consider cost-effectiveness (value for money). Their decision influences the Health Ministries from the Provinces to cover a treatment or not.

What did CADTH recommend after their reevaluation of Botox?

In November 2019, CADTH updated its recommendation on Botox. The previous recommendation was negative and did not support coverage by public payers. The current recommendation is positive and also suggests criteria for access (see below for the exact criteria). Of note, INESSS in Quebec provided a similar recommendation in 2019.

The key condition to access Botox:

  • Having a diagnosis of Chronic Migraine
  • Having tried 3 oral preventives for migraine without success (lack of benefit, side effects or contraindication).

What drug should a patient try to become eligible for Botox coverage?

Drugs to be considered for trial include:

  • Beta-blockers (propranolol, metoprolol, nadolol)
  • Tricyclic antidepressants (amitriptyline)
  • Topiramate
  • Calcium channel blockers (verapamil, flunarizine)
  • Sodium valproate
  • Gabapentin

It has to be underlined that many of those drugs have more side effects than Botox.

See more on prevention in the Migraine Tree: How to try a preventive – Top Questions and Answers and List of migraine preventives: classes and mechanism of action

See more on Botox in the Migraine Tree: Procedure Injection branch

What does that mean for people with Chronic Migraine?

It means that access will most likely be improved, especially for patients with public coverage. Public payers decisions also may influence the decisions of private payers.

Chronic Migraine is a disabling condition. Safe and effective treatment options are needed to improve the quality of life of Canadians living with Chronic Migraine.

Chronic migraine: basic facts

Disability and Migraine

Did Migraine Canada™ contribute to the evaluation process?

YES! Migraine Canada™ realized a survey (thanks to everyone who participated) and produced a report that was sent to CADTH. The input of patients is considered by CADTH, which is excellent.

Read our report! PDF CADTH Botox patient report

Conclusion: this is a step forward for Canadians living with Chronic Migraine.

Recommendation of CADTH: Full Text of Summary

ONABOTULINUMTOXINA (BOTOX — ALLERGAN INC.) Indication: Chronic Migraine RECOMMENDATION The CADTH Canadian Drug Expert Committee recommends that onabotulinumtoxinA (OnaA) be reimbursed for the prophylaxis of headaches in adults with chronic migraine, if the following conditions are met.

Conditions for Reimbursement Initiation criteria

  1. The patient has a confirmed diagnosis of chronic migraine according to the International Headache Society criteria, defined as headaches on at least 15 days per month for more than three months of which at least eight days per month are with migraine.
  2. The patient has already experienced an inadequate response, intolerance, or contraindication to at least three oral prophylactic migraine medications.
  3. The physician must provide the number of headache days per month and the score obtained on the Headache Impact Test (HIT-6) at the time of initial request for reimbursement.
  4. The maximum duration of initial authorization is nine months.

Renewal criteria

  1. The physician must provide proof of beneficial clinical effect when requesting continuation of reimbursement, defined as:
    • A reduction of at least 50% in the number of headache days per month compared with baseline, or
    • A reduction of at least 30% in the number of headache days per month and an improvement of at least five points in the HIT-6 score, compared with baseline. 2. The maximum duration of subsequent authorizations following the initial authorization is 12 months.

Prescribing conditions

  1. Administration should only be carried out by physicians with the appropriate qualifications and experience with the proper administration and therapeutic use of OnaA for migraine headaches.

More information on access to care!

What is the drug coverage system like in Canada?

Canadians pay their medications either through private insurance companies (with plans often linked with their work), public insurance systems or out-of-pocket (no insurance).

Estimates state that 60% of Canadians have private coverage, 30% public and 10% out of pocket. This varies depending on the province.

Private plans vary a lot, even with the same company between different people.