How can you access a new treatment?
What you need to know about the Special Access Program
Health Canada’s Special Access Program (SAP) considers requests from doctors for access to drugs that are unavailable in Canada to treat patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional therapies fail, are unsuitable or are unavailable.
Through SAP, your doctor may be able to access experimental drugs not yet approved by Health Canada and still in clinical trials, and other non-marketed drugs. These drugs must treat, diagnose or prevent a serious or life-threatening condition. The physician must have tried other alternatives unsuccessfully, and sufficient evidence of the drug’s safety and efficacy must support its use.
Getting drugs via SAP
The SAP has specific procedures to follow that are well documented on Health Canada’s website. A physician who is interested in using a particular treatment that is not yet available in Canada must send a request to the SAP on behalf of a patient, with that person’s consent. The doctor must complete the required forms and submit them for review.
Families affected by Duchenne muscular dystrophy (DMD) who are interested in finding out more about the SAP should ask their doctor and consult Health Canada’s website.
Who makes decisions on SAP requests?
Health Canada decides whether to approve or reject an SAP request. These decisions are made on a case-by-case basis and consider the:
- The urgency of the situation
- Patient’s condition
- Availability of alternative treatments already on the market
- Information provided by the doctor about the drug’s use, safety and efficacy
What is the drug manufacturer’s role?
When Health Canada issues an SAP authorization, the pharmaceutical company that makes the drug has the final word on whether it will supply the drug. It may place restrictions or conditions on the drug’s use, according to best practices. The pharmaceutical company supplies the drug directly to the requesting physician.
Who pays drug costs after a successful SAP request?
The patient’s family is solely responsible for drug costs after the patient is granted access to treatment – an important consideration to take into account.