6.2 Health Canada's Special Access Program Drugs

General Policy Description

Physicians occasionally treat patients with medications not approved for sale in Canada in cases of serious or life-threatening illness when conventional therapies have failed, are unsuitable, are unavailable, or offer limited options.

The Therapeutic Products Program (TPP) of Health Canada is mandated to authorize the sale of these medications to physicians. The Special Access Program (SAP) of the TPP administers this mandate. SAP is responsible for authorizing the sale of pharmaceutical, biologic and radio-pharmaceutical products that are not approved for sale in Canada.

The prescribing physician is required to submit an application to the SAP for approval to use an SAP drug for a patient. Once approved, the SAP authorizes release of the drug to the physician.

Policy Details

PharmaCare coverage of SAP drugs

PharmaCare coverage for SAP drugs is available only under exceptional circumstances through the Special Authority process.

PharmaCare otherwise does not cover non-approved indications or drugs that have not been approved for sale in Canada.

Special Authority approval must be in place before the drug is dispensed to the patient. Retroactive coverage cannot be provided.

Procedures for Physicians and Pharmacists

Applying for coverage of an SAP drug

A prescribing physician must submit an application to the SAP for approval to use an SAP drug for a patient. Once approved, the SAP sends a notification to the manufacturer and a copy to the physician, authorizing the release of the drug to the physician. The manufacturer then supplies the drug directly to the physician or to a hospital pharmacy. (Manufacturers cannot release SAP drugs directly to community pharmacies.)

Because SAP medications are not approved for sale in Canada, they do not have drug identification numbers (DINs). In order for a pharmacy to dispense an SAP drug, PharmaCare will assign a Product Identification Number (PIN). 

The pharmacist can request a PIN by providing the drug information (including manufacturer, generic name, brand name and dosage form) to PharmaCare.

If PharmaCare grants an individual patient Special Authority coverage for an SAP drug, a confirmation letter is sent to the patient's physician indicating the PIN for that drug. SAP approval does not guarantee PharmaCare will cover the SAP drug.

If the physician does not advise the pharmacist of the PIN to be used, the pharmacist can call the PharmaCare Help Desk to obtain it.

If PharmaCare has granted Special Authority coverage for an SAP drug, a claim must be entered on PharmaNet by a community or hospital pharmacy.

Physicians are advised to make arrangements with the hospital pharmacy or local community pharmacy before the SAP drug is received.

For instance, the hospital or community pharmacy may agree to purchase the drug from the physician. The pharmacy can then dispense the drug and enter the prescription details on PharmaNet. In addition to ensuring appropriate coverage by PharmaCare, this also ensures that the prescription information is included on the patient's medication profile. Please note that the physician would remain responsible for the manufacturer's invoice and should remit payment directly to the manufacturer. PharmaCare cannot reimburse physicians or patients directly. 

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