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By moonsoar

Accessing Investigational Treatments in Canada: Understanding Health Canada’s Special Access Program

For people living with desmoid tumors, treatment options can sometimes be limited. Patients may hear about promising therapies available in clinical trials or approved in other countries and wonder whether they can access them in Canada.

While Canada does not have a program called “Expanded Access” like the United States, Health Canada offers a similar pathway through the Special Access Program (SAP).

What is the Special Access Program?

The Special Access Program allows healthcare practitioners to request access to drugs that are not currently approved or commercially available in Canada for patients with serious or life-threatening conditions when standard treatment options have failed, are unsuitable, or are unavailable.

This pathway is intended for exceptional circumstances and is evaluated on a case-by-case basis.

Who Can Apply?

Patients cannot apply directly.

Requests must be submitted by a qualified healthcare practitioner, typically your treating physician or specialist. Your healthcare team must provide a clinical rationale explaining why the requested treatment may be appropriate for your situation.

When Might SAP Be Considered?

A physician may consider requesting access through SAP when:

    • Available treatments have not worked.
    • Available treatments are not appropriate for the patient.
    • A promising therapy is not yet approved in Canada.
    • The patient is unable to participate in a clinical trial.

Important Things to Know

Approval is not guaranteed.

Health Canada reviews each request individually and considers factors such as:

    • The seriousness of the condition.
    • Available treatment alternatives.
    • Evidence supporting the safety and effectiveness of the requested therapy.
    • Whether the manufacturer is willing and able to supply the drug.

Even if Health Canada authorizes access, the manufacturer must still agree to provide the medication.

What Should Patients Do?

If you are interested in a treatment that is not available in Canada:

    1. Speak with your treating physician.
    1. Ask whether a clinical trial may be an option.
    1. Discuss whether a Special Access Program request could be appropriate for your situation.
    1. Contact the Desmoid Tumour Foundation of Canada if you need help identifying clinical trials, treatment information, or patient resources.

Clinical Trials Remain the Preferred Route

Health Canada continues to view participation in a clinical trial as the preferred way to access investigational therapies whenever possible. Clinical trials provide important safety monitoring while helping researchers learn more about potential treatments.

Resources

    • Health Canada Special Access Program
    • Information for healthcare professionals on requesting access to non-marketed drugs

If you have questions about treatment access in Canada, speak with your healthcare team or contact the Desmoid Tumour Foundation of Canada for support and information.

For information https://springworkstx.com/patients/expanded-access/

Requests for access to a SpringWorks investigational or unlicensed therapy must be made voluntarily by the patient’s treating HCP. Requests cannot be made directly by an individual patient or a patient’s parent/legal guardian or caregiver.

To request access, HCPs should send an email to medinfo@springworkstx.com.