Special access to Remdesivir

Gilead Sciences Canada Inc. and Health Canada’s Special Access Programme (SAP) are considering requests for Remdesivir to treat COVID-19 on a patient by patient basis. The drug is not available on a future use basis for stockpiling in anticipation of needs. Requests for Remdesivir need to be submitted to both SAP and Gilead using the instructions below. You are advised to initiate the request with Gilead first. After submitting the request to Gilead, submit a Special Access Request Form to the SAP.

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity – it is not approved anywhere globally for any use. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19.

This is an experimental medicine that has only been used in a small number of patients with COVID-19 to date, so Gilead does not have an appropriately robust understanding of the effect of this drug to warrant broad use at this time. While there is a clinical trial investigating the use of Remdesivir in a small number of other jurisdictions, at this time Gilead is not in a position to start a clinical trial in Canada.

Submitting a request for remdesivir

Step 1: Submitting a request to Gilead

In order to effectively manage the rapidly increasing number of requests for compassionate access to Remdesivir – effective immediately all new referrals need to be done through the Gilead portal.

Compassionate use requests must be submitted by the patient’s lead treating physician. Gilead is currently assessing requests on an individual basis and requires, at a minimum that a patient be hospitalized with confirmed COVID-19 infection with significant clinical manifestations.

Key inclusion and exclusion criteria that must be met in order to submit a compassionate use request for remdesivir are available on the Gilead portal.

Decisions respecting each request will be communicated directly to the requesting physician.

Step 2: Submitting a request to the Special Access Program (SAP)

Complete SAP Request Form A

Ensure that all sections in the form are complete and that the request is signed and dated. Submit the form by fax (613) 941-3194 and call the SAP (613) 941-2108 to confirm receipt. During regular business hours, you will reach a staff member by following the prompts in the phone tree. After hours, follow the prompts to the on-call officer.

SAP will review the request promptly and if additional information or clarification is required, SAP will contact the requesting physician directly. A decision to approve will be held pending the outcome of the Gilead review. If Gilead approves the request, SAP will immediately issue a Letter of Authorization to Gilead which will permit shipping and other logistics. If Gilead does not approve the request, SAP will issue an administrative Letter of Cancellation to close the transaction.

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