Fostemsavir compassionate access program
ViiV Healthcare has built at least one manufacturing facility to make fostemsavir. The factory should have some supplies of fostemsavir available toward the end of 2019. Sometime in late 2020, fostemsavir should be licensed for use in Canada, the European Union and the United States.
ViiV has stated that it plans to make fostemsavir available on a compassionate access basis for selected patients around the end of 2019. The compassionate access program in Canada will involve a three-stage process that includes the following:
- An application to ViiV by the doctor asking for fostemsavir and explaining the reasons why the patient needs the drug. ViiV will review each application on a case-by-case basis, as currently there is a limited supply of the drug.
- If ViiV approves the application, the next step is for the doctor to apply to Health Canada’s Special Access Program (SAP) to seek approval for their patient to get a non-approved treatment (fostemsavir). This process is independent of ViiV.
- Finally, once Health Canada has approved the individual use of fostemsavir via the SAP, ViiV will then contact its factory to have the drug shipped.
Doctors can contact ViiV’s medical department to find out more about the compassionate access program.
—Sean R. Hosein