WHAT IS THE PCPA?
The pan-Canadian Pharmaceutical Alliance (pCPA) is an alliance of public drug program leaders from all provincial, territorial and federal governments. pCPA members work collaboratively to negotiate drug prices for their respective programs. Its pricing decisions are a precondition of having a medication covered on public drug formularies.
When a drug comes to Canada it must go through the Canadian drug regulatory, review and reimbursement system. The drug must go to various review bodies before it is eligible for public reimbursement. The pCPA is the second last stage before public health plans decide whether or not to list a drug. Successful negotiations through the pCPA then have to go through a final review by all public drug programs.
WHAT NEGOTIATIONS FOR CF MODULATORS HAVE OCCURRED WITH THE PCPA?
In 2019, the pCPA and the manufacturer completed price negotiations for additional Kalydeco mutations, and Kalydeco was included in the agreement struck between the manufacturer and the pCPA in 2021, as well as Orkambi, for all Health Canada approved mutations. Trikafta was added to this agreement for those 12+shortly after this deal was struck, upon Health Canada approval and positive cost-effectiveness studies. This agreement was amended in 2022 to include those who are 6+ and indicated for the drug.
Most Canadian jurisdictions now provide broader, albeit still limited, access to Kalydeco and Orkambi, and broad access to Kalydeco for those six years of age or older with at least one copy of the F508del mutation. People with rarer and ultra-rare mutations that can be treated by Trikafta and other modulators have not yet been indicated by Health Canada.
Cystic Fibrosis Canada is working to ensure that anyone who can benefit from a modulator can get one.
It amended the agreement signed with Vertex for Trikafta for the 12+ age group in 2021 to include those 6 years of age and older who have at least one copy of the F508del mutation.