Dr. Arthur Lau is an ORA member and active participant within the ORA EAP Committee. In this article, he shares his insights and thinking around the current processes of the pan-Canadian Pharmaceutical Alliance and how they may affect Rheumatology.
I have had the opportunity to serve on the ORA EAP committee for the last 2 years. Through this experience, I have gained some insight into the process by which a new therapeutic agent progresses from Health Canada application to ultimately achieving listing on individual provincial formularies.
The Pan Canadian Pharmaceutical Alliance (pCPA) is a body which is comprised of representation from all provinces and territories, and also has federal government representation. This body negotiates with individual pharmaceutical companies on an acceptable price that new therapeutic agents approved by Health Canada will cost Canadians. For each therapeutic agent, once the pCPA establishes an acceptable price with the pharmaceutical company, then negotiations are held between the individual provinces/territories with the pharmaceutical company to determine if the therapy will be listed on the provincial formulary.
In the last 6 months, there have been several notable therapies for the treatment of inflammatory arthritis which ended negotiations with the pCPA without agreeing on an acceptable price. We understand that this is a negotiation process, and that pharmaceutical companies must adjust their asking prices accordingly given the current landscape with many competitor products already available, and in a world where multiple biosimilars are already available, with more looming on the horizon.
In this particular example, a new therapy has been shown, through multiple high quality randomized controlled trials, to be non-inferior to some of the current available options. Additionally, there has been speculation that the negotiated price was at least competitive, if not lower than the cost of its closest comparators (based on mechanism of action), which would seem like an ideal opportunity for significant cost savings for an already strained healthcare budget. Therefore, we find it disappointing when these types of negotiations do not come to fruition. What concerns our committee is the lack of communication between the two sides, and unwillingness to have open transparent negotiations.
As a result, our patients are the ones who end up negatively impacted the most, as they are denied medications which may be helpful especially when other treatments are no longer effective. From the perspective of the treating physicians, this limits the number of options we have to offer to our patients. Decisions like this may also have a significant impact on effective medications being brought to Canada, and future innovative research coming to Canada, as pharmaceutical companies may no longer see Canada as a partner country to conduct trials, and invest funding to help develop the infrastructure for real world clinical data, which we rely on for clinical decision making.
In the future, similar situations may again occur where therapeutic agents, with proven efficacy are unsuccessful in their negotiations with the pCPA. This would be of particular concern when this therapy involves a disease where there is a significant unmet need, and no reasonable alternative therapies are available. It is essential that ORA members stand together and work with patient groups to act as advocates for our patients. Ultimately, there needs to be more transparency in these negotiations and decision making processes in order for common ground to be found, and our patients would ultimately be the beneficiaries of this.