On May 16th, Health Minister Jane Philpott announced a suite of proposed changes to Canadian pharmaceutical policy. While many of these changes are merely sketched out rather than fully realized, they represent potential fixes to the Canadian healthcare system that patient groups and healthcare providers have been hoping for. For people living with HIV, these updates could mean a future with better and more comprehensive access to necessary medications.
Expediting the Drug Approval Process
The pace of regulatory approval for medications in Canada has been a longstanding problem, and the process for getting new drugs listed on public drug plans can be particularly slow. Health Canada provides approval for the safety and efficacy of new drugs, after which they can be marketed and private insurance companies can add them to their formularies.
For drugs to make their way onto public drug plans, there are additional steps. A drug needs to be reviewed by the Canadian Agency for Drugs and Technology in Health (CADTH), which says whether a drug’s potential impact makes it worth listing. A price is then negotiated between the pan-Canadian Pharmaceutical Alliance (pCPA), representing the public drug plans, and a drug’s manufacturer. Assuming the pCPA and manufacturers agree on a price, the public plans then begin making individual price listing agreements to add the drugs to their formularies.
There were a variety of changes in Tuesday’s announcement that could streamline this process. A drug’s Health Canada review has typically preceded a review by CADTH, but the new changes seek to align these two processes. Concurrent Health Canada and CADTH reviews could potentially shave six months to a year off of the regulatory timeline for new drugs and technologies. This could put the timeline for price negotiations more in line with when private insurance plans negotiate drug prices.
There is also a commitment to expand the capacity of the pCPA - an organization that, despite its importance to the healthcare system, currently only has five staff positions. The proposed changes also recommend exploring a national drug formulary, which could also speed up public drug coverage by making pCPA negotiations a more direct route to public listing.
National Formulary- a precursor to national pharmacare?
Condensing the various public drug formularies into one national public drug formulary is a complicated but intriguing undertaking. The pCPA has been able to save hundreds of millions of dollars on public drug costs by consolidating the bargaining power of each plan, and a national formulary could strengthen that bargaining position further by guaranteeing negotiations lead to all plans covering a drug.
A national formulary could also eliminate situations where some Canadians have access to drugs through public drug plans because their province has agreed to cover them while other Canadians are left without access. If a national formulary were to build on the savings and access that the pCPA has generated already, it would also bolster the argument for national pharmacare as a cost-effective and equitable expansion of Canada’s public healthcare system.
There are many stumbling blocks - provincial drug plans would need to agree to yield power to a national formulary, and aligning access and prices across the country will require negotiations between various government and industry stakeholders. The proposal also makes little commitment to a truly national formulary, mentioning piecemeal solutions like a shared formulary of a limited bundle of commonly used drugs (similar to what the Ontario NDP proposed as part of an expanded Ontario Drug Benefit Plan) or a shared formulary for new drug entries on the market. With proposed consultations lasting through 2018, the exact form of a national formulary is still in the making.
How might these changes impact people living with HIV?
On the face of it, this might not seem to change much for people living with HIV. There are few new HIV drugs coming down the pipeline and existing treatments are largely covered under existing public formularies. However, as we see more people living into their senior years with HIV, expanded public coverage for new medications for other health conditions could provide a substantial benefit.
New treatments for cancer, diabetes, heart disease and a myriad of other health issues disproportionately impacting people aging with HIV would likely reach public plans quicker and in greater numbers under these changes. A national formulary would also mean more uniform access to drugs and less concern about losing access to medications when moving between jurisdictions.
Jack Mohr is a policy researcher with CTAC.