In its 2019 budget on Tuesday, the federal government confirmed it will work with partners to move forward on three foundational elements of national pharmacare.
The initial steps are the creation of a new national drug agency and a national formulary, which were both recommended by the advisory council on the implementation of national pharmacare in its interim report earlier this month.
In addition, the budget said the government will be working with provinces, territories and other partners to develop a national strategy for high-cost drugs for rare diseases. The strategy, which will include the proposed Canadian Drug Agency, could ensure more effective assessments of a drug’s efficacy, better manage costs and, where appropriate, expand coverage, noted the government.
“The high cost of many drugs for rare diseases and the fact that clinical evidence is often limited because of small patient populations make it difficult for patients and their families, employers and governments to make decisions on whether and how to pay for treatments,” stated the budget.
Pamela Fralick, chief executive officer of Innovative Medicines Canada, says the move isn’t entirely unexpected, referring to the work that’s been done around drugs for rare diseases since 2014. “Our understanding is this is one of the key concerns and drivers for the government, for Health Canada — it is those drugs that are high cost and anticipated to grow. We were very pleased to see it recognized in the budget.
“We see ourselves as a strong partner for government in determining how to do this properly,” she adds. ”And, in fact, I can say, our members — in partnership with members from BIOTECanada — have for several months now been working on what we can bring forward as a solution for government around the high-cost of rare diseases.”
In the budget, the government proposed an investment of up to $1 billion over two years, starting in 2022–23, with up to $500 million per year ongoing, to help Canadians with rare diseases access the drugs they need.
“It’s an area that all payers and patients are struggling with, so putting half a billion dollars a year towards that will be helpful,” says Stephen Frank, the chief executive officer of the Canadian Life and Health Insurance Association. “But we don’t have the details on how that will work, so we’ll need to wait to see . . . but on the face of it, [it’s] a very welcome initiative and welcome funding, and so on our end, we’ll look forward to working with government to understand how they’ll allocate that out and how it will be used.”
The creation of the Canadian Drug Agency, which will build on existing provincial and territorial successes and take a coordinated approach to assessing effectiveness and negotiating prescription drug prices on behalf of Canadians, is expected to help lower the cost of drugs for Canadians by up to $3 billion per year in the long term, according to the budget.
“Leveraging the buying power of the full Canadian market to bring prices down makes a lot of sense, so we think that could be a very positive development,” says Frank.
Fralick’s organization is keen to hear more about the national drug agency. “Canada has an unusually complex system to address getting drugs to Canadians, so anything that can be done to streamline that, to integrate all the different functions, to do that in a much more coherent and effective way, we really look forward to working with them and contributing our thoughts as well.”
The budget noted the proposed national formulary would provide the basis for a consistent approach to formulary listing and patient access to drugs across the country.
“In terms of the formulary, I would say we have some mixed feelings. . . . They used the word ‘comprehensive’ when they talked about a formulary . . . and that is reassuring for patients who want to make sure their health is not detrimentally affected by a restricted formulary. . . . But as we learned in the Ontario situation with OHIP+, when some folks were forced into a formulary situation and away from their private payer coverage, they were not as well off in terms of their access to medicines.”
The advisory council on the implementation of national pharmacare’s final report is due in the spring.