The Canadian government has announced amendments to its regulations concerning patented drugs that it says will make medicines more affordable. According to Health Canada, these changes will save Canadians $13.2 billion (US $9.97 billion) over the next decade.
The Canadian government has announced amendments to its regulations concerning patented drugs that it says will make medicines more affordable. According to Health Canada, these changes will save Canadians $13.2 billion (US $9.97 billion) over the next decade.
Under the Patent Act, enacted in Canada in 1987, the Patented Medicine Prices Review Board (PMPRB) can take action against patent holders who charge what the board determines to be an excessive price. Factors that PMPRB takes into consideration include the price for which a drug is sold, the prices of other drugs in the same class are sold, the price charged in other countries, and changes in the consumer price index (CPI).
Drugs are assessed for their therapeutic benefit relative to existing products, and depending on the outcome of that assessment, are given a ceiling price based on the median price of the same drug in United States, United Kingdom, France, Germany, Switzerland, Italy, and Sweden. The ceiling price can then grow in keeping with the CPI.
The new amendments, which will be published on August 21, 2019, will change the basket of countries to which Canada compares itself, and will remove the United States and Switzerland—the only 2 countries with higher drug prices than Canada—from consideration.
Health Canada also said that it will assess “the actual market price of medicines in Canada—rather than inflated list or 'sticker' price—to more accurately assess whether a price is reasonable when setting a price ceiling.” Finally, the PMPRB will have the power to consider whether the price of a drug reflects its value for patients.
In a statement, Canada’s Minister of Health, Ginette Petitpas Taylor, said that the reforms are “the biggest step to lower drug prices in a generation,” and that the changes will “lay the foundation” for universal drug coverage under the country’s Pharmacare program.
Drug makers were quick to voice concerns about the regulations; Innovative Medicines Canada (IMC), which represents drug makers, said in a statement that regulations will drop drug price ceilings by up to 70%, thereby weakening companies’ business cases to launch new medicines in Canada. IMC also warned that the regulations will impact decision-making with respect to conducting clinical trials in Canada.
The changes to Canadian regulation come shortly after the United States set forth 2 potential pathways for importing cheaper drugs from foreign countries, including Canada. The Trump administration has also proposed to use what it calls an International Pricing Index to allow Medicare to more closely align what it pays for Part B drugs with prices paid in other nations.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.