Pharma industry concerned about recent PMPRB guidelines for IRP in Canada
Blogpost by Dimitra Sotou, MIHP, Client Solutions Lead, GPI
Canada is due to adjust its international reference pricing (#IRP) basket of comparator countries come January, the 1st, 2021.
The change was announced by the PMPRB in the final version of new guidelines; after five years of extensive consultation. Reforms had been due to take effect in July 2020 but were delayed for further consultation in response to the COVID-19 pandemic.
Source: [PMPRB Website; Accessed on 27 Oct 2020] – https://www.canada.ca/en/patented-medicine-prices-review/services/legislation/about-guidelines/guidelines.html
Notable changes from the guidelines include:
- Canadian list prices will be compared to a new basket of International prices in 11 markets: Australia, Belgium, Japan, Netherlands, Norway, Spain, the UK, Sweden, France, the UK, and Italy; which means that the US and Switzerland—both considered as higher-priced markets than Canada—will be removed.
- Introduction of an initial screening process to identify drugs that are likely to be at higher risk of excessive pricing (“Category I” medicines), i.e. drugs that have a very high annual treatment cost (i.e. greater than 150% of GDP per capita) or are expected to capture a size-able share of the Canadian market (i.e. treatments that have estimated or actual sales of more than $50 million per year). This process offers the prospect of reductions of 20-50% off maximum list prices of treatments, depending on the level of therapeutic criteria.
- A statutory mandate to ensure that prices charged by pharmaceutical companies for patented drugs sold in Canada are not ”excessive”, and to report on pharmaceutical trends and R&D spending by pharmaceutical patentees.
Industry is opposing the reforms:
The pharmaceutical industry seems highly critical of the reforms and PMPRB’s decision to implement them in the middle of the current pandemic. Manufacturers are also reported to be frustrated that the admittedly long consultation process had little impact on the final guidelines. Industry has highlighted that companies will avoid launching new treatments in Canada due to the current disincentives towards a lucrative price.
A potential reduction in the number of new treatments launching in Canada will not only have an impact on the pricing of medicines, specifically in markets referencing Canada, but in patient access worldwide as Canada is considered one of the most major markets from a commercial point of view.
What remains to be seen is the actual impact once the guidelines are implemented in real practice.
To learn more about how we support bio-pharma keep up to date with the latest policy, regulatory and pricing & access updates please reach out at email@example.com
Keep track of all the latest changes with GPI pulse
GPI’s extensive platform, GPI PulseTM, stores policy, pricing, reimbursement, IRP matrix, and regulatory data in more than 96 countries. If you would like to keep up to date of all the latest regulations and policy along with historical and current pricing & access updates, please fill in your details below and a member of our expert team will get back to you.
We are leading the way forward with analytical and platform driven price and access solutions – to a future where reliable data insights empower confident strategic decision-making and drive meaningful change in the life sciences market.
Quick access to quality insights is the key to understanding global payer needs and setting the right prices at pace. And, when it comes to getting therapies to patients fast, consistently accurate insights are critical.
GPI pulse and GPI HORIZON, supported by experienced consultants use robust validated methodology to provide high quality, curated insights on global prices, market access decisions, asset evaluation, value perception and payer behaviour.
We provide an agile, data-driven, and future-focused perspective to pricing and market access. As your innovation partner, we will help you make the most of your insights to build strategies, optimise operations and identify market opportunities. With the right tools, insights, and know-how, you will make confident decisions to power the future of your business and shape the evolving biopharma landscape.