Market Access: Pricing
George Wyatt, Executive Senior Consultant, Market Access at Innomar Strategies takes you through what you need to know about how pharmaceutical prices are regulated and what has changed in respect to pricing and reimbursement.
Drug prices are regulated for patented medicines in Canada, by an agency known as the Patented Medicines Prices Review Board, also known as PMPRB. They set the maximum price based on a number of factors that they look at depending on 11 other countries. Now that price is the maximum price you can charge in Canada, but it's not necessarily the market price, or the list price, that companies list their product at in Canada. Things are always changing in the pricing and reimbursement world in Canada. I've been involved in this world for over 25 years and I still see lots of change.
The first thing to know, the PMPRB the pricing agency, there's a lot of change going on there. The maximum price that companies are able to change for their drug in Canada may change, but that might not affect their market situation. So that's one thing to keep an eye out.
Second thing, there's an initiative known as Regulatory Reform for Drugs and Devices sometimes called R2D2 which allows companies to put their regulatory submission and their reimbursement submission in at the same time. What'll happen there is Health Canada will do some of the file, and the HTA bodies will do other parts of the file trying to avoid some duplication and thereby making things move along a little bit faster.
It's really important that you have a solid consulting company, like Innomar, to help you through some of these particular processes because they're changing all the time. And we're on top of it. PMPRB is going through a significant change at this point in time. New regulations have been posted and those regulations will come into force on July 1st of 2020.
New guidelines are also being discussed at this point in time, and there is some discussion around those guidelines at the moment, so they're not finalised. So it's really important that you have a local consultancy like Innomar to help guide you through these particular processes.