The Patented Medicine Prices Review Board (PMPRB) has amended its Interim Guidance to address prices of “New Medicines”, implementing a review threshold based on “below the median” of the PMPRB11 countries (Median International Price, MIP). “New Medicines” are defined as patented medicines that did not receive a PMPRB ceiling price as of July 1, 2022.
There are no changes to the Interim Guidance for “Existing Medicines” that received a ceiling price prior to July 1, 2022. This means that taking a Consumer Price Index (CPI) list price increase can still trigger a Board investigation of Existing Medicines.
The Board also announced details regarding the process for consultation on a new set of complete guidelines.
On July 1, 2022 amendments to the Patented Medicines Regulations came into force and the Board’s previous price review Guidelines expired. The Interim Guidance was introduced on August 18, 2022 with the intent that it would remain in effect from July 1, 2022 until new guidelines come into force (the Interim Period). While the Board originally contemplated that these new guidelines would be ready by January 1, 2023, the 2022 draft was withdrawn. As explained in greater detail below, consultation on replacement guidelines is now expected to take place in 2024.
As we reported, the original Interim Guidance did not contemplate price review for New Medicines during the Interim Period. The amended Interim Guidance addresses the growing number of medicines that fall into this category by introducing a “below the MIP” criterion for determining the review status of a New Medicine:
|Interim Guidance: August 18, 2022||Amendment: September 27, 2023|
|Medicines without a MAPP (Maximum Average Potential Price) or NEAP as of July 1, 2022, will not be subject to price review by PMPRB Staff during the Interim Period. Furthermore, once new Guidelines are in place, no potentially excess revenues will be calculated by Staff retrospectively for any such medicines for sales made during the Interim Period.||Medicines without a MAPP (Maximum Average Potential Price) or NEAP (Non-Excessive Average Price) as of July 1, 2022 (“New Medicines”), are considered reviewed if their list price is below the median international price for the PMPRB11 countries.
The rights holders of these products will receive a Status Report letter once the assessment is completed.
Medicines that do not meet this criterion, are considered “under review” until new Guidelines are in place.
Once new Guidelines are in place, no potential excess revenues will be calculated by staff retrospectively for any New Medicines for sales made during the Interim Period.
The final amendment is substantively identical to the one proposed in the Board’s consultation, which ran for 60 days beginning June 20, 2023. The Board received 45 submissions, which are available online here.
The Board explains that New Medicines with prices exceeding the MIP may be subject to a greater level of scrutiny before new guidelines come into force:
“reviewed” medicine prices will not be subject to further price review during the Interim Guidance period, whereas medicines whose price is “under review” may be subject to further review during that period.
In its Decision, the Board also provided an update on its progress toward a new set of full guidelines to replace the Interim Guidance, outlining an “iterative process” that will include:
- a first stage of consultation on “themes relevant to new guidelines”, which the Board intends to launch “in the coming weeks”
- a second stage of consultation in 2024, which “will focus on the development of new guidelines”
We will continue to provide updates as more information becomes available from the Board.