The Patented Medicine Prices Review Board (PMPRB) has released a scoping paper on themes and questions to develop new price review Guidelines. The scoping paper also includes information on how stakeholders can participate in the consultation.
The deadline for written submissions addressing the scoping paper is December 20, 2023.
The PMPRB has not had a full set of Guidelines since July 1, 2022, when amendments to the Patented Medicines Regulations came into force implementing a new list of foreign reference price countries (PMPRB11). As we reported, the PMPRB has been operating under an Interim Guidance, which was recently amended to provide guidance on new medicines introduced during the Interim Period until new Guidelines are introduced.
The scoping paper is part of the first phase of consultations on new Guidelines. The Board previously indicated that a second phase of consultation in 2024 would focus on the development of new Guidelines. The scoping paper states that the Board intends to finalize new Guidelines in 2024.
Themes for consultation
The Board has identified six themes for discussion:
- Efficient Monitoring of Prices without Price Setting. Specific questions on this theme relate to whether elements of the prior Guidelines should be retained, whether medicines should continue to be classified by therapeutic class comparator characteristics, and whether the Board should accord more weight to one or more of the “excessive price” factors in section 85 of the Patent Act.
- Transition to PMPRB11 – New versus Existing Medicines. Specific questions on this theme relate to the measure for commencing investigations based on international price (e.g., median or highest international price), the process for initial review and monitoring when there are few or no international prices, and whether expedited review based solely on prices being below the median international price (MIP) would accelerate introduction of innovative medicines.
- Price Reviews during Product Life Cycle. Specific questions on this theme relate to how often price reviews should be conducted, what criteria besides time should be used to trigger price reviews, whether the relative weighting of section 85 “excessive price” factors should change over the life of a medicine, how the PMPRB should treat the allowable CPI increase, and the ideal timing for scientific review and therapeutic comparator identification.
- Investigations and Referral to Hearing. Specific questions on this theme relate to whether the investigation criteria in the prior Guidelines are still appropriate (assuming adjustment to PMPRB11), how much detail should be set out regarding what happens once an investigation is opened, and whether the PMPRB should continue to use Voluntary Compliance Undertakings as an investigation closure mechanism.
- Relation to pan-Canadian Health Partners, Insurers (Private and Public); and Alignment with Broader Government Initiatives. Specific questions on this theme relate to what efficiencies could be gained by coordinating PMPRB decisions and timelines with those of health technology assessment bodies (CADTH, INESSS) and pCPA/insurer price negotiations; as well as how the PMPRB can optimize its presence in the bio/pharmaceutical ecosystem and support a whole-of-government approach to issues relating to patented medicines.
- Engaging with Patients, Health Practitioners, Pharmacy, and other Stakeholders. Under this theme, the PMPRB states that its objective is to seek feedback from stakeholders who are not rights holders. Specific questions on this theme relate to experience with innovative medicines and their list prices, the role PMPRB Guidelines play in decision-making in Canada and globally, questions regarding the price review of drugs for rare diseases, and how the PMPRB can better engage.
Together with the scoping paper, the Board released details for registration in policy roundtable discussions scheduled to take place December 5 (English) and December 6 (French). The deadline for registration in the roundtables is November 24, 2023.
The deadline for written submissions in response to the scoping paper is December 20, 2023. The Board indicated that a “What We Heard” document will be released in 2024.