The Patented Medicines Pricing Review Board (PMPRB) has asked for comments on its proposed new guidelines, due to be enforced from next year.
Changes proposed would affect areas of market access such as: Maximum List Price (MLP) Test – International Price Comparison; Classifying a patented medicine as Category I; and Pharmacoeconomic Value (PV) Threshold & Accounting for Therapeutic Comparators – High Cost Medicines.
Under the proposals, a PV threshold could be as high as CA$200,000/QALY in some cases. In their explanation, PMPRB said:
“Pharmacoeconomic value is now a s.85(1) factor and the Board has a statutory obligation to consider it. However, until such time as there is more developed empirical evidence in Canada on opportunity cost in the public health system, an argument exists for erring in favour of more generous thresholds that are aligned with the higher end of what is seen internationally and that provide greater certainty and predictability for patentees.”
The full documentation is available here, explaining the influence of earlier consultations to produce the current draft of the guidelines.
The deadline for participation in the consultation is 20th July 2020. Follow the consultation on MAP’s consultation tracker here.