On Friday, October 23, the Patented Medicine Prices Review Board (PMPRB) released final Guidelines that are intended to take effect on January 1, 2021, together with the scheduled coming-into-force of amendments to the Patented Medicines Regulations (the Amendments).
According to the PMPRB:
The Guidelines provide information on the PMPRB’s general approach to the price review process and investigations. They supersede all previous guidance documents, policy communiqués and written or verbal statements of any kind by the PMPRB regarding the administration of the price review process and investigations, including all previous versions of the PMPRB’s Compendium of Guidelines, Policies and Procedures.
The PMPRB also released its October 2020 NEWSletter, which addresses a number of topics relating to the Amendments and the new Guidelines.
Changes to the Guidelines
The October 2020 NEWSletter identifies the following changes since the last version of the Draft Guidelines (discussed in our earlier post here):
- “The reassessment for Grandfathered and Line Extension medicines limited to HIP”. The list price ceilings for these medicines is set at the lower of (i) the highest international price (HIP) or (ii) the ceiling price under the previous Guidelines. An “extra reassessment provision”, which would have required further reductions to the median international price (MIP) in some situations, has now been removed.
- “Vaccines to be subject to the same complaints-based investigation criteria as patented biosimilars and generics”. The comments indicate that these medicines will not be subject to price review or investigation unless a complaint is received by the PMPRB, though they remain subject to reporting requirements.
- “Maximum Rebated Price (MRP) not a trigger to investigation”. The comments indicate that “absent a complaint being filed, the PMPRB will only commence an investigation into the price of a Category I medicine where it appears that the patentee has failed to comply with the Maximum List Price (MLP).” The PMPRB explains, “the MRP may become a relevant consideration in an actual investigation or in the context of a hearing before the Board.”
- “Allowing for increases in the Maximum Rebated Price for Category I new medicines to the Maximum List Price level”. The comments explain that this is in contrast to the Draft Guidelines, which only permitted downward adjustment.
- “Reduction in the Pharmacoeconomic Value Threshold (PVT) for Therapeutic Criteria Level IV”. The comments explain that the PVT for TCL IV medicines has been reduced from $150,000/QALY to $100,000/QALY, while TCL II and III medicines are subject to a $150,000/QALY threshold and TCL I medicines are subject to a $200,000/QALY threshold.
- “Guidelines Monitoring and Evaluation Plan (GMEP)”. The comments explain that the GMEP will “assess the impact of the Guidelines and inform any future adjustments required to ensure that they are working as intended.” The PMPRB has indicated that it will seek input from stakeholders on the “scope and methods” to be used.