The Patented Medicine Prices Review Board Provides an Update on its Activities
The Patented Medicine Prices Review Board (PMPRB) released its first Newsletter of 2017. This bulletin provides updates related to:
- Guidelines Modernization
- Upcoming Reports: NPDUIS Update
- New Policy: Complaint process for patented generic-drug price reviews
- PMPRB Governance/Administration
- Status of Ongoing Hearings
- Regulatory Details: CPI Adjustment Factors for 2017
Please see summary below for further information:
Submissions from Phase 1 of the consultations are being analyzed by the PMPRB. Timelines for Phase 2 of the consultation process will be announced at a later date.
Upcoming Reports: NPDUIS Update
A number of studies are planned for publication over 2017-18:
A Canadian Budget Impact Analysis on potential savings from Biosimilar drugs
The Canadian Drug Reimbursement Landscape: A Review of Public and Private Markets
New Policy: Complaint process for patented generic-drug price reviews
PMPRB will be moving patented generic drug price reviews to a complaint-based process, similar to the provisions for new and existing veterinary and over the counter drug products.
In accordance with the applicable guidelines and policies, an investigation into the price of a patented generic drug will be commenced if all the following conditions are met:
- a substantiated complaint has been received in respect of the patented generic drug;
- the patentee of the patented generic drug is the only company in Canada selling a generic version of the drug in Canada; and
- the patented generic drug is not the subject of a pricing agreement with the pan-Canadian Pharmaceutical Alliance (pCPA), to which it is compliant. The onus of proving to PMPRB staff that a patented generic drug is subject to, and compliant with, a pricing agreement with the pCPA will rest with the patentee for that patented generic drug.
Dr. Mitchell Levine has been reappointed for a 2nd 5-year term to the Board.
Ginette Tognet, Director of Regulatory Affairs and Outreach retired in December 2016 after 18 years of service with the PMPRB. Richard Lemay will be acting Director until Ginette’s successor, Matt Kellison, joins the PMPRB in early 2017.
Status of Ongoing Hearings
The newsletter provided updates on 3 hearings – Alexion Pharmaceuticals Inc. (Soliris), Galderma (Differin, Differin XP), and Baxalta Canada Corporation (Oncaspar). The hearing panel resolved the matter with Baxalta and has requested additional pricing and sales information from Galderma for the period covering January 1, 2010 and March 10, 2014. The public hearings from Alexion will resume on February 20, 2017 in Ottawa.
Regulatory Details: CPI Adjustment Factors for 2017
The following table provides the CPI-based price-adjustment factors for 2017. These factors were based on the actual rate of CPI inflation of 0.9% in 2013, 2.0% in 2014, and 1.1% in 2015.
Based on these factors, one can derive:
- a maximum allowable cumulative price increase between 2014 and 2017 of 4.0% for patented drug products with Canadian sales in 2014;
- a maximum allowable cumulative price increase between 2015 and 2017 of 3.1% for patented drug products with Canadian sales in 2015; and
- a maximum allowable cumulative price increase between 2016 and 2017 of 1.1% for patented drug products with Canadian sales in 2016.
The year-over-year price increase cap for the 12-month period ending December 2017 is 1.7% (=1.5 x Actual Inflation in 2015). For additional details please visit the PMPRB website.
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