IN THIS ISSUE:
National Pharmacare Update: Publication of the final report of the Advisory Council
PMPRB News
Federal Court upholds PMPRB’s pricing decision regarding Alexion’s SOLIRIS
New PMPRB Report examines most promising medicines currently in clinical trials worldwide
Health Canada News
Medical Devices Update
CADTH reports on integration of CDIAC functions into pCODR process
New Court Proceedings
National Pharmacare Update: Publication of the final report of the Advisory Council
By Urszula Wojtyra
On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the Advisory Council on the Implementation of National Pharmacare (the Council) (see also: news release and backgrounder). The Council recommends that Canada implement universal, single-payer, public pharmacare by enacting new legislation, and proceeding in a stepwise approach to implementation. As reported previously, the 2019 Federal Budget announced funding for some of the steps, including the formation of an arms-length national drug agency.
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PMPRB News
Federal Court upholds PMPRB’s pricing decision regarding Alexion’s SOLIRIS
By Katie Lee
On June 12, 2019, Justice Gleeson dismissed Alexion’s application for judicial review of a Panel of the Patented Medicines Price Review Board (PMPRB)’s (i) decision that SOLIRIS(eculizumab) was sold at an excessive price and (ii) Order fixing the amount of the payment to offset excess revenues ($4.2 million): Alexion Pharmaceuticals Inc. v Canada (Attorney General), 2019 FC 734. As described in our previous article on the PMPRB decision, the PMPRB found that the Guidelines were appropriate in assessing increases, but not appropriate in assessing the appropriate benchmark (instead, the Lowest International Price Comparison (LIPC) test was applied). The PMPRB rejected Alexion’s argument that the Guidelines were not appropriate regarding permitted increases as the fluctuations in the exchange rates and the appreciation of the Canadian dollar resulted in the Canadian price appearing higher than the international comparators, while the Canadian price remained unchanged, and in fact, decreased based on changes in the Consumer Price Index.
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New PMPRB Report examines most promising medicines currently in clinical trials worldwide
By Abigail Smith
On May 30, 2019, the PMPRB published the 2018 edition of the Meds Pipeline Monitor, a horizon scanning report which provides a snapshot of the new drug landscape (see news release). The report considered the 733 medicines currently in Phase III clinical trials or pre-registration with the US Food and Drug Administration and identified 30 that have the potential to address an unmet need, offer an improvement over existing therapies and/or treat a serious condition. These 30 medicines were also analyzed for their potential budgetary impact. Of the 30 new medicines selected, 20 were designated as orphan drugs by the Food and Drug Administration (FDA) or the European Medicines Agency (EMA) (including 8 gene therapies), 9 were oncology medicines and 3 were biologics. Future editions of this annual publication will monitor the pipeline list featured in this report.
Health Canada News
Medical Devices Update
By Katie Lee
On June 15, 2019, the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) (Regulations) were pre-published (see news release here). These proposed changes are made in accordance with Vanessa’s Law (see updated chart here).
The proposed Regulations would implement changes to the Food and Drug Regulations and Medical Devices Regulations, and, among other matters, would:
- establish a regulatory framework to require assessments, tests and studies of medical devices;
- support post-market safety through imposing notification requirements for foreign incidents which must be reported within 72 hours for medical devices; and
- require medical device licence holders to prepare annual summary reports and supporting information, related to adverse effects, reported programs, incident, and risks, similar to a provision in the Food and Drug Regulations.
Any comments are due on August 26, 2019.
Further updates: On May 29, 2019, Health Canada published amendments to the Management of Applications for Medical Device Licences Guidance Document, which was rewritten, including to update and conform to Good Guidance Practices.
CADTH reports on integration of CDIAC functions into pCODR process
By Brandon Heard
On June 12, 2019, the Canadian Agency for Drugs and Technologies in Health (CADTH) reported changes (effective July 1, 2019) to transition Cancer Drug Implementation Advisory Committee (CDIAC) functions to the CADTH pan-Canadian Oncology Drug Review (pCODR) review process. The purpose of the changes is to:
- “enhance the transparency of the pan-Canadian cancer drug review process”;
- “allow for greater stakeholder input into the development of a provisional algorithm for each new cancer drug or indication to indicate how the new therapy could be used compared to existing funded treatments; and to indicate the impact on the sequence of use for other existing funded therapies to better support jurisdictional decision-making for drug reimbursement”; and
- “streamline and reduce the duplication of administrative processes”.
The reported changes follow a period (beginning March 2019) of consultation with stakeholders.
New Court Proceedings
For complete details about these proceedings, click here.
PMNOC Actions
ESBRIET capsules (pirfenidone): Hoffmann-La Roche and InterMune v Sandoz
ZIEXTENZO (pegfilgrastim): Amgen v Sandoz
XARELTO (rivaroxaban): Bayer v Teva
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Canadian Firm of the Year
LMG Life Sciences
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Benchmark Canada
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