Private: Gallery Post #1

30

Jun2022

PMPRB Updates: Proposed Interim Guidelines Published

PMPRB Launches Consultation on its Proposed Interim Guidance Today, June 30, 2022, PMPRB published a proposed set of Interim Excessive Price Guidelines and has invited stakeholders to comment on the approach before July 18, 2022. This Interim Guidance outlines PMPRB’s intentions ... Read More

28

Jun2022

PDCI welcomes François-Xavier Houde to the Team
 

François-Xavier has joined PDCI Market Access as a Senior Health Economist. He is responsible for leading the conception and development of strategic, evidence-based economic components for submission to Canadian Health Technology Assessment (HTA) bodies and public/private payers. Among other roles, he ensures that PDCI is ... Read More

05

May2022

CADTH Update: Advice on Real-World Evidence (RWE) by Scientific Advice Program

On May 3, 2022, CADTH announced the mandate expansion of the Scientific Advice Program to include advice on RWE generation plans after protocols for pivotal trials are finalized. What to know: The expanded program will run for a 1-year learning ... Read More

25

Apr2022

The PMPRB to consult on a different set of guidelines

On April 14, 2022, Health Canada announced that the government will:  Proceed only with the proposed amendments to the Regulations pertaining to schedule of reference countries (the PMPRB11 replacing the PMPRB7).   Not proceed with new excessive price factors (cost effectiveness, market size, GDP) nor the reporting of third-party ... Read More

11

Apr2022

CADTH: New Clinical Evidence Template Requirement for October 2022 Submissions

The Canadian Agency for Drugs and Technologies in Health (CADTH) has published Issue 28 of its Pharmaceutical Reviews Update. Below PDCI has summarized the updates and clarifications, and provided implications for manufacturers. CADTH’s update also includes two consultations open until April 14, one concerning a streamlined drug class ... Read More

04

Apr2022

PMPRB 2020 Annual Report Shows Almost 30% Decrease in New Patented Medicines Reported Since 2018

On March 31, 2022, PMPRB published its 2020 Annual Report on its website. Key statistics reinforce concerns about Canada’s continued attractiveness for new medicine investment and launch since drug pricing reform began in 2017. Statistical Highlights201820192020Total # of Patented Medicines for Human Use Reported ... Read More

25

Mar2022

Supreme Court Dismisses Attorney General’s Application for Leave to Appeal FCA decision in PMPRB Alexion Soliris Matter

On September 29, 2021, the Attorney General of Canada applied for leave to appeal to the Supreme Court of Canada concerning the Federal Court of Appeal’s (FCA) July 2021 decision in Alexion Pharmaceuticals Inc v Canada (Attorney General). On March 24, 2022, the Supreme Court of Canada ... Read More

22

Feb2022

Quebec Court Strikes 2 of 3 PMPRB Changes

On February 18, 2022, the Quebec Court of Appeal ruled that two of the three major proposed changes to the PMPRB price regulations are unconstitutional: As more information becomes available, PDCI will share further insights and implications for ... Read More

14

Feb2022

Reminder: Form 3 filing is due to the PMPRB On March 1, 2022

This is a reminder to patentees of their filing requirements respecting revenues and development expenditures. These filing requirements are contained in section 5 of the Patented Medicines Regulations. The Annual Form 3 filing to the PMPRB is due on March 1, 2022. As ... Read More

31

Jan2022

Updates to the Ontario Guidelines for Drug Submission and Evaluation

The Ontario Ministry of Health has recently updated the Ontario Guidelines for Drug Submission and Evaluation (Guidelines). In an effort to reduce complexity and simplify their policy document, specific guidelines aiming to address individual product types are now available on the Ontario Ministry of Health website.... Read More