Introduction
The Canadian Association for Healthcare Reimbursement (CAHR) held its first virtual Market Access 201 conference on November 24, 2020. Members of the MORSE team attended this conference and have prepared a brief summary of the key highlights.
Disclaimer: Please note, this summary is based on our team’s interpretation of the discussion.
Session 1. Keynote: Evolution of HTA in United States and the Impact on International Markets
Speaker: Dr. Dan Ollendorf, Director of Value Measurement & Global Health Initiatives at CEVR
Moderator: Tarry Ahuja, Manager – Program Development Pharmaceutical Reviews & RWE Advisor at CADTH
In this keynote, Dr. Dan Ollendorf delineated the history of the US using cost-effectiveness as a tool for decision making. He started by explaining the initial Office of Technology Assessment (OTA), and went on to describe the Agency for Healthcare Research & Quality (AHRQ), and the Patient-Centered Outcomes Research Institute (PCORI), and finally to the current Institute for Clinical and Economic Review (ICER). With the recent political and social changes affecting ICER and HTA in the US, he anticipated limitations in international market access as well as reduced prices as a result of changes in reference pricing.
Session 2. Panel: Operationalizing of Proposed PMPRB Guidelines: A Global Perspective
Speakers: Joan McCormick, Principal at IQVIA;
Chris Cameron, Senior Vice President, Data Analytics & Evidence Synthesis at EVERSANA;
Heather McDonald, Global Vice President and Head, Pricing Innovation and Implementation at Bayer Pharmaceuticals
Moderator: Kimberly Robinson, Director, Pricing and Market Access at PDCI Market Access Inc.
In the panel on operationalizing of proposed PMPRB guidelines, Joan McCormick spoke to the new PMPRB rules and the current court challenges on this subject. She described how these challenges may potentially impact the future PMPRB framework. She also gave the audience an overview of the modernization process that the PMPRB has promised to deliver. Chris Cameron then provided his perspective as a former HTA reviewer, highlighting that cost-effectiveness analysis and market size analysis will become more pivotal in pricing for Category 1 drugs for both public and private payers. Finally, Heather McDonald offered a global perspective on the new PMPRB guidelines. She commented on the PMPRB reforms and how they have introduced a great deal of uncertainty and unpredictability for manufacturers looking to enter the Canadian market, emphasizing that the reforms may restrict access to innovative health technologies for Canadians.
Session 3. Panel: Global Health Technology Assessment: Where Does Canada Fit?
Speakers: Jason Flavin, Global Senior Health Economics and Outcomes Research Manager at Boehringer Ingelheim;
Demitri Diles, Access Lead of Neuroimmunology at Roche
Moderator: Tarry Ahuja, Manager – Program Development Pharmaceutical Reviews & RWE Advisor at CADTH
From a global perspective, Jason Flavin discussed the different HTA requirements across countries, including clinically driven HTA in Germany, cost-effectiveness driven HTA in Canada, as well as budget impact driven HTA in China. He commented that global differences in HTA have decreased due to common challenges and increased collaboration between HTA/reimbursement agencies. He also spoke to the complexity of international price referencing across different reference countries, methodologies and types of reference prices. Demitri Diles then offered a Canadian perspective on HTA, showing that Canadian Market Access teams need to work closely with their Global Market Access team to proactively plan to address common inquiries from Canadian HTA agencies including clinical protocol and efficacy, real world data, regulatory affairs, and pharmacoeconomics. In a challenging reimbursement climate, such as this one, early engagement with Global Market Access teams are crucial to facilitate the reimbursement process from start to finish.
Session 4. Keynote: Role of Real-World Data (RWD) & Artificial Intelligence and Global Market Access
Speaker: Dr. Brigham Hyde, President, Data & Analytics at EVERSANA
Moderator: Tarry Ahuja, Manager – Program Development Pharmaceutical Reviews & RWE Advisor at CADTH
Dr. Brigham Hyde spoke to how RWD can help address unmet needs in the market access landscape and confront healthcare challenges such as targeted and complex therapies, and value-based contracting. Further, he recognized the shortcomings of using RWD in decision making including the lack of standardization and implicit bias in data collection, which could be mitigated by expert human curation and meticulous audit.
Session 5. Keynote: Harmonizing Real World Datasets to Maximize Value in Global Research & Development, and Market Access
Speaker: Dr. Kim Van Naarden Braun, Associate Director, Translational Epidemiology at Bristol Myers Squibb
Moderator: Tarry Ahuja, Manager – Program Development Pharmaceutical Reviews & RWE Advisor at CADTH
In this keynote, Dr. Kim Van Naarden Braun started by emphasizing that the types and sources of RWD are highly diverse. She went on to explain that RWD harmonization is required to achieve adequate sample size and increase heterogeneity of patient populations. Once harmonized, the data can then be utilized to inform market access considerations. She cautioned that the potential of RWD should be harnessed with the overarching consideration that RWD needs to be ‘fit for purpose’ with transparent and defensible reliability, validity, and relevance.
Session 6. Panel: Budgetary Pressures in a Post-COVID World. Perspective from HTA and Payers and Industry
Speakers: Kevin Leshuk, Pharmaceutical Executive at Forus Group;
Dr. Trevor Richter, Director, Pharmaceutical Reviews at CADTH
Moderator: Ferg Mills, Director, Strategic Consulting at Innomar Strategies
In this panel discussion on Budgetary Pressures in a Post-COVID World, Kevin Leshuk from the Forus Group and Dr. Trevor Richter from CADTH provided their perspectives from industry and HTA, respectively. They highlighted the unprecedented nature of the current budgetary challenge. Kevin Leshuk discussed the decline in drug development and clinical trials for manufacturers, while Dr. Trevor Richter expressed optimism in drug review programs which have continued to meet previous metrics despite the COVID-19 pandemic. They subsequently spoke to topics including stakeholder engagement, prioritization of treatments and populations at risk, and the assessment of value & acceptance of uncertainty.
