Archived Content
Day 1 | Day 2
Tuesday, November 6
8:00-8:20am Morning Coffee
8:20 Chairperson’s Remarks
8:30 Patient Access to Cancer Drugs: Can We Place Fair Limits?
Joshua Cohen, Ph.D., Senior Research Fellow & Assistant Professor, Tufts Center for the Study of Drug Development
Policymakers need to find ways of placing fair, evidence-based limits on patient access to newly approved cancer drugs. The use of comparative effectiveness research (CER) findings could help resolve the tension between providing patients with adequate access to cancer drugs while containing cost growth. Our study comparing patient access to recently approved (2000-2011) cancer drugs in the US and Europe shows that Europe’s use of CER has resulted in restrictions on access, while US payers cover virtually all drugs with much higher patient cost sharing. On the one hand, use of CER by reimbursement authorities may restrict access to drugs deemed not clinically- and cost-effective. At the same time, CER creates conditions for a more affordable, equitable system of access. Although more oncology drugs are available in the US, and a higher percentage of them are covered, the evidence-based approach adopted by European systems has led to lower prices, improving the affordability of drugs considered cost-effective by the reimbursement authorities. In the US, the coverage with evidence development model offers a compromise solution to the problem of placing fair limits, as it provides patients with immediate access to newly approved drugs while generating evidence to assess their relative clinical effectiveness.
9:00 Creating and Applying Successful Strategies for Diagnostic Coverage and Reimbursement
Laura Housman, MPH, MBA, Vice President, Global Market Access, Pricing and HE&OR, Novartis Molecular Diagnostics
The landscape for understanding what is needed to demonstrate value for diagnostics is ever-shifting, but with change comes great opportunity for those who readily anticipate and address the dynamics. Discussion will focus on the landscape and dynamics as well as illustrating a case study of a process and approach to success for assay coverage, reimbursement and differentiation with payors and HTA.
9:30 Coding and Payment Landscape for Companion Diagnostics
Ester Stein, MBA, Director, Corporate Reimbursement and Government Affairs, Abbott Molecular
We are now seeing accelerated growth in the area of personalized medicine with the emergence of more targeted therapies becoming available to patients. The reimbursement landscape is evolving particularly for companion diagnostics. It is important for all stakeholders in this process to understand the challenges for coverage, coding and payment for molecular diagnostics.
10:00 Using Virtual Population Simulation to Generate Evidence for Reimbursement Discussions
Badri Rengarajan, M.D., Medical Director, Archimedes, Inc.
Product sponsors often have to negotiate reimbursement when they do not yet have a complete dataset (including long-term outcomes and real-world usage). Unfortunately, this makes it challenging to secure a high reimbursement price. Full-scale simulation modeling with virtual patients proceeding through a virtual healthcare system can generate longitudinal data in real-world settings in a matter of days, thereby changing the tone of the negotiation and potentially supporting a higher reimbursement.
10:15 Coffee Break in Exhibit Hall
10:45 Partnering with Payers to Shift to Value-Based Reimbursement
Douglas J. Moeller, M.D., Medical Director, Claims Performance & Advanced Diagnostics Management, McKesson Health Solutions
Several critical trends in the market are making it more difficult for Laboratories to get reimbursed for the advanced diagnostic tests they perform. For many labs, partnering with Health Plans may be the answer to not only improve reimbursement, but also to move towards an environment where they are reimbursed on value. Attendees will gain an understanding of those trends impacting the reimbursement of molecular and genetic tests and uncover the opportunities to partner with payers to move towards value-based reimbursement.
11:15 The Impact of Personalized Medicine and Genomics on the Development and Coverage of Targeted Diagnostics
Wendy Wifler, Senior Director, Government Affairs, Agendia, Inc.
The move toward providing the right treatment to the right person at the right time has influenced the development of targeted diagnostic tests. Personalized Medicine is now gaining traction in multiple disease areas due to progressive innovation and next generation thinking. In this session, attendees will examine reimbursement trends, how payors are making coverage and payment decisions, and, most importantly, real world strategies to optimize value-based reimbursement in today’s challenging healthcare marketplace.
11:45 The Role of Technology Assessment in Informing Coverage Decisions
Elise Berliner, Ph.D., Director, Technology Assessment Program, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality
Description of the role of AHRQ as a science partner to the Medicare coverage group. In this presentation I will explain the methods used by AHRQ in technology assessment and provide recent examples of assessments.
12:15 End of Generating Evidence for Reimbursement Decisions: Therapeutics
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