Archived Content
Day 1 | Day 2
Tuesday, November 6
8:00-8:20am Morning Coffee
8:20 Chairperson’s RemarksJoshua Cohen, Ph.D., Senior Research Fellow & Assistant Professor, Tufts Center for the Study of Drug Development
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
Jerry Conway, Vice President, Reimbursement and Payer Strategy, Foundation Medicine, 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 Morning Session
1:20 Chairperson’s RemarksRichard K. Schatzberg, President, Founder and CEO, Meta Diagnostic
1:30 A Payer’s Perspective: Generating Evidence for Reimbursement of Diagnostics
Richard K. Schatzberg, President, Founder and CEO, Meta Diagnostic
Payers often lack information regarding the clinical utility and comparative effectiveness of genomic/biomarker and other diagnostic tests to make informed reimbursement decisions. Conversely, Diagnostic developers often do not have those same data needed to establish and support the value of their products to payers, providers, and patients. Regulators are strongly advocating the development and use of targeted therapies for better patient outcomes and cost effectiveness, as well as the data documenting and supporting their validity and clinical utility. This discussion will examine the development of the optimal data package through the eyes of payers, prospective and retrospective analytical approaches to the needs of all key stake holders: payers, physicians and patients.
2:00 Evidence-Based Reimbursement for Diagnostic Tests; Proving the Value
Robert H Christenson, Department of Pathology, University of Maryland
Demonstrating the ‘value’ of a diagnostic test requires proving that tested patients have better health and/or improved process of care outcomes compared to patients who do not have the test. Improved outcomes can only be achieved if the test is linked to clinical action and fulfils an unmet clinical need or results in more successful screening, diagnosis, prognosis or management of patients. Quantifying the diagnostic test’s contribution to more effective clinical action is the essence of value.
2:30 Evidence-Based Reimbursement for Diagnostic Tests: Delivering the Value
Christopher P Price, Primary Healthcare Sciences, University of Oxford, United Kingdom
Delivering the value of a diagnostic test requires a value proposition built on evidence of utility and integration into the care process to deliver the outcome. The value proposition comprises value to the patient and the healthcare provider, the latter focused on resource consumption. Currently reimbursement is based on resource consumption, providing little incentive for realisation of value. Linking requirement for evidence of effectiveness to level of reimbursement will encourage better use of tests and improved outcomes.
3:00 Refreshment Break in Exhibit Hall
3:30 How to Develop and Execute Successful Evidence Strategies for Stand Alone and Companion Diagnostics
Anita J. Chawla, Ph.D., Managing Principal, Analysis Group
Little guidance is available to test developers on the evidence needed to demonstrate the value of their innovations and secure favorable pricing, nor are there effective structures for establishing coding and reimbursement. The optimal approach must consider characteristics of the innovation, whether the test is developed with a companion therapy, and the potential impact on economic/clinical outcomes. We provide a framework for developing the right evidence strategy and share lessons learned from examples in the marketplace.
4:00 Evidence of Clinical Utility and Validity - Requirements for Reimbursement of in vitro Diagnostics
Hua Gong, M.D., Ph.D., Executive Director, IVD, D-Target, a Premier Research Company
The requirements for clinical evidence will be increasing. The test results needs to be actionable and better than empirical practice. Conducting clinical trials places significant development and financial demands on IVD companies. Novel trial designs such as a multiple endpoint trial and adaptive trial design may help reduce the study cost and maximize the potential market.
4:15 Sponsored Presentation (Opportunity Available)
4:30 Clinical Development of a Gene Expression-Based Diagnostic for Molecular Diagnoses of Tumors
Catherine A. Schnabel, Ph.D., Senior Director, Medical & Scientific Affairs, bioTheranostics, Inc.
Innovative molecular diagnostics hold great promise as tools to inform individualized treatment and to support cost effective healthcare. The current lack of evidentiary standards for demonstrating clinical utility limit the adoption and impact of molecular tests, which play an integral role in the practice of personalized medicine. This presentation will overview perspectives and propose a framework for developing clinical utility and effectiveness through discussion of CancerTYPE ID, a 92-gene expression-based assay for molecular classification of tumors. In particular, clinical studies of analytical validity, clinical validity, and clinical utility will be presented along with highlighting how the clinical value story is organized for various healthcare stakeholders.
5:00 End of Day, Registration for Dinner Short Course
6:00 - 9:00 pm DINNER SHORT COURSE*
Reimbursement of Cancer Genomic Analysis
Jerry Conway, Vice President, Reimbursement and Payer Strategy, Foundation Medicine, Inc.
David Parker, PH.D., Vice President, Consulting, Boston Healthcare Associates
Genomic analysis of cancer has been established as an integral part of cancer patient management as well as of cancer clinical trials. The volume of this category of molecular testing is growing and more and more laboratories include it in the “test menu” and/or “services provided”. Hereby, the issue of reimbursement of clinical genotyping of cancers is at utmost importance for laboratories and molecular diagnostic companies. The situation is complicated by the fact that pharmaceutical companies working in the field of personalized oncology possess vested interest in these matters because many of the tests are falling in the category of companion diagnostics. The landscape of the diagnostics reimbursement in the health care industry is changing dramatically, as the usual mixed bag of payers is being compressed now by the reimbursement decisions of the number one customer : The US Govermnent.
High value diagnostic tests that carry expensive price tags are under the radar of payers as potential waste or major drivers of cost savings and superior outcomes. The reimbursement decisions in this country are going to be gradually shifting from well defined or arbitrary codes to more analytical categories based on the clinical utility the tests bring to the system. Traditionally, Diagnostics and Pharmaceutical companies have not been used to this type of payment criteria, and therefore might not be fully prepared to successfully navigate this new turbulent waters.
In this workshop we will present , analyze and discuss the following points.
- Overall situation of the reimbursement landscape today
- Coding, Coverage, Policies and payment fees for cancer genomic tests
- The Medicare /CMS new view of the value of new tests
- The view from large Insurance payers
- How to generate cost effectiveness data that payers will buy into
- How to generate clinical utility data that payers will endorse
- Case studies in Pathology, Molecular Diagnostics, Proteomics, Gene Expression, Nest Gen Sequencing.
* Separate registration required
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