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Generating Evidence for Reimbursement Decisions: Therapeutics Conference - Day 2


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Tuesday, October 22nd


Therapeutics Cross  

PLENARY SHARED SESSION: EVIDENCE-BASED REIMBURSEMENT IN PERSONALIZED MEDICINE /COMPANION DIAGNOSTICS  

7:30-8:20 am Morning Coffee

8:00 Problem Solving Breakout Discussions  

Concurrent Problem Solving Breakout Sessions are interactive, topic-specific discussions hosted by a moderator. These sessions are open to all attendees, sponsors, exhibitors, and speakers and provide a forum for discussing key issues and meeting potential partners.

 

TABLE 1: Reimbursement of Companion Diagnostics  

Laura Housman, MPH, MBA, SVP, Chief Commercial Officer, Molecular Health

 

TABLE 2: Oncology Reimbursement: Evidence Considerations 

Roy D. Baynes, M.D., Ph.D., Senior Vice President, Oncology Therapeutics, Gilead Sciences, Inc.

 

  • Generalizability and hierarchy of evidence 
  • Subset analyses for which the study was not randomized 
  • Indirect treatment comparisons 

 

 

TABLE 3: Pharma-Payers Collaboration: Approaches and Logistics 

Rebecca Chiappinelli, RPh , Director Business Development, HealthCore, Inc. (A WellPoint Company)

 

8:55 Chairperson's Remarks

David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine

9:00 Leaning In: Successful Strategies as a Manufacturer to Engage Payers in Diagnostic Technology Assessment and Coverage

Laura Housman, MPH, MBA, SVP, Chief Commercial Officer, Molecular Health

There has never been a more dynamic opportunity for diagnostic manufacturers to demonstrate their assay utility and advocate for commensurate value from payors. What is considered utility? Is it measureable improvement in patient outcomes based on patient management changes directed by the result of the test? Or, a change in patient management based on test results that is expected to benefit the patient? Or some combination? And how should a manufacturer prepare for evolving and incomparable assessment criteria across payors? Strategies, opportunities for learning and anticipation of future changes will be shared.

9:30 Translating Clinical Need into Clinical Utility that Delivers Payer Value

David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine

Diagnostic test development often begins with the identification of an unmet clinical need that is particularly amenable to addressing with a company’s platform and proprietary technology. Often this process is driven by interaction between clinical KOLs and the company’s scientists. Unfortunately, meeting clinical needs as expressed by front-line physicians does not necessarily deliver high-value clinical utility as perceived by payers. When that happens, a diagnostic test innovator can “win the battle, but lose the war”. In this session, we will share practical approaches to this real-world problem, such as: identifying clinical needs with high payer impact; selecting clinical utility propositions that payers will value; distinguishing between potential and realizable payer value; and matching company resources and business goals with clinical utility evidence needs.

10:00 Coffee Break in the Exhibit Hall

10:30 Oncology Drug Development - Meeting The Evidentiary Needs of Various Stakeholders

Roy D. Baynes, M.D., Ph.D., Senior Vice President, Oncology Therapeutics, Gilead Sciences, Inc.

11:00 Building an Effective Reimbursement Strategy for the Era of Personalized Medicine

Jerry Conway, Vice President, Reimbursement & Payer Strategy, Foundation Medicine, Inc.

As the industry moves farther away from a “one-size-fits-all” approach to prescribing medicines, the use of diagnostic tests and targeted therapies to fuel healthcare decisions has never been greater. The field of personalized medicine is advancing at a rapid pace, offering several advantages to healthcare providers and patients - namely, the ability to make more informed medical decisions, eliminate unnecessary treatments and reduce the probability of adverse drug reactions. The result is a higher probability of desired health outcomes and reduced healthcare costs. During this session, we will align current reimbursement and market access strategies with recent and future developments in the field of personalized medicine.

SimulConsult11:30 Automatable, Evidence-Based Prior Authorization for Gene Tests: A Reality Now

Lynn Feldman, MBA, CEO, SimulConsult

Reimbursement relies at its core on a decision of medical necessity. Today, approval remains mostly arbitrary and time-consuming.  An NIH-funded study showed that using patient’s symptoms and existing clinical diagnostic decision support tool scan document medical necessity in a consistent, automatable, evidence-based way for all inherited diseases. It’s time to establish evidence-based, prior authorization as the standard in genetic testing.

11:45 Evaluating Novel Diagnostics for Reimbursement

Elaine K. Jeter, M.D., J1 MolDx Medical Director, Palmetto GBA

12:00pm Panel Discussion: Evidence-Based Reimbursement for Evidence-Based Personalized Medicine: Does Any of It Exist?

Moderator:David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine

Panelists: Speakers of the Session 

12:30 Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own


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