NPC to Discuss Role of Pharmaceuticals, Applying Real-World Evidence at ISPOR Annual Meeting

NPC invites you to join us for a pre-conference symposium, panel presentations and poster sessions on issues ranging from the role of pharmaceuticals in accountable care organizations to the practical application of real-world evidence. We’ve highlighted the topics, sessions and speakers below to make it easier for you to connect with us. Also, be sure to visit NPC at booth #57 for more information on our latest research and policy issues.
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Planning to attend the International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR) 19th Annual International Meeting in Montreal May 31-June 4? The National Pharmaceutical Council (NPC) invites you to join us for a pre-conference symposium, panel presentations and poster sessions on issues ranging from the role of pharmaceuticals in accountable care organizations to the practical application of real-world evidence. We’ve highlighted the topics, sessions and speakers below to make it easier for you to connect with us. Also, be sure to visit NPC at booth #57 for more information on our latest research and policy issues.

Sunday, June 1, 2014

5:15 pm - 6:15 pm: You Get What You Pay For: Will ACOs Underuse Drugs? (Room 518abc)
Accountable care quality measures focus on a limited number of conditions and do not include those where medications are costly. Where are there gaps that could leave patients vulnerable to mismanagement and suboptimal care? Are current measurement methodologies reliable? Have providers reached the saturation point of how much they can measure? What are possible solutions?

  • Tom Valuck, MD, JD, partner, Discern Health
  • Robert Epstein, MD, MS, president & CEO, Epstein Health, LLC
  • Andrew Baskin, MD, interim chief medical officer; national medical director, Quality and Provider Performance Measurement, Aetna
  • Kimberly Westrich, MA, director, health services research, NPC (moderator)

Monday, June 2, 2014

8:30 am - 2:15 pm: Poster Presentations

  • The State of the Comparative Effectiveness Research Environment: Surveys of Stakeholders and Influentials (PHP80)

11:00 am - 12:00 pm: Real-World Evidence: Is It Fit for Purpose? And If So, When? (Room 519ab)
Despite the demand for better evidence on how treatments work in the real-world, few payers use real-world evidence in coverage or formulary decisions. This is complicated by evidence hierarchies that base evidence utility on study design rather than whether the evidence fits the purpose needed (“fit for purpose”). Better understanding is needed of the scenarios or circumstances when a specific research design is preferred. When are both needed? When is information from a variety of sources complementary? Without greater clarity there is the potential for misuse or non-use of evidence to inform payer decision-making.

  • Raj Sabharwal, MPH, senior manager, AcademyHealth
  • Steven Pearson, MD, MSc, FRCP, president, Institute for Clinical and Economic Review
  • Reed Tuckson, MD, FACP, managing director, Tuckson Health Connections
  • Jennifer S. Graff, PharmD, director, comparative effectiveness research, NPC (moderator)

Tuesday, June 3, 2014

8:30 am - 2:15 pm: Poster Presentation

  • Healthcare Spending Patterns In High Resource Patients (PHS134)
  • The Value of Specialty Biopharmaceuticals: Are They Worth Their Price? (PIH30)

11:00 am- 12:00 pm: Guidelines and Standards for Observational Studies: Are We Headed for Discourse or Harmony? (Room 710a)
The need for determining how to conduct high-quality observational studies is particularly acute now given the desire to produce valuable evidence for comparative effectiveness research decisions. While research standards for conducting observational studies have evolved and proliferated, currently there are not uniform standards for observational studies. Do we need standards for observational studies or will such standards stifle innovation? If we need standards, should there be one set or will many suffice and be more supportive of high-quality research?

  • Sally C. Morton, PhD, professor & chair, University of Pittsburgh
  • Rachael Fleurence, PhD, program director, Comparative Effectiveness Research Methods and Infrastructure Program, Patient-Centered Outcomes Research Institute (PCORI)
  • Jean Slutsky, PA, MSPH, program director, communication and dissemination research, PCORI
  • Robert W. Dubois, MD, PhD, chief science officer, NPC (moderator)

11:00 am - 12:00 pm: The Next Frontier for Risk-Sharing Agreements in the United States: Does the Changing Health Care Landscape Bring New Promise for Partnerships Between Manufacturers and Payers? (Room 710b)
Risk-sharing agreements have been leveraged frequently in Europe, and offer the potential for earlier access to new products by linking coverage and reimbursement levels to real-world performance or utilization of the product. There are potential advantages for patients, payers and manufacturers; however, the dearth of schemes in United States raises questions as to why their use has been limited and also as to what might become feasible in the rapidly evolving health care system, especially with the new emphasis on accountable care organizations.

  • Peter J. Neumann, ScD, professor & director, Tufts Medical Center
  • Adrian Towse, MA, MPhil, director, Office of Health Economics
  • Lou Garrison, PhD, professor, Pharmaceutical Outcomes Research and Policy Program, School of Pharmacy, University of Washington
  • Josh J. Carlson, MPH, PhD, assistant professor, University of Washington (moderator)

3:45 pm - 4:45 pm: How Can We Use Randomized Trial Data to Assess Heterogeneity of Treatment Effects? Let Me Count the Ways (Room 710a)
A variety of methods are available for exploring heterogeneity of treatment effect (HTE) from both prospectively designed studies aimed to test for HTE as well as retrospective analysis of individual or published trial data. This workshop will discuss a range of research approaches for evaluating HTE, and will demonstrate a selected set of these approaches including: 1) Systematic review of clinical trial reports and other sources; 2) Repeated period cross-over studies and series of n-of-1 trials; and 3) Various types of individual patient data and meta-analysis. By delineating the strengths and limitations of these methods, this workshop is meant to better enable outcomes researchers to understand aspects of HTE in the context of patient-centered outcomes research.

  • Robert W. Dubois, MD, PhD, chief science officer, NPC
  • C. Daniel Mullins, PhD, professor, University of Maryland School of Pharmacy
  • David M. Kent, MD, MSc, associate professor of medicine, neurology, clinical and translational science, Tufts Medical Center
  • Richard Willke, PhD, group lead, outcomes & evidence, Pfizer Inc