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Generating Evidence for Reimbursement Decisions: Therapeutics Conference - Day 1

Conference Proceeding CD Now Available
  • Speaker Presentations
  • Poster Abstracts
  • and More!
2013 Archived Content

Part 1 



It is important to formulate goals for generating, collecting, and analyzing reimbursement evidence early in product development in order to ensure commercial success of a drug or a biologic. We are witnessing the emergence of a new integrated strategy while the biopharmaceutical industry is partnering up with payers to develop evidence of a product’s validity and utility, as well as comparative clinical and cost effectiveness. The second annual Generating Evidence for Reimbursement Decisions: Therapeutics conference is designed to bring together all major stakeholders in the field of evidence-based reimbursement such as clinical development experts, reimbursement and government affairs specialists, health care economists and payers. The conference will be directly followed by the second annual Generating Evidence for Reimbursement Decisions: Diagnostics conference, with a shared session on Evidence-Based Reimbursement in Personalized Medicine/Companion Diagnostics bringing the two audiences together.

Day 1 | Day 2 | Download Brochure 

Monday, October 21st

7:30-8:15 am Conference Registration and Morning Coffee


8:15 Welcome Remarks from the Conference Director

Marina Filshtinsky, M.D., Cambridge Healthtech Institute

8:20 Chairperson’s Opening RemarksGregory Hess, M.D., Executive Vice President, Symphony Health Solutions 

8:30 Real-World Data as a Tool for Establishing the Value of a Therapeutic

Mark J. Cziraky, Pharm.D., Vice President, Industry Sponsored Research, HealthCore, Inc.

9:00 Joint Presentation: Utilizing EHRs in HEOR

Gregory Hess, M.D., Executive Vice President, Symphony Health Solutions
Sheikh Usman Iqbal, M.D., MPH, MBA, Senior Director & Head, Oncology, Global Evidence & Value Development (EVD), Medical Affairs,
Global R+D, Sanofi

Real world Data and Practice based research networks (PBNs) are key innovation platforms that provide representative assessment of the true treatment landscape and patient outcomes. PBNs can effectively provide rich information that can be systematically and strategically leveraged to optimize developmental strategy, inform decision making on trial design, execution and placement. Comprehensive assessment of unmet needs & competitive positioning followed by informed guidance on molecular epidemiology, trial design, target population is critical for both “Portfolio Prioritization & Trial Execution” as well as “Patient Access and Health Technology Assessment.” How is Pharma leveraging Big data towards drug development and what opportunities are at hand to position real world research to inform trial design and developmental Strategy?

10:00 Coffee Break

10:30 Towards a Continuous Learning Ecosystem: Data Innovations and Collaborations to Improve Clinical Outcomes and Reduce Cost of Care

Vipul Kashyap, Ph.D., Senior Director, Clinically integrated networks, NYU Langone Medical Center

A holistic view of the healthcare systems as a continuous learning ecosystem will be presented with a special emphasis on collaborations between payers, providers and pharmaceutical stakeholders. An illustrative list of different types of metrics, analytics and insights created by payers, providers and pharma is discussed along with overlaps and possible collaborations enabled by them. Examples of collaboration across various stakeholders will also be discussed. A use case scenario based on medication adherence/compliance will presented along with a discussion on how the investments and incentives required to facilitate the collaboration and realize the resulting value.

11:00 Why Hasn’t Your Real-World Data Given You the Real-World Evidence?

Hui Cao, M.D., Ph.D., Senior Director, Personalized Healthcare, R&D Information, AstraZeneca

In this talk, we try to answer the question ”why high investment on real-world data has not generated a high return” by examining true stories of failure. In recognition of the benefits, limitations and methodological challenges in using real-world data, we propose a strategy and a path forward to maximize the success of using real-world data to answer R&D and commercial questions and to support evidence generation.

Archimedes11:30 Using Simulation Modeling 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.

12:00 pm The Value and Impact of Real World Data in Healthcare Decision Making: A Case Study

Russell Knoth, Ph.D., Director, US Health Economics & Outcomes Research, Eisai, Inc.

Formulary decision making, in particular, can be enlightened by “real-world” data. Claims data are of particular value because they contain both utilization and costs, and are easily stratified by demographic, diagnostic, and treatment variables. Using a case from the oncology marketplace, Dr. Knoth will demonstrate how such an analysis can inform the value proposition of a drug for payers. The example will illustrate a classic retrospective analysis over a drug’s lifecycle, its inferred outcomes, its potential impact, and its limitations.

12:15 Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own


1:40 Chairperson’s Opening RemarksRobert Popovian, Pharm.D., MS, Senior Director, Advocacy and Professional Relations, US Public Affairs, Pfizer, Inc. 

1:45 Value-Based Pricing: Holy Grail or Fool’s Gold

J. Jaime Caro, MDCM, FRCPC, FACP, Senior Vice President, Research, EvideraEstablishing an acceptable price is the major hurdle to market access and obtaining reimbursement. The basic idea is straightforward: the price should reflect the value of the benefits provided by the product in question. But, the devil is in determining that value. The efficiency approaches based on the QALY fail because they leave too much out and are discriminatory. Will new “value-based” initiatives achieve the holy grail? Or are they doomed to fail as well?

Catenion2:15 Controlling the Cost of Cancer Drugs in Europe – HTA and the Case for a Fresh Start

Christian Elze, Senior Partner, Catenion

After briefly reviewing the rising cost of cancer drugs in Europe and the various approaches payors are taking to stem this trend, it is argued that we have collectively maneuvered ourselves into a dead end detrimental to patients, healthcare cost and innovation. To exit from this dead end, a novel reimbursement approach based on a “competitive market without prices” is presented for discussion.

2:45 What Are the Practical Drug Policies that Will Help Drive Down Health Care Spending and Improve Patient Outcomes?

Robert Popovian, Pharm.D., MS, Senior Director, Advocacy and Professional Relations, US Public Affairs, Pfizer, Inc.

Health care in the United States consumes greater than 18 percent of gross domestic product (GDP). Pharmaceuticals consume roughly greater than 10 percent of the overall health care costs. Other developed countries spend a greater percentage of their health care costs on drugs. Thus it is important to consider pharmaceutical policies that will drive down overall health care costs and improve patient outcomes.

3:15 Generating Evidence for Reimbursement Decisions: Strategies and Tactics

Josephine Sollano, Dr.P.H., Vice President, Health Economics and Outcomes Research and Medical Communications, Oncology Business Unit, Pfizer, Inc.

3:45 Refreshment Break in the Exhibit Hall

4:15 Case Study: Building a Global Value Dossier for a Novel Antibiotic and Differentiating a New Therapeutic Class

Carl Foster, Executive Vice President, Business Development, Cempra Pharmaceuticals

Unlike most other drug classes, the efficacy of antibiotics declines over time as bacterial resistance develops. Allowing pricing and reimbursement decisions to be made through reference to older antibiotics does not account for the fact that these products may no longer be effective or that the new product may reduce hospitalization costs. Using a global value dossier to differentiate a novel antibiotic will allow for pricing decisions to more accurately reflect therapeutic value.

4:45 Panel Discussion: Integrating Payer’s Perspective into Product DevelopmentModerator: Robert Popovian, Pharm.D., MS, Senior Director, Advocacy and Professional Relations, US Public Affairs, Pfizer, Inc.- How do we mesh the payer needs with regulatory expectations?
- What is the type of data that needs to be collected to ensure coverage by payers of innovative technologies?  What is the best vehicle to collect such data?  What are the principles that will ensure appropriate analysis and access to the data?
- What level of importance do reduction in overall health care costs, improvements in patient productivity, quality of life and patient satisfaction play in coverage decision by payers?  How do we ensure such parameters are meaningful in silo’d health care reimbursement schemes?
Panelists: Speakers of the Day

5:15 Welcome Reception in Exhibit Hall for Both Tracks of the Summit*

*Registration for Generating Evidence for Reimbursement Decisions: Diagnostics starts at 4:30 pm

6:15 End of Day

Day 1 | Day 2 | Download Brochure 

Conference at a Glance