Health Economics of Personalized Genomic Medicine Conference - Day 1


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Stratified genomic medicine is a new reality that brings tremendous advantages to the patients and some puzzling questions to pharmaceutical and biotech companies, healthcare providers and laboratories. The key questions are: who is going to pay for the innovation in pharma and healthcare, and how we can measure the cost-benefit ratio while providing state of art care. Health Economics of Personalized Genomic Medicine is designed to bring together major stakeholders and to search for the answers to these pressing questions.

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Monday, November 17

7:30 am Conference Registration & Morning Coffee

APPLICATION OF HEALTH ECONOMICS TO DEMONSTRATE VALUE OF PERSONALIZED THERAPY: EVIDENCE CONSIDERATIONS 

8:30 Chairperson’s Opening Remarks

8:40 Evidence Needs When Developing a Personalized Medicine

JosephineSollanoJosephine A. Sollano, Dr.PH, Vice President, Outcomes & Evidence, Global Health and Value, Pfizer, Inc.

As the development of oncologics and other specialty and biologics become increasingly targeted, pharmaceutical manufacturers must develop new approaches to demonstrating value. Often times the standard approaches to the generation of cost-effectiveness and outcomes evidence do not adequately address particular aspects that the new medicine delivers to patients, payors, and society. In this discussion we will examine new approaches to unlocking value for targeted therapies including those with companion diagnostics.

9:10 Meeting the Evidentiary Needs of Various Stakeholders

RoyBaynesRoy D. Baynes, M.D., Ph.D., Senior Vice President, Global Clinical Development, Merck

Meeting the complex and evolving evidentiary needs of various stakeholders represents a significant ongoing challenge and opportunity for industry. Additionally scientific progress has increasingly led to innovative novel agents with unambiguous large effect sizes in grievous disease and with clear advantage over current therapies. This has in certain areas led to a marked expansion of the addressable incident and prevalent populations and, despite demonstrable value, a significant increase in budgetary pressure. It is key that innovation penalties not limit advancing these important therapies for patients.

9:40 Pharmacogenetic-Guided Intervention: Where Are We and where Are We Headed?

GregoryHessGregory Hess, M.D., Senior Fellow, LDI Health Economics & Policy, University of Pennsylvania

This session will examine the growth of pharmacogenetic testing to guide therapeutic selection and interventions across a variety of disease areas. The discussion will include reported measures of effectiveness and outcomes, including an in-depth case study of psychiatric intervention, observed adherence and cost impacts. Trends and future directions for genetic guided interventions including potential payment models and pricing implications will be discussed.

10:10 Networking Coffee Break

10:40 Application of Health Economics to Demonstrate Medical Value of Companion Diagnostics

UsmanIqbalUsman Iqbal,M.D., Senior Medical Affairs Leader, Neuroscience, Global Medical Affairs, AstraZeneca

Companion diagnostics, either genomic or tumor-based, can readily influence efficacy gains and personalize treatment at the patient level. However the use of molecular diagnostics to aid treatment decisions has been restricted in many areas due to economic and coverage restrictions. The presentation will provide a framework to apply health economic considerations in genomic medicine and discuss methodological techniques that can demonstrate the clinical and economic utility of molecular diagnostics.

11:10 Justifying Next Generation Sequencing in the Clinic: Lessons from Cost-Effectiveness Analysis

MarkNunesMark E. Nunes, M.D., Associate Professor, Pediatrics, Division Chief, Medical Genetics, Kaiser Permanente

To produce financial and utility tools justifying clinical exome sequencing, we performed cost-effectiveness analysis (CEA) of next generation sequencing (NGS) multi-locus panels in congenital hearing loss evaluations. Total, average, and marginal cost per diagnosis established were determined for sequential (single gene, then NGS) and “NGS only” testing schemes introduced at varied points in the Diagnostic Odyssey. NGS introduced early in hearing loss evaluations demonstrated effective, saving time, money, and access.

SUPPORTING PHARMACEUTICAL INNOVATION 

11:40 Evolution of Pharmaceutical Innovation

RobertPopovianRobert Popovian, Pharm.D., Senior Director, US Government Relations, Pfizer, Inc.

Pharmaceutical innovation is critical to the long-term health of our economy. Supporting pharmaceutical innovation is a complex issue where several policy issues intersect and impact the final outcome. It is shortsighted to focus on any single issue as the primary driver of pharmaceutical innovation.

Such complex course of action requires a regime that facilitates this dynamism and a public that understands its machinations.

12:10 pm Sponsored Presentations (Opportunities Available)

12:40 Luncheon Presentation (Sponsorship Opportunity Available)

1:10 Session Break

PRICING AND REIMBURSEMENT OF STRATIFIED MEDICINE 

2:00 Chairperson’s Remarks

2:10 Precision Pricing for Precision Medicines

FinleyAustinFinley Austin, Ph.D., President, Founder, RxDx Experts

The failure of current pricing and reimbursement practices to incent companion diagnostics development is a well recognized impediment to targeting medicines. A novel approach that supports patient response evidence collection and companion diagnostic development post-drug launch will be described. The new model both creates and rewards better patient outcomes. While not applicable to all medicines it applies to many treatment regimes underdevelopment.

2:40 Demonstrating Product Differentiation

StephanieDysonStephanie Dyson, Senior Director, Government Affairs, Genentech

The reimbursement landscape will be challenging in 2014 and beyond. It has become more apparent that regulatory success does not automatically equate to commercial success. By understanding “market access” implications during development companies can design the right trial, better leverage “evidence-based” or “outcome-based” medicine, and eliminate “access hurdles” by demonstrating patient, payer and provider value.

Manufacturers must develop an informed view of the market and develop a process that evaluates elements that can impact the future success of a product such as challenging traditional assumptions and understanding the broader commercial issues impacting a product.

3:10 Sponsored Presentations (Opportunities Available)

3:40 Networking Refreshment Break

CHANGING REIMBURSEMENT ENVIRONMENT 

4:10 Panel Discussion: Changing Reimbursement Environment to Move Precision Genomic Cancer Treatment fORWARD

Moderator: Jorge A. Leon, Ph.D., President & CEO, Leomics Associates, Inc.

Panelists: Dane Dickson, M.D., Director, Clinical Science, MolDx, Palmetto GBA

John E. Steiner, Jr., Esq., CHC, Chief Compliance and Privacy Officer, Associate General Counsel, Cancer Treatment Centers of America

Additional Panelists to Be Announced

5:10 Welcome Reception

6:00 Close of Day and Registration for Dinner Short Course

6:15-9:15 SC1 Dinner Short Course: CPT Coding and Reimbursement in Diagnostics 101*

Instructor:

VictoriaPrattVictoria Pratt, Ph.D., FACMG, Director, Pharmacogenetics Laboratory, Indiana University School of Medicine

Additional Instructors to Be Announced

•Overview of the Molpath CPT codes: Difference between Tier 1 and Tier 2; how to obtain a CPT code

•Overview of reimbursement and billing processes

*Separate registration required

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