Over the course of the last few months there has been much controversy concerning the cost of several high profile specialty drugs offering unprecedented medical efficacy and even cures for various diseases and conditions for which treatments have been traditionally limited. These drugs, the most notable of which being Solvaldi for the treatment and cure of Hepatitis C, offer perfect case studies for health outcomes analysis and market access determinations. The UK’s NICE acceptance of Solvaldi for inclusion onto the UK’s National Health Service formulary on the basis of both medical efficacy and cost-effectiveness has stirred-up a global tempest on the subjects of therapeutic care, cost and value, the impact of which is also affecting the US.

Health outcomes data, comparative effectiveness research and pharmacoeconomic analysis are all essential components of the modern health care marketplace. They are also the cornerstone of U.S. Health Care Reform. These devices are the quantitative measures by which the medical efficacy and cost efficiency of prescription drug products are determined and also compliment the ‘triple aim’ of Obamacare being that of improving care, quality and cost. They are also the proofs which both private and public payors require for market access determinations and formulary placement of these drug products.

Communicating findings from health outcomes data and related comparative effectiveness and pharmacoeconomic research to demonstrate value for market access determinations is a critical competency fraught with numerous challenges. Pharmaceutical manufacturers struggle with the antiquated confines of FDAMA 114 to communicate data findings to payors and related parties. Ironically, Health Care Reform blesses the sharing of such data, while the provisions of FDAMA 114 set restrictions greatly curtailing such communication. While FDA has promised guidance on FDAMA 114 by the end of 2014, the threat of FDA sanctions and the looming specter of DOJ enforcement in relation to possible violations of the antikickback law safe harbor create uncertainty and a chilling effect in the sharing of this information.

Against the backdrop of this clear and present danger associated with data communications and market access determinations, American Conference Institute (ACI) has designed its inaugural conference on Health Outcomes Data Communications, Market Access and Contracting to provide a critical guide on what information can be shared in relation to such matters as:

• Formulary determinations
• Risk sharing agreements with payors and integrated health care entities such as ACOs
• Manufacturer - Payor collaborations for outcomes data procurement

The conference will also provide:

• Updates on anticipated guidance from FDA in relation to FDAMA 114
• Best practices for data procurement, and
• A case study on Solvaldi

To enhance your learning and networking experience, the conference also features two interactive workshops:

A: Global Health Outcomes Data Communications, Market Access and Contracting Boot Camp - A Guide for Navigating Established and Emerging International Markets

B: Master Class on Negotiating, Drafting and Structuring Successful Risk Sharing Agreements