AN ANALYSIS OF REAL WORLD DATA TRENDS IN GLOBAL HTA MARKETS

Author(s)

Horowicz-Mehler N1, Tao C2, Faulkner EC3, Doyle JJ4
1Quintiles Global Consulting, New York, NY, USA, 2Quintiles Consulting, Cambridge, MA, USA, 3Institute for Pharmacogenomics and Individualized Therapy, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA, 4Quintiles, Hawthorne, NY, USA

OBJECTIVES: The nature and frequency of global stakeholder real world data (RWD) “ask" is growing and there is an impact of not having RW evidence upon market entry such as delayed approval, suboptimal reimbursement and unfavorable re-evaluation. We aimed to assess RWD use for market access (MA) decisions in key global markets. METHODS: Search of the HTAWatch database supplemented by an online search of MA stakeholders in the US, UK, Australia, and Canada for use of RWD to support of initial assessment, re-evaluation or coverage and reimbursement recommendations. Use of RWD included safety, effectiveness, economic or quality of life studies. We also assessed theevidence level required from registry to provider or patient survey data.   RESULTS: In the UK, the National Health Service uses real-world adherence studies to update national treatment guidelines and inform reimbursement. In Australia, the Pharmaceutical Benefits Advisory Committee is willing to delay or make temporary decisions in anticipation of RWD on a product’s clinical effectiveness or economic value message. The Canadian Agency for Drugs and Technologies in Health is funding initiatives such as the Canadian Platform To increase Usage of Real-world Evidence (CAPTURE) project in which physicians collaborate on gathering RWD to inform and improve standard healthcare practices. Finally, some US hospitals are leveraging the RWD they generate to optimize clinical and economic outcomes for their populations. Additionally, US payers are funding comparative effectiveness studies in crowded markets with costly assets and generic competition.  CONCLUSIONS: There is a need to monitor HTA agencies’ use of RWD to optimize access of the right treatments to the right patients. There is also a need to approach evidence generation in a systematic manner to differentiate assets beyond approval and initial P&R as well as to generate evidence only for those gaps that will impact healthcare decisions.

Conference/Value in Health Info

2014-05, ISPOR 2014, Palais des Congres de Montreal

Value in Health, Vol. 17, No. 3 (May 2014)

Code

PHP111

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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