New York, NY (PRWEB) May 16, 2013
Leading UK company, PRMA Consulting launches PRMA Insights: Market Access Success for Companion Diagnostic–Drug Pairings in Oncology, a unique handbook that addresses the key issues that biopharmaceutical manufacturers should understand when developing new drug-test pairings.
Personalized medicine is gaining traction, particularly in oncology, with two recently approved drug–test pairings: Xalkori for ALK-positive NSCLC and Zelboraf for BRAF-mutation positive melanoma. Payors are willing to consider such high-price drugs in the context of small, clearly defined patient subpopulations. However, a largely unresolved issue is how the companion diagnostic testing is reimbursed; clearly, access to the drug risks being compromised if funding is not readily available.
Drug and diagnostics manufacturers must be familiar with the evidence requirements to support the drug and test as a pair, in order to ensure that clinical trials generate data that meets the expectations of both payors and regulators. Addressing these issues at the earliest stages allows manufacturers to develop a coherent and integrated market access strategy with realistic pricing expectations. This is clearly a major challenge for manufacturers, but there is little practical guidance available.
The new PRMA Insights handbook clearly addresses this by setting out payors’ attitudes to testing across the major markets, how tests are likely to be reimbursed, and realistic expectations of price points. It also offers practical recommendations to support strategy development for drug–test pairings.
David Sykes, founding partner of PRMA explains: “Many reports discuss the market opportunity for companion diagnostics but none considers the companion diagnostic and drug together, or offers practical advice on how to realize the market opportunity. Our handbook is packed full of strategic insights and recommend
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