“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.
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 recommendations.”
Examples of the issues covered in the handbook:
- What are the pricing and reimbursement mechanisms for the test? How are these connected, or disconnected, from the processes for the drug?
- What are realistic price expectations for the test within the different reimbursement frameworks?
- What evidence is needed for each element of the pairing?
- How should companion diagnostic testing be included in economic models?
- How is the clinical development program best designed to support both the drug and the test?
- How do manufacturers ensure that the requirement for a test does not become a barrier to prescription of the drug?
PRMA will be available to discuss the Insights series at the upcoming ISPOR Conference in New Orleans, May 18-22, 2013, and in Chicago, June 1–3, 2013. Founding Partner, David Sykes and the handbook’s lead author, Dr. Clare Jones will be available for interviews. Both are available for phone interviews. http://www.prmaconsulting.com.
About PRMA Consulting: UK-headquartered PRMA Consulting specializes in pricing, reimbursement, and market access strategy; health economics and outcomes research; and licensing and due diligence.