Navigation Links
Market Access Expert Firm, PRMA Consulting, Launches Companion Diagnostics Handbook

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.

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.

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. MarketsandMarkets: Lung Cancer Drugs Market in G7 Countries Worth $13 Billion by 2020
2. Sequenom Announces Participation at the Lazard Capital Markets 8th Annual Healthcare Conference
3. Organovo to Present at Lazard Capital Markets 8th Annual Healthcare Conference
4. Pharmasset to Present at the Lazard Capital Markets Healthcare Conference
5. MarketsandMarkets: Global Prostate Cancer Therapeutics Market worth $6,457 Million by 2020
6. MarketsandMarkets: Leukemia Therapeutics Market Worth $11.3 Billion by 2020
7. ResearchMoz: Ophthalmic Devices Market to 2017 - Glaucoma and Cataract Surgery Devices, Minimally Invasive Procedures in Ophthalmic Surgery to Drive the Ophthalmic Surgery Market
8. GeneLink Marketing Efforts Poised to Show Results
9. Animal Biotechnology - Technologies, Markets and Companies
10. Gene Therapy - Technologies, Markets and Companies
11. Biomarkers - Technologies, Markets and Companies
Post Your Comments:
(Date:11/25/2015)... , Nov. 25, 2015  Neurocrine Biosciences, Inc. (Nasdaq: ... , President and CEO of Neurocrine Biosciences, will be ... in New York . ... the website approximately 5 minutes prior to the presentation ... of the presentation will be available on the website ...
(Date:11/25/2015)... Oregon , November 25, 2015 ... Market Research Report is a professional and in-depth ... industry.      (Logo: ) ... overview of the industry including definitions, classifications, applications ... is provided for the international markets including development ...
(Date:11/24/2015)... , Nov. 24, 2015 Cepheid (NASDAQ: ... be speaking at the following conference, and invited investors ... York, NY      Tuesday, December 1, 2015 at ... York, NY      Tuesday, December 1, 2015 at ... Healthcare Conference, New York, NY ...
(Date:11/24/2015)... ... November 24, 2015 , ... International Society for ... of the premier annual events for pharmaceutical manufacturing: 2015 Annual Meeting. The conference ... ISPE hosted the largest number of attendees in more than a decade. ...
Breaking Biology Technology:
(Date:11/9/2015)... , Nov. 09, 2015 ... the addition of the "Global Law ... their offering. --> ) ... "Global Law Enforcement Biometrics Market 2015-2019" ... Research and Markets ( ) has ...
(Date:10/29/2015)... , Oct. 29, 2015  The J. Craig Venter ... titled, "DNA Synthesis and Biosecurity: Lessons Learned and Options ... of Health and Human Services guidance for synthetic biology ... --> --> ... has the potential to pose unique biosecurity threats. It ...
(Date:10/29/2015)... YORK , Oct. 29, 2015 ... technology, announced a partnership with 2XU, a global ... to deliver a smart hat with advanced bio-sensing ... and other athletes to monitor key biometrics to ... the strategic partnership, the two companies will bring together ...
Breaking Biology News(10 mins):