Biomarkers and Companion diagnostics: Payer Insights

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Publication Date:
July 2019
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What do you need to do to get payer support for companion diagnostics and biomarkers?

The investment decisions made by the biggest players in core disease areas drive market trends—so it's crucial to understand where the big money is going and why. And as advancements in technology as well as business forces are inspiring fresh thinking in R&D, data, systems and commercial models, itis critical to be on top of the bigger picture.

As CDx and BM move outside of their heartland of oncology into conditions such as rheumatoid arthritis and depression, what do payers want and expect from pharma and CDx developers to really drive wider use of CDx? In Companion Diagnostics and Biomarkers: Payer Perspectives, experienced US and European payers assess the current CDx and BM landscape and identify the issues, challenges and opportunities that industry must address.

Payers tackle key questions:

  • What are the key drivers for CDx and BM adoption and how will the market evolve over the next five years?
  • What is the value proposition of CDx from a payer perspective and what are the key drivers for adoption?
  • What assessment criteria do payers apply to determine the coverage of CDx and BM tests and for negotiating pricing and reimbursement?
  • Is funding an issue and if so what do CDx manufacturers and pharma need to provide in order to ensure coverage?
  • As new more complex tests emerge will current funding models be flexible enough to enable reimbursement of CDx and BMs, and if not, what needs to be done?
  • What should test manufacturers do to drive future uptake of CDx and BM-based tests?

What payers say about CDx and BM…

"Right now, I think it is really in the specialty area and the high cost area, in some sense that's the manufacturer saying, "Yes, I know my drug is expensive, but I have a way to ease that concern from the payer perspective, because now I have tests that may show patients who are responders versus non-responders." And that way you don't have to pay for patients who are non-responders. But even these tests are not very specific: there are very few tests that say yes or no, a lot of them say maybe, so they're not that predictive yet."
US Payer 3

"Payers always say do we need this NGS test? It's too much information, it's not needed. There is an abundance of information for the scientist or the manufacturer but it's always the question whether we need it. However, I think that discussion will soon be over and they will charge the same price for an NGS test as an IHC test."
German Payer

"I would be happy to use biomarkers or companion diagnosis to refine the population and reduce the budgetary impact of some drugs. We payers look at the companion diagnostic as a useful tool to help in defining the type of population and reducing the budget impact, of course. They can help restrict the use of drug in the population and ensure that there is appropriate drug use; it may help reduce drug wastage if a drug is used more appropriately. But we don't want to pay for the companion diagnosis and believe the price should be included in the price of the treatment."
Italian Payer

"I think the test manufacturers could be more visible if they are going to influence a payer whether to cover their product versus a competitor product, particularly if it has similar outcomes. For most payers coverage criteria are still going to be based on labelled indications, but it would be goof from a market access perspective to get buy-in or to get some feedback early on, which I think most manufacturers are already doing to an extent, but it's unlikely to influence coverage of the tests themselves."
US Payer 2

What to expect

  • A detailed report revealing the insights of 8 US and European payers who share their expectations and views on the challenges and opportunities for CDx and BM
  • An examination of 5 key issues which pharma and CDx developers needs to understand and respond to
  • 25 targeted questions put to payers
  • Their perceptive responses that provide 40 insights supported by 229 directly quoted comments

Expert contributors

This report harnesses the critical insights of 8 European and US payers all of whom meet the following criteria:

  • Have at least three years or more of experience with assessing companion diagnostics
  • Have at least three years of experience as a payer or advising payers regarding the coverage, pricing and reimbursement of companion diagnostics

Their identities have been kept anonymous to allow for full and frank disclosure of opinion.

  • French Payer is a a Professor of Clinical Pharmacology in Paris and holds several positions in regulatory bodies, such as the French Medicines Agency, where he is leading the market approval committee, and the French Public Health Agency where he has just been co-opted as a member of the expert group in charge of prevention and health promotion.
  • German Payer has over 18 years' experience in the German healthcare system. He is head of Drug Reimbursement and advisor to the board of the Kassenärztliche Vereinigung Hessen. His work focuses on the areas of drug therapy, quality assurance and new forms of care.
  • Italian Payer is Member of the Cardiovascular Working Party at the European Medicines Agency and Member of the European Assessment Board at AIFA, the Italian Drug Agency. He is a Consultant Cardiologist at a leading UK hospital. He has been Vice-Chair of the SAG Cardiovascular at the European Medicines Agency, and a Member of Pricing and Reimbursement Committee at AIFA.
  • Spanish Payer is the CEO-Director of a Leading institute in Barcelona. He has worked as Coordinator of the Health Policy Unit of the Agencia de Evaluación de Tecnología e Investigación Médicas (AATRM)
  • UK Payer is the Regional Medical Director for the Midlands and the East. His previous roles include the Medical Director of United Lincolnshire Hospitals Trust, the President of the British Columbia Cancer Agency, an academic healthcare organisation and posts with the Department of Health, York and Humber SHA and Sheffield Teaching Hospitals, the latter as a consultant neuro-oncologist, managing complex patients and their families.
  • US Payer 1, PharmD is a Vice President with a leading US Payer and has been working in the payer environment for more than 18 years. Payer 1 performs various leadership roles and is responsible for the growth and profitability of the business, developing business strategies, industry and trade relations and creating and executing strategies in sales, marketing, clinical, quality and products.
  • US Payer 2, PharmD is a Pharmacy Business Development Manager with a leading US Payer and has been working in the payer environment for more than 10 years. Payer 2 acts as a clinical consultant to managed care health plans and provides clinical support to strategic business planning, contract negotiations, new product sales, clinical programmes and operations. Payer 2 has conducted drug and CDx utilisation reviews to ensure safe and effective management of specialised medicines.
  • US Payer 3 is a Pharmacy Director with a leading US Payer and has been working in the payer environment for more than 20 years. Payer 3 acts as a clinical consultant to managed care health plans an is involved in collaborating with laboratory managers that supply and support diagnostic services to their clients. Payer 3 has conducted drug and CDx utilisation reviews to ensure safe and effective use of oncology therapies.

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