Looking at the Value of NGS-based Diagnostic Testing for Lung Cancer Patients

Mana Chandhok:
Hi, everyone. Welcome to this podcast from Cambridge Healthtech Institute for the Next-Generation Diagnostic Summit, which runs from August 20th to the 24th in Washington, D.C. I'm Mana Chandhok, an associate producer. We have with us today our speaker, Dr. Darryl Pritchard, the senior vice president of science policy at the Personalized Medicine Coalition. Darryl will be speaking at the Coverage and Reimbursement for Advanced Diagnostics Track this year. Darryl, thank you for joining us today.

Daryl Pritchard:
Thank you, Mana. I'm glad to be here.

Mana Chandhok:
In your session at the Next Generation Diagnostic Summit, you will cover the clinical and economic value of mNGS-based diagnostic testing. Can you give us a preview of what will be discussed?

Daryl Pritchard:
Certainly. Personalized medicine technologies are still relatively new, so there is a need for evidence that demonstrates their clinical and economic value. That evidence is needed by those stakeholders that control access to these diagnostics and targeted treatments payers and providers so that they can make the decisions necessary to provide that access to patients of these new technologies. Now, there's a strong scientific concept on the value of targeted treatment and prevention strategies, but no matter how much a new technology can improve medical practice, its uptake can be slow because as Machiavelli explained, most people do not believe in anything new until they've had actual experience of it. This has lead to a conundrum. Payers and providers need real world practice-based evidence in order to make the decisions necessary to provide access to personalized medicine. But, without access to personalized medical technologies and clinical practice, how can we build this sort of evidence? It's sort of a chicken and an egg scenario. What's going to develop first, the evidence for access or the access that can help us get that evidence?

PMC has looked to clinical practice areas where in some cases diagnostic testing is regularly being used. A prime example of this is in non-small cell lung cancer where diagnostic testing, either single gene testing or next generation sequencing-based diagnostics tests are regularly being used to diagnose and to provide information for targeting treatments to non-small cell lung cancer patients.

PMC is sponsoring a study conducted by a health economics research team led by Dr. Scott Ramsey at the Fred Hutchinson Cancer Research Center that will take a look at the value of diagnostic testing, next generation sequence-based diagnostic testing, in particular, for lung cancer patients. The study involves a value model that basically compares those patients that got next generation sequence-based tests looking at their clinical outcomes and their total costs versus those that did not. The value model we populated with real world data from the Flatiron database which includes electronic health records from a number of hospital systems throughout the United States and the US West.

The results of the study are in. The results of the studies will be published soon. We have found that there's a moderate value, a moderate cost effectiveness realized from next-gen sequencing testing for lung cancer patients compared to those that got standard treatment. We also found that the value would be greatly improved if practice was conducted most effectively. We saw that many of the patients that had actionable mutations that were determined for multiplex testing did not actually receive targeted treatment. The clinical value of the targeted treatments was clear. What we need to figure out next is why those patients that had targeted treatment eligibility did not always get those targeted treatments. The study showed a strong clinical benefit from next-generation sequencing multiplex testing and a moderate economic value. It further demonstrated that that economic value could be significantly improved with more appropriate practice elements in place.

Mana Chandhok:
What challenges that face the diagnostic reimbursement community right now do you think will be fixed in the next five years? What challenges do you anticipate we will face in the future.

Daryl Pritchard:
Well, as the evidence continues to be developed about the value of personalized medicine and diagnostics, I think the coverage situation will become more consistent, and these diagnostic tests will be covered when they have clear value to the system. The challenges that we'll then focus on will be about reimbursement payment levels. We continue to face a downward pricing pressure and will continue to face downward pricing pressure. We should continue to see a movement towards value-based practice and payment models.

Mana Chandhok:
Darryl, thank you for your time and insights today. That was Darryl Pritchard from PMC. Darryl will be speaking at the Coverage and Reimbursement for Advanced Diagnostics Track at the upcoming Next-Generation Diagnostic Summit that is held from August 20th to the 24th in Washington, D.C. I'm Mana Chandhok. Thank you for listening.