Then and Now: The Progress of Precision Medicine Diagnostics with Hannah Mamuszka and Lena Chaihorsky of Alva10
In celebration of the three-year anniversary of the Precision Medicine Podcast, we take a look back at how far precision diagnostics have come with the help of one of our first guests Hannah Mamuszka (episode 3), Founder and CEO of Alva10, and her business partner Lena Chaihorsky. Both women are focused on resolving the knowledge gap between payers and diagnostic companies and moving diagnostics to the forefront of the precision medicine conversation.
When we first spoke with Mamuszka back in December of 2018, she was busy raising awareness of how critical diagnostics tests are for properly applying precision medicine in cancer care, yet, at the time, they were still undervalued by payers. We wondered how that has changed and what’s next for precision diagnostics.
Mamuszka said that payers are starting to appreciate the value of diagnostics for informing later stage oncology care, and there has been an increase in coverage and reimbursement for larger panels of diagnostic tools that may or may not be actual companions. Chaihorsky added that more payers are now covering liquid biopsy in oncology.
We asked if that means payers are evolving their perceived value of clinical diagnostics. Mamuszka’s answer: There is still a disconnect with how diagnostic companies are reimbursed for their investment in R&D versus how pharmaceuticals set prices to be reimbursed. She said of diagnostic companies, “There's currently no clear method, no clear process, no governmental agency that if you jump through a certain number of hoops that you are guaranteed to get reimbursement.”
Chaihorsky added that payers must understand their role in creating—and solving—the problem. She said, “[Payers] haven't, up until recently, really considered themselves as part of both the problem and the solution because they hadn't appreciated the fact that when they said no to covering a diagnostic that that actually might mean that that diagnostic would never get to the market. In the diagnostics industry, when diagnostics struggle to get coverage, for the most part, those companies go under. And even if that diagnostic is something that the payers actually want to see, they'd actually economically benefit, their patients would clinically benefit. That diagnostic, that company, that tool may just go away permanently.” So, she said, the industry needs to define clinical utility for a diagnostic.
The women spend a lot of time engaging and educating payers on this topic.
As Lena says, “Diagnostics provide that compass of understanding. They can tell you in advance whether or not a patient is going to respond to a drug. And if you don't engage, you will not obtain the financial benefits of that information and you will continue to overspend and overutilize these drugs in this constant cycle of trial and error, waiting for this patient to finally find a drug that's going to work for them. And that has really been resonating.”
Our conversation went much deeper into the current issues with precision diagnostics, but the clear takeaway is that we are on the right track, and champions like Mamuszka and Chaihorsky are working hard to educate and inspire others to reach out for new solutions to old problems. We can’t wait to have them on in another three years to see how things have evolved. Meanwhile, we hope you listen to the entire episode to understand the role of payers and reimbursement in the future success of precision diagnostics.
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About Our Guests
Co-Founder and CEO Alva10
Hannah Mamuszka is Founder and Chief Executive Officer at Alva10, which she founded in 2015 to address the ‘vicious cycle’ of diagnostics-inadequate reimbursement leading to inadequate investment preventing promising diagnostic technology from impacting patient care. Alva10 partners with payers, employers, and diagnostic developers to develop diagnostic tools to address major areas of healthcare need, inefficient spending and poor patient outcomes.
Prior to Alva10, Hannah was VP of Exosome Diagnostics (acquired by BioTechne), where she led some of the earliest deals in the liquid biopsy diagnostic space. Earlier in her career, she was Global Director of Pharmaceuticals Services for Oncotech, and then by acquisition, Exiqon (acquired by QIAGEN). Prior to her time in diagnostics, she worked in drug development on VelcadeTM at Millennium Pharmaceuticals (acquired by Takeda). She started her laboratory career at the National Institutes of Health, holding laboratory positions in both the National Cancer Institute (NCI) and the National Institute of Allergy and Infectious Disease (NIAID). She earned a BS from the University of Maryland, College Park in Neurobiology and Physiology, and an MS in Biological Sciences from Harvard University.
Hannah is a speaker and writer on healthcare technology and writes a regular column for the Journal of Precision Medicine on the challenges of implementing change in healthcare. Hannah serves on the Board of Directors for Bionano Genomics (BNGO) and Circle Cardiovascular, as well as on the Advisory Board for the Carolina Health Informatics Program (CHIP), a graduate program in health informatics at the University of Carolina at Chapel Hill.
Co-Founder and VP Payer Innovation, Alva10
Lena is the co-founder and Vice President of Payer Innovation at Alva10. With a background in biology and mathematics from Tufts, she is a skilled healthcare executive with a proven track record of developing and commercializing impactful diagnostic tests that decrease medical spending and bring precision medicine to healthcare.
Today, Lena leverages her extensive leadership experience in sales, national contracting, and all aspects of reimbursement to enable insurers and employers to optimize their therapeutic and downstream medical spending through use of innovative and novel diagnostics. Her work on commercial approaches to health economics data analysis led to her appointment as co-chair of the World Economic Forum’s workgroup dedicated to the economics of rare disease data federations in 2019. She is active within the Tufts Alumni Career Networking Community, and a Study Design Task Force member at STRIPE, a public-private task force dedicated to improving access to Pharmacogenomics within the American Society of Pharmacovigilance.