About the author: @DanGebremedhin is a Principal at Flare Capital Partners, an early stage Health Technology and Services focused VC Firm. He is a practicing physician at the Massachusetts General Hospital, and previously served as an Associate Medical Director at the Harvard Pilgrim Health Plan, and spent five years as an entrepreneur in the Health IT Industry.
1. The 21st Century Cures Act makes “Real World Evidence” a buzzword in pharma and payer circles, and justifiably so
For the uninitiated, “Real World Evidence” (RWE) is a term that has received much attention and debate as a core component of the 21st Century Cures Act: a bill that received much press coverage in Q4 2016. The term refers to health care information about the use of a drug after it has been approved by the FDA and prescribed to patients in the “real world.” This data is usually derived from electronic health records, claims databases, and patient-reported registries. Given the several ramifications of the Cures Act, 2017 will see pharma and payers clamor to acquire solutions to harness the power of RWE, creating new revenue opportunities for incumbents and early stage companies.
Amongst its many regulations, the Cures Act speeds up the FDA New Drug Approval process while earmarking short term funding for other health related programs like NIH research, mental health, and Joe Biden’s cancer “Moonshot” initiative. The Act passed in overwhelmingly bipartisan fashion with a 295 – 14 vote in the house. Perhaps the most subtle, yet profound component of the law allows Pharma companies to do post-market launch research around “real world use” (read: off-label) of drug products. If data suggests positive outcomes of off label use, this evidence can be used to expand the indications of use for that drug. This game changer will allow biopharma companies to save tens to hundreds of millions of dollars as the previous standard practice of expanding indications required re-running costly randomized control trials.
In addition to expanding indications, there are a host of other biopharma use cases for RWE highlighted in the below QuintilesIMS schematic where the case is made for a Billion dollar opportunity per pharma client.
From a payer perspective, the impact of expanding indications will be immediate, but the looming hazard is the sheer volume of high cost, specialty drugs and biosimilars coming to market sooner than ever before. To mitigate the uncertainty of the value of new, high-cost drugs, Payers are turning to value based contracts powered by RWE. A great example is my former employer, Harvard Pilgrim Health Plan and their CMO Michael Sherman, who has pioneered a series of value based contracts for high cost cholesterol and congestive heart failure drugs.
Given the above catalysts, there is a clamoring in both biopharma and payer circles for solutions to harness the power of RWE. Answering this call are a score of companies who are focusing on “value based” therapeutics analyses. One exciting company with significant market traction focused exclusively on RWE is NYC based Aetion (Arrivi, Lakestar). The company, founded by Harvard pharmacoepidemiologists and Wall Street data scientists, is pioneering the concept of “Rapid Cycle Analytics” in healthcare. On behalf of its pharma and payer customers, the multidisciplinary team performs real-time simulated studies drawing on terabytes of distributed international data sets. With statistical precision, the company can perform comparative effectiveness studies and reproduce the results of large scale clinical trials with 10x the speed of traditional methods of database programming, statistical modeling, and analysis.
There are a handful of health tech analytics companies previously focused on biopharma market access, reimbursement, and R&D efficiency that are now reorienting around the RWE use case. Some notable early stage tech companies here are GNS Healthcare (Cambia/Echo, Alexandria) and Truveris (Canaan, New Leaf, First Round). In addition to these early stage companies, the Large HCIT Conglomerates (QuintilesIMS, Optum, Truven/IBM, Inovalon) and traditional consulting firms (Avalere, ZS Associates, Decisions Resources Group) are starting to devote significant resources to this emerging opportunity in RWE and are likely acquirers in this space.
Special mention in this category goes to Flare Portfolio company, Health Verity. The company is led by successful serial entrepreneur Andrew Kress, who sold his last health data start up SDI to QuintilesIMS in 2011. Health Verity is pioneering new ways for large healthcare enterprises to buy and sell rich healthcare data. By liberating, enriching, and marketing previously siloed patient data, Health Verity is on pace to become a market leading supplier of the RWE mentioned above.