EntityRisk’s cutting-edge analytics – powered by the PROVEN™ platform – are used today by clinical and commercial-stage biopharma companies (from multinationals to single-product pre-launch companies), investors, and NGOs to apply rigorous new methods to questions of market access and product value. Serving both the sellers and buyers in the biopharma marketplace, EntityRisk’s products answer critical questions about a therapy’s true value to patients and the factors that determine that value. PROVEN helps companies and investors identify clinical trial and real-world study designs to maximize value, conduct commercial diligence on potential late-stage investment opportunities, quantify the range of prices that most likely ensure “value-for-money,” and integrate clinical and commercial outcomes in value-based agreements for high-cost, high-risk treatments.

“The traditional way that companies have used value assessment – to deal with Health Technology Assessment agencies in a largely defensive capacity – is clunky and does not allow for ready adoption of new methods,” said EntityRisk CEO Neal Masia. “Now value assessment is getting more and more attention in the US, and companies need new tools to anticipate and shape how new products will be assessed in the market. The global picture is also becoming more uncertain, with continued pressure but some openness to new methods. Companies need scalable solutions to adapt to many potential methodologies.”

“It’s become clear in the last few years that biotech companies have to make a case for the value of their medicines to society as a whole, not just patients,” said Peter Kolchinsky, Ph.D., Managing Partner of the biotech investment firm RA Capital Management [not an investor in EntityRisk]. “We mustn’t let others be the first ones to declare how little a drug is worth using traditional CEA, which is simplified math that undervalues medicines. EntityRisk’s software makes it possible to do better, more generalized math, that takes into account that medicines go generic, help caregivers, and reduce risk for the whole population. Math alone won’t win favorable coverage – that takes a whole market access campaign – but when you’re being attacked with the wrong math, you need to know how the math works well enough to fight back. That’s the message I’m conveying to all of our companies once they are past Phase 2 and why I’m encouraging them to sign up with EntityRisk, which offers the only software for doing GCEA math [generalized cost-effectiveness analysis]. EntityRisk’s software can guide additional cost and benefit data gathering in parallel with the drug’s development, such as studying the benefit to caregivers, to inform the final model. By the time of launch, we want all our companies in solid command of their societal value position and ready to make their case. Because as EntityRisk has shown, medicines that the market values are often worth far more than traditional CEA would have us believe.”

“PROVEN builds and materially expands innovators’ and investors’ capacity for accurate, nimble and rapid value calculations,” said EntityRisk Co-Founder and Chief Scientific Officer Darius Lakdawalla, PhD. “Our platform operationalizes decades of research, embeds the collective expertise of a world-class team and scales it on demand. PROVEN permits users to tell a consistent story about value. It quickly quantifies risks and opportunities, future-proofs scientific methods, and translates data into practical commercial and investor insight.”

The PROVEN platform leverages clinical trial data, real-world data, financial data, and published estimates to produce a single, rigorous set of predictions for real-world outcomes and value. It fits and evaluates Bayesian machine learning models to generate probabilistic predictions, allowing flexible and detailed assessments of upside and downside risk. The platform seamlessly integrates scientific methods from key domains, including generalized cost-effectiveness and advanced mathematical simulation modeling.

About EntityRisk

EntityRisk was founded by Dana Goldman, PhD, Darius Lakdawalla PhD, and Neal Masia, PhD  — three leading health economists bringing together decades of academic and industry experience to unlock financial innovation in the way new medicines are brought to patients. The company’s data-driven solutions are helping large and small organizations across the healthcare ecosystem address the full spectrum of risk considerations ranging from the uncertainty of drug pricing and access to the uncertainty in real-world effectiveness, utilization, and value. Learn more here: EntityRisk.com.