Budding COVID-19 Treatments Underscore ‘Value Assessment’ Concerns

TRP Senior Vice Presidents Thayer Surette and Shea McCarthy explain how flawed value assessments for prescription drugs and other medicines can have a profound impact on patient access and innovation, especially during the COVID-19 public health emergency.

As the world grapples with the COVID-19 pandemic and innovators search for a vaccine, the research role of America’s pharmaceutical and biotechnology companies is more important than ever. But even in this critical moment, the issue of prescription drug pricing remains under a microscope by the press, policymakers, and watchdog groups like the Institute for Clinical and Economic Review (ICER). And as Dr. Anthony Fauci recently warned, these dynamics present a tangible threat to the very innovations we need to reopen the nation at full capacity.

To bring a new drug or biologic to market, manufacturers expose themselves to significant financial risks, investing billions into products that may never see FDA approval. The harsh reality for innovators is that not every investment is going to pay off; and while the risks taken by drug developers give us hope, price controls that threaten to limit their financial returns have exactly the opposite effect. 

In the U.S., ICER has sought to lay the foundation for such price controls by conducting “value assessments,” which seek to define an “appropriate” price for medications.  ICER’s methodology is controversial. It relies on a metric that many advocates argue undervalues treatments for people with disabilities; and assessments are frequently conducted before FDA approval, so they cannot incorporate real-world evidence. Despite their flaws, the impact of these assessments is very real. Insurers, ever looking to reduce costs, are increasingly relying on ICER’s assessments to make coverage decisions — regardless of their often-glaring shortcomings.

To avoid these harmful outcomes, it has become important that manufacturers and patient advocacy groups prepare well in advance of the launch of a new product. If handled proactively, there is an opportunity for companies to build their own value story through partnerships with leading patient and provider groups, a thoughtful communications strategy, more sensitive and accurate value assessments, and rigorous data collection that supports the value of a new treatment.

Building one’s own value narrative highlighting the true benefits of a new treatment has the potential to move the needle on the assessment debate and provide stakeholders with a more accurate story to tell.  Otherwise, we risk ceding the “value” debate to groups like ICER, who demonstrate little appreciation for the nuances of the patient experience or innovation lifecycle.