On this week’s episode of the Patients Rising Podcast, Terry and Bob discuss the second installment of the 21st Century Cures Act, a successor to the original 21st Century Cures Act passed in 2016. While the original legislation focused on modernizing the discovery of new patient treatments, the 2.0 version seeks to improve the delivery of these treatments. Sponsored by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.), this bipartisan proposal can help those with rare and chronic diseases overcome the bureaucratic insurance obstacles to accessing care by overhauling the clinical trial process and modernizing the CMS and the Food and Drug Administration.

Immediate access to innovative care has become even more necessary in the wake of the Covid-19 pandemic because an unprecedented number of patients are going to need efficient access to medications. Under the Cures Act 2.0, HHS would have to create a national plan for testing, data sharing infrastructure, vaccines, therapeutics, and a strategy to have medical supplies available to respond to current and future pandemics.

Terry interviews Diane Berry, senior vice president at Sarepta Therapeutics, to discuss what this forthcoming legislation means for patients in the rare disease community. Berry explains how the original Cures Act reduced regulatory barriers to speed the development of new treatments, yet this progress has been cold comfort for the countless patients who can’t access new medications because their insurers refuse coverage. Cures 2.0, she highlights, intends to fill this gap, bridging the divide between FDA approval and insurer coverage.

Under the status quo, insurers sometimes take several months to decide whether to cover a new treatment, a timeline that is too long for patients suffering from degenerative or chronic diseases. Berry points out that sometimes insurers duplicate the work already done by the FDA. As Terry has discussed, these delays have been particularly difficult for those patients suffering from Duchenne muscular dystrophy. Many of these patients watched a breakthrough treatment get developed only to see their insurers deny or delay coverage. Berry discusses how Cares 2.0 seeks to prevent insurance preauthorization from interfering with patient access. Insurers should be ready to cover treatments by the time the FDA approves them.

In this sense, the Cures Act 2.0, which would expand access and coverage, is the opposite of ICER’s value framework, which seeks to curtail access to treatments. Berry discusses how there is room for objective measurements of treatments’ effectiveness, but they must be far broader than ICER’s, which undervalues novel treatments. Any measurement, she argues, must 1) reward treatment innovation, and 2) recognize how new therapies help patients.

Roving correspondent Kate Pecora also interviews Lan Sena, who tells her story of several relapses with Hodgkin’s Lymphoma and her battles with her insurer over coverage. She points listeners to the website BeTheMatch.org, where people can sign up to become bone marrow donors and save the lives of patients like Lan.