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Pricing the uncertainty in expedited therapies
How new ideas about pay for performance aim to temper uncertainties, and controversies, about accelerated approvals
How new ideas about pay for performance aim to temper uncertainties, and controversies, about accelerated approvals.
Payment systems developed in an age dominated by small molecules for common chronic diseases are not up to the challenge of 21st century medicine. Drugs are increasingly being approved based on new mechanistic understanding of disease, rather than on modifying clinical symptoms or outcomes, and in some cases promise, but have not yet proven, durable functional cures.
Today’s payment systems aren’t able to distinguish between interventions that work well and those that provide marginal benefits, and the lack of infrastructure to support value-based payments, including the inability to track outcomes for individual patients or populations, forces healthcare systems to overpay for marginal treatments and ration access to highly effective medicines.
Moreover, the ability to collect real-world data and use it to continuously improve performance lags far behind the transformational effect it has had on other industries.
The gap in payment tools is especially obvious for drugs that are marketed through accelerated approval.
Congress, prodded by patient advocates, biopharma executives and medical researchers, has consistently urged FDA to lower the barriers to approving new drugs. It has also shielded some therapeutic areas from competition, at least in the Medicare Part D market.
Many of the drug approval tools invented in the U.S. have been taken up