IRA Drug Prices Could Be Less Than Actual Value, Researchers Say

As negotiators hash out prices for certain top-selling Medicare Part D drugs, the maximum fair price (MFP) could ultimately be far below the actual value that the drug offers to patients, according to researchers at the Tufts Center for the Study of Drug Development (CSDD).

It’s also not entirely clear which costs CMS will take into account during the negotiations.

A CMS guidance released in 2023 sought to clarify the issue but there are still ambiguities surrounding the eligible costs for the purposes of the price negotiations introduced in the Inflation Reduction Act, said Ken Getz, executive director, and Emily Botto, a senior research analyst at CSDD, in a March 28 webinar hosted by FDAnews, a WCG company.

For example, the CMS guidance offered no explicit direction on how long the timeline is for the inclusion of direct costs.

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