Just one month after the U.S. Food and Drug Administration (FDA) approved its first biosimilar cancer treatment, the Trump administration has announced that it will reverse a policy designed to help keep prices low on the next-generation therapies, Stat News reports.
The Obama-era policy had previously established Medicare payments that were specifically designed to encourage more price competition among biosimilars. Biosimilars are medications that are nearly identical to biologics, which are drugs manufactured using microorganisms or living cells and used to treat a range of diseases, including cancer, rheumatoid arthritis,
Much like generics, biosimilars are designed to help provide more options and cut treatment costs in crowded drug markets. Now, treatment advocates fear what will happen now that they are longer going to be
In short, the change would have the Center for Medicare and Medicaid Services (CMS) pay for biosimilar drugs similarly to how it currently pays for branded and generic drugs administered by doctors. This means reimbursing doctors for what is known as the average sales price of most medications, which takes into account the price of both the branded drug and any available generic treatments.
Before now, the Obama-era policy grouped all biosimilars into the same pricing category, which helped lower prices for the drugs overall. But the new Trump proposal would give each biosimilar its own pricing category, which would allow manufacturers more wiggle room for setting prices.
Trump’s reversal is a big win for pharmaceutical companies and manufacturers, who had been urging the Republican administration to reverse the policy on the grounds that it would discourage innovation in the young U.S. biosimilar market, which
Meanwhile, it’s unclear what will happen to the cost of Mvasi (bevacizumab-