UPDATED: Novartis, Seagen and Amgen meds among 48 flagged by Biden administration for IRA rebates

Ahead of 2026’s Medicare drug-price negotiations, the White House is getting ready to crack down on companies who’ve raised the costs of their medications faster than the rate of inflation. The move marks the latest in a series of price-fighting measures being rolled out under 2022’s Inflation Reduction Act (IRA).

Drugmakers are likely to have to pay rebates to Medicare in 2024’s first quarter over what the White House on Thursday called “outrageous” price hikes on certain prescription meds.

According to a new release, 48 Medicare Part B drugs saw their prices grow faster than inflation in the final quarter of 2023, and some drug companies raised prices faster than inflation during every quarter over the past year. 

All the drugs up for rebates are included under Medicare Part B, which specifically covers drugs and vaccines given to patients in doctors’ offices or hospital outpatient departments.

Starting in January, some Medicare patients who receive the 48 selected drugs—which include medications to treat cancer and fight infections—could have lower coinsurance than what they would have paid otherwise, the White House added.

Following the White House’s announcement, the Center for Medicare and Medicaid Services (CMS) rolled out its formal list of price-hike offenders, which includes both generic and brand-name drugs.

Some notable entrants include Novartis’ lymphoma and leukemia CAR-T Kymriah, Seagen's Adcetris for lymphoma, plus its Astellas-partnered urothelial carcinoma med Padcev. Amgen’s osteoporosis med Prolia and Amgen’s acute lymphoblastic leukemia injection Blincyto also made the cut.

For medicines on the list, the federal government plans to invoice drugmakers as a penalty for the speedy price hikes and deposit the rebates into the Medicare Trust Fund, according to a CMS fact sheet. Then, the funds will go toward patients' coinsurance payments.

Inflation-based rebates are just one of several drug pricing provisions sewn into 2022’s Inflation Reduction Act. Chief among those measures are the looming price negotiations on select drugs that account for a large chunk of Medicare Part D spending.

Back in August, the Centers for Medicare and Medicaid Services (CMS) unveiled its list of 10 drugs up for the first round of talks.

Just last week, meanwhile, the Biden Administration determined it has the power to take back patents of certain high-priced drugs under so-called “march-in” rights. "March-in" rights on government-funded research have long been debated as a potential measure to reduce drug prices, but never actually deployed.

Outside of IRA, the Federal Trade Commission has been taking actions to curb drug prices. For instance, the FTC recently released a policy statement warning brand-name drugmakers the agency could take legal action if patents are improperly listed in the FDA's Orange Book. 

Editor's note: This story has been updated with additional details from a CMS fact sheet.