The Centers for Medicare & Medicaid Services (CMS) recently announced the next round of drugs that would be impacted under the Inflation Reduction Act (IRA) in an effort to bring down prescription drug costs in the United States. These latest products, if negotiated to a Maximum Fair Price (MFP), would have MFP pricing effective January 1, 2028. Drug manufacturers will have until February 28, 2026, to decide if they will participate in price negotiations or face steep financial penalties. This is the third round of medications named, bringing the total to forty products, with the first round of negotiated drug prices effective at the start of this year. While it’s still too soon to calculate the financial impact of the program overall, CMS has stated that approximately 1.8 million people with Medicare Part D or Part B used these latest fifteen drugs between November 2024 through October 2025, and they accounted for approximately $27 billion, or 6% of Part B and Part D spending.

The latest products include:

Anoro Ellipta inhaler (COPD)

Biktarvy (HIV)

Botox; Botox Cosmetic (migraine, spasticity, overactive bladder, cosmetic)

Cimzia (Crohn’s disease, plaque psoriasis, rheumatoid arthritis, psoriatic arthritis)

Cosentyx (plaque psoriasis, psoriatic arthritis)

Entyvia (Crohn’s disease, ulcerative colitis)

Erleada (prostate cancer)

Kisqali (breast cancer)

Lenvima (cancer of the endometrium, liver, kidney, or thyroid)

Orencia (rheumatoid arthritis, psoriatic arthritis)

Rexulti (schizophrenia, major depressive disorder, Alzheimer’s-associated agitation)

Trulicity (type II diabetes)

Verzenio (breast cancer)

Xeljanz; Xeljanz XR (ulcerative colitis, rheumatoid arthritis, psoriatic arthritis)

Xolair (asthma, Ig-E mediated food allergies)

There are some notable changes from this year’s list compared to previous ones. This is the first time the list includes Medicare Part B drugs, which are outpatient medications typically injected or infused in physician offices. Previously, the list has only included Medicare Part D drugs, which are billed as a pharmacy benefit. Part B products on this list include Botox, Cimzia, Cosentyx, Entyvio, Orencia, and Xolair.

This is also the first round of products to be announced since the Big Beautiful Bill was passed in July 2025 and expanded the Orphan Drug Exclusion to the IRA. Previously, only drugs with a single orphan disease indication were exempt from negotiations. Now, drugs with multiple orphan disease indications are also exempt, and drugs which later gain non-orphan indications will have a delayed negotiation start date. The waiting period now begins upon approval for the non-orphan indication, rather than the initial FDA approval date. This shift has led to some blockbuster products, like Keytruda and Opdivo not being included at this time.

Roughly half the products on the recent list are anticipated to have generic or biosimilar competition by 2028 when pricing goes into effect. This alone may lower pricing and make cost savings calculations obscured. Products which are anticipated to have the greatest financial impact are those that fall into protected drug classes, including cancer, HIV, and mental health.  These products often have smaller rebates from the manufacturers because private Medicare plans are required to cover them.  This year, drugs in protected classes include Verzenio, Erleada, Biktarvy, and Rexulti.

One other product on the list is notable because it was included for re-negotiation. Although CMS and Boehringer Ingelheim negotiated a maximum fair price in late 2025 for Tradjenta for type II diabetes, CMS has requested an additional price negotiation this year. CMS indicated re-negotiation may occur when there is a change in monopoly status for the drug, a change in indication, and/or a material change that significantly impacts the MFP for the drug, and some experts believe this may become a regular occurrence in future years.

As part of their ongoing effort to support transparency in the drug selection process, CMS has also published a list of the top 50 drugs that are eligible for negotiation based upon high spending in the Medicare Part B and Part D programs. Making this list public is designed to help consumers and pharmacies understand what products will likely be named in future years.