Enzalutamide included in next round of Medicare drug price negotiations

The US Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), has announced their selection for the next 15 Medicare Part D drugs to be included in the second phase of price negotiations under the Inflation Reduction Act.¹

Included in this list is enzalutamide (Xtandi), which is indicated in the US for the treatment of patients with metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, nonmetastatic castration-sensitive prostate cancer (nmCRPC), and nmCRPC with biochemical recurrence at high risk for metastasis.²

The full list of drugs selected for price negotiations is as follows:

• Semaglutide (Ozempic, Rybelsus, Wegovy)
• Fluticasone/umeclidinium/vilanterol (Trelegy Ellipta)
• Enzalutamide (Xtandi)
• Pomalidomide (Pomalyst)
• Palbociclib (Ibrance)
• Nintedanib (Ofev)
• Linaclotide (Linzess)
• Acalabrutinib (Calquence)
• Deutetrabenazine (Austedo, Austedo XR)
• Fluticasone furoate/vilanterol (Breo Ellipta)
• Linagliptin (Tradjenta)
• Rifaximin (Xifaxan)
• Cariprazine (Vraylar)
• Sitagliptin/metformin HCI (Janumet; Janumet XR)
• Apremilast (Otezla)

The 15 drugs identified in this round of negotiations add to the 10 selected in the first round of negotiations that took place in 2023 and 2024.³ These negotiations are allowable under the Inflation Reduction Act of 2022, which enables Medicare to negotiate the prices of certain prescription drugs directly with participating drug companies, with the goal of lowering health care costs for those enrolled in the program. The drugs selected must be among the 50 medications with the highest total spending under Medicare in the previous 12 month period and must have had approval for at least 7 years (for drug products) or 11 years (for biologics), according to the Act.⁴

Negotiations will occur in 2025, and negotiated prices will take effect in 2027.

President Joe Biden commented in a statement released by the White House,⁵ “These 15 drugs, together with the 10 drugs that Medicare already negotiated, represent about a third of Medicare Part D spending on prescription drugs, which means the lower prices my Inflation Reduction Act is delivering will put money back in seniors’ pockets across the country.”

According to CMS, drug companies of the 15 newly selected therapies have until February 28, 2025 to decide if they will participate in negotiations. Negotiations will occur in 2025, and negotiated prices will take effect in 2027. According to the bill, manufacturers that fail to comply with negotiation requirements may face civil penalties, unless they choose to withdraw their drugs from CMS coverage.⁴

The agency explained, “In negotiating with participating manufacturers, CMS will consider the selected drug’s clinical benefit, the extent to which it addresses unmet medical needs, and its impact on specific populations, including people who rely on Medicare, among other considerations, such as costs associated with research and development as well as production and distribution for selected drugs.”

Last year, Medicare successfully negotiated lower prices with participating drug companies for all 10 drugs included in the first round of negotiations. These prices are set to go into effect on January 1, 2026.

CMS added, “If the new prices had been in effect in 2023, they would have saved an estimated $6 billion in net covered prescription drug costs, or approximately 22 percent, across the 10 selected drugs. The new, lower prices range from 38 to 79 percent discounts off of list prices. In 2026, people with Medicare prescription drug coverage are expected to see aggregated estimated savings of $1.5 billion in their personal out-of-pocket costs.”

The Inflation Reduction Act is a 10-year plan.⁶ In future years, CMS will select 15 additional drugs for 2028 (including those in Part B and Part D) and up to 20 more drugs in each year following that.

“Last year we proved that negotiating for lower drug prices works. Now we plan to build on that record by negotiating for lower prices for 15 additional important drugs for seniors,” said HHS Secretary Xavier Becerra, in the news release.¹ “Today’s announcement is pivotal – the Inflation Reduction Act is lowering prices for people on Medicare. HHS will continue negotiating in the best interest of people with Medicare to have access to innovative, life-saving treatments at lower costs.”

References

1. HHS announces 15 additional drugs selected for Medicare drug price negotiations in continued effort to lower prescription drug costs for seniors. News release. Centers for Medicare & Medicaid Services. Published online and accessed January 17, 2025. https://www.cms.gov/newsroom/press-releases/hhs-announces-15-additional-drugs-selected-medicare-drug-price-negotiations-continued-effort-lower

2. Indications. Xtandi. https://www.xtandi.com/clinical-trials

3. HHS selects the first drugs for Medicare drug price negotiation. US Department of Health and Human Services. August 29, 2023. Accessed January 17, 2025. https://public3.pagefreezer.com/browse/HHS.gov/02-01-2024T03:56/https://www.hhs.gov/about/news/2023/08/29/hhs-selects-the-first-drugs-for-medicare-drug-price-negotiation.html

4. H.R.5376 — 117th Congress (2021-2022). Congress.gov. Accessed January 17, 2025. https://www.congress.gov/bill/117th-congress/house-bill/5376

5. Statement from President Joe Biden on the next fifteen drugs selected for Medicare drug price negotiation. White House. Published online and accessed January 17, 2025. https://www.whitehouse.gov/briefing-room/statements-releases/2025/01/17/statement-from-president-joe-biden-on-the-next-fifteen-drugs-selected-for-medicare-drug-price-negotiation/

6. Inflation Reduction Act of 2022. IRS.gov. Accessed January 17, 2025. https://www.irs.gov/inflation-reduction-act-of-2022