BOOM: Biden Admin. announces first 10 drugs selected for Medicare price negotiation under Inflation Reduction Act

via the U.S. Dept. of Health & Human Services (HHS):

For the first time, Medicare will be able to negotiate prices directly with drug companies, lowering prices on some of the costliest prescription drugs.

For the first time, thanks to President Biden’s Inflation Reduction Act – the historic law lowering health care costs – Medicare is able to negotiate the prices of prescription drugs. Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced the first 10 drugs covered under Medicare Part D selected for negotiation. The negotiations with participating drug companies will occur in 2023 and 2024, and any negotiated prices will become effective beginning in 2026. Medicare enrollees taking the 10 drugs covered under Part D selected for negotiation paid a total of $3.4 billion in out-of-pocket costs in 2022 for these drugs.

“For far too long, pharmaceutical companies have made record profits while American families were saddled with record prices and unable to afford life-saving prescription drugs. But thanks to the landmark Inflation Reduction Act, we are closer to reaching President Biden’s goal of increasing availability and lowering prescription drug costs for all Americans,” said HHS Secretary Xavier Becerra. “Although drug companies are attempting to block Medicare from being able to negotiate for better drug prices, we will not be deterred. The Biden-Harris Administration will continue working to ensure that Americans with Medicare have access to innovative, life-saving treatments at lower costs.”

The Biden-Harris Administration has made lowering prescription drug costs and improving access to innovative therapies a key priority. Alongside other provisions in the new law that increase the affordability of health care and prescription drugs, allowing Medicare to negotiate prescription drug prices will strengthen the program’s ability to serve people with Medicare now and for generations to come. The negotiation process will consider the selected drug’s clinical benefit, the extent to which it fulfills an unmet medical need, and its impact on 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. As a result of negotiations, people with Medicare will have access to innovative, life-saving treatments at lower costs to Medicare.

The selected drug list for the first round of negotiation is:

• Eliquis
• Jardiance
• Xarelto
• Januvia
• Farxiga
• Entresto
• Enbrel
• Imbruvica
• Stelara
• Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill

These selected drugs accounted for $50.5 billion in total Part D gross covered prescription drug costs, or about 20%, of total Part D gross covered prescription drug costs between June 1, 2022 and May 31, 2023, which is the time period used to determine which drugs were eligible for negotiation. CMS will publish any agreed-upon negotiated prices for the selected drugs by September 1, 2024; those prices will come into effect starting January 1, 2026. In future years, CMS will select for negotiation up to 15 more drugs covered under Part D for 2027, up to 15 more drugs for 2028 (including drugs covered under Part B and Part D), and up to 20 more drugs for each year after that, as outlined in the Inflation Reduction Act.

via the Centers for Medicare & Medicaid Services (CMS):

For the first time, Medicare is able to directly negotiate the prices of prescription drugs due to President Biden’s lower cost prescription drug law, the Inflation Reduction Act. Today, leaders of the Centers for Medicare & Medicaid Services (CMS) issued the following statements on the historic announcement of the first 10 drugs covered under Medicare Part D selected for negotiation under the Medicare Drug Price Negotiation Program. The negotiations with participating drug companies for the selected drugs announced today will occur in 2023 and 2024 with the negotiated prices effective beginning in 2026. In addition, CMS is announcing more information about patient-focused listening sessions on the selected drugs with interested parties that will occur in Fall 2023.

“Today marks a significant and historic moment for the Medicare program with the announcement of the first drugs selected for Medicare drug price negotiation,” said CMS Administrator Chiquita Brooks-LaSure. “Our goal with these negotiations is to improve access to some of the costliest drugs for millions of people with Medicare while driving competition and innovation.” 

“Promoting transparency and engagement continue to be at the core of how we are implementing the new drug law and the Medicare Drug Price Negotiation Program, and that is why we set out a process for the first round of negotiation that engages the public throughout,” said Meena Seshamani, MD, PhD, CMS Deputy Administrator and Director of the Center for Medicare. “Along with the announcement of the selected drugs, we announced CMS’ plans to host a patient-focused listening session for each selected drug to hear directly from patients and others.”

This announcement is one of a number of steps CMS previously detailed in the Medicare Drug Price Negotiation Program timeline for the first cycle of negotiation. Other key upcoming dates for implementation include:

• October 1, 2023: Deadline for companies with a drug selected for the Negotiation Program to choose whether to sign agreements to participate in the negotiation process for 2026.

• October 2, 2023: Deadline for participating companies with a drug selected for the Negotiation Program to submit manufacturer-specific data for CMS to consider in the negotiations. In addition, this is the deadline for the public to submit data on therapeutic alternatives to the selected drugs, data related to unmet medical need, and data on impacts to specific populations.

• Fall 2023: CMS will invite each participating drug company with a selected drug to engage in a meeting on its data submission. CMS will also hold a patient-focused listening session for each selected drug. The patient-focused listening sessions, which will include participation from patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties, will be held between October 30, 2023 and November 15, 2023. The listening sessions are subject to change, including postponement and/or cancellation.

• February 1, 2024: CMS sends an initial offer of a maximum fair price for a selected drug with a justification to each drug company participating in the Negotiation Program.

• August 1, 2024: The negotiation period ends.

• September 1, 2024: CMS will publish the maximum fair prices that have been negotiated for drugs selected for negotiation for 2026.