First 10 drugs for Medicare price negotiation announced under IRA
Corey Ford, Vice President of Reimbursement and Policy Insights
On Tuesday, August 29, 2023 the Centers for Medicare & Medicaid Services announced the 10 Part D drugs selected for the Medicare Drug Price Negotiation Program during the 2026 plan year. For the first time in history, Medicare will directly negotiate a maximum fair price of select high expenditure, single source drugs without a generic or biosimilar equivalent. The 10 drugs include the following in the table below.
Selected Drugs for Price Negotiations in Part D for 2026
|Commonly treated conditions
|Total Part D Gross
Covered Prescription Drug Costs from June 2022-May 2023
|Prevention and treatment of blood clots
|Diabetes; Heart failure
|Prevention and treatment of blood clots; Reduction of risk for patients with coronary or peripheral artery disease
|Diabetes; Heart failure; Chronic kidney disease
|Rheumatoid arthritis; Psoriasis; Psoriatic arthritis
|Psoriasis; Psoriatic arthritis; Crohn’s disease; Ulcerative colitis
FlexTouch; Fiasp PenFill;
NovoLog; NovoLog FlexPen; NovoLog PenFill
Manufacturers with a product on this list must immediately work to collate the necessary data to be submitted to CMS by October 3. It will be critically important for manufacturers to leverage data from dossiers to help demonstrate the effectiveness of its products against competitors. While the financial impact on the selected drugs and their manufacturers will be considerable for 2026, I think that the impact of the negotiation program and the broader Inflation Reduction Act extends well beyond these targeted drugs. Part D plan sponsors may seek greater price concessions from the competitors of these selected products to maintain formulary coverage, and commercial payers may also adopt similar pricing requirements.
Potentially even more impactful for industry beyond the price negotiations, the Part D benefit redesign will usher in greater financial responsibilities for manufacturers and even narrower formularies with greater access restrictions. Given the complexity of the implementation of the Inflation Reduction Act, it is critical to engage with a partner who not only can decipher the regulatory complexity, but help you prepare for 2025 and beyond.