After the Centers for Medicare & Medicaid Services revealed the list of drugs set to face the first round of price negotiations under the Inflation Reduction Act (IRA), the drugmakers responsible for marketing them are confronting a series of deadlines.
First up, the companies need to tell CMS by Sunday whether they'll participate in the process or exit the Medicare and Medicaid programs entirely.
In a statement to Fierce Pharma, an AstraZeneca representative said the company plans to “participate in the process outlined by CMS to communicate the value of Farxiga to people covered by Medicare” as part of its commitment to ensuring access.
BMS plans to begrudgingly participate in the process, a spokesperson told Fierce Pharma in an emailed statement.
“If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid," the spokesperson said. "That is not a real choice.”
Aside from those companies, drugs from J&J, Merck, Novartis, Lilly, Novo Nordisk and Amgen face the first round of CMS price negotiations.
A spokesperson for Novo Nordisk said the company will “continue to explore all options that allow us to drive change" for people who need its medicines.
Amgen and Merck declined to comment, while J&J and Novartis didn’t immediately reply to Fierce Pharma’s requests for comment. Boehringer Ingelheim, which handles pricing and access for Jardiance under its partnership with Eli Lilly, also did not respond.
The companies that plan to participate must sign agreements stating as much by Sunday, according to the CMS.
Then, by Monday, the companies that are participating must submit any data they want to be considered in the negotiations. In addition, members of the public can submit information about therapeutic alternatives to the 10 drugs on CMS' list.
This fall will see each participating drugmaker engage in a meeting with CMS about its therapy. After that comes patient-focused listening sessions, which will be held between October 30 and November 15.
By February 1, CMS will send out an initial pricing proposal for each of the drugs. Companies can send their counterarguments up to 30 days after that.
Then, each company gets up to three negotiation meetings before the talks end on August 1, 2024. The new prices will take effect in 2026.
Companies that refuse to negotiate their prices face a sizable excise tax, which was a major point lamented in the several lawsuits aimed at the program.
As the negotiation process proceeds, so too does the litigation surrounding the law. Most of the companies facing price negotiations on their lucrative therapies have sued, alleging violations of their constitutional rights.

https://www.cnn.com/2023/08/29/politics/medicare-drug-price-negotiations/index.html