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Tuesday, February 28, 2023

Big-sellers from Merck, Novo and Lilly likely to face Medicare price negotiations

 While new drug pricing laws won’t empower Medicare to haggle over prescription costs for another three years, the dimensions of the talks have started to take shape.

Between 2026 and 2028, Medicare could parley on pricing for some 38 Part D drugs and 2 Part B drugs under Democrats’ Inflation Reduction Act (IRA), according to a new report from the Journal of Managed Care & Specialty Pharmacy (JMCP). 

In 2026—the first year Medicare’s price negotiations are set to start under the IRA—the top drugs expected to fall victim to discussions include blood thinners Eliquis from Bristol Myers Squibb and Xarelto from Johnson & Johnson. Oral diabetes drugs such as Merck's Januvia and Boehringer Ingelheim and Eli Lilly's Jardiance may also face negotiations during the first year, the journal says.

Under the law, CMS will apply negotiated maximum fair prices for select small molecule drugs that have been on the market for at least 9 years and for biologics marketed for more than 13 years. Starting in 2026, the Centers for Medicare & Medicaid Services (CMS) will hash out prices on the 10 highest spend Part D drugs, followed by 15 part D drugs for 2027 and 15 drugs across Medicare's Part B and D programs in 2028.

Amgen's Enbrel is also expected to be subject to cost discussions in 2026, JMCP said, plus the inhalers Symbicort from AstraZeneca and Breo Ellipta from GSK.

Three cancer meds—AbbVie and J&J's Imbruvica, Pfizer's Ibrance and Astellas and Pfizer's Xtandi—form another trio likely to enter Medicare’s pricing crosshairs in 2026, according to the journal.

Together, those 10 drugs made up $33.7 billion, or 17%, of Part D gross spending in 2020, JMCP notes.

Part D drugs are dispensed at pharmacies, while Part B drugs are doled out at the doctor’s office, the journal points out.

In 2027, Medicare is poised to haggle over 4 inhalers, 3 diabetes drugs, 2 kinase inhibitors for cancer and the antipsychotic Invega Sustenna from J&J, according to the research. The 15 drugs on the 2027 bargaining table accounted for $16.4 billion (8.3%) in gross Part D spending in 2020.

Some big stars in the potential 2027 cohort include Novo Nordisk’s diabetes stalwart Ozempic, GSK’s Trelegy Ellipta and Incyte’s Jakafi.

Come 2028, meanwhile, Part B drugs become eligible for negotiation under the IRA, though the journal only projects two medicines in that category will be subject to cost discussions. Those are Merck’s immuno-oncology cash cow Keytruda, plus Bristol Myers Squibb’s cancer blockbuster Opdivo. JMCP reasons that most Part B drugs that could come up in cost talks will likely face biosimilar competition before 2028, potentially making the discussions a moot point.

Under IRA’s cost negotiation provisions, a drug loses eligibility for inclusion in pricing talks when a generic or biosimilar version has been approved and marketed for at least nine months ahead of the first of the year when negotiated prices would apply. Between 2026 and 2028, major players like Bristol's Revlimid and AbbVie's Humira will maintain discussion immunity.

IRA’s cost negotiation provisions represent the first significant movement in a long-running national debate over the high price of pharmaceuticals. While there are still several more years to go before Medicare can start the haggling process, the move is expected to make a real difference for patients on the negotiated drugs.

“Some Medicare patients will benefit substantially from negotiations on these drugs, as a reduction in the drug’s price will result in lower coinsurance and liability during the deductible phase,” JMCP argues in its report. The talks will specifically help patients with common diseases like diabetes, cancer, respiratory conditions, or cardiovascular disease. 

https://www.fiercepharma.com/pharma/keytruda-ozempic-and-trulicity-may-fall-victim-medicare-price-talks-humira-escapes-looming

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