CMS trims first list of drugs tapped for inflation fines

03 Apr 2023
firstwordpharma.com
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The US Centers for Medicare and Medicaid Services (CMS) has quietly updated the list of Part B prescription medicines subject to penalties because their prices rose faster than the rate of inflation. In an update late last week, the agency cut seven medicines from its original list of 27 that was unveiled on March 15.
A provision in the Inflation Reduction Act (IRA), which came into force last year, penalises pharmaceutical companies for charging prices that go up faster than inflation for people with disabilities or those 65 and older who are on the government's Medicare health programme (for more, see ViewPoints: Inflation Reduction Act's myriad impacts to reverberate across pharma). The move is expected to lower out-of-pocket costs for some Medicare recipients by between $1 and $372 per average dose, as of April 1, depending on their individual coverage, according to an agency press release updated on March 30.
Gilead cell therapies knocked off
The seven drugs that have been cut from the original list include Gilead Sciences' CAR-T therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel); Stemline Therapeutics' Elzonris (tagraxofusp-erzs) used for blastic plasmacytoid dendritic cell neoplasm; Shionogi's Fetroja (cefiderocol), an antibiotic to treat complicated urinary tract infections; Arcotech Biopharma's Folotyn (pralatrexate) for relapsed or refractory peripheral T-cell lymphoma; Kamada's WinRho SDF (Rhₒ(D) immune globulin) to boost platelet counts in order to prevent excessive haemorrhage; and Bausch + Lomb's Xipere (triamcinolone acetonide), which is prescribed for macular oedema associated with uveitis.
CMS did not give a reason for why the original list was scaled back. Other products that remain include all five Pfizer drugs that were on the original list, namely Atgam (antithymocyte globulin equine), Bicillin L-A (penicillin G benzathine), Bicillin C-R (penicillin G benzathine and penicillin G procaine), Fragmin (dalteparin) and Nipent (pentostatin), as well as Johnson & Johnson's Rybrevant (amivantamab). Companies whose products have been flagged will be required to pay Medicare the difference in the form of a rebate ranging from roughly 14% to 20%.
Meanwhile, CMS has said that by September 1, it plans to publish the first 10 Medicare Part D drugs that will be subject to government price negotiations starting in 2026.
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