HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. They are:
- Eliquis (apixaban, Bristol Myers Squibb)
- Jardiance (empagliflozin, Boehringer Ingelheim)
- Xarelto (rivaroxaban, Janssen Pharms)
- Januvia (sitagliptin phosphate, Merck Sharp Dohme)
- Farxiga (dapagliflozin, AstraZeneca AB)
- Entresto (sacubitril; valsartan, Novartis Pharms Corp)
- Enbrel (etanercept, Immunex)
- Imbruvica (ibrutinib, Pharmacyclics LLC)
- Stelara (ustekinumab, Centocor Ortho Biotech Inc., Janssen Biotech)
- Fiasp; Fiasp FlexTouch; Fiasp PenFill (insulin aspart, Novo); NovoLog; NovoLog FlexPen; NovoLog PenFill (insulin aspart recombinant, Novo Nordisk Inc.)
The announcement comes ahead of the legal deadline for HHS to publish the list of selected drugs, which the IRA sets at September 1, 2023.
Five of the manufacturers whose drugs are on the list (Merck, BMS, Janssen, BI, and AstraZeneca) have pending lawsuits challenging the constitutionality of various aspects of the Drug Price Negotiation Program.
Of the 10 drugs, three are biologics (ENBREL, STELARA, and the FIASP and NOVOLOG products). The remainder are small-molecule drugs.
While industry members and observers had speculated on likely drugs to be included based on CMS expenditure data, today is the first time the government has definitively and publicly identified the specific drugs that would ultimately be selected for the Program.
For background on the IRA and its provisions regarding the drug selection process and the upcoming “negotiation” process, check out our previous post here. Additional resources and information are also available on the Goodwin IRA page.