BREAKING NEWS – HHS Announces The First 10 Drugs Selected For IRA Drug Price Negotiation Program – Food and Drugs Law

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:

1. Eliquis (apixaban, Bristol Myers Squibb)
2. Jardiance (empagliflozin, Boehringer Ingelheim)
3. Xarelto (rivaroxaban, Janssen Pharms)
4. Januvia (sitagliptin phosphate, Merck Sharp Dohme)
5. Farxiga (dapagliflozin, AstraZeneca AB)
6. Entresto (sacubitril; valsartan, Novartis Pharms Corp)
7. Enbrel (etanercept, Immunex)
8. Imbruvica (ibrutinib, Pharmacyclics LLC)
9. Stelara (ustekinumab, Centocor Ortho Biotech Inc., Janssen
   Biotech)
10. 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 posthere. Additional resources and
information are also available on theGoodwin IRA page.

The post BREAKING NEWS – HHS Announces the
First 10 Drugs Selected for IRA Drug Price Negotiation Program
appeared first on Big Molecule Watch.

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