
Stelara and Enbrel Chosen for IRA Price Negotiation
The Biden administration has released the first 10 drugs subject to price negotiation with Medicare under the Inflation Reduction Act (IRA), and among those chosen were Stelara (ustekinumab) and Enbrel (etanercept), both of which will face biosimilar competition within the next decade.
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Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that will face biosimilar competition within the next decade, were among the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA).
The full list of chosen drugs includes:
- Apixaban (Eliquis)
- Empagliflozin (Jardiance)
- Rivaroxaban (Xarelto)
- Sitagliptin (Januvia)
- Dapagliflozin (Farxiga)
- Sacubitril/valsartan (Entresto)
- Etanercept (Enbrel)
- Ibrutinib (Imbruvica)
- Ustekinumab (Stelara)
- Insulin aspart (Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, NovoLog PenFill)
The IRA was signed into law by President Joe Biden in August 2022 after contentious votes in the Senate and House of Representatives. As required by the IRA, price negotiations between Medicare Part D plans and pharmaceutical companies will take place through the rest of 2023 and throughout next year, with the negotiated prices taking effect in 2026.
Price negotiations will be implemented in phases. Drugs eligible for negotiation must be high-expenditure, single-source medicines
“The rationale for this delay is to not create financial incentives that could deter biosimilars from entering the market if, for example, a reference product (the original biological product approved by FDA against which a proposed biosimilar product is compared) is selected for negotiation and ultimately priced lower than potential competitor biosimilar products,” explained the Kaiser Family Foundation in its FAQ page on IRA price negotiation.
Although Enbrel has 2 FDA-approved biosimilars and Stelara has a few ustekinumab biosimilars coming down the pipeline, neither drug has biosimilars currently on the market. The chosen drugs must also have been on the market for over 9 years for small molecules and over 13 years for biologics.
Etanercept biosimilars are
According to the
While the negotiated prices for this initial list will take effect January 1, 2026, CMS will also select up to 15 additional drugs for which Part D negotiations will occur for 2027, up to 15 more for 2028 (including both Part B and Part D), and up to 20 more drugs for each subsequent year.
The price negotiation initiative
Additionally, the US Chamber of Commerce
Overall, the IRA law has 4 main pillars that will impact medicine pricing and cost sharing among stakeholders, including prescription drug inflation rebates, patient out-of-pocket caps, a redesign of Part D benefits, and lowering prices through negotiation.
In October 2022, the
Another piece of the IRA was the
New prescription drug inflation rebates will require manufacturers to pay rebates if their drug prices increase faster than general inflation. This portion of the IRA was implemented in October 2022.
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