CMS Guidance on IRA Price Negotiation: Part 2

What data do drug manufacturers need to submit to CMS as part of the IRA price negotiation? What data elements can they electively submit? The recent CMS guidance released May 3, 2024 outlines these elements. What mandatory data are manufacturers required to submit? On the mandatory side, drug manufacturers are required to provide CMS with…

CMS Guidance on IRA Price Negotiation: Part 1

CMS released guidance on IRA price negotiation last week. Below are some highlights regarding how drugs will be selected. Which drugs are eligible for negotiation? For small molecules, drugs have to be (i) FDA-approved, (ii) be FDA-approved at least 7 years ago, and (iii) have no generic equivalent on the market. For biologic molecules, drugs…

Is IRA drug price negotiation unconstitutional?

A federal judge says ‘no’. Endpoints reports: A New Jersey federal judge on Monday tossed cases brought by Johnson & Johnson and Bristol Myers Squibb against the Inflation Reduction Act, another victory for the law while Medicare works through the first year of price negotiations with industry. In a summary judgment, Judge Zahid Quraishi ruled…

How do different countries negotiate drug prices?

This question is particularly relevant with the passage of the Inflation Reduction Act (IRA) and the requirement that CMS negotiate a ‘maximum fair price’ for drugs with the biggest impact on Medicare’s bottom line. A Health Affairs Forefront paper by Lin et al. (2023) compares how drug price negotiation differs between Canada, France, Germany and…

Why you should include dynamic drug pricing in your CEA model

A Health Affairs Forefront paper by researchers Melanie Whittington, Peter Neumann, Joshua Cohen, and Jonathan Campbell makes a compelling case for incorporating drug price dynamics into cost effectiveness analysis. The first questions many people may have is ‘how do drug prices usually change over time?’ A drug’s net price often increases following launch and may…

CMS selects 10 drugs for price negotiation

Here is the CMS Factsheet and news coverage from NY Times. The companies that make each of these drugs is listed below. Eliquis – Bristol Myers Squibb and Pfizer Jardiance- Boehringer Ingelheim and Eli Lilly Xarelto – Johnson & Johnson Januvia – Merck Farxiga – AstraZeneca Entresto – Novartis Enbrel – Amgen Imbruvica,- AbbVie and…

CMS = HTA?

The U.S. is one of the the few developed nations without a government-run health technology assessment (HTA) body. Or are they? A recent perspective in the New England Journal of Medicine by Peter Neumann and Sean Tunis argues that the Centers for Medicare and Medicaid Services (CMS) already is serving as a de facto HTA…

Impact of IRA on drugs prices

How much money will IRA save Medicare? A paper by Hernandez et al. (2023) aims to answer this question. The methods they use are as follows: For the 10 drugs likely subject to negotiation by Medicare in 2026 based on 2020 gross spending and loss of exclusivity, we extracted 2020 data from 5 sources: (1)…