Unbiased Analysis of Today's Healthcare Issues
See my previous posts on IRA price negotiation on drug selection (Part 1) and manufacturer data submission (Part 2). Today we will talk about the negotiation process and how CMS will set the maximum fair price (MFP) How will CMS price across dosages? “CMS will base the single price on the cost of the selected…
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 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…
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…
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…
While the Inflation Reduction Act (IRA) aims to lower the prices of pharmaceuticals, at the same time it exempts drugs treating rare diseases (i.e., orphan drugs) from drug price negotiation. However, this exemption is only valid if the orphan drugs has a single approved indication. Thus, a key question is how frequently orphan drugs are…
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)…
CMS released a guidance on June 30, 2023 providing additional detail on on how the maximum fair price (MFP) will be calculated. The document also has nearly 100 pages of public input comments. A summary of some key points are below. Of most interest is that CMS is taking a ‘reference price’ based approach to…
This is the title of my Health Affairs Forefront article published today alongside co-authors Darius Lakdawalla, Jalpa Doshi, Louis Garrison, Anup Malani, Peter Neumann, Charles Phelps, Adrian Towse, and Richard Willke. The article begins by discussing some of the pros and cons of different approaches for CMS to set the maximum fair price (MFP). Across…
That is the title of a new USC Schaeffer Center white paper authored by Dana Goldman, Joe Grogan, Darius Lakdawalla, Barry Liden, Kyi-Sin Than, Erin Trish and myself. An excerpt from the press release is below, and the full white paper is here (HTML, PDF). 1. Bring transparency and a focus on value to the…