Unbiased Analysis of Today's Healthcare Issues
As reported by EndPoints: President Donald Trump on Tuesday signed an executive order offering support for a change to the IRA’s “pill penalty,” one of the industry’s long-standing policy priorities that could affect billions of dollars in drug costs under Medicare. The executive order on drug pricing contains a grab-bag of policy proposals, some of…
Some hints–and only hints–were provided in a CMS press release on Wednesday. Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his Administration. In accordance with the statutory requirements of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) released the list of 15 drugs…
Chuanzi Yue and Marisa Miraldo argue in a recent Health Affairs Forefront piece that the answer is ‘yes’, but I am highly skeptical of their claim. Will IRA cause firms to allocate funds from marketing to R&D? One point they make is that the IRA’s Medicare Drug Price Negotiation program will reduce pharmaceutical expenses on…
From the CMS document “Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027“: On January 17, 2025, CMS announced the selection of the below list of 15 drugs covered under Medicare Part D for the second cycle of negotiations (initial price applicability year 2027), based on total gross covered prescription drug…
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…
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…
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…
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…