Unbiased Analysis of Today's Healthcare Issues
The Inflation Reduction Act (IRA) allows the Centers for Medicare and Medicaid Services to negotiate drug prices. However, CMS can only negotiated drug prices 9 years after drug approval for small molecules and 13 years after approval for large molecules. Why the difference? Do biologic treatments produce superior health benefits for patients? This is the…
Potentially so, argues Adam Fein of Drug Channels. There are two mechanisms for this. First, for drugs not covered in the maximum fair price negotiations, Fein argues that drugs with high list prices and large rebates would lead to more net savings compared to drugs with lower list price and rebates in part because in…
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 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…
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…
The Kaiser Family Foundation (KFF) identifies the Part D drugs on which Medicare spends the most money. This is an important question since CMS will begin drug price negotiation under the Inflation Reduction Act (IRA) based on the top 10 top spending Part D drugs. Some relevant statistics and figures are below. In 2021, Medicare…
ASPE has a report out on the potential impact of the Inflation Reduction Act on Medicare Part D beneficiary out-of-pocket spending. This is a particularly relevant topic as the share of patients who have fallen into the catastrophic coverage has increased over time. Some of the medical conditions with the top out-of-pocket payments for Medicare…
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…