Unbiased Analysis of Today's Healthcare Issues
Recently, the Inflation Reduction Act (IRA) is getting a lot of attention, particularly for its provision that allows CMS to start drug price negotiation for selected drugs 9 (small molecules) or 13 (biologics) years after drug launch. However, the Centers for Medicare and Medicaid Innovation (CMMI) has proposed a number of a number of payment…
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…
The Biden Administration promised more access to Medicare data. Then the reverse happened. ProPublica explains: In January, the Biden administration pledged to increase public access to a wide array of Medicare information to improve health care for America’s most sick and vulnerable. Some Medicare plans’ lack of transparency “deprives researchers and doctors of critical data…
That is the finding from a recent report from the Congressional Budget Office (CBO) on the activities of the Centers for Medicare and Medicaid Innovation (CMMI) CBO previously estimated that CMMI’s activities would reduce net federal spending but now estimates that they increased that spending during the first 10 years of the center’s operation and will…
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…
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…
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…