Unbiased Analysis of Today's Healthcare Issues
Last week, the Federal Trade Commission (FTC) released a report titled “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.” While I won’t get into an analysis of the specific arguments FTC made, the report does have a number of interesting statistics and graphics on pharmacy benefit managers (PBMs). Some…
This is the title of a new paper I have out today at JMCP with co-authors Shanshan Wang, Jaehong Kim, Slaven Sikirica, and Alexander Sandhu with the subtitle “An economic model measuring the impact of sotagliflozin among patients with heart failure and diabetes“. The abstract is below: BACKGROUND: Heart failure (HF) is among the leading…
The Bureau of Labor Statistics’ (BLS’) Prescription Drug Consumer Price Index (CPI‐Rx) looks at price changes for drugs dispensed at outpatient retail pharmacies. However, many pharmaceuticals–especially infusions and injections–are administered at physician offices or hospitals. How would including physician-administered drugs impact the CPI-Rx? That is the question a paper by Hicks, Berndt and Frank (2024)…
The 340B Drug Pricing Program is a federal initiative designed to help certain healthcare providers, known as “covered entities,” stretch their resources to better serve vulnerable and underserved patient populations. Created in 1992, the program requires pharmaceutical manufacturers to sell outpatient drugs at significantly discounted prices (typically 25% to 50% off) to eligible hospitals, clinics,…
The good news: drug shortages in 2023 were down in the US from their recent peak between 2010 to 2012. The bad news: Drug shortages in 2023 were the highest they have been since 2012. These findings are from an FDA Report to Congress. Of note, shortages for biologic drugs (governed by CBER) increased a…
Delays in drug approvals cost pharmaceutical firms money. These costs include both lost sales as well as additional cost if clinical trials need to span a longer duration. While these facts are not in doubt, a key question is how much do delays in approval cost firms? A paper by Smith, DiMasi and Getz (2024)…
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…