Unbiased Analysis of Today's Healthcare Issues
That is the title of my new publication out today with the subtitle “A case study of rifaximin for the treatment of overt hepatic encephalopathy using QALY and non-QALY measures“. This was work with co-authors Shanshan Wang, Leonardo Passos Chaves, Olamide Olujohungbe, Sanjana Muthukrishnan, and Aditi Chaudhary. The abstract is below. BackgroundTraditional cost effectiveness analyses…
Today, the Centers for Medicare and Medicaid Services (CMS) released the results from the Medicare Drug Price Negotiation Program for Initial Price Applicability Year (IPAY) 2027 (press release). What was the average reduction in drug prices? Across the 15 drugs included in the 2027 negotiation, on average, drug prices fell by 62% (median: 63%); accounting…
In short, ‘yes’. Barry Linden (2024) provides a nice overview of FDA’s approach to patient preference information (PPI): FDA is very open to doing this and they’re encouraging sponsors to use this kind of data to help them. The FDA’s desire to incorporate patient perspectives into their risk-benefit decision-making process started during the HIV/AIDS crisis,…
Impact of scope of practice laws in anesthesia. Reforming PBMs. UK COVID response: “Too little, too late” Enforcement of network adequacy requirements in Medicare Advantage. Access to orphan drugs in Central and Eastern Europe.
A 2024 Data Quality Framework (DQF) from the European Medicines Agency (EMA) aims to provide some guidance for drug manufacturers. Here is a summary of that document. Factors to be considered when evaluating RWD Key factors to be considered in the EMA’s DQF include: Reliability: Are the data correct? Extensiveness: Are the data enough Coherence:…
On September 19, 2025, an executive order increased the fee for new H-1B petitions from approximately $3500 to $100 000 per applicant. How is this policy likely to impact the healthcare workforce in the U.S.? A paper by Liu et al. (2025) uses Department of Labor data on certified Labor Condition Applications (LCAs) supporting H-1B visas…
Ask. Helpful tips from Jim Rohn.
What drug characteristics lead to higher vs. lower prices in the US? A paper by Beinfeld et al. (2025) finds the answer using data from SSR Health (about rebates) and Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database (to inform drug characteristics. Among the 161 drugs in both SSR and SPEC data, the…
Last week, CMS announced the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model. The program basically is a ‘most favored nation’ style reference pricing based on net prices from developed countries. The program builds on the Medicaid Drug Rebate Program (MDRP). Specific details specified on the CMS website include: Participating manufacturers whose applications are accepted…
That is the topic of a recent BioSpace article titled “How Effective Will TrumpRx and Other Direct-to-Consumer Drug Pricing Initiatives Be?” A am quoted in the article as follows: While [direct-to-consumer] DTC has been a growing trend in biopharma for nearly two years now—Lilly launched LillyDirect in January 2024—the number of drugmakers looking to sell their…