Unbiased Analysis of Today's Healthcare Issues
That is the topic of an Evidence Base article out today titled “Reflecting on 2025, looking to 2026: Experts outline what to expect for drug pricing and market access“. In the article, a variety of experts reflect on how 2025 reshaped the global drug pricing and market access landscape as well as predict what to…
How will HEOR leaders respond to recent policy changes? A survey from Tufts and the Center for the Evaluation of Value and Risk in Health (CEVR) provides the answer. About 2/3 of the n=57 respondents were Head of their HEOR department and the remaining 1/3 had some other senior level HEOR role. Whereas 29.8% of…
Medicare Drug Price Negotiation aims to reduce the prices paid for high cost pharmaceuticals. Traditionally, biologic drug price reductions after loss of exclusivity (LOE) have occurred due to the introduction of biosimilar competitors. A recent paper by Beinfeld et al. 2025 examines whether Medicare Drug Price Negotiation enacted under the Inflation Reduction Act (IRA) is…
The Trump administration has introduced three most-favored-nation (MFN) drug pricing initiatives designed to link U.S. pharmaceutical costs to prices paid in economically comparable countries. Most-favored-nation pricing requires manufacturers to provide rebates when U.S. prices exceed those in reference nations—a direct response to the persistent gap between U.S. drug prices and those in other developed economies.…
That is the question asked in a recent Health Affairs Forefront article by Peter Neumann, Josh Cohen, Sean Sullivan and Feng Xie. They compare the CMS negotiated prices for Initial Price Applicability Year (IPAY) 2027 against value-based prices (using QALYs) from the Tufts Cost-Effectiveness Analysis (CEA) Registry. The authors found that cost-effectiveness estimates varied among…
That is the news out of the UK today. A press release from the United Kingdom government states: A 25% increase in medicine pricing corresponds to 2 changes to the way NICE evaluates medicines; a change to the cost effectiveness thresholds and the introduction of a new value set for judging health states.NICE currently assesses value for money…
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,…
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:…
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…