CER Daily Newsfeed

Value Viewpoint: April 2, 2026

(4/2, Kimberly Westrich, LinkedIn) comments “A recent article published in Value & Outcomes Spotlight from the ISPOR Living HTA Working Group argues that traditional HTA is no longer keeping pace with rapid innovation, evolving evidence, and growing pressure for earlier patient access. The authors propose ‘living HTA’ as a more dynamic alternative. Living HTA would be an ongoing assessment process that updates recommendations when meaningful new evidence, safety signals, or shifts in clinical practice emerge, rather than relying on a static review conducted at a single point in time...The article makes a strong case that living HTA could help health systems balance faster access with better evidence stewardship, especially in areas marked by uncertainty, high unmet need, or quickly changing data.” Full

In Sync With Technological Innovation and Ongoing Evidence Generation: The Need for an HTA Transformation Through the Operationalization of Living HTA

(January/February 2026, Grammati Sarri, PhD, et al., ISPOR: Value & Outcomes Spotlight) comments “...The living HTA approach offers a distinct advantage for health systems with limited resources, such as those in many [low-to-middle income countries]. These settings utilize adaptive HTA methods—for instance, adapting an economic model from another country to create an initial, resource-efficient assessment adapted in the local context. The living HTA process enables LMICs to make these otherwise static adaptive assessments dynamic by incorporating emerging evidence for decision making.” Full

Most Favored Nation Pricing Deals, Demos Complicate Medicare Negotiation Prospects

(4/2, Cathy Kelly, Pink Sheet) reports “...Real-world evidence is ‘really important because we learn a lot more about the comparative effectiveness of a drug once it’s on the market’ so having less of that evidence may ‘change how we think about all these different factors,’ [ICER CEO Sarah Emond] pointed out.” Subscription Required

Synthetic Data: Accelerating Discovery while Maintaining Trust

(4/2, Ayin Vala, Stanford Medicine) comments “...A practical model that is gaining traction is to use synthetic data as a development layer. Researchers can define cohorts, iterate on inclusion criteria, test models, and refine analysis pipelines using synthetic datasets. Once the analysis is finalized, the same code can be executed in a secure environment on real data, with only aggregate results returned. This approach reduces unnecessary exposure to sensitive data while accelerating early-stage research. This is particularly relevant for cancer research using real-world data. These datasets are often large, longitudinal, and linked across multiple sources, including claims, clinical records, and geographic or social data. They also include small subgroups that are critical for studying inequities but increase privacy risk. As a result, access is tightly controlled and collaboration across institutions is difficult.” Full

UK Signs off on US Pharma Deal, Ensuring Tariff Reprieve as Britain Aims to Reattract Investments

(4/2, Zoey Becker, Fierce Pharma) reports “...In exchange for the tariff reprieve, the U.K. will boost the net price its National Health Service (NHS) pays for novel treatments by 25%...The 25% price hike folded into the deal shakes out through a higher cost-effectiveness threshold for medicines evaluated by [NICE]...Bristol Myers Squibb CEO Chris Boerner called the deal a ‘step toward properly recognising the value of innovative medicines so patients in the UK can access them sooner,’ further pledging to work with the U.K. and U.S. governments to support the initiative.” Full

Euro Roundup: EMA Finalizes Reflection Paper on Biosimilar Comparative Efficacy Studies

(4/2, Nick Paul Taylor, Regulatory Focus) reports “The European Medicines Agency (EMA) has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative efficacy studies (CES).” Full