CER Daily Newsfeed

Heavy on Price, Light on Access: ICER’s Launch Price and Access Report Misses the Mark

(10/23, National Pharmaceutical Council: E.V.I.dently Today) comments “Today, the Institute for Clinical and Economic Review (ICER) released its inaugural Launch Price and Access Report (LPAR). The LPAR paints an incomplete view of the value of medicines to patients and society, and risks misinterpretation of the misleading ‘overspending’ analysis. It also highlights potential insurance concerns that hinder patient access to new medicines...ICER said the ‘report will contain hypotheses-generating research,’ used to inform policy discussions. Hypothesis-generating means that no direct cause-and-effect relationship can be established, and extrapolation would be inappropriate. Decision-makers will want to ensure they understand all the critical limitations before using this report to inform decisions. Patients are counting on them, and all of us, to get it right.” Full

NPC Shares Concerns about ICER Launch Price and Access Report

(10/23, Ed Silverman, STAT+) reports “...‘It’s disappointing that this new report is another ICER effort that does more harm than good due to a host of methodological, data, and analytic shortcomings,’ said Kimberly Westrich, chief scientific officer at the National Pharmaceutical Council...‘…Although the report has “access” in the title, ICER dedicates nearly twice as much analytical space to pricing. It demonstrates a willingness to overlook limitations on the pricing side when drawing conclusions, but not on the access side – even while acknowledging that patient access is often hindered by delayed insurance coverage policies.’” Subscription Required

Chair Cassidy Delivers Remarks During Hearing on 340B Drug Program, Impact on American Patients

(10/23, U.S. Senate Committee on Health, Education, Labor and Pensions) comments “...[U.S. Senator Bill Cassidy, M.D. (R-LA):] Anyone who says 340B is cost-neutral to the taxpayer, isn’t paying attention. As the 340B program grows, so do health care costs. In fact, this year, CBO reported the program's dramatic growth led to higher costs for patients and taxpayers. And I will also note, a recent study by the National Pharmaceutical Council found that 340B’s growth caused premiums for employer-sponsored insurance to increase an estimated $4.5 billion from 2017-2023.” Full

Harnessing Real-World Evidence to Future-Proof Drug Development

(10/23, Susan Haigney, PharmTech) comments “...Beyond mandatory safety monitoring, RWE is fundamentally tied to the industry’s push toward patient-centric and personalized therapies...By including RWE, companies can leverage patient data for adaptive regulatory pathways. For drug developers exploring novel therapies, RWE can be gathered from existing research or post-market drugs to help choose a drug development direction, such as investigating new cell therapies for oncology. RWE can help fill knowledge gaps quickly and offer tailored analyses that traditional clinical trials often cannot.” Full

GetReal Conference 2025: Bridging Clinical Trials and Real-World Evidence in Interventional Research

(10/23, Katie McCool, The Evidence Base) reports “...‘When we talk about interventional studies, we very often think about the really traditional, highly controlled RCTs,’ [Mira Zuidgeest (University Medical Centre Utrecht)] said. ‘Nowadays, we still have pharmacoepidemiology, but we call it real world evidence. We talk about real world data. We still have clinical trials, but these two are actually merging towards each other more and more, and that's really what the session that we're having today is all about.’ Zuidgeest highlighted four key roles for RWE in interventional research: informing trial design, serving as a data source, generating pragmatic or decentralized evidence, and enriching trial outcomes.” Full

Medicare’s WISeR Model And The Challenge Of Low-Value Care

(10/23, Elizabeth Fowler, Health Affairs Forefront) comments “...Not everyone is convinced the balance between addressing low-value care and preserving appropriate access will be struck. Some policymakers legitimately fear that WISeR could undermine the basic tenet of Traditional Medicare. They worry it will restrict access to needed services, increase administrative burdens, and substitute opaque algorithms for clinical judgment...Any experiment that intervenes in clinical decision-making must be approached cautiously, and this is particularly true for model tests focused on emerging AI technologies, particularly in light of reporting on inappropriate care denials tied to the use of AI by private insurance companies.” Full

Can Introducing Peanuts Early Prevent Allergies? Real-World Data Confirms it Helps

(10/22, Hugo Francisco de Souza, News Medical) reports “...The study leveraged electronic health record data from tens of thousands of US children to compare allergy diagnoses before and after the 2015 and 2017 guidelines were published. Study findings revealed a significant decrease in the incidence of both peanut-specific and overall food allergies following the implementation of the new recommendations, providing real-world evidence supporting these policies' intended protective effect.” Full

Shaping the Future of Global Health Technology Assessment

(10/23, Helen Knight, Nick Crabb, NICE Blog) comments “...HEMA has now published its first draft report for public comment. The report examines whether factors other than health benefits and costs to the system should be considered when deciding if treatments should be recommended. These factors include the burden on families and carers, if treatments address health inequalities, how much risk patients are willing to accept on novel treatments and the value of a diagnosis. The HEMA working group considered the evidence for each factor, taking into account relevance, measurability and trade-offs with other treatments. We’re now inviting comments and views on the findings of the draft report from patients, clinicians, and other stakeholders.” Full

Faster Access In England Under NICE-MHRA Scheme Hinges On ‘Optimal’ Drug Status

(10/23, Eliza Slawther, Pink Sheet) reports “...More light has been shed on how a new parallel health technology assessment and regulatory decision-making pathway in England will work in practice, and what requirements companies will need to meet to benefit from the scheme.” Subscription Required