CER Daily Newsfeed

The Comparative Effectiveness Research Daily Newsfeed®, known for short as the CER Daily Newsfeed®, offers the latest news, research and related information on comparative effectiveness research, real-world data and evidence, value assessment and other important health care topics. 

News from Thursday, September 28, 2023


ICER Revises its Value Assessment Framework, but Is it Enough?

(9/28, Joanne Walker, The Evidence Base) reports “...Kimberley Westrich, Director, Value and Access Strategy, Cencora, commented on LinkedIn that, ‘very little has changed,’ in the framework and it is the, ‘same as it ever was.’ This was echoed by Brian Reid, commenting in the Cost Curve, who explained, ‘ICER's approach is tilted toward a conservative (in the non-political sense!) way of thinking that tends to play down certain kinds of value and cost savings.’ John O'Brien, President and CEO at National Pharmaceutical Council claimed the revised framework, ‘bypassed or postponed addressing several key issues,’ making it a ‘disservice to patients and those who practice the scientific application of value methods.’ NPC also issued a press release outlining its remaining concerns about the framework.” Full


ICER’s Updated Treatment Assessment Still Ignores Patient Concerns

(9/27, BIO) comments “...ICER’s update ignores calls for improvements,from BIO and others. BIO questioned QALYs and recommended patient-centric assessments incorporating societal value. ICER rejected calls to add additional dimensions of value and a proposed Generalized Risk-Adjusted Cost-Effectiveness Analysis, which would give a more holistic assessment of impacts on patients, caregivers, and society...‘QALY is very discriminatory. If you’re disabled, you’re downgraded,’ explains Daniel Durham, BIO Senior Health Policy Advisor.” Full


The Problems with Drug Price Controls

(9/27, Tomas J. Philipson, National Review) comments “...The IRA dictates that drugs are selected based on list prices, which in the pharmaceutical industry can differ dramatically from the transaction prices that drug companies receive. Private drug plans and pharmacy-benefit managers obtain large discounts below list prices from drug companies in exchange for the plan offering lower copays for the drug or less interference with doctors prescribing it. For the ten drugs selected, such competition is already substantial in pushing down transaction prices.” Full


J&J's Rybrevant Combo Bests AstraZeneca's Established Tagrisso in Key Lung Cancer Study

(9/28, Zoey Becker, Fierce Pharma) reports “...In the MARIPOSA trial, J&J’s Rybrevant—combined with its Yuhan-partnered lazertinib—helped patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC survive longer without disease progression compared with Tagrisso.” Full


Video: Unpacking the Implications of the Negotiated Drug List, Part 2

(9/27, Avalere) “In Part 2 of our video series on the negotiated drug list, Avalere experts discuss topics including effectiveness measures that will inform CMS’s maximum fair price determinations, evidence generation strategies for manufacturers with products that have been selected for negotiation, or that are eligible for selection in the future, and CMS’s definition of therapeutic alternatives.” View Video


Finding New Value in Drugs: Q&A With Darius Lakdawalla, Chief Scientific Officer at EntityRisk

(9/28, Mike Hollan, Pharmaceutical Executive) reports “...Pharmaceutical Executive: How are drugs being improperly valued? Lakdawalla: We looked at how the Institute for Clinical and Economic Review evaluated 20 drugs over recent years and asked what would happen if you used more up to date methods of evaluation and how that would impact their conclusions. Essentially, what we found was that you would end up with the result that many more drugs represent more value for money than what the institute would have concluded.” Full


Embedding Equity In Financial Benchmarks: Changes To The Health Equity Benchmark Adjustment

(9/28, Amol S. Navathe and Joshua M. Liao, Health Affairs Forefront) comments “...A key equity-oriented feature in ACO REACH is the Health Equity Benchmark Adjustment (HEBA). As its name suggests, the adjustment permits increases or decreases to participants’ financial benchmarks based on the characteristics of beneficiaries served...Here we review how the HEBA is currently assessed; how it is outlined to change; and several key policy implications.” Full


Orchard On The Trials, Tribulations And Triumphs Of Gene Therapy HTA

(9/28, Eliza Slawther, Pink Sheet) reports “...Convincing payers to fund a $3m therapy is no mean feat, even for innovations with curative potential. Orchard Therapeutics, a company with much experience in this field, tells the Pink Sheet why it values open dialogues, and outlines how health technology assessment methods could be improved.” Subscription Required

Press Releases

CADTH’s Time-Limited Recommendation Category Aims to Support Earlier Access to Promising Drugs

(9/28, CADTH Press Release) “...Time-limited drug reimbursement recommendations are a new recommendation category that will aim to help provide earlier access to promising new treatments that target the unmet needs of people in Canada living with severe, rare, or debilitating illnesses. A time-limited recommendation is a recommendation to publicly fund a drug or drug regimen for a certain period of time. This recommendation is based on the condition the manufacturer will conduct ongoing clinical studies to address uncertainty in the evidence. CADTH will conduct a future reassessment of that additional evidence, which will lead to a final reimbursement recommendation.” Full


Real-World Experience of the Comparative Effectiveness and Safety of Combination Therapy with Remdesivir and Monoclonal Antibodies versus Remdesivir Alone for Patients with Mild-to-Moderate COVID-19 and Immunosuppression: A Retrospective Single-Center Study in Aichi, Japan

Jun Hirai, et al.

September 19, 2023, Viruses



Comparative Effectiveness of Dynamic Treatment Strategies for Medication Use and Dosage: Emulating a Target Trial Using Observational Data

Kate Birnie, et al.

November 2023, Epidemiology



White Paper: Improving Patient Subgroup Representation with Real-World Data

September 28, 2023

Duke Margolis Center for Health Policy


Harnessing the Potential of Real-World Evidence Master Protocols

September 28, 2023

Duke Margolis Center for Health Policy


Webinar Video: Updates to ICER’s Value Assessment Framework

September 28, 2023