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 Wednesday, September 27, 2023


Safety-Net Providers Bought a Record $53.7B of Discounted Drugs: Report

(9/27, Adriel Bettelheim, Axios) reports “...Safety-net providers bought a record $53.7 billion worth of medicines under the federal drug discount program last year - a 22% jump over 2021 that came while drug price growth lagged behind overall inflation, according to a published report. Why it matters: The report in the trade publication Drug Channels draws into question claims from some program advocates that drugmakers' business practices are eroding the health care safety net.” Full


Real-World Evidence Analysis Must Protect Patient Privacy, FDA Says

(9/26, Jessica Karins, InsideHealthPolicy) reports “...FDA specifically says sponsors should have protocols in place to ensure patients’ privacy is protected and that source data can be shared with FDA. ‘When appropriate, sponsors should consult with experts who consider data privacy issues to provide input on the protocol as part of the study design process for a non-interventional study, as these experts may help identify and address data privacy and security concerns raised when accessing health care data,’ the guidance says.” Subscription Required


RWE Tips from Boston Scientific Peripheral Interventions CMO Dr. Michael Jaff

(9/26, Jim Hammerand, Medical Design & Outsourcing) reports “...‘By the time a randomized trial is completed and published, the technology is already several years old, because those trials take a long time. They’re on a very selected patient population — not the population that’s routinely managed by physicians, but a subgroup of those patients,’ Jaff said. ‘So as people who are developing new therapies are thinking about, “What’s my next strike opportunity? Where can I really go?” I would urge them to think about looking into real-world evidence to help guide them.’” Full


Payers, Providers Are Cautiously Optimistic about Their Value-based Care Efforts. Here's How Their Sentiments Differ

(9/26, Anastassia Gliadkovskaya, Fierce Healthcare) reports “...Most respondents thought their VBC programs had been somewhat successful in controlling costs, improving the patient experience and improving clinical outcomes. Less than half thought they were somewhat successful when it came to improving the provider experience. Notably fewer respondents thought their programs were very successful at addressing any of these areas.” Full


Video: Collaboration Is Key to Success in Alternative Payment Models, Says COA’s Nick Ferreyros

(9/27, Maggie L. Shaw, The American Journal of Managed Care) “The number one ingredient that an oncology-based alternative payment model (APM) need to succeed is collaboration, working with stakeholders, participants, and practices, explained Nicolas Ferreyros, managing director of policy, advocacy, and communications, Community Oncology Alliance.” View Video


UK: NICE Poised to Reject AstraZeneca, Daiichi’s Enhertu in HER2-Low Breast Cancer

(9/27, Angus Liu, Fierce Pharma) reports “...Enhertu is not recommended for National Health Service coverage for treating HER2-low metastatic or unresectable breast cancer after chemotherapy, the National Institute for Health and Care Excellence said in draft guidance. NICE’s opinion comes as a surprise given Enhertu’s impressive clinical data, which the agency recognized in its evaluation.” Full

Press Releases

ICER Appoints Daniel Ollendorf as Chief Scientific Officer and Director of HTA Methods and Engagement

(9/27, ICER Press Release) “...From 2007-2018, Dr. Ollendorf was Chief Scientific Officer for ICER, where he oversaw the broader HTA process and managed relationships with multiple stakeholders and research collaborators. He is currently the Director of Value Measurement & Global Health Initiatives at the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts Medical Center, where he focuses on value assessment methods, drug pricing policy, and building international capacity for and interest in HTA.” Full


Atropos Health Announces Agreement to Accelerate Real World Evidence Generation

(9/27, Atropos Health Press Release) “...Building upon an existing collaboration, under the new agreement, Atropos and Janssen data scientists will utilize Atropos’s software platform to interrogate Janssen’s in-house real-world data sets to inform clinical development strategies, including optimizing trial design, understanding patient natural histories and assessing outcomes in real-world patient populations. The collaboration will span a broad portfolio of therapeutic areas.” Full


Comparative Effectiveness of Tacrolimus and Infliximab in Hospitalized Patients with Ulcerative Colitis

Takahiro Takahashi, et al.

September 27, 2023, Clinical and Translational Gastroenterology



Comparative Effectiveness, Time to Discontinuation, and Patient-Reported Outcomes with Baricitinib in Rheumatoid Arthritis: 2-Year Data from the Multinational, Prospective Observational RA-BE-REAL Study in European Patients

Rieke Alten, et al.

September 27, 2023, Rheumatology and Therapy



Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review

Harrison J. Hansford, BSc(Hons); Aidan G. Cashin, PhD; Matthew D. Jones, PhD; et al

September 27, 2023, JAMA Network Open

JAMA Network Open


Role of Registries in Medicare Coverage of New Alzheimer Disease Drugs

Ilina C. Odouard, MPH; Mariana P. Socal, MD, PhD; Gerard F. Anderson, PhD

September 27, 2023, JAMA