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 Friday, September 15, 2023

Articles

Real-World Data in a Post-Pandemic World

(9/15, Surani Fernando, Medical Marketing & Media) reports “...As for the FDA, when asked via email about source-related challenges, the spokesperson responded: ‘In regards to real-world data sources, we find issues related to data reliability and clinical relevance, a need for linkage to other data sources, missing or “mistimed” data and insufficient capture of endpoints. For non-randomized study designs, issues include the threat of residual confounding, problems with index date (“zero time”) and use of an inappropriate comparator.’” Full

 

Three Outstanding Questions About CMS’s Ambitious New AHEAD Model

(9/14, Troyen A. Brennan, Health Affairs Forefront) comments “...As a hospital executive, your key strategy, perhaps your only strategy, has been to increase in size, gain leverage with insurers, bargain for better fee-for-service rates, and do more procedures. Working under a prospective budget blocks that strategy. So one might ask about Pennsylvania, would centers like UPMC in the west, and Jefferson or University of Pennsylvania in the East, be ready to abandon the fee-for-service revenue generation program for one based solely on value-based care that improves population management. I wish that were true, but it seems doubtful.” Full

 

Americans Overwhelmingly Support Medicare Drug Negotiations, But Biden Sees Little Political Boost

(9/15, Seung Min Kim and Linley Sanders, Associated Press) reports “...Three-quarters of Americans, or 76%, favor allowing the federal health care program for the elderly to negotiate prices for certain prescription drugs. That includes strong majorities of Democrats (86%) and Republicans (66%), according to a new poll from The Associated Press-NORC Center for Public Affairs Research. About one in five Americans are neutral on the issue, while 6% outright oppose it. But the same poll shows Biden's approval rating, at 40%, is about where it's been for the last year.” Full

Press Releases

More People Could Be Offered Genetic Testing for Genes Linked to Ovarian Cancer in New Draft NICE Guideline for Public Consultation

(9/15, NICE News Release) “A new draft NICE guideline for inherited ovarian cancer published today (15 September 2023), recommends more people are tested for genes linked to ovarian cancer...The guideline aims to raise greater awareness and increase the availability of genetic testing, allowing people to take preventive measures such as surgery, meaning fewer people will go on to develop ovarian cancer.” Full

 

Towards a Permanent Collaboration Framework for EMA and Health Technology Assessment Bodies

(9/15, European Medicines Agency Press Release) “...‘EMA’s collaboration with EUnetHTA began in 2010 as a project to test out whether early engagement between regulators and HTA bodies could bring tangible benefits for patient access to medicines,’ said Michael Berntgen, Head of Scientific Evidence Generation Department at EMA. ‘Together, we were able to help medicine developers enhance clinical research and become more efficient in generating the evidence relevant for both regulatory authorities and HTA bodies.’” Full

Journals

The Cost–Effectiveness of Pegcetacoplan in Complement Treatment-Naïve Adults with Paroxysmal Nocturnal Hemoglobinuria in the USA

Jesse Fishman, et al.

September 2023, Journal of Comparative Effectiveness Research

Journal of Comparative Effectiveness Research

 

Comparative Effectiveness of Umeclidinium/Vilanterol versus Indacaterol/Glycopyrronium on Moderate-to-Severe Exacerbations in Patients with Chronic Obstructive Pulmonary Disease in Clinical Practice in England

Requena G, et al.

September 15, 2023, International Journal of Chronic Obstructive Pulmonary Disease

International Journal of Chronic Obstructive Pulmonary Disease

 

A Real-World Comparison of Apixaban and Rivaroxaban in Obese and Morbidly Obese Patients With Nonvalvular Atrial Fibrillation

Kevin T Burnham, et al.

September 15, 2023, Journal of Pharmacy Practice

PubMed

 

Viewpoint: The Problem of Limited-Supply Agreements for Medicare Price Negotiation

Sarah M. E. Gabriele, LLM, MBE; William B. Feldman, MD, DPhil, MPH

September 15, 2023, JAMA

JAMA