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 Tuesday, May 21, 2024

Articles

Kimberly Westrich's ICER Recommendations to Improve Drug Pricing Data Accuracy

(5/20, Pearl Steinzor, The American Journal of Managed Care) reports “...[Kimberly Westrich, MA:] ICER's methods and data systematically undervalues treatments, which can have impacts for the incentives for future innovation, and for patient access to those treatments. There are 3 simple recommendations that I would make to ICER that could improve the accuracy of their reports...#1: do some of the method changes that are low-hanging fruit [incorporate dynamic pricing and lower the discount rate]. #2: eliminate the shared savings approach. And #3: involve patient feedback and patient engagement in a way that it meaningfully impacts the results of the assessment.” Full

 

US Pharma and Biotech Summit 2024: Solving Drug Pricing

(5/21, Mike Hollan, PharmExec) reports “...According to O'Brien, the impact of the IRA might not be what was intended by those that wrote and signed the bill into law. ‘At this time, we've gotten some research that showed that on average, if you begin a development program, after your drug is approved, it typically takes you about seven years to get that indication,’ he explained. ‘If you go to somebody and say, “Hey, there's a very good chance that at nine years, the government is going to set your price, do you want to begin a development program that's going to lead to an additional indication in nine years and seven years?” It's hard to make the case for that. So, an alternative is that you should wait until you have more indication before launching your product was, which is essentially depriving patients on access to innovation.’” Full

 

Setting the Stage to Shape the International Harmonization of Real-World Evidence Standards

(5/21, Rachele Hendricks-Sturrup, Valerie Parker and Maryam Nafie, The Evidence Base) comments “...Launched online in late 2023, the International Harmonization of RWE Standards Dashboard provides timely updates and summaries of international regulatory guidance (both draft and final) on RWD/E and quick links to other related literature, including but not limited to the 2023 ICH Reflection Paper...The Dashboard summarizes each regulator’s definitions of RWD, data quality, fit-for-purpose, reliability, and relevance when those definitions are provided. The Dashboard’s summary to date, in fact, shows that there are early signs of alignment around certain key terms.” Full

 

France Reveals The Drugs That Are Most Likely To Require Post-Market RWE Studies

(5/21, Eliza Slawther, Pink Sheet) reports “...A study from the health technology assessment department of France’s national health agency, HAS, has identified which pharmaceutical products are most likely to receive a request for post-market studies. The agency hopes this information will aid in companies’ forward planning.” Subscription Required

Journals

Comparative Outcomes of Empagliflozin to Dapagliflozin in Patients With Heart Failure

Katherine L. Modzelewski, MD; Alexandra Pipilas, MD; Nicholas A. Bosch, MD

May 2, 2024, JAMA Network Open

JAMA Network Open

Reports

Building the Data Capacity for Patient-Centered Outcomes Research: The 2023 Annual Report

May 20, 2024

Office of the Assistant Secretary for Planning and Evaluation