CER Daily Newsfeed

Uncertainties Still Loom Over IRA Negotiations

(9/7, Angela Maas, AIS Health) reports “...‘The decisions around the key question of which therapeutic alternatives will be selected as comparators, how clinical superiority and clinical net benefits are demonstrated and how CMS plans to assign a price value to that difference in this first year will come too late for the manufacturers selected today and might come too late for the manufacturers selected for the next year of negotiation as well,’ [NPC president and CEO John O’Brien, Pharm.D.] maintains. ‘Manufacturers currently face uncertainty about what evidence should be developed and submitted, whether decisions explained in the concise justifications during the first year of negotiation under the program will be the same decisions made in future years and whether the people making the decisions next year will be the same. How this list was put together is a great question for the White House and HHS,’ he tells AIS Health. ‘The many questions people have about today’s announcement are a reminder of the lack of transparency and tremendous uncertainty surrounding the process.’” Full

Biden's Price Control Scheme Harms Patients, Compromises Free Market

(9/7, Tom Price, RealClearHealth) comments “...To preserve the pipeline of new innovative treatments, therapies, and vaccines, drug companies must have the opportunity to recoup investment rather than being forced to sell products at below market rates. Unlike Uncle Sam, businesses don't have the option to continuously spend beyond their means and take on trillions of dollars in debt. The Biden administration doesn't seem to grasp this concept. The White House's price control scheme-approved by his allies in Congress-is moving forward at full steam ahead. As a result, the free-market incentive to create new medicine will fade-compromising the health of future Americans.” Full

The Reality of Drug Pricing Negotiations Isn't a Slam Dunk for Patients

(9/7, Kenneth E. Thorpe, RealClearHealth) comments “ ...Congressional Budget Office prepared an estimate projecting changes in utilization rates for a similar drug price negotiation program that preceded the IRA. To achieve expected savings under the program, the score estimated reduced utilization for some medications of more than 25 percent. This disruption to access has no medical justification. Price negotiations will also have a chilling effect on drug research - and thereby diminish the number of new medicines available to patients in the years and decades to come. One recent study from Vital Transformation estimates that over the next decade, the IRA's drug price negotiations will result in 139 fewer medicines being developed.” Full

Video: Jeffrey Sparks, MD, MMSc: Treatment Strategies for Rheumatoid Arthritis

(9/7, HCP Live) “...[T]he number of choices has also made it more challenging to select the most suitable therapy. Additionally, most of the trials leading to drug approvals have compared the new drugs with placebos, with a limited number of head-to-head trials. In his presentation, he discusses these head-to-head trials to provide evidence of efficacy. Further, he explores real-world evidence, examining comparative effectiveness studies that assess different drug classes against each other.” View Video

NAACOS: Medicare Payment Incentives Favor Clinicians in Fee-For-Service

(9/8, Victoria Bailey, RevCycle Intelligence) reports “...According to the NAACOS blog post, MACRA’s incentives for Payment Year 2026 and Performance Year 2024 will favor clinicians who do not participate in advanced APMs and remain in the Merit-Based Incentive Payment System (MIPS). In 2026, MIPS clinicians will receive a 0.25 percent conversion factor update and can receive additional positive payment adjustments in MIPS. The average MIPS adjustment is typically 3 percent, meaning the total potential payment adjustment would be 3.25 percent. Meanwhile, clinicians in advanced APMs will only receive a 0.75 percent conversion factor update. Incentives will not favor clinicians in advanced APMs again until 2032.” Full

Lilly's Diabetes Drug Mounjaro Approved by UK Watchdog

(9/8, Reuters) reports “Eli Lilly's diabetes drug Mounjaro has gained the backing of Britain's healthcare cost-effectiveness watchdog, which said it would be a good option for patients with poorly controlled type 2 diabetes. The National Institute for Health and Care Excellence said in draft final guidance that it estimates some 180,000 people could benefit from the new treatment.” Full