High BMI eligibility for semaglutide could cost Medicare an additional $145 billion annually

Embargoed for release until 5:00 p.m. ET on 26 August 2024      
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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.      
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1. High BMI eligibility for semaglutide could cost Medicare an additional $145 billion annually  

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-00308     

URL goes live when the embargo lifts    

A brief research report found that 61% of Medicare-eligible adults have a BMI of 27 or higher, which means they may benefit from a GLP-1 receptor agonist like semaglutide for weight loss. However, the number of patients who will be eligible for semaglutide under new Medicare Part D plan guidelines that require patients to also have established cardiovascular disease will vary depending on how cardiovascular disease (CVD) is defined. When established cardiovascular disease is narrowly defined, only 1 in 7 Medicare beneficiaries with elevated BMI would likely be eligible to receive semaglutide, adding a maximum annual costs of $34 billion in additional drug spending. However, if any beneficiary with elevated cardiovascular risk was to become eligible for semaglutide, Medicare could face additional annual costs of up to $145 billion. The findings are published in Annals of Internal Medicine.   

Researchers from Brigham and Women’s Hospital, Harvard Medical School, and Northwestern University examined NHANES (National Health and Nutrition Examination Survey) between 2011 and 2020 to the Medicare beneficiaries who are most likely to be newly eligible for semaglutide based on SELECT trial criteria. They also describe which beneficiaries had any increased risk for future cardiac events and could be eligible pending future evidence generation and Part D coverage decisions. The researchers then estimated the maximum cost to Medicare Part D that would arise from providing coverage to these various groups of patients by multiplying the number of newly eligible Medicare beneficiaries by the annual net price of semaglutide, generated by subtracting a 41% average discount from the manufacturer list price of the medication in March 2024. The data showed that approximately 61% of Medicare-eligible adults with complete data had obesity and would potentially benefit from semaglutide for its weight loss benefits. However, when established cardiovascular disease is defined narrowly as in the SELECT trial, only 1 in 7, or 3.6 million people, would be likely to be newly eligible for semaglutide. Alternatively, if a more liberal definition of established CVD risk were used by Part D plans, then 15.2 million people would be eligible. Even in the most likely scenario where conservative definitions of CVD are used and many people do not stay on semaglutide long-term, Medicare spending could increase by $10 billion annually. The authors note that the analysis estimates maximum budgetary impacts but is not a spending projection and does not account for future payment reforms via the Inflation Reduction Act.  

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author, Alexander Chaitoff, please e-mail amchait@med.umich.edu.   

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2. Yoga no more effective than general exercise in reducing urinary incontinence in older women 

Abstract: https://www.acpjournals.org/doi/10.7326/M23-3051 

URL goes live when the embargo lifts  

A randomized trial involving middle aged and older women reporting daily urinary incontinence (UI) found that a pelvic floor yoga intervention did not result in a greater improvement in UI symptoms compared to a general muscle stretching and strengthening exercise program. However, participants in both intervention groups reported some improvement in their UI symptoms. These findings are important because 1 in 3 women in this age group experience UI, which can lead to depression, social isolation, and functional decline. The study is published in Annals of Internal Medicine.  

Yoga has been recommended for women with UI, but there is little data available to determine its efficacy.  Researchers from the University of California San Francisco randomly assigned 240 women aged 45 years or older reporting daily urgency-, stress-, or mixed-type UI to either 12 weeks of a yoga or a nonspecific stretching and strengthening exercise program to compare the two interventions for improving symptoms of UI. Women in the yoga group had twice-weekly group instruction and once-weekly self-directed practice of pelvic floor–specific Hatha yoga techniques, while the exercise group had equivalent-time instruction and practice of general skeletal muscle stretching and strengthening exercises. Participants used a diary to record each time they leaked urine by frequency and type of UI at baseline, 6 weeks, and 12 weeks and were also asked to complete and return diaries after 24 and 36 weeks for assessment of persistent changes in UI. The researchers found that the yoga intervention was not superior to the general exercise program in reducing clinically important UI and both groups had similar incidents of adverse events. According to the researchers, future studies should investigate potential effects of yoga on type-specific UI and factors underlying perceived improvements in UI among older women engaged in yoga and other physical interventions. 

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author, Alison Huang, MD, MAS, please email Elizabeth Fernandez at Elizabeth.Fernandez@ucsf.edu.  

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3. Dementia risk similar with SGLT2 inhibitors and dulaglutide  

Abstract:  https://www.acpjournals.org/doi/10.7326/M23-3220  

URL goes live when the embargo lifts        

A nation-wide, population-based cohort study compared the effects of sodium-glucose cotransporter-2 (SGLT2) inhibitors versus dulaglutide on risk for dementia in older patients with type 2 diabetes (T2D). The data revealed little difference in the risk for dementia for SGLT2 inhibitors compared with dulaglutide. The study is published in Annals of Internal Medicine.  

Researchers from the Sungkyunkwan University (SKKU) of South Korea studied data from over 13,000 adults from the National Health Information Database in South Korea to evaluate the effect of treatment strategies on risk of dementia. The eligibility criteria were selective, with participant requirements including being age 60 years or older, having a T2D diagnosis, no history of dementia, and no use of antidiabetic drugs for the three months preceding the study. Through these requirements, researchers aimed to improve the probability that participants in both treatment groups were at a similar disease stage. Researchers assigned participants to an SGLT2 inhibitor or dulaglutide, and to directly compare the effects of each treatment, they matched each patient receiving SGLT2 inhibitor with another patient receiving dulaglutide whose propensity score is closest to their own. For each patient, follow-up started at treatment assignment and ended at dementia onset, death, or 31 December 2022, whichever occurred first.  

Final data showed a risk for dementia between 2.5 percentage points lower and 0.6 percentage point greater for SGLT2 inhibitor than for dulaglutide, suggesting no statistically significant difference in dementia risk between the drugs. The study is novel in directly comparing the risk for dementia between the two novel antidiabetic agents, recently added to the researchers’ recommendations. These findings contribute to a library of previous studies that have suggested that both SGLT2 inhibitors and GLP-1 RAs, such as dulaglutide, may have potential neuroprotective effects.  

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Ju-Young Shin, PhD, please email shin.jy@skku.edu.   

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4. EUS-RV and precut sphincterotomy equally effective salvage techniques to treat benign biliary obstructions and can serve as a backup for each other  

Abstract:  https://www.acpjournals.org/doi/10.7326/M24-0092  

URL goes live when the embargo lifts        

A randomized control trial compared endoscopic ultrasound-guided rendezvous technique (EUS-RV) and precut sphincterotomy as salvage techniques for difficult bile duct cannulation in benign biliary obstruction. The data revealed EUS-RV and precut sphincterotomy have similar success rates, and in failure of one technique, the other technique was successful. The study is published in Annals of Internal Medicine.  

Researchers from the Postgraduate Institute of Medical Education and Research in Chandigarh, India, studied data from 100 adult patients with benign biliary disease and difficult bile duct cannulation requiring salvage strategy. Participants were selected if they were older than 18 years, have benign cause of extrahepatic biliary obstruction with native papilla, and experienced difficult bile duct cannulation at the index endoscopic retrograde cholangiopancreatography (ERCP) attempt. Researchers randomly assigned participants to either precut sphincterotomy or EUS-RV, although the participants were blind to the technique. 2 experienced endoscopists well-versed in both techniques performed the procedures. In the case of failed precut sphincterotomies, patients were crossed over to EUS-RV and vice versa. The technical success was defined as successful deep biliary cannulation confirmed on cholangiogram using either of the 2 techniques and compared using the Fisher exact test. Researchers found that both EUS-RV and precut sphincterotomy showed similar technical success, procedure time, and adverse events profile. Notably, in the failure of one technique, crossover to the other technique helped to achieve successful cannulation in all cases. This study is the first randomized control trial that has compared these salvage methods for difficult bile duct cannulation, and it adds to the currently limited data on biliary access for benign diseases.  

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Jayanta Samanta, MD, DM, please email dj_samanta@yahoo.co.in.   

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