Competition from “skinny label” generics saved Medicare billions

IMPORTANT UPDATE: 

The article referenced in Tip #4 on color ultrasound for suspected GCA will not be published on April 30. If you had planned to cover this topic, please hold your stories until further notice. In its place, Annals will publish the following: 

Sodium–Glucose Cotransporter-2 Inhibitors and the Risk for Dialysis and Cardiovascular Disease in Patients With Stage 5 Chronic Kidney Disease 

Abstract: https://www.acpjournals.org/doi/10.7326/M23-1874  

Please contact Angela Collom at acollom@acponline.org or 609-367-4225 with questions or for an embargoed PDF. Thank you.

Embargoed for release until 5:00 p.m. ET on Monday 29 April 2024    
Annals of Internal Medicine Tip Sheet     

@Annalsofim    
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. Competition from “skinny label” generics saved Medicare billions

Savings were greatest for rosuvastatin, pregabalin, and imatinib

Abstract: https://www.acpjournals.org/doi/10.7326/M23-3212  

URL goes live when the embargo lifts     

An analysis of 15 name-brand drugs and their “skinny label” generic counterparts found that competition from these counterparts saved Medicare Part D nearly $15 billion from 2015 to 2021. Skinny labeling allows generic drug manufacturers to exclude labeling information that remains patent-protected by the brand name manufacturer. However, a recent federal appeals court ruling involving a skinny-label generic version of the beta-blocker carvedilol (Coreg; GlaxoSmithKline) has increased liability risk for manufacturers of skinny-label generics. The brief research report is published in Annals of Internal Medicine.

Researchers from Brigham and Women’s Hospital and Harvard Medical School conducted an analysis of 15 brand-name drugs with a first-to-market skinny-label generic from 2015 to 2019. The authors compared actual spending on each brand-name drug and its skinny-label generics with projected spending had the skinny-label generics not been introduced. They estimated that actual Medicare spending on these 15 drugs and their skinny-label generics was $16.8 billion, and projected spending without generic competition was $31.5 billion, saving Medicare approximately $14.6 billion from 2015-2021. They note that savings were the greatest for rosuvastatin (Crestor, AstraZeneca; $6.5 billion), pregabalin (Lyrica, Pfizer; $4.2 billion), and imatinib (Gleevec, Novartis; $3.1 billion). The authors caution that deterring the use of skinny labeling, as the recent federal appeals court case might do, could be costly for Medicare and other US payers. They suggest that Congress should reinforce the skinny-label pathway by creating a safe harbor that protects manufacturers engaged in skinny labeling from induced patent infringement lawsuits. 

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Benjamin N. Rome, MD, MPH, please contact BROME@BWH.HARVARD.EDU.

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2. Semaglutide suitable for people with HIV and fatty liver disease

Abstract: https://www.acpjournals.org/doi/10.7326/M23-3354    

URL goes live when the embargo lifts      

A study of persons with HIV (PWH) and metabolic dysfunction–associated steatotic liver disease, also known as ‘fatty liver disease,’ (MASLD) found that semaglutide was highly effective at reducing liver fat and cardiovascular disease risk in this population. The brief research report was published in Annals of Internal Medicine.

Researchers conducted a study of 51 PWH with central adiposity, insulin resistance or prediabetes, and fatty liver disease who were observed over a period of 24 weeks and given semaglutide. The authors found that 29 percent of participants had complete resolution of MASLD, and 58 percent had a relative reduction in liver fat of at least 30 percent. They also report that all participants tolerated 1 mg weekly semaglutide. According to the authors, given the high cardiometabolic disease burden and growing obesity epidemic among PWH, semaglutide may reduce CVD risk while preventing progressive liver disease.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Jordan E. Lake, MD, MSCR, please contact Jordan.E.Lake@uth.tmc.edu or 713-500-3030.

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3. Small gains in survival with modestly higher risk for adverse events for cancer patients participating in experimental clinical trials

Abstract: https://www.acpjournals.org/doi/10.7326/M23-2515    

URL goes live when the embargo lifts      

A systematic review and analysis of 128 trials found that cancer patients’ participation in clinical trials are associated with gains in survival compared with patients given standard-of-care treatments that were statistically significant but not clinically important. These gains also came at the cost of greater risk for serious adverse events (SAEs). The review is published in Annals of Internal Medicine.

Researchers from McGill University conducted a systematic review of 128 trials comprising 141 comparisons of a new drug and a comparator. These comparisons included 47,050 patients. The authors found that patients in experimental trials about 5 weeks of progression-free survival (PFS) and overall survival (OS) compared with patients receiving usual standard-of-care. They also note that patients in phase 3 studies or those sponsored by large pharmaceutical companies seem to have greater clinical benefit. However, the authors also found that gains in PFS or OS are potentially offset by a modest but statistically significantly elevated risk for SAEs for patients assigned to experimental groups, corresponding with 7.40 percent increase in absolute risk for a SAE in this group. According to the authors, they believe their findings are best interpreted as suggesting that access to experimental interventions that have not yet received full FDA approval is associated with a marginal but nonzero clinical benefit.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Jonathan Kimmelman, PhD, please contact jonathan.kimmelman@mcgill.ca.

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4. Ultrasound may be viable first-line diagnostic tool for persons with suspected GCA

Abstract: https://www.acpjournals.org/doi/10.7326/M23-3417    

URL goes live when the embargo lifts      

A cohort study of persons with suspected giant cell arteritis (GCA) found that the use of ultrasound of the temporal arteries as a first-line diagnostic tool in patients with high clinical suspicion of GCA, further diagnostic tests for patients with positive ultrasound were avoided. The study is published in Annals of Internal Medicine.

Researchers from the Centre Hospitalier Rochefort, Rochefort, France, conducted a prospective cohort study of 165 patients with high clinical suspicion of GCA. The authors examined the use of color Doppler ultrasound of the temporal artery as a first-line diagnostic test and temporal artery biopsy (TAB) as a secondary test. The authors found that a diagnosis of GCA was confirmed in 44%, 17%, and 21% of patients by ultrasound, TAB, and clinical expertise and/or other imaging tests, respectively. According to the authors, their findings show that the use of temporal artery ultrasound may be an efficient way to make the diagnosis of GCA in patients with high clinical suspicion and to reduce imaging costs and the need for biopsy, thereby limiting complications and the need for a surgeon.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Guillaume Denis, MD, please contact guillaume.denis@ght-atlantique17.fr.

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