Metformin Hydrochloride

Medicare Part D spending on leading diabetes medications has reached unprecedented levels, with expenditure skyrocketing from $7.7 billion in 2019 to $35.8 billion in 2023 — translating to a 364% increase over the five-year period, according to newly released data.Auditors from the US Department of Health and Human Services' Office of Inspector General (OIG) identified and analysed Medicare Part D data for 10 widely prescribed type 2 diabetes medications, comprising seven GLP-1s and three SGLT-2 inhibitors, across the US and five overseas territories between January 2019 and December 2023. The analysis looked at utilisation metrics and spending patterns, drawing comparisons with metformin as a baseline therapy. GLP-1s lead uptickDuring the audit period, Medicare Part D expenditure for selected drugs totalled $92.8 billion, with six medications exhibiting substantial spending increases, led by GLP-1 products. Spending on Novo Nordisk's Rybelsus (semaglutide) jumped from $366,000 in 2019 to approximately $1.7 billion by 2023 — a 2182% increase — whereas Ozempic (semaglutide) expenditures increased nearly 16-fold from $552 million to $9.2 billion over the same period, with the number of beneficiaries receiving the medication rising by 929%. Meanwhile, Eli Lilly's Mounjaro (tirzepatide) showed 1541% spending growth in just its second year of coverage.The OIG noted that given a number of the medicines are commonly used off-label for other conditions, notably obesity, their increased use warrants "further inquiry to determine whether…the associated drugs were utilised for medically accepted indications." Meanwhile, TD Cowen analyst Rick Weissenstein suggested that "the data brief may provide ammunition for HHS Secretary Robert Kennedy Jr. and others who see the surge in GLP-1 use as a symptom of 'overmedication' more generally in the US."In contrast, use and spending on Novo's Victoza (liraglutide), Johnson & Johnson's Invokana (canagliflozin), as well as AstraZeneca's Byetta (exenatide) and Bydureon (exenatide extended-release), declined from 2019 to 2023, likely due to the introduction of newer alternatives. In addition, metformin expenditure decreased by 5% from $661 million in 2019 to $628 million in 2023.Spending growth outpaces enrolmentAccording to the analysis, the growth of the selected medications significantly outpaced the 12% increase in Medicare Part D enrolment during the same timeframe, raising concerns about the long-term financial sustainability of the programme. The report suggests that even if spending grows at the minimum observed annual rate of 42% during the five-year period, it could exceed $102 billion for the 10 drugs in 2026. “This substantial increase could have a financial impact on the Medicare programme,” the auditors noted in the report, adding that these findings “may be beneficial to CMS and other policymakers when developing future programme guidance related to these drugs.”Both Ozempic and Rybelsus made it on to the expanded list of medicines selected for the second round of Medicare price negotiations, drawn up by the outgoing Biden administration last month.

Merck said its “ once-in-a-lifetime ” drug Keytruda could be subject to price reductions under the Inflation Reduction Act, which would lead to a decline in sales. It expects Keytruda to be chosen for “government price setting” in 2026, which would become effective in 2028, according to an SEC filing published Tuesday. But even without the threat of the IRA, key patents protecting the PD-1 inhibitor will start to expire in 2028, after which biosimilar competition could start entering the market. Several Keytruda biosimilars are already in late-stage development, including Samsung Bioepis’ SB27, Amgen’s ABP 234 and Formycon’s FYB206. Back in 2023, Merck took action against the US government, filing a lawsuit with the aim of invalidating the IRA. Its arguments are similar to those of Boehringer Ingelheim, which failed in its attempt to challenge the legislation. In 2022, Merck’s CEO Rob Davis said the price negotiations could have a “chilling” long-term effect on both Merck and the broader pharma industry because it could disincentivize certain areas of cancer R&D, like developing drugs for smaller indications. Sales of Keytruda last year climbed 18% to $29.5 billion , but it has the potential to make even more, according to Wall Street analysts. It could hit peak sales of $34.3 billion in 2027, according to GlobalData analysts. The drug secured its first US approval in 2014 for advanced melanoma, followed by a flurry of label expansions for various settings of lung cancer, head and neck cancer, bladder cancer, cervical cancer and blood cancers, among other tumor types. Keytruda wouldn’t be the first Merck medicine subject to IRA negotiations. In January, the Department of Health and Human Services selected the diabetes drug Janumet and a version containing extended-release metformin, Janumet XR, for price setting effective from 2027.