Dapagliflozin

The Maryland Prescription Drug Affordability Board (PDAB) found that Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) and AstraZeneca’s Farxiga (dapagliflozin) present affordability challenges for the residents of Maryland. Credit: Robert Kneschke/Shutterstock.com Maryland’s prescription drug affordability board (PDAB) passed resolutions affirming that Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) and AstraZeneca’s Farxiga (dapagliflozin) carry affordability challenges to the state’s residents, in a meeting on 28 July. These resolutions will now kickstart a process whereby the board will consider policy measures to address the affordability issues with these drugs, including one to set up an upper payment limit (UPL), which the pharma industry and several lobbying groups have consistently opposed. PDABs have been set up in at least 10 states in the US, with similar proposed legislation in several states. These state boards are made up of experts in the field, with most including physicians, health economists, pharmacists, and others. Each state has taken a unique approach with the framework governing these bodies with a distinct mandate and scope. However, the main objective across these boards is the same—to review and address rising prescription drug prices through several measures. Prescription drug prices have been in the news following tariffs, an executive order on the Most Favored Nation (MFN) policy , and the negotiations under the Inflation Reduction Act (IRA) for Medicare Part B drugs. Amidst these polices on the federal level, the role of states in influencing drug prices is often underestimated, but is still likely to be key given historical precedence, and recent Medicaid cuts . The Maryland PDAB made significant strides in formalising this review process, culminating in the July 28 meeting, where the board members deliberated on information contained in dossiers prepared for each drug. “The next step is we go into our policy review process,” Andrew York, Executive Director of the Maryland PDAB, tells Pharmaceutical Technology . Jardiance and Farxiga prices closely scrutinised After a drug is set to have an affordability challenge, the PDAB’s executive committee is tasked with finding the drivers behind those affordability challenges, and what policies the state can implement to address these, says York. Board meetings, like the latest Maryland PDAB, are usually livestreamed and are being closely followed by pharma companies, lobbyists, legal experts, patient advocacy organisations, and more. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence In the July 28 meeting, the board determined Farxiga had an ‘affordability challenge’ because the percentage change of its wholesale acquisition cost (WAC) over time was substantially higher than the rate of inflation; in certain cases, patient out-of-pocket costs were disproportionate to the net costs by the payers; and the total gross spending for Farxiga for state and local markets exceeded 1% of prescription drug spend for state and local governments. AstraZeneca did not respond to this news service for a comment, but in a July 5 letter to the board, an AstraZeneca spokesperson said that Farxiga accounts for only a fraction of the state’s spending—$20–30 million—while Maryland spends $6 billion on diabetes care. The spokesperson said the drug’s cost analysis does not take into account the burden of chronic kidney disease and heart failure, and the therapy’s impact in treating those conditions. In Jardiance’s case, the board said the drug presented an affordability challenge due to similar reasons, with the proportion of total gross spending for Jardiance by state and local governments exceeding 1.8% of gross spending for the state and local governments. Boehringer said the PDAB’s analysis using total gross spending did not represent out-of-pocket costs, or discounts and rebates that influence the final cost of a drug to a patient, in a July 9 letter. In 2024, Jardiance earned EUR8.4 billion ($8.8 billion), while Farxiga sales touched $7.7 billion. As part of the board proceedings being public, the cost review analysis made public includes information on each drug’s commercial and Medicaid utilization spending, its Medicare negotiated price, and more. Opinions divided on approach to improve access Chief among the concerns from pharma companies with PDABs is any measure to set a UPL on the drugs. On the subject of UPLs, York says, “That’s probably the thing that we’re most famous for. But right now, I think our board looks at it like it is a tool in the toolbox.” Throughout the public comment process, several patient advocates have expressed concerns that a UPL may deter companies from making their drugs available in a certain state. However, Peter Maybarduk, who directs the nonprofit Public Citizen’s access to medicines group, says this concern should not deter any review of drug prices. “Companies are responsible to shareholders. It [discontinuing access] would be extreme stance, especially if patients are outraged,” he says. Apart from Jardiance and Farxiga, both most commonly prescribed to patients with diabetes and cardiovascular issues, four other drugs have been chosen to be part of the drug review process—Novo Nordisk’s Ozempic (semaglutide), Eli Lilly’s Trulicity, AstraZeneca’s Dupixent (dupilumab), and AbbVie’s Skyrizi (risankizumab). York says the policy review for multiple drugs is likely to take place in parallel depending on whether they are said to present affordability challenges. The next meeting for the Maryland PDAB is scheduled for 15 September, 2025. This story is part of a reporting fellowship sponsored by the Association of Health Care Journalists and supported by The Commonwealth Fund. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

New Delhi: The Fixed Dose Combination (FDC) of popular anti-diabetes medicine Metformin Hydrochloride and Voglibose is set to be excluded from the list of unapproved FDCs notified by the CDSCO in April this year. In a statement before the Delhi High Court over a petition challenging the classification of the combination as an unapproved drug, the Drugs Controller General of India ( DCGI ) has formally stated to exclude the above combination from the notified list. In April this year, the apex drug regulator issued a list of 35 unapproved fixed dose combinations (FDCs) and directed state regulatory authorities to prohibit their manufacture, sale, and distribution, citing concerns over “ patient safety .” However, Mumbai-based Macleods Pharmaceuticals challenged the directive and sought the exclusion of ‘Metformin Hydrochloride IP (As Prolonged-Release) 500mg & Voglibose IP 0.2mg Tablet’ from the notified list. During the earlier proceedings the counsel for the petitioner (Macleods) stated that it is “completely erroneous and appears to be a result of oversight / clerical error.” Macleods Pharma markets one such drug under the brand name Voglimac MF’ and during the proceedings the drugmaker highlighted that “it has been manufacturing and marketing the said formulation since 2016 under valid licences.” Giving its response on the arguments at the most recent hearing, the regulator informed the single judge bench presided over by Justice Sachin Datta, that the concerned FDC shall stand “excluded from the list of unapproved FDCs.” “It is stated by learned counsel for the respondents (DCGI) on instructions that the concerned FDC of Metformin Hydrochloride IP (As Prolonged-Release) 500mg & Voglibose IP 0.2mg Tablet, shall stand excluded from the list of unapproved FDCs,” the court order stated. In its order Justice Datta pronounced that the grievance of the petitioner stands “redressed and taking on record the aforesaid statement, the court has disposed of the petition. Metformin Hydrochloride and Voglibose is a widely prescribed oral FDC formulation indicated for the treatment of Type-2 diabetes. The drug helps to reduce glucose production in the liver, improve insulin sensitivity (metformin function) and slow down the digestion and absorption of carbohydrates in the intestines to prevent post-meal sugar spikes (voglibose function). Metformin is also widely used in fixed-dose combinations with other notable antidiabetic agents such as empagliflozin, dapagliflozin, and several others, to enhance glycemic control through complementary mechanisms. Notably, besides the above-mentioned FDC, the list issued by the regulator also includes three other anti-diabetes combinations that have metformin as an active ingredient. According to PharmaTrack data, of India’s total ₹21,000 crore anti-diabetic (OAD) therapy market, OAD combos account for nearly 60 per cent of the total market. The monthly sales tracker suggests that in June this year, OAD combos recorded total sales of ₹1079 crore, where metformin combos accounted for over 21 per cent of the total share with a MTH value of ₹230 crore. By Online Bureau ,