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Why wasn't mirabegron chosen for the first year of the CMS negotiation program?
Urogynecology (Phila)
January 2025
UConn Health, Farmington, CT.
Importance: The most used overactive bladder (OAB) medications are anticholinergics, which professional societies recommend avoiding in older patients given dementia risk. Cost prevents patients from switching to preferred beta-3 agonists. Mirabegron was the only beta-3 agonist eligible for the Centers for Medicare/Medicaid Services (CMS) 2023 Drug Negotiation Program (DNP).
View Article and Find Full Text PDFMethodological standards for comparative effectiveness research: considerations for evidentiary review for medicare drug price negotiation.
Expert Rev Pharmacoecon Outcomes Res
January 2025
Real World Solutions, IQVIA, Durham, NC, USA.
Introduction: The 2022 Inflation Reduction Act is expected to result in lower drug prices for Medicare beneficiaries in the United States (US). The Centers for Medicare & Medicaid Services (CMS) released the most recent draft guidance for the medicare drug price negotiation (DPN) program in May 2024.
Areas Covered: In August 2023, the list of 10 drugs selected for the DPN were published and the first round of negotiations are now complete.
Guidance for an Effective Approach to Integrated Evidence Planning in a Dynamic World.
Clin Pharmacol Ther
January 2025
Boston Consulting Group, Zurich, Switzerland.
The value of a medicine is defined by its impact on patients, caregivers, health system, and society. A pharmaceutical company will generate evidence to demonstrate this value in various studies, including randomized clinical trials, non-interventional and observational studies, real-world data analyses, modeling, and simulation. The quality and strength of the evidence supporting a medicine's effectiveness, safety and product quality will drive decisions by healthcare system stakeholders for marketing authorization (regulatory authorities).
View Article and Find Full Text PDFFinancial challenges of being on long-term, high-cost medications.
Neurooncol Pract
February 2025
Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
The isocitrate dehydrogenase (IDH) inhibitor, vorasidenib, may offer a promising new treatment option for patients with IDH-mutant gliomas. However, the indefinite nature of this targeted therapy raises significant financial concerns. High costs of targeted cancer therapies, often exceeding $150 000 annually, contribute to financial toxicity, characterized by medical debt, income loss, and psychological stress, and place stress on health systems.
View Article and Find Full Text PDFBotulinum toxin type A for the treatment of patients with post-stroke spasticity in Thailand: cost-utility and budget impact analysis.
BMJ Open
January 2025
Siriraj Health Policy Unit, Mahidol University Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
Objectives: To evaluate the cost-utility of botulinum toxin A (BoNT-A) for treating upper limb (UL) and lower limb (LL) post-stroke spasticity.
Design: Using a Markov model, adopting a societal perspective and a lifetime horizon with a 3% annual discount rate, the cost-utility analysis was conducted to compare BoNT-A combined with standard of care (SoC) with SoC alone. Costs, utilities, transitional probabilities and treatment efficacy were derived from 5-year retrospective data from tertiary hospitals and meta-analysis.
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