ICER will conduct its second annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. In the upcoming report, to be released in October 2026, ICER will analyze launch price trends over four years (2022-2025). ICER is also conducting an in-depth review of newly launched drugs (July 2024 to June 2025 novel drug approvals). For questions […]
ICER, in collaboration with Verdant Research, published a new white paper that examines the evolution – and perception – of the FDA accelerated approval pathway. The paper, titled “Strengthening the FDA’s Accelerated Approval Pathway: Progress and Unfinished Business,” reviews recent regulatory and market changes and proposes several policy options that focus on improvements that could be made by regulators, payers, and manufacturers. Date of publication: […]
Intervention of interest: ICER published a Special Report on Entyvio® (vedolizumab, Takeda Pharmaceutical Co. Ltd.) for the treatment of ulcerative colitis and Crohn’s disease. This report will be submitted to the Centers for Medicare & Medicaid Services (CMS) as part of the 2026 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price […]
ICER, in collaboration with researchers from Brown University, has published a new white paper that provides clear policy and market solutions to help manage affordable and equitable access to GLP-1 obesity medications. The paper, entitled, “Affordable Access to GLP-1 Obesity Medications: Strategies to Guide Market Action and Policy Solutions,” seeks to present insights and lessons […]
ICER conducted a new analysis it plans to release on an annual basis titled the “Launch Price and Access Report” which examines launch pricing for FDA-approved treatments. This report reviewed the affordability and access of the treatments and their value to the overall health system. ICER examined all novel drug approvals in the previous 3 […]
Interventions of interest: ICER developed a special report for CMS on two therapies in high demand for treating chronic obstructive pulmonary disease (COPD). This report was submitted to CMS as part of the 2025 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2027. Final Documents ICER’s President and CEO […]
ICER published its fourth annual “Barriers to Fair Access” assessment of prescription drug coverage policies within US commercial insurance, and the Veterans Health Administration. The analysis found that major payer coverage policies for the 11 drugs in scope often met fair access criteria for several categories, while areas for improvements were identified in the transparency […]
ICER and NEWDIGS at Tufts Medical Center released a white paper on the challenges and potential policy options for paying for gene therapies. The report analyzes the intersecting challenges of ensuring patient access for gene therapies, including determining fair prices, managing clinical uncertainty, and mitigating financial shocks. This paper draws upon the body of work […]
This initiative identified the 10 net price increases occurring in 2023 that had the largest impact on national drug spending and determine whether new clinical evidence existed that could support those price increases. For questions or additional information, please contact [email protected]. Final Documents ICER’s Vice President of Research Foluso Agboola, MBBS, MPH stated: “We continue […]
ICER and the Peterson Health Technology Institute (PHTI) collaborated on an assessment framework for digital health technologies (DHTs), which includes the conceptual model and associated methods that will guide assessments of DHTs within broader evaluative reports produced by the PHTI. Click here for the full framework. Date of publication: September 2023 For more information, please […]