Research Type: Policy Paper

Special Assessment to Inform CMS Drug Price Negotiation: Breo Ellipta and Trelegy Ellipta

Mar 2025 | Policy Paper

Interventions of interest: ICER will develop a special report for CMS on two therapies in high demand for treating chronic obstructive pulmonary disease (COPD). This report will be 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.  Date of publication: March […]

Fair Access: Coverage Policies in 2024

Dec 2024 | Policy Paper

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 […]

Managing the Challenges of Paying for Gene Therapies

Apr 2024 | Policy Paper

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 […]

Unsupported Price Increases Occurring in 2023

Dec 2024 | Policy Paper

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 info@icer.org. Final Documents ICER’s Vice President of Research Foluso Agboola, MBBS, MPH stated: “We continue […]

ICER-PHTI Assessment Framework for Digital Health Technologies

Sep 2023 | Policy Paper

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 […]

Special Assessment to Inform CMS Drug Price Negotiation: Eliquis and Xarelto

Oct 2023 | Policy Paper

ICER developed a special report evaluating the evidence on apixaban (Eliquis®, Bristol Myers Squibb) and rivaroxaban (Xarelto®, Bayer) for the treatment of nonvalvular atrial fibrillation (NVAF). ICER submitted this report to the Centers for Medicare and Medicaid Services (CMS) as part of the public comment process defined in CMS guidance.  The report was tailored to […]

Methods Update: Value Assessment Framework

Sep 2023 | Policy Paper

The ICER value framework describes the conceptual framework and set of associated methods that guide the development of ICER evidence reports. ICER typically updates the value assessment framework once every three years. The purpose of the value framework is to form the backbone of rigorous, transparent evidence reports that, as a basis for broader stakeholder and […]

White Bagging, Brown Bagging, and Site of Service Policies

Apr 2023 | Policy Paper

The White Paper examines the efforts of payers to manage drug markups by implementing white bagging and brown bagging policies to shift the drug purchasing channel from providers to specialty pharmacies, as well as site of service policies requiring patients to receive treatment at lower-cost sites of care.  The Paper examines the existing evidence and […]

Fair Access: Coverage Policies in 2023

Nov 2023 | Policy Paper

ICER conducted our third annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards developed by ICER with expert input from patient advocates, clinician specialty societies, US payers, pharmacy benefit managers, and life science companies. For each of the drugs reviewed by ICER in 2021 we […]

Unsupported Price Increases Occurring in 2022

Dec 2023 | Policy Paper

Of 10 high-expenditure drugs that had substantial 2022 net price increases, eight were not supported by new clinical evidence; these increases accounted for $1.27 billion in additional costs over one year. Separately, one of three Medicare Part B drugs with high list price increases in 2021 lacked adequate supporting new evidence, directly raising annual out-of-pocket expenses […]