A5092665398- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical Economics and Policy
- Pharmaceutical studies and practices
- Biomedical and Engineering Education
- Nutrition, Genetics, and Disease
- Health and Medical Research Impacts
- Consumer Attitudes and Food Labeling
- Biotechnology and Related Fields
- Science, Research, and Medicine
Tufts Medical Center
2023-2025
Abstract Under the Inflation Reduction Act's (IRA's) - Medicare Drug Price Negotiation Program, Centers for & Medicaid Services' (CMS's) “maximum fair price” must be informed by evidence on factors such as therapeutic advance of selected drug compared with its alternative, comparative effectiveness across clinical and patient-reported outcomes, impact specific populations, ability to address unmet medical needs. This paper describes how real-world could improve CMS decision-making...
Recent developments have compelled Medicare to expand its role in conducting health technology assessment. Steps such as building the CMS workforce and coordinating with FDA could improve prospects for success.
Abstract Regulatory agencies worldwide have taken significant steps to expedite approval and market authorization of medicines based on their potential address areas unmet medical need severe disease burden. However, initial such is often accompanied by limited evidence benefit, posing a conundrum for payers health systems who may desire greater certainty value. This paper describes system “accelerated access” manage these tensions coordinate activities across stakeholders, discussions held...
Accelerated and conditional regulatory pathways for drug approvals are intended to enable earlier patient access potentially life-saving treatments, or treatments that provide benefits in addressing a significant unmet need. However, there questions about how well such work, appropriately they applied, the work of regulators can be better coordinated with health technology assessment (HTA) payer bodies, providers systems, other stakeholders. In June 2023, multi-stakeholder, international...