Propelling Healthcare with Advanced Therapy Medicinal Products: A Policy Discussion
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Overview
Policy review demonstrates key regulatory and reimbursement barriers for advanced therapies, highlighting the need for stakeholder collaboration.
Key Points
- The paper aims to evaluate current regulatory, clinical, and commercial barriers facing advanced therapy medicinal products (ATMPs) and outline policy recommendations to improve patient access.
- Conducted a policy analysis examining global clinical trial landscapes, commercialization pipelines, and European regulatory environments.
- Assessed scientific, manufacturing, and health technology assessment frameworks governing gene, cell, and tissue-engineered products.
- Over 450 companies and more than 1,000 clinical trials globally are developing gene therapies, with an anticipated 20 to 30 new ATMP filings annually in Europe over the next five years.
- High costs, limited manufacturing expertise, and evidentiary uncertainty surrounding real-world data continue to delay reimbursement and market access decisions by European payers.
- Cross-sector reforms—including early stakeholder dialogues, standardized control frameworks, and patient registry integration—are critical to enabling sustainable evidence generation and payment pathways.
Cite This Study
Horgan et al. (2020) studied this question.