Advancing early access policies for innovative cancer drugs: a scoping review and explorative analysis in the Italian setting.
J Pharm Policy Pract
; 17(1): 2377697, 2024.
Article
en En
| MEDLINE
| ID: mdl-39015752
ABSTRACT
Introduction:
Considering the clinical impact of innovative cancer therapies, policy makers strive to balance timely access and thorough value-assessment. While some European countries promoted early access schemes, Italy does not yet display a consolidated strategy for innovative drugs or for medicines targeting pathologies with a high unmet need.Methods:
To better understand the risks and opportunities of early access strategies that could be applied in the Italian setting, we performed a scoping review, searching the PubMed and Web of Science databases and interviewing two field experts. The review results were complemented with an exemplificative quantitative analysis for a subset of innovative oncology drugs, to assess the clinical and economic impact of the price and reimbursement negotiation.Results:
Our study suggests that early access schemes developed in Germany and France, combining a free-pricing period, pay-back mechanism, and arbitration, could serve as a basis for developing a feasible strategy in Italy. The quantitative analysis indicated that timely access to innovative drugs could have potentially prevented many cancer progressions, associated with a significant healthcare expenditure.Conclusion:
Albeit not allowing to express a conclusive assessment, this study proposes a potential early access strategy for Italy and highlights the need for opening a debate on the opportunities and risks of such schemes.
Texto completo:
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Base de datos:
MEDLINE
Idioma:
En
Revista:
J Pharm Policy Pract
Año:
2024
Tipo del documento:
Article
País de afiliación:
Italia