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Role of Clinical Development in Reimbursement of Gene Therapies
Although, to date, there are hundreds of developing gene therapy medicinal products (GTMPs), only a tiny part of them will be able to receive marketing authorization (MA) and gain reimbursement. Clinical development can be effective and innovative, but it does not guarantee that it will be funded. In addition, it is essential but difficult to “strengthen clinical evidence with additional data from systematic reviews, meta-analyses of studies and registries” (Van Overbeeke et al. 407). Thus, the level of clinical development affects the possibility of reimbursement: the better characteristics it has, there are more chances that GTMPs can be funded.
Regulatory Requirements
The set of regulatory requirements complicates the access of GTMPs to market and, correspondingly, their reimbursement. The FDA, guided by these standards that are sometimes “unclear and differ between jurisdictions,” has approved only several products, making them available and giving them the right to gain reimbursement (Van Overbeeke et al. 404). The role of regulation is quite ambiguous: on the one hand, it strives to ensure that gene products are high-quality, safe, and effective; on the other hand, it creates additional challenges of their receiving MA.
Providing Gene Therapy Reimbursement
The gene therapy should be provided with reimbursement: the invention of a practical and helpful product capable of helping individuals involves the hard work of many people and a large number of clinical trials. Perhaps the FDA should reconsider its requirements: it is challenging to believe that only a dozen developed GTMPs are effective and safe. The reimbursement can be provided by different public-private collaboration platforms and by state bodies financing medical institutions.
The Process of Determining the Quality
Determining the quality of GTMP should be based on reconsidered FDA’s primary requirements and three main criteria: safety, effectiveness, and long-term functioning. In addition, it would be helpful to define the quality and consider the issue of reimbursement in half of the year after GTMP’s start of work to ensure that product meets all criteria. Thus, financing should be provided for all achievements of gene therapy that demonstrate their beneficial features.
Work Cited
Van Overbeeke, Eline, et al. “Market Access of Gene Therapies across Europe, USA, and Canada: Challenges, Trends, and Solutions.” Drug Discovery Today, vol. 26, no. 2, 2021, pp. 399-415.
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