In the EU, there are four major classes, gene therapy, somatic cell therapy, tissue-engineered therapies, and combined advanced therapies, while in the US two groups of products are defined, gene therapy and cellular therapy. Managed entry agreements (MEA), with financing being conditional to the submission of additional evidence, associated with methods of leased payments, may offer effective strategies to address the uncertainties caused by the evidence gap associated with ATMPs, ensuring affordable and sustained access.Īdvanced therapy medicinal products (ATMPs) are a category of highly innovative and complex biological products and the classification of these products differs between regions.
The high efficacy/high price dynamic of many advanced therapies will demand novel financing models, both in the EU and US. Early scientific advice by regulatory and HTA bodies to developers is key, as it will contribute to diminish the perspective gap between developers, regulators and payers. The pricing and reimbursement framework should ensure the balance between encouragements to innovation and maximization of value for money for payers, through the attribution of a fair price to new health technologies. As a consequence, value-based pricing methodologies have been gaining terrain to cope with the specific challenges of ATMPs. Standard Health Technology Assessment (HTA) is not designed for ATMPs, and may delay access to these health technologies, thus a broader concept of value is required. The aim of this article is to analyze the challenges of traditional value assessment and price and reimbursement methods in the evaluation of ATMPs and to characterize the current and prospective financing solutions that may ensure patient access and affordability for these health technologies. The emergence of advanced therapy medicinal products (ATMPs), a disruptive class of health technologies, is generating important challenges in terms of value assessment and their high prices introduce critical access and affordability concerns.
0 kommentar(er)
