Abstract
Advanced therapy medicinal products (ATMPs) are the new frontier of medicine. Advanced therapy medicinal products are set out to satisfy unmet medical needs and provide new innovative, cutting-edge therapies for serious or life-threatening diseases, thus providing new therapeutic options for people with few or no possibility of treatment. They are divided into four groups including gene therapy medicinal products, cell-based therapy medicinal products, tissue-engineered products, and combined ATMPs, which in Europe refer to products that incorporate one or more medical devices with any of the previously mentioned ATMPs as part of the advanced medicine product (AIFA, 2017; Ten Ham et al., 2018). Advanced therapy medicinal products can potentially have long-term benefits, thus bringing a long-lasting positive impact on patient health. Advanced therapy medicinal product therapies are often administered just once or twice, which gives patients the possibility to heal quickly compared to traditional therapies. They also provide a long-term saving opportunity, both in terms of costs of treatments and procedures that are no longer necessary and in terms of quality of life and productivity. The resolution of the patient’s illness has a monetary impact on the patient, the patient’s caretakers, and especially on the society (Alliance for Regenerative Medicine, 2019). The aim of this paper was to provide an overview on the use of ATMPs approved in Europe, with a focus on blindness and visual impairment and the related economic burden. In this case study, the effective cost of a blind patient in different European countries was compared after treatment with ATMPs or traditional therapies, focusing on visual impairment caused by corneal opacity. Our evaluation includes an overview of the global economic impact of the two types of therapies on the society. We estimated direct healthcare costs, direct non-healthcare costs, and labor productivity losses, to include costs on healthcare, services, patients, their families and for the society in general. We could conclude that the costs of the two therapeutic approaches are comparable.
Highlights
Advanced therapy medicinal products (ATMPs) have unique attributes which differentiate them from standard pharmaceuticals and biologics
Other causes are glaucoma (2%); and age-related macular degeneration (AMD), trachoma, diabetic retinopathy, and corneal opacities (1%)
Current clinical practices mainly rely on day surgeries, with a decrease on in-hospital patient average length of stay in European Union (EU) countries over the past few years, the pace of diffusion has varied widely across countries
Summary
Advanced therapy medicinal products (ATMPs) have unique attributes which differentiate them from standard pharmaceuticals and biologics. ATMPs have curative potential as they address underlying genetic or cellular mechanisms of disease, which means that they can have a dramatic and long-lasting positive impact on health. They act through multiple mechanisms and on different cellular targets. ATMPs are often administered just once or a handful of times within a short period As they are typically paid as a one-time treatment, they have a high up-front cost. Many cell-based gene therapies, for example CAR-T therapy used to treat some blood cancers, are individually manufactured for each patient: cells are collected from the patient’s blood using a process called apheresis, they are modified and expanded in the laboratory, and re-infused into the patient several hours later These processes are usually carried out by trained individuals in specialized centers
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