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2.6.2 Drug Delivery: Calls for Change
ОглавлениеThere are currently two biologic delivery methods that are used for the great majority of biologic products, intravenous (IV) and subcutaneous (SC). Today, many biologics have subcutaneous formulations available. This has the advantage of enabling patient self‐administration and often cutting down on the delivery time. This solves many of the challenges of IV delivery; however, there is still room for improvement and innovation. Much of the work for innovative biologic delivery has been in the diabetes space. This is because diabetes is a primary care area with an extremely large and growing patient population that could see significant benefit and increased compliance with insulin treatment should administration be made easier and less onerous. Once established, these technologies could spread to other disease areas. This will be particularly important in diseases with large patient populations like asthma, chronic obstructive pulmonary disease (COPD), and hypercholesterolemia.
Collectively these drug technologies make up 18% of the Phase II+ biologic drug pipeline. It is still not clear which of these platforms will enter the mainstream market. The performance of each particular technology class is somewhat dependent on the first few launches. If they fail to deliver clinically and commercially, these launches serve as warnings to investors for the platform as a whole. Existing marketed examples of cell and gene therapies have faced multiple challenges in commercialization, particularly in the funding of treatment. The western world's first gene therapy, Glybera®, was priced at €1.1 million in Germany. Glybera® is used to treat an ultra‐orphan indication, lipoprotein lipase deficiency, but much of the pipeline similarly aims to cure disease and will likely be priced highly. The challenges associated with the cost of groundbreaking curative treatments in the pipeline must be tackled proactively. Innovative approaches to funding will be a necessary prerequisite to success when commercializing such valuable treatments. Instilling payer confidence in a technology's curative promise is challenging given the inability for clinical trials to model a lifelong cure. Schemes such as the UK's Early Access to Medicines and the Accelerated Access Review can enable early collection of real‐world data before approval and enable longer periods of evaluation.19