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Innovative therapies and welfare: a new paradigm

Rome, 17/07/2019, National Interest

The Italian and European healthcare systems are under increasing pressure as the result of a series of dynamics involving their populations and of new technological and scientific trends that are calling into question the efficacy and appropriateness of current approaches to the provision of healthcare services.

Population aging, the chronicization of a range of pathologies, the availability of increasingly widespread digital technologies and treatment innovations are posing new challenges to public policy makers, healthcare facilities, doctors and health professionals; this along with introducing new opportunities to expand services, optimize resources consumption and improve clinical outcomes. The new health paradigm beginning to take shape is more focused on patient participation, prevention and local assistance, and less bound to hospital facilities and the treatment of acute events.

Innovations in the field of pharmacology are offering major new prospects for patients and hospitals, an apt example being the CAR T-Cell therapies that have triggered a revolution in key sectors such as oncology and neurodegenerative diseases. Personalized treatments capable of deeply changing the way treatments are administered and the quality of life of patients. However, this calls for a complete paradigm shift with regard to regulation and authorization, but also to how cost-benefit assessments are conducted.

Indeed, on the one hand, regulatory authorities are being pressed to streamline authorization processes and make them more flexible in order to keep up with and support the innovations under way. On the other, policy makers are faced with replacing models for assessing therapies solely on a cost/benefit basis – including their analyses of the impact of new therapies on patient life quality – and broadening the horizon for the evaluation of those indirect costs averted thanks to the therapy itself. Finally, the instrumentation used today in performing cost/benefit analyses needs updating in order to make full use of “real world” databases, while those legal barriers that currently hinder the data access and combination already available to the public administration need to be eliminated.

In addition to therapeutic innovations, the rapid multiplication of new services and instruments made possible by digital technologies (artificial intelligence, big data, blockchains, digital therapies, along with 5G and virtual and augmented reality) has the potential to profound changes in the way healthcare services are offered and administered. This would foster the better management and use of data in support of clinical diagnoses and the appropriateness and efficacy of treatments, at the same time innovating at the level of the patient-physician-healthcare facility interface that promotes an active role for patients and a better use of the data they generate (using mobile and/or wearable devices and the mobile applications associated with them).

The adoption of the above innovations should be included within the broader framework of a reformed and redesigned approach to healthcare services, replacing a model based until now on selective universalism. A model plagued by regressive factors that threatens to deny the weaker segments of the population access to appropriate treatment due to inefficiently allocated resources and inappropriately managed services. These innovations are to be thought of as replacing, and not adding to, current expenditures for hospital facilities that often do not meet the standards already set by various legislative and regulatory interventions (D.M. 70/2015, the National Outcomes Program, and so forth), which still do not enjoy full compliance.

In conclusion, this highly fertile period in scientific research – with the proliferation of new generation drugs and therapies – and widespread digital innovation in medicine is an invitation to public institutions to take up the challenge by developing multi-year reform and innovation strategies (and not only in the healthcare field but for the entire social welfare system) and drafting policies capable of untying the hands of an already under-financed National Healthcare Fund.