PSPS AND SUPRANATIONAL DESIGN

The growing number of publications and observational studies regarding PSPs in Europe over the last 10 years demonstrates the significance of their impact on healthcare. However, as demonstrated by the literature in this field, achieving their full potential requires developing guidelines and recommendations to harmonize the definition of PSPs at the European level, standardizing their methods, systematically measuring their impact, and developing digital technologies and care models capable of integrating with each nation’s individual healthcare offering.
The challenges of glocalization
Each PSP presents unique challenges and requires a design targeted at specific objectives, target audiences, and countries. There is no plug-and-play method that can be replicated across different territories, although it is possible to define a set-up of standardized components with the flexibility for last-mile adaptations differentiated by country. In the pharma-provider relationship, it therefore becomes crucial to create value for all PSP stakeholders, monitor and analyze the services and products delivered through a data-driven approach, and optimize the application of regulations and GDPR regarding personal data processing and privacy.
The financial return
Today, healthcare companies are called upon to develop treatments and services that support people suffering from rare, chronic, or degenerative diseases (and their caregivers) throughout their entire stay in therapy. The PSP represents the model capable of satisfying this therapy-service combination, ensuring patient safety and pharmacovigilance by monitoring all potentially serious side effects; better disease management, especially in chronic conditions and long-term monitoring; and greater treatment efficacy.
In a 2018 briefing paper prepared by the NHS Confederation, which supports and speaks for the healthcare system in England, Wales, and Northern Ireland, it was estimated that there are over 15 million patients with long-term conditions in the UK, whose care accounts for the largest consumption of NHS resources, averaging 55% of GP appointments, 68% of outpatient and emergency department appointments, and 77% of inpatient bed days. Improving care for chronic patients is therefore the objective for better managing healthcare budgets. The design of effective PSPs aimed at patient-centered care and digital management represents the solution to this challenge.
Digital support e home therapy
A study conducted by Rock Health Advisory, a digital health innovation accelerator, regarding the growth of investments and digital health startups has shown how investor interest in remotely managed digital health, through mHealth platforms, generated a turnover of 6 billion dollars in 2017 alone. Digital technologies certainly require attention both from the perspective of the structure of the service provided—to ensure that there are appropriate features to guarantee compliance with obligations such as Pharmacovigilance —and from the perspective of personal data protection, but they open up new scenarios for PSP customization and the streamlining of multi-country procedures. Indeed, through technological innovations and software solutions, it is possible to dematerialize the patient journey and make the entire care process, as well as the activities of the figures involved—from patients and doctors to healthcare professionals—more efficient. In the case, however, of applying care-based support, such as home therapy, it is necessary to possess a knowledge and setup that, in addition to integrating with each national reality’s individual offering, complies with the procedures and regulations set forth by the responsible supranational bodies, such as the European Medicines Agency (EMA), the Committee for Advanced Therapies (CAT), the Committee for Medicinal Products for Human Use (CHMP).

