THE VITACCESS HEOR TEAM LOOKS AT NICE EVIDENCE STANDARDS FRAMEWORK FOR DIGITAL HEALTH TECHNOLOGIES
The National Institute for Health and Care Excellence (NICE) recently consulted on their evidence standards framework for digital health technologies (DHTs), to develop standards to support commissioning based on clinical effectiveness and economic value. DHTs are apps, programmes and software that can allow improved access to care, more convenient care, and reduce clinical resource use.
Vitaccess have been involved in the consultation process and have given our views on the DHT evidence standards framework. The framework provides an excellent starting point to describe the levels of evidence needed to establish accurate and consistent assessment criteria for DHTs. But the potential for DHTs to systematically collect real world evidence (RWE) is not recognised fully.
DHTs can be used to generate detailed longitudinal RWE datasets from patients in close to real time based on a range of validated PRO instruments and symptom questionnaires. The data can reflect disease burden, unmet need, and changes in the treatment landscape.
The use of proxies in children, or age-specific instruments, allows appropriate data collection and analysis in a wide range of patients;
Data generated in orphan diseases can be fundamental to closing gaps in the published literature;
Gamification or reward motivators can support sustained patient engagement and retention for long-term data collection;
Use of bring your own device (BYOD) technology – i.e. apps that can be downloaded onto any mobile device – removes barriers for the need for specific expensive trackers or wearables;
DHTs can support sophisticated data analysis dashboards, and tailored data analysis plans.
Both pre-and post-marketing authorization, acceptance of RWE is increasingly common in the UK – e.g., data collection as part of managed access agreements through the Cancer Drugs Fund, and data to support the Medicines and Healthcare Products Regulatory Agency (MHRA) Early Access to Medicines Scheme.
DHTs provide a unique opportunity to collect RWE to support these HTA hurdles.
Readers can reach out to the consulting team at HEOR@Vitaccess.com to discuss any of these points in more detail.