Evidence in Digital Therapeutics – Proof and Power

The key differentiator between ‘digital health and wellbeing technologies’ and ‘digital therapeutics’ is that the latter must show improved outcomes.

Approximately 140 studies were published in 2017 which contained clinical evidence of digital health efficacy^[1]. Clinically validated technologies have looked to show value for health systems by reducing emergency hospitalisation, A&E, ambulatory, drug and other intervention costs^[2] as a means to create reimbursement strategies. So far, there has been less emphasis on Patient Reported Outcomes (PROs) for reimbursement as they are seen as more difficult to quantify and compare.

There is increasing emphasis on evidence of cost effectiveness in not only digital therapeutics but all medicines. National Institute for Clinical Excellence (NICE) Health Technology Assessment submissions often reference Real World Evidence (RWE) but only a minority (18% in 2016) include RWE on the technology being appraised^[3]. Only 8% of studies of app efficacy have taken place in the NHS^[4]. As systems such as the NHS hold some of the most comprehensive health system utilisation data, why are they not becoming leaders in creating this evidence?

NICE have created an expert panel to assess digital therapeutics, primarily in psychological therapies, as part of the Improving Access to Psychological Therapies (IAPT) scheme. Solutions are assessed over 2 years on effectiveness, content, digital standards and resource impact^[5].

Gathering health system utilisation data is easier in a single payer market such as the NHS, where there is more importance placed on the long term, holistic savings from reducing wider healthcare utilisation. However, gathering data such as this puts pressure on the provider to do something with the data. Digital therapeutics need to be designed with this in mind, tackling the responsible collection of data from users which generate actionable insights.

It is this data that will also drive development and innovation in these solutions, we must recognise that the power of digital therapeutics is in the data driven algorithms that allow them to function. This increases the value of data sets such as NHS data, which the NHS should utilise to their benefit.

Outcomes data collected from healthcare systems, and PROs that the digital therapeutics collect themselves, can be re-invested into the further evolution of digital therapeutics. This is to not only to measure success in the treatment of our patients, but to increase the intelligence of the solution. Clinicians and developers can analyse this to refine the algorithms that are used to allow digital therapeutics to react to changes in a patient’s health or wellbeing. Future uses of artificial intelligence (AI) can be responsibly developed by mapping the impact of these changes in not only the patient’s immediate health but their holistic health and resource utilisation.

The problem with NHS data is that it is often complex and ‘messy’; therefore, there is generally a large amount of skilled work involved in the cleaning and organising of NHS data before it can be utilised in something as precise as an AI model.

By building in data collection to our digital therapeutics we can achieve both objectives at once, creating new cleaner datasets to drive and improve the AI that powers our therapeutics and creating robust data sets to asses efficacy. This only increases the need to make empathetic therapeutics that gather robust real-world evidence without over-burdening HCPs with manual feedback mechanisms.

1. https://digitalhealth.london/wp-content/uploads/2018/04/DigitalTherapeuticsNHS.pdf
2. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/digital-therapeutics-preparing-for-takeoff
3. The use of published real-world evidence in HTA: An analysis of the evidence base of company submissions in 2016 NICE appraisals. Van Lier H, de Boeck M, Edwards V, Hanekamp E, Hartog T E, Richmond. G, van den Broek R. Value in Health, October November 2017, Volume 20, Issue 9, Page A410
4. https://www.iqvia.com/blogs/2018/05/the-balancing-act-of-digital-therapeutics
5. https://www.england.nhs.uk/men...

pH Associates has experience in conducting RWE studies in multiple therapy areas using different methodologies and would be happy to discuss how RWE can meet the needs of your brand.

Please contact Sam Oliver samoliver@phassociates.com or Amanda Pulfer amandapulfer@phassociates.com, Joint Managing Directors, to arrange a meeting.