Funding Digital Therapeutics – Who counts?

Digital therapeutics, when created empathetically to patients and health care professionals (HCPs), can show significant value to all stakeholders in the healthcare pathway [1].

A question at a recent NHS conference prompted an important question: if pharma is funding these innovations with a commercial motivation, how do you ensure equality in access to digital therapeutics?

HCPs are often offered new portals, apps, systems and gizmos which they can logon, review their patient data and make decisions on their care. The access to this information will be of great benefit to those HCPs who have the capacity to analyse more and more information about their patients. However, to the many HCPs who treat large numbers of patients with a wide variety of diagnoses and treatments, the burden of accessing so many individual portals, the excess of information and the expectation that they will process and react to patient reported outcomes (PROs) is a major turn off. This is an example of digital therapeutics becoming competitive, causing users to disengage.

With the digital therapeutic market estimated to grow consistently over the next decade ^[2], this competitive market is going to become more crowded. Now is the time to reflect on the drivers in the development of these tools.

The US department of health & human services has been able to reimburse digital therapeutics since 2016 ^[3]. The UK offers a £35 million fund over 4 years through the digital health technology catalyst ^[4], though most digital therapeutic development in the US, UK and EU is funded by pharma.

So how do you marry the needs of a commercial institution with the desires of the consumer? When designing an app to help IBD patients track their trigger foods and avoid stresses that exacerbate their condition, why would a commercial enterprise fund access to this by patients with visual impairment?

These patients have the same, if not a greater need for support. Their disease is not different due to their visual impairment but they are a minority of patients. From a commercial point of view, you would concentrate on your largest consumer group, building a solution to suit the needs to the greatest group of IBD patients. Perhaps later in the product life cycle making amends to help accommodate those with visual impairments. It is still likely to be years before those who are hard of sight can access this new tool.

As patients and healthcare systems such as the NHS are the final users of these therapeutics should more be done to demand a minimal level of accessibility and equity before new digital therapeutics are endorsed? Or do we start to view patient’s characteristics such as visual ability, language, and technical ability as contraindications to new therapeutics? If so, who’s responsibility is it to drive the diversification of these tools to encourage access by all patients? As with every new field in patient care, innovation generally runs ahead of regulation. By keeping accessibility and equality in mind when designing new therapeutics, the relationship between innovation and regulation can be a harmonious one.

1. Sarah Neville, August 24 2018, Financial Times – Digital therapeutics show potential for healthcare disruption. www.ft.com/content/8ba02c74-997d-11e8-ab77-f854c65a4465  
2. RockHealth Report, Healthcare consumers in a digital transition, https://rockhealth.com/reports/healthcare-consumers-in-a-digital-transition/
3. https://www.fda.gov/medicaldevices/digitalhealth/
4. https://www.gov.uk/government/collections/leading-edge-healthcare-industrial-strategy-challenge-fund

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.