The National Institute for health and Care Excellence (NICE) provides guidance to the NHS in England on the clinical and cost effectiveness of selected new and established technologies through its healthcare technology assessment (HTA) program. Using the experience it has gained from this program, NICE intends to develop a system for evaluating digital apps. The pilot phase for this project was set in place in November 2016, and, from March 2017, NICE will publish non-guidance briefings on mobile technology health apps, to be known as “Health App Briefings”. These briefings will set out the evidence for an app, but will not provide a recommendation on its use; this will remain subject to the judgment of the treating physician.
The existing HTA program consists of an initial scoping process, during which NICE defines the specific questions that the HTA will address. NICE then conducts an assessment of the technology, in which an independent academic review group conducts a review of the quality, findings and implications of the available evidence for a technology, followed by an economic evaluation. Finally, an Appraisal Committee considers the report prepared by the academic review group and decides whether to recommend the technology for use in the NHS.
The new program builds on the current Paperless 2020 simplified app assessment process, which was recommended in the Accelerated Access Review Report discussed in a previous post. It has many parallels with the HTA program. In particular, it will be a four-stage process, comprising: (1) the app developer’s self-assessment against defined criteria; (2) a community evaluation involving crowd-sourced feedback from professionals, the public and local commissioners; (3) preparation of a benefit case; and (4) an independent impact evaluation, considering both efficacy and cost-effectiveness.
NICE is currently preparing five Health App Briefings, of which NICE’s Deputy Chief Executive and Director of Health and Social Care, Professor Gillian Leng, has confirmed one will relate to Sleepio, an app shown in placebo-controlled clinical trials to improve sleep through a virtual course of cognitive behavioral therapy.
We understand that future Health App Briefings will also focus on digital tools with applications in mental health and chronic conditions, consistent with NHS England’s plans to improve its mental healthcare provision and, in particular, access to tailored care.
For apps that have evidence to support their use and the claims made about them, the new Innovation and Technology Tariff, announced by the Chief Executive of NHS England in June 2016, could provide a reimbursement route for the app. This will provide a national route to market for a small number of technologies, and will incentivize providers to use digital products with proven health outcomes and economic benefits.