Regulators and payers start adapting to digital therapeutics

The traditional paradigm of medical device regulation does not suit digital health technologies

Regulators and payers are responding to the demands of digital health with innovative approaches

Assessments of clinical effectiveness and cost-effectiveness will be key to wider uptake of digital therapeutics

As momentum builds towards fully-fledged methods of assessing digital therapeutics, pharmaphorum’s Dominic Tyer looks at how regulators and payers are responding to advances in technology

Digital therapeutics could, according to some predictions, one day rival mainstream pharmaceutical products, with many developers eyeing the chronic disease space in particular as a significant market opportunity.

Though it’s still early days for software that can be prescribed by doctors, digital therapeutics offer a host of potentially valuable tools for patients and the healthcare systems that look after them.

But, as a July 2018 editorial in The Lancet asked: Is digital medicine different? It concluded: “Without a clear framework to differentiate efficacious digital products from commercial opportunism, companies, clinicians, and policy makers will struggle to provide the required level of evidence to realise the potential of digital medicine.”

Building frameworks

Regulatory structures are being built, but they’re by no means complete. Nonetheless, the last 12 months have seen some significant developments.

A big step forward was taken in September 2017 when the US Food and Drug Administration (FDA) approved the first mobile medical application for substance use disorders involving alcohol, cocaine, marijuana and stimulants.

The Reset app from Pear Therapeutics provides cognitive behavioural therapy and is used alongside outpatient therapy and a substance disorder programme. It works by teaching users skills to increase their abstinence and keep them in outpatient therapy programmes.

It wasn’t the first mobile medical application to receive US approval, but what made Reset noteworthy was that it was the first time the FDA had cleared a prescription ‘digital therapeutic’ with claims to improve clinical outcomes in a disease. Approval for the app came on the back of a 12-week clinical trial involving 399 patients on either standard treatment or standard treatment plus a desktop version of Reset.

Companies like Pear have long been pushing regulators to take a more rigorous approach to their technology as they look to open up some ground between consumer-level, generalist applications for digital wellness and the clinical and regulatory validation of digital health tools.

FDA pilots digital health programme

Pear was also one of nine firms picked last year for an FDA digital health pilot programme. The FDA’s Digital Health Precertification (Pre-Cert) Program, the pilot of which was launched in September 2017, also involved the likes of Apple, Verily and Fitbit as it looked to make good on the promise of the regulator’s Digital Health Innovation Action Plan.

As the Plan put it: “The FDA can help encourage digital health innovation by redesigning our policies and processes and modernising our tools so that they match the needs of digital health technology and provide clarity on those policies and processes so that manufacturers and developers know what they need to do.”

More recently, the latest version of the Apple Watch has added a new dimension to the FDA’s work, with the regulator noting that its approval of two medical apps for the mobile device “marked a significant step forward” for its approach to digital health. The apps are intended to identify possible atrial fibrillation, so were reviewed as medical devices, but the Watch’s new built-in, ECG-generating heart monitor sensor was not.

“The FDA’s approach to digital health isn’t to regulate the every-day health and lifestyle uses of consumer devices, but rather to focus our resources on reviewing more sophisticated medical apps that sit on top of this,” FDA commissioner Scot Gottlieb explained.

Noting the rapid pace at which digital health technology changes, he added: “The highly iterative nature of these tools requires a flexible regulatory approach to allow product developers, patients, and regulators to keep pace with the software updates that happen frequently in this space. Having a regulatory framework that enables a rapid cycle of product improvement is integral to ensuring innovation and success for digital health technologies.”

The FDA’s Pre-Cert Program will be, Gottlieb said, “ideally suited” to these challenges and its pilot phase will explore a regulatory approach that suits both the requirements of the technology and the regulator’s safety and efficacy standards.

Evidence-based cost-effectiveness reviews

The UK is another country whose regulatory framework for digital therapeutics is evolving. NHS England is working with health technology assessment body NICE to support a new assessment programme for ‘digitally-enabled therapies.’

It’s a programme that will focus on mental health and assess up to 14 digital therapies for use in NHS Improving Access to Psychological Therapies (IAPT) services by 2020 to expand the provision of psychological therapies and improve access to digital services.

NHS England said it would be looking to “good quality, evidence-based digital therapy packages,” putting contenders through a three-stage process beginning with NICE’s traditional selection and prioritisation criteria. Next, NICE will lead an objective, transparent assessment process and produce an ‘IAPT assessment briefing’ (IAB), which will be reviewed by a panel of impartial experts. Finally, the therapies will be used and evaluated by IAPT services for up to two years.

Ultimately, NHS England wants to be able to help its IAPT services access information on which digital therapies are “high quality, evidence-based products, which are cost-effective and achieve good outcomes for those who wish to access therapy in this way”.

As part of this programme, NICE began technology supplier selection and assessment work in June 2017 for digital therapies – applications or computer programmes that sit alongside face-to-face, phone and online therapy – that can help treat anxiety and depression.

Evidence for Effectiveness

Alongside that mental health focus, the UK has a broader initiative underway called Evidence for Effectiveness. This takes aim at making it easier for innovators and commissioners to understand what ‘good’ evidence for digital tools looks like, while also meeting the needs of the NHS and patients. The Evidence for Effectiveness joint project is led by NHS England, involves MedCity, NICE, Public Health England and DigitalHealth.London, and is set to develop guidance and standards to address and streamline support for therapeutic digital health tools.

The framework it’s working on is set to be launched in January 2019, when it will be embedded within the ecosystem as standard practice for evidence generation.

“As therapeutic digital health tools develop at an increasing pace, it is important that they are clinically effective and offer economic value,” NHS England said.

The goal is to develop a tool that points to appropriate evidence generation plans for different types of digital health tools by including a set of standards for generating evidence of effectiveness and economic impact.

Relentless innovation

There is unlikely to be any shortage of digital innovation to put through these new programmes.

Already this year has seen the launch of the first digital therapeutics service for blood pressure management from Amicomed and Generali Welion, Voluntis and Roche Pharma France take important steps forward in the development of their breast cancer digital therapeutic while Natural Cycles Nordic won FDA approval for its contraception app. Meanwhile, Germany’s Merck is testing a digital behavioural change programme in diabetes from Blue Mesa Health that combines remote health coaching, peer support and connected technology.

Given the relentless speed of software development, regulators and payers alike will have to move quickly from pilot projects to full-on launches if they are to make use of the alternative healthcare tools that innovative digital technologies can provide.

Dominic Tyer is a trained journalist and editor with 19 years of pharmaceutical and healthcare publishing experience. He serves as a contributing editor at pharmaphorum media, which facilitates productive engagement for pharma, bringing healthcare together to drive medical innovation. He is also creative director at the company’s specialist healthcare content consultancy, pharmaphorum connect.

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