Digital therapeutics grow up

Back in January, pharmaphorum caught up with the Syneos Health team to discuss their experience and insights into the emerging category of digital therapeutics (DTx), and the use of software-based services to deliver preventative, management, or treatment interventions to patients either as a monotherapy or as an adjunct to a pharmacological treatment.

While a number of key challenges were identified, not least from a pharma perspective, the challenges of traditionally slow-moving product development processes needing to adjust to the swifter more agile world of rapid software development and distribution, and their perspective on this aspect of pharma’s future was largely positive.

Much of this positivity was driven by the apparent early successes of some well-known DTx poster-children, best personified by Pear Therapeutics reSET for treating opioid use disorder.

Not only did Pear’s solution provide a uniquely modern approach to a uniquely modern epidemic, but its 12-week programme of digitally delivered cognitive behavioural therapy shot through FDA approval supported by robust claims of improving clinical outcomes. As a result, the company inked a highly publicised headline deal with Novartis’ Sandoz to partner on commercialisation and development, with reSET intended to work hand-in-hand with therapy on buprenorphine.

Now, however, that co-promotion deal has come to an end, inevitably placing the topic of pharma’s role in the DTx market – particularly in the shortterm – back into the spotlight.

Duncan Arbour, SVP innovation at Syneos Health is sanguine about what could easily be seen as a reversal of expectations for the sector. “I think our point a year ago was very much that forward-looking pharma companies, those already committed to a digital future, no longer had their heads in the sand around the potential of DTx – and the Sandoz deal was a key marker of this.

“But what we’re seeing now isn’t those heads going back into the sand – it’s more a case of those heads looking around a little wide-eyed and dazzled, not yet able to see a clear short-term horizon for a new and potentially challenging treatment class.”

In many ways, the horizon Arbour describes is obscured by something of a perfect storm. Firstly, there’s the wider context of social, political and economic uncertainty around the future of industry-wide pricing, reimbursement and access in general (clouds that will remain at least until we’re well over the other side of Brexit and a 2020 US election). And for DTx specifically there’s also the recognition that despite some early successes for the category, widespread adoption for any one treatment in the category is still far from being achieved.

Syneos Health asset strategist Skye Hodson is quick to frame this current situation: “Yes, the DTx market is clearly still at a fragmented, subscale experimentation phase, but that’s not the same as being unhealthy.”

Rather, to Hodson it’s just a well-known station on the track of mainstreaming any new technology: “You can see parallels with any new technology, it’s like the William Gibson quote: ‘The future is already here, it’s just unevenly distributed.’”

And in the bigger picture, this change in direction for Pear and Sandoz doesn’t signify any real changes for the wider DTx opportunity. It’s still an area tipped to reach a value of more than $7.8bn by 2025 with a compound annual growth rate of 20.5%. Neither has this divorce appeared to throw Pear off course. The company is still moving forwards with new partnerships and ventures that will see it expand its offer beyond the DTx heartland of CNS into areas such as inflammatory and gastrointestinal conditions.

But what might the cold feet on the Sandoz side of things mean for pharma’s DTx approach going forwards?

For Syneos Health’s EU head of digital Alex Brock, this bump in the road reflects a familiar problem that the industry has been grappling with for years as it tries to understand that ‘digital’ is a mindset as much as it is a series of technologies.

“It’s a cliché, I know, but there’s an epic gulf between the old Silicon Valley mantra of ‘move fast and break things’, and the conventional but entirely appropriate healthcare approach of ‘move slowly and take care’. But if you’re wholehearted about being focused on your patients then you have to be equally wholehearted in recognising and responding to the inevitability of a patient preference for interventions that can be delivered through their personal digital devices. In terms of healthcare technology, you could argue that daily insulin syringes are more likely to go away than smartphones in the next 20 years.”

While this doesn’t necessarily suggest that medicines manufacturers should be looking to enter into DTx co-promoted partnerships in the Pear/Sandoz mould just as this original template comes to an end, Brock is however clear on the need for industry not to lose its focus on continuing to hire the right digital talent to support these initiatives in the future.

“It’s great that we’ve seen senior leaders come into the industry from non-healthcare leaders like Sainsbury’s and Walmart, but these companies also need to make sure that they’re making similar hires for roles that are more operational and on the ground. A strategic partnership to set a vision is one thing – but delivering practically on its promise is another, and it requires a whole new set of smarts.”

If anything, what the end of the Pear/Sandoz partnership highlights is a tension between the models of small DTx start-ups and big pharma’s incumbents. The former are looking to pharma for funding and partnerships as the fastest possible route to scale via access to marketing and sales support; but traditional players will always be preoccupied with protection of core business and investor returns, to which it’s hard to see DTx as a significant contributor in the immediate future.

Nevertheless, the Syneos Health team sees the last 12 months as a period of significant progress for the sector.

Hodson is quick to point to a raft of developments in the US that may point to a new and necessary paradigm for reimbursement – a critical roadblock to committed investment thus far.

“So far, even some digital therapeutics which have had regulatory approval for a while have still struggled for reimbursement outside of trials. But now we’re seeing things like a digital formulary from Express Scripts, and an announcement from the pharmacy benefit manager (PBM) at Caremark of a platform for validating digital health apps so that payers can more easily review and select effective solutions for their plans. And for solutions that incorporate remote monitoring, there has finally been the introduction of CMS codes allowing physicians to code their time.”

Europe is following suit, notes Alex Brock. “People often think of Europe, particularly outside the UK, as lagging behind the US. But France and Germany were trailblazers in this area, with Servier’s roll out of the Deprexis programme on prescription for depression before people were even using the term ‘DTx’.

“People talk about our health minister Matt Hancock as a digital evangelist, but our German team are always reminding me that his equivalent over there, Jens Spahn, is equally progressive. There’s draft legislation out there right now which could see the establishment of a new registry of digital health solutions, even allowing ones which get approved to gain market access and reimbursement without full supporting evidence, as long as they can generate it within the next twelve months.”

France, notes Brock, has similarly introduced its own MyHealth 2022 bill which also includes ePrescriptions and guidance on certification and prescribing of digital health apps.

So it has been an eventful year for an emerging sector, but what can we expect in 2020? Arbour believes it may be the year that we actually see the impact of patient wants and needs shaping the market. “You don’t hear a lot about patients and patient experience in the current DTx conversation, but it’s their adoption – or not – of new healthcare tools that will see the sector stand or fall. I don’t believe in the line that ‘patients are just like consumers in other sectors’, but I do believe that one place in which they always have consumer-level expectations is with the experiences they have on their smartphones. And what consumers need from DTx more than a route to prescription and reimbursement is a brand they can trust that delivers an exceptional experience.

“I wouldn’t be at all surprised if we saw a successful global smartphone health super brand like Headspace or Calm – both big names in mindfulness – move explicitly into the DTx space in the near future and replace newer start-ups with no brand recognition as the focus of pharma partnership activity across a host of therapy areas where co-morbidities include anxiety, stress or even physical pain.”

While there remains a fair amount of uncertainty in the DTx space, history demonstrates that the industry’s cautious embrace of digital possibilities is very much business as usual. This is something to be very much expected of any technology that has such transformative potential for patients and the healthcare sector and shouldn’t be a cause for pessimism. The industry and the public’s appetite for DTx is clear, and the organisations that make a concerted effort to understand, embrace and evangelise for it stand to make a huge impact on patients’ lives.

Syneos Health is the only fully integrated biopharmaceutical solutions organisation. The company, including a contract research organisation (CRO) and contract commercial organisation (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry-leading companies – INC Research and inVentiv Health – it brings together approximately 24,000 clinical and commercial minds to help its biopharmaceutical customers shorten the distance from lab to life. Learn more at syneoshealth.com

Skye Hodson, a Syneos One asset strategy director at Syneos Health, has seven years of multi-sector experience that has seen him not only shape strategies but also ensure their successful implementation. He specialises in supporting the commercialisation of new and disruptive innovation, working across healthcare systems and the lifecycle of assets, with a particular focus on digital strategies and digital therapeutics.

Alex Brock leads digital for communications across Syneos Health Europe, and runs the central digital team based in our London HQ.

He has worked at Syneos Health for the past seven years, overseeing the evolution of digital insight, strategy and optimisation across the business. Prior to this he has worked in various insight and digital strategy roles in healthcare and consumer sections over the past 14 years.

Duncan Arbour

Duncan Arbour works in the Innovation team within Syneos Health Communications. He has been with Syneos Health for the last seven years and has had an exclusive focus on life sciences for the last 12. Prior to healthcare, Duncan spent a decade in senior strategy roles for some of Europe’s leading digital agencies including DigitasLBi and Syzygy, leading projects for clients in sectors including financial services, automotive and government.

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Digital therapeutics grow up

“But what we’re seeing now isn’t those heads going back into the sand – it’s more a case of those heads looking around a little wide-eyed and dazzled, not yet able to see a clear short-term horizon for a new and potentially challenging treatment class.”

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