Discussing DTx challenges and go-to-market in the UK with Charlotte Lee-Sinclair (ex-Big Health)

If you’re working in digital therapeutics, you might have heard of Charlotte. Former UK Director and then Chief of Staff at Big Health, she was responsible for the first ever approval for a DTx (Big Health's Sleepio) for national reimbursement in the UK's NHS.

It wasn’t easy! Three years and a lot of hard work behind the scenes. Michael, one of our co-founders, spoke to Charlotte to get her take on the outlook for DTx and understand whether she would recommend this go-to-market strategy for others, looking at the UK and the US.

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Why did you get into digital therapeutics in the first place?

Digital therapeutics can scale medicine, and I wanted to build a health system that I would be proud to use. A lot of people ask me why I left clinical practice, I don’t feel like I ever stopped being a doctor. I just treat patients in a different way. 

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What advice would you give other DTx companies looking to scale in the UK?

That’s a big question. I would say you should focus on the patient and their needs and don’t focus so much on building “digital” therapeutics that you lose sight of what you’re actually building, which is a treatment. Also, you don’t scale in the UK, you start in the UK and scale in the US.

How important is clinical evidence for DTx companies? What tips do you have for building that clinical evidence package?

In my mind, digital therapeutics are defined by their clinical evidence package. You don't have a digital therapeutic until you've got robust evidence that your intervention works. 

For any digital therapeutics company, there are three evidence challenges. 

1. Clinical evidence - Does your therapeutic actually work?
2. Cost-effectiveness - Will it enable a cost saving vs what is currently being prescribed as the standard of care? 
3. Real-world evidence (RWE) - Just because it's worked in a clinical trial, does it translate over to the messy world?

I think my top tip is don't do it alone. At Big Health, we worked with academic partners and with forward-thinking CROs. There are some fantastic companies out there, like Lindus Health [Thank you for the plug, Charlotte!], who are fast, flexible and reliable.

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You don't have a digital therapeutic until you've got robust evidence that your intervention works. 

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Do you think it’s always necessary to prove your DTx is superior to the standard (drug) treatment approach being used currently? Or can being as good be enough? 

I think so. Or at least the treatment has to be superior in some way. It should be a given that your DTx is more scalable, more data-driven than existing treatment, and has fewer side effects. There are different ways of defining superiority; in my mind, the key factor is demonstrating better cost for the payor.

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So it's an uphill battle for DTx evidence generation. What, in your opinion, is the gold standard for proving superiority? 

From a clinical perspective, I would want to see evidence that the DTx works with strong real-world and clinical evidence ‘if I prescribe this, will patients engage and get better?’, and that it’s fairly priced based on its cost effectiveness. 

Despite that, I don't think the standards for evidence have been set yet. We spend a lot of time talking about what's proportionate evidence for software. At the moment, there's a set of standards for biotech and pharma, and this has translated into a disproportionate set of standards for digital therapeutics because they are so new. No one ever believes that your evidence is going to be enough. 

I've met digital therapeutics companies with multiple RCTs where, and this is partly my fault, they've now been asked in the UK to now also go for NICE (The National Institute for Health and Care Excellence) recommendation. What’s more, it's going to cost them hundreds of thousands of pounds and many years of going through this process with no promise of reimbursement at the end of it. 

So it sort of begs the question, what should proportionate assessment look like for DTx therapies?

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There's a set of standards for biotech and pharma, and this has translated into a disproportionate set of standards for digital therapeutics because they are so new.

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That sounds difficult to achieve. In the US, some prescription DTx products are being reimbursed. Is there a difference between getting an FDA 510K approval and actually being able to prove clinical effectiveness? 

Yes, the FDA regulates safety, and clinical trials are designed to that end. However, for a digital therapeutic to get reimbursed, you’re going to need more than that. 

The 510K gives you the right to be at the table and potentially be one of the few there, but the decision-making around how to reimburse, when and how much will be based partly on whether your product is clinically and cost-effective, something that evidence for a 510K won’t be able to 100% satisfy. 

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Is this also a problem when it comes to looking at reimbursement pathways in the UK?

In the UK, there is no FDA equivalent for DTx. NICE is the closest, but they focus on clinical and cost-effectiveness, which sounds great on paper until you realise that Sleepio was the first one that got a positive recommendation, despite years of innovation in this space.  

The US market isn’t evolving rapidly either. I read that the median time to national coverage was 17 months from FDA approval. You've got examples in Pear Therapeutics and Akili Interactive of getting FDA approval and there being a code created for reimbursement. And then recently, Highmark announced coverage of digital therapeutics approved by the FDA, well now that’s progress. There’s an existing paradigm for getting national coverage that is rapidly evolving in the US for DTx.  

You would think that this would translate to the UK, but it’s not (yet). Look at pharmaceutical funding. Drugs that haven’t yet been fully proven are still funded for eligible patients under a Managed Access agreement. Yet, for some reason, we can’t find funding for a safe, accessible, digital therapeutic already being nationally commissioned elsewhere, just because the treatment is delivered through algorithms rather than a molecule.
This is why I feel like the NHS is not a great market to play in right now because it does feel like a lot of the decisions are politically and ideologically driven. 

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Given the success that you had getting Sleepio a positive NICE recommendation in the UK, do you think that other digital therapeutics should follow your lead?

No. Do as I say, not as I do! 

Through the Sleepio/NICE case study, I’ve tried to argue that there is an established and safe way to assess treatments, regardless of delivery model, through existing assessment channels, and therefore, there should be established reimbursement routes for them too. 

However, with the NHS in its current state and the economic climate, I don’t think digital therapeutics companies with a pure NHS go-to-market strategy will survive. I would love to be proven wrong, though. 

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With the NHS in its current state and the economic climate, I don’t think digital therapeutics companies with a pure NHS go-to-market strategy will survive. I would love to be proven wrong, though. 

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You're reasonably bearish on the NHS. Do you see the reimbursement pathway in the UK changing? Or how long do you think it would take for that situation to improve?

Getting digital therapeutics reimbursement in the NHS would be incredible, but it could be years and only when the stars align across politics, national bodies, clinicians and industry.  With the current economic and access challenges in the NHS, it’ll take someone in NHS England with a long-term vision, resources and guts to get the system to change. 

You’re not going to get a Daily Mail headline that 20% of people with insomnia die within a year. That's never going to be a problem. So a digital therapeutic that is safe and tolerated and treats something like insomnia, that's a chronic disease that currently isn't really being treated in the NHS, is such small fry. 

Given the highly political nature of this decision, I’ve been advising a lot of digital therapeutics scale-ups to go for the private sector first and keep an eye out for national reimbursement routes. Unless you’re as well funded as Big Health, don’t try to influence national strategy.  

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Having left Big Health, what are you working on now?

Quite simply, I help MedTech and Pharma companies go-to-market with novel digital treatments. 

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‍Thanks so much for speaking to us, Charlotte. If you want to find out more about Charlotte and her role in getting DTx and medtech companies to market, read more here.