A digital therapy can be economically sustainable?

Efficacy/effectiveness* is not enough. As a society we can’t limit our requests to clinical benefits alone, but we have to demand sustainability of medical treatments.

Beyond effectiveness: a holistic evaluation

Healthcare costs are already high and continuously increasing due to ageing populations. Thus, new treatments must prove to be cost-effective to be “better” than what’s already available.

Health Technology Assessment (HTA) provide these answers.

“HTA is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner.”

This is true for pharmaceuticals and also for digital therapeutics. HTA informs reimbursement and coverage decisions by national health services and insurers. Considering the novelty of DTx and the initial scepticism of some stakeholders, the need of strong positive results is especially important for digital therapies.

The cost-effective potential of DTx

Due to its digital nature, DTx (and digital health in general) have a great potential to optimize costs and scale-up.

• Their development is expected to be cheaper than drugs. This is due for example to preclinical studies avoidance and no need to set up a GMP-validated manufacturing plant.
• Digital and analytics are extremely related: what is digital easily generates data and so it’s easier to optimize.
• Time from lab to the bedside should be considerably reduced (and time is money too).
• DTx may also free staff time, automatizing some procedures and facilitating other ones.
• Unless some DTx will require a lot of computing power to work, scaling-up costs will be marginal (for web- or app-based DTx, mainly servers/data centres costs).

Furthermore, DTx have a great potential of improving access to cures (e.g. in rural/underserved areas or with mental health disorders otherwise untreated due to the associated stigma and subsequent patient refusal to see a specialist) or enhancing health outcomes (e.g. less hospital readmissions). If confirmed, this dual potential will determine a reduction of indirect costs associated with diseases/conditions.

DTx are already economically advantageous: some facts

I listed above some possible ways which could make a digital therapy cost-effective, but I believe few real-world examples worth more.

Example 1: treating diabetes

BlueStar is a digital assistant which provides diabetic patients tailored guidance driven by artificial intelligence. This digital therapeutic demonstrated in clinical trials a 1.7-2.0-point mean reduction of glycated haemoglobin (HbA1c) in adults with type 2 diabetes. This HbA1c reduction, according to an economic analysis conducted in partnership with IBM Watson Health, would correspond to the average cost savings of $254-$271 per user per month. Considering that currently there are more than 400 millions of people living with diabetes, being able to improve clinical and economic outcomes could be extremely impactful.

Example 2: a preventive program

Speaking again of diabetes, it worths mentioning Omada. It is an interactive diabetes prevention program. In at risk subjects with metabolic syndrome or prediabetes, it achieved good clinical outcomes (weight loss, glycated haemoglobin reduction) together with a saving in medical costs of about 500$ per participant per year. This saving doesn’t include the costs of the program itself but, as reported on Omada website, 3 independent health claims analysis conducted by their clients observed that the amount of time for employers to recoup their investment in Omada was 6-24 months.

Example 3: fighting asthma attacks

The Propeller system consists in a sensor to be attached to asthma/COPD inhaler which, through a digital platform, helps understanding what may be causing symptoms. Propeller demonstrated to be able to improve adherence, reduce asthma attacks and symptoms, but also rates of asthma-related hospitalizations and emergency department visits (with benefits both for patients’ quality of life and resource utilizations).

In a randomized clinical trial on 495 asthma patients, Propeller shown than 63% of uncontrolled patients at baseline achieved control, as defined by the Asthma Control Test (vs 49% in the usual care group). According to Zieger and collegues (in a study on 96,631 patients) reaching asthma control means a yearly saving of 2,101$ per patient (direct and indirect costs).

DTx: a solution to improve access to cures and optimize healthcare expenditure?

There is no doubt that the DTx have enormous potential. The spending optimization opportunities, as well as the examples already available of savings for patients / health insurances, demonstrate this potential.

Not surprisingly, some DTx are already covered by some US private health insurances and the UK NHS. Furthermore, starting from 2020, in Germany doctors will be able to prescribe digital apps with proven health benefits, which will be reimbursed by the country’s health insurance system.

Digital therapies can be economically sustainable and, enabled by a proper regulatory / reimbursement framework, will open a new healthcare era.

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* Speaking of therapies, it’s usually made a distinction between efficacy and effectiveness. Efficacy regards the results as demonstrated through clinical trials. Effectiveness refers to drug performances in a real-world setting.