The advent of digisimilars

Pharma and Digital health companies alike are slowly shifting away from multi-million, ten year-old-long presale research cycles and embracing decentralized studies in which patients get to continue living their “normal” lives. The generation of real-world evidence (RWE) from patients may reduce research costs, ease data collection and accelerate the commercialization of innovations. Therefore, from a Digital Health Tools standpoint, it is seen as a unique opportunity, as the generation of RWE allows for rapid validation of one’s Digital health intervention.

Nevertheless, it may also accelerate the capacity of a wide variety of stakeholders to copy brand-named innovations. This further complexify the industry, as patients, providers, and payors interact with various innovations with a wide variety of commercialization strategies and levels of validation.

As pulled together by stakeholders involved with the Digital Medicine Society, an increasing number of pharmaceutical industry incumbents start to generate RWE through decentralized studies. While some are using devices such as smartwatches and smartphones, others are looking at digitally-led questionnaires to produce evidence on their products’ safety and efficacy. We call these Patient-Reported Outcomes and Experience Measures (PROMs/PREMs).

Digital Health Tools companies alike are investing in the generation of RWE to support their claims. The industry sees this as one strategy to obtain coverage (reimbursement) by payors (like Big Health did last year and a few other Digital therapeutic companies). An approach that we expect to be more prevalent in this industry, as the collection of RWE serves both for validation and for the digitally-enabled intervention itself.

In other words, in this particular case, the app is the drug.

Considering the speed to which Digital health companies may generate RWE and iterate products accordingly, we expect an increasing number of organizations to commercialize innovations strongly inspired by highly successful, previously launched software-based interventions. We call the latter reference products in this article.

In the wellness space, Apple did it.

Inspiration often comes from unexpected places. However, that was not the case for Apple’s recent inclusion of a fertility tracker into the Health app.

Thanks to its App Store, Apple has access to valuable data to inspire their strategy for the launch of new products.

One may argue that Apple was strongly inspired by Clue, back in October 2019. Back then, the fertility tracking app was amongst the top 3 of femtech apps in the App Store. Shortly after, Apple launched iOS 13 in which it included a fertility tracker, called Cycle, free of charge for all iOS users.

It was not the first time that Apple released App Store-inspired products, as stated in this Washington Post article, and it probably won’t be the last time.

As Apple and Google collect tremendous and highly valuable usage data on apps through their App Stores, businesses ultimately share secrets on their apps’ performance. It allows tech giants to perform head-to-head comparisons of apps. They may then design new products that are desirable (open rate, engagement rate) and efficacious (RWE generation through HealthKit/Google Fit, Health Records for iPhone).

Perhaps, that’s what Clue’s CEO refers to as “a love-hate relationship” between app manufacturers and Apple.

In the Digital Care space, UnitedHealth Group did it.

Level2 is another example of how digital health interventions may be released, strongly inspired by a reference product, and by a stakeholder that is not a traditional Digital health company.

This product was released earlier last month by the largest US health insurer, UnitedHealth Group (UHG). Level2 acts as a direct competitor to Livongo, Omada and Virta, which claim they can reverse type 2 diabetes through a whole set of features (e.g. virtual community, glucose intake monitoring, automatic coaching, etc.). Speaking of RWE, Level2 will be made available to 230'000 people (employees) for free in the next couple of weeks, to allow for further iterations and validations.

Introducing digisimilars

All these considerations lead us to believe that we are in the glimpses of a new label in this industry: digisimilars.

The concept digisimilar is similair to its counterpart from the pharma industry (biosimilars), meaning that the products are cheaper versions of an original name-brand product (reference). They act in a highly related way and contain similar digital components (or active ingredients) than a pricier/original version.

Thanks to the fact that highly successful software-based interventions may also come from wellness apps (e.g. Clue), reference products may not be validated per se. One should focus on price, originality and success to assess if either or not a product is the reference.

When it comes to digital health products, equivalence (or digiequivalence?) doesn’t need to be drawn from pharmacokinetic studies like it is the case with biosimilars. Instead, it is drawn from RWE generation, even after an initial launch, as a company may modify a Digital Health Tool on an ongoing basis based on RWE. Moreover, most of Digital health interventions are not patent-protected.

So, what does this means :

1) for Digital Health Tools manufacturers?

You need to collect RWE, even if you consider yourself a wellness app. By doing so, decision-makers like payors and clinicians will have a better understanding of your product’s value. Moreover, this will facilitate their coverage or prescription decisions.

Using Apple HealthKit or Google Fit is a great way to facilitate the user experience. However, remember that it simplifies tech giants’ jobs by a lot if your niche product becomes inspirational. The best alternative is to use a service that collects RWE. You need to focus on meaningful outcomes as data points for iteration processes and validating your tool’s efficacy and effectiveness. Remember: If you expect to make medical claims based on the data you collect, you will need to engage conversations with regulatory bodies (SaMD). RWE may help facilitate discussions and classification of your tool.

If you consider yourself a manufacturer of Digital Therapeutic products (DTx), be aware that competition may come elsewhere from companies adopting the DTx label. It may very well come from key players with whom you already had discussions (non-traditional Digital health companies, such as employers or even investors).

2) for decision-makers (payors, healthcare organizations)?

In short, it means that the pool of products you may interact with for formulary/partnership decisions is much larger than you first considered. With the help of RWE, new players will soon knock at your door to offer cheaper alternatives to the flagship products you were once considering. Sure, they won’t be showcasing evidence gathered through a well-designed study published in a peer-reviewed journal. Still, they will claim their evidence supports their clinical assumptions and was generated by users of their tool’s current version. In particular (not all) use-cases, they might be right.

At Therappx, we support decision-makers by providing insights on 58 data points regarding a vast number of Digital Health Tools available on the Canadian market through our flagship product (Therappx CORE). Should our clients need reviews following vendors solicitation, we proceed to provide our insightful data in 48 hours or less.

3) for providers and their patients?

As a clinician, you’ll be asked a lot of questions by your patients on Digital Health Tools.

Therefore, you’ll rapidly face a quick learning curve in terms of what’s available in the Digital Health landscape. Care is being offered to your patient from a myriad of different channels and varies in terms of value for your patients.

Plus, you’ll want to make sure that the tool you have recommended to your patient translates into value. So, you’ll not only need tools to grasp the quality of the available innovations quickly. You’ll also need to make sure a recommended tool translates into value for your patient. Therefore, you’ll need to confirm the efficacy of a given tool in a real-life setting.

To comprehend the difference between quality and value in Digital health, you may read this article. Therappx is currently involved in research projects regarding the recommendation/prescription of Digital Health Tools in clinical settings. That will be the subject of a future article and product launch, such as Therappx PRESCRIBE. For now, you may use our website as a reference.

In conclusion, RWE allows Digital Health manufacturers to validate and iterate their products efficiently. We expect that Randomized Controlled Trials (RCT), while best in the validation of traditional interventions like drugs and some Digital therapeutic products, will be less adopted by the industry in the next few years. Even if RCTs are still highly considered and demonstrate a manufacturer’s culture of quality and organizational excellence, stakeholders may make decisions based on available RWE data more than anything else. On another note, we claim there are chances RWE will support some organizations in the design of digisimilars, based on inspiring programs.