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November 3, 2021

Prescription DTx: Commercialisation models & Adoption

Commentary
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This blog is the output from HealthXLs’ meeting series that explored the commercialisation models for Prescription DTx as well as its adoption and the last-mile delivery challenges. Collective inputs from:

Aahuti Rai (Strategic Advisor | Healthcare Innovation at Four Points Consulting), Ashley Mateus (VP Decision Support and Strategic Planning at Akili Interactive), Brendan Staunton (co-Founder and CEO at Amara Therapeutics), Chris Cera (CEO at Arcweb Technologies), Francesca Wuttke (Chief Digital Officer at Almirall), Jeff Berkowitz (CEO at Real Endpoints), John Mattison (Operating Partner, CMIO at Arsenal Therapeutics), Joe Rubinsztain (CEO at ChronWell), Justin Norden (Partner at GSR Ventures), Lee Shapiro (Managing Partner at 7wire Ventures), Matt Norton (VP of Marketing & Commercial Development at S3 Connected Health), Michael Pace (CEO & Founder at PalmHealth.co), Robert Garber (Partner at 7wire Ventures), Zina Manji (Sr. Director, Regulatory Affairs Lead - Innovation, at GSK), & Meaghan Schedel (Digital Health Consultant at HealthXL), Judit Faus (Community Manager at HealthXL)


*All opinions are participants’ own and do not reflect the stance of their respective employers.

In the past 2 years a wide variety of companies have co-opted the term “Digital Therapeutics (DTx)” to describe their digital health offerings. In this HealthXL sprint we focused on a smaller subset of this group: prescription digital therapeutics (PDTs). PDTs are changing the legacy of what is considered a ‘prescription’. Currently for biomedical treatments, globally a prescription is considered a regulated method of obtaining a drug - i.e. a qualified health professional authorises a pharmacist to dispense a drug with instructions to the patient. For good reason, this is a strict process. 


On the other hand, non-prescription products can be accessed without a prescription. In some countries such as the UK, certain non-prescription products are available as OTC (over the counter) and classified as a General Sale List (GSL) product that allows broader access for purchase, such as in sweet shops and supermarkets. Other products do not require a prescription but are classified as a Pharmacy (P) product where a customer needs to ask a pharmacist to assist them with drugs that are behind the counter. 


Prescription DTx are starting to blur the definition of the very term that historically has no ambiguity. This raises questions about physician authorisation vs. approval, directly downloadable OTC apps, both FDA regulation and marketing use of the label ‘PDT,’ as well as the criteria associated with this terminology. As the industry has evolved to carve out definitions for digital health tools, DTx and PDTs, the market has shown certain general wellness solutions that may fall into the digital health tool category which are low or minimal risk and can be sold with little regulatory oversight. While on the other end of the spectrum, we have Prescription DTx, which can be defined as Software as Medical Device (SaMD) that are intended to treat, diagnose or mitigate a disease or condition that will need HCPs oversight and care and classified as high risk. For instance, SaMD’s that are intended to diagnose, manage or treat a psychiatric condition have been deemed by the FDA as requiring HCP oversight and therefore are for Rx only, and would have a label/Instructions For Use indicating the PDT is to be used as an adjunct to clinician supervised care. These solutions considered PDTs would need to generate rigorous evidence and submit it to the regulatory bodies (e.g FDA) for approval. It should be noted that in the middle of the spectrum are certain OTC SaMD products, where a consumer can appropriately follow the product label for the intended use without HCP supervision and require FDA premarket review, e.g. moderate risk medical devices.


With the industry evolving so quickly, there is often much confusion and discussion around the inclusion and exclusion criteria that would determine if a solution is a digital health tool, DTx, or PDT. Today, the term PDT is being used to describe digital products that fit into the following three categories: 



It is also important to highlight the fact that there are digital products that may have multiple intended uses whereby some functions are highly regulated and require a prescription, while other functions are available with no need of prescription (e.g an electronic fitness diary). 


As the field evolves, it will be important to move towards a strict definition of what a PDT is in order to avoid confusion among both patients and providers. Stronger qualifiers to meet official PDT criteria and FDA premarket review will also help to eliminate other digital health tools and DTx solutions that mislead patients by wrongly claiming to be PDTs. 


It’s important to take note of market regulations to help create clear marketing materials for appropriate distinctions between these product categories with rigorous evidence, regulatory approval and HCPs oversight being required for PDTs. There should also be a space in the market for low and moderate risk OTC DTx solutions that plan to use the prescription distribution channels and HCP recommendation to drive higher adoption.

Why should a DTx company go through the prescription route?

Some see PDTs  as the future of the DTx market and have the potential to unlock current access, capacity, and efficacy challenges for many chronic conditions, ultimately transforming how such conditions are prevented, treated and managed. 


In the early days, some DTx companies went through the prescription route simply because at the time prescriptions were seen as the only possible route to get reimbursed. While the industry has proven that there are other viable market routes for DTx companies, the prescription route does present some competitive advantages: 


And how do we get these PDTs to the market?

We explored six commercialisation models to get these products into patients’ hands: 


Pharma partnerships


Employer route

The employer market in the US is an attractive one to gain early proof of concept, paid pilots and earlier revenue streams, but it is highly fragmented and accounts for only about half of the market in the US.

This route is especially good for products that are addressing chronic conditions with a high prevalence. However, even though many mental health offerings are being sold into the employer market, this route might not be the best option for stigmatized conditions because of employee concern about the employer learning of their conditions, which can lead to low levels of adoption.  


D2C approach

Due to the newness of the industry, clinicians are often not confident enough to prescribe PDT solutions. They may not have faith in its efficacy, may lack an understanding of the solution, or they may have concerns about data privacy. However, considering that physicians will only prescribe when a patient comes to see them, using D2C marketing strategies for PDT products can be a really powerful approach to accelerate uptake. This approach can be more advantageous in markets in which patients or their caregivers are actively seeking new solutions (e.g. pediatric ADHD), as opposed to those in which clinicians drive more of the seeking behavior (e.g. opioid addiction).  A D2C approach:

On the other hand, there are some things that need to be taken into consideration when using a D2C approach for PDT products:


Telemedicine companies

Partnering or building out with a telemedicine provider channel can be a good way to make the prescription and distribution easier (e.g. models like Teladoc-Livongo merger). This is an emerging option some PDT companies are still testing. 


Pharmacy Benefit Management (PBM) in the US

PBM can be an important activation platform for PDTs. However, getting your product in a formulary does not mean all of the work is done. In this commercialisation model it is also key to work on the prescription piece to activate the HCP and get as many prescriptions/recommendations as possible.


Regardless of the commercialization model, there are 3 key points any PDT company should look at to be successful:


Adoption and Last-Mile Delivery Challenges for Prescription DTx

PDT adoption is one of the biggest pain points for DTx manufacturers. From a general perspective, there are 3 big challenges to get these products used:


Physician adoption


Physicians will decide the destiny of PDT, therefore it is key that DTx companies focus on showing them the high value of these solutions and make sure solutions fit into provider flows and pathways. In order to drive physician prescription of DTx we need to have solid clinical evidence, give them proper education on the product and provide them with tools that make the prescribing process easy and fast (e.g prescription platforms or integration into electronic health records). Physicians also need clarity around liability and responsibility for how information is used. Getting reimbursed can also help on some occasions. Most importantly, in light of staffing shortages and HCP’s need to balance many competing priorities, solutions will need to show that they are actually saving HCP’s time. Hence, the right approach depends on how physicians get incentivized by their institutions (coding system vs. patient outcomes). 


In terms of raising awareness and educating physicians of PDTs, there is no consensus on whether or not we should use the same model used for drugs. However, this is the model the industry knows, physicians are also used to it and it is hard to find alternative ways that are as effective as the traditional sales rep model. However, as tech organizations, DTx companies are in a good place to leverage their technology knowledge to build new models. Another approach that can help in certain therapeutic areas is using the patient (D2C marketing) to raise HCPs awareness and educate them, as explained in the section ‘Commercialisation models for Prescription DTx’.


But beyond raising awareness and educating physicians, what else can we do to drive their adoption? 




Patient adoption


Getting physicians to prescribe DTx products is the first step. We really need to engage patients so that they actually follow the prescription and stay with the product. What happens after a physician prescribes a PDT to a patient? Who carries the responsibility to onboard patients? 


These new treatments are out of the scope of physicians because of their training and their time is limited, so resting too heavily on them to educate patients can be risky. By the authors of this piece, pharmacists were seen by most as even less suited for this role than physicians. The majority of the group (65%) felt other alternatives such as nurses or other members of the care team were best suited. But ultimately, the DTx manufacturer should be the main responsible party for the onboarding process. Solution developers need to work on creating the best user experience to make onboarding easy and effective as well as to keep patients engaged to ensure they finish treatment.


The Future of Prescription DTx

Despite tremendous excitement for PDTs in certain communities, it is still very early days in PDT development and adoption. It is important to remember that today most people in healthcare are unfamiliar with the term PDT, and PDTs are still fighting battles educating physicians, obtaining reimbursement, and developing the highest quality evidence. As the PDT environment continues to show successes and build familiarity with patients and physicians, we imagine there will be very strong repeat behavior to try other PDT interventions due to their accessible nature and better safety profiles. Similar to what happened with telemedicine, after physicians and patients used it, they became repeat users. While it may still be a few years away, PDTs will become a ubiquitous tool across our healthcare system. 

Interesting links you may find useful:


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