Earlier this month, TechToMed organized the 3rd edition of Dtx France in Paris. Karine Soulat shares her takeaways from this insightful day.
Digital therapeutics (DTx) are at the forefront of healthcare innovation, using software to provide therapeutic interventions based on clinical evidence. The value chain of DTx includes several essential steps, from design to market entry, through clinical validation and reimbursement. This value chain is enriched with elements from discussions and presentations from DTx France, which gathered 170 participants in Paris and more participants online.
1. Content of DTx Software
The content includes defining algorithms and intervention protocols, as well as UX design. To ensure that the content is relevant and of of high quality, collaborations between startups, patient associations, academic societies and universities are essentials. On the other hand, investments in this phase are often high, but they are crucial for developing innovative and clinically effective solutions.
2. Regulatory Requirements
Before anything else, DTx must meet the requirements of medical devices (MDR). In Europe, this involves first obtaining CE marking and then ensuring the confidentiality and security of personal data. DTx should also integrate with existing healthcare systems, enabling seamless communication between different devices and platforms. Interoperability standards are crucial to ensure that health data can be securely shared between different systems.
"There is a growing call for harmonization of regulations across Europe to facilitate market access for DTx" mentioned Matthias Mieves, a member of the German Bundestag.
Indeed, "harmonized regulation would reduce administrative barriers and promote faster adoption at the European level" emphasized Paul-Louis Belletante from Résilience.
Finally, DTx must undergo rigorous clinical validation to demonstrate their effectiveness and safety. This phase is necessary to gain the support and trust of professionals and patients.
3. Market Access
Market access and reimbursement are critical steps for the sustainability of DTx. This involves convincing payers, including health insurance companies and public health systems, to reimburse these therapies. During DTx France, we noted that current reimbursement models are not yet fully established, although significant progress has been made, particularly in Germany and France:
The German Model: DIGA (Digital Health Applications):
The DIGA process allows developers to submit digital health applications to the Federal Institute for Drugs and Medical Devices (BfArM) for evaluation. If approved, the application is listed in the DIGA directory and can be prescribed by doctors and reimbursed by health insurance. This process enables rapid market entry, facilitated by an accelerated evaluation taking only a few months. "To date, there are 56 active DIGA, including 21 provisional and 35 definitive", specified Diana Meskendahl, a board member of the German Digital Health Association (Spitzenverband Digitale Gesundheitsversorgung). But there is still an information gap to fill: many healthcare professionals still don't know about DIGA.
The French Model: PECAN (Prise en Charge Anticipée Numérique):
Launched over a year ago, PECAN aims to accelerate market access for digital health innovations by providing a framework for their evaluation and early reimbursement. So far, no digital therapeutic has received early reimbursement. After evaluation by the French National Authority for Health (HAS) and the Digital Health Agency (ANS) for CE marking and interoperability standards, DTx company can ask for early reimbursement, allowing patients to access them quicker while generating necessary clinical data for further evaluation and price determination, starting six months later. "Think of PECAN as the porch of a house. It’s important to stay focused on reimbursement, even though PECAN allows for early reimbursement for a few months", recommend Dorothée Camus from SNITEM (The National Union of the Medical Technology Industry that represents medical device and digital medical device companies). DTx manufacturers should think about permanent reimbursement (LPPR) even before submitting their PECAN file and anticipate the clinical data that will be required. Three criteria are important when it comes to PECAN: innovation of the solution, CE mark, and ongoing clinical studies.
The remuneration of DTx prescribers is an important issue. Financial incentives need to be put in place to encourage doctors to prescribe these new technologies while avoiding conflicts of interest. However, this is not yet planned for therapeutic digital medical devices in France but is expected to be implemented in Germany by the end of the year.
The Belgian Model: The Pyramid
The evaluation process by the National Institute for Health and Disability Insurance (INAMI) and the Federal Agency for Medicines and Health Products (AFMPS) was established in 2018 and took the form of a pyramid, with 28 companies included today but none reached the top level which grants reimbursement. In October 2023, Belgium launched a new framework for DTx, more similar to the German framework.
Market Access in Spain:
There is no national validation process. "Access in Spain is currently complex: each hospital has a budget, and access must be negotiated for each hospital. This is a very slow and costly way to promote and sell DTx. Private clinics are currently the only potential clients" explained Carmen Sanchez Gomez Casuso from the Consorcio DTx. Things are slowly moving in Spain. Consorcio DTx just released a White Paper to encourage the implementation of DTx in Spain. Meanwhile Catalonia are launching their PASS program to facilitate adoption of healthcare innovations in the catalan hospitals (including but not limited to DTx).
Market Access in the United States:
The Food and Drug Administration (FDA) evaluates and approves DTx through several regulatory pathways. Once approved by the FDA, DTx must obtain Current Procedural Terminology (CPT) codes for reimbursement by insurers. CPT codes standardize the billing of medical services. Companies then need to negotiate with private insurers and Medicare to obtain coverage and reimbursement. These negotiations can be complex and require economic studies demonstrating the clinical and financial benefits of DTx.
4. Commercialization Model and Adoption
The simplest model is a digital therapeutic offered directly to end users (B2C).
The second model is a B2B model where the digital therapeutic is promoted to hospitals for use in clinical trials for instance.
Another option is the B2B2C model, which involves contracting with complementary insurers or pharmaceutical laboratories.
Deploying multiple models simultaneously can increase potential distribution channels. François Vonthron, founder & CEO of Poppins, a DTx for children with a reading deficit (dyslexia) even mentioned a B2C2B model where parents talk about Poppins to speech therapists who try it and then prescribe it to their patients.
Regardless of the chosen model, raising awareness among healthcare professionals and patients about the benefits of these solutions is necessary.
"It’s best when scientific societies take up the issue of DTx and include recommendations for using DTx for certain patients at a particular stage of the disease" remarked A. Depil-Duval.
As for adoption, "it goes hand in hand" says Anne-Aurélie Epis de Fleurian from Tilak Healthcare. Proving efficacy and reimbursement is not enough to ensure usage. "A new care moment, a new organizational model often need to be created" explained Sarrazine Vadier from Viatris. This also includes technical support for users and possibly healthcare professionals to help them change their organization.
Conclusion
The value chain of digital therapeutics is complex and multidimensional, involving interactions between the proposed content, regulatory validation, reimbursement, clinical validation, daily use, personalization, and continuous improvement. DTx France organized by TechToMed highlighted the importance of each step and the associated challenges while emphasizing the enormous potential of DTx to transform healthcare. By integrating technological advancements, harmonizing regulations, and developing appropriate reimbursement models, DTx can provide innovative and effective solutions to improve population health. The future of healthcare will likely be algorithmic, as Stéphane Maillard explained.
For more details and to review the sessions from this day, you can visit DTx France's website.
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