The world of healthcare and medicine has welcomed a new type of health solution called Digital Therapeutics (DTx). These are high-tech tools, often in the form of apps, designed to help people stay healthy by providing science-backed guidance for preventing, managing, and treating various medical conditions. However, the success of DTx depends on how well they can be used and paid for.  

Studies have indicated that digital healthcare management can lead to a 45 percent decrease in the occurrence of Major Adverse Cardiovascular Events (MACEs) within a three-month period and a 50 percent reduction in hospital readmissions within 30 days for patients following an Acute Myocardial Infarction (AMI) (Marvel et. al, 2021). 

This article explores why getting these DTx to as many people as possible is essential for managing diseases. It also looks at the challenges DTx companies face, important players in the industry, and the key strategies that can make these high-tech solutions work better for everyone.  

Significance of Market Access for DTx  

Market access is crucial for making any healthcare product, including DTx, to succeed. It means that these products need to be affordable and easy for patients, and they should be eligible for reimbursement from sources like insurance companies and government healthcare programs. Without proper market access, DTx may encounter difficulties in reaching their intended user base, which could curtail their potential impact and undermine their economic viability. 

DTx offer a unique way of managing diseases. They strive to improve patient health, cut healthcare costs, and offer personalized care. But these benefits can only happen if DTx are integrated into existing healthcare systems and are accessible and available for the patient population. That’s why market access strategies are important in making sure that DTx can be used and paid for widely. 

Eddie Martucci, the Co-Founder and CEO at Akili Interactive, a digital therapeutics company believes digital therapeutics will become “a brand-new pillar of medicine” (In interview with Andrew Greenstein, Host of The Next Great Thing Podcast) 

Key Players in DTx Market Access  

To effectively navigate the landscape of market access for DTx, it is indispensable to comprehend the key stakeholders involved. These players have different roles and interests and need to work together for better market access. 

  • Patients: Patients are at the center of the DTx world. Their needs and choices should guide how DTx products are made available. Knowing patient demographics, healthcare experiences, and interest in digital solutions is essential for creating market access strategies. Patient advocacy groups also play a big role in pushing for reimbursement and acceptance of DTx. 
  • Payers: Payers, encompassing insurance companies and government healthcare programs, wield significant influence in shaping reimbursement policies for DTx. They evaluate the clinical and economic value of these treatments and make determinations regarding coverage and reimbursement. Understanding the payer’s perspective at an early stage can facilitate the formulation of market access strategies and ensure they align with payer requirements. 
  • Healthcare Providers: For DTx to be adopted by patients, healthcare providers need to support and use these treatments. Working with healthcare providers and addressing their concerns, like how DTx fit into their work, is crucial for successful market access. 
  • Regulators: Regulatory bodies, for example the Food and Drug Administration (FDA) in the United States, are entrusted with evaluating the safety and efficacy of a DTx product. Compliance with regulatory prerequisites, therefore, is necessary for marketing approval. DTx companies must have a firm grasp on the regulatory requirements to smoothen the path to market entry. 
  • Industry Stakeholders: Industry stakeholders, including pharmaceutical companies, technology providers, and investors, influence market access for DTx in the following ways: 
    • Investment: Investors provide funding for DTx development, commercialization etc affecting the speed at which DTx solutions reach the market. 
    • Collaborations: Partnerships with pharmaceutical and technology companies help DTx reach wider audiences and navigate regulatory processes. 

Effective Market Access Strategies  

To get DTx widely adopted for disease management, companies can adopt a variety of strategies: 

Show the Value: Companies must explain why their DTx products are valuable. They should show how these products improve patient health and save money. Gathering evidence, like data from tests and real-world use, can help prove that DTx works and should be reimbursed. 

Follow Regulations: Companies must follow the rules and standards set by regulators to get their products approved. Safety, effectiveness, and data privacy rules must be followed carefully. 

Prove Health and Economic Benefits: Companies should show that DTx are not just good for patients but also cost-effective. They should do health economic evaluations to prove the value of their products in managing diseases. 

Set Prices and Reimbursement: Companies need to think about how much they’ll charge and how they’ll get paid for their products. Pricing models, reimbursement methods, and negotiation strategies are all important. 

Use Health Technology Assessment: Health Technology Assessment (HTA) stands as a systematic appraisal of the clinical, economic, and societal impact of healthcare interventions. DTx companies should contemplate the conduction of HTA to present a robust case for the value of their products. HTA findings can offer invaluable insights to payers and support reimbursement decisions. HTA pathways for DTx solutions need to be defined, accompanied by transparent directives, prerequisites, and details concerning the procedure (such as processing duration and progress status). Depending on the particularities of each country, it may be advisable to create a procedure resembling that of pharmaceuticals, yet this procedure should be notably efficient and brief. Its primary emphasis should be on assessing the impacts of specific DTx solutions within the healthcare pathways they are intended for (Prodan et. al, 2022). 

Offer Help to Patients: Making it easy for patients to get reimbursed is vital. Companies can provide resources, like hotlines and online tools, to help patients navigate the process. This can reduce financial stress and increase the chance of DTx being used. 

Gather Real-World Data: Collecting and analyzing data from real-world use is important for proving that DTx work in practical settings. This adds more evidence that can support reimbursement. 

Keep Learning: Market access strategies should be reviewed and updated regularly. Companies should monitor changes in the market, reimbursement policies, and feedback from stakeholders to improve their strategies. 


Market access strategies are crucial for the success of DTx in managing diseases. By understanding the challenges, working closely with key players, and following smart strategies, DTx companies can make sure their products can be used and reimbursed. Market access should be considered from the start and monitored continuously to navigate the complex healthcare landscape. With the right strategies, DTx have the potential to change how we manage diseases and improve patient health. 


Marvel, F. A., Spaulding, E. M., Lee, M. A., Yang, W. E., Demo, R., Ding, J., … & Martin, S. S. (2021). Digital health intervention in acute myocardial infarction. Circulation: Cardiovascular Quality and Outcomes, 14(7), e007741. 

Prodan, A., Deimel, L., Ahlqvist, J., Birov, S., Thiel, R., Toivanen, M., … & Kalra, D. (2022). Success factors for scaling up the adoption of digital therapeutics towards the realization of P5 medicine. Frontiers in Medicine, 9, 854665.