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  • Writer's pictureSAKS Market Access Team

3 Market Access Challenges in the Digital Therapeutics and Health Innovation Space


The rapidly growing discipline of digital health can drive the delivery of medicine to be more personalized and precise. Digital Therapeutics (DTx) are a subset of digital health and focus on evidence-based interventions implemented through software programs and devices. While DTx solutions offer great promise and renewed hope to improve patient outcomes, they need to overcome several challenges. The first and most basic hurdle is navigating regulations and establishing DTx options as valid healthcare solutions. Below we highlight 3 DTx market access challenges from the payer, HCP, and patient perspectives:

1. Payers

DTx solutions are fundamentally different from traditional or established treatments, which can make the decision to cover difficult or delayed.

  • Payers (including health plans, pharmacy benefit managers, employers, integrated delivery networks, etc.) currently do cover many DTx

  • DTx can be covered under the medical benefit, pharmacy benefit, or through other avenues of contracting

  • Operating in an ambiguous space without one clear pathway can confuse payers when they are presented with new DTx

  • Private insurance companies are unable to refer to public programs (such as the Center for Medicare and Medicaid Services) in the US for reimbursement guidance

  • Most existing value assessment methodologies are designed for pharmaceutical products and may not be well-suited for DTx

2. HCPs

DTx solutions involve device, data, and dashboard components, which make them more complex than “simple” and traditional pharmaceutical prescriptions.

  • Even if DTx solutions show clinical effectiveness and safety, HCPs may be hesitant to prescribe them due to considerations of other factors such as randomization, if the study was double blind, and if a software placebo was used (Source)

  • DTx solutions must show an overwhelming improvement in patient experience in comparison to the current standard of care (if there is one), as well as significant cost savings

  • Once an HCP “trusts” DTx options enough to consider prescribing them to patients, there are also challenges to ensure that DTx integrate with their workflow and electronic health records

  • If physicians are introduced to DTx that do not allow for integration with electronic health records and work flows of their offices or organizations, they may not be willing or able prescribe them

  • The most frequently reported barriers to use of DTx, as reported by physicians, include lack of integration with workflow, lack of validation technology, and lack of usability and support (Source)

3. Patients

The disparity in access to DTx disproportionately affects minority and elderly populations.

  • Varying socioeconomic disparities make it difficult for DTx, not unlike traditional pharmaceutical options, to be inclusive to all patient populations and demographics

  • Technology and internet utilization patterns vary by race/ethnicity and socioeconomic factors, so adoption of DTx solutions primarily affects the elderly, less educated, and certain minority groups

  • African Americans, Latinos, Filipinos, and those with lower educational attainment in the US are less likely to utilize DTx solutions due to social factors such as lack of internet access, competing time demands, and limited digital literacy (Source)

  • Demonstrating the usability of a product is crucial because showing adherence to therapy, set-up, and administration will be vital to the adoption and success of DTx

    • DiGa are the health legislation and rules in Germany, put into effect December 2019, that manages all DTx and how these therapies are approved and accessed by patients

    • DiGa implemented a 12 month testing period, where patients are given access and reimbursement to DTx seeking DiGa approval. This period allows new DTx the opportunity to demonstrate success in a real-world clinical setting before being fully approved (Source)

    • The US may need payers to approach DTx coverage in a similar manner

Although DTx provide a new and exciting approach to healthcare, they have been and will continue to be confronted with many obstacles before they’re commercially integrated into our current healthcare system. SAKS Health believes in the utility and innovation of DTx options for appropriate patients. We’re working with several digital innovation client partners, and are lucky to have the opportunity to help them navigate these (and other) healthcare commercialization challenges so that, together, we can help patients embrace a Better Healthcare Tomorrow.



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