e-Health / Digital Health Market Access

Pricing and reimbursement pathways and evidence requirements for digital/e-health products depend on whether the product is considered to be a medical, lifestyle, or combination product. In most countries, a health technology assessment (HTA) has to be performed to evaluate the clinical and economic (i.e. cost-effectiveness and/or budget impact) value proposition of medical technologies to determine whether coverage/reimbursement should be granted. This assessment is followed by price negotiations with national, regional, and local payers. The evidence requirements of these decision-makers vary widely Many digital/e-health products that successfully obtain the CE marking fail to achieve Market Access as payers deny reimbursement because of insufficient evidence or a significant mismatch between payer willingness to pay and industry aspirations. One document that exemplifies these evidence requirements is the evidence standards framework (ESF) for digital health technologies (DHTs) developed by the National Institute for Health and Care Excellence (NICE) in the UK. Our firm’s consultants partner with our clients to navigate these requirements and ensure the evidence resonates with key decision-makers.
To this end, our consulting agency’s consultants recommend a tailored approach (i.e. advisory board, scientific consultation, primary research, etc.) based on our client’s objectives.

Our company’s consultants are at the forefront of emerging trends in the field, such as the rise of Software as a Medical Device (SaMD), which diagnoses, treats, or prevents medical conditions. While SaMD offers benefits such as easier updates, challenges include ensuring its safety and efficacy, prompting regulators to develop guidelines for its development and use.

As a service provider for the digital/e-health industry, our experts are informed of the latest developments. The European Commission’s 2018 Communication on Digital Health and Care outlined a strategic framework focused on three pillars: secure data access and sharing, connecting and sharing health data for research, and strengthening citizen empowerment and personalized care through digital services. Our agency consultants are now following closely the implications of HTA Regulation 2021/2282 and the potential eligibility/requirements for joint clinical assessments (JCA) of medical technologies.

A significant shift in the market landscape is exemplified by the Digital Health Act (DVG)1 in Germany, introduced on December 19, 2019. This act introduced the first European pricing and reimbursement pathway for digital health apps based on the concept of the “app on prescription” as an integral part of patient healthcare. With approximately 73 million individuals covered by statutory health insurance, they now have the right to access healthcare through digital health applications (DiGA)2. Physicians and psychotherapists can prescribe these applications, and their costs are reimbursed by health insurers. Following DiGA, Digital Nursing Applications (DiPA)3 was introduced to contribute to a high-quality home care situation adapted to the individual circumstances and needs of those in need of care. Another notable example of effective eHealth integration is Denmark, which provides citizens with a personalized online platform for confidential monitoring of treatments and diagnoses. This platform facilitates appointment scheduling, medication tracking, and prescription ordering.

The U.S. Food and Drug Administration (FDA) recently announced the creation of the Digital Health Advisory Committee4, which will be fully operational in 2024, to advise the agency on the benefits, risks, and clinical outcomes associated with the use of digital health technologies (DHTs), including artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.

However, challenges remain, including insufficient funding, inadequate infrastructure, and limited patient awareness, which hinder the full realization of digital/e-Health benefits. The most common issues associated with the use of digital/e-Health products include the lack of evidence of efficacy and reliability in clinical decision-making, concerns about patient privacy, and potential impact on the patient-provider relationship. Overcoming these challenges requires a comprehensive understanding of the complexities and nuances of the industry.