Value Assessment Frameworks Fit for the Digital Age
The adoption of proven, cost-effective digital health technologies (DHTs) offers great promise for both patient outcomes and healthcare efficiencies, but can only be realised if the current market access barriers are lessened. Traditional HTA frameworks, predominantly designed for pharmaceuticals, are largely inadequate for evaluating DHTs, due to the pace of innovation and challenges in meeting the same rigorous evidence standards. Instead, there is a need for flexible and supportive value assessment frameworks tailored to DHTs to ensure timely access to proven technologies.
In Copenhagen, the spotlight was on Germany’s Digitale Gesundheitsanwendungen (DiGA) pathway as the current gold standard for digital health assessment; a topic of many posters but also excellently covered by Professor Volker Amelung, whose work is focused on international healthcare system research at the Medical University of Hannover, in Session 219.1 Introduced in 2020 as part of Germany’s Digital Care Act (DVG) to accelerate the digital transformation of the German healthcare system, the DiGA pathway enables DHTs to be fast-tracked into the statutory health insurance reimbursement system (Figure 1).2 Once a DHT has been positively assessed for its efficacy, functionality, quality, security and data protection measures – note the breadth of value domains compared to pharmaceutical HTA – the Federal Institute for Drugs and Medical Devices (BfArM) includes it in the DiGA directory, and the price is subject to negotiation with the German National Association of Statutory Health Insurance Funds. The app can then be prescribed by physicians and psychotherapists throughout Germany.
Figure 1. Overview of the DiGA pathway
Source: BfArM
The assessment of technologies is rigorous, with only ~50 technologies available for prescription currently, but there is also an understanding of the need for differing approaches to evidence generation. One route within the pathway is a conditional 1-year approval, during which further evidence is collected to confirm the value of the technology; a similar approach is also taken in the NICE Early Value Assessment.3 These pathways embrace an agile evaluation process that enables early adoption while ensuring a methodical approach to evidence generation, placing a growing emphasis on real-world evidence generation to demonstrate value. It also highlights the role for earlier collaboration between developers and HTA bodies to ensure evidence generation strategies are fit for purpose, something that feels relatively new for the MedTech realm.
Interestingly, Professor Amelung acknowledged the DiGa pathway is not perfect, but “you have to start somewhere.” The development of effective value assessment frameworks elsewhere has been limited by a lack of agreement on how the value of DHTs should be assessed. It was no coincidence that many other talks at ISPOR focused on developing value assessment frameworks using Delphi Panel methodology, attempting to bring together broad stakeholder groups and reach agreement on key value domains for DHTs. However, these talks highlighted that consensus was difficult to reach; patients, clinicians and payers all consider differing value domains to be of greater importance.
But is this a surprise? The idea that the solution is a one-size-fits-all framework for all digital health technologies feels almost impossible. Should the focus instead be on developing multiple adaptable frameworks, with a broad array of value domains that satisfy all stakeholders, to accommodate the broad diversity of technologies encompassed under the term ‘digital health’? Or should frameworks mirror the path trodden previously for pharmaceutical HTA appraisals, accepting that it may not be possible to satisfy all stakeholders initially and instead focus on payers, for example, before weaving in other voices in future iterations? This is before we even dwell on whether HTA assessments are appropriate for DHTs. For example, local tendering processes might suffice for some applications, bypassing the need for a stringent HTA. This doesn’t mean that effective value assessment frameworks are not required, but we do need to consider how they’ll be used, and in what setting; to echo an earlier message, “you have to start somewhere.”
Perhaps the DiGA pathway highlights a route forward for others; rather than developing the perfect value assessment framework, that somehow addresses all value domains perfectly for all stakeholders for the myriad of DHTs developed, instead implement a sensible, flexible pathway that can be updated following feedback in due course. At least this way, effective technologies can make it to patients, and feedback from across the pathway can shape future iterations.
Finally, the challenges do not end with the development of an effective value assessment framework. Sessions brought to light the misconception that market access equates to sales. For example, it was highlighted how DHTs that negotiated the DiGA pathway were prescribable, but often not prescribed. Effective market access strategies must still incorporate a robust local presence and comprehensive medical education programmes to convert approvals into clinical usage, ultimately benefiting patients, developers, and healthcare systems alike.
