December 12, 2022
Last month, Trinity attended the ISPOR Europe 2022 conference in Vienna. The main theme of the conference was “Collaborating Across Borders: Building & Using Evidence to Enable Access”, which facilitated many interesting discussions amongst different stakeholders in life sciences, including manufacturers, regulatory leaders and health economists. Among the myriad of topics covered, digital health emerged as a hot topic for podium sessions, poster presentations and group discussions.
A highlight for Trinity Life Sciences was presenting two posters, and one podium presentation focused on decentralized rapid diagnostics. Sonia Acosta, a Senior Consultant from the MedTech team was pleased to discuss her team’s research and strengthen Trinity’s presence as a leading strategic partner within the medical device, diagnostics and digital health industries.
Trinity’s MedTech team actively monitors trends and delivers regular intelligence articles that provide strategic advice to clients to support their decision-making within this rapidly evolving landscape.
Recent examples of their work include:
- White Paper | Reimbursement of Digital Therapeutics in the U.S. – What Is the Outlook?
- Advisory Brief | Surgical Procedures Are Moving to Ambulatory Surgical Centers (ASCs) – or Are They?
- Podium Presentation | Evaluating the Clinical, Economic, and Societal Value of Rapid Diagnostic Testing in Emerging Markets: A Systematic Literature Review Assessing Infectious Diseases
ISPOR Europe 2022: Key Topics and Themes
1. Centralized cross-European HTAs are emerging1; however, significant cross-stakeholder alignment will be critical for successful implementation
The development of a centralized Health Technology Assessment (HTA) process within the EU would formalize both methodologies and processes for the evaluation of new technologies. The key elements for this HTA process include old stalwarts like product efficacy, safety, budget impact/cost effectiveness and pricing along with increasing focus on societal impact and environmental impact/sustainability as key future elements of the evaluation process.
A centralized HTA process is an ongoing effort that requires the alignment of processes (i.e., evidence transfer, evaluation framework set up, priority alignment) and stakeholders (i.e., convergence between European Medicines Agency [EMA] and HTA outcomes).
2. The use of Real-World Evidence (RWE) to support and validate clinical trial data is becoming more widely accepted by government bodies as a part of the review of the long-term value of innovative technologies
Government bodies have increased their acceptance of the use of real-world evidence, in combination with clinical trial data, to analyze product value and enable the inclusion of voice-of-the-patient/patient priorities within their decision-making processes. Comprehensive and longitudinal evidence generation across the product lifecycle is expected to bring light to the impact that technologies have in patient outcomes and potentially simplify patient access.
Another key driver in this area is the need to develop a multi-stakeholder approach (and multi-patient group) to be successful in the rollout of innovative technologies.
3. Some European countries have facilitated patient access through digital health, enabled by reimbursement programs or value assessment frameworks; this will likely become a future trend
The COVID-19 pandemic and the need for use of remote healthcare access has force governments to understand the potential value of digital health and are developing new approaches that facilitate access (i.e., DiGA in Germany, Fast-track and investment in digital health acceleration strategy in France, or mHealth Validation Pyramid in Belgium).
The UK’s HTA body, NICE, has specifically advanced the development of an Evidence Standards framework (ESF) for digital health technologies that could lead to earlier interaction with assessment bodies. This would ensure evidence development aligns with the requirements raised by authorities. The evaluation framework includes design factors (safety and quality), environmental sustainability, health and care inequality considerations and data practices between others.
4. Value-based medical technology procurement remains a key area of interest; however, its rollout and implementation across markets has not been successful to date
For medical technologies, the promise of value-based procurement was a key focus of conversations. However, the lack of consistent evaluation frameworks across markets creates additional complexities for manufacturers looking to enter the European markets.
The use of simple categories focusing on reduction in consumption, switching from inpatient to outpatient care provision, impact across the patient pathway widely and interoperability and workflow efficiency would simplify the development and assessment process of these technologies.
ISPOR Europe 2022: Looking Forward – Concerns and Uncertainties
As the industry moves forward, there are still significant uncertainties around the long-term effects of the implementation of these policies within the healthcare, medical technology and digital health industries.
1. Digital health technologies require continuous improvement over time; uncertainties remain about how different versions of the same tool will be assessed (and reimbursed)
Digital health technologies are dynamic, and developers continue iterating on these platforms during the testing and post-commercialization stages of the lifecycle (in the U.S., issues related to the regulatory approval of different versions of the same technology could be directly approved if the manufacturer has been included in the FDA’s Pre-Certification Program – read Trinity’s white paper about the reimbursement of digital therapeutics for more details.
It is still unknown how European policy makers and country level governments will assess the value of different versions of the same technology, and whether there would be limitations on the reimbursement of these iterations. Uncertainties in the reimbursement potential for new technologies might represent a headwind to innovation.
2. Healthcare system stability, especially for Central and Eastern European markets is a concern, as knowledge sharing across markets becomes common and patient pressures to enable access to innovative therapies increase
While the implementation of a European-level HTA for medical technology and digital health could support a more rapid assessment of the value of these tools, country/regional or local level assessments remain key for reimbursement and procurement decision-making.
As a result, there might be gaps in access for patients in Western European vs. Central and Eastern European markets, given issues with healthcare sustainability vs market demand.
We look forward to further discussing these topics at the ISPOR Annual 2023 conference in Boston, MA; in the meantime, we would like to leave you with a quote from the opening session of the 2022 European conference that presents an important sentiment for the industry to reflect upon when thinking about the future of healthcare:
“Medical innovation only matters when it reaches a patient”
1 European Commission, 2021. Health Technology Assessment: Commission welcomes the adoption of new rules to improve access to innovative technologies. Accessed on November 23rd 2022. https://ec.europa.eu/commission/presscorner/detail/en/IP_21_6771
Author: Sonia Acosta
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