Patient involvement in health technology assessment (HTA) has come a long way. Once seen as an optional add-on, it is now a key element of decision-making in many HTA processes worldwide. Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) has taken a significant step forward by refining its approach in the latest draft of its General Methods (version 8.0), which is currently open for consultation until April 29. This update marks a pivotal moment in the evolution of patient involvement in HTA.
How IQWiG is Advancing Patient Engagement
The inclusion of patient perspectives has grown steadily, as HTA agencies increasingly recognize the value of real-world experiences in evaluating medical interventions. Patients contribute crucial insights into quality of life, disease burden, and treatment expectations—factors that clinical trials often struggle to capture fully. IQWiG, along with other HTA bodies like NICE, has worked to formalize and standardize these contributions.
Key Challenges in Patient Involvement
While progress has been made, several challenges remain:
- Lack of Standardization: There is no universally accepted model for patient engagement in HTA. Each country and agency approaches patient involvement differently, leading to inconsistencies in how patient input is incorporated into decision-making – if at all
- Measuring Impact: The influence of patient feedback on final HTA decisions remains unclear, making it difficult to assess its true value and effectiveness.
- Recruitment Difficulties: Finding a diverse and representative group of patients, especially for rare diseases, remains a challenge. Ensuring that underrepresented populations have a voice requires proactive outreach and engagement strategies.
Future Developments in Patient Involvement
To address these challenges, IQWiG is rolling out structured improvements, including:
- Systematic Evaluation of Methods: IQWiG is implementing structured assessments of its patient involvement processes, including international feedback loops and data-driven evaluations to refine and optimize engagement models.
- Expansion of Patient Recruitment: The focus is on diversifying patient participation by strengthening partnerships with advocacy organizations, leveraging digital outreach, and improving access for underrepresented groups.
- Enhanced Digital Tools for Participation: New AI-driven sentiment analysis tools and mobile-friendly platforms are being tested to make patient participation more inclusive and accessible.
- Increased weighting of Patient-Reported Outcomes: A greater emphasis will be placed on patient-reported data to ensure that HTA recommendations truly reflect real-world patient experiences.
By incorporating these developments, IQWiG aims to build a more transparent, structured, and accountable framework for patient involvement.
What’s Next for Patient Involvement in HTA?
Looking forward, patient engagement in HTA is set to evolve further. The EU HTA Regulation (EU 2021/2282) and its implementing regulation (2024/1381) are establishing new benchmarks for patient participation across Europe. IQWiG’s latest draft reflects these regulatory changes, signaling a more structured and accountable approach to integrating patient voices into the process.
For professionals in market access and policy, these changes mean that strategies must evolve. Companies should proactively collaborate with patient organizations, leverage innovative engagement tools, and closely monitor regulatory developments to stay ahead of the curve – shifting patient input from optional to essential.
The growing emphasis on patient involvement is reshaping HTA processes for the better. Those who embrace these changes will not only meet regulatory expectations but also help develop therapies for – and with – the ones using them.
Source:
Allgemeine Methoden Entwurf für Version 8.0 vom 25.02.2025
https://www.iqwig.de/methoden/allgemeine-methoden_entwurf-fuer-version-8-0.pdf
Holtorf A-P, Bertelsen N, Jarke H, Dutarte M, Scalabrini S, Strammiello V. Stakeholder perspectives on the current status and potential barriers of patient involvement in health technology assessment (HTA) across Europe. International Journal of Technology Assessment in Health Care. 2024;40(1):e81. doi:10.1017/S0266462324004707
Klein B, Perfetto EM, Oehrlein EM, Weston F, Lobban TCA, Boutin M. Measuring and Demonstrating the Value of Patient Engagement Across the Medicines Lifecycle: A Patient Engagement Impact Measurement Framework. Patient. 2025 Jan;18(1):3-18. doi: 10.1007/s40271-024-00713-7. Epub 2024 Sep 16. PMID: 39285138; PMCID: PMC11717831.
Written by Pina Haberl, Senior Director
