Potential Barriers of Patient Involvement in Health Technology Assessment in Central and Eastern European Countries

Dimitrova, Maria; Jakab, Ivett; Mitkova, Zornitsa; Kamusheva, Maria; Tachkov, Konstantin; Németh, Bertalan; Zemplényi, Antal; Dawoud, Dalia; Delnoij, Diana; Houÿez, François; Kaló, Zoltán

doi:10.3389/fpubh.2022.922708

Cited by 6 publications

(9 citation statements)

References 59 publications

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“…Putting the patient at the centre of its actions is one of its strategic approaches to public health. However, improving the involvement of ‘people concerned’ is not an easy task 28. It should not be limited to organisational methods of committees, but assessment, pharmacovigilance, surveillance and drug development processes should be adapted to incorporate the different forms of patient involvement.…”

Section: Discussionmentioning

confidence: 99%

“…However, improving the involvement of ‘people concerned’ is not an easy task. 28 It should not be limited to organisational methods of committees, but assessment, pharmacovigilance, surveillance and drug development processes should be adapted to incorporate the different forms of patient involvement. Training and support should be offered and tailored to the needs of patients and other members of the public involved in the process.…”

Section: Discussionmentioning

confidence: 99%

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Patient and public involvement in the benefit–risk assessment and decision concerning health products: position of the Scientific Advisory Board of the French National Agency for Medicines and Health Products Safety (ANSM)

Belgodère,

Pougheon Bertrand,

Jaulent

et al. 2023

BMJ Glob Health

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Patient and public involvement in the benefit–risk assessment and decision concerning health products: position of the Scientific Advisory Board of the French National Agency for Medicines and Health Products Safety (ANSM)

Belgodère,

Pougheon Bertrand,

Jaulent

et al. 2023

BMJ Glob Health

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“…Although the quantitative study does not extensively investigate the underlying reasons for this gap, possible explanations exist regarding the underutilization of patient data. Some sources highlight the absence of clear methodologies and regulatory mechanisms guiding the integration of patient data in HTA processes (22). In response to this challenge, a French working group convened in 2021 to address the role of Patient-Reported Outcome & Experiences Measurements (PROMs/PREMs) in the evaluation and pricing of health technologies in France (23).…”

Section: Discussionmentioning

confidence: 99%

Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France

Martin,

Guercio,

Besseau

et al. 2023

Int J Technol Assess Health Care

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Objectives To better understand the process of hospital acquisition of innovative medical devices (MDs) and the hospital-based health technology assessment (HB-HTA) pathways in France, an in-depth study based on a quantitative approach is needed. The aim of the present study was to assess through a national survey how HB-HTA is currently implemented in French hospitals and to identify its level of formalization. Methods A quantitative online survey was conducted among hospitals performing HB-HTA in France, with a focus on the acquisition of innovative MDs for individual use. The survey, conducted between March and June 2022, was developed by a scientific board composed of members of the French-speaking Society for HB-HTA. Results Sixty-seven out of 131 surveyed hospitals with HB-HTA activities responded, including 29 university hospitals, 24 nonprofit private hospitals, and 14 local hospitals. Sixty-one respondents (91 percent) reported the existence of a process dedicated to evaluating innovative MDs; of these, 16 declared that their hospitals had a formalized unit with HB-HTA activity. These units were more frequently found in larger hospitals with more than 500 inpatient beds (n = 16, p = 0.0160) and in university hospitals (n = 12, p = 0.0158). No hospital reported any collaboration with HAS, the French national HTA agency. Conclusion A diverse range of HB-HTA organizations with different structural levels exist in France for MD procurement linked to the category of hospitals. The study highlights the need for recognition of HB-HTA activity at the regulatory level in France and for direct collaboration between HTA activities performed at local and national levels.

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“…With some exceptions, CEE countries are generally at less advanced stages of implementing HTA ( 1 ), which is particularly true for patient involvement in HTA ( 5 ). Patient involvement practices are limited in CEE countries lacking clear methodologies or regulatory mechanisms to guide patient involvement in the HTA process ( 5 ). This raises the question of transferability of practices used in other countries and calls for the development of new CEE-specific recommendations.…”

Section: Introductionmentioning

confidence: 99%

“…As the first step of our research, we mapped potential barriers to patient involvement in HTA in countries of the CEE region through a scoping literature review and discussions with CEE stakeholders ( 5 ). Based on the scientific literature, 22 potential barriers in two domains were identified.…”

Section: Introductionmentioning

confidence: 99%

Recommendations for patient involvement in health technology assessment in Central and Eastern European countries

Jakab,

Dimitrova,

Houÿez

et al. 2023

Front. Public Health

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IntroductionMeaningful patient involvement in health technology assessment (HTA) is essential in ensuring that the interests of the affected patient population, their families, and the general public are accurately reflected in coverage and reimbursement decisions. Central and Eastern European (CEE) countries are generally at less advanced stages of implementing HTA, which is particularly true for patient involvement activities. As part of the Horizon2020 HTx project, this research aimed to form recommendations for critical barriers to patient involvement in HTA in CEE countries.MethodsBuilt on previous research findings on potential barriers, a prioritisation survey was conducted online with CEE stakeholders. Recommendations for prioritised barriers were formed through a face-to-face workshop by CEE stakeholders and HTx experts.ResultsA total of 105 stakeholders from 13 CEE countries completed the prioritisation survey and identified 12 of the 22 potential barriers as highly important. The workshop had 36 participants representing 9 CEE countries, and 5 Western European countries coming together to discuss solutions in order to form recommendations based on best practices, real-life experience, and transferability aspects. Stakeholder groups involved in both phases included HTA organisation representatives, payers, patients, caregivers, patient organisation representatives, patient experts, health care providers, academic and non-academic researchers, health care consultants and health technology manufacturers/providers. As a result, 12 recommendations were formed specified to the CEE region’s context, but potentially useful for a broader geographic audience.ConclusionIn this paper, we present 12 recommendations for meaningful, systematic, and sustainable patient involvement in HTA in CEE countries. Our hope is that engaging more than a hundred CEE stakeholders in the study helped to spread awareness of the importance and potential of patient involvement and that the resulting recommendations provide tangible steps for the way forward. Future studies shall focus on country-specific case studies of the implemented recommendations.

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Potential Barriers of Patient Involvement in Health Technology Assessment in Central and Eastern European Countries

Cited by 6 publications

References 59 publications

Patient and public involvement in the benefit–risk assessment and decision concerning health products: position of the Scientific Advisory Board of the French National Agency for Medicines and Health Products Safety (ANSM)

Patient and public involvement in the benefit–risk assessment and decision concerning health products: position of the Scientific Advisory Board of the French National Agency for Medicines and Health Products Safety (ANSM)

Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France

Recommendations for patient involvement in health technology assessment in Central and Eastern European countries

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