Reported Challenges in Health Technology Assessment of Complex Health Technologies

Milou A. Hogervorst; Rick A. Vreman; Aukje K. Mantel-Teeuwisse; Wim G. Goettsch

doi:10.1016/j.jval.2021.11.1356

Reported Challenges in Health Technology Assessment of Complex Health Technologies

Milou A. Hogervorst, Rick A. Vreman, Aukje K. Mantel-Teeuwisse, Wim G. Goettsch^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Objectives: With complex health technologies entering the market, methods for health technology assessment (HTA) may require changes. This study aimed to identify challenges in HTA of complex health technologies.

Methods: A survey was sent to European HTA organizations participating in European Network for HTA (EUnetHTA). The survey contained open questions and used predefined potentially complex health technologies and 7 case studies to identify types of complex health technologies and challenges faced during HTA. The survey was validated, tested for reliability by an expert panel, and pilot tested before dissemination.

Results: A total of 22 HTA organizations completed the survey (67%). Advanced therapeutic medicinal products (ATMPs) and histology-independent therapies were considered most challenging based on the predefined complex health technologies and case studies. For the case studies, more than half of the reported challenges were “methodological,” equal in relative effectiveness assessments as in cost-effectiveness assessments. Through the open questions, we found that most of these challenges actually rooted in data unavailability. Data were reported as “absent,” “insufficient,” “immature,” or “low quality” by 18 of 20 organizations (90%), in particular data on quality of life. Policy and organizational challenges and challenges because of societal or political pressure were reported by 8 (40%) and 4 organizations (20%), respectively. Modeling issues were reported least often (n = 2, 4%).

Conclusions: Most challenges in HTA of complex health technologies root in data insufficiencies rather than in the complexity of health technologies itself. As the number of complex technologies grows, the urgency for new methods and policies to guide HTA decision making increases.

Original language	English
Pages (from-to)	992-1001
Number of pages	10
Journal	Value in Health
Volume	25
Issue number	6
DOIs	https://doi.org/10.1016/j.jval.2021.11.1356
Publication status	Published - Jun 2022

Keywords

challenges
cost-effectiveness assessment
data quality
decision making
health technology assessment
personalized health technologies
relative effectiveness assessment

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Cite this

@article{2d97d5f960f644d986a304eb6fc4ca9d,

title = "Reported Challenges in Health Technology Assessment of Complex Health Technologies",

abstract = "Objectives: With complex health technologies entering the market, methods for health technology assessment (HTA) may require changes. This study aimed to identify challenges in HTA of complex health technologies. Methods: A survey was sent to European HTA organizations participating in European Network for HTA (EUnetHTA). The survey contained open questions and used predefined potentially complex health technologies and 7 case studies to identify types of complex health technologies and challenges faced during HTA. The survey was validated, tested for reliability by an expert panel, and pilot tested before dissemination. Results: A total of 22 HTA organizations completed the survey (67%). Advanced therapeutic medicinal products (ATMPs) and histology-independent therapies were considered most challenging based on the predefined complex health technologies and case studies. For the case studies, more than half of the reported challenges were “methodological,” equal in relative effectiveness assessments as in cost-effectiveness assessments. Through the open questions, we found that most of these challenges actually rooted in data unavailability. Data were reported as “absent,” “insufficient,” “immature,” or “low quality” by 18 of 20 organizations (90%), in particular data on quality of life. Policy and organizational challenges and challenges because of societal or political pressure were reported by 8 (40%) and 4 organizations (20%), respectively. Modeling issues were reported least often (n = 2, 4%). Conclusions: Most challenges in HTA of complex health technologies root in data insufficiencies rather than in the complexity of health technologies itself. As the number of complex technologies grows, the urgency for new methods and policies to guide HTA decision making increases.",

keywords = "challenges, cost-effectiveness assessment, data quality, decision making, health technology assessment, personalized health technologies, relative effectiveness assessment",

author = "Hogervorst, {Milou A.} and Vreman, {Rick A.} and Mantel-Teeuwisse, {Aukje K.} and Goettsch, {Wim G.}",

note = "Funding Information: Funding/Support: The HTx project has received funding from the European Union{\textquoteright}s Horizon 2020 research and innovation programme under grant agreement No 825162. This dissemination reflects only the author's view and the Commission is not responsible for any use that may be made of the information it contains. Funding Information: It has been recognized since the start of HTA that sound and sufficient data are required and the described developments even further pressurize the HTA decision making process. 21 HTA organizations are expected to make more tailored decisions on more complex health technologies, using more limited data from multiple sources. Therefore, new HTA methods may need to be developed. 22 The HTx project, of which this study is a part, is a Horizon 2020 project supported by the European Union lasting for 5 years from January 2019. 3 The main aim of HTx is to create a framework for the next-generation HTA to support patient-centered, societally oriented, real-time decision making on access to and reimbursement for health technologies throughout Europe. To guide this development of new methodologies for the next-generation HTA, in-depth knowledge is needed of the challenges that are currently faced by HTA organizations during the assessment of complex health technologies. There is ample knowledge available on challenges associated with some specific types of health technologies over the past. 8 , 23-28 Nevertheless, a comprehensive overview of the challenges in light of the changing nature of health technologies in European HTA practice is missing. Such an overview would be necessary to determine how to mitigate the risks associated with uncertain decision making, for example, through scrutinizing the quality of data generation, development of advanced HTA methods, or employment of more sophisticated reimbursement agreements. Publisher Copyright: {\textcopyright} 2021 ISPOR - The professional society for health economics and outcomes research",

year = "2022",

month = jun,

doi = "10.1016/j.jval.2021.11.1356",

language = "English",

volume = "25",

pages = "992--1001",

journal = "Value in Health",

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AU - Vreman, Rick A.

AU - Mantel-Teeuwisse, Aukje K.

AU - Goettsch, Wim G.

N1 - Funding Information: Funding/Support: The HTx project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 825162. This dissemination reflects only the author's view and the Commission is not responsible for any use that may be made of the information it contains. Funding Information: It has been recognized since the start of HTA that sound and sufficient data are required and the described developments even further pressurize the HTA decision making process. 21 HTA organizations are expected to make more tailored decisions on more complex health technologies, using more limited data from multiple sources. Therefore, new HTA methods may need to be developed. 22 The HTx project, of which this study is a part, is a Horizon 2020 project supported by the European Union lasting for 5 years from January 2019. 3 The main aim of HTx is to create a framework for the next-generation HTA to support patient-centered, societally oriented, real-time decision making on access to and reimbursement for health technologies throughout Europe. To guide this development of new methodologies for the next-generation HTA, in-depth knowledge is needed of the challenges that are currently faced by HTA organizations during the assessment of complex health technologies. There is ample knowledge available on challenges associated with some specific types of health technologies over the past. 8 , 23-28 Nevertheless, a comprehensive overview of the challenges in light of the changing nature of health technologies in European HTA practice is missing. Such an overview would be necessary to determine how to mitigate the risks associated with uncertain decision making, for example, through scrutinizing the quality of data generation, development of advanced HTA methods, or employment of more sophisticated reimbursement agreements. Publisher Copyright: © 2021 ISPOR - The professional society for health economics and outcomes research

PY - 2022/6

Y1 - 2022/6

N2 - Objectives: With complex health technologies entering the market, methods for health technology assessment (HTA) may require changes. This study aimed to identify challenges in HTA of complex health technologies. Methods: A survey was sent to European HTA organizations participating in European Network for HTA (EUnetHTA). The survey contained open questions and used predefined potentially complex health technologies and 7 case studies to identify types of complex health technologies and challenges faced during HTA. The survey was validated, tested for reliability by an expert panel, and pilot tested before dissemination. Results: A total of 22 HTA organizations completed the survey (67%). Advanced therapeutic medicinal products (ATMPs) and histology-independent therapies were considered most challenging based on the predefined complex health technologies and case studies. For the case studies, more than half of the reported challenges were “methodological,” equal in relative effectiveness assessments as in cost-effectiveness assessments. Through the open questions, we found that most of these challenges actually rooted in data unavailability. Data were reported as “absent,” “insufficient,” “immature,” or “low quality” by 18 of 20 organizations (90%), in particular data on quality of life. Policy and organizational challenges and challenges because of societal or political pressure were reported by 8 (40%) and 4 organizations (20%), respectively. Modeling issues were reported least often (n = 2, 4%). Conclusions: Most challenges in HTA of complex health technologies root in data insufficiencies rather than in the complexity of health technologies itself. As the number of complex technologies grows, the urgency for new methods and policies to guide HTA decision making increases.

AB - Objectives: With complex health technologies entering the market, methods for health technology assessment (HTA) may require changes. This study aimed to identify challenges in HTA of complex health technologies. Methods: A survey was sent to European HTA organizations participating in European Network for HTA (EUnetHTA). The survey contained open questions and used predefined potentially complex health technologies and 7 case studies to identify types of complex health technologies and challenges faced during HTA. The survey was validated, tested for reliability by an expert panel, and pilot tested before dissemination. Results: A total of 22 HTA organizations completed the survey (67%). Advanced therapeutic medicinal products (ATMPs) and histology-independent therapies were considered most challenging based on the predefined complex health technologies and case studies. For the case studies, more than half of the reported challenges were “methodological,” equal in relative effectiveness assessments as in cost-effectiveness assessments. Through the open questions, we found that most of these challenges actually rooted in data unavailability. Data were reported as “absent,” “insufficient,” “immature,” or “low quality” by 18 of 20 organizations (90%), in particular data on quality of life. Policy and organizational challenges and challenges because of societal or political pressure were reported by 8 (40%) and 4 organizations (20%), respectively. Modeling issues were reported least often (n = 2, 4%). Conclusions: Most challenges in HTA of complex health technologies root in data insufficiencies rather than in the complexity of health technologies itself. As the number of complex technologies grows, the urgency for new methods and policies to guide HTA decision making increases.

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KW - cost-effectiveness assessment

KW - data quality

KW - decision making

KW - health technology assessment

KW - personalized health technologies

KW - relative effectiveness assessment

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JO - Value in Health

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Reported Challenges in Health Technology Assessment of Complex Health Technologies

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