Unmet need: definitions, literature evidence and implications for HTA
The present paper illustrates the definition of unmet need provided by the peer-reviewed literature and the Health Technology Assessment (HTA) authorities across Europe in the assessment and appraisal process and within the early access schemes for medicines. The analysis relied on a descriptive re...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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AboutScience Srl
2023-10-01
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| Series: | Global & Regional Health Technology Assessment |
| Subjects: | |
| Online Access: | https://journals.aboutscience.eu/index.php/grhta/article/view/2624 |
| _version_ | 1797667211225071616 |
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| author | Claudio Jommi Michela Meregaglia Carmine Pinto |
| author_facet | Claudio Jommi Michela Meregaglia Carmine Pinto |
| author_sort | Claudio Jommi |
| collection | DOAJ |
| description | The present paper illustrates the definition of unmet need provided by the peer-reviewed literature and the Health Technology Assessment (HTA) authorities across Europe in the assessment and appraisal process and within the early access schemes for medicines.
The analysis relied on a descriptive review of the peer-reviewed literature and HTA documents on the definition of need (disease severity) and the way it is satisfied (existence and validity of alternatives).
HTA agencies were found using (i) a narrow definition of need, focused on the clinical impact and the impact on health-related quality of life of the disease and (ii) a broad definition of comparators, including treatments used off-label in the clinical practice. Most of the contributions of the literature advocated for a broader definition of need, including additional dimensions (for example, the socio-economic impact of the disease) and the effects of existing treatments beyond their risk-benefit profile (for example, acceptability to patients).
On the one hand, these contributions should be considered by HTA agencies, considering its multi-disciplinary and multi-stakeholder nature. On the other one, the explicit inclusion of the unmet need domains, at present disregarded, should depend on the decisions taken on the ground of the assessment.
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| first_indexed | 2024-03-11T20:10:00Z |
| format | Article |
| id | doaj.art-f3c60db5350241e8b04f0758395eafe6 |
| institution | Directory Open Access Journal |
| issn | 2284-2403 2283-5733 |
| language | English |
| last_indexed | 2024-03-11T20:10:00Z |
| publishDate | 2023-10-01 |
| publisher | AboutScience Srl |
| record_format | Article |
| series | Global & Regional Health Technology Assessment |
| spelling | doaj.art-f3c60db5350241e8b04f0758395eafe62023-10-03T12:48:11ZengAboutScience SrlGlobal & Regional Health Technology Assessment2284-24032283-57332023-10-0110110.33393/grhta.2023.2624Unmet need: definitions, literature evidence and implications for HTAClaudio Jommi0Michela Meregaglia1Carmine Pinto2Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale, Novara - ItalyDipartimento di Scienze del Farmaco, Università del Piemonte Orientale, Novara - Italy and Cergas, SDA Bocconi School of Management, Università Bocconi - ItalyOncologia Medica, Comprehensive Cancer Centre, AUSL-IRCCS Arcispedale di Reggio Emilia - ItalyThe present paper illustrates the definition of unmet need provided by the peer-reviewed literature and the Health Technology Assessment (HTA) authorities across Europe in the assessment and appraisal process and within the early access schemes for medicines. The analysis relied on a descriptive review of the peer-reviewed literature and HTA documents on the definition of need (disease severity) and the way it is satisfied (existence and validity of alternatives). HTA agencies were found using (i) a narrow definition of need, focused on the clinical impact and the impact on health-related quality of life of the disease and (ii) a broad definition of comparators, including treatments used off-label in the clinical practice. Most of the contributions of the literature advocated for a broader definition of need, including additional dimensions (for example, the socio-economic impact of the disease) and the effects of existing treatments beyond their risk-benefit profile (for example, acceptability to patients). On the one hand, these contributions should be considered by HTA agencies, considering its multi-disciplinary and multi-stakeholder nature. On the other one, the explicit inclusion of the unmet need domains, at present disregarded, should depend on the decisions taken on the ground of the assessment. https://journals.aboutscience.eu/index.php/grhta/article/view/2624Early AccessHealth Technology AssessmentUnmet need |
| spellingShingle | Claudio Jommi Michela Meregaglia Carmine Pinto Unmet need: definitions, literature evidence and implications for HTA Global & Regional Health Technology Assessment Early Access Health Technology Assessment Unmet need |
| title | Unmet need: definitions, literature evidence and implications for HTA |
| title_full | Unmet need: definitions, literature evidence and implications for HTA |
| title_fullStr | Unmet need: definitions, literature evidence and implications for HTA |
| title_full_unstemmed | Unmet need: definitions, literature evidence and implications for HTA |
| title_short | Unmet need: definitions, literature evidence and implications for HTA |
| title_sort | unmet need definitions literature evidence and implications for hta |
| topic | Early Access Health Technology Assessment Unmet need |
| url | https://journals.aboutscience.eu/index.php/grhta/article/view/2624 |
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