Universität zu Köln

Gaultney, Jennifer G., Bouvy, Jacoline C., Chapman, Richard H., Upton, Alexander J., Kowal, Stacey, Bokemeyer, Carsten, Sola-Morales, Oriol, Wolf, Jurgen and Briggs, Andrew H. (2021). Developing a Framework for the Health Technology Assessment of Histology-independent Precision Oncology Therapies. Appl. Health Econ. Health Policy, 19 (5). S. 625 - 635. CHAM: SPRINGER INTERNATIONAL PUBLISHING AG. ISSN 1179-1896

Full text not available from this repository.

Abstract

The arrival of precision oncology is challenging the evidence standards under which technologies are evaluated for regulatory approval as well as for health technology assessment (HTA) purposes. Several key concepts are discussed to highlight the source of the challenges in evaluating these products, particularly those impacting the HTA of histology-independent therapies. These include the basket trial design, high uncertainty in (potentially substantial) benefits for histology-independent therapies, and the inability to identify and quantify benefits of standard of care in daily practice when the biomarker is not currently used in practice. There is little precedent for a technology with the unique mixture of challenges for HTA of histology-independent therapies and they will be evaluated using standard HTA, as there currently is no evidence suggesting the standard HTA framework is not appropriate. A number of questions proposed to help guide HTA bodies when assessing the appropriateness of local processes to optimally evaluate histology-independent therapies. Pragmatic solutions are further proposed to decrease uncertainty in the benefits of histology independent therapies as well as fill gaps in comparative evidence. The proposed solutions ensure a consistent and streamlined approach to evaluation across histology-independent products, although with varying strengths and limitations. Alongside these solutions, sponsors should engage early with HTA bodies/payers and regulatory agencies through parallel/joint scientific advice to facilitate the integration of both regulatory and HTA perspectives into one clinical development programme, potentially reconciling evidence requirements.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Gaultney, Jennifer G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bouvy, Jacoline C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chapman, Richard H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Upton, Alexander J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kowal, Stacey UNSPECIFIED UNSPECIFIED UNSPECIFIED Bokemeyer, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Sola-Morales, Oriol UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolf, Jurgen UNSPECIFIED UNSPECIFIED UNSPECIFIED Briggs, Andrew H. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-598617
DOI:	10.1007/s40258-021-00654-4
Journal or Publication Title:	Appl. Health Econ. Health Policy
Volume:	19
Number:	5
Page Range:	S. 625 - 635
Date:	2021
Publisher:	SPRINGER INTERNATIONAL PUBLISHING AG
Place of Publication:	CHAM
ISSN:	1179-1896
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language BASKET TRIALS; ECONOMIC EVALUATIONS; CANCER; OUTCOMES; BENEFIT; MODELS Multiple languages Economics; Health Care Sciences & Services; Health Policy & Services Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/59861