Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies

Ting Wang; Neil McAuslane; Helga Gardarsdottir; Wim G Goettsch; Hubert G M Leufkens

doi:10.1016/j.drudis.2021.09.014

Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies

Ting Wang
, Neil McAuslane
, Helga Gardarsdottir
, Wim G Goettsch
, Hubert G M Leufkens

Utrecht University, University Medical Center Utrecht
Centre for Innovation in Regulatory Science (CIRS)

Research output: Contribution to journal › Review article › peer-review

Abstract

There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies, enable better trial design, and support the goals of positive HTA recommendation for reimbursement. This study uses information collected directly from companies on individual products to assess their strategies and practices for seeking HTA-related scientific advice in terms of which stakeholders to engage and for what purpose, when to seek scientific advice, and whether to implement that advice within global clinical development.

Original language	English
Pages (from-to)	347-353
Number of pages	7
Journal	Drug Discovery Today
Volume	27
Issue number	1
Early online date	28 Sept 2021
DOIs	https://doi.org/10.1016/j.drudis.2021.09.014
Publication status	Published - Jan 2022

Bibliographical note

Funding Information:
The authors thank the pharmaceutical companies that took part in the study and facilitated the long-term annual data collection. The authors would also like to acknowledge Jenny Sharpe for her support in the editing and submission of this manuscript.

Publisher Copyright:
© 2021 Elsevier Ltd

Keywords

Drug development
Early scientific advice
Health Technology Assessment
Parallel scientific advice
Regulator
Reimbursement

Access to Document

10.1016/j.drudis.2021.09.014

1-s2.0-S1359644621004086-mainFinal published version, 269 KBLicence: Taverne

Cite this

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abstract = "There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies, enable better trial design, and support the goals of positive HTA recommendation for reimbursement. This study uses information collected directly from companies on individual products to assess their strategies and practices for seeking HTA-related scientific advice in terms of which stakeholders to engage and for what purpose, when to seek scientific advice, and whether to implement that advice within global clinical development.",

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note = "Funding Information: The authors thank the pharmaceutical companies that took part in the study and facilitated the long-term annual data collection. The authors would also like to acknowledge Jenny Sharpe for her support in the editing and submission of this manuscript. Publisher Copyright: {\textcopyright} 2021 Elsevier Ltd",

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AU - Goettsch, Wim G

AU - Leufkens, Hubert G M

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Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies

Abstract

Bibliographical note

Keywords

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