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Medicine characteristics affecting the time to guidance publication by National Institute for Health and Care Excellence in the single technology appraisal process

Published online by Cambridge University Press:  22 December 2021

Shunsuke Takada Open the ORCID record for Shunsuke Takada [Opens in a new window]  and
Mamoru Narukawa
Shunsuke Takada*
Affiliation:
Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo 108-8641, Japan Daiichi Sankyo Co., Ltd., Tokyo, Japan
Mamoru Narukawa
Affiliation:
Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo 108-8641, Japan
*
Author for correspondence: Shunsuke Takada, E-mail: [email protected]
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Abstract

Objective

In England, the time gap between marketing authorization (MA) and guidance publication by National Institute for Health and Care Excellence (NICE) can limit patients’ access to new medicines. In this study, our aim was to identify medicine characteristics associated with the long time gap between MA and guidance publication and explore the influencing factors.

Methods

We identified 116 single technology appraisals from 2016 to 2020 using publicly available data, and extracted information on the year of appraisal completion, application type, experiences of similar appraisals, orphan medicinal products (OMPs), cancer medicines, and accelerated assessment. Multiple regression analyses were performed to analyze the associations between the medicine characteristics and key time periods related to health technology assessment and MA processes.

Results

OMPs were associated with a long period between MA and guidance publication. Specifically, OMPs and cancer medicines were associated with slow guidance publication after the final scope (FS) development. However, there was no association between OMPs and the period between validation of MA application and FS development. Non-double-blinded randomized clinical trials and the use of comparators not specified in the FS were associated with slow guidance publication after the FS development.

Conclusions

Our results demonstrate that OMPs are associated with a longer period between MA and guidance publication by the NICE than non-OMPs; this may be attributed to the slow guidance publication after the FS development. These findings indicate the necessity to shorten the appraisal process for OMPs.

Keywords

Health technology assessmentNational Institute for Health and Care ExcellenceAccess to medicineOrphan medicinal product
Type
Assessment
Information
International Journal of Technology Assessment in Health Care , Volume 38 , Issue 1 , 2022 , e11
Copyright
Copyright © The Author(s), 2021. Published by Cambridge University Press

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