Dunlop, Will http://orcid.org/0000-0002-9794-8978
van Keep, Marjolijn
Elroy, Peter
Perez, Ignacio Diaz
Ouwens, Mario J. N. M.
Sarbajna, Tina
Zhang, Yiduo
Greystoke, Alastair
Funding for this research was provided by:
AstraZeneca
Article History
Accepted: 22 August 2021
First Online: 16 September 2021
Declarations
:
: The PACIFIC study (NCT02125461) was funded by AstraZeneca.
: Will Dunlop, Ignacio Diaz Perez, Mario JNM Ouwens, Tina Sarbajna, and Yiduo Zhang report employment by AstraZeneca and stock ownership in AstraZeneca. Marjolijn van Keep and Peter Elroy report employment by BresMed (under contract with AstraZeneca). Alastair Greystoke has received honoraria, speaker’s fees, and research funding from AstraZeneca.
: Details of the original economic model submitted to NICE can be found in the committee papers associated with the STA for durvalumab [ID1175] [CitationRef removed]. The 4-year update of clinical outcomes from the PACIFIC study is published in the <i>Journal of Thoracic Oncology</i> [CitationRef removed], and clinical outcomes for the subpopulation of patients whose tumours express PD-L1 on ≥ 1% of tumour cells are included in the online data supplement accompanying that publication. AstraZeneca’s data-sharing policy is described at ExternalRef removed.
: A detailed overview of the model structure and inputs has been published as in the original NICE submission (available as part of the NICE appraisal committee papers [ID1175] [CitationRef removed]); however, the coded model itself has not been published.
: MvK, YZ, MJNMO, TS, PE, and AG contributed to the original company STA submission to the National Institute for Health and Care Excellence (NICE; ID1175). WD, MvK, PE, YZ, MJNMO, and TS were involved in the conception and design of the current analysis. MvK, PE, WD, MJNMO, and YZ contributed to data analysis. IDP and AG contributed to clinical interpretation of the data. A medical writer under the supervision of WD wrote the manuscript. WD, MvK, TS, AG, IDP, MJNMO, YZ, and PE reviewed the manuscript, made substantial contributions to the content, and approved the final draft.
: This cost-effectiveness analysis was based on data from the PACIFIC study, which was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with the International Council on Harmonisation guidelines for good clinical practice.
: All patients provided written informed consent for participation in the PACIFIC study.
: Not applicable.