Oral Azacitidine for Maintenance Treatment of Acute Myeloid Leukaemia After Induction Therapy: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Willem Witlox (), Sabine Grimm, Jeremy Howick, Nigel Armstrong, Charlotte Ahmadu, Kevin McDermott, Thomas Otten, Caro Noake, Robert Wolff and Manuela Joore
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Willem Witlox: Maastricht University Medical Centre+ (MUMC+)
Sabine Grimm: Maastricht University Medical Centre+ (MUMC+)
Jeremy Howick: Kleijnen Systematic Reviews Ltd
Nigel Armstrong: Kleijnen Systematic Reviews Ltd
Charlotte Ahmadu: Kleijnen Systematic Reviews Ltd
Kevin McDermott: Kleijnen Systematic Reviews Ltd
Thomas Otten: Maastricht University Medical Centre+ (MUMC+)
Caro Noake: Kleijnen Systematic Reviews Ltd
Robert Wolff: Kleijnen Systematic Reviews Ltd
Manuela Joore: Maastricht University Medical Centre+ (MUMC+)

PharmacoEconomics, 2023, vol. 41, issue 8, No 3, 857-867

Abstract: Abstract The National Institute for Health and Care Excellence (NICE) invited the manufacturer (Celgene) of oral azacitidine (ONUREG), as part of the Single Technology Appraisal (STA) process, to submit evidence for the clinical effectiveness and cost-effectiveness of oral azacitidine for maintenance treatment of acute myeloid leukaemia (AML) after induction therapy compared with watch-and-wait plus best supportive care (BSC) and midostaurin. Kleijnen Systematic Reviews Ltd, in collaboration with Maastricht University Medical Centre+, was commissioned to act as the independent Evidence Review Group (ERG). This paper summarises the company submission (CS), presents the ERG’s critical review on the clinical and cost-effectiveness evidence in the CS, highlights the key methodological considerations and describes the development of the NICE guidance by the Appraisal Committee. In the QUAZAR AML-001 trial, oral azacitidine significantly improved overall survival (OS) versus placebo: median OS gain of 9.9 months (24.7 months versus 14.8 months; hazard ratio (HR) 0.69 (95% CI 0.55–0.86), p

Date: 2023
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DOI: 10.1007/s40273-023-01272-9

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