Ofatumumab for the treatment of chronic lymphocytic leukaemia in ...

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Apr 6, 2010 - See the HTA programme website for ... free survival (PFS) and overall survival (OS) times were 5.7 and 13.7 months, respectively. ... evidence submission is submitted by the evidence review group (ERG), an external ...
 DOI: 10.3310/hta15suppl1/07

Health Technology Assessment 2011; Vol. 15: Suppl. 1

Ofatumumab for the treatment of chronic lymphocytic leukaemia in patients who are refractory to fludarabine and alemtuzumab: a critique of the submission from GSK M Hoyle, L Crathorne,* R Garside and C Hyde PenTAG, Peninsula College of Medicine and Dentistry, Universities of Exeter and Plymouth, UK *Corresponding author Declared competing interests of authors: none

HTA 09/96/01 Date of ERG submission: 6 April 2010 TAR Centre(s): Peninsula Technology Assessment Group (PenTAG) List of authors: M Hoyle, L Crathorne, R Garside and C Hyde Contact details: Martin Hoyle, Research Fellow, Peninsula Technology Assessment Group (PenTAG), Peninsula College of Medicine and Dentistry, Veysey Building, Salmon Pool Lane, Exeter EX2 7SG, UK Email: [email protected] The research reported in this article of the journal supplement was commissioned and funded by the HTA programme on behalf of NICE as project number 09/96/01. The assessment report began editorial review in June 2010 and was accepted for publication in September 2010. See the HTA programme website for further project information (www.hta.ac.uk). This summary of the ERG report was compiled after the Appraisal Committee’s review. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Department of Health. Discussion of ERG reports is invited. Visit the HTA website correspondence forum (www.hta.ac.uk/correspond).

Abstract This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of ofatumumab for the treatment of refractory chronic lymphocytic leukaemia (CLL), based upon the manufacturer’s submission (MS) to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The submitted clinical evidence included one study: a non-randomised, single-arm © Queen’s Printer and Controller of HMSO 2011. This work was produced by Hoyle et al. under the terms of a commissioning contract issued by the Secretary of State for Health.

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Ofatumumab for the treatment of chronic lymphocytic leukaemia

study. Two other studies were identified but both were non-comparative and provided evidence for therapies other than ofatumumab. For this reason these studies were not discussed in full in the main body of the submission. In the Hx-CD20-406 study, the overall response rate was 58% (99% confidence interval 40% to 74%, p