Abstract
As part of its single technology appraisal (STA) process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer of adalimumab (AbbVie) to submit evidence on the clinical effectiveness and cost effectiveness of adalimumab for the treatment of moderate-to-severe hidradenitis suppurativa (HS). The appraisal assessed adalimumab as monotherapy in adult patients with an inadequate response to conventional systemic HS therapy. The School of Health and Related Research Technology Appraisal Group was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical effectiveness and cost effectiveness of the technology based on the company’s submission to NICE. The evidence was mainly derived from three randomised controlled trials comparing adalimumab with placebo in adults with moderate-to-severe HS. The clinical-effectiveness review found that significantly more patients achieved a clinical response in the adalimumab groups than in the control groups but that the treatment effect varied between trials and there was uncertainty regarding its impact on a range of other relevant outcomes as well as long-term efficacy. The company’s submitted Markov model assessed the incremental cost effectiveness of adalimumab versus standard care for the treatment of HS from the perspective of the UK NHS and Personal Social Services (PSS) over a lifetime horizon. The original submitted model, including a patient access scheme (PAS), suggested that the incremental cost-effectiveness ratio (ICER) for adalimumab versus standard care was expected to be £16,162 per quality-adjusted life-year (QALY) gained. Following a critique of the model, the ERG’s preferred base case, which corrected programming errors and structural problems surrounding discontinuation rules and incorporated a lower unit cost for HS surgery, resulted in a probabilistic ICER of £29,725 per QALY gained. Based on additional analyses undertaken by the company and the ERG following the publication of the appraisal consultation document (ACD), the Appraisal Committee concluded that the maximum possible ICER for adalimumab compared with supportive care was between £28,500 and £33,200 per QALY gained but was likely to be lower. The Appraisal Committee recommended adalimumab (with the PAS) for the treatment of active moderate-to-severe HS in adults whose disease has not responded to conventional systemic therapy.
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This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (Project No. 15/06/09). See the HTA programme website for further project information (http://www.hta.ac.uk). This summary of the ERG report was compiled after NICE issued the FAD. All authors have commented on the submitted manuscript and have given their approval for the final version to be published. The views expressed in this report are those of the authors and not necessarily those of the NIHR HTA Programme. Any errors are the responsibility of the authors.
Conflict of interest
John Ingram was a local principal investigator for an observational HS study sponsored by AbbVie. Dr. Ingram has agreed to speak at a HS innovation forum sponsored by AbbVie; he will receive travel expenses to attend but has donated his speaker’s honorarium to charity. Fiona Collier provided some informal comments by email to AbbVie on their submission of adalimumab for treatment of HS to the Scottish Medicines Consortium in 2015; this was unpaid. Dr. Collier was a site co-investigator in an observational study of associations and disease course of HS, funded by AbbVie in 2014; Dr. Collier received no payment from AbbVie. Dr. Collier received payment by NHS Forth Valley for four extra clinic sessions to recruit and enrol patients in the study. NHS Forth Valley received payment from AbbVie per patient recruited. Paul Tappenden, Christopher Carroll, John Stevens, Andrew Rawdin, Sabine Grimm, Mark Clowes, Mohammad Ghazavi and Eva Kaltenthaler declare no financial conflicts of interest.
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Tappenden, P., Carroll, C., Stevens, J.W. et al. Adalimumab for Treating Moderate-to-Severe Hidradenitis Suppurativa: An Evidence Review Group Perspective of a NICE Single Technology Appraisal. PharmacoEconomics 35, 805–815 (2017). https://doi.org/10.1007/s40273-017-0488-2
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DOI: https://doi.org/10.1007/s40273-017-0488-2