Adalimumab for Treating Moderate-to-Severe Hidradenitis Suppurativa: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.
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.
Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, England, UK. p.tappenden@sheffield.ac.uk.
Paul
http://orcid.org/0000-0001-6612-2332
P
Tappenden
Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, England, UK.
Christopher
C
Carroll
Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, England, UK.
John W
JW
Stevens
Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, England, UK.
Andrew
A
Rawdin
Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, England, UK.
Sabine
S
Grimm
Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, England, UK.
Mark
M
Clowes
Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, England, UK.
Eva
E
Kaltenthaler
Institute of Infection and Immunity, Cardiff University, Cardiff, UK.
John R
JR
Ingram
Stirling Community Hospital, Stirling, UK.
Fiona
F
Collier
Nottingham NHS Treatment Centre, Nottingham, UK.
Mohammad
M
Ghazavi
D000068879:Adalimumab / Q000191:economics / Q000627:therapeutic use*; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D017497:Hidradenitis Suppurativa / Q000188:drug therapy* / Q000191:economics / Q000503:physiopathology; D006801:Humans; D008390:Markov Chains; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D013673:Technology Assessment, Biomedical / Q000379:methods
D000893:Anti-Inflammatory Agents; D000068879:Adalimumab
Adalimumab; Appraisal Committee; Evidence Review Group; Hidradenitis Suppurativa; Minimum Clinically Important Difference