Note from the National Guideline Clearinghouse (NGC): The National Institute for Health and Clinical Excellence (NICE) commissioned an independent academic centre to perform a systematic literature review on the technology considered in this appraisal and prepare an Evidence Review Group (ERG) report. The ERG report for this technology appraisal was prepared by the Centre for Health Economics, University of York and Regional Drug and Therapeutics Centre (Newcastle) (see the "Availability of Companion Documents" field).
Clinical Effectiveness
Search Strategy
A systematic literature search was undertaken by the ERG to verify the completeness of the methodology used by the manufacturer to retrieve relevant clinical studies presented in the submission.
Searches were undertaken on the following resources to identify relevant clinical effectiveness data: MedLine, Embase, Science Citation Index, Cochrane Library, the European League Against Rheumatism (EULAR), American College of Rheumatology (ACR), British Society for Rheumatology (BSR), Food and Drug Administration (FDA), European Medicines Agency (EMEA), and National Institute for Health and Clinical Excellence (NICE). All databases were searched from their inception to the date of the search. No language or other restrictions were applied to the study selection. The bibliographies of all included studies and the manufacturer's submission were reviewed to identify any further relevant studies. Due to the paucity of efficacy data available trials reported as abstracts were included in the review.
Inclusion criteria:
Participants: Adults with psoriatic arthritis (PsA)
Interventions: Adalimumab administered by subcutaneous injection for the treatment of PsA.
Comparator: Placebo or any other active agent.
Outcomes: No restrictions applied; (outcomes included: American College of Rheumatology [ACR] response criteria, total sharp score [TSS], psoriatic arthritis response criteria [PsARC], psoriasis area and severity index [PASI], health assessment questionnaire [HAQ], SF-36 and functional assessment of chronic illness therapy [FACIT])
Design: Randomised controlled trials (RCTs) and open-label extension studies were included in the evaluation of efficacy.
Exclusion criteria:
Participants: Juveniles with PsA (<16 years of age)
Intervention: Adalimumab for other indications (e.g. rheumatoid arthritis and ankylosing spondylitis)
Study selection: Peer review panel
Refer to Appendix 1in the ERG Report (see the "Availability of Companion Documents" field) for additional information on the search strategy.
Cost-Effectiveness
Existing Cost-Effectiveness Evidence
As part of the manufacturer's submission, a systematic search was undertaken with the aim of identifying published studies evaluating the cost-effectiveness of adalimumab for the treatment of moderate to severe psoriatic arthritis. The search strategy, key words, date range and sources searched to identify the economic studies were appropriate for this purpose. The manufacturer's search did not identify any studies which evaluated the cost-effectiveness of adalimumab for this indication. Two published studies assessing the cost-effectiveness of alternative anti-tumor necrosis factor (TNF) agents were identified and subjected to a detailed critical appraisal by the manufacturer.
The searches undertaken by the manufacturer were replicated by the ERG in order to validate the evidence base considered. The ERG found that the search was reproducible, and the results were consistent with the original search. However, it was not clear from the company submission how many different results met their search criteria, as they did not show how many of them were duplicated among the databases.
A second search was conducted by the ERG using a much broader search strategy designed to capture all National Health Service Economic Evaluation Database (NHS EED) records relating to PsA. In addition, the ERG ran searches of the NHS EED administrative system (CAIRS B) and of Medline, Cinahl, Embase and EconLit to identify any recent studies not yet screened for NHS EED. After deduplication there were 16 potential studies that met the inclusion criteria. Of the 16 studies identified, only 2 of these were full cost-effectiveness analyses. Both studies assessed the cost-effectiveness of alternative anti-TNF agents (etanercept and infliximab). Refer to Appendix 5 in the ERG Report (see the "Availability of Companion Documents" field) for details of the search strategies conducted by the ERG.