GOLIMUMAB FOR PSORIATIC ARTHRITIS

Golimumab for psoriatic arthritis: an assessment based on the manufacturer’s submission to NICE

Background

The aim of this NICE STA was to appraise the clinical and cost-effectiveness of golimumab within its licensed indication for the treatment of active and progressive psoriatic arthritis (PsA) in patients who have responded inadequately to previous disease-modifying anti-rheumatic drugs (DMARDs). CRD researchers together with researchers from the Centre for Health Economics (CHE) comprised the Evidence Review Group for this STA. The work involved a detailed assessment of the manufacturer’s submission to NICE on the clinical and cost-effectiveness of golimumab.

Findings

Clinical effectiveness: The manufacturer's evaluation of clinical efficacy included evidence relating to monthly golimumab therapy versus placebo, and a comparison of the relative efficacy between anti-tumour necrosis factor (TNF) agents which included evidence relating to the other three relevant comparators (etanercept, infliximab and adalimumab)

Cost effectiveness was assessed by the manufacturer based on a decision analysis assessing the cost-effectiveness of golimumab compared with etanercept, infliximab, adalimumab and palliative care.

The main clinical effectiveness data were derived from a single phase III randomised controlled trial (GO-REVEAL) that compared golimumab with placebo. The short and medium term data showed that, compared with placebo, golimumab 50 mg significantly improved both joint skin disease, with  a significant improvement in patients’ functional status as measured by Health Assessment Questionnaire (HAQ) change from baseline at 24 weeks . Data froman  open-label extension showed that these beneficial effects were maintained at 52 and 104 weeks. The results of a network meta-analysis indicated somewhat lower efficacy with golimumab compared with comparator biologics (etanercept, infliximab, adalimumab).

The manufacturer's own model showed that golimumab was unlikely to be cost-effective, relative to currently accepted thresholds. However, a key area in determining the cost-effectiveness of biologics was whether they should be treated as a class. The ERG concluded that if all biologics were considered equally effective, then etanercept, adalimumab and golimumab had almost equal costs and equal quality adjusted life years (QALYs); and all had an ICER of about £15,000 per QALY versus palliative care, whilst infliximab, with a higher acquisition cost, was dominated by the other biologics.

Conducted by: Huiqin Yang1, David Epstein2, Laura Bojke2, Dawn Craig1, Kate Light1, Ian Bruce3, Mark Sculpher2, Nerys Woolacott1

1. Centre for Reviews and Dissemination; 2. Centre for Health Economics; 3. University of Manchester

Further details

Project page on NIHR HTA Programme website

Related guidance

Commissioned to inform NICE Technology Appraisal Guidance: Golimumab for the treatment of psoriatic arthritis. London: National Institute for Clinical Excellence; 2011

Publications

Centre for Reviews and Dissemination and Centre for Health Economics Technology Assessment Group. Golimumab for the treatment of psoriatic arthritis: a Single Technology Appraisal. Centre for Reviews and Dissemination / Centre for Health Economics, 2010

Yang H, Craig D, Epstein D, Bojke L, Light K, Bruce IN, Sculpher M, Woolacott N. Golimumab for the treatment of psoriatic arthritis: a NICE Single Technology Appraisal. Pharmacoeconomics 2012; 30(4):257-70

Yang H, Epstein D, Bojke L, Craig D, Light K, Bruce I, Sculpher M, Woolacott N. Golimumab for the treatment of psoriatic arthritisHealth Technol Assess 2011;15(Supp 1):87-96

Funding

Commissioned by the NIHR HTA Programme in support of NICE's Single Technology Appraisal process.

NICE’s single technology appraisal (STA) process is specifically designed for the appraisal of a single product, device or other technology, with a single indication. The STA process normally covers new technologies and is designed to provide recommendations in the form of NICE guidance soon after the technology is introduced into the UK market. The principal evidence in the STA process is submitted by the manufacturer or sponsor of the technology.