This paper presents a summary of the evidence review group (ERG) report into the 
clinical effectiveness and cost-effectiveness of certolizumab pegol (CZP) for 
adults with active rheumatoid arthritis (RA) that have not responded adequately 
to treatment with conventional disease modifying anti-rheumatic drugs (DMARDs) 
including methotrexate (MTX), in accordance with the licensed indication, based 
upon the evidence submission from the manufacturer to the National Institute for 
Health and Clinical Excellence (NICE) as part of the single technology appraisal 
(STA) process. The outcome measures included American College of Rheumatology 
(ACR) 20, 50 and 70 response rates and quality of life measures after 3 months 
and 6 months of treatment. The ERG examined the submission's search strategies 
and considered they appeared comprehensive and that it was unlikely that 
relevant studies would have been missed. Only English language studies were 
considered in the submission and non-English language studies relevant to the 
decision problem may possibly have been ignored. The ERG analysed the first 
submitted economic model so as to itemise in detail clarification points that 
were brought to the attention of the manufacturer. In response the manufacturer 
submitted a modified cost-effectiveness analysis. The ERG undertook further 
analysis of this second model and other additional submitted evidence. The 
clinical evidence was derived from two multicentre blinded randomised controlled 
trials (RCTs) comparing CZP + MTX to placebo + MTX (the RAPID 1 and RAPID 2 
trials). RAPID 1 lasted 52 weeks with 982 patients and RAPID 2 24 weeks with 619 
patients. Evidence for clinical effectiveness of CZP in mono-therapy came from 
the 24-week FAST4WARD trial with 220 patients that compared CZP (400 mg every 4 
weeks) versus placebo. The three key RCTs demonstrated statistically significant 
superiority of CZP + MTX versus placebo + MTX and of CZP versus placebo with 
respect to a variety of outcomes including ACR 20, ACR 50 and ACR 70 measures 
and quality of life measures at 3 and 6 months. On the basis of results from the 
indirect comparison meta-analyses, the manufacturer suggested that CZP may be at 
least as effective as other 'biological' DMARD (bDMARD) comparators and, in a 
few ACR measures at 3 and 6 months, more effective. CZP is an effective therapy 
for adult RA patients whose disease has failed to respond adequately to cDMARDs 
including MTX or who are intolerant of MTX. The cost-effectiveness of CZP 
relative to other bDMARDs is unclear because the economic modelling undertaken 
may have ignored relevant effectiveness data and potential differences between 
trial populations, and so may have included effectiveness results that were 
biased in favour of CZP; underestimated uncertainty in the relative 
effectiveness of compared DMARDs; and ignored the potential influence of 
differences between bDMARDs with regard to adverse events and their related 
costs and health impacts. The NICE guidance issued in October 2009 states that: 
the Committee is minded not to recommend certolizumab pegol as a treatment 
option for people with RA; and the Committee recommends that NICE asks the 
manufacturer of CZP for more information on the clinical effectiveness and 
cost-effectiveness of CZP for the treatment of people with RA. On receipt of 
this information and details of a patient access scheme NICE issued final 
guidance recommending CZP, under certain criteria, as a treatment option for 
people with RA.