2 The technology

2 The technology

Description of the technology

Certolizumab pegol (Cimzia, UCB Pharma) is a recombinant humanised antibody Fab' fragment against tumour necrosis factor-alpha (TNF‑alpha) and is conjugated to polyethylene glycol (PEG). TNF‑alpha is a pro-inflammatory mediator that is partly responsible for damage to the joints in rheumatoid arthritis.

Marketing authorisation

Certolizumab pegol in combination with methotrexate (MTX) has a marketing authorisation in the UK for 'the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate'. Certolizumab pegol can be given as 'monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate'.

Certolizumab pegol also has a marketing authorisation in combination with MTX for 'the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX or other DMARDs', but this is not within the remit of this technology appraisal.

Adverse reactions

Certolizumab pegol is contraindicated in people with active tuberculosis or other severe infections, and in people with moderate or severe heart failure. The summary of product characteristics lists no adverse reactions as very common but notes that in clinical trials the most common adverse reactions were bacterial and viral infections. For full details of adverse reactions and contraindications see the summary of product characteristics.

Recommended dose and schedule

The recommended starting dose of certolizumab pegol for adult patients is 400 mg (given as 2 subcutaneous injections of 200 mg each) at weeks 0, 2 and 4. After the starting dose, the recommended maintenance dose of certolizumab pegol is 200 mg every 2 weeks. Once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered. MTX should be continued during treatment with certolizumab pegol when appropriate.

Price

The net price of certolizumab pegol is £357.50 per 200‑mg prefilled syringe (excluding VAT; 'British national formulary' [BNF] edition 71). The company has agreed a patient access scheme with the Department of Health. In the scheme, the first 12 weeks of therapy (currently 10 pre-loaded syringes of 200 mg each) with certolizumab pegol are free of charge. The acquisition cost is £6,793 in the first year of treatment and then £9,295 per year. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)