2 The technologies

2 The technologies

Description of the technology

Certolizumab pegol (Cimzia, UCB Pharma) is a biological therapy (a recombinant humanised antibody Fab' fragment against tumour necrosis factor [TNF]‑alpha) and is conjugated to polyethylene glycol.

Secukinumab (Cosentyx, Novartis) is a biological therapy (a fully human monoclonal antibody that selectively neutralises interleukin 17A [IL-17A]).

Marketing authorisation

Certolizumab pegol has a marketing authorisation in the UK for treating active psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug (DMARD) therapy has been inadequate, either:

  • in combination with methotrexate or

  • as monotherapy, if methotrexate cannot be tolerated or when continued treatment with methotrexate is inappropriate.

Secukinumab has a marketing authorisation in the UK for treating active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate, either:

  • in combination with methotrexate or

  • as monotherapy.

Adverse reactions

The most common treatment-related adverse events associated with certolizumab pegol and secukinumab include upper respiratory tract infections and nasopharyngitis. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Certolizumab pegol is given subcutaneously:

  • as a loading dose of 400 mg at weeks 0, 2 and 4

  • at a recommended maintenance dose of 200 mg every 2 weeks, after the loading dose. Once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered. Methotrexate should be continued during treatment where appropriate.

Clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in patients whose disease has shown no evidence of therapeutic benefit within the first 12 weeks of treatment.

Secukinumab is given subcutaneously:

  • For patients with concomitant moderate to severe plaque psoriasis or patients whose disease has responded inadequately to TNF‑alpha inhibitors, the initial recommended dose is 300 mg at weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at week 4. Each 300 mg dose is given as 2 injections of 150 mg each.

  • For other patients, the recommended initial dose is 150 mg at weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at week 4.

Consideration should be given to stopping treatment in patients whose disease has shown no response by 16 weeks of treatment. Some patients whose disease has shown an initial partial response may subsequently improve with continued treatment beyond 16 weeks.

Price

Certolizumab pegol costs £357.50 per 200-mg prefilled pen or prefilled syringe. The company has agreed a patient access scheme with the Department of Health. The first 12 weeks of therapy with certolizumab pegol will be free of charge. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

Secukinumab costs £1,218.78 per 2 × 150-mg prefilled pen or syringe. The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of secukinumab, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. 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)