2 The technology

2 The technology

Description of the technology

Apremilast (Otezla, Celgene) is a small-molecule inhibitor of phosphodiesterase 4 (PDE4). Apremilast down-regulates the inflammatory response by modulating the expression of inflammatory and anti-inflammatory cytokines and mediators associated with psoriatic arthritis (including tumour necrosis factor [TNF]-alpha and interleukin [IL]-23).

Marketing authorisation

Apremilast 'alone or in combination with disease-modifying antirheumatic drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy'.

Adverse reactions

The summary of product characteristics includes the following adverse reactions for apremilast: gastrointestinal (GI) disorders (most commonly diarrhoea and nausea); upper respiratory tract infections; headache; and tension headache. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Apremilast is an oral tablet. The recommended dosage is 30 mg twice daily after an initial titration schedule. A single 10-mg dose is given on the first day of treatment; this is titrated to 30 mg twice daily over 5 days (see the summary of product characteristics for the dose titration schedule).

Price

The price of apremilast is £550.00 for a 28-day pack (56×30-mg tablets) (excluding VAT; British National Formulary online, accessed September 2016).

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of apremilast, 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)