2 The technology

2 The technology

Description of the technology

Ibrutinib (Imbruvica, Janssen) inhibits a protein called Bruton's tyrosine kinase, stopping B-cell (lymphocyte) proliferation and promoting cell death.

Marketing authorisation

Ibrutinib has a marketing authorisation in the UK for the treatment of adults 'with relapsed or refractory mantle cell lymphoma'.

Adverse reactions

The most common adverse reactions associated with ibrutinib include diarrhoea, musculoskeletal pain, upper respiratory tract infection, haemorrhage, bruising, rash, and nausea. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Ibrutinib is taken orally (4×140‑mg capsules) once daily, until the disease progresses or there is unacceptable toxicity.

Price

Ibrutinib is available at the list price of £4,599.00 for 90×140‑mg capsules (£51.10 per capsule) and £6,132.00 for 120×140‑mg capsules (£51.10 per capsule; excluding VAT, British national formulary [BNF] June 2016). The pricing arrangement considered during guidance development was a patient access scheme agreed with the Department of Health that applied to all indications for ibrutinib. The company subsequently agreed a commercial access agreement with NHS England that replaced the patient access scheme on equivalent terms. The financial terms of the agreement are commercial in confidence.

  • National Institute for Health and Care Excellence (NICE)