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 treating adults with Waldenstrom's macroglobulinaemia:

  • who have had at least 1 prior therapy, or

  • as first-line treatment in patients for whom chemo-immunotherapy is unsuitable.

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 (3×140‑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 company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of ibrutinib with the discount applied at the point of purchase or invoice. The level of the discount increased during the appraisal and is commercial in confidence. The Department of Health considered that this patient access scheme would not constitute an excessive administrative burden on the NHS.

The managed access agreement agreed between the company and NHS England will replace this patient access scheme. The terms of this agreement are commercial in confidence.

  • National Institute for Health and Care Excellence (NICE)