2 The technology

2 The technology

Description of the technology

Ibrutinib (Imbruvica, Janssen) is a covalent inhibitor of Bruton's tyrosine kinase.

Marketing authorisation

Ibrutinib 'as a single agent is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)' and 'as a single agent or in combination with bendamustine and rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy'.

This appraisal was started before ibrutinib received a license extension to include all 'adult patients with previously untreated chronic lymphocytic leukaemia'. It therefore only includes consideration of the second-line use of ibrutinib in adults with CLL and the first-line use of ibrutinib in patients with a 17p deletion or TP53 mutation when chemo-immunotherapy is unsuitable.

Adverse reactions

The most common adverse reactions included diarrhoea, neutropenia, haemorrhage (for example, bruising), musculoskeletal pain, nausea, rash and pyrexia. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Ibrutinib is administered orally at a daily dose of 420 mg (3 tablets) until disease progression or intolerance.

Price

The list price for a single tablet of ibrutinib (140 mg) is £51.10 (excluding VAT; 'British national formulary' [BNF] online, accessed October 2016). The cost of a year's course of ibrutinib treatment is £55,954.50 (excluding VAT). The company has agreed a patient access scheme with the Department of Health. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme would not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)