2 The technology

2 The technology

Description of the technology

Ponatinib (Iclusig, Incyte Corporation) is a third-generation antineoplastic protein kinase inhibitor that acts on the breakpoint cluster region-Abelson oncogene that leads to chronic myeloid leukaemia and Philadelphia-chromosome-positive acute lymphoblastic leukaemia.

Marketing authorisation

Ponatinib has a marketing authorisation for 'adult patients with:

  • chronic‑phase, accelerated‑phase, or blast‑phase chronic myeloid leukaemia who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation

  • Philadelphia-chromosome-positive acute lymphoblastic leukaemia who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.'

Recommended dose and schedule

Once‑daily oral doses: 15 mg, 30 mg or 45 mg. Dose levels and dose adjustments are determined by time on treatment, treatment response, and adverse reactions to treatment. For full details about treatment discontinuation and dose reduction, see the summary of product characteristics.

Price

Ponatinib is available at a cost of £5,050 for 60 15‑mg tablets, or 30 45‑mg tablets (excluding VAT; British national formulary online, accessed January 2017).

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