NICE approves Incyte’s leukaemia drug for routine NHS use

The National Institute for Health and Care Excellence (NICE) published draft guidance recommending ponatinib (Iclusig, Incyte Corporation) for routine use on the NHS, to treat some patients with chronic myeloid leukaemia and acute lymphoblastic leukaemia.

Ponatinib is currently available to patients in the Cancer Drugs Fund. It had not been previously appraised by NICE. A positive recommendation by NICE, once final, means that ponatinib can come off the CDF and be routinely available to patients on the NHS.

The independent appraisal committee concluded that ponatinib offered effective treatment and benefits over other treatments, such as bosutinib, meaning it could be considered a clinically and cost effective use of NHS resources.

In patients with chronic myeloid leukaemia (CML), NICE has recommended the use of ponatinib in adults with:

• chronic phase CML who have genetic changes present – known as the T315I gene
• accelerated or blast phase CML, whose disease is resistant to dasatinib or nilotinib, or when they cannot have dasatinib or nilotinib or for whom imatinib is not clinically appropriate, or when the T315I gene mutation present.

However, ponatinib is not recommended for patients with chronic phase CML who do not have the T315I gene mutation present.

The company estimates that just over 100 patients a year with CML would be eligible for treatment with ponatinib.

In patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (ALL), NICE has recommended the use of ponatinib in adults when:

• their disease is resistant to dasatinib, or
• they cannot have dasatinib or imatinib (if it is not clinically appropriate), or
• the T315I gene is present.

It is estimated that 33 patients a year with acute lymphoblastic leukaemia would be eligible for treatment with ponatinib.

The draft recommendations are now out for public consultation, and comments received during this time will be fully considered by the committee.