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NICE issues ponatinib recommendation

written by

Leukaemia Care, Charity

  • Clinical trials - pg 18-19

The National Institute for Health and Care Excellence (NICE) has today issued its final appraisal determination (FAD) in relation to the appraisal of ponatinib (ID 671). Ponatinib is marketed by Incyte as Iclusig®.

Leukaemia CARE have been involved throughout the NICE appraisal and are pleased to announce that:

Chronic myeloid leukaemia (CML)

NICE has recommended ponatinib for treating “chronic-, accelerated- or blast-phase chronic myeloid leukaemia in adults when:

This overturns a previous preliminary recommendation, known as an appraisal consultation document (ACD), which did not recommend ponatinib as a cost-effective treatment for chronic phase CML patients without the T315i mutation.

Acute lymphoblastic leukaemia (ALL)

NICE has also recommended ponatinib for treating “Philadelphia-chromosome-positive acute lymphoblastic leukaemia in adults when:

These decisions approve ponatinib for use across its indication, as licensed by the European Medicines Agency (EMA). They are consistent with previous recommendations in 2015 from the Scottish Medicines Consortium (SMC) and the All Wales Medicines Strategy Group (AWMSG).

In England, access was previously provided via the Cancer Drugs Fund, but did not include chronic phase CML patients without the T315i mutation. Following this decision, these patients will now have access. The regional variations which were causing a ‘Cancer Lottery’ will come to an end for these patients, as ponatinib will be consistently available in England, Scotland and Wales.

Zack Pemberton-Whiteley, Head of Campaigns and Advocacy at Leukaemia CARE commented:

“We are delighted that NICE has revised their previous recommendation and approved ponatinib for patients in England and Wales. Ponatinib is an additional treatment option for patients with and without the T315i mutation.

This decision brings to and end unacceptable regional variations, between the treatments available for patients in England and those available to patients in Scotland.”

For further information, please contact our Campaigns and Advocacy team. They are available Monday to Friday from 9:00am – 5:30pm. If you would like to contact them, you can: