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13
Apr
Leukaemia treatment ponatinib (Iclusig®) approved in Scotland

written by

Leukaemia Care, Charity

  • SMC 2

It was announced today (13/04/15) by the Scottish Medicines Consortium (SMC) that following a full submission under the orphan and end of life process, ponatinib has been accepted for use within NHS Scotland. Ponatinib is marketed by Ariad as Iclusig®.

Ponatinib has been accepted for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) 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. It has also been accepted for the treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) 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.

The advice also takes account of the views from a Patient and Clinician Engagement (PACE) meeting, which was held with patient group representatives (including Leukaemia CARE) and clinical specialists to consider the added value of ponatinib, in the context of NHS Scotland.

A full copy of the SMC advice is available here.

Leukaemia starts in blood-forming tissue, usually the bone marrow and leads to the production of large numbers of abnormal white blood cells. White blood cells are part of the immune system, the body’s defence against infection. CML and Ph+ ALL are both rare and aggressive forms of leukaemia.

Tony Gavin, Director of Campaigning and Advocacy at Leukaemia CARE said:

“This decision by the SMC is excellent news for both CML and Ph+ ALL patients who have failed to respond, either through resistance or intolerance, to the currently best available treatment options for their disease.

We are delighted to see that the new PACE framework is continuing to deliver patient access in Scotland for the rarer disease areas. This decision now brings Scotland in line with a comparable decision already made in Wales by the AWMSG. 

Unfortunately for similar patients in England this is not yet the case, NICE has failed to review ponatinib for this rare group of patients and this treatment option is currently not available for them. This inequitable situation needs to be remedied as soon as possible, NICE was set up to obviate post-code prescribing and cross border inequalities not to exacerbate them!”

If you are affected by this change and would like to speak to somebody about it, please call our CARE line on 08088 010 444.