Arsenic trioxide for APL in Scotland

The Scottish Medicines Consortium (SMC) have today announced that arsenic trioxide is not recommended for NHS patients in Scotland. Find out more about this decision and how it affects acute promyelocytic leukaemia (APL) patients.

The Scottish Medicine Consortium (SMC) have today announced that arsenic trioxide is not recommended for NHS patients in Scotland. The brand name for this drug is Trisenox and it is manufactured by Teva. Teva are resubmitting with further evidence in response to this decision.

Arsenic trioxide was appraised by the SMC for treating acute promyelocytic leukaemia (APL). APL is a rare form of acute myeloid leukaemia. In APL there is a genetic abnormality called a translocation which usually leads to the creation of a faulty gene called PML/RAR-alpha. It was considered for use in newly diagnosed, low to intermediate risk APL patients when combined with all-trans-retinoic acid (ATRA).

The Scottish Medicines Consortium (SMC) is responsible for appraising technologies for use within NHS Scotland. The SMC undertakes assessments to review the value of each new medicine and to determine the benefits and costs. The Scottish Medicine Consortium (SMC) announcement states that the manufacturer, Teva, did not submit a “sufficiently robust” economic analysis to allow the SMC to make a recommendation. Teva are resubmitting with further evidence in response to this decision.

Arsenic trioxide is a medicine that acts to slow or stop the growth of the cancer cells. It has been used for a number of years to treat leukaemia. Whilst toxicity of arsenic is well recognised, alternative treatments for APL also come with significant side effects. Arsenic trioxide has been investigated in clinical trials against the standard treatments (anthracycline chemotherapy). The trials included patients that were newly diagnosed and low to intermediate risk. Risk is defined by the number of white blood cells in the patient’s blood at diagnosis; more white blood cells indicates that disease has progressed already, which may be harder to treat and is therefore higher risk. The trial did show that arsenic is as good as anthracycline chemotherapy (a common first line treatment) in terms of event-free survival. Arsenic trioxide was superior to anthracycline chemotherapy in terms of overall survival too.

“We are disappointed with the SMC’s decision not to allow individuals diagnosed with acute promyelocytic leukaemia access to arsenic trioxide,” said Zack Pemberton-Whiteley, Patient Advocacy Director at Leukaemia Care. “The manufacturer Teva have resubmitted to the Scottish Medicines Consortium with further evidence for assessment. We will continue to work with the SMC to ensure patients are given access in the future.”

If anyone has any concerns or questions regarding arsenic trioxide or the decision discussed in this article, please contact the advocacy team on 01905 755977 or email advocacy@leukaemiacare.org.uk

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