Scottish Medicine Consortium (SMC) approve arsenic trioxide for NHS patients in Scotland.

The Scottish Medicines Consortium (SMC) have today announced that arsenic trioxide is recommended for NHS acute promyelocytic leukaemia (APL) patients in Scotland. Find out what this decision means for patients in our article.

The Scottish Medicine Consortium (SMC) have today announced that arsenic trioxide is recommended for NHS patients in Scotland. The brand name for this drug is Trisenox and it is manufactured by Teva.

This follows Teva submitting extra evidence to the SMC to help them make a decision. The SMC originally decided against recommending this treatment, citing that Teva had not made a sufficiently robust” economic analysis. Click here to see our response to the initial decision in January.

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. This gene means that APL must be treated differently to AML. Arsenic trioxide was considered for use in newly diagnosed, low to intermediate risk APL patients, when combined with all-trans-retinoic acid (ATRA).

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.

Our Advocacy Officer, Charlotte Martin, said in response to the new decision: “We are pleased that the SMC has approved this medicine for APL patients in Scotland. This creates equal access to this treatment in Scotland, England and Wales, as it was approved by NICE in May 2018. It makes a welcome alternative to chemotherapy, which can have long lasting side effects.”

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