The Scottish Medicine Consortium (SMC) approves gilteritinib for relapsed/refractory AML patients in Scotland

The Scottish Medicine Consortium (SMC) has recommended the use of gilteritinib for patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. Find out what this means for patients in Scotland here.

The Scottish Medicine Consortium (SMC) has recommended the use of gilteritinib on the NHS in Scotland, for patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. This treatment has already been approved by NICE for use on the NHS in England. You can read more here.

Why will patients with a FLT3 mutation benefit from this treatment?

This treatment is only for patients with a certain type of mutation called the FLT3 mutation. This type of mutation is typically associated with a higher risk of relapse. FLT3 is a tyrosine kinase receptor, a type of protein that becomes too active when mutated. As a result, the protein increases the growth and survival of leukaemia cells.

How does gilteritinib work?

Gilteritinib targets and blocks the activity of the FLT3 protein; it does this by directly binding to the protein. As a result of the binding, the protein is not able to carry out its cancer promoting functions, targeting and preventing the growth of leukaemia cells.

Why has gilteritinib been approved?

Patients with relapsed or refractory AML with a FLT3 mutation have very limited treatment options available to them. The current salvage chemotherapy is not very effective in many patients and is also associated with side effects not favoured by patients and likely impacts their quality of life. In the ADMIRAL clinical trial for this treatment, the study concluded an improvement in overall survival of 9 months compared to current treatment with salvage chemotherapy of 5.5 months. This provides a potential alternative for this set of patients.

How does the SMC make its decision?

The SMC considers and advises on all new medicines for NHS Scotland, on evidence of clinical (how well the drug works in patients) and cost-effectiveness (whether it is better value for money than alternatives). The SMC will make its decision based on the evidence submitted by the company, healthcare professionals and also request input from patient groups such as Leukaemia Care. The company manufacturing the medicine provides evidence of why the medicine is effective both in how well it works and the cost to NHS Scotland compared to current treatments. Patient groups are involved in representing the views of patients by talking about any potential impact this new medicine will have on patients and carers. The healthcare professionals advise on any potential benefits of this new medicine compared to the current treatment landscape for this set of patients. Collectively, this helps the SMC make its final decision.

You can find more information here: https://www.scottishmedicines.org.uk/medicines-advice/gilteritinib-xospata-full-smc2252/

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