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Midostaurin for treating advanced systemic mastocytosis

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2 Information about midostaurin

Marketing authorisation indication

2.1 Midostaurin (Rydapt, Novartis) is indicated 'as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM‑AHN), or mast cell leukaemia (MCL)'.

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics.

Price

2.3 The list price of midostaurin is £5,609.94 for a 56-pack of 25 mg capsules (excluding VAT; British national formulary online, accessed September 2020), which equates to an annual cost of £146,359.33 at the standard dose of 100 mg twice daily. The company has a commercial arrangement, which would have applied if the technology had been recommended.