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.


2.3 The list price of midostaurin is £5,609.94 for a 56‑pack of 25 mg capsules (excluding VAT; BNF online, accessed September 2020), which equates to an annual cost of £292,719 at the standard dose of 100 mg twice daily.

2.4 The company has a commercial arrangement. This makes midostaurin available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)