Midostaurin (Rydapt®) for ASM

Assessment Status Suspended
Drug Midostaurin
Brand Rydapt®
Indication Midostaurin 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).
Assessment Process
Rapid review commissioned 13/08/2018
Rapid review completed 10/09/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of midostaurin compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 19/09/2018
Pre-submission consultation with Applicant 16/10/2018
NCPE assessment outcome This appraisal has been suspended until further evidence and analyses are included in a re-submission. An update on the appraisal and associated timelines will be provided in due course.

The company has not submitted a HTA dossier to the NCPE therefore the cost effectiveness of the technology could not be proven.