following a full submission assessed under the end of life and orphan equivalent medicine process:
azacitidine (Onureg®) is accepted for use within NHSScotland.
Indication under review: maintenance therapy in adult patients with acute myeloid leukaemia who achieved complete remission or complete remission with incomplete blood count recovery following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, haematopoietic stem cell transplantation.
Oral azacitidine plus best supportive care resulted in statistically significant improvements in overall survival and relapse-free survival, when compared with placebo plus best supportive care.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Download detailed advice809KB (PDF)
Medicine details
- Medicine name:
- azacitidine oral (Onureg)
- SMC ID:
- SMC2533
- Indication:
Maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).
- Pharmaceutical company
- Bristol-Myers Squibb Pharmaceuticals Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 10 July 2023