following a full submission:
defibrotide (Defitelio®) is accepted for use within NHS Scotland.
Indication under review: Treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.
In a phase III open-label study, defibrotide was associated with improved complete response rate and survival in patients with severe VOD, compared with a historical control group.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of defibrotide. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
Download detailed advice175KB (PDF)
Medicine details
- Medicine name:
- defibrotide (Defitelio®)
- SMC ID:
- 967/14
- Indication:
- treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.
- BNF chapter
- Cardiovascular system
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 09 June 2014