following a full submission
idelalisib (Zydelig®) is accepted for restricted for use within NHS Scotland.
Indication under review: In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
- who have received at least one prior therapy, or
- as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
SMC restriction: patients with relapsed CLL who are unsuitable for chemotherapy and treatment naïve patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy.
Idelalisib in combination with an anti-CD20 antibody significantly improves progression free survival compared with an anti-CD20 antibody alone in patients with relapsed CLL. The treatment effect across subgroups with 17p deletion and/or TP53 mutation was consistent with that of the total study population.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of idelalisib. It 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 advice219KB (PDF)
Medicine details
- Medicine name:
- idelalisib (Zydelig)
- SMC ID:
- 1026/15
- Indication:
- In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
- Pharmaceutical company
- Gilead Sciences Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 09 March 2015
In March 2016 the European Medicines Agency recommended new safety monitoring procedures for idelalisib, which include close monitoring and antibiotics to prevent pneumonia. In September 2016 the licensed indication for first-line treatment in the presence of 17p deletion or TP53 mutation was revised to reserve use to patients who are not eligible for any other therapies.