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.
|Drug Name:||idelalisib (Zydelig)|
|SMC Drug ID:||1026/15|
|Manufacturer:||Gilead Sciences Ltd|
|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.|
|Sub Category:||8.2 Drugs affecting the immune response|
|Submission Type:||Full submission|
|Date Advice Published:||9 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.