Idelalisib (Zydelig) has been accepted for restricted use by NHS Scotland. you can read more & access the full guidance PDF from the download on the SMC website.
CLLSA have participated in the consultation process, it is rewarding to see this now gain approval.
SMC intitial guidance details:
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.
Gilead have set up an early access scheme that provodes access for relapsed/refractory and 1st line 17p UK CLL patients not covered by CDF and NHSS for the EMEA licensed indication, please talk to your doctor for more information.
Outline details: Gilead have released an early access programme (supported by Idis on behalf of Gilead) in the UK (including Wales) for patients who fit within licensed indications subject to certain eligibility criteria. Patients are advised to contact their treating physician in the first instance. Their doctor may contact Idis to obtain more details on this programme, or to request a form for eligibility at this email address: email@example.com