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New HTA Decisions in England
November 2019
Drug name
ZYDELIG® (idelalisib)
Company
Gilead
Decision date
23/08/2019
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood and bone marrow cancers
Decision
Not recommended
Indication
Idelalisib is not recommended, within its marketing authorisation, for treating follicular lymphoma that has not responded to 2 prior lines of treatment in adults.
Decision Detail
Summary
The key clinical evidence for idelalisib came from the single-arm phase II DELTA study. The company supplemented the DELTA study evidence from the Compassionate Use Programme (CUP), providing retrospective observational data from patients with follicular lymphoma having compassionate treatment in the UK and Ireland. The committee concluded that the evidence in DELTA and the CUP was not adequate enough for using to determine how well patients on idelalisib fared compared with people who had not taken idelalisib. Idelalisib has not been compared directly with current individual chemotherapeutic treatments. The most plausible ICERs were uncertain and the committee considered that the cost-effectiveness estimates lacked robustness, concluding that it needed to account for this in its decision making. The committee concluded that idelalisib was not considered to represent a cost-effective use of NHS resource because of the range of ICERs presented (between £16,481 and £86,161 per QALY gained) and its concerns with the quality of the evidence. Idelalisib cannot be recommended for inclusion in the Cancer Drugs Fund. This is because data collected in the Cancer Drugs Fund cannot resolve the key problems determining whether idelalisib is more effective that chemotherapy, nor document the adverse effects associated with individual chemotherapeutic regimens.