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New HTA Decisions in England
August 2019
Drug name
LIBTAYO® (cemiplimab)
Decision date
Therapeutic area
Therapeutic sub area
Skin cancer
Recommended (CDF)
Recommended for use within the Cancer Drugs Fund as an option for treating locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate.
Decision Detail
It is recommended only if the conditions in the managed access agreement are followed.
Clinical data on response and survival outcomes for cemiplimab were reported in 2 single-arm trials. The committee concluded that the trial data are likely to be generalisable to the NHS, but recognised that some uncertainty remains, including limited data and shorter follow-up for people who had the anticipated licensed fixed-dose regimen. The committee noted that the overall response rates reported in the trials are very promising. However, the committee noted the uncertainties related to generalisability of the data, that the data come from single‑arm trials with no comparator arm and the trial data are immature. The committee noted the significant uncertainty about the clinical effectiveness of cemiplimab compared with standard care in the NHS, particularly the issues related to using data from single-arm immature trials and the absence of any reliable comparator data. The committee concluded that the cost-effectiveness estimates for cemiplimab are not robust and therefore may or may not be within a range that could be recommended, even if the end-of-life criteria apply. The committee concluded that the end-of-life criteria might be met, but this is unproven at present. Because of uncertainty about the most plausible ICER, and about whether the end-of-life criteria are met, the committee was unable to recommend cemiplimab for routine commissioning. However, if more mature data become available from an ongoing trial of cemiplimab, and more data on life expectancy with current treatments are obtained, this could confirm the expectation that the end-of-life criteria apply. If this is the case, there is plausible potential for cemiplimab to be a cost-effective treatment. Therefore, cemiplimab is recommended for use within the Cancer Drugs Fund.