Nivolumab (Opdivo) will be routinely available on the NHS for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum-based chemotherapy, if new draft NICE guidance is accepted.
The draft guidance recommends the treatment for recurrent or metastatic SCCHN which has progressed within six months of having chemotherapy.
Previously, nivolumab was available on the Cancer Drugs Fund (CDF), where new evidence was collected. The new data suggests that people who have nivolumab are likely to live up to 9 months longer than those who have other treatments, though it is unclear how well nivolumab works compared with docetaxel, which is the most relevant comparator.
As a condition of the CDF funding and the managed access arrangement, the company was required to collect updated efficacy data from the CheckMate 141 study. Data was also collected using the Systemic Anti-Cancer Therapy (SACT) dataset.
For this guidance review, the company provided an additional 37 months of follow-up data (up to October 2019) from Checkmate 141. The results for the intention-to-treat population showed that people who had nivolumab lived longer than people who had the investigator-choice treatment (7.7 months vs 5.1 months; hazard ratio [HR] 0.69; 95% CI 0.55-0.86).
In the original appraisal, the committee concluded that there was evidence of nivolumab's benefit for tumours expressing ≥1% PD-L1 protein, but at lower expression levels the benefit was not clear. For this guidance review, the company provided subgroup analyses based on the latest available data (up to 15 October 2019) for PD-L1 of ≥1% and PD-L1 of <1% subgroup. For the subgroup with a PD-L1 score of ≥1%, median overall survival gain was 3.6 months with nivolumab compared with investigator-choice treatment (HR 0.54; 95% CI 0.39-0.76). For the <1% PD-L1 group, median overall survival gain was one month (HR 0.74; 95% CI 0.50-1.10).
The appraisal committee concluded that nivolumab meets NICE’s criteria to be considered a life-extending treatment at the end of life and the cost-effectiveness estimates are considered to be an acceptable use of NHS resources. Nivolumab is recommended for routine use.
