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New HTA Decisions in England
October 2021
Drug name
OPDIVO® (nivolumab)
Company
Bristol-Myers Squibb
Decision date
15/09/2021
Therapeutic area
Cancer
Therapeutic sub area
Head and neck cancers
Decision
Recommended with restrictions (CDF)
Indication
Nivolumab as monotherapy is indicated for treating recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.
Decision Detail
It is recommended only if: • the disease has progressed within 6 months of having chemotherapy and • the company provides it according to the commercial arrangement (commercial access agreement).
Summary
This guidance review looks at additional data collected as part of the Cancer Drugs Fund managed access arrangement for nivolumab for treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum based chemotherapy. In the original appraisal, the committee concluded that docetaxel was the most relevant comparator, but was not convinced about the company's assumption that docetaxel is equivalent to methotrexate. It also concluded that excluding paclitaxel from the trial and including cetuximab, a drug not used in clinical practice at that time and therefore not included in the NICE scope, introduced uncertainty about the relevance of CheckMate 141 trial evidence to UK clinical practice. This meant that using investigator choice data from the intention-to-treat population to model all comparators would likely underestimate the effectiveness of docetaxel because it includes other treatments that are less effective than docetaxel. In this guidance review, the committee acknowledged the uncertainty surrounding the intention-to-treat population with regard to the docetaxel comparator. The new evidence includes data from a randomised controlled trial (CheckMate 141) comparing nivolumab with the investigator's choice of therapy, and from people having treatment in the NHS while this treatment was available in the Cancer Drugs Fund in England. 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 (median overall survival for nivolumab was 7.7 months; investigator's choice was 5.1 months). The company also provided results for the docetaxel subgroup that showed a numerical survival benefit for nivolumab compared with docetaxel, but this was not statistically significant (the exact data are confidential and cannot be reported). The committee acknowledged that there was uncertainty about the results from the docetaxel subgroup because of the small number of people in the subgroup analysis, and in NHS clinical practice not all patients would have docetaxel. It concluded that it was uncertain whether nivolumab was clinically effective compared with docetaxel alone, which is the most relevant comparator. In the original appraisal, the committee concluded that there was evidence of nivolumab's benefit for tumours expressing 1% or more 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 above and PD L1 of less than 1% subgroups in the intention-to-treat population of CheckMate 141. For the subgroup with a PD L1 score of 1% and above, the median overall-survival gain was 3.6 months with nivolumab compared with investigator choice treatment. For the less than 1% PD L1 group, the median overall-survival gain was 1 month. The committee acknowledged that there was uncertainty about the results from the subgroup analyses based on PD L1 expression because of the small number of people in the subgroup analysis. However, the committee concluded that there was evidence that nivolumab is clinically beneficial for tumours with a PD L1 score of 1% and above but the benefit for those with a low PD L1 score was less certain. Nivolumab meets NICE's criteria to be considered a life-extending treatment at the end of life. The committee agreed that the most likely ICER for nivolumab compared with docetaxel, based on its preferred assumptions and using treatment-dependent and treatment-independent utilities, would be substantially below £50,000 per QALY gained. Taking into account the updated commercial arrangement, the ICER was within the range that could be considered a cost-effective use of NHS resources when the stopping rule was removed, a 5 year treatment waning effect was applied, and time-to-treatment discontinuation was extrapolated using the generalised gamma distribution in the 2 arms. When the treatment-independent utility values were applied instead of the treatment-dependent utilities in the same scenario the ICER increased but it still remained within the range that could be considered cost effective. It concluded that incorporating the company's updated commercial arrangement meant that its preferred ICERs were in the range that could be considered cost effective, even though some uncertainties remained. So, nivolumab is recommended for routine use in the NHS.