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New HTA Decisions in England
October 2020
Drug name
OPDIVO® (nivolumab)
Company
Bristol-Myers Squibb
Decision date
17/09/2020
Therapeutic area
Cancer
Therapeutic sub area
Lung cancer
Decision
Recommended with restrictions
Indication
Nivolumab is recommended as an option for treating locally advanced or metastatic squamous non-small-cell lung cancer (NSCLC) in adults after chemotherapy.
Decision Detail
It is recommended only if: it is stopped at 2 years of uninterrupted treatment, or earlier if their disease progresses and they have not had a PD‑1 or PD‑L1 inhibitor before. It is recommended only if the company provides nivolumab according to the commercial arrangement (simple discount patient access scheme).
Summary
This review looks at additional evidence collected as part of the Cancer Drugs Fund to address uncertainties identified during the original appraisal. Key clinical trial data from CheckMate 017, an open-label randomised trial, showed nivolumab was associated with a statistically significant improvement in overall survival compared with docetaxel (the exact data are confidential and cannot be reported here). The committee concluded that nivolumab was clinically effective compared with docetaxel alone for people with squamous NSCLC after chemotherapy. There is uncertainty about how long people should have nivolumab for, but evidence suggests that there is continued benefit when treatment is stopped at 2 years. The committee concluded that nivolumab meets the end-of-life criteria and can be considered a life-extending treatment at the end of life. The cost-effectiveness estimates for nivolumab compared with docetaxel are likely to be within what NICE considers to be an acceptable use of NHS resources. Therefore, it is now recommended in the NHS after chemotherapy for people who have not had a PD 1 or PD L1 inhibitor before, if it is stopped at 2 years.