The U.K.’s National Institute for Health and Care Excellence (NICE) does not recommend Opdivo (nivolumab) treatment for locally advanced unresectable or metastatic urothelial carcinoma (mUC) after platinum-containing chemotherapy.
NICE provides national guidance and advice to improve health and social care in the U.K.
Urothelial carcinoma affects the bladder or the ureters, the tiny channels that carry urine from the kidney to the bladder. Treatment options are limited for unresectable or metastatic urothelial carcinoma (cancers that cannot be surgically removed or have spread) after platinum-based chemotherapy. Patients are currently offered Taxotere (docetaxel), Taxol (paclitaxel), and best supportive care.
Opdivo (nivolumab) obtained approval from the European Commission to treat adults with locally advanced unresectable or mUC after the failure of prior platinum-based therapy. It is the only immunotherapy agent available in Europe for this condition.
The approval was based on data from the single-arm CheckMate-275 Phase 2 trial (NCT02387996), where 20% of patients responded to treatment with Bristol-Myers Squibb’s Opdivo.
But NICE considers that it is difficult to determine the clinical benefit of Opdivo compared with standard clinical practice because studies have not yet compared the drug with existing therapies.
Also, NICE considers that the cost is unacceptable. When compared with Taxotere and Taxol, the cost of quality-adjusted life years (QALY) would be approximately £76,000 ($100,400) more per QALY gained. QALY is an estimate in years of the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions.
“Nivolumab is not recommended, within its marketing authorization, as an option for treating locally advanced unresectable or metastatic urothelial carcinoma in adults after platinum-containing therapy,” the committee wrote in its appraisal consultation document.
The recommendation will not affect treatment with Opdivo that had already begun before the guidance was published.
“Nivolumab could not be recommended for routine use in the NHS [the U.K.’s National Health Service]. It does not appear to have the potential to be cost effective and is therefore not suitable for use within the Cancer Drugs Fund for people with unresectable or metastatic urothelial cancer after platinum-containing therapy,” the committee stated.
This is not NICE’s final decision on the subject, however. The recommendation will be submitted for consultations with consultees, commentators, and the public before NICE makes its final decision. The closing date for comments is Nov. 9, 2017.
For further details, see NICE’s guide to the processes of technology appraisal.
