NICE says no to Opdivo
- England's health technology assessment body, NICE, failed to recommend Bristol-Myers Squibb's Opdivo (nivolumab) for the treatment of locally advanced or metastatic non-small cell lung cancer after chemotherapy in people expressing PD-L1 at less than 10%. The committee is also 'minded not to recommend' Opdivo for patients with higher levels of expression of PD-L1. NICE has also recently turned down Merck's Keytruda for second line treatment of NSCLC.
- Lung cancer is the third most common cancer in the U.K., with 36,653 new cases reported in England in 2013; NSCLC makes up around 10-15% of cases of lung cancer.
- On the flip side, Opdivo has been given positive CHMP opinion in Europe for the treatment of Hodgkin's lymphoma.
NICE (National Institute for Health and Care Excellence), England's watchdog on drug pricing, didn't see the value in the checkpoint inhibitor.
Despite the rejection, the HTA offered a small get out clause with the suggestion that Bristol submits a proposal for inclusion in England's Cancer Drugs Fund (CDF), along with extra data and 'a plausible potential for cost effectiveness'. It's still draft guidance at the moment, so there could be room for a stronger case from Bristol over cost, currently at £73,500 ($89,000) per quality-adjusted life year (QALY) gained for squamous NSCLC and £150,000 ($182,000) for non-squamous NSCLC even with the offer of a discount.
Bristol hasn't been having the best of times with Opdivo in lung cancer of late. In August the drug failed a Phase 3 study in first line therapy, and the news resulted in a stock value fall for Bristol and a rise for Merck and its PD-1 inhibitor Keytruda, Opdivo's key competitor.
However, there is positive news for Opdivo in other indications. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Opdivo in adults with relapsed or refractory Hodgkin's lymphoma after stem cell transplant and treatment with Adcetris (brentuximab vedotin).
"If approved by the European Commission, Opdivo will become the first PD-L1 inhibitor approved to treat a hematologic malignancy in the European Union," said Emmanuel Blin, senior vice president and chief strategy officer of Bristol in a statement.
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