British medical costs regulator - the National Institute of Health Clinical and optimization (NICE) recently issued final guidelines, refused to Roche melanoma combination therapy Cotellic (cobimetinib) + Zelboraf (vemurafenib ) for advanced cancer and unresectable proliferation has occurred Treatment of BRAF V600 mutation-positive melanoma patients. After reviewing NICE, the combination therapy is not cost effective.
Cotellic+Zelboraf combination therapy was approved by the US and EU at the end of 2015; among them, Cotellic is an oral small molecule MEK1 and MEK2 kinase inhibitor, and Zelboraf is a BRAF inhibitor. BRAF proteins and MEK1 and MEK2 kinases are part of the same cellular signaling pathway that promotes cell division and survival and is often activated in human cancers, including melanoma. By selectively inhibiting these proteins and kinases, Cotellic and Zelboraf block downstream signaling pathways, thereby preventing the proliferation and survival of melanoma cells. Currently, Roche is also investigating the therapeutic potential of Cotellic in combination with other drugs, including immunotherapy, for a variety of types of tumors, including non-small cell lung cancer (NSCLC), colon cancer, triple-negative breast cancer, and melanoma.
In the melanoma clinical trial, the risk of disease progression or death was significantly reduced in the Cotellic+Zelboraf combination group compared with the Zelboraf group, with progression-free survival (median PFS: 12.3 months vs 7.2 months, p<0.001) significant Prolonged, overall survival (median OS: 22.3 months vs 17.4 months, p=0.005) significantly prolonged, objective response rate (ORR: 70% vs 50%, p<0.001), complete response rate (16% vs 11 %)higher.
It is estimated that approximately 1,000 people in the UK are eligible for treatment with the Cotellic+Zelboraf combination. But NICE said its committee agrees that the combination therapy can provide a clinical benefit of extending lifespan compared to Zelboraf monotherapy, but its incremental cost-benefit ratio exceeds £100,000 per quality adjusted life year (QALY) compared to other alternative therapies. Too expensive and not cost effective.
It is worth mentioning that in June this year, NICE issued a final guide to support the melanoma combination therapy Tafinlar (dabrafenib) + Mekinist (trametinib) of another Swiss pharmaceutical giant Novartis for the same patient population. It is reported that this is because Novartis and the British Ministry of Health reached an undisclosed discount agreement.
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