NICE reverses earlier ruling and recommends use of Stivarga in liver cancer.- Bayer HealthCare.

The National Institute for Health and Care Excellence (NICE) has recommended the NHS use of Stivarga (regorafenib) from Bayer HealthCare, for patients in England and Wales with advanced liver cancer whose liver is well-functioning but unable to be surgically removed and who have already taken the life extending medicine sorafenib. The guidelines also stipulate that to qualify, patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, meaning they are fully active and able to carry on all pre-disease behaviour without restriction or they are restricted in physically strenuous activity but able to carry out work of a light or sedentary nature. NICE estimates that several hundred patients each year will benefit from the drug. This is a reversal of an earlier decision when NICE rejected Stivarga in this setting for being too costly. NICE's new assessment includes analyses with a new commercial arrangement which makes regorafenib available to the NHS at a discount, hence Stivarga now meets NICE's criteria as a being a cost effective and life-extending end of life treatment.

Comment: Stivarga is oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumour angiogenesis. In one clinical trial underpinning its approval in patients with unresectable HCC whose disease had progressed during treatment with Nexavar (sorafenib), the drug significantly improved overall survival (OS) compared to placebo, with a 2.8-month difference in median OS (10.6 months versus 7.8 months), respectively. Also, Stivarga was linked with an overall 37 percent reduction in the risk of death.