NICE Recommends Regorafenib for Use on NHS

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NICE has recommended the use of regorafenib as a treatment for NHS patients with advanced liver cancer, following consideration of a new commercial arrangement.

The National Institute for Health and Care Excellence (NICE) has recommended the use of regorafenib (Stivarga, manufactured by Bayer) as a treatment for the United Kingdom’s National Health Service (NHS) patients with advanced liver cancer, following consideration of a new commercial arrangement.

This announcement comes after NICE performed a rapid review of guidance published earlier in the year and means that regorafenib will be offered to patients whose livers are working well but are not surgically treatable and have already taken the medicine sorafenib. 

Additionally, to be eligible for regorafenib, patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1-defined as patients who are fully active and capable of performing normal daily activities unrestricted, or patients who are restricted in physically strenuous activity but can perform work of a light or sedentary nature.

The new commercial arrangement, leading to NICE recommending the drug as a cost-effective end-of-life treatment, has not been disclosed. 


“Regorafenib is an important treatment option to extend the lives of people with previously treated advanced hepatocellular carcinoma after they’ve already been prescribed sorafenib,” said Meindert Boysen, director for the NICE Centre for Health Technology Evaluation, in a Nov. 29, 2018 press release. “We are pleased that the company has responded by seeking a rapid review of our original guidance and offered a price that allows us to conclude that the drug is cost-effective for routine use on the NHS in England and Wales.”

“Hepatocellular carcinoma (HCC) is the most common form of liver cancer. It is particularly aggressive with the five-year survival rate being on average only 12% and a diagnosis is therefore devastating for the patient and their families,” added Judi Rhys, chief executive of the British Liver Trust. “There are also very few effective treatments so the decision to approve regorafenib for routine use in England and Wales is a welcome step forward. Access to the drug will potentially provide patients with valuable extra time with their loved ones.”

Source: NICE