NICE approves Bayer’s liver cancer drug

NICE has given Bayer’s advanced liver cancer therapy Stivarga (regorafenib) the go-ahead after it undertook a rapid review following earlier guidance that rejected the drug.

The medicine is for adults in England and Wales whose liver is well functioning but unable to be surgically removed and who have already taken Bayer’s life extending medicine Nexavar (sorafenib).

In March this year, the National Institute for Health and Care Excellence (NICE) found that regorafenib was less cost-effective than treatments it usually considers are an acceptable use of resources for end-of-life care.

But it reversed its decision after a new commercial arrangement made regorafenib available to the NHS at a confidential, lower price.

Regorafenib is an oral multi-kinase inhibitor that blocks multiple protein kinases involved in tumour angiogenesis. It slows down the growth and spread of cancer cells by cutting off their blood supply.

Clinical evidence demonstrated that those treated with sorafenib, and who have good performance status and less severe liver impairment, live longer with regorafenib than patients having supportive care.

There was an overall survival (OS) of 2.8 months compared to placebo – 10.6 months versus 7.8 months.

Meindert Boysen, director for the NICE Centre for Health Technology Evaluation, said: “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.

“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.”

This is hopeful news for patients, especially as around 15 people are diagnosed with liver cancer every day, according to the British Liver Trust.

Judi Rhys, chief executive of the British Liver Trust, said: “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.

“Access to the drug will potentially provide patients with valuable extra time with their loved ones.”

Earlier this month, the European Commission approved Ipsen’s Cabometyx (cabozantinib) as a second line therapy for patients who had been treated with Nexavar.

Cabometyx can be used as a second line monotherapy for hepatocellular carcinoma, giving patients another treatment option, as the only medicine previously available after Nexavar was Stivarga.