Bayer’s Stivarga wins NICE approval for GIST

Bayer’s Stivarga has been recommended by the National Institute for Health and Care Excellence as a treatment for some patients with gastrointestinal stromal tumours (GIST).

Specifically, the cost watchdog has ruled that the treatment can be routinely funded on the NHS to treat unresectable or metastatic GIST in adults whose disease has progressed on, or who are intolerant to, prior treatment with imatinib and sunitinib.

NICE also stipulates that the recommendation only stands if patients have an Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1, and the company provides Stivarga (regorafenib) with the discount agreed in the confidential patient access scheme.

Current treatment for patients in this setting is best supportive care (BSC). NICE says evidence shows that people treated with Stivarga have longer before their disease progresses compared with those having BSC, but also that there is "some uncertainty" around how long regorafenib increases the overall length of time people live.

In any case, the drug meets the criteria to be considered a life-extending end-of-life treatment, and with a most plausible cost-effectiveness estimate of around £44,000 per quality-adjusted life year gained, can be recommended for use in the NHS, the Institute noted.

The decision came just days after Stivarga was rejected by NICE for certain patients with advanced unresectable hepatocellular carcinoma in draft guidelines.