NICE no for Roche’s Alecensa

The National Institute for Health and Care Excellence has turned down NHS funding for Roche’s Alecensa as a first-line treatment for lung cancer.

In draft guidelines, the Institute rejected the drug for untreated ALK-positive advanced non-small-cell lung cancer (NSCLC) in adults.

Alecensa (alectinib) was approved in Europe in this setting last December after Phase III data showed median progression-free survival of 25.7 months for people given the drug compared with 10.4 months for those taking crizotinib, the current standard of care.

The findings also showed that Alecensa slashed the risk of tumours spreading to, or growing in the brain or central nervous system (CNS) compared to crizotinib by 84 percent. Around 60 percent of patients will develop metastases in the central nervous system.

However, NICE noted that the while the current evidence suggests that Alecensa is more effective than crizotinib at delaying disease progression, it is not yet certain whether Roche’s drug prolongs survival.

It also voiced concerns over some of the assumptions used in the cost-effectiveness modelling, including on drug waste, the types of treatments that people receive after disease progression, and the types of care used to manage disease progression in the central nervous system.

Based on the most plausible assumptions, cost-effectiveness estimates for Alecensa versus crizotinib came in above the range that the committee considered to be cost-effective for the NHS, NICE said.

Roche has previously noted that most patients with ALK-positive NSCLC develop resistance to the current standard of care within one year of treatment, and around 60 percent will develop metastases in the central nervous system, highlighting the need for new treatment options.

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