Roche’s Alecensa has won NICE backing as a treatment for a rare type of lung cancer, over-turning a prior decision to reject NHS funding for the drug.
In draft guidelines, the Institute is now endorsing the drug, within its marketing authorisation, as an option for untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), which affects around 925 people in England.
“This is welcome news for clinicians and patients,” said Dr Riyaz Shah, consultant medical oncologist, commenting on the decision.
“ALK-positive NSCLC is a rare type of lung cancer that predominantly affects younger people, non-smokers and has a propensity to spread into the brain.
“Alectinib has demonstrated substantial improvements in delaying cancer growth in these patients. It has also shown significant improvements in preventing and delaying cancer spread into the brain.”
The recommendation comes as a result of an ongoing clinical trial that has shown Alecensa (alectinib) is more effective in delaying disease progression, by around 15 months more, than the current standard of care, crizotinib, NICE said.
The committee concluded that the most plausible instrumental cost effectiveness estimate (ICER) for Alecensa compared with crizotinib in people with untreated ALK-positive advanced NSCLC was between £20,000 and £30,000 per QALY gained.
However, NICE’s recommendation is also contingent upon Roche providing the drug at the commercial discount agreed in the patient access scheme.
Alecensa 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.
Prior to this approval, Roche provided Alecensa via the UK’s Early Access to Medicines Scheme (EAMS), which allows patients access to promising new unlicensed medicines that have a high unmet clinical need before official approval is obtained.
“We are delighted that patients with this rare type of lung cancer will have access to alectinib via the NHS,” said Simon Eayrs, Cancer Immunotherapy lead for Roche UK.