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New HTA Decisions in England
May 2020
Drug name
LORVIQUA® (lorlatinib)
Decision date
Therapeutic area
Therapeutic sub area
Lung cancer
As an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults whose disease has progressed after: alectinib or ceritinib as the first ALK tyrosine kinase inhibitor, or crizotinib and at least 1 other ALK tyrosine kinase inhibitor.
Decision Detail
It is recommended only if the company provides lorlatinib according to the commercial arrangement. The company has a commercial arrangement (simple discount patient access scheme).
The main clinical evidence for lorlatinib came from study 1001, a single-arm, open-label, multicentre phase 1 to 2 trial, done in 13 countries but not in the UK. This study investigated the effect of lorlatinib in adults with metastatic (stage 4) ALK-positive NSCLC. The primary outcome of study 1001 was objective response rate. Secondary outcomes included overall survival and progression‑free survival. The results showed an objective response rate of 40.3% (95% confidence interval [CI] 32.1 to 48.9) with lorlatinib. The results also showed a progression-free survival of 6.9 months (95% CI 5.4 to 8.2) and a median overall survival of 20.4 months (95% CI 16.1 to not reached). Lorlatinib, has not been compared directly with other drugs. However, analyses indirectly comparing lorlatinib with PDC (platinum doublet chemotherapy) and ABCP (atezolizumab with bevacizumab, carboplatin and paclitaxel) suggest that people who take lorlatinib: have longer before their disease progresses and may live longer than people who take PDC; have longer before their disease progresses and may live longer than people who take ABCP. Lorlatinib meets NICE's criteria to be considered a life-extending treatment at the end of life. Although the methods and results of the cost-effectiveness modelling are uncertain, the most likely cost-effectiveness estimates are within what NICE normally considers an acceptable use of NHS resources. Therefore, lorlatinib is recommended. Because lorlatinib and the comparators have commercial arrangements, the exact ICERs are confidential and cannot be reported here.