Adults in England with advanced lung cancer will not have access to a new targeted cancer drug, lorlatinib (Lorviqua).
The National Institute for Health and Care Excellence (NICE) provisionally rejected lorlatinib because it couldn’t be confident the drug offers significant benefits over existing treatment options. This meant they couldn’t be certain the drug would be a good use of NHS resources.
A final decision is expected later this year, after the drug’s manufacturer has had an opportunity to provide additional data on the drug’s benefits or offer a new price.
Lorlatinib would provide a new treatment option for adults with the most common type of lung cancer, non small cell lung cancer, whose tumours test positive for a fault in the ALK gene.
It’s used to treat people whose disease has progressed after treatment with other targeted drugs such as crizotinib, alectinib or ceritinib.
Rose Gray, policy manager at Cancer Research UK, said the decision will be “hugely disappointing” for people with this type of lung cancer.
“Clinicians told NICE this drug could give patients longer before starting chemotherapy, as well as improving people’s quality of life.”
If approved, lorlatinib would replace chemotherapy-containing treatments that are used once someone’s lung cancer has progressed.
NICE looked at clinical trial data from 139 patients who most closely matched the patients the drug would be used to treat in the NHS. Of these 139 people, around 4 in 10 responded to the treatment and they lived for an average of 20.4 months.
But the targeted treatment has not been tested against existing chemotherapy-based treatments during trials.
Indirect comparisons suggest lorlatinib increases the time before tumours get bigger compared to chemotherapy. And it may improve overall survival compared to one of the two main possible chemotherapy-based combination treatments.
Clinical experts also claimed lorlatinib could be more effective than chemotherapy in treating secondary tumours growing in the brain (metastases), which appear in around 1 in 2 people with this type of lung cancer.
But these comparisons were deemed highly uncertain and there were concerns about the quality of the data. This made comparing the benefits of the different treatment options very difficult.
NICE said this uncertainty, like the limited clinical trial data, meant they couldn’t be confident lorlatinib would be cost effective on the NHS.
And because the clinical trials testing the drug are now complete and not expected to produce any new evidence on the drug’s benefits, NICE couldn’t recommend lorlatinib for the Cancer Drugs Fund either. The Cancer Drugs Fund pays for promising new drugs while more evidence is collected on their benefits.
“This makes it crucial NICE, NHS England and the drug’s manufacturer continue to work together before this decision is reviewed later this year, so patients have the best chance of accessing the drug as quickly as possible,” says Gray.
NICE decisions are usually adopted in Wales and Northern Ireland as well as England, so the decision is likely to affect patients in all three nations. Scotland has a separate process for reviewing drugs.
NICE (2020) Lorlatinib for treating ALK-positive advanced non-small-cell lung cancer [ID1338]