Two targeted lung cancer drugs get initial ‘no’ for NHS in England

Patients with a certain type of lung cancer will not have access to two targeted cancer drugs on the NHS in England.

The two drugs – dacomitinib (Vizimpro) and osimertinib (Tagrisso) – were each being considered as initial treatments for patients whose non small cell lung cancer had begun to spread to other parts of the body. Patients’ cancers cells would also need to test positive for a certain molecule, called EGFR. 

But due to uncertainties around long-term outcomes and comparisons with existing drugs, the National Institute for Health and Care Excellence (NICE) judged neither drug offers good value for money for the NHS. 

Rose Gray, policy manager at Cancer Research UK, said the decisions will be disappointing for people with this type of non small cell lung cancer. 

“In both cases, clinical trial evidence suggests these drugs could offer patients more time before their disease gets worse compared to some existing treatment options, and potentially even extend their lives – though NICE felt there wasn’t enough evidence to be confident about any possible survival benefit.” 

A tale of two drugs

Dacomitinib and osimertinib are both targeted cancer drugs that block the growth signals delivered to cells via a molecule called EGFR. By blocking these signals the drugs are designed to stop cancer cells from growing and dividing so quickly. 

Both drugs target the same molecule as existing treatments for patients whose lung cancer cells test positive for EGFR, afatinib (Giotrif), erlotinib (Tarceva) or gefitinib (Iressa). 

And the treatments have been tested in clinical trials involving patients whose cancer has at least one fault in the EGFR molecule. 

In a trial involving 452 patients with non small cell lung cancer that had spread to other parts of the body, taking dacomitinib increased the time before patient’s cancer got worse compared to those taking gefitinib.

Patients taking dacomitinib were alive for an average of 14.7 months without their cancer getting worse, compared to 9.2 months for those taking gefinitib. Dacomitinib also increased overall survival, with patients taking the drug living for an average of 34.1 months, compared to 26.8 months for those taking gefitinib. 

But serious side effects were more common in the group taking the new targeted drug, with 9 in 100 patients taking dacomitinib experiencing severe side effects compared with 4 in 100 patients taking gefinitib.

Osimertinib was tested in a trial involving 556 patients with advanced non small cell lung cancer. Taking osimertinib was found to extend the time before patient’s cancer got worse compared to those taking gefitinib or elotinib. 

Patients taking osimertinib were alive for an average of 18.9 months without their cancer getting worse, compared to 10.2 months for those taking existing treatments. But the trial has not been running for long enough to know how much the drug will improve long-term survival for these patients.

Unlike with dacomitinib, serious side effects were less common for those taking osimertinib than those taking the existing standard-of-care drugs.

The lowdown on the latest decisions

While the drugs are being developed for the same group of patients, the reasons the NICE committee gave for the draft rejections differed for each of the two treatments.

For dacomitinib, clinical trials have not compared it to afatanib, which the committee felt was the most suitable and widely-used alternative. And based on the data provided, NICE concluded that patients taking dacomitinib wouldn’t see significant additional benefits compared with afatanib in either the short or the long-run. 

The committee therefore concluded that the price of dacomitinib put it above the threshold for cost-effectiveness and couldn’t be approved for routine use on the NHS. 

Osimertinib is already available on the NHS to treat some patients with non small cell lung cancer if initial treatments have failed, but only if their cancer carries a specific fault in the EGFR molecule. This week’s decision was looking at whether all patients whose disease tests positive for the EGFR molecule should be able to have it as the first treatment they receive.

The committee concluded there wasn’t enough evidence around the long-term benefits the drug offers patients to make the treatment cost effective. And, like dacomitinib, trials of osimertinib have not compared it to the standard-of-care drug afatanib.

NICE also noted that trials testing osimertinib included patients who are likely to be in better health than the patients who would be treated in the NHS. Considering all these factors together, they concluded that the treatment would not be cost-effective on the NHS. 

Gray urged NICE, NHS England and the drugs’ manufacturers to work together before NICE reviews these decisions next month to explore how the drugs can be made available to NHS patients.