A proposal by NHS cost regulators to no longer back the second-line use of Tarceva (erlotinib) to treat relapsed non-small cell lung cancer has angered the drug's manufacturer Roche and will no doubt come as a shock to patients.

Following a review of existing guidance the National Institute for Health and Care Excellence (NICE) has decided that treatment with Tarceva after first-line therapy has failed is no longer a cost-effective option for the NHS.

According to Roche, the move means that more than a thousand patients in England and Wales every year will be at risk from being left without an active second-line treatment option.

Clinicians use Tarceva to treat 60% of patients receiving active anticancer therapy for relapsed NSCLC, but NICE's latest stance would only allows access to the chemotherapy docetaxel, which, as Roche points out, many patients are simply too sick to tolerate. 

Because of this, those less fit patients would be left with no active treatment option to fight their cancer, going against NHS England’s policy that no patient will be without access to cancer treatment, it argues.

And in another stark illustration of the postcode lottery of health, these patients would be unable to access Tarveca in this setting while their counterparts in Scotland and indeed the rest of Europe continue to benefit from it.

"It seems perverse that this NICE guidance will limit the treatment options available to only docetaxel, given that the independent evidence review shows the total NHS treatment costs of docetaxel to be higher than those of erlotinib," says Mick Peake, Consultant Physician at the University Hospitals of Leicester NHS Trust and Clinical Lead, National Cancer Intelligence Network, (NCIN). 

"This difference arises because docetaxel needs to be given intravenously in hospital, whereas erlotinib is an oral treatment taken at home, [and] the cost of managing treatment side effects is also greater," he said.

Change in practice

However, explaining its decision, NICE said clinical practice has changed since its original guidance so that patients with NSCLC are now tested for an EGFR-TK mutation at diagnosis, which helps determine their most appropriate first-line therapy.

The Institute has already recommended Tarceva and AstraZeneca's Iressa (gefitinib) as first-line treatments in the EGFR-TK mutation-positive population. 

But its independent committee heard from clinical specialists that in clinical practice, where this group of patients have received Tarceva and Iressa as first-line treatment, "it is unlikely that they would be re-treated with a EGFR-TK inhibitor as part of second-line treatment because of reduced sensitivity of the tumour to these drugs".