Roche’s Tarceva (erlotinib) has been recommended in final guidance as a first-line option for people with EGFR mutation-positive non-small-cell lung cancer (NSCLC).

NICE’s independent Appraisal Committee concluded the treatment was a clinical and cost effective use of NHS resources, when supplied under an agreed Patient Access Scheme.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the Institute was “pleased to be able to recommend another treatment option for this stage of the disease.”

As part of the appraisal, the Committee discussed the results from the updated analysis comparing Tarceva with Iressa. On balance, the Committee concluded, the sums of money either spent or saved are small given the uncertainties associated with the data.

Therefore, when supplied under the Patient Access Scheme, Tarceva is recommended as an option with patients who have locally advanced or metastatic EGFR-TK mutation-positive NSCLC.

Roche’s Tarceva (erlotinib) has been recommended in final draft guidance as a first-line option for people with EGFR mutation-positive non-small-cell lung cancer (NSCLC).

The decision comes after Roche provided NICE with additional data on the clinical and cost effectiveness of Tarceva when supplied under an agreed Patient Access Scheme (PAS).

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the health regulator is “pleased to recommend another treatment” for NSCLC.

NICE recently recommended Iressa (gefitinib) as a first-line treatment for NSCLC. Roche were unable to provide any clinical data comparing Tarceva with Iressa, but specialists confirmed the two were similar and equally effective.

Tarceva and Iressa work differently to chemotherapy. The oral treatments are known as “target agents” due to the way they block certain processes in the cancer cells.

Data supplied by Roche showed Tarceva showed longer progression-free survival and similar overall survival compared with current treatment options. It expects that NICE’s recommendation will benefit approximately 11% of patients with NSCLC.

The PAS agreed between Roche and the DH may mean that Tarceva is supplied to the NHS free of charge in certain circumstances. Tarceva will be made available at a single cost of £12,200 per patient irrespective of the duration of treatment. However, Roche will only invoice the health service after the third monthly pack of Tarceva is supplied. Any patients who receive only one or two months of treatment will receive the drug without the NHS being charged.

NICE has requested further data on Tarceva (erlotinib) from Roche for the first-line treatment of locally advanced or metastatic EFGR mutation-positive non-small-cell lung cancer (NSCLC) in new draft guidance.

Roche failed to provide evidence on Tarceva’s clinical and cost effectiveness when compared to Iressa (gefitinib), NICE’s Appraisal Committee said.

Sir Andrew Dillon, NICE Chief Executive, said the data provided by Roche was not sufficient to compare Tarceva with a recommended option but hoped further information would be supplied.

The Committee has now asked Roche for an updated cost effectiveness analysis of Tarceva compared with Iressa with different progression-free survival and utility assumptions. Further sensitivity analyses on the cost of Tarceva changes depending on how many patients are able to continue taking the drug and Iressa after 60 days of treatment – the point at which the NHS currently has to start paying for Iressa under its agreed Patient Access Scheme – are also required.

“When it was asked to consider Tarceva, our independent advisory committee concluded that it did not have enough information to be able to make the decision to recommend or not recommend it for routine use in the NHS as an alternative to gefitinib,” said Sir Andrew. “It has therefore asked the manufacturer provide further analyses. We hope that Roche will be able to provide this additional information so that the Committee can consider it at its next meeting on the topic.”

The SMC recently approved the use of Tarceva as a first-line treatment for NSCLC. Lung cancer, after breast cancer, is the second most common cancer in England and Wales, with an estimated 40,800 newly diagnosed cases each year.