NICE Halts Second-Line Use of Tarceva

NICE Halts Second-Line Use of TarcevaNHS cost regulatory body, NICE, have today published updated draft guidance, proposing to stop backing the second-line use of Tarceva (erlotinib) to treat relapsed non-small cell lung cancer (NSCLC).

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

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

Tarceva is used to treat 60% of patients receiving active anticancer therapy for relapsed NSCLC, but the regulatory affairs body’s latest stance would only permit access to docetaxel, which, as Roche noted, many patients are simply too sick to tolerate.

Roche has argued that this means that those less fit patients would be left with no active treatment option to fight cancer, going against NHS England’s policy that no patient will be without access to cancer treatment.

“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,” Mick Peake, Consultant Physician at the University Hospitals of Leicester NHS Trust and Clinical Lead, National Cancer Intelligence Network, (NCIN), commented in a statement published by Roche.

“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,” Peake added.

Change in practice

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

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

But NICE’s 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 an EGFR-TK inhibitor as part of second-line treatment because of reduced sensitivity of the tumour to these drugs.”

The updated guidance is out for consultation until February 24th 2014, and will be finalised in June this year.

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