Erlotinib for the treatment of non-small cell lung cancer

The UK equivalent of the FDA (the National Institute for Health and Clinical Excellence - NICE) has recommended erlotinib, an epidermal growth factor receptor inhibitor, as an alternative to docetaxel as a second-line treatment option for patients with non-small-cell lung cancer (NSCLC) provided the manufacturer (Roche) supplies erlotinib at a discounted and equivalent price to docetaxel. A Special Report in The Lancet Oncology published early Online reports on the evidence considered during this final approval process.

NICE had previously ruled against recommending the drug and after considering some quality of life issues such as the oral administration of erlotinib and the reduced risk of toxicities such as febrile neutropenia, the NICE Committee concluded that these additional benefits were not sufficient to consider erlotinib cost-effective compared with docetaxel. However, after Roche proposed a scheme to equalise costs between the two treatments, the Committee recommended approval for patients as an alternative second-line treatment: “The recommendation was made on the condition that the manufacturer provides erlotinib at an overall treatment cost (including administration, adverse events, and monitoring costs) equal to that of docetaxel”, state the authors of the Special Report. This is the latest example of NICE and manufacturers collaborating to reduce drug costs within the NHS.

NICE guidance now reads: “Erlotinib is recommended as an alternative to docetaxel for patients with non-small-cell lung cancer (NSCLC) who have already tried one chemotherapy regimen but it has not worked. Erlotinib should be used only when the manufacturer provides the drug at the same overall treatment cost as docetaxel. This cost includes the cost of giving the drug, treatments for any side effects and the cost of monitoring patients to check that treatment is working. If the overall treatment cost is equal, specialists should discuss with patients the potential benefits and risks of erlotinib and docetaxel before deciding which treatment to use. Erlotinib is not recommended for people with locally advanced or metastatic NSCLC who cannot take docetaxel and have already tried one chemotherapy regimen but it has not worked. Erlotinib is not recommended for people who have already tried two chemotherapy regimens, including docetaxel, but they haven't worked. Healthcare professionals should not stop prescribing erlotinib for people who were already taking it when the guidance was issued. These patients should be able to carry on taking erlotinib until they and their specialist decide that it is the right time to stop treatment.”

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