IQWiG Dossier Assessment Shows No Added Benefit of Ceritinib (Zykadia) in NSCLC

IQWiG Dossier Assessment Shows No Added Benefit of Ceritinib (Zykadia) in NSCLC

A new report from one of Germany’s public health agencies is shedding new light on an approved therapy often used in the treatment of non-small cell lung cancer.

Ceritinib (Zykadia) was approved in May of this year as a treatment for adults with non-small cell lung cancer (NSCLC). The drug is a secondary treatment option for patients who have already been treated with crizotinib and an option for when certain alterations in tumor cells (anaplastic lymphoma kinase-positive) incite tumor growth.

The German Institute for Quality and Efficiency in Health Care (IQWiG) recently conducted a dossier assessment of the added benefit of the drug in comparison with standard, appropriate therapy. However, the IQWiG noted that an additional advantage of the drug as providing an added benefit cannot be confirmed from the dossier, since in the dossier there was no data appropriate for the evaluation.

The Federal Joint Committee (G-BA) has recently identified two clinical research interrogations: the comparison of ceritinib as an add-on therapy for patients who are elgible to be treated with either pemetrexed or docetaxel. In patients with NSCLC who are not elgible to be treated with chemotherapy, the G-BA stipulated best supportive care (BSC) as proper comparator treatment.

Since there is a lack of evidence comparing ceritinib against chemotherapy, the manufacturer of the drug noted distinctive unadjusted historical comparisons, however, these were not assessed in the recent dossier due to the fact that different groups of patients were studied (those NSCLC patients that received treatment with crizotinib and those crizotinib-naive NSCLC patients). Furthermore, the G-BA was not able to confirm that the data regarding overall survival was in fact collected through testing ceritinib.

Nevertheless, historical comparisons are known for their low result certainty, which is why differential results need to achieve a particular magnitude to be considered reliable. The results from the comparisons reported in the dossier assessment revealed small differences regarding ceritinib as an add-on, which shows that systematic bias may exist.

The dossier evaluation is part of the early benefit evaluation according to the Act on the Reform of the Market for Medicinal Products (AMNOG) managed by the G-BA. Following publication of the dossier assessment, the G-BA performs a noting process and does its final assessment on the magnitude of the added benefit.

There was no data available for the BSC comparison, so conclusions cannot be drawn regarding the added benefit of ceritinib.

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