IQWiG is tentatively saying yes to Boehringer’s oncology drug Vargatef (nintedanib) in new guidance released this week.
The German health technology assessor says the treatment can be used in combination with chemotherapy agent docetaxel for patients with advanced non-small cell lung cancer (NSCLC) of the glandular tissue (adenocarcinoma), who have already received chemotherapy.
The German Institute for Quality and Efficiency in Health Care (IQWiG) said in its assessment of the drug that there is an “indication of a minor added benefit” of Vargatef in combination with docetaxel in patients without brain metastases.
However, in patients with brain metastases, the new drug has more disadvantages than chemotherapy with docetaxel alone. This results in a hint of a lesser benefit of nintedanib with the extent “considerable”.
Patients without brain metastases who received Vargatef in combination with docetaxel lived longer than study participants who were only treated with docetaxel (median: 13.5 versus 10.3 months). This results in an indication of a minor added benefit of the drug.
Although diarrhoea was more frequent in patients receiving the drug, this disadvantage does not challenge the survival advantage. Therefore, overall an indication remains of a minor added benefit for patients without brain metastases.
If patients who already had brain metastases at the start of the study were treated with the treatment, loss of appetite occurred more often and the symptoms nausea and vomiting, as well as diarrhoea, worsened during treatment.
These disadvantages result in a hint of a lesser benefit of Boehringer’s drug in patients with brain metastases, according to IQWiG.
But the body is still happy to recommend the treatment to the final stage of assessment, which will come from the G-BA in the coming months.