Package advice on entrectinib (Rozlytrek®) for the treatment of ROS1 fusion-positive advanced non-small cell lung cancer

Zorginstituut Nederland has completed its assessment whether entrectinib (Rozlytrek®) can be included in the insured package. Entrectinib is indicated as monotherapy for the treatment of adult patients with ROS1 fusion-positive advanced non-small cell lung cancer (NSCLC). The reason for this advice was the placing of this medicinal product in the so-called lock procedure or ‘sluice’ for expensive medications.The Zorginstituut advises the Minister not to include entrectinib in the insured package.

Registered indication

Entrectinib is indicated as monotherapy for the treatment of adult patients with ROS1 fusion-positive advanced non-small cell lung cancer (NSCLC) who have not previously been treated with ROS1 inhibitors.

Zorginstuut's advice

Based on the considerations mentioned in the report, the Zorginstituut concludes that entrectinib as monotherapy for the treatment of the indicated patient group does not yet conform to established medical science and medical practice, due to insufficient evidence. Therefore the Zorginstituut advices the minister not to include entrectinib in the basic insured package.

Entrectinib for this indication also does not meet the criteria for eligibility for the conditional inclusion of orphan drugs, conditionals and exceptionals.

This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.