Osimertinib (Tagrisso®) for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) with an epidermal growth factor receptor (EGFR) mutation (reassessment)

The Minister of Medical Care has requested Zorginstituut Nederland to reassess whether osimertinib (Tagrisso®) for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) with an epidermal growth factor receptor (EGFR) mutation, should continue to be included in the insured package. The basis of the request is the availability of additional evidence from the FLAURA study, the study on which the earlier assessment of 2018 was based. The Zorginstituut advises the Minister to continue the inclusion of osimertinib in the package, following successful price negotiations where the price of osimertinib should drop by about 35% to be cost effective.

Background

In the package advice of 7 November 2018, the Zorginstituut advised the Minister not to include osimertinib in the health insurance package, unless a cost-effective use of osimertinib could be achieved through price negotiation. The negotiations were completed at the end of 2019 and since the beginning of 2020, the treatment has been part of the insured package. The Zorginstituut also advised the Minister to have a new assessment carried out if more evidence becomes available.

Zorginstuut's advice

The Zorginstituut assessed osimertinib based on the four package criteria:

  • effectiveness;
  • cost-effectiveness;
  • necessity;
  • feasibility.

Osimertinib is still considered the preferred treatment option, despite the fact that some new treatment options have become available for the mentioned indication. On this basis, the Zorginstituut sees no reason for a reassessment of the therapeutic value of osimertinib. The Zorginstituut confirms the conclusion that osimertinib complies with the legal criterion 'established medical science and medical practice' for the above indication. However, the price of the treatment is too high for a cost-effective use. The Zorginstituut advises the Minister to continue the inclusion of osimertinib in the package following successful price negotiations where the price of osimertinib should drop by about 35%.

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