Position of the National Health Care Institute on nivolumab (Opdivo®) for the treatment of dMMR- of MSI tumors
The National Health Care Institute informs the Minister of Medical Care about its position regarding the application of nivolumab (Opdivo®). Nivolumab is indicated for the treatment of certain patients with locally advanced or metastatic solid tumours that are deficient in mismatch repair (dMMR) or show microsatellite instability (MSI). We conclude that this application of nivolumab meets the established medical science and medical practice. This treatment is therefore one of the benefits to be insured under the Dutch Health Insurance Act (Zvw).
Registered indication
Nivolumab is indicated for the treatment of adult patients with locally advanced or metastatic solid tumours that are deficient in mismatch repair (dMMR) or show microsatellite instability (MSI) and that have failed to respond to the standard treatment(s) or where no standard treatment exists or is indicated.
Special assessment
In 2016, the Drug Rediscovery Protocol (DRUP) study was set up by Dutch oncologists. In this study registered medicinal products are off-label applied in different cancers but with the same sites of action. In the meantime, the data collection for one of the cohorts has been finalised and the question arises whether the medicinal product in the relevant patient population complies with the established medical science and medical practice.
This is the completed DRUP cohort of patients treated with nivolumab with dMMR or MSI tumours. A request has been made to the National Health Care Institute by the health insurers and oncologists for the assessment of this application of nivolumab. In view of the special situation, the National Health Care Institute carries out this assessment in the context of risk-oriented package management in the form of a pilot.
Conclusion
The application of nivolumab in adult patients with locally advanced or metastasized solid tumours that are deficient in mismatch repair (dMMR) or show microsatellite instability (MSI) and have failed to respond to the standard treatment(s) or where no standard treatment exists or is indicated, meets the established medical science and medical practice and is thus an insurable benefit.
By now, a registered and good immune therapy (pembrolizumab) has become available in the first line for patients with colorectal carcinoma (about 50% of the DRUP screening population). In practice, this patient group will not be eligible for the last line treatment with nivolumab. Therefore, the number of patients with MSI status who have not yet had mmune therapy in the last line of the metastatic setting is not expected to be large.