COVID-19: Pembrolizumab and nivolumab - Temporary removal of specified dose regimen and radiological monitoring requirements
March 31, 2020
Immune checkpoint inhibitors (ICI), nivolumab and pembrolizumab, have been funded since 2016 to treat advanced melanoma.
Removal of specified dose regimen and radiological monitoring requirements
PHARMAC has removed the specification of dose regimen and radiological monitoring from the Special Authority criteria for funded nivolumab and pembrolizumab.
These changes come into effect in the Pharmaceutical Schedule on 1 April 2020. Patients with current approvals can be changed to alternate dose schedules or monitoring at any time.
This change includes:
- Sections B and H of the Schedule
- initial and renewal criteria.
This means that all patients can be administered treatment at fixed doses and extended intervals. Also, disease response monitoring no longer requires CT or MRI scanning.
We are keeping the requirement to stop treatment at signs of disease progression and retaining reference to the RECIST criteria (which has provision for non-radiologic monitoring).
Reducing pressure on the health system
We're making these changes to support the DHBs while New Zealand is responding to COVID-19. These changes help ensure patients still receive the medicine they need while:
- reducing clinic contact time
- supporting isolation principles as much as possible
- freeing up resources across clinical staffing, infusion centres and pharmacy.
We intend to change the criteria back to the current status once health services have stabilised to a point where it becomes practical.
Who to contact
If you have questions about this change, email enquiry@pharmac.govt.nz