PHARMAC to amend Special Authority criteria for PD-1 inhibitor re-treatment for melanoma patients
October 6, 2019
PHARMAC are currently looking to progress amendment to the Special Authority criteria for both pembrolizumab and nivolumab for advanced melanoma to allow patients who have stopped treatment for reasons other than disease progression or toxicity to recommence funded treatment upon signs of disease progression.
Under the current Special Authority criteria patients with signs of disease progression would not be eligible for ongoing funded treatment as they would not meet the current renewal criteria which require no signs of disease progression, whether treatment was continuous or not.
As this amendment to the Pharmaceutical Schedule will take time to implement and public consultation is required, an interim approval pathway has been put in place.
Clinicians need to manually complete the relevant Special Authority form indicating clearly which criteria are and are not met, noting that the reason for the waiver application is for retreatment. Type of previous response, length of previous treatment, length of treatment holiday should also be noted.