Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Castration resistant non-metastatic carcinoma of the prostate

The condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition; AND

The condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug; AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND

Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND

Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or

Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND

Patient must be undergoing concurrent treatment with androgen deprivation therapy; AND

Must be treated by a medical practitioner; or

Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.

Prescribing instructions:

Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient's medical records - do not submit copies of these with this authority application.

The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading.