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

Urothelial carcinoma

Initial treatment - neoadjuvant setting

Patient must be initiating treatment with this drug for this condition; or

Patient must be transitioning from non-PBS to PBS-subsidised treatment with this drug for this condition; AND

The condition must not have previously been treated with systemic therapy for muscle-invasive bladder cancer at the time this drug was initiated for this condition; AND

The treatment must be once in a lifetime with this drug for this condition; AND

The condition must be of muscle-invasive type disease with both: (i) clinical tumour stage of either T2, T3 or T4a, (ii) nodal status of up to stage N1; AND

The treatment must be for neoadjuvant use in a patient preparing for radical cystectomy; AND

Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND

The treatment must be/have been initiated with both: (i) gemcitabine, (ii) cisplatin (refer to Product Information of gemcitabine and cisplatin for dosing information); AND

Patient must not be undergoing PBS-subsidised treatment where this prescription extends treatment beyond whichever comes first: (i) 4 cycles from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease progression recurrence despite treatment with this drug, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.

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

Urothelial carcinoma

Continuing treatment - adjuvant setting

Patient must have previously received PBS-subsidised neoadjuvant treatment with this drug in combination with gemcitabine plus cisplatin for this condition; or

Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised treatment with this drug for this condition, (ii) previously treated in combination with cisplatin and gemcitabine as neoadjuvant treatment for this condition; AND

Patient must have undergone radical cystectomy; AND

The treatment must be for adjuvant therapy that is/was initiated within 6 months of radical cystectomy for this condition; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND

Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) maximum of 8 cycles for this condition from the first administered dose following radical cystectomy, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.

Treatment with this drug for this condition must not exceed 12 treatment cycles (neoadjuvant and adjuvant) in a lifetime.