1.  The whole of this instrument

1 October 2022

1 October 2022

SW

sanofi‑aventis Australia Pty Ltd

31 008 558 807

C13290

P13290

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy - Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 13290

C13303

P13303

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy - Grandfathering treatment
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 October 2022; AND
Patient must have received first-line platinum-based chemotherapy prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease following first-line platinum-based chemotherapy; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures - Streamlined Authority Code 13303

C13313

P13313

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy - Initial treatment
Patient must have received first-line platinum-based chemotherapy; AND
Patient must not have progressive disease following first-line platinum-based chemotherapy; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 13313

C13280

P13280

Advanced or metastatic gastro-oesophageal cancers
The condition must be a gastro-oesophageal cancer type as specified in the drug's 'Indications' section of the approved Australian Product Information; AND
The treatment must be prescribed in accordance with the drug's 'Indications' section of the approved Australian Production Information with respect to each of: (i) concomitant drugs/therapies, (ii) line of therapy (i.e. prior treatments, if any); AND
Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1.
Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.

Compliance with Authority Required procedures - Streamlined Authority Code 13280

C9894

P9894

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 9894

C9921

P9921

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Initial treatment
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy; OR
The condition must have progressed on or within 12 months of completion of adjuvant platinum‑containing chemotherapy following cystectomy for localised muscle‑invasive urothelial cancer; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum‑containing chemotherapy prior to cystectomy for localised muscle‑invasive urothelial cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must not exceed a total of 7 doses under this restriction.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 9921

C13278

P13278

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Initial treatment
The condition must be incurable by local therapies in the locally advanced setting; AND
Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating PBS-subsidised treatment with this drug for this condition; AND
Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if previously treated in the locally advanced setting; AND
Patient must have had a WHO performance status of 0 or 1; AND
The treatment must be either: (i) the sole PBS-subsidised therapy where the condition expresses programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND
The treatment must not exceed a total of 7 doses under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 13278

C13279

P13279

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a total of 35 doses or up to 24 months of combined initial and continuing treatment in a lifetime for this condition whichever comes first.

Compliance with Authority Required procedures - Streamlined Authority Code 13279

C13289

P13289

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 13289

C13296

P13296

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy; OR
The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must not exceed a total of 7 doses under this restriction; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 13296

C13316

P13316

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2022; AND
Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if treated in the locally advanced setting prior to non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must have been initiated as non-PBS-subsidised therapy as either: (i) the sole therapy where the condition expressed programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 doses, or up to 24 months, of combined non-PBS-subsidised and PBS-subsidised treatment under the Grandfather and Continuing treatment restrictions in a lifetime.

Compliance with Authority Required procedures - Streamlined Authority Code 13316