1.  The whole of this instrument

1 August 2024

1 August 2024

Injection 25 mg (as hydrochloride) in 12.5 mL

Injection

Onkotrone

P15471

360 mg

2

Atezolizumab

Solution for subcutaneous injection 1875 mg in 15 mL

Injection

Tecentriq SC

C10125 C10206 C10216 C10297 C10521 C10939 C13443 C13448 C15455

P10206 P10939

1

3

C10125 C10206 C10216 C10297 C10521 C10939 C13443 C13448 C15455

P10521

1

4

C10125 C10206 C10216 C10297 C10521 C10939 C13443 C13448 C15455

P10125 P13443 P13448

1

5

C10125 C10206 C10216 C10297 C10521 C10939 C13443 C13448 C15455

P10216 P10297 P15455

1

7

Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL

Injection

Leucovorin Calcium (Pfizer Australia Pty Ltd)

10

1

C15455

P15455

Atezolizumab

Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC)

1,875 mg administered once every 3 weeks

Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; OR

Patient must be continuing existing PBS-subsidised treatment with this drug; OR

Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated.

Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug.

The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND

The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND

The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.

Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.

Compliance with Authority Required procedures - Streamlined Authority Code 15455

C15471

P15471

Nivolumab

Resectable non-small cell lung cancer (NSCLC)

The condition must be at least one of: (i) node positive, (ii) at least 4 cm in size; AND

The treatment must be for neoadjuvant use in a patient preparing for surgical resection; AND

Patient must have a WHO performance status of 0 or 1; AND

The treatment must be in combination with platinum-based chemotherapy.

Patient must not be undergoing treatment with more than 3 PBS-subsidised doses of this drug per lifetime for this indication.

In non-squamous type NSCLC where any of the following is known to be present, this drug must not be a PBS benefit: (i) activating epidermal growth factor receptor (EGFR) gene mutation, (ii) anaplastic lymphoma kinase (ALK) gene rearrangement.

Compliance with Authority Required procedures - Streamlined Authority Code 15471

C15485

P15485

Avelumab

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; 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 15485

C15500

P15500

Durvalumab

Unresectable Stage III non-small cell lung cancer

Initial treatment

Patient must have received platinum based chemoradiation therapy; AND

The condition must not have progressed following platinum based chemoradiation therapy; AND

Patient must have a WHO performance status of 0 or 1; AND

Patient must be untreated with immunotherapy at commencement of this drug; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 15500

C15527

P15527

Nivolumab

Urothelial carcinoma

The treatment must be for each of: (i) adjuvant therapy that is/was initiated within 120 days of radical surgical resection, (ii) muscle invasive type disease, (iii) disease considered to be at high risk of recurrence based on pathologic staging of radical surgery tissue (ypT2-ypT4a or ypN+), but yet to recur, (iv) use as the sole PBS-subsidised anti-cancer treatment for this condition; AND

Patient must have received prior platinum containing neoadjuvant chemotherapy; 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 be undergoing treatment with a dosing regimen as set out in the drug's Therapeutic Goods Administration (TGA) approved Product Information; 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) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.

An increase in repeat prescriptions, up to a value of 11, may only be sought where the prescribed dosing is 240 mg administered fortnightly.

Compliance with Authority Required procedures