Federal Register of Legislation - Australian Government

Primary content

PB 70 of 2019 Arrangements as made
This instrument amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to add, delete and make changes to drugs, forms, brands, responsible person codes, maximum quantities and repeats, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 30 Aug 2019
Tabling HistoryDate
Tabled HR09-Sep-2019
Tabled Senate09-Sep-2019
To be repealed 15 Nov 2019
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

PB 70 of 2019

 

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 8)

 

National Health Act 1953

___________________________________________________________________________

 

I, NATASHA PLOENGES, Assistant Secretary (Acting), Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

 

Dated                   29 August 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NATASHA PLOENGES

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health


 

 

___________________________________________________________________________

1          Name of Instrument

(1)          This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 8).

(2)          This Instrument may also be cited as PB 70 of 2019.

2          Commencement

This Instrument commences on 1 September 2019.

3          Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

 


Schedule 1       Amendments

[1]        Schedule 1, entry for Azacitidine

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Azacitidine Juno

JO

EMP

C6132 C6143 C6144 C6177 C6186 C6199

 

See Note 1

See Note 2

D

[2]        Schedule 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

(c)        omit from the column headed “Purposes”: P8444 P8445 P8446

(d)        insert in numerical order in the column headed “Purposes”: P9222 P9258 P9302

[3]        Schedule 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

[4]        Schedule 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

(c)        omit from the column headed “Purposes”: P8444 P8445 P8446

(d)        insert in numerical order in the column headed “Purposes”: P9222 P9258 P9302

[5]        Schedule 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

[6]        Schedule 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

(c)        omit from the column headed “Purposes”: P8444 P8445 P8446

(d)        insert in numerical order in the column headed “Purposes”: P9222 P9258 P9302

[7]        Schedule 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

[8]        Schedule 1, entry for Deferiprone in the form Tablet 500 mg

(a)        omit from the column headed “Circumstances”: C6380

(b)        omit from the column headed “Circumstances”: C6442

(c)        insert in numerical order in the column headed “Circumstances”: C9228 C9286

[9]        Schedule 1, entry for Deferiprone in the form Oral solution 100 mg per mL, 250 mL

(a)        omit from the column headed “Circumstances”: C6380

(b)        omit from the column headed “Circumstances”: C6442

(c)        insert in numerical order in the column headed “Circumstances”: C9228 C9286

[10]      Schedule 1, entry for Doxorubicin - Pegylated Liposomal

(a)        omit from the column headed “Circumstances” (all instances): C6233

(b)        omit from the column headed “Circumstances” (all instances): C6264

(c)        insert in numerical order in the column headed “Circumstances” (all instances): C9223 C9287

[11]      Schedule 1, entry for Ibandronic acid

(a)        omit from the column headed “Circumstances”: C5257

(b)        insert in numerical order in the column headed “Circumstances”: C9333

[12]      Schedule 1, entry for Interferon Alfa-2a in each of the forms: Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe; and Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe

(a)        omit from the column headed “Circumstances”: C5003

(b)        insert in numerical order in the column headed “Circumstances”: C9259

[13]      Schedule 1, entry for Lanreotide in the form Powder for suspension for injection 30 mg (as acetate) with diluent

(a)        omit from the column headed “Circumstances”: C7063

(b)        insert in numerical order in the column headed “Circumstances”: C9225

[14]      Schedule 1, entry for Lanreotide in each of the forms: Injection 60 mg (as acetate) in single dose pre-filled syringe; and Injection 90 mg (as acetate) in single dose pre-filled syringe

(a)        omit from the column headed “Circumstances”: C4569

(b)        omit from the column headed “Circumstances”: C7041

(c)        insert in numerical order in the column headed “Circumstances”: C9260 C9261

[15]      Schedule 1, entry for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre-filled syringe

(a)        omit from the column headed “Circumstances”: C4569

(b)        omit from the column headed “Circumstances”: C7041

(c)        omit from the column headed “Circumstances”: C8261

(d)        insert in numerical order in the column headed “Circumstances”: C9260 C9261 C9323

[16]      Schedule 1, entry for Lenograstim in each of the forms: Powder for injection 13,400,000 I.U. (105 micrograms); and Powder for injection 33,600,000 I.U. (263 micrograms)

(a)        omit from the column headed “Circumstances”: C6488 C6490 C6494

(b)        omit from the column headed “Circumstances”: C6512

(c)        omit from the column headed “Circumstances”: C6521

(d)        omit from the column headed “Circumstances”: C6543 C6546 C6622 C6623 C6633

(e)        omit from the column headed “Circumstances”: C6649

(f)         omit from the column headed “Circumstances”: C6656

(g)        omit from the column headed “Circumstances”: C6663

(h)        omit from the column headed “Circumstances”: C6681

(i)         insert in numerical order in the column headed “Circumstances”: C9226 C9227 C9229 C9230 C9231 C9263 C9264 C9265 C9266 C9314 C9324 C9325 C9326 C9327

[17]      Schedule 1, entry for Lipegfilgrastim

(a)        omit from the column headed “Circumstances”: C7823

(b)        omit from the column headed “Circumstances”: C7862

(c)        insert in numerical order in the column headed “Circumstances”: C9224 C9322

[18]      Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL

(a)        omit from the column headed “Circumstances” (all instances): C6388

(b)        omit from the column headed “Circumstances” (all instances): C6477 C8148

(c)        insert in numerical order in the column headed “Circumstances” (all instances): C9232 C9233 C9289

[19]      Schedule 1, entry for Octreotide in each of the forms: Injection (modified release) 10 mg (as acetate), vial and diluent syringe; Injection (modified release) 20 mg (as acetate), vial and diluent syringe; and Injection (modified release) 30 mg (as acetate), vial and diluent syringe

(a)        omit from the column headed “Circumstances”: C5899

(b)        omit from the column headed “Circumstances”: C5910

(c)        omit from the column headed “Circumstances”: C8196

(d)        insert in numerical order in the column headed “Circumstances”: C9262 C9288 C9313

[20]      Schedule 1, entry for Pamidronic Acid in each of the forms: Concentrated injection containing pamidronate disodium 15 mg in 5 mL; Concentrated injection containing pamidronate disodium 30 mg in 10 mL; and Concentrated injection containing pamidronate disodium 60 mg in 10 mL

(a)        omit from the column headed “Circumstances”: C4430

(b)        insert in numerical order in the column headed “Circumstances”: C9234

[21]      Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing pamidronate disodium 90 mg in 10 mL

(a)        omit from the column headed “Circumstances”: C4430

(b)        omit from the column headed “Circumstances”: C5256 C5257

(c)        insert in numerical order in the column headed “Circumstances”: C9234 C9315 C9335

[22]      Schedule 1, entry for Pegfilgrastim

(a)        omit from the column headed “Circumstances” (all instances): C7823

(b)        omit from the column headed “Circumstances” (all instances): C7862

(c)        insert in numerical order in the column headed “Circumstances” (all instances): C9235 C9303

[23]      Schedule 1, entry for Plerixafor

(a)        omit from the column headed “Circumstances”: C4550

(b)        insert in numerical order in the column headed “Circumstances”: C9329

[24]      Schedule 1, entry for Ribavirin

omit:

 

Tablet 200 mg

Oral

Ibavyr

IX

EMP

C5957 C5958

P5957

28

2

 

 

 

 

 

 

EMP

C5957 C5958

P5958

28

5

 

[25]      Schedule 1, entry for Thalidomide in each of the forms: Capsule 50 mg; and Capsule 100 mg

(a)        omit from the column headed “Circumstances”: C5909

(b)        insert in numerical order in the column headed “Circumstances”: C9290

[26]      Schedule 1, entry for Valaciclovir

(a)        omit from the column headed “Circumstances” (all instances): C5939

(b)        insert in numerical order in the column headed “Circumstances” (all instances): C9267

[27]      Schedule 1, entry for Valganciclovir in each of the forms: Tablet 450 mg (as hydrochloride); and Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL

(a)        omit from the column headed “Circumstances” (all instances): C5031

(b)        insert in numerical order in the column headed “Circumstances” (all instances): C9316

[28]      Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

(a)        omit from the column headed “Circumstances” (all instances): C5606 C5676 C5677

(b)        omit from the column headed “Circumstances” (all instances): C5736

(c)        insert in numerical order in the column headed “Circumstances” (all instances): C9268 C9304 C9317 C9328

[29]      Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL vial

(a)        omit from the column headed “Circumstances”: C5606 C5676 C5677

(b)        omit from the column headed “Circumstances”: C5736

(c)        insert in numerical order in the column headed “Circumstances”: C9236 C9269 C9270 C9291

[30]      Schedule 1, entry for Zoledronic acid in the form Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL

(a)        omit from the column headed “Circumstances” for the brand “DBL Zoledronic Acid”: C5606 C5676 C5677

(b)        omit from the column headed “Circumstances” for the brand “DBL Zoledronic Acid”: C5736

(c)        insert in numerical order in the column headed “Circumstances” for the brand “DBL Zoledronic Acid”: C9268 C9304 C9317 C9328

(d)        omit:

 

 

 

Zoledronic Acid 4 mg/100 mL APOTEX

TX

EMP

C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736

 

1

11

PB

[31]      Schedule 3, entry for Deferasirox

(a)        omit:

 

C8444

P8444

Chronic iron overload
Continuing treatment
Patient must be transfusion dependent; AND
Patient must not have a malignant disorder of erythropoiesis; AND
Patient must have previously received PBS‑subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures

 

C8445

P8445

Chronic iron overload
Continuing treatment
Patient must not be transfusion dependent; AND
The condition must be thalassaemia; AND
Patient must have previously received PBS‑subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures

 

C8446

P8446

Chronic iron overload
Continuing treatment
Patient must be red blood cell transfusion dependent; AND
Patient must have a malignant disorder of haemopoieisis; AND
Patient must have previously received PBS‑subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures

(b)        insert in numerical order after existing text:

 

C9222

P9222

Chronic iron overload
Continuing treatment
Patient must not be transfusion dependent; AND
The condition must be thalassaemia; AND
Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9222

 

C9258

P9258

Chronic iron overload
Continuing treatment
Patient must be red blood cell transfusion dependent; AND
Patient must have a malignant disorder of haemopoieisis; AND
Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9258

 

C9302

P9302

Chronic iron overload
Continuing treatment
Patient must be transfusion dependent; AND
Patient must not have a malignant disorder of erythropoiesis; AND
Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9302

[32]      Schedule 3, entry for Deferiprone

insert in numerical order after existing text:

 

C9228

 

Iron overload
Patient must have thalassaemia major; AND
Patient must be one in whom desferrioxamine therapy has proven ineffective.

Compliance with Authority Required procedures - Streamlined Authority Code 9228

 

C9286

 

Iron overload
Patient must have thalassaemia major; AND
Patient must be unable to take desferrioxamine therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9286

[33]      Schedule 3, entry for Doxorubicin - Pegylated Liposomal

(a)        omit:

 

C6233

 

Kaposi sarcoma
The condition must be AIDS‑related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement.

Compliance with Authority Required procedures

(b)        omit:

 

C6264

 

Kaposi sarcoma
The condition must be AIDS‑related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement.

Compliance with Authority Required procedures

(c)        insert in numerical order after existing text:

 

C9223

 

Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement.

Compliance with Authority Required procedures - Streamlined Authority Code 9223

 

C9287

 

Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement.

Compliance with Authority Required procedures - Streamlined Authority Code 9287

[34]      Schedule 3, entry for Ibandronic acid

(a)        omit:

 

C5257

 

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures

(b)        insert in numerical order after existing text:

 

C9333

 

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 9333

[35]      Schedule 3, entry for Infliximab

(a)        omit entry for C4524 and substitute:

 

C4524

 

Acute severe ulcerative colitis
Must be treated by a gastroenterologist; OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology].
Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND
Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR
Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND
Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital.
Patient must be 6 years of age or older.
For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:
(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L
(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood.
For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours.
At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.
Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient's medical records.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 4524

(b)        omit entry for C4535 and substitute:

 

C4535

 

Acute severe ulcerative colitis
Must be treated by a gastroenterologist; OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology].
Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND
Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR
Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND
Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital.
Patient must be 6 years of age or older.
For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:
(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L
(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood.
For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours.
At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.
Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient's medical records.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records.

Compliance with Authority Required procedures

[36]      Schedule 3, entry for Interferon alfa-2a

(a)        omit:

 

C5003

 

Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Chronic Myeloid Leukaemia (CML)
The condition must be Philadelphia chromosome positive.

Compliance with Authority Required procedures

(b)        insert in numerical order after existing text:

 

C9259

 

Chronic Myeloid Leukaemia (CML)
The condition must be Philadelphia chromosome positive.

Compliance with Authority Required procedures - Streamlined Authority Code 9259

[37]      Schedule 3, entry for Lanreotide

(a)        omit:

 

C4569

 

Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

Compliance with Authority Required procedures

(b)        omit:

 

C7041

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS‑subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures

(c)        omit:

 

C7063

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS‑subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures

(d)        omit:

 

C8261

 

Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.
Lanreotide is not PBS‑subsidised for use in combination with everolimus or sunitinib for this condition.

Compliance with Authority Required procedures

(e)        insert in numerical order after existing text:

 

C9225

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures - Streamlined Authority Code 9225

 

C9260

 

Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 9260

 

C9261

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures - Streamlined Authority Code 9261

 

C9323

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
Lanreotide is not PBS-subsidised for use in combination with everolimus or sunitinib for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9323

[38]      Schedule 3, entry for Lenograstim

(a)        omit:

 

C6488

 

Chemotherapy‑induced neutropenia
Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures

 

C6490

 

Chemotherapy‑induced neutropenia
Patient must be receiving first‑line chemotherapy for Hodgkin disease; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures

 

C6494

 

Chemotherapy‑induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.

Compliance with Authority Required procedures

(b)        omit:

 

C6512

 

Chemotherapy‑induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.

Compliance with Authority Required procedures

(c)        omit:

 

C6521

 

Chemotherapy‑induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.

Compliance with Authority Required procedures

(d)        omit:

 

C6543

 

Chemotherapy‑induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.

Compliance with Authority Required procedures

 

C6546

 

Chemotherapy‑induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.

Compliance with Authority Required procedures

 

C6622

 

Chemotherapy‑induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma.

Compliance with Authority Required procedures

 

C6623

 

Assisting peripheral blood progenitor cell or bone marrow transplantation
The treatment must be following marrow‑ablative chemotherapy for non‑myeloid malignancy prior to the transplantation.

Compliance with Authority Required procedures

 

C6633

 

Mobilisation of peripheral blood progenitor cells
The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non‑myeloid malignancy who has had myeloablative or myelosuppressive therapy.

Compliance with Authority Required procedures

(e)        omit:

 

C6649

 

Mobilisation of peripheral blood progenitor cells
The treatment must be in a normal volunteer for use in allogeneic transplantation.

Compliance with Authority Required procedures

(f)         omit:

 

C6656

 

Chemotherapy‑induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma.

Compliance with Authority Required procedures

(g)        omit:

 

C6663

 

Chemotherapy‑induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma.

Compliance with Authority Required procedures

(h)        omit:

 

C6681

 

Chemotherapy‑induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non‑Hodgkin's lymphoma (intermediate or high grade).

Compliance with Authority Required procedures

(i)         insert in numerical order after existing text:

 

C9226

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9226

 

C9227

 

Assisting peripheral blood progenitor cell or bone marrow transplantation
The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.

Compliance with Authority Required procedures - Streamlined Authority Code 9227

 

C9229

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9229

 

C9230

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.

Compliance with Authority Required procedures - Streamlined Authority Code 9230

 

C9231

 

Mobilisation of peripheral blood progenitor cells
The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9231

 

C9263

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.

Compliance with Authority Required procedures - Streamlined Authority Code 9263

 

C9264

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade).

Compliance with Authority Required procedures - Streamlined Authority Code 9264

 

C9265

 

Chemotherapy-induced neutropenia
Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures - Streamlined Authority Code 9265

 

C9266

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9266

 

C9314

 

Mobilisation of peripheral blood progenitor cells
The treatment must be in a normal volunteer for use in allogeneic transplantation.

Compliance with Authority Required procedures - Streamlined Authority Code 9314

 

C9324

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.

Compliance with Authority Required procedures - Streamlined Authority Code 9324

 

C9325

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9325

 

C9326

 

Chemotherapy-induced neutropenia
Patient must be receiving first-line chemotherapy for Hodgkin disease; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures - Streamlined Authority Code 9326

 

C9327

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9327

[39]      Schedule 3, entry for Lipegfilgrastim

(a)        omit:

 

C7823

 

Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures

(b)        omit:

 

C7862

 

Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures

(c)        insert in numerical order after existing text:

 

C9224

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures - Streamlined Authority Code 9224

 

C9322

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures - Streamlined Authority Code 9322

[40]      Schedule 3, entry for Octreotide

(a)        omit:

 

C5899

 

Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures

(b)        omit:

 

C5910

 

Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures

(c)        omit:

 

C6388

 

Vasoactive intestinal peptide secreting tumour (VIPoma)
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures

(d)        omit:

 

C6477

 

Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures

 

C8148

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND
The treatment must not be given concomitantly with PBS‑subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

Compliance with Authority Required procedures

(e)        omit:

 

C8196

 

Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS‑subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

Compliance with Authority Required procedures

(f)         insert in numerical order after existing text:

 

C9232

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND
The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

Compliance with Authority Required procedures - Streamlined Authority Code 9233

 

C9233

 

Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

Compliance with Authority Required procedures - Streamlined Authority Code 9262

 

C9262

 

Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 9288

 

C9288

 

Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 9289

 

C9289

 

Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 9313

 

C9313

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND
The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

Compliance with Authority Required procedures - Streamlined Authority Code 9233

[41]      Schedule 3, entry for Pamidronic Acid

(a)        omit:

 

C4430

 

Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti‑neoplastic therapy

Compliance with Authority Required procedures

(b)        omit:

 

C5256

 

Multiple Myeloma

Compliance with Authority Required procedures

 

C5257

 

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures

(c)        insert in numerical order after existing text:

 

C9234

 

Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9234

 

C9315

 

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 9315

 

C9335

 

Multiple myeloma

Compliance with Authority Required procedures - Streamlined Authority Code 9335

[42]      Schedule 3, entry for Pegfilgrastim

(a)        omit:

 

C7823

 

Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures

(b)        omit:

 

C7862

 

Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures

(c)        insert in numerical order after existing text:

 

C9235

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures - Streamlined Authority Code 9235

 

C9303

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures - Streamlined Authority Code 9303

[43]      Schedule 3, entry for Plerixafor

(a)        omit:

 

C4550

 

Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte‑colony stimulating factor (G‑CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G‑CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G‑CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records.

Compliance with Authority Required procedures

(b)        insert in numerical order after existing text:

 

C9329

 

Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 9329

[44]      Schedule 3, entry for Thalidomide

(a)        omit:

 

C5909

 

Multiple myeloma

Compliance with Authority Required procedures

(b)        insert in numerical order after existing text:

 

C9290

 

Multiple myeloma

Compliance with Authority Required procedures - Streamlined Authority Code 9290

[45]      Schedule 3, entry for Valaciclovir

(a)        omit:

 

C5939

 

Cytomegalovirus infection and disease
Prophylaxis
Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease.

Compliance with Authority Required procedures

(b)        insert in numerical order after existing text:

 

C9267

 

Cytomegalovirus infection and disease
Prophylaxis
Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9267

[46]      Schedule 3, entry for Valganciclovir

(a)        omit:

 

C5031

 

Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.

Compliance with Authority Required procedures

(b)        insert in numerical order after existing text:

 

C9316

 

Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9316

[47]      Schedule 3, entry for Zoledronic acid

(a)        omit:

 

C5606

 

Bone metastases
The condition must be due to castration‑resistant prostate cancer.

Compliance with Authority Required procedures

 

C5676

 

Multiple myeloma

Compliance with Authority Required procedures

 

C5677

 

Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti‑neoplastic therapy.

Compliance with Authority Required procedures

(b)        omit:

 

C5736

 

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures

(c)        insert in numerical order after existing text:

 

C9236

 

Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9236

 

C9268

 

Multiple myeloma

Compliance with Authority Required procedures - Streamlined Authority Code 9268

 

C9269

 

Multiple myeloma

Compliance with Authority Required procedures - Streamlined Authority Code 9269

 

C9270

 

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 9270

 

C9291

 

Bone metastases
The condition must be due to castration-resistant prostate cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 9291

 

C9304

 

Bone metastases
The condition must be due to castration-resistant prostate cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 9304

 

C9317

 

Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9317

 

C9328

 

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 9328