Azacitidine Juno

JO

EMP

C6132 C6143 C6144 C6177 C6186 C6199

See Note 1

See Note 2

D

Tablet 200 mg

Oral

Ibavyr

IX

EMP

C5957 C5958

P5957

28

2

EMP

C5957 C5958

P5958

28

5

Zoledronic Acid 4 mg/100 mL APOTEX

TX

EMP

C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736

1

11

PB

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

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

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

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

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

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

C5257

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures

C9333

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 9333

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

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

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

C9259

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

Compliance with Authority Required procedures - Streamlined Authority Code 9259

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

C4430

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

Compliance with Authority Required procedures

C5256

Multiple Myeloma

Compliance with Authority Required procedures

C5257

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures

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

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

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

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

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

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

C5909

Multiple myeloma

Compliance with Authority Required procedures

C9290

Multiple myeloma

Compliance with Authority Required procedures - Streamlined Authority Code 9290

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

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

C5031

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

Compliance with Authority Required procedures

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

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

C5736

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures

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