National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 8) (PB 70 of 2019) (Cth)
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
___________________________________________________________________________
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.
Commencement
This Instrument commences on 1 September 2019.
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
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 |
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Schedule 1, entry for Plerixafor
(a)omit from the column headed “Circumstances”: C4550
(b)insert in numerical order in the column headed “Circumstances”: C9329
Schedule 1, entry for Ribavirin
omit:
| Tablet 200 mg | Oral | Ibavyr | IX | EMP | C5957 C5958 | P5957 | 28 | 2 |
| EMP | C5957 C5958 | P5958 | 28 | 5 |
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
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
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
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
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
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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