National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 10) (PB 93 of 2016) (Cth)

PB 93 of 2016
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 10)
National Health Act 1953
___________________________________________________________________________
I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.
Dated 27 October 2016
Julianne Quaine
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
Part 1 Preliminary

1 Name of Instrument
(1)This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 10).

(2)This instrument may also be cited as PB 93 of 2016.

2 Commencement
This instrument commences on 1 November 2016.
3 Amendment
The Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule – Amendments
Schedule
National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
[1]     Schedule 1, entry for Azacitidine       Omit:

Celazadine JU EMP C6132 C6143 C6144 C6177 C6186 C6199 See Note 1 See Note 2 D
[2]     Schedule 1, entry for Foscarnet          Omit from the column headed ‘Responsible Person’: IX                 Insert: LM
[3]     Schedule 1, after entry for Levodopa with carbidopa      Insert:

Lipegfilgrastim
Injection 6 mg in 0.6 mL single use pre-filled syringe Injection Lonquex TB EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6501 C6507 C6512 C6513 C6514 C6515 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6554 C6555 1 11 D
[4]     Schedule 1, entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir          Omit from the column headed ‘Section 100 only’: the letter ‘D’

[5] Schedule 1, entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin Omit from the column headed ‘Section 100 only’ (for all instances): the letter ‘D’
[6] Schedule 1, entry for Pegfilgrastim
Substitute:

Pegfilgrastim Injection 6 mg in 0.6 mL single use pre‑filled syringe Injection Neulasta AN EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 1 11 D

[7]     Schedule 1, entry for Ribavirin      Insert:

Tablet 200 mg Oral Ibavyr IX EMP

C5957 C5958 P5957 28 2

EMP C5957 C5958 P5958 28 5
[8]     Schedule 2, after entry for code LL         Insert:

LM Link Medical Products Pty Ltd 73 010 971 516
[9]     Schedule 3, item dealing with Etanercept with Circumstances code C4540
Insert in Authority Requirements - Part of Circumstances column: Compliance with Written Authority Required procedures

[10] Schedule 3, after entry for Levodopa with carbidopa
Insert:

Lipegfilgrastim C6488
Where the patient is receiving treatment at/from a private hospital

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

C6489
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; 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
Where the patient is receiving treatment at/from a private hospital

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

C6491
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; 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

C6492
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; 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 6492

C6493
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.
Compliance with Authority Required procedures - Streamlined Authority Code 6493

C6501
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).
Compliance with Authority Required procedures

C6507
Where the patient is receiving treatment at/from a public hospital

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 6507

C6512
Where the patient is receiving treatment at/from a private hospital

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

C6513
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.
Compliance with Authority Required procedures

C6514
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.
Compliance with Authority Required procedures

C6515
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving chemotherapy for myeloma; AND

Patient must have had a prior episode of febrile neutropenia; 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 6515

C6521
Where the patient is receiving treatment at/from a private hospital

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

C6522
Where the patient is receiving treatment at/from a public hospital

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 6522

C6523
Where the patient is receiving treatment at/from a public hospital

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 6523

C6531
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.
Compliance with Authority Required procedures

C6532
Where the patient is receiving treatment at/from a public hospital

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 6532

C6533
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.
Compliance with Authority Required procedures - Streamlined Authority Code 6533

C6534
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).
Compliance with Authority Required procedures - Streamlined Authority Code 6534

C6535
Where the patient is receiving treatment at/from a public hospital

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 6535

C6536
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.
Compliance with Authority Required procedures - Streamlined Authority Code 6536

C6543
Where the patient is receiving treatment at/from a private hospital

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

C6544
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.
Compliance with Authority Required procedures - Streamlined Authority Code 6544

C6545
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; 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 6545

C6554
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.
Compliance with Authority Required procedures

C6555
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving chemotherapy for myeloma; AND

Patient must have had a prior episode of febrile neutropenia; 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
[11] Schedule 3, entry for Pegfilgrastim
Substitute:

C6488
Where the patient is receiving treatment at/from a private hospital

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

C6489
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; 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
Where the patient is receiving treatment at/from a private hospital

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

C6491
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; 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

C6492
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; 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 6492

C6493
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.
Compliance with Authority Required procedures - Streamlined Authority Code 6493

C6494
Where the patient is receiving treatment at/from a private hospital

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

C6501
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).
Compliance with Authority Required procedures

C6502
Where the patient is receiving treatment at/from a public hospital

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 6502

C6507
Where the patient is receiving treatment at/from a public hospital

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 6507

C6512
Where the patient is receiving treatment at/from a private hospital

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

C6513
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.
Compliance with Authority Required procedures

C6514
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.
Compliance with Authority Required procedures

C6515
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving chemotherapy for myeloma; AND

Patient must have had a prior episode of febrile neutropenia; 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 6515

C6516
Where the patient is receiving treatment at/from a public hospital

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 6516

C6521
Where the patient is receiving treatment at/from a private hospital

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

C6522
Where the patient is receiving treatment at/from a public hospital

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 6522

C6523
Where the patient is receiving treatment at/from a public hospital

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 6523

C6531
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.
Compliance with Authority Required procedures

C6532
Where the patient is receiving treatment at/from a public hospital

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 6532

C6533
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.
Compliance with Authority Required procedures - Streamlined Authority Code 6533

C6534
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).
Compliance with Authority Required procedures - Streamlined Authority Code 6534

C6535
Where the patient is receiving treatment at/from a public hospital

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 6535

C6536
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.
Compliance with Authority Required procedures - Streamlined Authority Code 6536

C6543
Where the patient is receiving treatment at/from a private hospital

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

C6544
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.
Compliance with Authority Required procedures - Streamlined Authority Code 6544

C6545
Where the patient is receiving treatment at/from a public hospital

Chemotherapy-induced neutropenia

Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; 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 6545

C6546
Where the patient is receiving treatment at/from a private hospital

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

C6554
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.
Compliance with Authority Required procedures

C6555
Where the patient is receiving treatment at/from a private hospital

Chemotherapy-induced neutropenia

Patient must be receiving chemotherapy for myeloma; AND

Patient must have had a prior episode of febrile neutropenia; 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

[12]After Schedule 3, Part 1 – General statement for drugs for the treatment of hepatitis C
Substitute:
1Criteria for eligibility for drugs for the treatment of chronic hepatitis C
   The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:
(1)   the patient is 18 years or older; and
(2)   the patient has been assessed in accordance with paragraph 2 of this Part; and
(3)   the patient is:
a.   treated by a medical practitioner who is experienced in the treatment of patients with chronic hepatitis C infection; or
b.   treated in consultation with a medical practitioner who is experienced in the treatment of patients with chronic hepatitis C infection and who is:
i.   a gastroenterologist; or
ii.   a hepatologist; or
iii.   an infectious diseases physician

2Assessment of patient
For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:
(1)   documented the following information in the patient’s medical records:
a.   evidence of chronic hepatitis C infection; and
b.   evidence of the patient’s hepatitis C virus genotype; and

(2)   chosen a regimen in accordance with paragraph 3 of this Part; and
(3)   collected the following information for the purposes of the authority application:
a.   the patient’s hepatitis C virus genotype; and
b.   whether the patient is:
i.   cirrhotic; or
ii.   Non-cirrhotic

(4)   In this paragraph, evidence of chronic hepatitis C infection is documentation of:
a.   repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and
b.   test result showing hepatitis C virus ribonucleic acid (RNA) positive

3Treatment regimen
   For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:
(1)   is a kind of patient mentioned for an Item in column 2 of the following table; and
(2)   is to receive one of the regimens mentioned in column 3 of the same Item of the following table

Item	Kind of patient	Regimen
1	Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is non-cirrhotic	Either: (a) LEDIPASVIR with SOFOSBUVIR for 8 weeks; or (b) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or (f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks.
2	Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is non-cirrhotic	Either: (a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or (f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks.
3	Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is non-cirrhotic	SOFOSBUVIR and RIBAVIRIN for 12 weeks.
4	Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is non-cirrhotic	SOFOSBUVIR and RIBAVIRIN for 12 weeks.
5	Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is non-cirrhotic	Either: (a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
6	Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is non-cirrhotic	Either: (a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
7	Patient: (a) with: (i) Genotype 4; or (ii) Genotype 5; or (iii) Genotype 6; and (b) who is treatment naïve; and (c) who is non-cirrhotic	SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
8	Patient: (a) with: (i) Genotype 4; or (ii) Genotype 5; or (iii) Genotype 6; and (b) who is treatment experienced; and (c) who is non-cirrhotic	SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
9	Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is cirrhotic	Either: (a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks.
10	Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is cirrhotic	Either: (a) LEDIPASVIR with SOFOSBUVIR for 24 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 24 weeks.
11	Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is cirrhotic	SOFOSBUVIR and RIBAVIRIN for 12 weeks.
12	Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is cirrhotic	SOFOSBUVIR and RIBAVIRIN for 12 weeks.
13	Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is cirrhotic	Either: (a) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (d) DACLATASVIR and SOFOSBUVIR and RBV for 12 weeks; or (e) DACLATASVIR and SOFOSBUVIR and RBV for 24 weeks.
14	Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is cirrhotic	Either: (a) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (d) DACLATASVIR and SOFOSBUVIR and RBV for 12 weeks; or (e) DACLATASVIR and SOFOSBUVIR and RBV for 24 weeks.
15	Patient: (a) with: (i) Genotype 4; or (ii) Genotype 5; or (iii) Genotype 6; and (b) who is treatment naïve; and (c) who is cirrhotic	SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
16	Patient: (a) with: (i) Genotype 4; or (ii) Genotype 5; or (iii) Genotype 6; and (b) who is treatment experienced; and (c) who is cirrhotic	SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.

Tablet 200 mg	Oral	Ibavyr	IX	EMP	C5957 C5958	P5957	28	2
EMP	C5957 C5958	P5958	28	5

Lipegfilgrastim	C6488	Where the patient is receiving treatment at/from a private hospital 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
	C6489	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; 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	Where the patient is receiving treatment at/from a private hospital 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
C6491	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; 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
C6492	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; 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 6492
C6493	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6493
C6501	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).	Compliance with Authority Required procedures
C6507	Where the patient is receiving treatment at/from a public hospital 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 6507
C6512	Where the patient is receiving treatment at/from a private hospital 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
C6513	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.	Compliance with Authority Required procedures
C6514	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.	Compliance with Authority Required procedures
C6515	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving chemotherapy for myeloma; AND Patient must have had a prior episode of febrile neutropenia; 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 6515
C6521	Where the patient is receiving treatment at/from a private hospital 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
C6522	Where the patient is receiving treatment at/from a public hospital 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 6522
C6523	Where the patient is receiving treatment at/from a public hospital 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 6523
C6531	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.	Compliance with Authority Required procedures
C6532	Where the patient is receiving treatment at/from a public hospital 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 6532
C6533	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 6533
C6534	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).	Compliance with Authority Required procedures - Streamlined Authority Code 6534
C6535	Where the patient is receiving treatment at/from a public hospital 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 6535
C6536	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.	Compliance with Authority Required procedures - Streamlined Authority Code 6536
C6543	Where the patient is receiving treatment at/from a private hospital 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
C6544	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.	Compliance with Authority Required procedures - Streamlined Authority Code 6544
C6545	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; 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 6545
C6554	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.	Compliance with Authority Required procedures
C6555	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving chemotherapy for myeloma; AND Patient must have had a prior episode of febrile neutropenia; 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