National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 12) (PB) 113 of 2016) (Cth)

Case

PB 113 of 2016

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 12)

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 21 December 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. 12).

(2)This instrument may also be cited as PB 113 of 2016.

2              Commencement

This instrument commences on 1 January 2017.

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. Division 1, Section 4, definition for CAR drug

Substitute:

CAR drug (Complex Authority Required drug) means any of the following highly specialised drugs:

a)    abatacept

b)    adalimumab

c)    ambristenan

d)    azacitidine

e)    bosentan

f)     eculizumab

g)    eltrombopag

h)    epoprostenol

i)      etanercept

j)      iloprost

k)    infliximab

l)      ivacaftor

m)    lenalidomide

n)    macitentan

o)    mepolizumab

p)    omalizumab

q)    pasireotide

r)     pomalidomide

s)     riociguat

t)      rituximab

u)    romiplostim

v)    sildenafil

w)    tadalafil

x)    tocilizumab

y)    vedolizumab

  1. Division 1, Section 4, definition for eligible medical practitioner

Substitute for entry (c):

(c)  who is, for the prescription of medication for the treatment of hepatitis C:

(i)an accredited prescriber of medication for the treatment of hepatitis C; or

(ii)a medical practitioner, for Daclatasvir, Ledipasvir with sofosbuvir, Ribavirin, Sofosbuvir, Paritaprevir with ritonavir with ombitasvir and dasabuvir, Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin, and Grazoprevir with elbasvir; or

  1. Division 4, Section 24, HSD pharmaceutical benefits that have CAR drugs – quantity exceptions

Insert after existing entry:

(x)  for HSD pharmaceutical benefits that have the drug riociguat, for the treatment of   

      Chronic thromboembolic pulmonary hypertension (CTEPH):

              (i)      for Grandfathered patients – the maximum quantity authorised will be limited 

to provide sufficient supply for 1 month. 

(ii)     for Initial treatment – prescriptions for dose titration must provide sufficient  

quantity for dose titrations by 0.5 mg increments at 2-week intervals to

achieve up to a maximum of 2.5 mg three times daily.  Approvals for

subsequent authority prescriptions will be limited to 1 month of treatment. 

(iii)    for Continuing treatment – the maximum quantity per prescription will be 

limited to provide sufficient supply for 1 month of treatment.

(y)   for HSD pharmaceutical benefits that have the drug riociguat, for balance of

       supply for patient who has received insufficient therapy with this agent:

(i)      for Grandfathering– maximum of 24 weeks of treatment.

(ii)     for Initial treatment – maximum of 20 weeks of treatment.

(iii)    for Continuing treatment – maximum of 24 weeks of treatment

         —the treatment must provide no more than the balance up to 20 or 24 weeks of

treatment available under the above respective restriction. 

  1. Division 4, Section 25, HSD pharmaceutical benefits that have CAR drugs – repeat exceptions

Insert after existing entry:

(zb)   for riociguat, for the treatment of Chronic thromboembolic pulmonary

       hypertension (CTEPH):

(i)  for grandfathering – up to 5 repeat supplies.

(ii) for initial treatment – up to 3 repeat supplies.

              (iii) for continuing treatment – up to 5 repeat supplies.

  1. Schedule 1, entry for Apomorphine, in the form ‘Injection containing apomorphine hydrochloride 10 mg in 1 mL’, and brand ‘Apomine’   Omit from the column headed ‘Responsible Person’: HH                         Insert: PF

  1. Schedule 1, entry for Azithromycin      Omit from the column headed ‘Circumstances: C1299 C3317                   Insert: C6356 C6361

  1. Schedule 1, entry for Clozapine

    Substitute:  

Clozapine Tablet 25 mg Oral Clopine 25 PF EMP C4998 C5001 C5015 200 0 D
Clozaril 25 NV EMP C4998 C5001 C5015 200 0 D
Tablet 50 mg Oral Clopine 50 PF EMP C4998 C5001 C5015 200 0 D
Tablet 100 mg Oral Clopine 100 PF EMP C4998 C5001 C5015 200 0 D
Clozaril 100 NV EMP C4998 C5001 C5015 200 0 D
Tablet 200 mg Oral Clopine 200 PF EMP C4998 C5001 C5015 200 0 D
Oral liquid 50 mg per mL, 100 mL Oral Clopine Suspension PF EMP C4998 C5001 C5015 1 0 D

  1. Schedule 1, entry for Cyclosporin  

    Substitute:

Cyclosporin Capsule 10 mg Oral Neoral 10 NV EMP C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676 120 5 C
Capsule 25 mg Oral Cyclosporin Sandoz SZ EMP C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676 120 5 C
Neoral 25 NV EMP C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676 120 5 C
Capsule 50 mg Oral Cyclosporin Sandoz SZ EMP C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676 120 5 C
Neoral 50 NV EMP C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676 120 5 C
Capsule 100 mg Oral Cyclosporin Sandoz SZ EMP C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676 120 5 C
Neoral 100 NV EMP C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676 120 5 C
Oral liquid 100 mg per mL, 50 mL Oral Neoral NV EMP C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676 4 5 C
Solution concentrate for I.V. infusion    50 mg in 1 mL Injection Sandimmun NV EMP C6628 C6677 10 0 PB

  1. Schedule 1, entry for Desferrioxamine  

Omit from the column headed ‘Responsible Person’: HH   Insert: PF

  1. Schedule 1, entry for Didanosine                Omit:

Capsule 125 mg (containing enteric coated beadlets) Oral Videx EC BQ EMP

 C4454 C4512 60 5 D
Capsule 200 mg (containing enteric coated beadlets) Oral Videx EC BQ EMP

 C4454 C4512 60 5 D

  1. Schedule 1, entry for Eculizumab                                    Substitute:

Eculizumab Solution concentrate for I.V. infusion  300 mg in 30 mL Injection Soliris XI EMP C6626 C6637
C6642 C6668
C6686 C6687
C6688 		P6626 1 0 D
C6626 C6637
C6642 C6668
C6686 C6687
C6688 		P6642 1 4 D
C6626 C6637
C6642 C6668
C6686 C6687
C6688 		P6668 P6686
P6687 P6688 		1 5 D
C6626 C6637
C6642 C6668
C6686 C6687
C6688 		P6637 1 6 D

  1. Schedule 1, entry for Filgrastim

Substitute:

Filgrastim

 Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim) Injection Nivestim PF 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen) Injection Neupogen 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim) Injection Nivestim PF 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim) Injection TevaGrastim TB 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Zarzio) Injection Zarzio SZ 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D
Injection 300 micrograms in 1 mL Injection Neupogen 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D
Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen) Injection Neupogen 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D
Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim) Injection Nivestim PF 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D
Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Zarzio) Injection Zarzio SZ 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D
Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim) Injection TevaGrastim TB 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D
Injection 480 micrograms in 1.6 mL Injection Neupogen 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 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680 20 11 D

  1. Schedule 1, after entry for Ganciclovir

Insert:

Grazoprevir with elbasvir Tablet containing grazoprevir 100 mg with elbasvir 50 mg Oral Zepatier MK EMP C5969 C6625 P5969 28 2
EMP C5969 C6625 P6625 28 3

  1. Schedule 1, entry for Infliximab, in the form ‘Powder for I.V. infusion 100 mg’ and brands ‘Inflectra’ and ‘Remicade’ [Maximum quantity: 1           

Number of repeats: 0]

Omit from the column headed ‘Circumstances: C6616                    Insert: C6669

Omit from the column headed ‘Purposes’: P6616   Insert: P6669

  1. Schedule 1, entry for Infliximab and brand ‘Inflectra’

Omit from the column headed ‘Responsible Person: HH                          Insert: PF

  1. Schedule 1, entry for Lenograstim

Substitute:

Lenograstim Powder for injection 13,400,000 I.U. (105 micrograms) Injection Granocyte 13 PF EMP C6488 C6490 C6494 C6502 C6507 C6512 C6516 C6521 C6522 C6523 C6532 C6535 C6543 C6546 C6622 C6623 C6633 C6634 C6644 C6649 C6653 C6654 C6656 C6657 C6663 C6673 C6681 C6682 20 11 D
Powder for injection 33,600,000 I.U. (263 micrograms) Injection Granocyte 34 PF EMP C6488 C6490 C6494 C6502 C6507 C6512 C6516 C6521 C6522 C6523 C6532 C6535 C6543 C6546 C6622 C6623 C6633 C6634 C6644 C6649 C6653 C6654 C6656 C6657 C6663 C6673 C6681 C6682 20 11 D

  1. Schedule 1, after entry for Maraviroc

Insert:

Mepolizumab Powder for injection 100 mg Injection Nucala GK EMP C6635 C6646 C6665 P6635 P6646 1 5 D
EMP C6635 C6646 C6665 P6665 1 7 D

  1. Schedule 1, entry for Octreotide in 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’ and brand ‘Hospira Pty Limited’

Omit from the column headed ‘Responsible Person’: HH  Insert: PF

  1. Schedule 1, entry for Omalizumab

Omit from the column headed ‘Circumstance’: C4880 C6142                  Insert: C6627 C6689

  1. Schedule 1, entry for Pamidronic Acid

Omit from the column headed ‘Responsible Person’: HH                          Insert: PF

  1. Schedule 1, after entry for Rilpivirine

Insert:

Riociguat Tablet 500 micrograms Oral Adempas BN EMP C6624 C6641 C6645 C6664 See note 1 See note 2 D
Tablet 1 mg Oral Adempas BN EMP C6624 C6641 C6645 C6664 See note 1 See note 2 D
Tablet 1.5 mg Oral Adempas BN EMP C6624 C6641 C6645 C6664 See note 1 See note 2 D
Tablet 2 mg Oral Adempas BN EMP C6624 C6641 C6645 C6664 See note 1 See note 2 D
Tablet 2.5 mg Oral Adempas BN EMP C6624 C6641 C6645 C6664 See note 1 See note 2 D

  1. Schedule 1, entry for Zoledronic acid in the forms ‘Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL’ and ‘Solution for I.V.

infusion 4 mg (as monohydrate) in 100 mL’ and brand ‘DBL Zoledronic Acid’

Omit from the column headed ‘Responsible Person’: HH                         Insert: PF

  1. Schedule 2, entry for code HH

Omit:

HH Hospira Pty Limited 13 107 058 328

  1. Schedule 3, entry for Azithromycin

Omit entry for: C1299 C3317

Substitute:

C6356

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

Mycobacterium avium complex infection

The treatment must be for prophylaxis; AND

Patient must be human immunodeficiency virus (HIV) positive; AND

Patient must have CD4 cell counts of less than 75 per cubic millimetre.

 Compliance with Authority Required procedures - Streamlined Authority Code 6356
C6361

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

Mycobacterium avium complex infection

The treatment must be for prophylaxis; AND

Patient must be human immunodeficiency virus (HIV) positive; AND

Patient must have CD4 cell counts of less than 75 per cubic millimetre.

 Compliance with Authority Required procedures

  1. Schedule 3, entry for Cyclosporin

Omit entry for: C1504 C1654 C1655 C1656 C1657 C1658 C3328 C3329 C3330 C3331 C3332 C3333

Insert in numerical order:

C6628

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

Management of transplant rejection

The treatment must be used by organ or tissue transplant recipients.

 Compliance with Authority Required procedures - Streamlined Authority Code 6628
C6629

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

Severe atopic dermatitis

Management (initiation, stabilisation and review of therapy)

The condition must be ineffective to other systemic therapies; OR

The condition must be inappropriate for other systemic therapies.

Must be treated by a dermatologist; OR

Must be treated by a clinical immunologists.

 Compliance with Authority Required procedures
C6630

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

Severe psoriasis

Management (initiation, stabilisation and review of therapy)

The condition must be ineffective to other systemic therapies; OR

The condition must be inappropriate for other systemic therapies; AND

The condition must have caused significant interference with quality of life.

Must be treated by a dermatologist.

 Compliance with Authority Required procedures
C6631

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

Nephrotic syndrome

Management (initiation, stabilisation and review of therapy)

Patient must have failed prior treatment with steroids and cytostatic drugs; OR

Patient must be intolerant to treatment with steroids and cytostatic drugs; OR

The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND

Patient must not have renal impairment.

Must be treated by a nephrologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6631
C6638

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

Severe active rheumatoid arthritis

Management (initiation, stabilisation and review of therapy)

The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); OR

The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate).

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6638
C6643

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

Management of transplant rejection

Management (initiation, stabilisation and review of therapy)

Patient must have had an organ or tissue transplantation; AND

The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Authority Required procedures - Streamlined Authority Code 6643
C6659

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

Severe active rheumatoid arthritis

Management (initiation, stabilisation and review of therapy)

The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); OR

The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate).

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist.

 Compliance with Authority Required procedures
C6660

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

Severe atopic dermatitis

Management (initiation, stabilisation and review of therapy)

The condition must be ineffective to other systemic therapies; OR

The condition must be inappropriate for other systemic therapies.

Must be treated by a dermatologist; OR

Must be treated by a clinical immunologists.

 Compliance with Authority Required procedures - Streamlined Authority Code 6660
C6670

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

Management of transplant rejection

Management (initiation, stabilisation and review of therapy)

Patient must have had an organ or tissue transplantation; AND

The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Authority Required procedures
C6671

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

Nephrotic syndrome

Management (initiation, stabilisation and review of therapy)

Patient must have failed prior treatment with steroids and cytostatic drugs; OR

Patient must be intolerant to treatment with steroids and cytostatic drugs; OR

The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND

Patient must not have renal impairment.

Must be treated by a nephrologist.

 Compliance with Authority Required procedures
C6676

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

Severe psoriasis

Management (initiation, stabilisation and review of therapy)

The condition must be ineffective to other systemic therapies; OR

The condition must be inappropriate for other systemic therapies; AND

The condition must have caused significant interference with quality of life.

Must be treated by a dermatologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6676
C6677

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

Management of transplant rejection

The treatment must be used by organ or tissue transplant recipients.

 Compliance with Authority Required procedures

  1. Schedule 3, entry for Eculizumab

Substitute:

Eculizumab C6626 P6626

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

Atypical haemolytic uraemic syndrome (aHUS)

Initial treatment

Patient must have active and progressing thrombotic microangiopathy (TMA) caused by aHUS; AND

Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND

Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND

Patient must have clinical features of active organ damage or impairment; AND

Patient must not receive more than 4 weeks of treatment under this restriction.

Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.

Evidence of active and progressing TMA is defined by the following:

(1) a platelet count of less than 150x10^9/L; and evidence of two of the following:

(i) presence of schistocytes on blood film;

(ii) low or absent haptoglobin;

(iii) lactate dehydrogenase (LDH) above normal range;

OR

(2) in recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA;

AND

(3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:

(a) kidney impairment as demonstrated by one of the following:

(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or

(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or

(iii) a sCr of greater than the age-appropriate ULN in paediatric patients; or

(iv) a renal biopsy consistent with aHUS;

(b) onset of TMA-related neurological impairment;

(c) onset of TMA-related cardiac impairment;

(d) onset of TMA-related gastrointestinal impairment;

(e) onset of TMA-related pulmonary impairment.

Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised eculizumab (where possible), and should be supported by objective clinical measures. The prescriber's cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.

Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.

The authority application must be in writing and must include:

(1) A completed authority prescription form; and

(2) A completed aHUS eculizumab Authority Application Supporting Information Form - Initial PBS-subsidised eculizumab treatment; and

(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and

(4) A detailed cover letter from the prescriber; and

(5) A copy of a current Certificate of vaccination or a statement that vaccination has or will be administered and appropriate antibiotic prophylaxis has been prescribed; and

(6) A measurement of body weight at the time of application; and

(7) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the two weeks prior to collection of the ADAMTS-13 assay; and

(8) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 1-2 weeks following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to the Department of Human Services within 27 days of commencement of eculizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised eculizumab treatment, underInitial treatment 1-balance of supply; and

(9) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days; and

(10) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within one month of application; and

(11) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.

 Compliance with modified Authority Required procedures
C6637 P6637

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

Atypical haemolytic uraemic syndrome (aHUS)

Extended initial treatment - Assessment phase

Patient must have received treatment under the initial restriction with PBS subsidised eculizumab for this condition; AND

Patient must have demonstrated on-going treatment response of PBS-subsidised eculizumab treatment for this condition; AND

Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND

Patient must not receive more than 56 weeks of treatment under this restriction.

Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.

A treatment response is defined as:

(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND

(2) One of the following:

a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or

b) an eGFR within +/- 25% from baseline; or

c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.

PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure.

A treatment failure is defined as a patient who is:

(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or

(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.

A maximum of up to 56 weeks of treatment is allowed under this restriction, however an application must be submitted at 6 months, 12 months, 18 months and 24 months following commencing PBS-subsidised eculizumab.

The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).

The authority application must be in writing and must include:

(1) A completed authority prescription form; and

(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Extended Initial treatment; and

(3) A detailed cover letter from the prescriber; and

(4) A copy of a current Certificate of vaccination or a statement that vaccination has or will be administered and appropriate antibiotic prophylaxis has been prescribed; and

(5) A measurement of body weight at the time of application; and

(6) An identified genetic mutation, if applicable; and

(7) A family history of aHUS, if applicable; and

(8) A history of multiple episodes of aHUS before commencing eculizumab treatment, if applicable; and

(9) A history of kidney transplant, if applicable, (especially if required due to aHUS); and

(10) An inclusion of the individual consequences of recurrent disease, if applicable; and

(11) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application; and

(12) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and

(13) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.

This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.

 Compliance with modified Authority Required procedures
C6642 P6642

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

Atypical haemolytic uraemic syndrome (aHUS)

Initial treatment - Balance of Supply

Patient must have received PBS-subsidised initial supply of eculizumab for this condition; AND

Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND

Patient must not receive more than 20 weeks supply under this restriction.

Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.

ADAMTS-13 activity result must have been submitted to the Department of Human Services. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application forInitial Treatment,ADAMTS-13 activity must have been measured 1-2 weeks following the last plasma exchange or infusion, and must have been submitted to the Department of Human Services within 27 days of commencement of eculizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the two weeks prior to collection of the ADAMTS-13 assay must also have been provided to Department of Human Services.

Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.

 Compliance with modified Authority Required procedures
C6668 P6668

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

Atypical haemolytic uraemic syndrome (aHUS)

Continuing treatment

Patient must have received treatment under Extended Initial restriction with PBS subsidised eculizumab for this condition; AND

Patient must have demonstrated on-going treatment response of PBS-subsidised eculizumab treatment for this condition; AND

Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND

Patient must not receive more than 24 weeks of treatment under this restriction.

Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.

A treatment response is defined as:

(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND

(2) One of the following:

a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or

b) an eGFR within +/- 25% from baseline; or

c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.

PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure.

A treatment failure is defined as a patient who is:

(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or

(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.

The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).

The authority application must be in writing and must include:

(1) A completed authority prescription form; and

(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and

(3) A detailed cover letter from the prescriber; and

(4) A copy of a current Certificate of vaccination or a statement that vaccination has or will be administered and appropriate antibiotic prophylaxis has been prescribed; and

(5) A measurement of body weight at the time of application; and

(6) An identified genetic mutation, if applicable; and

(7) A family history of aHUS, if applicable; and

(8) A history of multiple episodes of aHUS before recommencing eculizumab treatment, if applicable; and

(9) A history of kidney transplant if applicable (especially if required due to aHUS); and

(10) An inclusion of the individual consequences of recurrent disease, if applicable; and

(11) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application; and

(12) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and

(13) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.

This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.

 Compliance with modified Authority Required procedures
C6686 P6686

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

Atypical haemolytic uraemic syndrome (aHUS)

Extended Continuing treatment

Patient must have received treatment under the Continuing treatment with PBS-subsidised eculizumab for this condition; AND

Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND

Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND

Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40% on current objective measurement; OR

Patient must have severe TMA-related neurological impairment; OR

Patient must have severe TMA-related gastrointestinal impairment; OR

Patient must have severe TMA-related pulmonary impairment on current objective measurement; OR

Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 mL/min); OR

Patient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with eculizumab; AND

Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.

Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.

A treatment response is defined as:

(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND

(2) One of the following:

a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or

b) an eGFR within +/- 25% from baseline; or

c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.

PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure. A treatment failure is defined as a patient who is:

(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or

(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.

The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).

The authority application must be in writing and must include:

(1) A completed authority prescription form; and

(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and

(3) A detailed cover letter from the prescriber; and

(4) A copy of a current Certificate of vaccination or a statement that vaccination has or will be administered and appropriate antibiotic prophylaxis has been prescribed; and

(5) A measurement of body weight at the time of application; and

(6) An identified genetic mutation, if applicable; and

(7) A family history of aHUS, if applicable; and

(8) A history of multiple episodes of aHUS before commencing eculizumab treatment, if applicable; and

(9) A history of kidney transplant, if applicable (especially if required due to aHUS); and

(10) An inclusion of the individual consequences of recurrent disease; and

(11) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment; and

(12) Evidence that the patient has had a treatment response including haematological results of no more than 1 month old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 month old at the time of application; and

(13) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and

(14) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.

This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.

 Compliance with modified Authority Required procedures
C6687 P6687

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

Atypical haemolytic uraemic syndrome (aHUS)

Recommencement of treatment

Patient must have demonstrated treatment response to previous treatment with PBS-subsidised eculizumab for this condition; AND

Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND

Patient must have the following clinical conditions:(i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal;AND(ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L);OR(iii) TMA-related organ impairment including on recent biopsy; AND

Patient must not receive more than 24 weeks of treatment under this restriction.

Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.

A treatment response is defined as:

(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND

(2) One of the following:

a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or

b) an eGFR within +/- 25% from baseline; or

c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.

PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure. A treatment failure is defined as a patient who is:

(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or

(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.

The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).

The authority application must be in writing and must include:

(1) A completed authority prescription form(s); and

(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Recommencement of treatment; and

(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and

(4) A detailed cover letter from the prescriber; and

(5) A copy of a current Certificate of vaccination or a statement that vaccination has or will be administered and appropriate antibiotic prophylaxis has been prescribed; and

(6) A measurement of body weight at the time of application, and

(7) An identified genetic mutation, if applicable; and

(8) A family history of aHUS if applicable; and

(9) A history of multiple episodes of aHUS following the treatment break, if applicable; and

(10) A history of kidney transplant if applicable (especially if required due to aHUS); and

(11) An inclusion of the individual consequences of recurrent disease; and

(12) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;

(13) Evidence that the patient has had a treatment response to their previous treatment with eculizumab; and

(14) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and

(15) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.

This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.

 Compliance with modified Authority Required procedures
C6688 P6688

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

Atypical haemolytic uraemic syndrome (aHUS)

Continuing recommencement of treatment

Patient must have received treatment under Recommencement of treatment restriction with PBS-subsidised eculizumab for this condition; AND

Patient must have demonstrated ongoing treatment response to the previous 24 weeks of PBS-subsidised eculizumab for this condition; AND

Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND

Patient must not receive more than 24 weeks of treatment under this restriction.

Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.

A treatment response is defined as:

(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND

(2) One of the following:

a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or

b) an eGFR within +/- 25% from baseline; or

c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.

PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure. A treatment failure is defined as a patient who is:

(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or

(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.

The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).

The authority application must be in writing and must include:

(1) A completed authority prescription form; and

(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and

(3) A detailed cover letter from the prescriber; and

(4) A copy of a current Certificate of vaccination or a statement that vaccination has or will be administered and appropriate antibiotic prophylaxis has been prescribed; and

(5) A measurement of body weight at the time of application; and

(6) An identified genetic mutation, if applicable; and

(7) A family history of aHUS, if applicable; and

(8) A history of multiple episodes of aHUS before recommencing eculizumab treatment, if applicable; and

(9) A history of kidney transplant if applicable (especially if required due to aHUS); and

(10) An inclusion of the individual consequences of recurrent disease, if applicable; and

(11) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application; and

(12) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and

(13) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.

This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Filgrastim

Substitute:

Filgrastim 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
C6619

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

Assisting autologous peripheral blood progenitor cell transplantation

The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.

 Compliance with Authority Required procedures
C6620

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

Chronic cyclical neutropenia

Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND

Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; OR

Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.

 Compliance with Authority Required procedures
C6621

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

Severe chronic neutropenia

Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; OR

Patient must have neutrophil dysfunction; AND

Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; OR

Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.

 Compliance with Authority Required procedures - Streamlined Authority Code 6621
C6633

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

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
C6640

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

Chronic cyclical neutropenia

Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND

Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; OR

Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.

 Compliance with Authority Required procedures - Streamlined Authority Code 6640
C6649

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

Mobilisation of peripheral blood progenitor cells

The treatment must be in a normal volunteer for use in allogeneic transplantation.

 Compliance with Authority Required procedures
C6650

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

Assisting bone marrow transplantation

Patient must be receiving marrow-ablative chemotherapy prior to the transplantation.

 Compliance with Authority Required procedures
C6651

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

Severe congenital neutropenia

Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND

Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.

 Compliance with Authority Required procedures
C6652

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

Severe chronic neutropenia

Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; OR

Patient must have neutrophil dysfunction; AND

Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; OR

Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.

 Compliance with Authority Required procedures
C6653

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

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 6653
C6654

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

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 6654
C6655

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

Assisting autologous peripheral blood progenitor cell 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 6655
C6679

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

Assisting bone marrow transplantation

Patient must be receiving marrow-ablative chemotherapy prior to the transplantation.

 Compliance with Authority Required procedures - Streamlined Authority Code 6679
C6680

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

Severe congenital neutropenia

Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND

Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.

 Compliance with Authority Required procedures - Streamlined Authority Code 6680

  1. Schedule 3, after entry for Ganciclovir

Insert:

Grazoprevir with elbasvir C5969 P5969

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND

Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND

The treatment must be limited to a maximum duration of 12 weeks.

 Compliance with Authority Required procedures
C6625 P6625

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND

Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND

The treatment must be limited to a maximum duration of 16 weeks.

 Compliance with Authority Required procedures

  1. Schedule 3, entry for Infliximab

Omit entry for: C6616

Insert in numerical order:

C6669 P6669

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

Moderate to severe ulcerative colitis

Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)

Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal; AND

Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR

Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR

Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more months of treatment of an appropriately dosed thiopurine agent; AND

Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR

Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR

Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; OR

Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years).

Patient must be 6 years of age or older.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR

Must be treated by a paediatrician; OR

Must be treated by a specialist paediatric gastroenterologist.

Applications for authorisation of initial treatment must be in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and

(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and

(iii) the signed patient acknowledgement or guardian acknowledgement.

A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.

All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.

The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application.

Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis.

Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.

A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.

The patient or guardian (required if patient is aged 6 to 17 years) must have signed a patient acknowledgement indicating that he or she understands and acknowledges that the PBS-subsidised treatment will cease if he or she does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.

If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.

If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.

Details of the accepted toxicities including severity can be found on the Department of Human Services website.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Lenograstim

Substitute:

Lenograstim 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
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
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
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
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
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
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
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
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
C6622

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 rhabdomyosarcoma.

 Compliance with Authority Required procedures
C6623

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

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

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

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
C6634

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 osteosarcoma.

 Compliance with Authority Required procedures - Streamlined Authority Code 6634
C6644

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 Ewing's sarcoma.

 Compliance with Authority Required procedures - Streamlined Authority Code 6644
C6649

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

Mobilisation of peripheral blood progenitor cells

The treatment must be in a normal volunteer for use in allogeneic transplantation.

 Compliance with Authority Required procedures
C6653

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

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 6653
C6654

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

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 6654
C6656

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 Ewing's sarcoma.

 Compliance with Authority Required procedures
C6657

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

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 6657
C6663

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 osteosarcoma.

 Compliance with Authority Required procedures
C6673

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's lymphoma (intermediate or high grade).

 Compliance with Authority Required procedures - Streamlined Authority Code 6673
C6681

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's lymphoma (intermediate or high grade).

 Compliance with Authority Required procedures
C6682

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 rhabdomyosarcoma.

 Compliance with Authority Required procedures - Streamlined Authority Code 6682

  1. Schedule 3, entry after Maraviroc

Insert:

Mepolizumab C6635 P6635

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

Uncontrolled severe eosinophilic asthma

Continuing treatment

Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug; AND

The treatment must not be used in combination with, or within 6 months of treatment with, PBS-subsidised omalizumab.

Patient must be aged 12 years or older.

Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.

An adequate response to mepolizumab treatment is defined as:

(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,

OR

(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline.

All applications for continuing treatment with mepolizumab must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, and the assessment of oral corticosteroid dose, must be made at around 26 to 30weeks after the first dose of PBS-subsidised mepolizumab so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

The first assessment should, where possible, be completed by the same physician who initiated treatment with mepolizumab. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with mepolizumab.

A patient who fails to respond to a course of PBS-subsidised mepolizumab for the treatment of uncontrolled severe eosinophilic asthma will not be eligible to receive further PBS-subsidised treatment with mepolizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of mepolizumab sufficient for 24 weeks of therapy.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Severe Eosinophilic Asthma Continuing PBS Authority Application - Supporting Information Form which includes details of maintenance oral corticosteroid dose; and

(c) a completed Asthma Control Questionnaire (ACQ-5) calculation sheet including the date of assessment of the patient's symptoms

 Compliance with modified Authority Required procedures
C6646 P6646

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

Uncontrolled severe eosinophilic asthma

Initial treatment - grandfather patients

Patient must have received non-PBS treatment with this drug for this condition prior to 1 January 2017; AND

Patient must be receiving treatment with this drug for this condition at the time of application; AND

Patient must have had, prior to commencement of mepolizumab, a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) Forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or(ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or(iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; AND

Patient must have had blood eosinophil count greater than or equal to 300 cells per microlitre prior to commencement of mepolizumab; AND

Patient must have had a duration of asthma of at least 1 year prior to commencement of mepolizumab; AND

Patient must have failed to achieve adequate control with optimised asthma therapy prior to mepolizumab therapy despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND

Patient must have signed a patient or parent/guardian acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; AND

Patient must have demonstrated an adequate response to treatment with mepolizumab; AND

The treatment must not be used in combination with omalizumab.

Patient must be aged 12 years or older.

Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.

Optimised asthma therapy includes:

(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;

AND

(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.

If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.

A review of the patient's records should be conducted to extract pre- and post-mepolizumab data on symptoms, quality of life, medication doses, exacerbations and hospitalisations. Parameters to establish response are: (i) a reduction in Asthma Control Questionnaire (ACQ-5) score of at least 0.5; and/or(ii) maintenance oral corticosteroid dose reduced by at least 25% from baseline.

The assessment of the patient's response to the initial PBS subsidised course of treatment must be made at around 18 to 22 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The same parameters used to establish response to non-PBS-subsidised therapy with mepolizumab should be used for the assessment.

This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with mepolizumab.

Patients will be eligible to receive continuing courses of mepolizumab treatment of up to 24 weeks providing they continue to demonstrate an adequate response to treatment.

A patient may qualify for PBS-subsidised treatment under this restriction once only.

A patient who fails to respond to a course of PBS-subsidised mepolizumab for the treatment of uncontrolled severe eosinophilic asthma will not be eligible to receive further PBS-subsidised treatment with mepolizumab or omalizumab within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for a continuing course of mepolizumab sufficient for 24 weeks of therapy.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Severe Eosinophilic Asthma Grandfather PBS Authority Application - Supporting Information Form,

which includes the following:

(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and

(ii) details of pre- and post-mepolizumab data on symptoms, quality of life, medication doses, severe exacerbation/s and hospitalisations, and

(iii) the signed patient or parent/guardian acknowledgement; and

(c) a copy of the pre-mepolizumab eosinophil pathology report.

 Compliance with modified Authority Required procedures
C6665 P6665

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

Uncontrolled severe eosinophilic asthma

Initial treatment

Patient must be under the care of the same physician for at least 12 months; AND

Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; AND

Patient must have a duration of asthma of at least 1 year; AND

Patient must have forced expiratory volume (FEV1) less than or equal to 80% predicted, documented on 1 or more occasions in the previous 12 months; AND

Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 6 weeks; AND

Patient must have signed a patient or parent/guardian acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; AND

Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND

The treatment must not be used in combination with, or within 6 months of treatment with, PBS-subsidised omalizumab.

Patient must be aged 12 years or older.

Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.

Optimised asthma therapy includes:

(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;

AND

(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.

If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.

The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:

(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND

(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.

The Asthma Control Questionnaire (5 item version) assessment of the patient must be made at time of application for treatment (to establish baseline score) and again around 26 to 30 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

This assessment at around 26 to 30 weeks, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with mepolizumab.

A patient who fails to respond to a course of PBS-subsidised mepolizumab for the treatment of uncontrolled severe eosinophilic asthma will not be eligible to receive further PBS-subsidised treatment with mepolizumab or omalizumab within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request 7 repeats to provide for an initial course of mepolizumab sufficient for 32 weeks of therapy.

Mepolizumab and omalizumab may not be used concurrently or within 6 months of each other. A patient is required to have ceased treatment with omalizumab for 6 months prior to initiating treatment with mepolizumab.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Severe Eosinophilic Asthma Initial PBS Authority Application - Supporting Information Form,

which includes the following:

(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and

(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and

(iii) the signed patient or parent/guardian acknowledgement; and

(c) a copy of the eosinophil pathology report; and

(d) a completed Asthma Control Questionnaire (ACQ-5) calculation sheet including the date of assessment of the patient's symptoms.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Omalizumab

Omit entry for: C4880 C6142

Insert in numerical order:

C6627

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

Uncontrolled severe allergic asthma

Initial treatment

Patient must be under the care of the same physician for at least 12 months; AND

Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; AND

Patient must have a duration of asthma of at least 1 year; AND

Patient must have forced expiratory volume (FEV1) less than or equal to 80% predicted, documented on 1 or more occasions in the previous 12 months; AND

Patient must have past or current evidence of atopy, documented by skin prick testing or RAST; AND

Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND

Patient must have signed a patient or parent/guardian acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; AND

Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND

Patient must not receive more than 28 weeks of treatment under this restriction; AND

The treatment must not be used in combination with, or within 6 months of treatment with, PBS-subsidised mepolizumab.

Patient must be aged 12 years or older.

Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.

Optimised asthma therapy includes:

(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;

AND

(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.

If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.

The initial IgE assessment must be no more than 12 months old at the time of application.

The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:

(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND

(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.

The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, must be made at around 22 to 26 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with omalizumab.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab or mepolizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Severe Allergic Asthma PBS Authority Application - Supporting Information Form,

which includes the following:

(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and

(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and

(iii) the signed patient or parent/guardian acknowledgement; and

(c) the IgE pathology report; and

(d) a completed Asthma Control Questionnaire (ACQ-5) calculation sheet including the date of assessment of the patient's symptoms.

 Compliance with modified Authority Required procedures
C6689

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

Uncontrolled severe allergic asthma

Continuing treatment

Patient must have a documented history of severe allergic asthma; AND

Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

The treatment must not be used in combination with, or within 6 months of treatment with, PBS-subsidised mepolizumab.

Patient must be aged 12 years or older.

Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.

An adequate response to omalizumab treatment is defined as:

(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR

(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline, OR

(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).

All applications for continuing treatment with omalizumab must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose, and the assessment of time adjusted exacerbation rate must be made at around 18 to 22 weeks after the first dose of PBS-subsidised omalizumab so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with omalizumab.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks of therapy.

The authority application must be made in writing and must include:

(a) a completed authority prescription form(s); and

(b) a completed Severe Allergic Asthma PBS Authority Application and Supporting Information Form which includes details of maintenance oral corticosteroid dose; and

(c) a completed Asthma Control Questionnaire (ACQ-5) calculation sheet including the date of assessment of the patient's symptoms and is endorsed with the signature of the prescriber; for patients transitioned from the paediatric to the adolescent/adult restrictions an exacerbation calculation sheet may be submitted.

 Compliance with modified Authority Required procedures

  1. Schedule 3, after entry for Rilpivirine

Insert:

Riociguat C6624

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

Chronic thromboembolic pulmonary hypertension (CTEPH)

Grandfathered patients

Patient must have previously received treatment with this drug for this condition prior to 1 January 2017; AND

Patient must have a documented history of WHO Functional Class II, III or IV CTEPH; AND

The condition must be inoperable by pulmonary endarterectomy; OR

The condition must be recurrent or persistent following pulmonary endarterectomy; AND

The treatment must be the sole PBS-subsidised agent for this condition.

Patient must be aged 18 years or older.

Must be treated in a centre with expertise in the management of CTEPH.

CTEPH that is inoperable by pulmonary endarterectomy is defined as follows:

Right heart catheterisation (RHC) demonstrating pulmonary vascular resistance (PVR) of greater than 300 dyn*sec*cm-5measured at least 90 days after start of full anticoagulation; and

A mean pulmonary artery pressure (PAPmean) of greater than 25 mmHg at least 90 days after start of full anticoagulation.

CTEPH that is recurrent or persistent subsequent to pulmonary endarterectomy is defined as follows:

RHC demonstrating a PVR of greater than 300 dyn*sec*cm-5measured at least 180 days following pulmonary endarterectomy.

Where a RHC cannot be performed due to right ventricular dysfunction, an echocardiogram demonstrating the dysfunction must be provided at the time of application.

Applications for authorisation must be in writing and must include:(1) A completed authority prescription form; and(2) a completed CTEPH PBS Initial Authority Application - Supporting Information form which includes results from the 3 tests below, to establish baseline measurements, where available:(i) RHC composite assessment, and(ii) ECHO composite assessment, and(iii) 6 Minute Walk Test (6MWT); and(3) a signed patient acknowledgment form; and(4) confirmation of evidence of inoperable CTEPH including results of a pulmonary vascular resistance (PVR), a mean pulmonary artery pressure (PAPmean) and the starting date of full anticoagulation; or(5) confirmation of evidence of recurrent or persistent CTEPH including result of PVR and the date that pulmonary endarterectomy was performed; or(6) confirmation of an echocardiogram demonstrating right ventricular dysfunction.

Where it is not possible to perform all 3 tests above on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:(1) RHC plus ECHO composite assessments;(2) RHC composite assessment plus 6MWT;(2) RHC composite assessment only.

In circumstance where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:(1) ECHO composite assessment plus 6MWT;(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.

A maximum of 5 repeats will be authorised.

A patient may qualify for PBS-subsidised treatment under this restriction once only.

For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

 Compliance with modified Authority Required procedures
C6641

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

Chronic thromboembolic pulmonary hypertension (CTEPH)

Balance of supply

Patient must have received insufficient therapy with this agent under the Initial treatment restriction to complete a maximum of 20 weeks of treatment; OR

Patient must have received insufficient therapy with this agent under the Continuing treatment restriction to complete a maximum of 24 weeks of treatment; OR

Patient must have received insufficient therapy with this agent under the Grandfathering restriction to complete a maximum of 24 weeks of treatment; AND

The treatment must provide no more than the balance of up to 20 or 24 weeks of treatment available under the above respective restriction; AND

The treatment must be the sole PBS-subsidised agent for this condition.

Patient must be aged 18 years or older.

Must be treated in a centre with expertise in the management of CTEPH.

 Compliance with modified Authority Required procedures
C6645

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

Chronic thromboembolic pulmonary hypertension (CTEPH)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must demonstrate stable or responding disease; AND

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

Patient must be aged 18 years or older.

Must be treated in a centre with expertise in the management of CTEPH.

Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed CTEPH PBS Continuing Authority Application - Supporting Information form which includes results from the three tests below, where available:(i) RHC composite assessment; and(ii) ECHO composite assessment; and(iii) 6 Minute Walk Test (6MWT).

Test requirements to establish response to treatment for continuation of treatment are as follows:

The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments plus 6MWT;

(2) RHC plus ECHO composite assessments;

(3) RHC composite assessment plus 6MWT;

(4) ECHO composite assessment plus 6MWT;

(5) RHC composite assessment only;

(6) ECHO composite assessment only.

The results of the same tests as conducted at baseline should be provided with each written continuing treatment application (i.e., every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.

The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.

Response to this drug is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease.

The assessment of the patient's response to the continuing 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

The maximum quantity per prescription must be based on the dosage recommendations in the TGA-approved Product Information and be limited to provide sufficient supply for 1 month of treatment.

A maximum of 5 repeats will be authorised.

Applications for continuing treatment with this drug should be made two weeks prior to the completion of the 6-month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.

Patients who fail to demonstrate disease stability or improvement to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

 Compliance with modified Authority Required procedures
C6664

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

Chronic thromboembolic pulmonary hypertension (CTEPH)

Initial treatment

Patient must have WHO Functional Class II, III or IV CTEPH; AND

The condition must be inoperable by pulmonary endarterectomy; OR

The condition must be recurrent or persistent following pulmonary endarterectomy; AND

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

Patient must be aged 18 years or older.

Must be treated in a centre with expertise in the management of CTEPH.

CTEPH that is inoperable by pulmonary endarterectomy is defined as follows:

Right heart catheterisation (RHC) demonstrating pulmonary vascular resistance (PVR) of greater than 300 dyn*sec*cm-5measured at least 90 days after start of full anticoagulation; and

A mean pulmonary artery pressure (PAPmean) of greater than 25 mmHg at least 90 days after start of full anticoagulation.

CTEPH that is recurrent or persistent subsequent to pulmonary endarterectomy is defined as follows:

RHC demonstrating a PVR of greater than 300 dyn*sec*cm-5measured at least 180 days following pulmonary endarterectomy.

Where a RHC cannot be performed due to right ventricular dysfunction, an echocardiogram demonstrating the dysfunction must be provided at the time of application.

Applications for authorisation must be in writing and must include:(1) completed authority prescription forms sufficient for dose titration; and(2) a completed CTEPH PBS Initial Authority Application - Supporting Information form which includes results from the 3 tests below, to establish baseline measurements, where available:(i) RHC composite assessment, and(ii) ECHO composite assessment, and(iii) 6 Minute Walk Test (6MWT); and(3) a signed patient acknowledgment form; and(4) confirmation of evidence of inoperable CTEPH including results of a pulmonary vascular resistance (PVR), a mean pulmonary artery pressure (PAPmean) and the starting date of full anticoagulation; or(5) confirmation of evidence of recurrent or persistent CTEPH including result of PVR and the date that pulmonary endarterectomy was performed; or(6) confirmation of an echocardiogram demonstrating right ventricular dysfunction.

Where it is not possible to perform all 3 tests above on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:(1) RHC plus ECHO composite assessments;(2) RHC composite assessment plus 6MWT;(3) RHC composite assessment only.

In circumstance where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:(1) ECHO composite assessment plus 6MWT;(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Prescriptions for dose titration must provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.

Approvals for subsequent authority prescription will be limited to 1 month of treatment, The quantity approved must be based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 3 repeats.

The assessment of the patient's response to the initial 20-week course of treatment should be made following the preceding 16 weeks of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

 Compliance with modified Authority Required procedures

  1. After Schedule 3, Part 1 – General statement for drugs for the treatment of hepatitis C

Substitute:

1  Criteria 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

2  Assessment 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

3  Treatment 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; or

(g)     GRAZOPREVIR with ELBASVIR 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; or

(g)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(h)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 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 Genotype 4; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks.
8

Patient:

(a)     with Genotype 4; and

(b)     who is treatment experienced; and

(c)              who is non-cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
9

Patient:

(a)     with:

(i)     Genotype 5; or

(ii)     Genotype 6; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
10

Patient:

(a)     with:

(i)     Genotype 5; or

(ii)     Genotype 6; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
11

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; or

(f)    GRAZOPREVIR with ELBASVIR for 12 weeks.
12

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; or

(g)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(h)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
13

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
14

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
15

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 RIBAVIRIN for 12 weeks; or

(e)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks.
16

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 RIBAVIRIN for 12 weeks; or

(e)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks.

17

Patient:

(a)     with Genotype 4; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks.
18

Patient:

(a)     with Genotype 4; and

(b)     who is treatment experienced; and

(c)             who is cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
19

Patient:

(a)     with:

(i)     Genotype 5; or

(ii)     Genotype 6; and

(b)   who is treatment naïve; and

(c)    who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
20

Patient:

(a)     with:

(i)     Genotype 5; or

(ii)     Genotype 6; and

(b)   who is treatment experienced; and

(c)    who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
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