National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 11) (PB 104 of 2017) (Cth)

PB 104 of 2017

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 11)

National Health Act 1953

___________________________________________________________________________

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

Dated 14 December 2017

JULIANNE QUAINE

Assistant Secretary

Private Health Insurance and Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 11).

(2)This Instrument may also be cited as PB 104 of 2017.

Commencement

This Instrument commences on 1 January 2018.

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

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

Schedule 1 Amendments

Part 1, Division 1, Section 4, definition for medication for the treatment of HIV or AIDS

(a)omit: (k) doxorubicin, pegylated liposomal substitute: (k) doxorubicin - pegylated liposomal

(b)omit: (s) foscarnet

(c)omit: (zj) tenofovir with emtricitabine efavirenz substitute: (zj) tenofovir with emtricitabine and efavirenz

Part 5, Division 2, Subsection 39(1)(a)(ii)(A)

omit duplicate: the

Part 5, Division 2, Subsection 39(1)(b)(ii)(A)

omit duplicate: the

Part 5, Division 2, Subsection 39(1)(c)(iii)(A)

omit duplicate: the

Schedule 1, entry for Alemtuzumab [Maximum Quantity: 5; Number of Repeats: 0]

(a)omit from the column headed “Brand”: Lemtrada

(b)omit from the column headed “Responsible Person”: GZ

Schedule 1, entry for Mannitol

omit from the column headed “Circumstances”: C5658 C5799 substitute: C7349 C7362 C7364 C7367

Schedule 2

omit table and substitute:

Code Responsible Person Australian Business Number

AF Alphapharm Pty Ltd 93 002 359 739

AN Amgen Australia Pty Limited 31 051 057 428

AT Actelion Pharmaceuticals Australia Pty Ltd 32 097 278 512

BD Biogen Australia Pty Ltd 30 095 760 115

BN Bayer Australia Ltd 22 000 138 714

BQ Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

BY Boehringer Ingelheim Pty Ltd 52 000 452 308

BZ Boucher & Muir Pty Ltd 58 000 140 474

CJ Celgene Pty Limited 42 118 998 771

CR Pharmacor Pty Limited 58 121 020 835

DZ Medsurge Healthcare Pty Ltd 92 124 728 892

EA Amneal Pharmaceuticals Pty Ltd 21 147 854 484

FK A. Menarini Australia Pty Limited 62 116 935 758

FN Fresenius Medical Care Australia Pty Ltd 80 067 557 877

GI Gilead Sciences Pty Limited 71 072 611 708

GK GlaxoSmithKline Australia Pty Ltd 47 100 162 481

GQ Generic Health Pty Ltd 93 110 617 859

GV Amgen Australia Pty Limited 31 051 057 428

GZ sanofi-aventis Australia Pty Ltd 31 008 558 807

IS Ipsen Pty Ltd 47 095 036 909

IX Clinect Pty Ltd 76 150 558 473

JC Janssen-Cilag Pty Ltd 47 000 129 975

JU Juno Pharmaceuticals Pty Ltd 55 156 303 650

LL Astellas Pharma Australia Pty Ltd 81 147 915 482

LQ Astellas Pharma Australia Pty Ltd 81 147 915 482

LR Cipla Australia Pty Ltd 46 132 155 063

LY Eli Lilly Australia Pty Ltd 39 000 233 992

MK Merck Sharp & Dohme (Australia) Pty Ltd 14 000 173 508

NV Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

OC Accord Healthcare Pty Ltd 49 110 502 513

PF Pfizer Australia Pty Ltd 50 008 422 348

RA Sun Pharma ANZ Pty Ltd 17 110 871 826

RI Dr Reddy's Laboratories (Australia) Pty Ltd 16 120 092 408

RO Roche Products Pty Ltd 70 000 132 865

RW Arrow Pharma Pty Ltd 35 605 909 920

RZ Dr Reddy’s Laboratories (Australia) Pty Ltd 16 120 092 408

SZ Sandoz Pty Ltd 60 075 449 553

TB Teva Pharma Australia Pty Limited 41 169 715 664

TD Stada Pharmaceuticals Australia Pty Limited 73 154 966 944

TK Takeda Pharmaceuticals Australia Pty Ltd 71 095 610 870

TX Apotex Pty Ltd 52 096 916 148

VE AbbVie Pty Ltd 48 156 384 262

VI ViiV Healthcare Pty Ltd 46 138 687 448

VR Vertex Pharmaceuticals (Australia) Pty Ltd 34 160 157 157

XA Pharmaxis Ltd 75 082 811 630

XI Alexion Pharmaceuticals Australasia Pty Ltd 59 132 343 036

ZI Shire Australia Pty Limited 29 128 941 819

Schedule 3

(a)omit from the column headed “Circumstances and Purposes” (all instances, where occurring):

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

(b)omit from the column headed “Circumstances and Purposes” (all instances, where occurring):

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

(c)omit from the column headed “Circumstances and Purposes” (all instances, where occurring):

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

(d)omit from the column headed “Authority Requirements – Part of Circumstances” (all instances, where occurring):

Written or Telephone

(e)omit from the column headed “Authority Requirements – Part of Circumstances” (all instances, where occurring):

Written and Telephone

Schedule 3, entry for Mannitol

substitute:

Mannitol C7349 Cystic fibrosis
The treatment must be as monotherapy; AND
Patient must be intolerant or inadequately responsive to dornase alfa.
Patient must be 6 years of age or older.
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.
To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. Compliance with Authority Required procedures

C7362 Cystic fibrosis
The treatment must be as monotherapy; AND
Patient must be intolerant or inadequately responsive to dornase alfa.
Patient must be 6 years of age or older.
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.
To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. Compliance with Authority Required procedures - Streamlined Authority Code 7362

C7364 Cystic fibrosis
The treatment must be in combination with dornase alfa; AND
Patient must be inadequately responsive to dornase alfa; AND
Patient must have trialled hypertonic saline for this condition.
Patient must be 6 years of age or older.
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.
To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. Compliance with Authority Required procedures

C7367 Cystic fibrosis
The treatment must be in combination with dornase alfa; AND
Patient must be inadequately responsive to dornase alfa; AND
Patient must have trialled hypertonic saline for this condition.
Patient must be 6 years of age or older.
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.
To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. Compliance with Authority Required procedures - Streamlined Authority Code 7367

Schedule 3, entry for Thalidomide

substitute:

Thalidomide C5909 Multiple myeloma Compliance with Authority Required procedures

C5914 Multiple myeloma Compliance with Authority Required procedures - Streamlined Authority Code 5914

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Citations

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 11) (PB 104 of 2017) (Cth)

Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0

Code	Responsible Person	Australian Business Number
AF	Alphapharm Pty Ltd	93 002 359 739
AN	Amgen Australia Pty Limited	31 051 057 428
AT	Actelion Pharmaceuticals Australia Pty Ltd	32 097 278 512
BD	Biogen Australia Pty Ltd	30 095 760 115
BN	Bayer Australia Ltd	22 000 138 714
BQ	Bristol-Myers Squibb Australia Pty Ltd	33 004 333 322
BY	Boehringer Ingelheim Pty Ltd	52 000 452 308
BZ	Boucher & Muir Pty Ltd	58 000 140 474
CJ	Celgene Pty Limited	42 118 998 771
CR	Pharmacor Pty Limited	58 121 020 835
DZ	Medsurge Healthcare Pty Ltd	92 124 728 892
EA	Amneal Pharmaceuticals Pty Ltd	21 147 854 484
FK	A. Menarini Australia Pty Limited	62 116 935 758
FN	Fresenius Medical Care Australia Pty Ltd	80 067 557 877
GI	Gilead Sciences Pty Limited	71 072 611 708
GK	GlaxoSmithKline Australia Pty Ltd	47 100 162 481
GQ	Generic Health Pty Ltd	93 110 617 859
GV	Amgen Australia Pty Limited	31 051 057 428
GZ	sanofi-aventis Australia Pty Ltd	31 008 558 807
IS	Ipsen Pty Ltd	47 095 036 909
IX	Clinect Pty Ltd	76 150 558 473
JC	Janssen-Cilag Pty Ltd	47 000 129 975
JU	Juno Pharmaceuticals Pty Ltd	55 156 303 650
LL	Astellas Pharma Australia Pty Ltd	81 147 915 482
LQ	Astellas Pharma Australia Pty Ltd	81 147 915 482
LR	Cipla Australia Pty Ltd	46 132 155 063
LY	Eli Lilly Australia Pty Ltd	39 000 233 992
MK	Merck Sharp & Dohme (Australia) Pty Ltd	14 000 173 508
NV	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
OC	Accord Healthcare Pty Ltd	49 110 502 513
PF	Pfizer Australia Pty Ltd	50 008 422 348
RA	Sun Pharma ANZ Pty Ltd	17 110 871 826
RI	Dr Reddy's Laboratories (Australia) Pty Ltd	16 120 092 408
RO	Roche Products Pty Ltd	70 000 132 865
RW	Arrow Pharma Pty Ltd	35 605 909 920
RZ	Dr Reddy’s Laboratories (Australia) Pty Ltd	16 120 092 408
SZ	Sandoz Pty Ltd	60 075 449 553
TB	Teva Pharma Australia Pty Limited	41 169 715 664
TD	Stada Pharmaceuticals Australia Pty Limited	73 154 966 944
TK	Takeda Pharmaceuticals Australia Pty Ltd	71 095 610 870
TX	Apotex Pty Ltd	52 096 916 148
VE	AbbVie Pty Ltd	48 156 384 262
VI	ViiV Healthcare Pty Ltd	46 138 687 448
VR	Vertex Pharmaceuticals (Australia) Pty Ltd	34 160 157 157
XA	Pharmaxis Ltd	75 082 811 630
XI	Alexion Pharmaceuticals Australasia Pty Ltd	59 132 343 036
ZI	Shire Australia Pty Limited	29 128 941 819

Mannitol	C7349	Cystic fibrosis The treatment must be as monotherapy; AND Patient must be intolerant or inadequately responsive to dornase alfa. Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures
C7362	Cystic fibrosis The treatment must be as monotherapy; AND Patient must be intolerant or inadequately responsive to dornase alfa. Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 7362
C7364	Cystic fibrosis The treatment must be in combination with dornase alfa; AND Patient must be inadequately responsive to dornase alfa; AND Patient must have trialled hypertonic saline for this condition. Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures
C7367	Cystic fibrosis The treatment must be in combination with dornase alfa; AND Patient must be inadequately responsive to dornase alfa; AND Patient must have trialled hypertonic saline for this condition. Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 7367

Thalidomide	C5909	Multiple myeloma	Compliance with Authority Required procedures
C5914	Multiple myeloma	Compliance with Authority Required procedures - Streamlined Authority Code 5914