National Health Act 1953 Amendment Special Arrangements under subsection 100(1) Highly specialised drugs program for public hospitals (No. PB 104 of 2009) (Cth)

Amendment Special Arrangements —Highly specialised drugs program for public hospitals

(PB 104 of 2009)

made under subsection 100(1) of the

National Health Act 1953

I, DECLAN O’CONNOR-COX, Assistant Secretary, Access and Systems Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.

Dated 23 October 2009

Signed

DECLAN O’CONNOR-COX

Assistant Secretary

Access and Systems Branch

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program

1 Commencement

This instrument commences on 1 November 2009.

2 Amendment of PB 61 of 2009

Schedule 1 amends PB 61 of 2009.

Schedule 1 Amendments

Schedule 1, item dealing with Abacavir

omit from the column headed “Circumstances”:

42. (a) CD4 cell counts of less than 500 per cubic millimetre; or
43. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Abacavir with Lamivudine

omit from the column headed “Circumstances”:

44. (a) CD4 cell counts of less than 500 per cubic millimetre; or
45. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Abacavir with Lamivudine and Zidovudine

omit from the column headed “Circumstances”:

46. (a) CD4 cell counts of less than 500 per cubic millimetre; or
47. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Atazanavir

omit from the column headed “Circumstances”:

48. (a) CD4 cell counts of less than 500 per cubic millimetre; or
49. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Baclofen

omit from the column headed “Circumstances”:

50. (1) of cerebral origin; or
51. (2) due to multiple sclerosis; or
52. (3) due to spinal cord injury; or
53. (4) due to spinal cord disease

and substitute:

(1) of cerebral origin; or
(2) due to multiple sclerosis; or
(3) due to spinal cord injury; or
(4) due to spinal cord disease

Schedule 1, item dealing with Clozapine

omit from the column headed “Circumstances”:

54. (a) non-responsive to other neuroleptic agents; or
55. (b) intolerant of other neuroleptic agents

and substitute:

(a) non-responsive to other neuroleptic agents; or
(b) intolerant of other neuroleptic agents

Schedule 1, item dealing with Cyclosporin

omit from the column headed “Circumstances”:

56. (1) dermatologists or clinical immunologists of patients with severe atopic
dermatitis for whom other systemic therapies are ineffective or inappropriate

57. (2) dermatologists of patients with severe psoriasis for whom other systemic
therapies are ineffective or inappropriate and in whom the disease has caused
significant interference with quality of life

58. (3) nephrologists of nephrotic syndrome in patients in whom steroids and
cytostatic drugs have failed or are not tolerated or are considered inappropriate
and in whom renal function is unimpaired

59. (4) rheumatologists or clinical immunologists of patients with severe active
rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents
(including methotrexate) are ineffective or inappropriate

and substitute:

(1) dermatologists or clinical immunologists of patients with severe atopic
dermatitis for whom other systemic therapies are ineffective or inappropriate

(2) dermatologists of patients with severe psoriasis for whom other systemic
therapies are ineffective or inappropriate and in whom the disease has caused
significant interference with quality of life

(3) nephrologists of nephrotic syndrome in patients in whom steroids and
cytostatic drugs have failed or are not tolerated or are considered inappropriate
and in whom renal function is unimpaired

(4) rheumatologists or clinical immunologists of patients with severe active
rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents
(including methotrexate) are ineffective or inappropriate

Schedule 1, item dealing with Darunavir

omit from the column headed “Circumstances”:

60. (a) evidence of HIV replication (viral load greater than 10,000 copies per mL); and/or
61. (b) CD4 cell counts of less than 500 per cubic millimetre.

A patient must have failed previous treatment with, or have resistance to, 3 different antiretroviral regimens which have included:
62. (i) at least 1 non-nucleoside reverse transcriptase inhibitor; and
63. (ii) at least 1 nucleoside reverse transcriptase inhibitor; and
64. (iii) at least 2 protease inhibitors.

and substitute:

(a) evidence of HIV replication (viral load greater than 10,000 copies per mL); and/or
(b) CD4 cell counts of less than 500 per cubic millimetre.

A patient must have failed previous treatment with, or have resistance to, 3 different antiretroviral regimens which have included:
(i) at least 1 non-nucleoside reverse transcriptase inhibitor; and
(ii) at least 1 nucleoside reverse transcriptase inhibitor; and
(iii) at least 2 protease inhibitors.

Schedule 1, item dealing with Delavirdine

omit from the column headed “Circumstances”:

65. (a) CD4 cell counts of less than 500 per cubic millimetre; or
66. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Didanosine

omit from the column headed “Circumstances”:

67. (a) CD4 cell counts of less than 500 per cubic millimetre; or
68. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Dornase Alfa

omit from the column headed “Circumstances”:

Use by cystic fibrosis patients who satisfy all of the following criteria:

69. (1) are 5 years of age or older

70. (2) have a FVC greater than 40% predicted for age, gender and height

71. (3) have evidence of chronic suppurative lung disease (cough and sputum
most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways
disease)

72. (4) are participating in a 4 week trial as detailed below or have achieved a
10% or greater improvement in FEV1 (compared to baseline established prior to
dornase alfa treatment) after a 4 week trial

In order for patients to be eligible for participation in the highly specialised drug
program, the following conditions must be met:

73. (1) Patients must be assessed at cystic fibrosis clinics/centres which are under
the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of dornase alfa under the highly specialised drug program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit

74. (2) The measurement of lung function is to be conducted by independent
(other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation

75. (3) Prior to dornase alfa therapy, a baseline measurement of FEV1 must be
undertaken during a stable period of the disease

76. (4) Initial therapy is limited to 4 weeks' treatment with dornase alfa at a dose
of 2.5 mg daily

77. (5) At or towards the end of the initial 4 weeks' trial, patients must be
reassessed and a further FEV1 measurement be undertaken (single test under
conditions as above). Patients who achieve a 10% or greater improvement in
FEV1 (compared to baseline established prior to dornase alfa treatment) are
eligible for continued subsidy under the HSD program at a dose of 2.5 mg daily

78. (6) Patients who fail to meet a 10% or greater improvement in FEV1 after the
initial 4 weeks' treatment at a dose of 2.5 mg daily, may have 1 further trial in the
next 12 months but not before 3 months after the initial trial

79. (7) Following an initial 6 months' therapy, a global assessment must be
undertaken involving the patient, the patient's family (in the case of paediatric
patients) and the treating physician(s) to establish that all agree that dornase alfa
treatment is continuing to produce worthwhile benefits. (Dornase alfa therapy
should cease if there is not general agreement of benefit as there is always the
possibility of harm from unnecessary use.) Further reassessments are to be
undertaken at six-monthly intervals

80. (8) Other aspects of treatment, such as physiotherapy, must be continued

81. (9) Where there is documented evidence that a patient already receiving

dornase alfa therapy would have met the criteria for subsidy (i.e. satisfied the
criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1)
then the patient is eligible to continue treatment under the highly specialised drug
program. Where such evidence is not available, patients will need to satisfy the
initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period)

and substitute:

Use by cystic fibrosis patients who satisfy all of the following criteria:

(1) are 5 years of age or older

(2) have a FVC greater than 40% predicted for age, gender and height

(3) have evidence of chronic suppurative lung disease (cough and sputum
most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways
disease)

(4) are participating in a 4 week trial as detailed below or have achieved a
10% or greater improvement in FEV1 (compared to baseline established prior to
dornase alfa treatment) after a 4 week trial

In order for patients to be eligible for participation in the highly specialised drug
program, the following conditions must be met:

(1) Patients must be assessed at cystic fibrosis clinics/centres which are under
the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of dornase alfa under the highly specialised drug program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit

(2) The measurement of lung function is to be conducted by independent
(other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation

(3) Prior to dornase alfa therapy, a baseline measurement of FEV1 must be
undertaken during a stable period of the disease

(4) Initial therapy is limited to 4 weeks' treatment with dornase alfa at a dose
of 2.5 mg daily

(5) At or towards the end of the initial 4 weeks' trial, patients must be
reassessed and a further FEV1 measurement be undertaken (single test under
conditions as above). Patients who achieve a 10% or greater improvement in
FEV1 (compared to baseline established prior to dornase alfa treatment) are
eligible for continued subsidy under the HSD program at a dose of 2.5 mg daily

(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the
initial 4 weeks' treatment at a dose of 2.5 mg daily, may have 1 further trial in the
next 12 months but not before 3 months after the initial trial

(7) Following an initial 6 months' therapy, a global assessment must be
undertaken involving the patient, the patient's family (in the case of paediatric
patients) and the treating physician(s) to establish that all agree that dornase alfa
treatment is continuing to produce worthwhile benefits. (Dornase alfa therapy
should cease if there is not general agreement of benefit as there is always the
possibility of harm from unnecessary use.) Further reassessments are to be
undertaken at six-monthly intervals

(8) Other aspects of treatment, such as physiotherapy, must be continued

(9) Where there is documented evidence that a patient already receiving

dornase alfa therapy would have met the criteria for subsidy (i.e. satisfied the
criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1)
then the patient is eligible to continue treatment under the highly specialised drug
program. Where such evidence is not available, patients will need to satisfy the
initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period)

Treatment of cystic fibrosis in a patient less than 5 years of age who has:

(1) A severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring frequent hospital admissions more frequently than 3 times per year; or

(2) Significant bronchiectasis on chest high resolution computed tomography scan; or

(3) Severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or

(4) Severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy.

In order for the patient to be eligible for participation in the highly specialised drugs program, the following conditions must be met:

(1) The patient must be assessed at a cystic fibrosis clinic/centre which is under the supervision of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis, and the prescribing of dornase alfa under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;

(2) Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented involving the patient, the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team to establish agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. Further reassessments are to be undertaken and documented yearly.

Continuation of treatment of cystic fibrosis in a patient 5 years of age or older, who initiated treatment with dornase alfa at an age of less than 5 years and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team, documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.

Treatment of cystic fibrosis in a patient less than 5 years of age who initiated treatment with dornase alfa prior to 1 November 2009 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team, documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.

Schedule 1, item dealing with Doxorubicin – Pegylated Liposomal

omit from the column headed “Circumstances”:

82. (a) extensive mucocutaneous involvement; or
83. (b) extensive visceral involvement

and substitute:

(a) extensive mucocutaneous involvement; or
(b) extensive visceral involvement

Schedule 1, item dealing with Efavirenz

omit from the column headed “Circumstances”:

84. (a) CD4 cell counts of less than 500 per cubic millimetre; or
85. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Emtricitabine

omit from the column headed “Circumstances”:

86. (a) CD4 cell counts of less than 500 per cubic millimetre; or
87. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Etanercept

omit from the column headed “Circumstances”:

Juvenile chronic arthritis — initial treatment
(previous treatment not PBS-subsidised)
Initial PBS-subsidised supply for continuing treatment by a rheumatologist, or
under the supervision of a paediatric rheumatology treatment centre, of severe
active polyarticular course juvenile chronic arthritis in patients receiving treatment with etanercept prior to 1 December 2002, whose parent or authorised guardian has signed a patient agreement form indicating that they understand and
acknowledge that PBS-subsidised treatment will cease if the predetermined
response criteria do not support continuation of PBS-subsidised treatment, and
who have demonstrated a response as specified in the criteria for continuing PBS subsidised treatment with etanercept; and

where the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment

Schedule 1, item dealing with Etanercept

omit from the column headed “Circumstances”:

In respect of the injections 50mg in 1 mL single use pre-filled syringes, 4:

and substitute:

In respect of the injections 50mg in 1 mL single use pre-filled syringes, 4 and the injection 50 mg in 1 mL single use auto-injector, 4:

Schedule 1, item dealing with Everolimus

omit from the column headed “Circumstances”:

88. (a) prophylaxis of renal allograft rejection, where management includes
initiation, stabilisation and review of therapy as required; or
89. (b) prophylaxis of cardiac allograft rejection, where management includes
initiation, stabilisation and review of therapy as required

and substitute:

(a) prophylaxis of renal allograft rejection, where management includes
initiation, stabilisation and review of therapy as required; or
(b) prophylaxis of cardiac allograft rejection, where management includes
initiation, stabilisation and review of therapy as required

Schedule 1, item dealing with Fosamprenavir

omit from the column headed “Circumstances”:

90. (a) CD4 cell counts of less than 500 per cubic millimetre; or
91. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Indinavir

omit from the column headed “Circumstances”:

92. (a) CD4 cell counts of less than 500 per cubic millimetre; or
93. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Lamivudine with Zidovudine

omit from the column headed “Circumstances”:

94. (a) CD4 cell counts of less than 500 per cubic millimetre; or
95. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, after item dealing with Lanthanum

insert in the columns in the order indicated:

Lenalidomide

Initial PBS-subsidised treatment, as monotherapy or in combination with dexamethasone, of multiple myeloma in a patient who has progressive disease, who has received at least 1 prior therapy (other than thalidomide), who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily; and

where thalidomide treatment failure is defined as:

(1) confirmed disease progression during or within 6 months of discontinuing thalidomide treatment; or

(2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment;

where progressive disease is defined as at least 1 of the following:

(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or

(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or

(c) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or

(d) an increase in the size or number of lytic bone lesions (not including compression fractures); or

(e) at least a 25% increase in the size of an existing, or the development of a new, soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or

(f) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause);

where severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living;

where toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug-related seizures, serious Grade 3 or 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity; and

where the following conditions apply:

the patient is not receiving concomitant PBS-subsidised bortezomib;

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form, which includes details of prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of thalidomide treatment failure; and details of the basis of the diagnosis of progressive disease; and

(2) duration of thalidomide and daily dose prescribed; and

(3) a signed patient acknowledgment;

if the dosing requirement for thalidomide cannot be met, the authority application states the reasons why this criterion cannot be satisfied;

to enable confirmation of eligibility by the Medicare Australia CEO, current diagnostic reports of the following are required:

(a) the level of serum M protein (monoclonal protein); and

(b) if Bence-Jones proteinuria is present, the results of 24-hour urinary light chain M protein excretion;

if neither serum M protein nor urine Bence-Jones protein is present in measurable quantities, additional diagnostic reports are required, including:

(c) bone marrow aspirate and trephine; and

(d) if present, the size and location of lytic bone lesions (not including compression fractures); or

(e) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination, i.e. magnetic resonance imaging or computed tomography scan; or

(f) if present, the level of hypercalcaemia, corrected for albumin concentration; or

(g) if present, the serum free light chain levels;

results of the above diagnostic reports must be provided with the authority application as follows:

(i) for all patients, results for (a) and (b) must be provided;

(ii) where the patient has oligo-secretory or non-secretory multiple myeloma, (c) must be provided and if relevant (d), (e) or (f);

(iii) in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, (g) must be provided;

where results for 1 or more of the specified diagnostic reports cannot be provided, the authority application states the reason or reasons these cannot be provided

Continuing PBS-subsidised treatment, as monotherapy or in combination with dexamethasone, of multiple myeloma in a patient who has previously been issued with an authority prescription for lenalidomide and who does not have progressive disease, and where progressive disease is defined as at least 1 of the following:

(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or

(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or

(c) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or

(d) an increase in the size or number of lytic bone lesions (not including compression fractures); or

(e) at least a 25% increase in the size of an existing, or the development of a new, soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or

(f) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause)

Schedule 1, item dealing with Lopinavir with Ritonavir

omit from the column headed “Circumstances”:

96. (a) CD4 cell counts of less than 500 per cubic millimetre; or
97. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Nevirapine

omit from the column headed “Circumstances”:

98. (a) CD4 cell counts of less than 500 per cubic millimetre; or
99. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Ritonavir

omit from the column headed “Circumstances”:

100. (a) CD4 cell counts of less than 500 per cubic millimetre; or
101. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Saquinavir

omit from the column headed “Circumstances”:

102. (a) CD4 cell counts of less than 500 per cubic millimetre; or
103. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Stavudine

omit from the column headed “Circumstances”:

104. (a) CD4 cell counts of less than 500 per cubic millimetre; or
105. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Tenofovir

omit from the column headed “Circumstances”:

106. (a) CD4 cell counts of less than 500 per cubic millimetre; or
107. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Tenofovir with Emtricitabine

omit from the column headed “Circumstances”:

108. (a) CD4 cell counts of less than 500 per cubic millimetre; or
109. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 1, item dealing with Zidovudine

omit from the column headed “Circumstances”:

110. (a) CD4 cell counts of less than 500 per cubic millimetre; or
111. (b) viral load of greater than 10,000 copies per mL

and substitute:

(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL

Schedule 2, after item dealing with Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL

insert in the columns in the order indicated:

Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre-filled syringe

Injection

Apomine PFS

Schedule 2, item dealing with Atazanavir

insert as the first entry in the columns in the order indicated:

Capsule 100 mg (as sulfate)

Oral

Reyataz

Schedule 2, item dealing with Etanercept

omit from the columns in the order indicated:

Injection 50 mg in 1 mL single use injection pen, 4

Injection

Enbrel

and substitute:

Injection 50 mg in 1 mL single use auto-injector, 4

Injection

Enbrel

Schedule 2, after items dealing with Lanthanum

insert in the columns in the order indicated:

Lenalidomide	Capsule 5 mg	Oral	Revlimid
Capsule 10 mg	Oral	Revlimid
Capsule 15 mg	Oral	Revlimid
Capsule 25 mg	Oral	Revlimid

Schedule 2, item dealing with Ribavirin and Peginterferon Alfa-2a

omit from the columns in the order indicated:

Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms	Injection/oral	Pegasys RBV
Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms	Injection/oral	Pegasys RBV
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms	Injection/oral	Pegasys RBV

Schedule 3, item dealing with Ribavirin and Peginterferon Alfa-2a

omit from the columns in the order indicated:

Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms

Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms

Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms

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Citations

National Health Act 1953 - Amendment Special Arrangements under subsection 100(1) - Highly specialised drugs program for public hospitals (No. PB 104 of 2009) (Cth)

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