National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 6) (No. PB 47 of 2012)

Link to law: https://www.comlaw.gov.au/Details/F2012L01615

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PB 47 of 2012
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 6)
 
National Health Act 1953
___________________________________________________________________________
 
 
I, FELICITY MCNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated       25 July 2012
 
 
 
 
 
 
 
 
 
 
 
 
 
FELICITY MCNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
___________________________________________________________________________
 
 
 
 
1              Name of Instrument
 
(1)                This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No.6).
 
(2)                This Instrument may also be cited as PB 47 of 2012.
 
2             Commencement
This Instrument commences on 1 August 2012.
3              Amendments to PB 116 of 2010
Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).
 
 
Schedule 1                   Amendments
[1]    Schedule 1, entry for Adalimumab
omit from the column headed ‘Responsible Person’ ( all instances):
AB
substitute:
VE
 
[2]    Schedule 1, after entry for Lamivudine in the form of Tablet 150 mg with manner of administration Oral and brand 3TC
insert:
 
 
 
Lamivudine RBX
RA
EMP
C3586 C3587 C3588 C3589
 
120
5
D
 
[3]    Schedule 1, after entry for Lamivudine in the form of Tablet 300 mg with manner of administration Oral and brand 3TC
insert:
 
 
 
Lamivudine RBX
RA
EMP
C3586 C3587 C3588 C3589
 
60
5
D
 
[4]    Schedule 1, entry for Levodopa with Carbidopa
omit from the column headed ‘Responsible Person’:
AB
substitute:
VE
 
[5]    Schedule 1, entry for Lopinavir with Ritonavir
omit from the column headed ‘Responsible Person’ ( all instances):
AB
substitute:
VE
 
 
[6]    Schedule 1, after entry for Lopinavir with Ritonavir
insert:
Mannitol
Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers
Inhalation by mouth
bronchitol
XA
EMP
C4061 C4062 C4063 C4064
 
4
5
D
 
[7]    Schedule 1, entry for Octreotide in the form Injection 50 micrograms (as acetate) in 1 mL with manner of administration Injection and brand Octreotide MaxRx
omit from the column headed ‘Responsible Person’:
XF
substitute:
GQ
 
[8]    Schedule 1, entry for Octreotide in the form Injection 100 micrograms (as acetate) in 1 mL with manner of administration Injection and brand Octreotide MaxRx
omit from the column headed ‘Responsible Person’:
XF
substitute:
GQ
 
[9]    Schedule 1, entry for Octreotide in the form Injection 500 micrograms (as acetate) in 1 mL with manner of administration Injection and brand Octreotide MaxRx
omit from the column headed ‘Responsible Person’:
XF
substitute:
GQ
 
 
[10]  Schedule 1, entry for Ritonavir
omit from the column headed ‘Responsible Person’ ( all instances):
AB
substitute:
VE
 
[11]  Schedule 1, entry for Tipranavir in the form Oral liquid 100mg per mL, 95 mL
omit
 
Oral liquid 100 mg per mL, 95 mL
Oral
Aptivus
BY
EMP
C3602 C3603
 
7
5
D
 
[12]  Schedule 2, after entry for GM
insert:
GQ
Generic Health Pty Ltd
93 110 617 859
 
[13]  Schedule 2, after entry for TX
insert:
VE
AbbVie Pty Ltd
48 156 384 262
 
[14]  Schedule 2, after entry for VI
insert:
XA
Pharmaxis Ltd
75 082 811 630
 
[15]  Schedule 2, omit entry for XF
 
[16]  Schedule 3, after entry for Lopinavir with Ritonavir
insert:

Mannitol                                                                                                                                                                                                                                                                                                                                                                                
C4061
 
Where the patient is receiving treatment at/from a private hospital
Treatment of cystic fibrosis in a patient who satisfies all of the following criteria:
(1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
(2) Is 6 years of age or older;
(3) Has a FEV1 greater than 30% predicted for age, gender and height;
(4) Is intolerant or inadequately responsive to dornase alfa;
(5) Has 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);
(6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial.
In order for patients to be eligible for participation in the HSD 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 mannitol therapy under the HSD 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 mannitol 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 mannitol at a dose of 400 mg twice 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 mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily;
(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice 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 mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol 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 mannitol 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 HSD 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).
Compliance with Written or Telephone Authority Required procedures

 
C4062
 
Where the patient is receiving treatment at/from a private hospital
Grandfather — for patients who initiated mannitol treatment prior to 1 August 2012
Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.
Compliance with Written or Telephone Authority Required procedures

 
C4063
 
Where the patient is receiving treatment at/from a public hospital
Treatment of cystic fibrosis in a patient who satisfies all of the following criteria:
(1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
(2) Is 6 years of age or older;
(3) Has a FEV1 greater than 30% predicted for age, gender and height;
(4) Is intolerant or inadequately responsive to dornase alfa;
(5) Has 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);
(6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial.
In order for patients to be eligible for participation in the HSD 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 mannitol therapy under the HSD 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 mannitol 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 mannitol at a dose of 400 mg twice 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 mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily;
(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice 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 mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol 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 mannitol 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 HSD 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)
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4063


 
C4064
 
Where the patient is receiving treatment at/from a public hospital
Grandfather — for patients who initiated mannitol treatment prior to 1 August 2012
Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4064


 
[17]  Schedule 3, entry for Tipranavir 
omit:
 
C3602
 
Where the patient is receiving treatment at/from a private hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co‑administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting  toxicity
Compliance with Written or Telephone Authority Required procedures

 
C3603
 
Where the patient is receiving treatment at/from a public hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co‑administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting   toxicity
Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3603

 
[18]  Schedule 4, Patient Contributions
omit from the column heading:
Claimed ex-manfacturer price $
substitute:
Claimed ex-manufacturer price $
 
[19]  Schedule 4, omit entry for Cyclosporin (all forms)
 
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.  See http://www.frli.gov.au.