National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 10) (No. PB 106 of 2012)

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PB 106 of 2012
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 10)
 
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   26  November 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.10).
 
(2)                This Instrument may also be cited as PB 106 of 2012.
 
2              Commencement
This Instrument commences on 1 December 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
Section 3
[1]           Section 45(2)(b)
Omit:
subsection 48 (1)
Substitute
section 48
[2]           Section 46(3)
Omit:
subsection 48 (1)
Substitute
section 48
[3]           Section 47(3)
Omit:
subsection 48 (1)
Substitute
section 48
[4]           Section 48
Omit
Insert:
48        Additional patient contributions
For paragraph 45 (2) (b) and subsections 46 (3) and 47 (3), the amount is the amount that is the difference between:
(a)      the price that would have been the dispensed price for the quantity of the HSD pharmaceutical benefit supplied if that dispensed price had been based on the claimed price mentioned for the benefit in the column in Schedule 4 headed ‘Claimed Price’; and
(b)      the dispensed price for that quantity of the HSD pharmaceutical benefit.
[5]           Schedule 1, entry for Apomorphine
Omit from the column headed ‘Number of Repeats’ (all instances):
0
Substitute (all instances):
5
[6]           Schedule 1, entry for Apomorphine in the form injection containing apomorphine hydrochloride 20 mg in 2 mL, in the column headed ‘Maximum Quantity’
Omit:
5
Substitute:
360
[7]           Schedule 1, entry for Apomorphine in the form injection containing apomorphine hydrochloride 50 mg in 5 mL, in the column headed ‘Maximum Quantity’
Omit:
5
Substitute:
180
[8]           Schedule 1, entry for Apomorphine in the form Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre‑filled syringe, in the column headed ‘Maximum Quantity’
Omit:
5
Substitute:
180
[9]           Schedule 1, entry for Clozapine in the forms Tablet 25 mg, Tablet 50 mg, Tablet 100 mg and Tablet 200 mg, in the column headed ‘Maximum Quantity’
Omit (all instances):
100
Substitute (all instances):
200
[10]         Schedule 1, entry for Lamivudine in the forms Tablet 150 mg and Tablet 300 mg with manner of administration Oral and brand Alphapharm Lamivudine
Omit from the column headed ‘Brand’ (both instances):
Alphapharm Lamivudine
Substitute (both instances):
Lamivudine Alphapharm
[11]         Schedule 1, entry for Lenalidomide, in the column headed ‘Circumstances’
Omit (all instances):
C3205 C3821
Insert (all instances):
C4090 C4091
[12]         Schedule 1, entry for Mycophenolic Acid in the form Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid, in the column headed ‘Circumstances’
Omit:
C1650 C3355
Substitute:
C4108 C4146 C4084 C4095
[13]         Schedule 1, entry for Mycophenolic Acid in the form Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid, in the column headed ‘Circumstances’
Omit:
C1650 C3355
Substitute:
C4108 C4146 C4084 C4095
[14]         Schedule 1, entry for Nevirapine in the form Tablet 200 mg
Omit:
Nevirapine
Tablet 200 mg
Oral
Viramune
BY
EMP
C3586 C3587 C3588 C3589
 
120
5
D
 
Substitute:

Nevirapine
Tablet 200 mg
Oral
Nevirapine Alphapharm
AF
EMP
C3586 C3587 C3588 C3589
 
120
5
D

 
 
 
Viramune
BY
EMP
C3586 C3587 C3588 C3589
 
120
5
D

[15]         Schedule 1, after entry for Octreotide in the form Injection 50 micrograms (as acetate) in 1 mL with manner of administration Injection and brand Octreotide MaxRX
Insert:
 
 
 
Octreotide (SUN)
ZF
EMP
C2622 C2623 C3407 C3408
 
90
11
D
[16]         Schedule 1, after entry for Octreotide in the form Injection 100 micrograms (as acetate) in 1 mL with manner of administration Injection and brand Octreotide MaxRX
Insert:
 
 
 
Octreotide (SUN)
ZF
EMP
C2622 C2623 C3407 C3408
 
90
11
D
[17]         Schedule 1, after entry for Octreotide in the form Injection 500 micrograms (as acetate) in 1 mL  with manner of administration Injection and brand Octreotide MaxRX
Insert:
 
 
 
Octreotide (SUN)
ZF
EMP
C2622 C2623 C3407 C3408
 
90
11
D
[18]         Schedule 2, after entry for XA
Insert:
ZF
Sun Pharmaceutical Industries (Australia) Pty Ltd
64 130 119 603
 
[19]         Schedule 3, entry for Lenalidomide
Omit
Substitute:
Lenalidomide
C4090
 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Multiple myeloma
Initial PBS-subsidised treatment
 
The condition must be confirmed by a histological diagnosis,
 
The treatment must be as monotherapy; OR
The treatment must be in combination with dexamethasone,
 
Patient must have progressive disease after at least one prior therapy,
 
Patient must have undergone or be ineligible for a primary stem cell transplant,
 
Patient must have experienced treatment failure after a trial of at least four (4) weeks of thalidomide at a dose of at least 100 mg daily or have failed to achieve at least a minimal response after eight (8) or more weeks of thalidomide-based therapy for progressive disease,
 
Patient must not be receiving concomitant PBS-subsidised bortezomib.
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) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) 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
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) 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
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Thalidomide treatment failure is defined as:
(1) confirmed disease progression during thalidomide treatment or within 6 months of discontinuing thalidomide treatment; or
(2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment.
Severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living.
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.
Failure to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease is defined as:
(1) less than a 25% reduction in serum or urine M protein; or
(2) in oligo-secretory and non-secretory myeloma patients only, less than a 25% reduction in the difference between involved and uninvolved serum free light chain levels.
If the dosing requirement for thalidomide cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma lenalidomide Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, 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; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and
(3) duration of thalidomide and daily dose prescribed; and
(4) a signed patient acknowledgment.
To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.
Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program.
Compliance with modified Authority Required procedures

 
C4091
 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Multiple myeloma
Continuing PBS-subsidised treatment
 
Patient must have previously received an authority prescription for lenalidomide,
 
Patient must not have progressive disease,
 
The treatment must be as monotherapy; OR
The treatment must be in combination with dexamethasone.
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) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) 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
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) 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
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Patients receiving lenalidomide under the PBS listing must be registered in the access risk management program.
Compliance with modified Authority Required procedures

[20]         Schedule 3, entry for Mycophenolic Acid
Insert after entry C3356:
 
C4084
 
Where the patient is receiving treatment at/from a public hospital
Prophylaxis of renal allograft rejection
Management
The treatment must be under the supervision and direction of a transplant unit.
Compliance with Written or Telephone Authority Required Procedures – Streamlined Authority Code 4084

 
C4095
 
Where the patient is receiving treatment at/from a public hospital
WHO Class III, IV or V lupus nephritis
Management
The condition must be proven by biopsy,
Must be treated by a nephrologist or in consultation with a nephrologist.
The name of the consulting nephrologist must be included in the patient medical records.
Compliance with Written or Telephone Authority Required Procedures – Streamlined Authority Code 4095

 
C4108
 
Where the patient is receiving treatment at/from a private hospital
Prophylaxis of renal allograft rejection
Management
The treatment must be under the supervision and direction of a transplant unit.
Compliance with Written or Telephone Authority Required Procedures

 
C4146
 
Where the patient is receiving treatment at/from a private hospital
WHO Class III, IV or V lupus nephritis
Management
The condition must be proven by biopsy,
Must be treated by a nephrologist or in consultation with a nephrologist.
The name of the consulting nephrologist must be included in the patient medical records
Compliance with Written or Telephone Authority Required Procedures

 
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.

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