National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 8) (No. PB 76 of 2012) (Cth)
PB 76 of 2012
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 8)
National Health Act 1953
___________________________________________________________________________
I, KIM BESSELL, First Assistant Secretary (Acting), 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 September 2012
KIM BESSELL
First Assistant Secretary (Acting)
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.8).
(2)This Instrument may also be cited as PB 76 of 2012.
2 Commencement
This Instrument commences on 1 October 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 4, definition of manufacturers’ pack
Omit the definition.
[2] Section 4, Note (4th occurring)
Insert in alphabetical order:
·approved ex-manufacturer price
·claimed price
·pack quantity
·proportional ex-manufacturer price
[3] Paragraph 28(2)(e)
Omit:
manufacturers’
[4] Section 37
Omit.
Insert:
Subject to section 43, the dispensed price for the supply of an HSD pharmaceutical benefit, by a hospital authority for a public hospital, is as follows:
(a) if the quantity of the HSD pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity of the benefit— the sum of the approved ex‑manufacturer price or the proportional ex-manufacturer price for each pack quantity;
(b) if the quantity of the HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit — the amount calculated in accordance with section 38;
(c) if the quantity of the HSD pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity of the benefit — the sum of:
(i) the approved ex‑manufacturer price or the proportional ex-manufacturer price for each pack quantity; and
(ii) the amount calculated in accordance with section 38 for the remainder of the quantity supplied that is less than a pack quantity.
[5] Section 38
Omit the heading to the section and the section.
Insert:
38 Where quantity is less than a pack quantity
If the quantity of an HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in paragraph 37 (b) and subparagraph 37 (c) (ii) is to be calculated by:
(a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(b) applying that percentage to the approved ex-manufacturer price or proportional ex-manufacturer price for the pack quantity.
[6] Paragraph 39(1)(a)
Omit:
the quantity contained in the manufacturers’ pack
Insert:
a multiple of a pack quantity
[7] Subparagraph 39(1)(a)(i)
Omit:
the price ex‑manufacturer of the manufacturers’ pack
Insert:
the approved ex‑manufacturer price or the proportional ex-manufacturer price for each pack quantity
[8] Paragraph 39(1)(b)
Omit:
the quantity contained in the manufacturers’ pack
Insert:
a pack quantity
[9] Paragraph 39(1)(c), chapeau and subparagraphs (i) and (ii)
Omit.
Insert:
(c) if a quantity of the HSD pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity, the sum of:
(i) for each pack quantity, the approved ex‑manufacturer price or the proportional ex-manufacturer price for the pack quantity, plus the mark‑up mentioned in section 40, taken to the nearest cent, with one half cent being counted as 1 cent; and
(ii) the amount calculated in accordance with section 41 for the remainder of the quantity supplied that is less than a pack quantity; and
[10] Paragraph 39 (2)(b)
Omit.
[11] Section 40
Omit.
Insert:
For subparagraphs 39(1)(a)(i) and 39(1)(c)(i) and paragraph 41(a), the mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit is:
(a) if the pack quantity for which a mark-up is to be calculated under this section is equal to a maximum quantity of the HSD pharmaceutical benefit, the mark-up is the amount mentioned in the table below for the approved ex-manufacturer price (AEMP) or proportional ex-manufacturer price (PEMP) for that quantity.
| Item | AEMP or PEMP for Maximum Quantity | Mark‑up for Maximum Quantity |
| 1 | < $40 | 10% of AEMP or PEMP |
| 2 | ≥ $40, ≤ $100 | $4.00 |
| 3 | > $100, ≤ $1,000 | 4% of AEMP or PEMP |
| 4 | > $1,000 | $40.00 |
(b) if the pack quantity for which a mark-up is to be calculated under this section is not equal to a maximum quantity of the HSD pharmaceutical benefit, the mark-up is worked out as follows:
(i) if the mark-up that would apply to the maximum quantity is shown in the table in paragraph (a) as a monetary amount – the mark-up for the pack quantity is that monetary amount reduced proportionately for the relative quantities; and
(ii)if the mark-up that would apply to the maximum quantity is shown in the table in paragraph (a) as a percentage of AEMP or PEMP – the mark-up for the pack quantity is that percentage of the AEMP or PEMP for the pack quantity.
[12] Section 41
Omit the heading to the section and the section.
Insert:
41 Where quantity is less than a pack quantity
If the quantity of an HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in subparagraph 39 (b) (i) and 39 (c) (ii) is to be calculated by:
(a) adding the mark‑up mentioned in section 40 to the approved ex‑manufacturer price or the proportional ex-manufacturer price for the pack quantity, taking the result to the nearest cent, with one half cent being counted as 1 cent; and
(b) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(c) applying the percentage worked out under subparagraph (b) to the amount worked out under subparagraph (a).
[13] Section 43
Omit.
[14] Subsection 48(1)
Omit:
the amount mentioned for the HSD pharmaceutical in the column in Schedule 4 headed ‘Approved ex‑manufacturer price’ from the amount mentioned for the listed drug in the column in Schedule 4 headed ‘Claimed ex‑manufacturer price’
Insert:
the amount mentioned for the HSD pharmaceutical benefit in the column in Schedule 4 headed ‘Approved Ex‑manufacturer Price or Proportional Ex-manufacturer Price’ from the amount mentioned for the benefit in the column in Schedule 4 headed ‘Claimed Price’
[15] Subsection 48(2)
Omit:
Insert:
However, if the quantity of the HSD pharmaceutical benefit supplied is not the same as the quantity mentioned for the benefit in the column in Schedule 4 headed ‘Pack Quantity’, the amounts mentioned in the columns in Schedule 4 headed ‘Approved Ex‑manufacturer Price or Proportional Ex-manufacturer Price’ and ‘Claimed Price’ must be adjusted proportionally.
[16] Schedule 1, after entry for Mycophenolic Acid in the form Capsule containing mycophenolate mofetil 250 mg with manner of administration Oral and brand CellCept
Insert:
| Cellplant | WQ | EMP | C1650 C1651 C3355 C3356 | 600 | 5 | C |
[17] Schedule 1, after entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg with manner of administration Oral and brand CellCept
Insert:
| Cellplant | WQ | EMP | C1650 C1651 C3355 C3356 | 300 | 5 | C |
[18] Schedule 1, entry for Zidovudine
omit from the column headed ‘Responsible Person’ ( all instances):
GK
substitute:
VI
[19] Schedule 2, after entry for VI
insert:
| WQ | Willow Pharmaceuticals Pty Limited | 80 118 534 704 |
[20] Schedule 4
Omit.
Insert:
Schedule 4 Patient contributions
(section 48)
| Listed Drug | Form (strength, type, size, etc.) | Manner of Administration | Brand | Pack Quantity | Approved $ | Claimed $ |
| Desferrioxamine | Powder for injection containing desferrioxamine mesylate 500mg | Injection | Desferal 500 mg | 10 | 93.14 | 100.86 |
| Powder for injection containing desferrioxamine mesylate 2 g | Injection | Desferal 2 g | 1 | 37.25 | 37.63 |
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
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