National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 9) (PB 77 of 2016) (Cth)

PB 77 of 2016

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 9)

National Health Act 1953

I, Julianne Quaine, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this instrument under subsection 100(2) of the National Health Act 1953.

Dated 31 August 2016

Julianne Quaine
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division

Department of Health

Contents

1............ Name of instrument....................................................................................................... 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)        2

1  Name of instrument

(1)  This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 9).

(2)  This instrument may also be cited as PB 77 of 2016.

2  Commencement

This instrument commences on 1 September 2016.

3  Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

4  Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

1  Section 3 (definition of compound fee)

Repeal the definition, substitute:

compound fee, for the compounding of a dose of a chemotherapy drug for an infusion, means:

(a)  for a TGA licensed compounder—an amount of $60; or

(b)  in any other case—an amount of $40.

2  Section 3 (at the end of the definition of preparation fee)

Add:

Note:          The preparation fee for a dose of a chemotherapy drug in an infusion includes:

(a)    if the dose is compounded by a TGA licensed compounder—$40 of the compound fee for the TGA licensed compounder; and

(b)    if the dose is compounded by a compounder (other than a TGA licensed compounder)—the compound fee for the compounder.

3  Section 3 (definition of start date)

Repeal the definition.

4  Section 3 (at the end of the definition of TGA licensed compounder)

Add, “for aseptic compounding of sterile cytotoxic preparations”.

5  Division 2A of Part 4

Repeal the Division, substitute:

Division 2A—Payments to TGA licensed compounders

46A  Payments in relation to infusions prepared between 1 July 2015 and 31 March 2017

(1)  A TGA licensed compounder may make a claim for payment for the compounding of a dose of a chemotherapy drug for an infusion prepared between 1 July 2015 and 31 March 2017.

(2)  A claim under subsection (1) must:

(a)  be in writing; and

(b)  include a certification by the TGA licensed compounder that:

(i)  each dose of a chemotherapy drug for the infusion to which the claim relates was prepared in accordance with a compounding order; and

(ii)  the information provided in the claim is correct.

(3)  If a claim is made under subsection (1), the Secretary may, at his or her discretion, if the Secretary is satisfied on reasonable grounds that it is appropriate to do so, pay an amount of $20 to the TGA licensed compounder for the compounding.

46B  Payments in relation to infusions prepared on and after 1 April 2017

(1)  If a TGA licensed compounder compounds a dose of a chemotherapy drug for an infusion prepared on or after 1 April 2017, the compounder is entitled to be paid a compound fee by the Commonwealth.

(2)  A TGA licensed compounder must not be paid more than one compound fee for the compounding of a dose of a chemotherapy drug for a single infusion that is prepared in accordance with an infusion prescription for an individual patient.

6  Section 61

Repeal the section.

7  Schedule 1, Part 1 (table item dealing with Irinotecan)

Repeal:

Irinotecan Actavis 500 EA MP D

8  Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form solution concentrate for I.V. infusion 100 mg in 16.7 mL)

Repeal:

Plaxel ED MP D

9  Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form solution concentrate for I.V. infusion 150 mg in 25 mL)

Repeal:

Plaxel ED MP D

10  Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form solution concentrate for I.V. infusion 30 mg in 5 mL)

Repeal:

Plaxel ED MP D

11  Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form solution concentrate for I.V. infusion 300 mg in 50 mL)

Repeal:

Plaxel ED MP D

12  Schedule 1, Part 1 (cell at table item dealing with Topotecan, column headed “Responsible Person”)

Omit “NV”, substitute “SZ”.

13  Schedule 1, Part 1 (table item dealing with Vinorelbine)

Repeal:

Vinorelbine Kabi PK MP PB