National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Rituximab) Instrument 2022 (Cth)

PB 80 of 2022

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Rituximab) Instrument 2022

I, Kirsten Buckingham, as delegate of the Minister for Health and Aged Care, make the following instrument.

Dated   26 August 2022

Kirsten Buckingham

Assistant Secretary (Acting)
Pharmacy Branch
Technology Assessment and Access Division
Health Resourcing Group
Department of Health and Aged Care

Contents

1............ Name............................................................................................................................. 1

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

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

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

Schedule 1—Amendments  2

National Health (Highly Specialised Drugs Program) Special Arrangement 2021            2

1  Name

(1)  This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Rituximab) Instrument 2022.

(2)  This instrument may also be cited as PB 80 of 2022.

2  Commencement

(1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	1 September 2022.	1 September 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

This instrument is made under sections 85, 85A and 88, and 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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 (Highly Specialised Drugs Program) Special Arrangement 2021

1  Section 6 (paragraph (dd) of the definition of CAR drug)

Repeal the paragraph.

2  Section 6

Insert:

EFC patient has the meaning given by subsection 8(7).

3  Section 6 (definition of non‑CAR drug)

Repeal the definition.

4  Section 6

Insert:

UNAR drug (short for Unrestricted—No Authority Required drug) means any of the following highly specialised drugs:

(a)  rituximab.

5  At the end of subsection 8(1)

Add:

; and (d)  is not an EFC patient (see subsection (7)) for the benefit.

6  At the end of subsection 8(4)

Add:

; and (c)  is not an EFC patient (see subsection (7)) for the benefit.

7  At the end of section 8

Add:

EFC patient

(7)  A person is an EFC patient for an HSD pharmaceutical benefit that has a UNAR drug if the benefit is or will be prescribed to the person:

(a)  in accordance with the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011; or

(b)  for the purposes of chemotherapy treatment for cancer.

8  Subparagraph 13(1)(b)(ii)

After “CAR drug”, insert “or UNAR drug”.

9  Subparagraphs 13(1)(c)(iii) and (2)(c)(iii)

Before “in circumstances mentioned”, insert “unless the benefit has a UNAR drug—”.

10  Subsections 14(1) and (3)

After “HSD pharmaceutical benefit”, insert “mentioned in Part 1 of Schedule 1 to the Listing Instrument”.

11  Subsection 14(4)

Repeal the subsection.

12  Subsections 15(1) and (2)

After “HSD pharmaceutical benefit”, insert “, other than a benefit that has a UNAR drug,”.

13  Subsection 16(1)

After “in Schedule 3”, insert “(if any)”.

14  Subsection 18(1) (heading)

Repeal the heading, substitute:

HSD pharmaceutical benefits that have CAR drugs or rituximab

15  At the end of subsection 18(1)

Add “or rituximab”.

16  Schedule 1 (entry for Rituximab)

Repeal the entry, substitute:

Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Riximyo	6	0
Ruxience	6	0
Truxima	6	0
Solution for I.V. infusion 500 mg in 50 mL	Injection	Riximyo	2	1
Ruxience	2	1
Truxima	2	1

17  Schedule 2 (entry for Rituximab)

Repeal the entry.

18  Schedule 3 (entry for Rituximab)

Repeal the entry.