This instrument is the Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment (No. 2) Determination 2025.

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 November 2025.	1 November 2025

Note: This table relates only to the provisions of this instrument as originally made.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.

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 subsection 3C(1) of the Health Insurance Act 1973.

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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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

Health Insurance (Section 3C – Lutetium PSMA Treatment) Determination 2025

1 Section 1

Omit “PSMA Treatment”, substitute “Therapeutic Nuclear Medicine Treatments”.

2 Subsection 4(1) (definition of disease progression)

Repeal the definition, substitute:

disease progression means, for items 16050 and 16055 only, either or both:

(a) a rise in PSA of >2ng/mL confirmed by two tests a minimum of two weeks apart, or

(b) evidence of new soft tissue or bone metastases on diagnostic imaging computed tomography as per established guidelines (such as the Response Evaluation Criteria in Solid Tumours criteria, as published by the European Organisation for Research and Treatment of Cancer, or the Response Evaluation Criteria in PSMA-Imaging Criteria.

3 Subsection 4(1)

Insert:

formally convened neuroendocrine multidisciplinary board means a formal board of relevant practitioners, including specialists in medical oncology and nuclear medicine with experience in managing neuroendocrine neoplasms, endocrinology and surgery specialists, as well as medical practitioners from different areas of medical practice. The board must include at least one oncologist and one surgeon.

peptide receptor radionuclide therapy means a targeted form of radiation treatment that can be used to treat neuroendocrine neoplasms.

4 Section 6

Omit “Items 16050 and 16055 of Schedule 1”, substitute “the items listed in Schedule 1”.

5 Section 7

Omit “Item 61528 of Schedule 2”, substitute “items listed in Schedule 2”.

6 Section 8

Repeal the section, substitute:

Limitation of items listed in Schedule 2

An item listed in Schedule 2 of this instrument does not apply unless:

the patient was referred by a specialist or consultant physician; and
the service is provided by a nuclear medicine credentialled specialist.

7 Schedule 1 (after item 16055)

Insert:

16060

177Lutetium-DOTA-somatostatin receptor agonist treatment cycle for patients with histologically confirmed and inoperable neuroendocrine neoplasm (NEN), either locally advanced or metastatic, with documented disease progression or uncontrolled symptoms related to their NEN despite standard therapy who:

have high tumour somatostatin receptor expression demonstrated on whole body 68Ga DOTA somatostatin agonist PET study; and
are considered suitable for a course of 177Lutetium-DOTA-somatostatin receptor agonist therapy by a formally convened NEN multidisciplinary board.

Includes the necessary patient preparation, administration and treatment, immediate patient aftercare required for the treatment cycle, consultation with the supervising specialist within 36 hours of treatment, and a post-infusion SPECT if performed.

9,999.95

8 Schedule 2 (after item 61528)

Insert:

61530

Whole body 68Ga-DOTA-somatostatin receptor agonist PET study for:

staging of histologically confirmed neuroendocrine neoplasm (NEN) considered surgically incurable on conventional imaging, or
evaluation of somatostatin receptor expression of histologically confirmed and inoperable NEN, either locally advanced or metastatic, under consideration for peptide receptor radionuclide therapy (PRRT); or
evaluation of response to PRRT therapy; or
evaluation of suspected recurrent or metastatic disease in known somatostatin receptor positive NEN.

(R) (Anaes.)

953.00