Division 1General

## Part 1—Preliminary ### Division 1—General #### 1 Name (1) This instrument is the National Health (Botulinum Toxin Program) Special Arrangement 2025. (2) This instrument may also be cited as PB 111 of 2025. #### 3 Authority This instrument is made under sections 99 and 100 of the National Health Act 1953. #### 5 Simplified outline This instrument makes a special arrangement for, or in relation to, providing that an adequate supply of botulinum toxin pharmaceutical benefits will be available to certain persons who are receiving treatment for certain conditions. Botulinum toxin pharmaceutical benefits can only be supplied in accordance with this instrument by approved hospital authorities, and must be administered directly to the person receiving treatment. The benefits cannot be supplied by community pharmacies. This instrument also deals with payments for supplies of botulinum toxin pharmaceutical benefits. > Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act). #### 6 Definitions > Note 1: A number of expressions used in this instrument are defined in the Act, including the following: (a) hospital; (b) public hospital. > Note 2: Under subsection 4(1A) of the Act, a word or phrase used in the Act that is defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act. Expressions used in this instrument that take their meaning from that Act include the following: (a) medical practitioner; (b) private hospital; (c) specialist. In this instrument: > Act means the National Health Act 1953. > approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act. > approved hospital authority has the same meaning as in Part VII of the Act. > botulinum toxin pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1. > CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement. > CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016. > dispensed price: (a) for the special arrangement supply of a botulinum toxin pharmaceutical benefit by an approved hospital authority for a public hospital—has the meaning given by section 13; and (b) for the special arrangement supply of a botulinum toxin pharmaceutical benefit by an approved hospital authority for a private hospital—has the meaning given by section 15. > eligible medical practitioner: see section 7. > eligible patient: see section 8. > listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act. > Listing Instrument means the National Health (Listing of Pharmaceutical Benefits) Instrument 2024. > maximum quantity: see subsection 16(2). > pack quantity of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act. > PBS prescriber has the same meaning as in Part VII of the Act. > pharmaceutical benefit has the same meaning as in Part VII of the Act. > pharmaceutical item has the same meaning as in Part VII of the Act. > proportional ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act. > ready‑prepared dispensing fee has the same meaning as in the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020. > ready‑prepared pharmaceutical benefit has the same meaning as in the Listing Instrument. > special arrangement supply: see subsection 9(1). #### 7 Definition of eligible medical practitioner If: (a) under paragraph 85(7)(b) of the Act, a prescription for the supply of a particular botulinum toxin pharmaceutical benefit may be written in circumstances that include one or more sets of circumstances relating to a patient or a medical practitioner treating the patient; and (b) at least one of those sets of circumstances exists in relation to a particular patient and the medical practitioner treating the patient; the medical practitioner is an eligible medical practitioner for the patient and the benefit. > Note: In the Listing Instrument, as in force on 1 October 2025, a set of circumstances (in which a prescription for the supply of a pharmaceutical benefit may be written) is the set of circumstances mentioned in the table in Part 1 of Schedule 4 to that instrument in relation to a particular circumstances code that is mentioned in the table in Part 1 of Schedule 1 to that instrument in relation to the pharmaceutical benefit. #### 8 Definition of eligible patient A person is an eligible patient in relation to a botulinum toxin pharmaceutical benefit if: (a) the person is entitled to receive pharmaceutical benefits as mentioned in section 86 of the Act; and (b) if, under paragraph 85(7)(b) of the Act, a prescription for the supply of the botulinum toxin pharmaceutical benefit may be written in circumstances that include one or more sets of circumstances relating to a patient—at least one of those sets of circumstances exists in relation to the person; and (c) in any case—the person is being treated: (i) in or at a private hospital; or (ii) in or at a public hospital as a non‑admitted patient, a day‑admitted patient, or an in‑patient admitted for less than 24 hours; or (iii) by an eligible medical practitioner for the person and the benefit at a business at an address for which the eligible medical practitioner has a provider number (within the meaning of the Health Insurance Regulations 2018). > Note: In the Listing Instrument, as in force on 1 October 2025, a set of circumstances (in which a prescription for the supply of a pharmaceutical benefit may be written) is the set of circumstances mentioned in the table in Part 1 of Schedule 4 to that instrument in relation to a particular circumstances code that is mentioned in the table in Part 1 of Schedule 1 to that instrument in relation to the pharmaceutical benefit. ### Division 2—Special arrangement supplies #### 9 Supply of botulinum toxin pharmaceutical benefits under this instrument (1) A supply of a botulinum toxin pharmaceutical benefit to a person is a special arrangement supply of the benefit if: (a) the person is an eligible patient for the benefit; and (b) the benefit is supplied by an approved hospital authority; and (c) the benefit is directly administered to the person by an eligible medical practitioner for the person and the benefit; and (d) a valid prescription for supply of the benefit to the person is given or presented to the approved hospital authority: (i) prior to the supply; or (ii) within 7 days after the eligible medical practitioner administered the benefit; and (e) if, under paragraph 85A(2)(a) of the Act, the Minister has determined that a maximum quantity or number of units of the benefit, or pharmaceutical item in the benefit, applies in relation to the supply of the benefit on any one occasion either for all purposes, or for the purpose for which the supply was made—the prescription directs the supply of less than or equal to that maximum quantity or number; and (f) if, under subsection 85A(2A) of the Act, the Minister has determined that particular conditions must be satisfied when writing a prescription to which a determination referred to in paragraph (e) of this subsection applies—the conditions are satisfied. > Note: Under this instrument, the supplier of a botulinum toxin pharmaceutical benefit cannot physically supply or hand the benefit directly to an eligible patient. (2) The following sections of the National Health (Pharmaceutical Benefits) Regulations 2017 do not apply in relation to a special arrangement supply of a botulinum toxin pharmaceutical benefit: (a) section 48 (about supply of pharmaceutical benefits before surrender of written prescription); (b) section 49 (about circumstances in which quantity of repeated supply can be directed to be supplied on one occasion); (c) section 55 (about presentation of urgent prescriptions). #### 10 Special arrangement supplies by approved hospital authorities to patients receiving treatment from hospitals (1) Despite section 94 of the Act, a hospital authority approved for the purpose of its supplying pharmaceutical benefits to patients receiving treatment in or at the hospital of which the hospital authority is the governing body or proprietor may also make special arrangement supplies of botulinum toxin pharmaceutical benefits to patients receiving treatment from that hospital. (2) In the application of Part VII of the Act, and regulations or other instruments made for the purposes of that Part, to special arrangement supplies of botulinum toxin pharmaceutical benefits, a reference to a person receiving treatment in or at a hospital is taken to include a reference to a person receiving treatment from the hospital. ## Part 2—Prescription for supply of botulinum toxin pharmaceutical benefits under this instrument #### 11 Writing prescriptions—when pharmaceutical benefits are the same For the purposes of the application of paragraph 40(3)(a) of the National Health (Pharmaceutical Benefits) Regulations 2017 to a prescription for the special arrangement supply of a botulinum toxin pharmaceutical benefit, a botulinum toxin pharmaceutical benefit is taken to be the same as a botulinum toxin pharmaceutical benefit for which the PBS prescriber has written, on the same day, another prescription only if: (a) the prescriptions for the supply of both benefits are written in relation to the treatment of: (i) moderate to severe spasticity of the upper limb (whether or not following an acute event); or (ii) moderate to severe spasticity of the lower limb following an acute event; or (iii) urinary incontinence; or (iv) spasmodic torticollis; or (v) dynamic equinus foot deformity; or (vi) blepharospasm; or (vii) hemifacial spasm; or (viii) chronic migraine; or (ix) severe primary axillary hyperhidrosis; or (x) chronic sialorrhea; or (b) the prescriptions for the supply of both benefits are written in circumstances, determined by the Minister under paragraph 85(7)(b) of the Act, that have the same circumstances code (within the meaning of the Listing Instrument). ## Part 3—Payment for special arrangement supplies of botulinum toxin pharmaceutical benefits ### Division 1—Supplies by approved hospital authorities for public hospitals #### 12 Rates of payment for approved hospital authorities for public hospitals (1) For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a public hospital in respect of a special arrangement supply of a botulinum toxin pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the hospital authority was entitled to charge under section 87 of the Act in respect of the supply. > Note 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits. > Note 2: However, see Part 4 of this instrument in relation to the supply of a pharmaceutical benefit to a CTG registered patient. (2) This section applies despite the National Health (Commonwealth Price—Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017 (PB 25 of 2017). > Note: See subsection 99(4) of the Act (read with section 10 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved. #### 13 Dispensed price for approved hospital authorities for public hospitals (1) The dispensed price for a special arrangement supply of a botulinum toxin pharmaceutical benefit by an approved hospital authority for a public hospital is as follows: (a) if the quantity of the benefit 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 (as applicable) for each pack quantity; (b) if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the amount worked out in accordance with subsection (2); (c) if neither paragraph (a) or (b) applies to the quantity of the benefit supplied—the sum of: (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and (ii) the amount worked out in accordance with subsection (2) for the remainder of the quantity supplied that is less than a pack quantity. > Note: No mark‑ups may be added to the cost of a pharmaceutical benefit for which payment is claimed by an approved hospital authority for a public hospital. Broken quantities (2) For the purposes of paragraph (1)(b) and subparagraph (1)(c)(ii), the amount for a broken quantity is worked out 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 (as applicable) for the pack quantity. Rounding (3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards). ### Division 2—Supplies by approved hospital authorities for private hospitals #### 14 Rates of payment for approved hospital authorities for private hospitals (1) For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a private hospital in respect of a special arrangement supply of a botulinum toxin pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the authority was entitled to charge under section 87 of the Act in respect of the supply. > Note 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits. > Note 2: However, see Part 4 of this instrument in relation to the supply of a pharmaceutical benefit to a CTG registered patient. (2) This section applies despite the National Health (Commonwealth Price ‑ Pharmaceutical benefits supplied by private hospitals) Determination 2020 (PB 99 of 2020). > Note: See subsection 99(4) of the Act (read with section 10 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved. #### 15 Dispensed price for approved hospital authorities for private hospitals (1) The dispensed price for a special arrangement supply of a botulinum toxin pharmaceutical benefit by an approved hospital authority for a private hospital is as follows: (a) if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of: (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and (ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 16 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and (iii) the ready‑prepared dispensing fee; (b) if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the sum of: (i) the amount worked out in accordance with subsection (2); and (ii) the ready‑prepared dispensing fee; (c) if neither paragraph (a) or (b) applies to the quantity of the benefit supplied—the sum of: (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and (ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 16 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and (iii) the amount worked out in accordance with subsection (2) for the remainder of the quantity that is a broken quantity; and (iv) the ready‑prepared dispensing fee. Broken quantities (2) For the purposes of subparagraphs (1)(b)(i) and (c)(iii), the amount for a broken quantity is worked out 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 sum of: (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for the pack quantity; and (ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 16 for the pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards). Rounding (3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards). #### 16 Mark‑up for ready‑prepared pharmaceutical benefits (1) For the purposes of subparagraphs 15(1)(a)(ii), 15(1)(c)(ii) and 15(2)(b)(ii), the mark‑up for a pack quantity of a botulinum toxin pharmaceutical benefit that is a ready‑prepared pharmaceutical benefit is: (a) if the pack quantity of the benefit is equal to the maximum quantity of the benefit—the amount mentioned in the following table for the approved ex‑manufacturer price (AEMP) or proportional ex‑manufacturer price (PEMP) (as applicable) for that quantity; or (b) if the pack quantity of the benefit is less than the maximum quantity of the benefit: (i) if the mark‑up mentioned in the following table for the maximum quantity is a monetary amount—that monetary amount reduced proportionately for the relative quantities; or (ii) if the mark‑up mentioned in the following table for the maximum quantity is a percentage of the AEMP or PEMP (as applicable)—that percentage of the AEMP or PEMP for the pack quantity. ```html <table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Mark</span><span>‑</span><span>up for ready</span><span>‑</span><span>prepared pharmaceutical benefits</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:56.16%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>If the AEMP or PEMP (as applicable) for the maximum quantity is …</span></p></td><td style="width:35.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>the mark</span><span>‑</span><span>up for the maximum quantity is …</span></p></td></tr></thead><tbody><tr><td style="width:8.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:56.16%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>less than $40</span></p></td><td style="width:35.26%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>10% of the AEMP or PEMP</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:56.16%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>at least $40 but not more than $100</span></p></td><td style="width:35.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>$4</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:56.16%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>more than $100 but not more than $1,000</span></p></td><td style="width:35.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>4% of the AEMP or PEMP</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:56.16%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>more than $1,000</span></p></td><td style="width:35.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>$40</span></p></td></tr></tbody></table> ``` (2) The maximum quantity of a ready‑prepared pharmaceutical benefit having a pharmaceutical item is the maximum number of units of the pharmaceutical item that may, in one prescription, be directed to be supplied on any one occasion, as determined for the item under paragraph 85A(2)(a) of the Act. > Note: The Listing Instrument, as in force on 1 October 2025, contains the determination of the maximum quantity of a ready‑prepared pharmaceutical benefit having a pharmaceutical item. ## Part 4—Supply to CTG registered patients #### 17 Application of this Part This Part applies to a special arrangement supply of a botulinum toxin pharmaceutical benefit if the supply is made to an eligible patient who is a CTG registered patient. #### 18 Application of the CTG Special Arrangement—co‑payment and payment etc. (1) Despite section 87 of the Act and sections 12 and 14 of this instrument, subsections 11(1), (2), (3) and (4) (co‑payment reduction etc.) and section 13 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the special arrangement supply with the modification set out in subsection (2) of this section. (2) A reference in the CTG Special Arrangement to: (a) a supply of a pharmaceutical benefit under the CTG Special Arrangement is taken to be a reference to the special arrangement supply; and (b) a CTG supplier is taken to be a reference to the approved hospital authority who made the special arrangement supply. (3) However, the notes to subsections 11(2) and (3) of the CTG Special Arrangement do not apply in relation to the special arrangement supply. > Note: The notes to subsections 11(2) and (3) of the CTG Special Arrangement relate to suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the special arrangement supply are instead dealt with under section 19 of this instrument. #### 19 Claim for payment (1) If a claim for payment of an amount to which an approved hospital authority is entitled in respect of the special arrangement supply is made using the manual system referred to in section 99AAA of the Act, the claim must include an indicator that the supply was made to a CTG registered patient. (2) This section has effect in addition to section 99AAA of the Act. ## Part 5—Application, saving and transitional provisions ### Division 1—Provisions relating to this instrument as made #### 20 Things done under the National Health (Botulinum Toxin Program) Special Arrangement 2015 (1) If: (a) a thing was done for a particular purpose under the National Health (Botulinum Toxin Program) Special Arrangement 2015 as in force immediately before that instrument was repealed; and (b) the thing could be done for that particular purpose under this instrument; the thing has effect for the purposes of this instrument as if it had been done for that particular purpose under this instrument. (2) Without limiting subsection (1), a reference in that subsection to a thing being done includes a reference to a supply of pharmaceutical benefits or claim for payment being made.