Part 1 General
Division 1 Preliminary
1 Name of Special Arrangement
(1) This Special Arrangement is the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.
(2) This Special Arrangement may also be cited as PB 79 of 2011.
2 Commencement
This Special Arrangement commences on 1 December 2011.
3 Definitions
In this Special Arrangement:
ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.
Act means the National Health Act 1953.
authorised prescriber means:
(a) for a chemotherapy pharmaceutical benefit — a kind of person identified by a prescriber code mentioned in the column in Part 1 of Schedule 1 headed ‘Authorised Prescriber’ for the benefit; or
(b) for a related pharmaceutical benefit — a kind of person identified by a prescriber code mentioned in the column in Schedule 2 headed ‘Authorised Prescriber’ for the benefit.
authority prescription means a prescription or medication chart (including an infusion prescription or infusion medication chart) that has been authorised:
(a) in accordance with regulation 13 of the Regulations as modified by this Special Arrangement; or
(b) in accordance with Division 3 of Part 2 of this Special Arrangement.
benefit card means any of the following:
(a) a PBS Entitlement Card;
(b) a PBS Safety Net Concession Card;
(c) a Pensioner Concession Card;
(d) a Health Care Card (including Low Income Health Care Card and Foster Child Health Care Card);
(e) a Commonwealth Seniors Health Card;
(f) a cleft lip and cleft palate identification card;
(g) a DVA Gold Card;
(h) a DVA White Card;
(i) a DVA Orange Card;
(j) War Widow/Widower Transport Card;
(k) a card or voucher approved by the Chief Executive Medicare for this paragraph.
chemotherapy drug, means a drug that is mentioned in the column in Part 1 of Schedule 1 headed ‘Listed Drug’ for one or more chemotherapy pharmaceutical benefits.
Note Each chemotherapy drug is also mentioned in Part 2 of Schedule 1.
chemotherapy pharmaceutical benefit means a pharmaceutical benefit that is mentioned in Part 1 of Schedule 1.
circumstances code means the letter ‘C’ followed by a number.
diluent fee means an amount of $4.75.
dispensing fee means an amount of $6.42.
distribution fee means an amount of $24.
dose, for a chemotherapy drug, means the quantity of the drug contained in an infusion.
eligible patient means a person who:
(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and
(b) is receiving treatment from an authorised prescriber.
eligible public hospital patient means an eligible patient who is receiving treatment at, or from, a public hospital as a non‑admitted patient, day admitted patient or patient on discharge.
entitlement number, for an eligible patient, means the number listed on the patient’s benefit card.
HSD hospital authority means a public hospital authority approved by the Chief Executive Medicare under section 52 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010.
Human Services Department means the Department administered by the Human Services Minister.
infusion means a single treatment for a patient that is made from one or more chemotherapy pharmaceutical benefits.
infusion medication chart means a medication chart directing the supply of an infusion.
infusion prescription means a prescription directing the supply of an infusion.
non-approved public hospital authority means a public hospital authority that is not an approved hospital authority or an HSD hospital authority.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
participating hospital authority means an approved hospital authority for a public hospital that is participating in a Pharmaceutical Reform Arrangement within the meaning of the National Healthcare Agreement.
preparation fee means an amount of $40.
prescriber code means any of the following codes identifying the kind of person mentioned for the code:
(a) MP — medical practitioner;
(b) PDP — participating dental practitioner;
(c) AO — authorised optometrist;
(d) MW — authorised midwife;
(e) NP — authorised nurse practitioner.
purposes code means the letter ‘P’ followed by a number.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.
related pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 2.
Streamlined Authority Code means the number mentioned in subsection 22 (5).
supplier means a person who may supply an infusion or related pharmaceutical benefit under Part 3 of this Special Arrangement.
Note Terms used in this Special Arrangement have the same meaning as in the Act — see section 13 of the Legislative Instruments Act 2003. These terms include:
approved hospital authority
approved medical practitioner
approved pharmacist
approved supplier
pharmaceutical benefit
pharmaceutical item
public hospital authority.
Division 2 Pharmaceutical benefits
4 Pharmaceutical benefits covered by this Special Arrangement
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Part 1 of Schedule 1 or in Schedule 2.
(2) Each pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2:
(a) in the form mentioned in Part 1 of Schedule 1 or in Schedule 2 for the listed drug; and
(b) with the manner of administration mentioned in Part 1 of Schedule 1 or in Schedule 2 for the form of the listed drug.
Note Each listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2 has been declared by the Minister under subsection 85 (2) of the Act. The form, manner of administration and brand mentioned in Part 1 of Schedule 1 or in Schedule 2 have been determined by the Minister under subsections 85 (3), (5) and (6) of the Act respectively.
5 Application of Part VII of the Act
(1) Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.
Note Under this Special Arrangement, pharmaceutical benefits listed in Part 1 of Schedule 1 are supplied as an infusion made from one or more pharmaceutical benefits.
(2) A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.
Note See subsection 100 (3) of the Act.
6 Responsible person
(1) If a code is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in paragraph (2) (a) is the responsible person for the brand of the pharmaceutical item.
(2) For subsection (1):
(a) the person is the person mentioned in Schedule 3 for the code, with the ABN, if any, mentioned in Schedule 3 for the person; and
(b) the pharmaceutical item is the listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2:
(i) in the form mentioned in Part 1 of Schedule 1 or in Schedule 2 for the listed drug; and
(ii) with the manner of administration mentioned in Part 1 of Schedule 1 or in Schedule 2 for the form of the listed drug.
Note A person identified by a code in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Responsible Person’ has been determined by the Minister, under section 84AF of the Act, to be the responsible person for the brand of the pharmaceutical item.
7 Authorised prescriber
(1) Only an authorised prescriber for a chemotherapy pharmaceutical benefit may prescribe the supply of an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit to an eligible patient.
(2) Only an authorised prescriber for a related pharmaceutical benefit may prescribe the supply of the related pharmaceutical benefit to an eligible patient.
Note Each person mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Authorised Prescriber’ is authorised by subsection 88 (1) of the Act, or has been authorised by the Minister under section 88 of the Act, to prescribe the pharmaceutical benefit.
8 Prescription circumstances
(1) If at least one circumstances code is mentioned in the column in Part 1 of Schedule 1 headed ‘Circumstances’ for a chemotherapy pharmaceutical benefit, the circumstances in Schedule 4 for a code are circumstances in which the supply of an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit may be prescribed.
(2) If each chemotherapy pharmaceutical benefit that has the same chemotherapy drug has at least one circumstances code, then the supply of an infusion that includes the chemotherapy drug may only be prescribed in circumstances mentioned for a circumstances code.
(3) If at least one circumstances code is mentioned in the column in Schedule 2 headed ‘Circumstances’ for a related pharmaceutical benefit:
(a) the circumstances mentioned in Schedule 4 for a code are circumstances in which the related pharmaceutical benefit may be prescribed; and
(b) the related pharmaceutical benefit may only be prescribed in circumstances mentioned for a circumstances code.
Note Circumstances for a code mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Circumstances’ have been determined by the Minister under paragraph 85 (7) (b) of the Act, except for circumstances in relation to chemotherapy pharmaceutical benefits containing trastuzumab or fluorouracil.
9 Maximum amount – chemotherapy drug
(1) This section applies subject to section 17.
(2) The maximum amount of a chemotherapy drug that an authorised prescriber may direct to be included in an infusion in one infusion prescription or infusion medication chart is the amount mentioned in the column in Part 2 of Schedule 1 headed ‘Maximum Amount’ for the chemotherapy drug.
(3) If at least one purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’ for a chemotherapy drug, the amount mentioned in the column headed ‘Maximum Amount’ is the maximum for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’, the amount mentioned in the column headed ‘Maximum Amount’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same chemotherapy drug.
10 Maximum quantity – related pharmaceutical benefit
(1) This section applies subject to section 21.
(2) The maximum quantity or number of units of the pharmaceutical item in a related pharmaceutical benefit that an authorised prescriber may direct to be supplied in one prescription or medication chart is the quantity or number of units mentioned in the column in Schedule 2 headed ‘Maximum Quantity’ for the pharmaceutical benefit.
(3) If at least one purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’ for a related pharmaceutical benefit, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same related pharmaceutical benefit.
(5) For subsection (2), the pharmaceutical item is the listed drug mentioned in Schedule 2:
(a) in the form mentioned in Schedule 2 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 2 for the form of the listed drug.
Note The maximum quantities and numbers of units mentioned in the column in Schedule 2 headed ‘Maximum quantity’ have been determined by the Minister under paragraph 85A (2) (a) of the Act.
11 Maximum number of repeats – chemotherapy drug
(1) This section applies subject to section 17.
(2) The maximum number of occasions an authorised prescriber may, in one infusion prescription or infusion medication chart, direct that the supply of an infusion containing a chemotherapy drug be repeated is the number in the column in Part 2 of Schedule 1 headed ‘Number of Repeats’ for the chemotherapy drug.
(3) If at least one purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’ for the chemotherapy drug, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for all purposes, other than a purpose for which a different maximum is mentioned for the same chemotherapy drug.
(5) If an infusion contains more than one chemotherapy drug, the maximum number of repeats for the infusion is the smallest maximum number that applies in relation to one of the chemotherapy drugs.
12 Maximum number of repeats – related pharmaceutical benefit
(1) This section applies subject to section 21.
(2) The maximum number of occasions an authorised prescriber may, in one prescription or medication chart, direct that the supply of a related pharmaceutical benefit be repeated is the number in the column in Schedule 2 headed ‘Number of Repeats’ for the related pharmaceutical benefit.
(3) If at least one purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’ for the related pharmaceutical benefit, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for all purposes, other than a purpose for which a different maximum is mentioned for the same related pharmaceutical benefit.
Note The numbers of repeats mentioned in the column in Schedule 2 headed ‘Number of Repeats’ have been determined by the Minister under paragraph 85A (2) (b) of the Act.
13 Section 100 only supply
(1) If the letter ‘D’ is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a listed drug, the listed drug may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the listed drug.
(2) A pharmaceutical benefit that has a drug mentioned in subsection (1) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note The Minister has declared, under subsection 85 (2A) of the Act, that the listed drug can only be supplied under a section 100 Special Arrangement.
(3) If the letters ‘PB’ are mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a pharmaceutical benefit, the pharmaceutical benefit may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the pharmaceutical benefit.
(4) A pharmaceutical benefit mentioned in subsection (3) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note The Minister has determined, under paragraph 85 (8) (a) of the Act, that this pharmaceutical benefit can only be supplied under a section 100 Special Arrangement.
(5) If the letter ‘C’ is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a pharmaceutical benefit and a code is mentioned in the column headed ‘Circumstances’, the pharmaceutical benefit may be supplied in the circumstances signified by the code only in accordance with this Special Arrangement and any other Special Arrangement relating to the pharmaceutical benefit.
(6) A pharmaceutical benefit mentioned in subsection (5) is not available in the circumstances mentioned in subsection (5) for general supply on the Pharmaceutical Benefits Scheme.
Note The Minister has determined, under paragraph 85 (8) (b) of the Act, that one or more of the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written are circumstances in which the benefit can only be supplied under a section 100 Special Arrangement.
Part 2 Prescription
Division 1 Chemotherapy pharmaceutical benefits
14 Methods of prescribing chemotherapy pharmaceutical benefit
(1) An authorised prescriber may prescribe a chemotherapy pharmaceutical benefit under this Special Arrangement by:
(a) writing an infusion prescription for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with regulation 19 of the Regulations as modified by section 15; or
(b) for an eligible public hospital patient — preparing an infusion medication chart for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with section 16.
(2) However, chemotherapy pharmaceutical benefits containing the following chemotherapy drugs may only be prescribed by writing an infusion prescription:
(a) bortezomib;
(b) trastuzumab.
(3) An infusion prescription written in accordance with section 15 or an infusion medication chart prepared in accordance with section 16 is taken to be a duly written prescription for regulation 19 of the Regulations.
(4) Paragraph 19 (2) (a) of the Regulations does not apply to an infusion prescription or infusion medication chart.
15 Information to be included in infusion prescription
(1) For paragraph 14 (1) (a), this section modifies the requirements of regulation 19 of the Regulations.
(2) An infusion prescription must include the following information:
(a) the name of each chemotherapy drug included in the infusion;
(b) the dose of each chemotherapy drug;
(c) if supply of the infusion is to be repeated — the number of times it is to be repeated;
(d) for an authority prescription, in relation to each circumstance for which authorisation of the prescription is required:
(i) the authority approval number allotted to the prescription by the Chief Executive Medicare, unless the prescription is to be posted or delivered to the Chief Executive Medicare for authorisation; or
(ii) the Streamlined Authority Code.
(3) An infusion prescription does not need to include the following information:
(a) the form of a chemotherapy drug to be supplied;
(b) the quantity or number of units of a pharmaceutical benefit to be supplied;
(c) the number of times supply of a pharmaceutical benefit is to be repeated.
Note If the prescription does include this information, a supplier is not required to follow the prescriber’s directions — see section 33.
16 Information to be included in infusion medication chart
For paragraph 14 (1) (b), an infusion medication chart for an eligible public hospital patient must include the following information:
(a) the name and provider number of the hospital where the chart is prepared;
(b) the name, signature and prescriber number of the authorised prescriber;
(c) the Streamlined Authority Code for each circumstance, if any, in relation to which authorisation of the medication chart is required;
(d) the patient’s name and address;
(e) the patient’s entitlement number, if applicable;
(f) the letters ‘PBS’ or ‘RPBS’, whichever is applicable;
(g) the name of each chemotherapy drug included in the infusion;
(h) the dose of each chemotherapy drug;
(i) the number of repeats of the infusion;
(j) the date the medication chart is prepared.
Note If the medication chart includes information about the form or brand of a chemotherapy drug to be supplied, or the quantity, number of units or number of repeats of a particular pharmaceutical benefit to be supplied, a supplier is not required to follow the prescriber’s directions except if they relate to the method of administering the chemotherapy drug — see section 33.
17 Dose or number of repeats greater than maximum
(1) If an authorised prescriber prescribes a dose of a chemotherapy drug that is greater than the maximum amount permitted under section 9, then:
(a) for an infusion prescription written in accordance with paragraph 14 (1) (a) — the prescription must be authorised in accordance with the procedures mentioned in regulation 13 of the Regulations as modified by subsection (2); and
(b) for an infusion medication chart prepared in accordance with paragraph 14 (1) (b) — the medication chart must be authorised in accordance with the procedures mentioned in section 28.
(2) A reference in regulation 13 of the Regulations to a determination in force under paragraph 85A (2) (a) of the Act is to be read as a reference to the maximum amount of the chemotherapy drug as described in section 9.
(3) If an authorised prescriber directs that the supply of an infusion be repeated more times than the maximum number of repeats permitted under section 11 for one or more of the chemotherapy drugs included in the infusion, then:
(a) for an infusion prescription written in accordance with paragraph 14 (1) (a) — the prescription must be authorised in accordance with the procedures mentioned in regulation 13 of the Regulations as modified by subsection (4); and
(b) for an infusion medication chart prepared in accordance with paragraph 14 (1) (b) — the medication chart must be authorised in accordance with the procedures mentioned in section 28.
(4) A reference in regulation 13 of the Regulations to a determination in force under paragraph 85A (2) (b) of the Act is to be read as a reference to the maximum number of repeats for a chemotherapy drug as described in section 11.
18 Direction to vary dose of chemotherapy drug in infusion
(1) An authorised prescriber may direct a supplier to increase or decrease the dose of a chemotherapy drug in a prescribed infusion, without writing a new infusion prescription or infusion medication chart, if the new dose of the drug is between 90% and 110% of the dose that was originally prescribed.
(2) A new dose directed under subsection (1) that is greater than the maximum amount for the chemotherapy drug does not require approval under section 17.
(3) If a supplier receives a direction in accordance with subsection (1), the supplier must record on the infusion prescription or infusion medication chart:
(a) the name of the authorised prescriber who gave the direction; and
(b) the means by which the supplier was notified of the direction (for example, by phone or by fax); and
(c) the date and time the supplier was notified.
Division 2 Related pharmaceutical benefits
19 Methods of prescribing related pharmaceutical benefit
(1) An authorised prescriber may prescribe a related pharmaceutical benefit under this Special Arrangement by:
(a) writing a prescription for the related pharmaceutical benefit in accordance with regulation 19 of the Regulations; or
(b) preparing a medication chart for the related pharmaceutical benefit in accordance with section 20.
Note Related pharmaceutical benefits can only be supplied under this Special Arrangement by a participating hospital authority to eligible public hospital patients — see section 32.
(2) A medication chart prepared in accordance with section 20 is taken to be a duly written prescription for regulation 19 of the Regulations.
20 Information to be included in medication chart for related pharmaceutical benefit
For paragraph 19 (1) (b), a medication chart for an eligible public hospital patient in relation to a related pharmaceutical benefit must include the following information:
(a) the name and provider number of the hospital where the chart is prepared;
(b) the name, signature and prescriber number of the authorised prescriber;
(c) if the circumstance in which the related pharmaceutical benefit is being prescribed requires authorisation — the Streamlined Authority Code;
(d) the patient’s name and address;
(e) the patient’s entitlement number, if applicable;
(f) the letters ‘PBS’ or ‘RPBS’, whichever is applicable;
(g) the listed drug in the related pharmaceutical benefit;
(h) the strength of the related pharmaceutical benefit;
(i) the quantity or dosage, or both, of the related pharmaceutical benefit;
(j) if the dosage is provided — how often the dosage is to be taken by the patient and the period that the pharmaceutical benefit is prescribed;
(k) the number of repeats;
(l) the date the medication chart is prepared.
21 Quantity or number of repeats greater than maximum
(1) If an authorised prescriber prescribes a supply of a related pharmaceutical benefit that is greater than the maximum quantity or number of units permitted under section 10, then:
(a) for a prescription written in accordance with paragraph 19 (1) (a) — the prescription must be authorised in accordance with the procedures mentioned in regulation 13 of the Regulations; and
(b) for a medication chart prepared in accordance with paragraph 19 (1) (b) — the medication chart must be authorised in accordance with the procedures mentioned in section 28.
(2) If an authorised prescriber directs that the supply of a related pharmaceutical benefit be repeated more times than the maximum number of repeats permitted under section 12, then:
(a) for a prescription written in accordance with paragraph 19 (1) (a) — the prescription must be authorised in accordance with the procedures mentioned in regulation 13 of the Regulations; and
(b) for a medication chart prepared in accordance with paragraph 19 (1) (b) — the medication chart must be authorised in accordance with the procedures mentioned in section 28.
Division 3 Authority required procedures
22 Authority required procedures to be followed
(1) This section applies to an infusion prescription or infusion medication chart if:
(a) a circumstances code is mentioned in Part 1 of Schedule 1 for a chemotherapy pharmaceutical benefit that has a chemotherapy drug included in the infusion; and
(b) the supply of the infusion is prescribed in the circumstances mentioned in Schedule 4 for the code; and
(c) the circumstances include one of the following statements:
(i) Compliance with Authority Required procedures;
(ii) Compliance with Written Authority Required procedures;
(iii) Compliance with Telephone Authority Required procedures;
(iv) Compliance with Written or Telephone Authority Required procedures;
(v) Compliance with modified Written Authority Required procedures.
Note If at least one circumstances code is mentioned in Part 1 of Schedule 1 for each chemotherapy pharmaceutical benefit that has the same chemotherapy drug, supply of an infusion containing the chemotherapy drug may only be prescribed in one of the circumstances to which a code relates — see subsections 8 (1) and (2).
(2) This section applies to a prescription or medication chart for a related pharmaceutical benefit if:
(a) a circumstances code is mentioned in Schedule 2 for the related pharmaceutical benefit; and
(b) the related pharmaceutical benefit is prescribed in the circumstances mentioned in Schedule 4 for the code; and
(c) the circumstances include one of the following statements:
(i) Compliance with Authority Required procedures;
(ii) Compliance with Written Authority Required procedures;
(iii) Compliance with Telephone Authority Required procedures;
(iv) Compliance with Written or Telephone Authority Required procedures;
(v) Compliance with modified Written Authority Required procedures.
Note If at least one circumstances code is mentioned in Schedule 2, the related pharmaceutical benefit may only be prescribed in one of the circumstances to which the code relates — see subsection 8 (3).
(3) The table sets out which procedure in this Division must be followed for:
(a) an infusion prescription written in accordance with paragraph 14 (1) (a) to be authorised in the circumstances mentioned in Schedule 4; or
(b) a prescription written in accordance with paragraph 19 (1) (a) to be authorised in the circumstances mentioned in Schedule 4.
If the circumstances in Schedule 4 include the statement … | the procedure that must be followed is … |
Compliance with Authority Required procedures | any one of the Written Authority Required procedure set out in section 23, the Telephone Authority Required procedure set out in section 26 or the Electronic Authority Required procedure set out in section 27 |
Compliance with Written Authority Required procedures | the Written Authority Required procedure set out in section 23 |
Compliance with Telephone Authority Required procedures | the Telephone Authority Required procedure set out in section 26 |
Compliance with Written or Telephone Authority Required procedures | either the Written Authority Required procedure set out in section 23 or the Telephone Authority Required procedure set out in section 26 |
Compliance with modified Written Authority Required procedures | the modified Written Authority Required procedure set out in section 24 |
(4) The procedure set out in section 28 must be followed for:
(a) an infusion medication chart prepared in accordance with paragraph 14 (1) (b) to be authorised in the circumstances mentioned in Schedule 4; or
(b) a medication chart prepared in accordance with paragraph 19 (1) (b) to be authorised in the circumstances mentioned in Schedule 4.
(5) However, if the circumstances mentioned in Schedule 4 include the words ‘Streamlined Authority Code’ followed by a number:
(a) a prescription written in accordance with paragraph 14 (1) (a) is taken to be authorised if the authorised prescriber has:
(i) prepared and signed the prescription in accordance with paragraph 23 (1) (a), (b), (c) or (d); and
(ii) has written the Streamlined Authority Code for the circumstances on the prescription; and
(b) a prescription written in accordance with paragraph 19 (1) (a) is taken to be authorised if the authorised prescriber has:
(i) prepared and signed the prescription in accordance with paragraph 23 (1) (a), (b), (c) or (d); and
(ii) has written the Streamlined Authority Code for the circumstances on the prescription; and
(c) a medication chart prepared in accordance with paragraph 14 (1) (b) or 19 (1) (b) is taken to be authorised.
23 Written Authority Required procedure
(1) To have a prescription authorised using the Written Authority Required procedure, the authorised prescriber must deliver or post to the Chief Executive Medicare the prescription prepared and signed by the authorised prescriber:
(a) in a form approved by the Secretary and completed by the authorised prescriber in ink in his or her own handwriting; or
(b) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under paragraph (a); or
(c) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or
(d) by a method approved in writing by the Secretary.
(2) A prescription submitted in accordance with subsection (1) may be authorised by the Chief Executive Medicare signing his or her authorisation on the prescription, and:
(a) if the Chief Executive Medicare requires the authorised prescriber to alter the prescription — returning it to the authorised prescriber for alteration before the authorised prescriber gives it to the person in respect of whom it was prepared; or
(b) in any other case, either:
(i) returning the authorised prescription to the authorised prescriber; or
(ii) sending it to the person in respect of whom it was prepared.
24 Modified Written Authority Required procedure
(1) To have a prescription authorised using the modified Written Authority Required procedure, the authorised prescriber:
(a) must submit the prescription in accordance with subsection 23 (1); and
(b) must comply with any other requirements included in the circumstances in Schedule 4 that apply to the prescription.
Example
The circumstances in Schedule 4 require additional documents to be submitted along with the prescription.
(2) A prescription submitted in accordance with subsection (1) may be authorised by the Chief Executive Medicare in the way set out in subsection 23 (2).
25 Submission of prescription by agent permitted
For sections 23 and 24, a prescription prepared and signed by an authorised prescriber is taken to have been submitted by the authorised prescriber if it is submitted by his or her agent.
26 Telephone Authority Required procedure
(1) To have a prescription authorised using the Telephone Authority Required procedure, the authorised prescriber must submit to the Chief Executive Medicare, by telephone, details of the prescription prepared and signed by the authorised prescriber in accordance with paragraph 23 (1) (a), (b), (c) or (d).
(2) However, if the authorised prescriber is unable to submit the prescription because the telephone system established by the Chief Executive Medicare for that purpose is unavailable, the authorised prescriber must submit the prescription in accordance with the instructions in an emergency telephone message provided by the Chief Executive Medicare.
(3) A prescription submitted in accordance with subsection (1) may be authorised by the Chief Executive Medicare telling the authorised prescriber by telephone, at the time the Chief Executive Medicare is given the details of the prescription, that the prescription is authorised.
(4) If the Chief Executive Medicare authorises a prescription under subsection (3):
(a) the Chief Executive Medicare must tell the authorised prescriber by telephone the number given by the Chief Executive Medicare to the prescription; and
(b) the authorised prescriber must:
(i) mark that number on the prescription; and
(ii) retain a copy of the prescription for 1 year from the date the prescription was authorised.
(5) A prescription submitted in accordance with subsection (2) is taken to have been authorised by the Chief Executive Medicare if the authorised prescriber completes the prescription in accordance with the instructions given in the emergency telephone message.
27 Electronic Authority Required procedure
(1) To have a prescription authorised using the Electronic Authority Required procedure, the authorised prescriber must submit to the Chief Executive Medicare, by means of an electronic communication of a kind approved in writing by the Chief Executive Medicare, details of the prescription prepared and signed by the authorised prescriber in accordance with paragraph 23 (1) (a), (b), (c) or (d).
(2) A prescription submitted in accordance with subsection (1) may be authorised by the Chief Executive Medicare sending his or her authorisation by electronic communication to the authorised prescriber.
(3) If the Chief Executive Medicare authorises a prescription under subsection (2):
(a) the Chief Executive Medicare must tell the authorised prescriber by electronic communication the number given by the Chief Executive Medicare to the prescription; and
(b) the authorised prescriber must:
(i) mark that number on the prescription; and
(ii) retain a copy of the prescription for 1 year from the date the prescription was authorised.
28 Medication chart authorisation
(1) To have a medication chart authorised, a pharmacist employed or engaged by the public hospital authority must, on behalf of the authorised prescriber, submit the information in the chart mentioned in section 16 or 20 to the Chief Executive Medicare by means of an electronic communication of a kind approved by the Chief Executive Medicare.
(2) A medication chart for which information has been submitted in accordance with subsection (1) is taken to have been authorised when:
(a) the pharmacist receives a message by electronic communication from the system established by the Chief Executive Medicare indicating that the authorisation has been granted; and
(b) the pharmacist completes the medication chart in accordance with the instructions given by the message.
29 Alternative if medication chart not authorised
(1) This section applies if:
(a) a pharmacist attempted to comply with subsection 28 (1) but was unable to do so because the system established by the Chief Executive Medicare for the provision of authorisations was unavailable; or
(b) a pharmacist submitted information for a medication chart in accordance with subsection 28 (1) but the authorisation was not granted by the system established by the Chief Executive Medicare.
(2) An authorisation for the supply of the infusion in the circumstances requiring authorisation may be obtained if the authorised prescriber prepares an infusion prescription in accordance with paragraph 14 (1) (a) and submits the infusion prescription in accordance with a procedure allowed by subsection 22 (3) for the prescription.
(3) An authorisation for the supply of the related pharmaceutical benefit in the circumstances requiring authorisation may be obtained if the authorised prescriber prepares a prescription in accordance with paragraph 19 (1) (a) and submits the prescription in accordance with a procedure allowed by subsection 22 (3) for the prescription.
Part 3 Supply
30 Entitlement to infusion or related pharmaceutical benefit
An eligible patient is entitled to receive an infusion or a related pharmaceutical benefit under this Special Arrangement without payment or other consideration, other than a charge made under Part 5.
31 Supply of infusion under this Special Arrangement
(1) An infusion may be supplied under this Special Arrangement by any of the following:
(a) an approved pharmacist;
(b) an approved medical practitioner;
(c) an approved hospital authority for a private hospital;
(d) a public hospital authority to an eligible public hospital patient.
(2) However, a public hospital authority that is not a participating hospital authority may only supply an infusion that contains trastuzumab and that does not contain any other chemotherapy drug.
(3) An infusion that is prescribed in an infusion medication chart may only be supplied by a participating hospital authority to an eligible public hospital patient.
32 Supply of related pharmaceutical benefits under this Special Arrangement
A related pharmaceutical benefit may be supplied under this Special Arrangement by a participating hospital authority to an eligible public hospital patient.
33 Selection of chemotherapy pharmaceutical benefits to make infusion
Form, brand and method of administering
(1) If an authorised prescriber directs the supply of a form of a chemotherapy drug in an infusion prescription or infusion medication chart, the supplier of the infusion may use chemotherapy pharmaceutical benefits with the same chemotherapy drug but a different form to make the infusion.
(2) If an authorised prescriber directs the supply of a listed brand of a chemotherapy drug in an infusion prescription or infusion medication chart, the supplier of the infusion may use chemotherapy pharmaceutical benefits with the same chemotherapy drug but a different listed brand to make the infusion.
(3) If an authorised prescriber identifies a method of administering a chemotherapy drug in an infusion prescription or infusion medication chart, the supply of the infusion must be consistent with the method.
(4) Subsection (3) applies regardless of whether the method identified by the authorised prescriber is also a manner of administration for one or more chemotherapy pharmaceutical benefits containing the chemotherapy drug.
Note Authorised prescribers are required to identify each chemotherapy drug in an infusion and the dose of each drug. They are not required to identify a particular chemotherapy pharmaceutical benefit by including the form, manner of administration or brand.
Quantity and number of repeats
(5) If an authorised prescriber directs the supply of a quantity or number of units of a particular chemotherapy pharmaceutical benefit, the supplier of the infusion may disregard the direction.
(6) If an authorised prescriber directs how many times the supply of a particular chemotherapy pharmaceutical benefit is to be repeated, the supplier of the infusion may disregard the direction.
Note Authorised prescribers are required to identify the dose of each chemotherapy drug and the number of times that supply of the infusion is to be repeated. They are not required to identify the quantity or number of units of a pharmaceutical benefit to be supplied, or the number of times supply of a pharmaceutical benefit is to be repeated.
Circumstances
(7) If an infusion prescription or infusion medication chart has been authorised in circumstances mentioned in Schedule 4, the supplier must only use chemotherapy pharmaceutical benefits for which the circumstances code for those circumstances is mentioned in the column in Part 1 of Schedule 1 headed ‘Circumstances’.
Note If this subsection applies, an authority approval number or Streamlined Authority Code will appear on the infusion prescription or infusion medication chart — see sections 15 and 16 and Division 3 of Part 2.
34 Modified application of Act and Regulations
Infusions
(1) A supply of an infusion under this Special Arrangement is not an early supply of a specified pharmaceutical benefit within the meaning of subsection 84AAA (1) of the Act.
(2) Subregulations 25 (2) to (4) of the Regulations do not apply to the supply of an infusion under this Special Arrangement.
Note The effect of those subregulations is to restrict how soon a repeat supply may be made. There is no restriction on how soon a repeat supply of an infusion may be made under this Special Arrangement.
(3) Regulations 24 and 26A of the Regulations do not apply to the supply of an infusion under this Special Arrangement.
(4) A reference elsewhere in the Regulations to the supply of a pharmaceutical benefit is taken to include the supply of an infusion under this Special Arrangement.
Medication charts
(5) Regulations 22 and 31 of the Regulations do not apply to:
(a) the supply of an infusion that is prescribed in an infusion medication chart in accordance with paragraph 14 (1) (b); or
(b) the supply of a related pharmaceutical benefit that is prescribed in a medication chart in accordance with paragraph 19 (1) (b).
35 Medication charts — acknowledging receipt of infusion or related pharmaceutical benefit
(1) If the supply of an infusion is prescribed to an eligible public hospital patient in accordance with paragraph 14 (1) (b), the treating medical practitioner, or a person employed or engaged by the participating hospital authority, must record on the patient’s medication chart the date that the infusion was supplied to the patient.
(2) If the supply of a related pharmaceutical benefit is prescribed to an eligible public hospital patient in accordance with paragraph 19 (1) (b), the treating medical practitioner, or a person employed or engaged by the participating hospital authority, must record on the patient’s medication chart the date that the pharmaceutical benefit was supplied to the patient.
Part 4 Claims and payment
Division 1 Claims for payment
36 How claims to be made
(1) The following may make a claim for payment for the supply of an infusion or related pharmaceutical benefit to an eligible patient under this Special Arrangement in accordance with section 99AAA of the Act, and the rules made under subsection 99AAA (8) of the Act, as modified by this Division:
(a) an approved supplier;
(b) an HSD hospital authority.
(2) If a non-approved public hospital authority supplies an infusion that contains trastuzumab under this Special Arrangement, the State or Territory responsible for the hospital may make an off‑line claim for payment in accordance with section 40.
37 Modified references for claim by HSD hospital authority
The rules made by the Minister under subsection 99AAA (8) of the Act apply to a claim made by an HSD hospital authority as follows:
(a) a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority;
(b) a reference to a number allotted to an approval under regulation 8A of the Regulations includes a reference to a number allotted to an approval under section 52 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010.
38 Modified requirements for supply from medication chart
(1) This section applies to a claim, made by a participating hospital authority, for:
(a) supply of an infusion that was prescribed in an infusion medication chart; or
(b) supply of a related pharmaceutical benefit that was prescribed in a medication chart.
(2) The requirements in the rules determined by the Minister under subsection 99AAA (8) of the Act are modified as follows:
(a) the participating hospital authority is not required to supply the medication chart with the claim;
(b) the participating hospital authority must keep an electronic version of the information supplied with the claim for 1 year from the day that the infusion or related pharmaceutical benefit is supplied;
(c) if requested by the Chief Executive Medicare, the participating hospital authority must give the Chief Executive Medicare a copy of:
(i) the medication chart; and
(ii) the information supplied with the claim.
39 Modified requirements for supply of infusion
For a claim for supply of an infusion, the requirements in the rules determined by the Minister under subsection 99AAA (8) of the Act are modified as follows:
(a) a reference to a pharmaceutical benefit includes a reference to an infusion;
(b) a reference to an authority prescription in the rules includes a reference to an authority prescription within the meaning given by section 3 of this Special Arrangement;
(c) the claim must include:
(i) a drug code for each chemotherapy drug in the infusion, being the code for the drug published in the Schedule of Pharmaceutical Benefits published by the Department; and
(ii) the dose of each chemotherapy drug in the infusion; and
(iii) for a claim submitted on or after 1 April 2012 — the authority approval number or Streamlined Authority Code in relation to each circumstance, if any, for which authorisation of the prescription or medication chart is required;
(d) the supplier is not required to include in the claim:
(i) the PBS/RPBS Item Code for the supplied pharmaceutical benefit; or
(ii) the brand of the supplied pharmaceutical item.
40 Off-line claim by State or Territory
To make an off-line claim, a State or Territory must:
(a) lodge with the Human Services Department one claim per calendar month for payment for all infusions containing trastuzumab supplied by all non‑approved public hospital authorities within the State or Territory; and
(b) submit the claim within 3 months (or such longer period as the Chief Executive Medicare allows) after the end of the calendar month to which the claim relates; and
(c) include in the claim the following information for each supply of an infusion containing trastuzumab:
(i) the hospital provider number of the hospital that supplied the infusion;
(ii) the authority approval number allotted to the prescription by the Chief Executive Medicare;
(iii) whether the supply is the original or repeated supply;
(iv) the date on which the infusion was supplied;
(v) the dose of trastuzumab in the infusion.
Division 2 Payment of claim
41 Payment of approved pharmacist or approved medical practitioner for supply of infusion
An approved pharmacist or approved medical practitioner who makes a claim under Division 1 for the supply of an infusion is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the infusion is greater than the amount that the approved pharmacist or approved medical practitioner was required to charge under subsection 54 (2).
42 Payment of approved hospital authority or HSD hospital authority for supply of infusion
An approved hospital authority or HSD hospital authority that makes a claim under Division 1 for the supply of an infusion is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the infusion is greater than the amount that the approved hospital authority or HSD hospital authority was entitled to charge under subsection 55 (2).
43 Payment of participating hospital authority for supply of related pharmaceutical benefit
A participating hospital authority that makes a claim under Division 1 for the supply of a related pharmaceutical benefit is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the related pharmaceutical benefit is greater than the amount that the supplier was entitled to charge under subsection 57 (2).
44 Payment of State or Territory for supply of trastuzumab by non‑approved public hospital authorities
A State or Territory that makes a claim in accordance with section 40 for the supply of an infusion containing trastuzumab is entitled to be paid by the Commonwealth 99.2% of the dispensed price for the dose of trastuzumab.
45 Method of working out dispensed price
Infusion
(1) The dispensed price for the supply of an infusion is the sum of:
(a) the dispensed prices of the doses of chemotherapy drugs in the infusion; and
(b) if the supply is a repeated supply — an amount equivalent to the amount that may be charged under subsection 87 (2) of the Act for the supply of a pharmaceutical benefit to the eligible patient.
(2) The dispensed price for a dose of a chemotherapy drug is to be worked out under Division 3.
Related pharmaceutical benefit
(3) The dispensed price for the supply of a related pharmaceutical benefit is to be worked out under Division 4.
Rounding
(4) A dispensed price worked out under Division 3 or 4 is rounded to the nearest cent, with a half cent being rounded up.
46 No separate entitlement to payment for supply of diluent
(1) If a supplier adds a pharmaceutical benefit to an infusion supplied under this Special Arrangement as a diluent, no amount is payable under Part VII of the Act for supply of the pharmaceutical benefit.
(2) Subsection (1) applies regardless of whether the pharmaceutical benefit added as a diluent is one to which this Special Arrangement applies.
Note For the application of this Special Arrangement to pharmaceutical benefits, see section 5.
Division 3 Dispensed price of chemotherapy drug
47 Dispensed price if drug is in infusion supplied by approved pharmacist or approved medical practitioner
(1) For a dose of a chemotherapy drug in an infusion supplied by an approved pharmacist or an approved medical practitioner to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) the distribution fee;
(c) the dispensing fee;
(d) the preparation fee;
(e) the diluent fee.
(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.
(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example
Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug — see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.
(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the sum, rounded to the nearest cent (with a half cent being rounded up), of:
(a) the ex-manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and
(b) the mark‑up for the chemotherapy pharmaceutical benefit worked out under:
(i) if the chemotherapy pharmaceutical benefit does not have trastuzumab — section 48; or
(ii) if the chemotherapy pharmaceutical benefit has trastuzumab — section 49.
Note The reference price and the ex-manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
48 Mark-up for chemotherapy pharmaceutical benefit that does not have trastuzumab
(1) For subparagraph 47 (4) (b) (i), the mark-up for a chemotherapy pharmaceutical benefit that does not have trastuzumab is:
where:
mark-up for maximum multiple means the amount worked out under subsection (2).
maximum multiple of pharmaceutical benefit is the whole number of multiples of the form of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of the chemotherapy drug in the benefit that is permitted under section 9.
Note The form of a chemotherapy pharmaceutical benefit is mentioned in Part 1 of Schedule 1 in the column headed ‘Form’ — see section 5.
(2) The mark-up for the maximum multiple of a chemotherapy pharmaceutical benefit with an ex-manufacturer price mentioned in the table is the amount mentioned in the table.
Item | Ex-manufacturer price for maximum multiple of pharmaceutical benefit | Mark‑up for maximum multiple |
1 | ≤ $30 | 15% of ex-manufacturer price for maximum multiple of pharmaceutical benefit |
2 | > $30, ≤ $45 | $4.50 |
3 | > $45, ≤ $180 | 10% of ex-manufacturer price for maximum multiple of pharmaceutical benefit |
4 | > $180, ≤ $450 | $18 |
5 | > $450, ≤ $1 750 | 4% of ex-manufacturer price for maximum multiple of pharmaceutical benefit |
6 | > $1 750 | $70 |
49 Mark-up for chemotherapy pharmaceutical benefit that has trastuzumab
(1) For subparagraph 47 (4) (b) (ii), the mark-up for a chemotherapy pharmaceutical benefit that has trastuzumab is:
where:
mark-up for maximum multiple means the amount worked out under subsection (2).
maximum multiple of pharmaceutical benefit is the whole number of multiples of the form of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of trastuzumab that is permitted under section 9.
Note The form of a chemotherapy pharmaceutical benefit is mentioned in Part 1 of Schedule 1 in the column headed ‘Form’ — see section 5.
(2) The mark-up for the maximum multiple of a chemotherapy pharmaceutical benefit with an ex-manufacturer price mentioned in the table is the amount mentioned in the table.
Item | Ex-manufacturer price for maximum multiple of pharmaceutical benefit | Mark‑up for maximum multiple |
1 | ≤ $40 | 10% of ex-manufacturer price for maximum multiple of pharmaceutical benefit |
2 | > $40, ≤ $100 | $4 |
3 | > $100, ≤ $1 000 | 4% of ex-manufacturer price for maximum multiple of pharmaceutical benefit |
4 | > $1 000 | $40 |
50 Dispensed price if drug is in infusion supplied by approved private hospital authority
(1) For a dose of a chemotherapy drug in an infusion supplied by an approved hospital authority of a private hospital to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) for a drug other than trastuzumab — the distribution fee;
(c) the dispensing fee;
(d) the preparation fee;
(e) the diluent fee.
(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.
(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example
Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug — see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.
(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the sum, rounded to the nearest cent (with a half cent being rounded up), of:
(a) the ex-manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and
(b) 1.4% of the ex-manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
Note The reference price and the ex-manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
51 Dispensed price if drug is in infusion supplied by public hospital authority
(1) For a dose of a chemotherapy drug in an infusion supplied by a public hospital authority to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) the preparation fee.
(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.
(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example
Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug — see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.
(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the ex-manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up).
Note The reference price and the ex-manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
Division 4 Dispensed price of related pharmaceutical benefit
52 Dispensed price for supply of related pharmaceutical benefit
(1) For a related pharmaceutical benefit supplied by a participating hospital authority to an eligible patient, the dispensed price is as follows:
(a) if the quantity of the related pharmaceutical benefit that is ordered and supplied is equal to the quantity contained in the manufacturer’s pack — the ex‑manufacturer price for the pack;
(b) if the quantity of the related pharmaceutical benefit that is ordered and supplied is less than the quantity contained in the manufacturer’s pack — the amount worked out under section 53;
(c) if the quantity of the related pharmaceutical benefit that is ordered and supplied is more than the quantity contained in the manufacturer’s pack — the sum of:
(i) the ex-manufacturer price for each complete pack in the quantity; and
(ii) the amount worked out under section 53 for any remainder.
(2) However, if there are 2 or more related pharmaceutical benefits that are different brands of the same pharmaceutical item, the dispensed price of those pharmaceutical benefits is to be based on the pharmaceutical benefit with the lowest ex-manufacturer price.
53 Quantity less than manufacturer’s pack
For paragraph 52 (1) (b) and subparagraph 52 (1) (c) (ii), the amount for a quantity of a related pharmaceutical benefit that is less than the quantity contained in the manufacturer’s pack (a broken quantity) is worked out by:
(a) dividing the quantity or number of units in the broken quantity by the quantity or number of units in the manufacturer’s pack expressed as a percentage to 2 decimal places; and
(b) applying that percentage to the ex‑manufacturer price for the complete pack.
Part 5 Patient contributions
54 Supply of infusion by approved pharmacist or approved medical practitioner
(1) The amount that an approved pharmacist or approved medical practitioner may or must charge an eligible patient for the supply of an infusion is the total of the amounts set out in this section.
Patient co-payment for original supply
(2) For an original supply of an infusion, the approved pharmacist or approved medical practitioner must charge the eligible patient an amount that is equivalent to the amount that is required to be charged under subsection 87 (2) of the Act for the supply of a pharmaceutical benefit to the patient.
Note This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.
(3) No amount may be charged under subsection (2) for a repeat supply.
Special patient contribution for Schedule 5 pharmaceutical benefit
(4) If a chemotherapy pharmaceutical benefit the approved pharmacist or approved medical practitioner uses to make the infusion is mentioned in Schedule 5, the approved pharmacist or approved medical practitioner may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.
Note If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.
55 Supply of infusion by approved hospital authority or HSD hospital authority
(1) The amount that an approved hospital authority or HSD hospital authority may charge an eligible patient for the supply of an infusion is the total of the amounts set out in this section.
Patient co-payment for original supply
(2) For an original supply of an infusion, the hospital authority may charge the eligible patient an amount not exceeding the amount that the patient could have been required to pay under subsection 87 (2) of the Act if the patient had obtained a pharmaceutical benefit from an approved pharmacist.
Note This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.
(3) No amount may be charged under subsection (2) for a repeat supply.
Special patient contribution for Schedule 5 pharmaceutical benefit
(4) If a chemotherapy pharmaceutical benefit the hospital authority uses to make the infusion is mentioned in Schedule 5, the hospital authority may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.
Note If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.
56 Supply of infusion by non-approved public hospital authority
(1) The amount that a non-approved public hospital authority may charge an eligible patient for the supply of an infusion containing trastuzumab is the total of the amounts set out in this section.
Patient co-payment for original supply
(2) For an original supply of an infusion, the hospital authority may charge the eligible patient the relevant amount specified as the maximum value of a supply of out‑patient medication in the determination made under subsection 84BA (2) of the Act, as in force on the date of the supply of the infusion.
Note This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.
(3) No amount may be charged under subsection (2) for a repeat supply.
Special patient contribution for Schedule 5 pharmaceutical benefit
(4) If a chemotherapy pharmaceutical benefit the hospital authority uses to make the infusion is mentioned in Schedule 5, the hospital authority may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.
Note If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.
57 Supply of related pharmaceutical benefit by participating hospital authority
(1) The amount that a participating hospital authority may charge an eligible patient for the supply of a related pharmaceutical benefit is the total of the amounts set out in this section.
Patient co-payment
(2) The participating hospital authority may charge the eligible patient an amount not exceeding the amount that the patient could have been required to pay under subsection 87 (2) of the Act if the patient had obtained the related pharmaceutical benefit from an approved pharmacist.
Special patient contribution for Schedule 5 pharmaceutical benefit
(3) If the related pharmaceutical benefit is mentioned in Schedule 5, the participating hospital authority may also charge the eligible patient an amount not exceeding the amount for the related pharmaceutical benefit worked out under section 58.
58 Special patient contribution for Schedule 5 pharmaceutical benefit
(1) The amount an eligible patient may be charged for a pharmaceutical benefit mentioned in Schedule 5 is worked out by subtracting the amount mentioned for the pharmaceutical benefit in the ‘Approved Ex-manufacturer Price’ column in Schedule 5 from the amount mentioned for the pharmaceutical benefit in the ‘Claimed Ex-manufacturer Price’ column in Schedule 5.
(2) However, the amounts mentioned in the ‘Approved Ex‑manufacturer price’ and ‘Claimed Ex-manufacturer price’ columns must be adjusted proportionally if:
(a) for a chemotherapy pharmaceutical benefit — the quantity or number of units of the pharmaceutical benefit used to make the infusion is more or less than the number mentioned in the ‘Quantity or Number of Units’ column; and
(b) for a related pharmaceutical benefit — the quantity or number of units of the pharmaceutical benefit supplied is more or less than the number mentioned in the ‘Quantity or Number of Units’ column.
59 Amounts taken into account for eligibility for concession and entitlement cards
An amount charged under any of the following provisions is to be taken into account when determining a person’s eligibility for a concession card or entitlement card under section 84C of the Act:
(a) subsection 54 (2);
(b) subsection 55 (2);
(c) subsection 56 (2);
(d) subsection 57 (2).
Part 6 Transitional
60 Prescriptions for general supply
(1) This section applies if:
(a) a prescription for a pharmaceutical benefit was written before the commencement of this Special Arrangement; and
(b) the pharmaceutical benefit was not supplied before the commencement of this Special Arrangement; and
(c) on 30 November 2011 the pharmaceutical benefit was available for general supply on the Pharmaceutical Benefits Scheme; and
(d) under section 13 of this Special Arrangement, the pharmaceutical benefit is not available for general supply on the Pharmaceutical Benefits Scheme.
(2) Despite section 13 of this Special Arrangement, the pharmaceutical benefit may be supplied as if it continued to be available for general supply on the Pharmaceutical Benefits Scheme in accordance with the Act, and the instruments made under the Act that applied to the pharmaceutical benefit, as in force on 30 November 2011.
(3) However, if the pharmaceutical benefit is no longer determined as a pharmaceutical benefit under section 85 of the Act on the date of proposed supply:
(a) the pharmaceutical benefit must not be supplied; and
(b) a substitute benefit within the meaning of subsection 103 (2A) of the Act may be supplied if:
(i) immediately before the determination under section 85 was revoked, the Schedule of Pharmaceutical Benefits issued by the Department stated that the prescribed pharmaceutical benefit and the substitute benefit were equivalent; and
(ii) the requirements of paragraphs 103 (2A) (a), (c) and (d) of the Act are met.
(4) Subsection (2) stops having effect on 1 April 2012.
