National Health (Trastuzumab) Special Arrangement 2011 (No. PB 94 of 2011)

Link to law: https://www.comlaw.gov.au/Details/F2011L02481

PB 94 of 2011
National Health (Trastuzumab) Special Arrangement 2011
 
National Health Act 1953
 
I, FELICITY MCNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Special Arrangement under subsections 100 (1) and (2) of the National Health Act 1953.
Dated  23 November 2011
 
 
 
 
 
 
FELICITY MCNEILL
 
Acting First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
Contents
Part 1                          Preliminary                                                                                     
Division 1                    General                                                                                              
                        1      Name of Special Arrangement                                                             4
                        2      Commencement                                                                                  4
                        3      Revocation                                                                                         4
                        4      Definitions                                                                                          4
Division 2                    Trastuzumab pharmaceutical benefit                                                  
                        5      Pharmaceutical benefits covered by this Special Arrangement              5
                        6      Application of Part VII of Act                                                               5
                        7      Responsible person                                                                            6
                        8      Authorised prescriber                                                                          6
                        9      Prescription circumstances                                                                  6
                       10      Section 100 only supply                                                                      6
Division 3                    Trastuzumab modified Authority Required procedures                       
                       11      Trastuzumab modified Authority Required procedures                          7
                       12      Trastuzumab modified Authority required procedures — submission of prescription  7
                       13      Trastuzumab modified Authority required procedures — authorisation   8
Division 4                    Maximum quantity and maximum repeats                                          
                       14      Maximum quantity                                                                               9
                       15      Maximum number of repeats                                                               9
                       16      No repeats for visitors                                                                       10
Part 2                          Supply of trastuzumab pharmaceutical benefits                 
                       17      Entitlement to trastuzumab pharmaceutical benefit                              11
                       18      Supply of trastuzumab pharmaceutical benefit under this Special Arrangement          11
Part 3                          Claiming procedures and payment amounts                             
                        19                                                                                                                            Application      12
                       20      Claim for payment by approved hospital authority for a public hospital 12
                       21      Payment for supply of trastuzumab pharmaceutical benefit to approved hospital authority for public hospital                                                                                  12
                       22      Limit on number of prescriptions in one claim                                     12
Part 4                          Patient contributions                                                                                               
                       23      Patient contribution in relation to approved hospital authorities for public hospitals   13
Part 5                          Miscellaneous                                                                               
                       24      PBS Safety Net                                                                                    14             
Part 6                    Transitional Arrangements
                   
                       25      Prescriptions written prior to 1 December 2011                                      15
                       26      Old Arrangements                                                                                   15
Schedule 1                  Pharmaceutical benefits to which this Special Arrangement applies and related information                                                                                                        16
Schedule 2                  Responsible Person Codes                                                              17
Schedule 3                  Circumstances                                                                                 18
                                                                                                                                         
 
Part 1                 Preliminary
Division 1              General
1              Name of Special Arrangement
         (1)   This Special Arrangement is the National Health (Trastuzumab) Special Arrangement 2011.
         (2)   This Special Arrangement may also be cited as PB 94 of 2011.
2              Commencement
                This Special Arrangement commences on 1 December 2011.
3              Revocation
                Instrument PB 115 of 2010 is revoked.
4              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, for a trastuzumab pharmaceutical benefit, means a person who is a kind of person identified by a prescriber code mentioned in the column in Schedule 1 headed ‘Authorised prescriber’ for the pharmaceutical benefit.
Note   Section 5 sets out the pharmaceutical benefits to which this Special Arrangement applies and section 8 sets out the prescriber code for those pharmaceutical benefits.
approved hospital authority, for a public hospital, means the hospital authority for the public hospital that is approved:
                 (a)   by the Minister under section 94 of the Act; or
                 (b)   by the Chief Executive Medicare under section 52 of PB 116 of 2010.
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 medical treatment by a medical practitioner at, or from, the hospital as a non‑admitted patient, day admitted patient or patient on discharge.
hospital authority, for a public hospital, means the governing body of a public hospital.
Human Services Department means the Department administered by the Human Services Minister.
PB 63 of 2010 means the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010.
PB 116 of 2010 means the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010.
prescriber code has the meaning given by paragraph 8 (2) (b).
Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.
trastuzumab means the listed drug mentioned in Schedule 1 in the column headed Listed Drug.
trastuzumab pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
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:
·      pharmaceutical benefit
·      pharmaceutical item.
Division 2              Trastuzumab pharmaceutical benefit
5              Pharmaceutical benefits covered by this Special Arrangement
         (1)   This Special Arrangement applies to each trastuzumab pharmaceutical benefit mentioned in Schedule 1.
         (2)   Each trastuzumab pharmaceutical benefit to which this Special Arrangement applies is the brand of the listed drug mentioned in Schedule 1:
                (a)    in the form mentioned in Schedule 1 for the listed drug; and
               (b)    with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note   The listed drug mentioned in Schedule 1 is trastuzumab — see definition of trastuzumab in section 4. The listed drug has been declared by the Minister under subsection 85 (2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85 (3), (5) and (6) of the Act respectively.
6              Application of Part VII of Act
         (1)   Each trastuzumab pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.
         (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.
7              Responsible person
         (1)   If a code is mentioned in the column in Schedule 1 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 2 for the code, with the ABN, if any, mentioned in Schedule 2 for the person; and
               (b)    the pharmaceutical item is the listed drug mentioned in Schedule 1:
                          (i)    in the form mentioned in Schedule 1 for the listed drug; and
                         (ii)    with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note 1   Each  trastuzumab pharmaceutical benefit mentioned in Schedule 1 is a brand of a pharmaceutical item. Each listed drug mentioned in Schedule 1 has been declared under subsection 85 (2) of the Act and the form of the listed drug, the manner of administration for the form, and the brand have been determined under subsections 85 (3), 85 (5) and 85 (6) of the Act respectively.
8              Authorised prescriber
         (1)   Only an authorised prescriber may write a prescription for the supply of a trastuzumab pharmaceutical benefit under this Special Arrangement.
         (2)   For this Special Arrangement:
                (a)    only a medical practitioner is an authorised prescriber; and
               (b)    the prescriber code for the authorised prescriber is the letters ‘MP’.
         (3)   A reference in this Special Arrangement to a medical practitioner is a reference to an authorised prescriber.
9              Prescription circumstances
         (1)   The circumstances mentioned in Schedule 3 are the circumstances in which a prescription for the supply of a trastuzumab pharmaceutical benefit may be written under this Special Arrangement.
         (2)   For subsection (1), a trastuzumab pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
                (a)    in the form mentioned in Schedule 1 for the listed drug; and
               (b)    with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
10            Section 100 only supply
         (1)   If the letter ‘D’ is mentioned in the column in Schedule 1 headed ‘Section 100 only’ for the listed drug, the pharmaceutical benefits with 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 trastuzumab pharmaceutical benefit 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.
Division 3              Trastuzumab modified Authority Required procedures
11            Trastuzumab modified Authority Required procedures
         (1)   This section applies to a trastuzumab pharmaceutical benefit if the circumstances mentioned in Schedule 3 for the pharmaceutical benefit include any of the following:
                (a)    Compliance with modified Written Authority Required procedures;
               (b)    Compliance with Telephone Authority Required procedures;
         (2)   A prescription for the supply of the trastuzumab pharmaceutical benefit must be:
                (a)    submitted by the medical practitioner to the Chief Executive Medicare in accordance with section 12; and
               (b)    authorised by the Chief Executive Medicare in accordance with section 13.
12            Trastuzumab modified Authority Required procedures — submission of prescription
         (1)   The medical practitioner must:
                (a)    deliver or post to the Chief Executive Medicare a prescription for the supply of the trastuzumab pharmaceutical benefit, prepared and signed by the medical practitioner:
                          (i)    in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or
                         (ii)    in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subparagraph (i); or
                        (iii)    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
                        (iv)    by a method approved in writing by the Secretary; or
               (b)    submit to the Chief Executive Medicare, by telephone, details of a prescription for the supply of the pharmaceutical benefit prepared and signed by the medical practitioner in accordance with subparagraph (a) (i), (ii), (iii) or (iv); or
                (c)    if medical practitioner has attempted give details of the prescription to the Chief Executive Medicare in accordance with paragraph (b) but has been unable to do so because the telephone system established by the Chief Executive Medicare for the provision of such authorisations was unavailable — submit the prescription in accordance with the instructions in an emergency telephone message provided to the medical practitioner by the Chief Executive Medicare.
         (2)   If a circumstance mentioned in Schedule 3 includes Compliance with modified Written Authority Required procedures, the medical practitioner:
                (a)    must submit a prescription for the supply of the trastuzumab pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1) (a); and
               (b)    must submit with the prescription:
                          (i)    the completed Early Breast Cancer — PBS Supporting Information Form; and
                         (ii)    a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
                        (iii)    a copy of the signed patient acknowledgement form; and
                (c)    is not required to complete the medical indication section of the prescription.
         (3)   If a circumstance mentioned in Schedule 3 includes Compliance with Telephone Authority Required procedures, the medical practitioner must submit a prescription for the supply of the trastuzumab pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1) (b) or (c).
         (4)   For paragraph (1) (a), a prescription prepared and signed by the medical practitioner in accordance with subsection (1) is taken to have been submitted by the medical practitioner if it is submitted by his or her employee.
Note   This section modifies the ordinary Authority Required procedures set out in the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 by inserting additional requirements in subsection 12(2) and removing the option to submit a prescription electronically.
13            Trastuzumab modified Authority Required procedures — authorisation     
         (1)   A prescription submitted in accordance with paragraph 12 (1) (a) may be authorised by the Chief Executive Medicare:
                (a)    signing his or her authorisation on the prescription; and
               (b)    either:
                          (i)    if the Chief Executive Medicare requires the medical practitioner to alter the prescription — returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or
                         (ii)    in any other case:
                                   (A)     returning the authorised prescription to the medical practitioner; or
                                   (B)     sending it to the person in respect of whom it was prepared.
         (2)   A prescription submitted in accordance with paragraph 12 (1) (b) may be authorised by the Chief Executive Medicare telling the medical practitioner by telephone, at the time the Chief Executive Medicare is given details of the prescription, that the prescription is authorised.
         (3)   If the Chief Executive Medicare authorises a prescription under subsection (2):
                (a)    the Chief Executive Medicare must tell the medical practitioner the number given by the Chief Executive Medicare to the prescription: and
               (b)    the medical practitioner 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.
         (4)   For paragraph (3) (a), the Chief Executive Medicare must tell the medical practitioner the number by telephone or by electronic communication.
         (6)   A prescription submitted in accordance with paragraph 12 (1) (c) is taken to have been authorised by the Chief Executive Medicare if the medical practitioner completes the prescription in accordance with the instructions given in the emergency telephone message.
Division 4              Maximum quantity and maximum repeats
14            Maximum quantity
                The maximum quantity of a trastuzumab pharmaceutical benefit that may, in 1 prescription, be directed to be supplied on 1 occasion under this Special Arrangement is:
                (a)    for a 3‑weekly course of treatment — a sufficient number of vials to provide for a single infusion based on the weight of the patient and the dosage recommendations in the Product Information for the trastuzumab pharmaceutical benefit approved by the Therapeutic Goods Administration; or
               (b)    for a weekly course of treatment — a sufficient number of vials to provide for 3 infusions based on the weight of the patient and the dosage recommendations in the Product Information for the trastuzumab pharmaceutical benefit approved by the Therapeutic Goods Administration.
15            Maximum number of repeats
                Subject to section 16, the maximum number of repeats of a trastuzumab pharmaceutical benefit that may be prescribed under this Special Arrangement is:
                (a)    for a prescription for the initial treatment in a patient not previously treated with a trastuzumab pharmaceutical benefit for HER2 positive early stage breast cancer — no repeats; or
               (b)    for a prescription for the continuing treatment in a patient previously treated with a trastuzumab pharmaceutical benefit for HER2 positive early stage breast cancer — 3 repeats; or
                (c)    for a prescription for a new loading dose in a patient previously treated with a trastuzumab pharmaceutical benefit for HER2 positive early stage breast cancer — no repeats.
16            No repeats for visitors
                A medical practitioner must not write a repeat prescription for a trastuzumab pharmaceutical benefit for a person who is a visitor to Australia even if the person is, in accordance with section 7 of the Health Insurance Act 1973, to be treated as an eligible person within the meaning of that Act.
 
Part 2                 Supply of trastuzumab pharmaceutical benefits
  
17            Entitlement to trastuzumab pharmaceutical benefit
                Subject to this Special Arrangement, an eligible patient is entitled to receive a trastuzumab pharmaceutical benefit under this Special Arrangement without payment or other consideration, other than a charge made under Part 4.
18            Supply of trastuzumab pharmaceutical benefit under this Special Arrangement
 
A trastuzumab pharmaceutical benefit may be supplied under this Special Arrangement by an approved hospital authority for a public hospital to an eligible patient.
Part 3                 Claiming procedures and payment amounts
19            Application
                This Part applies if an approved hospital authority for a public hospital:
                (a)    supplies a trastuzumab pharmaceutical benefit under this Special Arrangement to an eligible patient; and
               (b)    makes a claim for payment under this Special Arrangement.
20            Claim for payment by approved hospital authority for a public hospital
         (1)   An approved hospital authority may, subject to subsection (2) and section 22, make the claim for payment in accordance with the rules made by the Minister under subsection 99AAA (8) of the Act.
         (2)   In the application of those rules to a claim under this Special Arrangement:
                (a)    a reference in the rules to an approved supplier or an approved hospital authority includes a reference to a hospital authority that is approved under subsection 52 (2) of PB 116 of 2010; and
               (b)    a reference in the rules to a number allotted to an approval under regulation 8A includes a reference to a number allotted to an approval under section 52 of PB 116 of 2010 or under section 52 of PB 63 of 2010; and
                (c)    a reference in the rules to an authority prescription includes a reference to a prescription for a trastuzumab pharmaceutical benefit under this Special Arrangement.
21            Payment for supply of trastuzumab pharmaceutical benefit to approved hospital authority for public hospital
                The approved hospital authority for a public hospital is entitled to be paid the amount worked out in accordance with section 35 and paragraph 37 (a) of PB 116 of 2010 as if a reference in that paragraph to an HSD pharmaceutical benefit were a reference to a trastuzumab pharmaceutical benefit under this Special Arrangement.
22            Limit on number of prescriptions in one claim
                The claim for payment must not contain more than 3 500 prescriptions.
Part 4                 Patient contributions
  
            
23            Patient contributions in relation to approved hospital authorities for public hospitals
 
         (1)   This section applies if an approved hospital authority for a public hospital:
                         (a)    supplies a trastuzumab pharmaceutical benefit under this Special Arrangement to an eligible patient; and
                         (b)    makes a claim for payment under Part 3 of this Special Arrangement.
         (2)   The approved hospital authority may charge the person 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 patient.
Part 5                 Miscellaneous
  
24            PBS Safety Net
                Any payment an eligible patient makes for the supply of a trastuzumab pharmaceutical benefit under this Special Arrangement counts towards the patient’s PBS Safety Net.
Note   Division 1A of Part VII of the Act contains provisions about safety net concession cards and entitlement cards.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Part 6              Transitional arrangements
 
25          Prescriptions written prior to 1 December 2011
 
(1)        This section applies to a prescription for a trastuzumab pharmaceutical benefit that was written under the old Arrangements, and the supply was not made prior to the commencement of this Special Arrangement.
 
(2)        The trastuzumab pharmaceutical benefit may be supplied:
 
(a)    under this Special Arrangement, in accordance with the old Arrangements as in force on 30 November 2011, by any of the following suppliers:
 
(i)          an approved pharmacist;
(ii)               an approved medical practitioner;
(iii)             an approved hospital authority for a private hospital; or
(iv)             a hospital authority for a public hospital that is not an approved hospital authority.
 
(b)   by an approved hospital authority for a public hospital under and in accordance with this Special Arrangement.
 
(3)        If a supply of a trastuzumab pharmaceutical benefit is made under paragraph (2)(a), a claim may be lodged and processed for the supply in accordance with the old Arrangements, as in force on 30 November 2011.
 
(4)        Paragraph (2)(a) stops having effect on 1 April 2012.
26          Old Arrangements
 
In this Part, old Arrangements means the National Health (Trastuzumab) Special Arrangement 2010 (PB 115 of 2010).
 
 
 
 
 
 
 
 
 
 
 
Schedule 1     Pharmaceutical benefits to which this Special Arrangement applies and related information
(section 5 and subsection 7 (1))
  
 
Listed Drug
Form
Manner of Administration
Brand
Responsible Person
Authorised prescriber
Section 100 only

Trastuzumab
Powder for I.V. infusion 60mg
Injection
Herceptin
RO
MP
D

Trastuzumab
Powder for I.V. infusion 150mg
Injection
Herceptin
RO
MP
D

Schedule 2        Responsible Person Codes
(subsection 7 (2))
  
 
Code
Responsible Person
Australian Business Number

RO
Roche Products Pty Ltd
70 000 132 865

Schedule 3        Circumstances
(subsection 9 (1) and 11 (1))
  
 
Circumstances number
Circumstances
Authority Requirements  — Part of Circumstances

1
Initial treatment for HER2 positive early breast cancer commencing concurrently with adjuvant chemotherapy following surgery.
The total duration of PBS‑subsidised treatment (initial plus continuing) that will be authorised is 52 weeks.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
Trastuzumab must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
The medical practitioner should request sufficient quantity based on the weight of the patient to provide for a maximum of 3 weeks’ treatment (equivalent to the loading dose for the 3 weekly regimen, and the loading dose and 2 weekly doses for the once weekly regimen).
Compliance with modified Written Authority Required procedures

2
Continuing treatment for HER2 positive early breast cancer where the patient has previously received treatment with PBS‑subsidised trastuzumab.
The patient is eligible to receive sufficient trastuzumab to complete 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy.
Trastuzumab must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
The medical practitioner should request sufficient quantity based on the weight of the patient for 3 weeks’ supply.
Compliance with Telephone Authority Required procedures

Note
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See http://www.frli.gov.au.
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