National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 6) (PB 59 of 2015) (Cth)
PB 59 of 2015
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 6)
National Health Act 1953
___________________________________________________________________________
I, Julianne Quaine, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 29 June 2015
JULIANNE QUAINE
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________
1 Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No.6).
(2)This Instrument may also be cited as PB 59 of 2015.
2 Commencement
This Instrument commences on 1 July 2015.
3 Amendments to PB 79 of 2011
Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Amendments
Section 3, Insert the definition:
compounder means an entity (including a person, pharmacy, hospital or a body corporate) who undertakes and is responsible for the compounding of an infusion, so the infusion may be supplied by an approved supplier under this Special Arrangement.
Section 3, Insert the definition:
compound fee means an amount of:
a) $60 for a TGA licensed compounder; or
b) $40 for a compounder
Section 3, Definition for diluent fee
omit: $5.00 substitute: $5.07
Section 3, Definition for dispensing fee
omit: $6.76 substitute: $6.93
Section 3, Definition for distribution fee
omit: $25.26 substitute: $25.59
Repeal the definition, substitute:
preparation fee means an amount:
a) of $82.67 for the period between 1 July 2015 and the day before the start date; or
b) of $42.67 on and from the start date.
Insert the definition:
start date means the earlier of:
a) 1 September 2015; or
b) the day the Secretary decides a compounding fee payment computer system is operational.
Insert the definition:
TGA licensed compounder means a compounder who holds a license issued under the Therapeutic Goods Act 1989.
After Part 4, Division 2
After Part 4, Division 2, insert Division 2A.
Division 2A –Payments to compounders
46A Fee payment to TGA licensed compounder between 1 July and the day before the start date
(1) A TGA licensed compounder may make a claim for payment for the compounding of an infusion prepared between 1 July 2015 and the day before the start date.
(2) If a claim for a fee is made under subsection (1), the Secretary may, at his or her discretion, pay an amount of $20 to a TGA licensed compounder for the compounding of the infusion.
46B Compound fee payment to compounder on and after the start date
(1) Subject to subsections (2) and (3), a compounder, who makes a claim under this Division for the compounding of an infusion, is entitled to be paid a compound fee by the Commonwealth.
(2) A compounder must not be paid a compounding fee for the compounding of an infusion prepared between 1 July 2015 and the start date.
(3) Only a single compound fee can be paid for the compounding of an infusion prepared in accordance with an infusion prescription for an individual patient.
46C How claims are to be made - compounders
(1) A compounder must submit a claim for payment on an approved form when seeking payment from the Commonwealth for a fee under sections 46A and 46B.
(2) The compounder must certify with each claim:
(a)that each infusion to which the claim relates was prepared in accordance with a compounding order; and
(b)that the information in the claim form is correct.
[10] Section 48
Repeal the section, substitute:
48 Mark-up for a chemotherapy pharmaceutical benefit that does not have trastuzumab
For subparagraph 47(4)(b)(i), the mark-up for a chemotherapy pharmaceutical benefit that does not have trastuzumab is:
(mark-up for maximum multiple) divided by (maximum multiple of pharmaceutical benefit).
where:
mark-up for maximum multiple means the administration, handling and infrastructure fee worked out under the determination made under paragraph 98B(1)(a) of the Act.
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.
[11] After section 60
After section 60, insert section 61.
61 Transitional provisions for fees
(1) If a claim is made for the supply of an infusion under section 41 or 42, where the approved pharmacist, approved medical practitioner, approved hospital authority or HSD hospital authority has already directly paid a compounder to prepare the infusion, the compounder is not entitled to be paid a compound fee.
(2) If section 61(1) applies, the preparation fee to be paid under Division 2 to the approved pharmacist, approved medical practitioner, approved hospital authority or HSD hospital authority, is an amount of $82.67.
(3) This section ceases to operate on and from 1 November 2015.
Schedule 1 Part 1 entry for Ofatumumab in each of the forms: Solution concentrate for I.V. 100 mg in 5 mL; and Solution concentrate for I.V. 1000 mg in 50 mL and brand Arzerra:
omit from the column headed “Responsible Person”: GK substitute: NV
[13] Schedule 1, Part 1 after the entry for Pemetrexed:
insert:
Pertuzumab Solution for I.V. infusion 420 mg in 14 mL Injection Perjeta RO MP C4971
C5013
C5023
D
[14] Schedule 1 Part 1 entry for Topotecan in the form Powder for I.V. infusion 4 mg (as hydrochloride) and brand Hycamtin:
omit from the column headed “Responsible Person”: GK substitute: NV
[15] Schedule 1 Part 1 entry for ‘Transtuzumab’ in each of the forms ‘Powder for I.V. infusion 60 mg’ and ‘Powder for I.V. infusion 150 mg’ with manner of administration Injection:
insert in the column headed ‘Circumstances’ (in numerical order): C5024 C5032 C5041
[16] Schedule 1, Part 1 after the entry for Trastuzumab:
insert:
Trastuzumab emtansine Powder for I.V. infusion 100 mg Injection Kadcyla RO MP C4978
C4986
C4987
D Powder for I.V. infusion 160 mg Injection Kadcyla RO MP C4978
C4986
C4987
D
[17] Schedule 1, Part 2 after the entry for Pemetrexed:
insert:
Pertuzumab P4971 420 3 P5013 840 0 P5023 840 1
[18]
[18] Schedule 1, Part 2 entry for Trastuzumab:
substitute:
Trastuzumab P4104 250 9 P4156 P4142 500 0 P4164 P4083 750 3 P4093 P5024 P4143 1000 0 P4144 P5032 P5041 1000 3
[19] Schedule 1, Part 2 after the entry for Trastuzumab:
insert:
Trastuzumab emtansine 450 8
[20] Schedule 3, Responsible Person codes:
omit:
GK GlaxoSmithKline Australia Pty Ltd 47 100 162 481
[21] Schedule 3, Responsible Person codes, after entry for MK:
insert:
NV Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160
[22] Schedule 4, after the entry for Pemetrexed:
insert:
Pertuzumab C4971 P4971 Metastatic (Stage IV) HER2 positive breast cancer
Treatment Phase: Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition, AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug, AND
The treatment must be in combination with trastuzumab, AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
The treatment must not exceed a lifetime total of one continuous course. However, short treatment breaks are permitted. A patient who has a treatment break of less than 6 weeks in PBS-subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS-subsidised treatment with this drug. A patient who has a treatment break of more than 6 weeks in PBS-subsidised treatment with this drug is not eligible to receive PBS-subsidised treatment with this drug.
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.Compliance with Written or Telephone Authority Required procedures
C5013 P5013 Metastatic (Stage IV) HER2 positive breast cancer
Treatment Phase: Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, AND
Patient must have a WHO performance status of 0 or 1, AND
Patient must not have received prior anti-HER2 therapy for this condition, AND
Patient must not have received prior chemotherapy for this condition, AND
The treatment must be in combination with trastuzumab and a taxane, AND
The treatment must not be in combination with nab-paclitaxel, AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease; and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.Compliance with Written Authority Required procedures
C5023 P5023 HER2 positive breast cancer
Treatment Phase: Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR
Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015, AND
Patient must not have received non-PBS-subsidised treatment with trastuzumab for this condition before 1 July 2014, AND
Patient must not have received prior therapy with trastuzumab emtansine or lapatinib for this condition, AND
The treatment must be in combination with trastuzumab, AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for treatment must be made in writing and must include a completed authority prescription form and a copy of the signed patient acknowledgement form.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.Compliance with Written Authority Required procedures
[23] Schedule 4, entry for Trastuzumab:
insert (in numerical order):
C5024 P5024 Metastatic (Stage IV) HER2 positive breast cancer
Treatment Phase: Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition, AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, authority approval will be granted for a new loading dose.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.Compliance with Written or Telephone Authority Required procedures
C5032 P5032 Metastatic (Stage IV) HER2 positive breast cancer
Treatment Phase: Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, AND
The treatment must not be in combination with nab-paclitaxel, AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the patient has Stage IV disease.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.Compliance with Written Authority Required procedures
C5041 P5041 HER2 positive breast cancer
Treatment Phase: Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015, AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.
Compliance with Written or Telephone Authority Required procedures
[24] Schedule 4, after the entry for Trastuzumab:
insert:
TRASTUZUMAB EMTANSINE C4978 Metastatic (Stage IV) HER2 positive breast cancer
Treatment Phase: Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition, AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug, AND
The treatment must be as monotherapy, AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
The treatment must not exceed a lifetime total of one continuous course.Compliance with Written or Telephone Authority Required procedures
C4986 Metastatic (Stage IV) HER2 positive breast cancer
Treatment Phase: Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR
Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; OR
Patient must have received PBS-subsidised lapatinib for this condition before 1 July 2015, AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug, AND
The treatment must be as monotherapy, AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for treatment must be made in writing and must include a completed authority prescription form and a copy of the signed patient acknowledgement form.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.Compliance with Written Authority Required procedures
C4987 Metastatic (Stage IV) HER2 positive breast cancer
Treatment Phase: Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, AND
The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR
The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab, AND
Patient must have a WHO performance status of 0 or 1, AND
The treatment must be as monotherapy, AND
*Patient must not have received prior treatment with lapatinib; OR
Patient must have developed intolerance to lapatinib of a severity necessitating permanent treatment withdrawal, AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease;
(ii) a copy of the signed patient acknowledgement form;
(iii) dates of treatment with trastuzumab and pertuzumab; and
(iv) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or
(v) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
Patients who have progressive disease on lapatinib are not eligible to receive PBS-subsidised trastuzumab emtansine.
Patients who have developed intolerance to lapatinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised trastuzumab emtansine.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.Compliance with Written Authority Required procedures
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