National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 11) (PB 96 of 2017) (Cth)
PB 96 of 2017
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 11)
National Health Act 1953
I, JULIANNE QUAINE, Assistant Secretary, Private Health Insurance and Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.
Dated 28 November 2017
JULIANNE QUAINE
Assistant Secretary
Private Health Insurance and Pharmacy Branch
Technology Assessment and Access Division
Department of Health
Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 11).
(2)This Instrument may also be cited as PB 96 of 2017.
1 Commencement
This Instrument commences on 1 December 2017.
2Amendment of National Health (Efficient Funding of Chemotherapy)Special Arrangement 2011 (PB 79 of 2011)
This Instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Schedule 1— Amendments
[1]Part 1, Division 1, Section 3, after definition of “Act”
insert:
additional TGA licensed compounding fee, for the compounding of a dose of a chemotherapy drug for an infusion by a TGA licensed compounder – an amount of $20.
[2]Part 1, Division 1, Section 3, definition of “authority prescription”
omit: regulation 13 substitute: section 30
[3]Part 1, Division 1, Section 3, omit definition of “compound fee”
[4]Part 1, Division 1, Section 3, after definition of “compounder”
insert:
compounder ID means the identification number allocated to a compounder by the Chemotherapy Compounding Payment Scheme Administration Agency in respect of a compounding site.
Note: Australian Healthcare Associates Pty Ltd is currently the Chemotherapy Compounding Payment Scheme Administration Agency.
[5]Part 1, Division 1, Section 3, definition of “preparation fee”
omit:
Note: The preparation fee for a dose of a chemotherapy drug in an infusion includes:
(a) if the dose is compounded by a TGA licensed compounder—$40 of the compound fee for the TGA licensed compounder; and
(b) if the dose is compounded by a compounder (other than a TGA licensed compounder)—the compound fee for the compounder.
substitute:
Note: The preparation fee includes $40 for compounding the dose of chemotherapy drug in the infusion. Where a TGA licensed compounder has compounded the dose of a chemotherapy drug, an additional TGA licensed compounding fee of $20 is payable to that TGA licensed compounder - see section 46B.
[6]Part 1, Division 1, Section 3, definition of “Regulations”
omit: National Health (Pharmaceutical Benefits) Regulations 1960
substitute: National Health (Pharmaceutical Benefits) Regulations 2017
[7]Part 2, Division 1, Paragraph 14(1)(a)
omit: regulation 19 of the Regulations as modified by section 15
substitute: section 40 of the Regulations as modified by section 15 of this Special Arrangement
[8]Part 2, Division 1, Paragraph 14(1)(b)
omit: regulation 19AA of the Regulations as modified by section 16
substitute: section 41 of the Regulations as modified by section 16 of this Special Arrangement
[9]Part 2, Division 1, Subsection 14(4)
omit: regulation 19 or 19AA substitute: section 40 or 41
[10]Part 2, Division 1, Subsection 14(5)
(a)omit: Paragraph 19(2)(a) substitute: Paragraph 40(3)(a)
(b)omit from Note: Regulation 19AA substitute: Section 41 of the Regulations
[11]Part 2, Division 1, Subsection 15(1)
omit: regulation 19 substitute: section 40
[12]Part 2, Division 1, Subsection 16(1)
omit: regulation 19AA substitute: section 41
[13]Part 2, Division 1, Section 17
omit (all instances): regulation 13” substitute: section 30
[14]Part 2, Division 2, Paragraph 19(1)(a)
omit: regulation 19 substitute: section 40
[15]Part 2, Division 2, Paragraph 19(1)(b)
omit: regulation 19AA substitute: section 41
[16]Part 3, Subsection 34(2)
omit: Subregulations 25(2) to (4) substitute: Subsections 51(2) to (4)
[17]Part 3, Subsection 34(3)
(a)omit: Regulations 24 and 26A substitute: Sections 49 and 53
(b)omit from Note: Regulations 24 and 26A substitute: Sections 49 and 53
[18]Part 4, Division 1, Paragraph 37(1)(b)
omit: regulation 8A substitute: section 16
[19]Part 4, Division 1, Paragraph 39(c)
insert after sub-paragraph (ii):
(iii) the compounder ID of the site at which the compounder compounded the dose of a chemotherapy drug for the infusion; and
[20]Part 4, Division 1, Sub-paragraph 39(d)(iii)
omit: regulation 24 substitute: section 49
[21]Part 4, Division 2A, Section 46A
omit section heading, substitute:
46A Payments in relation to infusions prepared between 1 July 2015 and 30 November 2017
[22]Part 4, Division 2A, Subsection 46A(1)
omit: 31 January 2018 substitute: 30 November 2017
[23]Part 4, Division 2A, Section 46B
substitute:
46B Payments in relation to infusions prepared on or after 1 December 2017
(1) If a TGA licensed compounder compounds a dose of a chemotherapy drug for an infusion prepared on or after 1 December 2017, the compounder is entitled to be paid an additional TGA licensed compounding fee by the Commonwealth.
(2) A TGA licensed compounder must not be paid more than one additional TGA licensed compounding fee for the compounding of a dose of a chemotherapy drug for a single infusion that is prepared in accordance with an infusion prescription for an individual patient.
[24]Part 6, Subsection 60(1)
omit: before 1 March 2019,
[25]Part 6, omit Subsection 60(4)
[26]Schedule 1, Part 1, entry for Brentuximab vedotin in the form Powder for I.V. infusion 50 mg
omit from the column headed “Circumstances”: C4719
insert in numerical order in the column headed “Circumstances”: C7244
[27]Schedule 1, Part 1, entry for Eribulin
insert in numerical order in the column headed “Circumstances”: C7258 C7280
[28]Schedule 1, Part 1, entry for Etoposide
omit:
Powder for I.V. infusion 100 mg (as phosphate) Injection Etopophos BQ MP PB [29]Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); Powder for I.V. infusion 500 mg (as disodium); and Powder for I.V. infusion 1 g (as disodium)
omit from the column headed “Circumstances” (all instances): C4789
insert in numerical order in the column headed “Circumstances” (all instances): C7195
[30]Schedule 1, Part 2, entry for Brentuximab vedotin [Maximum Amount 200; Number of Repeats 3]
omit from the column headed “Purposes”: P4719
insert in numerical order in the column headed “Purposes”: P7244
[31]Schedule 1, Part 2, entry for Eribulin
substitute:
Eribulin P7258 P7280 3 7 P4649 3 13 [32]Schedule 4, entry for Brentuximab vedotin
(a)omit:
C4719 P4719 CD30 positive systemic anaplastic large cell lymphoma
Initial treatment
The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity from a biopsy subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy or other agents;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy;
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory;
(v) a declaration of whether the patient has had, or is planned to have, a transplant
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction.Compliance with Written Authority Required procedures
(b)insert in numerical order after existing text:
C7244 P7244 CD30 positive systemic anaplastic large cell lymphoma
Initial treatment
The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity from a biopsy subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy or other agents;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy; and
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction.Compliance with Written Authority Required procedures [33]Schedule 4, entry for Eribulin
(a)insert in the column headed “Purposes Code” for Circumstances Code C4649: P4649
(b)insert in numerical order after existing text:
C7258 P7258 Advanced (unresectable and/or metastatic) liposarcoma
Initial treatment
Patient must have an ECOG performance status of 2 or less; AND
The condition must be dedifferentiated, myxoid, round-cell or pleomorphic subtype; AND
Patient must have received prior chemotherapy treatment including an anthracycline and ifosfamide (unless contraindicated) for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.Compliance with Authority Required procedures - Streamlined Authority Code 7258 C7280 P7280 Advanced (unresectable and/or metastatic) liposarcoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop progressive disease while being treated with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.Compliance with Authority Required procedures - Streamlined Authority Code 7280 [34]Schedule 4, entry for Pemetrexed
(a)omit:
| C4789 | Mesothelioma The treatment must be in combination with cisplatin. | Compliance with Authority Required procedures - Streamlined Authority Code 4789 |
(b)insert in numerical order after existing text:
C7195 Mesothelioma
The treatment must be in combination with platinum-based chemotherapy.
The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated
Doses greater than 500 mg per metre squared BSA are not PBS-subsidisedCompliance with Authority Required procedures - Streamlined Authority Code 7195
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