National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 8) (Cth)

Case

PB 82 of 2022

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 8)

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

Date                 25 August 2022  

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011
(PB 79 of 2011)
   2

  1. Name

(1)This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 8).

(2)This instrument may also be cited as PB 82 of 2022.

  1. Commencement

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1.  The whole of this instrument 1 September 2022 1 September 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)     Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

  1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

  1. Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

  1. Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg

insert in the columns in the order indicated and in alphabetical order for the column headed “Brand”:

Bortezomib-AFT AE MP C11099 D
  1. Schedule 1, Part 1, entry for Brentuximab vedotin

omit from the column headed “Circumstances”: C8722 C8736 C10519 C10524 C10811 C10902 C12085 C12087 C12088 C12141   substitute: C13134 C13179 C13181 C13182 C13208 C13209 C13212 C13231 C13259 C13261

  1. Schedule 1, Part 1, entry for Cabazitaxel in the form Concentrated injection 60 mg in 1.5 mL, with diluent

omit from the column headed “Circumstances” (all instances): C4662                     substitute: C13207

  1. Schedule 1, Part 1, after entry for Cabazitaxel in the form Concentrated injection 60 mg in 1.5 mL, with diluent

insert:

Solution concentrate for I.V. infusion 60 mg in 3 mL Injection Cabazitaxel Accord OC MP C13207 D
  1. Schedule 1, Part 1, entry for Cabazitaxel in the form Solution concentrate for I.V. infusion 60 mg in 6 mL

omit from the column headed “Circumstances”: C4662                substitute: C13207

  1. Schedule 1, Part 1, entry for Pembrolizumab

(a)omit from the column headed “Circumstances”: C9863 C9864

(b)omit from the column headed “Circumstances”: C10679

(c)omit from the column headed “Circumstances”: C10702

(d)omit from the column headed “Circumstances”: C11993

(e)insert in numerical order in the column headed “Circumstances”: C13126 C13213 C13214 C13245

  1. Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)

insert in the columns in the order indicated and in alphabetical order for the column headed “Brand”:

Pemetrexed-AFT AE MP D
  1. Schedule 1, Part 1, entry for Rituximab

substitute:

Rituximab Solution for I.V. infusion 100 mg in 10 mL Injection Riximyo SZ MP C7399 C7400 C9451 C9542 C10227 D
Ruxience PF MP C7399 C7400 C9451 C9542 C10227 D
Truxima EW MP C7399 C7400 C9451 C9542 C10227 D
Riximyo SZ MP D
Ruxience PF MP D
Truxima EW MP D
Solution for I.V. infusion 500 mg in 50 mL Injection Riximyo SZ MP C7399 C7400 C9451 C9542 C10227 D
Ruxience PF MP C7399 C7400 C9451 C9542 C10227 D
Truxima EW MP C7399 C7400 C9451 C9542 C10227 D
Riximyo SZ MP D
Ruxience PF MP D
Truxima EW MP D
  1. Schedule 1, Part 2, entry for Brentuximab vedotin

substitute:

Brentuximab vedotin P13179 180 3
P13181 180 11
P13212 200 1
P13182 P13209 P13259 200 3
P13134 200 5
P13208 P13231 P13261 200 11
  1. Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 6]

(a)omit from the column headed “Purposes”: P9863 P9864

(b)omit from the column headed “Purposes”: P10679

(c)omit from the column headed “Purposes”: P10702 P11993

(d)insert in numerical order in the column headed “Purposes”: P13126 P13213 P13214 P13245

  1. Schedule 1, Part 2, entry for Rituximab

substitute:

Rituximab P10227 800 3
P7399 800 5
P7400 P9542 800 7
P9451 800 11
800 11
  1. Schedule 4, entry for Brentuximab vedotin

substitute:

Brentuximab vedotin C13134 P13134 CD30 positive peripheral T-cell lymphoma, non-cutaneous type
Initial treatment
Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND
The treatment must be for first line therapy for this condition; AND
The treatment must be for curative intent; AND
The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND
The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample from an Approved Pathology Authority showing CD30 positivity of at least 3% malignant cells; and
(b) The date of initial diagnosis of Peripheral T-cell lymphoma.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Compliance with Written Authority Required procedures
C13179 P13179 CD30 positive cutaneous T-cell lymphoma
Initial treatment
Patient must have pathologically confirmed CD30 positive cutaneous T-cell lymphoma; AND
Patient must have CD30 positivity of at least 3% of malignant cells; AND
Patient must have a diagnosis of mycosis fungoides; OR
Patient must have a diagnosis of Sezary syndrome; OR
Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; AND
Patient must have received prior systemic treatment for this condition; AND
The condition must be relapsed or refractory; AND
The treatment must not exceed 4 cycles under this restriction in a lifetime; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of the histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and
(b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and
(c) Date of commencement and completion of the most recent prior systemic treatment.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Compliance with Written Authority Required procedures
C13181 P13181 CD30 positive cutaneous T-cell lymphoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have achieved an objective response with this drug; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
The treatment must not exceed 12 cycles under this restriction in a lifetime.
An objective response is defined as the demonstration of response by clinical observation of skin lesions, or response by positron-emission tomography (PET) and/or computed tomography (CT) standard criteria.
Compliance with Authority Required procedures
C13182 P13182 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; AND
Patient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type; AND
The treatment must not exceed 4 cycles under this restriction.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number or provider number) of a histology report showing evidence of the tumour's CD30 positivity; and
(b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and
(c) Dates of commencement and completion of front-line curative intent chemotherapy; and
(d) 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.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Compliance with Written Authority Required procedures
C13208 P13208 Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT) for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime.
Compliance with Authority Required procedures
C13209 P13209 Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.
If the application is submitted through HPOS upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Compliance with Written Authority Required procedures
C13212 P13212 CD30 positive peripheral T-cell lymphoma, non-cutaneous type
Continuing treatment
The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND
Patient must have completed 6 initial cycles of PBS-subsidised treatment with this drug for this indication; AND
Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as:
(a) Positron emission tomography-based response: lymph nodes and extralymphatic sites - a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR
(b) Computed tomography-based response: lymph nodes and extralymphatic sites - greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable.
Compliance with Authority Required procedures
C13231 P13231 Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime.
Compliance with Authority Required procedures
C13259 P13259 Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT); AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.
If the application is submitted through HPOS upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Compliance with Written Authority Required procedures
C13261 P13261 CD30 positive systemic anaplastic large cell lymphoma
Continuing treatment
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed 12 cycles under this restriction in a lifetime.
Compliance with Authority Required procedures
  1. Schedule 4, entry for Cabazitaxel

substitute:

Cabazitaxel C13207 Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone; AND
The condition must be resistant to treatment with docetaxel; OR
Patient must have a documented intolerance necessitating permanent treatment withdrawal or a contraindication to docetaxel; AND
The treatment must not be used in combination with a novel hormonal drug; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.
Compliance with Authority Required procedures - Streamlined Authority Code 13207
  1. Schedule 4, entry for Pembrolizumab

(a)omit:

C9863 P9863 Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; OR
Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND
Patient must not have received prior treatment with a PD‑1 (programmed cell death‑1) inhibitor for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The treatment must not exceed a total of 7 doses under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma pembrolizumab PBS Authority Application.
Compliance with Written Authority Required procedures
C9864 P9864 Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles in a lifetime.
Compliance with Authority Required procedures

(b)omit:

C10679 P10679 Relapsed or refractory primary mediastinal B‑cell lymphoma
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles in a lifetime.
Compliance with Authority Required procedures

(c)omit:

C10702 P10702 Relapsed or refractory primary mediastinal B‑cell lymphoma
Initial treatment
The condition must be diagnosed as primary mediastinal B‑cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography ‑ computed tomography (PET‑CT) scan, (ii) PET scan, (iii) CT scan, with the results retained in the patient's medical records; AND
Patient must have been treated with rituximab‑based chemotherapy for this condition; AND
Patient must be experiencing relapsed/refractory disease; AND
Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; OR
Patient must have undergone an autologous stem cell transplant (ASCT); OR
Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab‑based chemotherapy; AND
Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The treatment must not exceed a total of 7 doses under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed primary mediastinal B‑cell lymphoma pembrolizumab PBS Authority Application, which includes:
(i) confirmation that histology results with PET/CT scans support a diagnosis of primary mediastinal B‑cell lymphoma and are retained on the patient's medical records;
(ii) details of prior treatments for this condition.
Compliance with Written Authority Required procedures

(d)omit:

C11993 P11993 Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer
Transitioning from non‑PBS to PBS subsided treatment ‑ Grandfather treatment
Patient must have received non‑PBS subsidised treatment with this drug for this condition prior to 1 August 2021; AND
Patient must not have received prior PBS funded treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for colorectal cancer; AND
Patient must have been untreated for this indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease), prior to initiating treatment with this drug; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment in a lifetime for this condition.
A patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
Compliance with Authority Required procedures

(e)insert in numerical order after existing text:

C13126 P13126 Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; OR
Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND
Patient must not have received prior treatment with a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 7 doses under this restriction.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.
If the application is submitted through HPOS upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Compliance with Written Authority Required procedures
C13213 P13213 Relapsed or refractory primary mediastinal B-cell lymphoma
Initial treatment
The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan; AND
Patient must be experiencing relapsed/refractory disease; AND
Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; OR
Patient must have undergone an autologous stem cell transplant (ASCT); OR
Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 7 doses under this restriction.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or be in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of the histology results with PET/CT scans that support a diagnosis of primary mediastinal B-cell lymphoma; and
(b) details of prior treatments for this condition.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Compliance with Written Authority Required procedures
C13214 P13214 Relapsed or refractory primary mediastinal B-cell lymphoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles in a lifetime.
Compliance with Authority Required procedures
C13245 P13245 Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles in a lifetime.
Compliance with Authority Required procedures
  1. Schedule 4, entry for Trastuzumab emtansine

omit entry for circumstances code “C13004” and substitute:

C13004 P13004 Early HER2 positive breast cancer
Initial adjuvant treatment
The treatment must be prescribed within 12 weeks after surgery; AND
Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND
Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; 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; AND
The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.
Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.
The pathology report must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Compliance with Written Authority Required procedures
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