National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (July Update) Instrument 2022 (Cth)

Case

PB 57 of 2022

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (July Update) Instrument 2022

National Health Act 1953

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

Date     29 June 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 (Highly Specialised Drugs Program) Special Arrangement 2021
(PB 27 of 2021)   2

  1. Name

(1)This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (July Update) Instrument 2022.

(2)This instrument may also be cited as PB 57 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 July 2022 1 July 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Note:          This table relates only to the provisions of this instrument as originally made.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 (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

  1. Section 6, definition for “CAR drug”

substitute:

CAR drug (short for Complex Authority Required drug) means any of the following highly specialised drugs:

(a)      abatacept;

(b)      adalimumab;

(c)      ambrisentan;

(d)      azacitidine;

(e)      benralizumab;

(f)      bosentan;

(g)      dupilumab;

(h)      eculizumab;

(i)       elexacaftor with tezacaftor and with ivacaftor, and ivacaftor;

(j)       eltrombopag;

(k)      epoprostenol;

(l)       etanercept;

(m)     iloprost;

(n)      infliximab;

(o)      ivacaftor;

(p)      lenalidomide;

(q)      lumacaftor with ivacaftor;

(r)      macitentan;

(s)      mepolizumab;

(t)       midostaurin;

(u)      nusinersen;

(v)      omalizumab;

(w)     onasemnogene abeparvovec;

(x)      pasireotide;

(y)      pegvisomant;

(z)      pomalidomide;

(aa)    ravulizumab

(bb)    riociguat;

(cc)    risdiplam

(dd)    rituximab;

(ee)    romiplostim;

(ff)     selexipag;

(gg)    sildenafil;

(hh)    tadalafil;

(ii)      teduglutide;

(jj)      tezacaftor with ivacaftor and ivacaftor;

(kk)    tocilizumab;

(ll)      ustekinumab;

(mm)  vedolizumab.

  1. Schedule 1, entry for Azacitidine

(a)omit from the column headed “Circumstances” (all instances): C6132 C6143 C6144 C6177 C6186 C6199

(b)insert in numerical order in the column headed “Circumstances” (all instances): C12983 C12986 C13010 C13011 C13012 C13015 C13029

  1. Schedule 1, entry for Lenalidomide in each of the forms: Capsule 5 mg; and Capsule 10 mg

(a)omit from the column headed “Circumstances”: C4282 C4287

(b)insert in numerical order in the column headed “Circumstances”: C12985 C12997

  1. Schedule 1, entry for Midostaurin

(a)omit from the column headed “Circumstances”: C11801 C11814

(b)insert in numerical order in the column headed “Circumstances”: C13001 C13013

  1. Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg

omit:

TACROLIMUS APOTEX C5569 C9697 200 5

  1. Schedule 1, entry for Tacrolimus in the form Capsule 1 mg

omit:

TACROLIMUS APOTEX C5569 C9697 200 5

  1. Schedule 1, entry for Tacrolimus in the form Capsule 5 mg

omit:

TACROLIMUS APOTEX C5569 C9697 100 5

  1. Schedule 2, entry for Azacitidine

substitute:

Azacitidine C12439 C12983 C13010 C13029 14 units 2
C12986 C13011 C13012 C13015 14 units 5

  1. Schedule 2, entry for Lenalidomide [Maximum quantity: 21 tablets; Maximum repeats: 3]

(a)omit from the column headed “Circumstances”: C4282 C4287

(b)insert in numerical order in the column headed “Circumstances”: C12985 C12997

  1. Schedule 2, entry for Midostaurin

substitute:

Midostaurin C11699 C13001 C13013 1 pack 2

  1. Schedule 3, entry for Azacitidine

(a)omit:

C6132 Chronic Myelomonocytic Leukaemia
Initial treatment
The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.
The first authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Azacitidine PBS Authority Application ‑ Supporting Information Form; and
(c) a copy of the bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia ; and
(d) a copy of the full blood examination report; and
(e) a signed patient acknowledgement.
No more than 3 cycles will be authorised. 		Compliance with Written Authority Required procedures
C6143 Acute Myeloid Leukaemia
Initial treatment
The condition must have 20% to 30% marrow blasts and multi‑lineage dysplasia, according to World Health Organisation (WHO) Classification.
The first authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Azacitidine PBS Authority Application ‑ Supporting Information Form; and
(c) a copy of the bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and
(d) a copy of the full blood examination report; and
(e) a signed patient acknowledgement.
No more than 3 cycles will be authorised. 		Compliance with Written Authority Required procedures
C6144 Chronic Myelomonocytic Leukaemia
Continuing treatment
The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease.
Applications for continuing therapy may be made by telephone.
Up to 6 cycles will be authorised. 		Compliance with Authority Required procedures
C6177 Myelodysplastic syndrome
Initial treatment
The condition must be classified as Intermediate‑2 according to the International Prognostic Scoring System (IPSS); OR
The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS).
Classification of the condition as Intermediate‑2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations:
a. 11% to 30% marrow blasts with good karyotypic status (normal, ‑Y alone, del(5q) alone, del(20q) alone), and 0 to 1 cytopenias; OR
b. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR
c. 11% to 20% marrow blasts with good karyotypic status (normal, ‑Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR
d. 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
e. 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR
f. Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias.
Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations:
a. 21% to 30% marrow blasts with good karyotypic status (normal, ‑Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR
b. 21% to 30% marrow blasts with intermediate (other abnormalities) or poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
c. 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
d. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias.
The first authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Azacitidine PBS Authority Application ‑ Supporting Information Form; and
(c) a copy of the bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and
(d) a copy of the full blood examination report; and
(e) a copy of the pathology report detailing the cytogenetics demonstrating intermediate‑2 or high risk disease according to the International Prognostic Scoring System (IPSS); and
(f) a signed patient acknowledgment form.
No more than 3 cycles will be authorised. 		Compliance with Written Authority Required procedures
C6186 Acute Myeloid Leukaemia
Continuing treatment
The condition must have 20% to 30% marrow blasts and multi‑lineage dysplasia, according to World Health Organisation (WHO) Classification; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease.
Applications for continuing therapy may be made by telephone.
Up to 6 cycles will be authorised. 		Compliance with Authority Required procedures
C6199 Myelodysplastic syndrome
Continuing treatment
The condition must be classified as Intermediate‑2 according to the International Prognostic Scoring System (IPSS); OR
The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS); AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease.
Applications for continuing therapy may be made by telephone.
Up to 6 cycles will be authorised. 		Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C12983 Myelodysplastic syndrome
Initial treatment
The condition must be myelodysplastic syndrome confirmed through a bone marrow biopsy report and full blood examination; AND
The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); OR
The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS).
Classification of the condition as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations:
a. 11% to 30% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 0 to 1 cytopenias; OR
b. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR
c. 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR
d. 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
e. 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR
f. Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias.
Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations:
a. 21% to 30% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR
b. 21% to 30% marrow blasts with intermediate (other abnormalities) or poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
c. 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
d. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias.
The following information must be provided by the prescriber at the time of application:
(a) The patient's International Prognostic Scoring System (IPSS) score
The following reports must be documented in the patient's medical records:
(a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and
(b) full blood examination report; and
(c) pathology report detailing the cytogenetics demonstrating intermediate-2 or high-risk disease according to the International Prognostic Scoring System (IPSS).
No more than 3 cycles will be authorised under this restriction in a patient's lifetime. 		Compliance with Authority Required procedures
C12986 Acute Myeloid Leukaemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease. 		Compliance with Authority Required procedures - Streamlined Authority Code 12986
C13010 Acute Myeloid Leukaemia
Initial treatment
The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND
The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification.
The following reports must be documented in the patient's medical records:
(a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and
(b) full blood examination report. 		Compliance with Authority Required procedures
C13011 Myelodysplastic syndrome
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease.
Up to 6 cycles will be authorised. 		Compliance with Authority Required procedures
C13012 Acute Myeloid Leukaemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease. 		Compliance with Authority Required procedures - Streamlined Authority Code 13012
C13015 Chronic Myelomonocytic Leukaemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease.
Up to 6 cycles will be authorised. 		Compliance with Authority Required procedures
C13029 Chronic Myelomonocytic Leukaemia
Initial treatment
The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND
The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.
The first 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 bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and
(b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS 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)
The following reports must be documented in the patient's medical records:
(a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and
(b) full blood examination report
No more than 3 cycles will be authorised under this restriction in a patient's lifetime. 		Compliance with Written Authority Required procedures

  1. Schedule 3, entry for Lenalidomide

(a)omit:

C4282 Myelodysplastic syndrome
Continuing treatment
Patient must be classified as Low risk or Intermediate‑1 according to the International Prognostic Scoring System (IPSS); AND
Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; AND
Patient must have received PBS‑subsidised initial therapy with lenalidomide for myelodysplastic syndrome; AND
Patient must have achieved and maintained transfusion independence; or least a 50% reduction in red blood cell unit transfusion requirements compared with the four month period prior to commencing initial PBS‑subsidised therapy with lenalidomide; AND
Patient must not have progressive disease.
Patients receiving lenalidomide under the PBS listing must be registered in the i‑access risk management program.
The first authority application for continuing supply must be made in writing. Subsequent authority applications for continuing supply may be made by telephone.
The following evidence of response must be provided at each application:
(i) a haemoglobin level taken within the last 4 weeks; and
(ii) the date of the last transfusion; and
(iii) a statement of the number of units of red cells transfused in the 4 months immediately preceding this application; and
(iv) a statement confirming that the patient has not progressed to acute myeloid leukaemia. 		Compliance with Written Authority Required procedures
C4287 Myelodysplastic syndrome
Initial treatment
The treatment must be limited to a maximum duration of 16 weeks; AND
Patient must be classified as Low risk or Intermediate‑1 according to the International Prognostic Scoring System (IPSS); AND
Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; AND
Patient must be red blood cell transfusion dependent.
Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination: less than 5% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 0/1 cytopenias.
Classification of a patient as Intermediate‑1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations:
1. 5%‑10% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 0/1 cytopenias; OR
2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR
3. less than 5% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 2/3 cytopenias; OR
4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR
5. 5%‑10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR
6. 5%‑10% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 2/3 cytopenias; OR
7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias.
Classification of a patient as red blood cell transfusion dependent requires that:
(i) the patient has been transfused within the last 8 weeks; and
(ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS‑subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment.
Patients receiving lenalidomide under the PBS listing must be registered in the i‑access risk management program.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Myelodysplastic Syndrome Lenalidomide Authority Application ‑ Supporting Information Form; and
(c) a copy of the bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and
(d) a copy of the full blood examination report; and
(e) a copy of the pathology report detailing the cytogenetics demonstrating Low risk or Intermediate‑1 disease according to the IPSS (note: using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS ‑5q is acceptable); and
(f) details of transfusion requirements including: (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red cell units transfused in the 4 and 6 months preceding the date of this application; and
(g) a signed patient acknowledgement form. 		Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C12985 Myelodysplastic syndrome
Continuing treatment
Patient must have received PBS-subsidised initial therapy with lenalidomide for myelodysplastic syndrome; AND
Patient must have achieved and maintained transfusion independence; or at least a 50% reduction in red blood cell unit transfusion requirements compared with the four month period prior to commencing initial PBS-subsidised therapy with lenalidomide; AND
Patient must not have progressive disease; AND
The condition must not have progressed to acute myeloid leukaemia.
Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program.
The first authority application for continuing supply must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. Subsequent authority applications for continuing supply may be made via the Online PBS Authorities System or by telephone.
The following evidence of response must be provided at each application:
(i) a haemoglobin level taken within the last 4 weeks; and
(ii) the date of the last transfusion; and
(iii) a statement of the number of units of red cells transfused in the 4 months immediately preceding this application;
All reports must be documented in the patient's medical records.
For first continuing applications, if the application is submitted through HPOS form 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
C12997 Myelodysplastic syndrome
Initial treatment
The treatment must be limited to a maximum duration of 16 weeks; AND
Patient must be classified as Low risk or Intermediate-1 according to the International Prognostic Scoring System (IPSS); AND
Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; AND
Patient must be red blood cell transfusion dependent.
Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination: less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias.
Classification of a patient as Intermediate-1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations:
1. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias; OR
2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR
3. less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR
4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR
5. 5%-10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR
6. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR
7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias.
Classification of a patient as red blood cell transfusion dependent requires that:
(i) the patient has been transfused within the last 8 weeks; and
(ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS-subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment.
Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program.
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 bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has myelodysplastic syndrome; and
(b) details (date, unique identifying number/code or provider number) of the full blood examination report; and
(c) details (date, unique identifying number/code or provider number) of the pathology report and details of the cytogenetics demonstrating Low risk or Intermediate-1 disease according to the IPSS (note: using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS -5q is acceptable); and
(d) details of transfusion requirements including: (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red blood cell units transfused in the 4 and 6 months preceding the date of this application.
All the reports must be documented in the patient's medical records.
If the application is submitted through HPOS upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority 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

  1. Schedule 3, entry for Midostaurin

(a)omit:

C11801 Acute Myeloid Leukaemia
Maintenance therapy ‑ Initial 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
Patient must have demonstrated complete remission after induction and consolidation chemotherapy in combination with midostaurin; AND
Patient must not be undergoing or have undergone a stem cell transplant; AND
The condition must have been internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition.
A maximum of 3 cycles will be authorised under this restriction in a lifetime.
Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.
Progressive disease is defined as the presence of any of the following:
Leukaemic cells in the CSF;
Re‑appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
Extramedullary leukaemia.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) 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
C11814 Acute Myeloid Leukaemia
Induction / Consolidation therapy
Patient must not have received prior chemotherapy as induction therapy for this condition; OR
The treatment must be for consolidation treatment following induction treatment with midostaurin in combination with chemotherapy; AND
The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition; AND
The condition must not be acute promyelocytic leukaemia; AND
The treatment must be in combination with standard intensive remission induction or consolidation chemotherapy for this condition.
A maximum of 6 cycles will be authorised under this restriction in a lifetime.
Standard intensive remission induction combination chemotherapy must include cytarabine and an anthracycline.
The FLT3 ITD or TKD mutation test result and date of testing must be provided at the time of application.
This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting.
Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.
Progressive disease is defined as the presence of any of the following:
Leukaemic cells in the CSF;
Re‑appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
Extramedullary leukaemia.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug. 		Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C13001 Acute Myeloid Leukaemia
Induction / Consolidation therapy
Patient must not have received prior chemotherapy as induction therapy for this condition; OR
The treatment must be for consolidation treatment following induction treatment with midostaurin in combination with chemotherapy and the patient must not have progressive disease; AND
The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority; AND
The condition must not be acute promyelocytic leukaemia; AND
The treatment must be in combination with standard intensive remission induction or consolidation chemotherapy for this condition.
A maximum of 6 cycles will be authorised under this restriction in a lifetime.
Standard intensive remission induction combination chemotherapy must include cytarabine and an anthracycline.
The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.
Progressive disease is defined as the presence of any of the following:
Leukaemic cells in the CSF;
Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
Extramedullary leukaemia.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. 		Compliance with Authority Required procedures
C13013 Acute Myeloid Leukaemia
Maintenance therapy - Initial 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
Patient must have demonstrated complete remission after induction and consolidation chemotherapy in combination with midostaurin confirmed through a bone marrow biopsy pathology report; AND
Patient must not be undergoing or have undergone a stem cell transplant; AND
The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority.
A maximum of 3 cycles will be authorised under this restriction in a lifetime.
Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.
Progressive disease is defined as the presence of any of the following:
Leukaemic cells in the CSF;
Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
Extramedullary leukaemia.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
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) confirmation that the patient is not undergoing or has not undergone a stem cell transplant; and
(b) confirmation that the patient does not have progressive disease; and
(c) details (date, unique identifying number/code or provider number) of a recent bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient is in complete remission; and
(d) details (date, unique identifying number/code or provider number) of the pathology test demonstrating that the condition was FMS tyrosine kinase 3 (FLT3) (ITD or TKD) mutation positive prior to commencing midostaurin.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority 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
Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0