PB 63 of 2013
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No. 6)
National Health Act 1953
___________________________________________________________________________
I, STEVE DUNLOP, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated 23 September 2013
STEVE DUNLOP
Acting Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
1 Name of Instrument
(1) This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No.6).
(2) This Instrument may also be cited as PB 63 of 2013.
2 Commencement
This Instrument commences on 1 October 2013.
3 Amendments to PB 116 of 2010
Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
Section 3
[1] Section 24, HSD pharmaceutical benefits that have CAR drugs—quantity exceptions
Substitute:
24 HSD pharmaceutical benefits that have CAR drugs—quantity exceptions
(1) An eligible medical practitioner may write a prescription for an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2) to be supplied to an eligible patient on any 1 occasion only in accordance with the limitation mentioned in subsection (2) for each HSD pharmaceutical benefit mentioned in subsection (2).
(2) The drugs and limitations are as follows:
(a) for HSD pharmaceutical benefits that have the drug ambrisentan, bosentan, epoprostenol, etanercept, iloprost, sildenafil or tadalafil—a quantity of units sufficient for up to 1 month of treatment with the drug;
(b) for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of an adult with severe active rheumatoid arthritis—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 3 milligrams per kilogram;
(c) for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of an adult with active ankylosing spondylitis, severe active psoriatic arthritis or severe chronic plaque psoriasis—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram;
(d) for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of a patient with refractory Crohn disease or fistulating Crohn disease—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram;
(e) for HSD pharmaceutical benefits that have the drug rituximab—a quantity of units sufficient to provide for a single dose;
(f) for HSD pharmaceutical benefits that have the drug abatacept—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose;
(g) for HSD pharmaceutical benefits that have the drug tocilizumab, for the treatment of adult patients with severe active rheumatoid arthritis—a quantity of units that are sufficient, based on the weight of the patient and taking into account whether any other strength injections will contribute part of the dose, to provide for the whole or part of a single dose of 8 mg per kg;
(h) for HSD pharmaceutical benefits that have the drug adalimumab—a quantity of units that are sufficient, based on the weight of the patient, to provide for 2 doses;
(i) for HSD pharmaceutical benefits that have the drug lenalidomide, for the treatment of a patient with multiple myeloma:
(i) with the form Capsule 5 mg – up to 84 tablets;
(ii) with the form Capsule 10 mg – up to 42 tablets;
(iii) with the form Capsule 15 mg – up to 21 tablets;
(iv) with the form Capsule 25 mg – up to 21 tablets;
(j) for HSD pharmaceutical benefits that have the drug lenalidomide, for the treatment of a patient with myelodysplastic syndrome:
(i) with the form Capsule 5 mg – up to 21 tablets;
(ii) with the form Capsule 10 mg – up to 21 tablets;
(k) for HSD pharmaceutical benefits that have the drug azacitidine with the form Powder for injection 100mg – up to 14 units.
(l) for HSD pharmaceutical benefits that have the drug romiplostim, for initial treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):
(i) at the time of the initial written authority application—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 1 microgram per kilogram;
(ii) during the initial period of dose titration—a quantity of units sufficient to provide for a single dose;
(iii) for a patient whose dose has been stable for a period of 4 weeks—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.
(m) for HSD pharmaceutical benefits that have the drug romiplostim, for initial PBS‑subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Romiplostim prior to 1 April 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with Romiplostim was commenced:
(i) at the time of the initial written authority application—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 1 microgram per kilogram;
(ii) during the initial period of dose titration—a quantity of units sufficient to provide for a single dose;
(iii) for a patient in the titration phase of treatment whose dose has been stable for a period of 4 weeks—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks;
(iv) for a patient whose dose had been stable for a period of at least 4 weeks at the time of the initial application for PBS‑subsidy—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment.
(n) for HSD pharmaceutical benefits that have the drug romiplostim, for the first period of continuing treatment or re‑initiation of interrupted PBS subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has displayed a sustained platelet response to treatment with Romiplostim during the initial period of PBS‑subsidised treatment—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks treatment.
(o) for HSD pharmaceutical benefits that have the drug romiplostim, for the second and subsequent periods of continuing treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who continues to display a sustained platelet response to treatment with Romiplostim—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment.
(p) for HSD pharmaceutical benefits that have the drug omalizumab, for initial treatment of uncontrolled severe allergic asthma—a quantity of units that are sufficient to provide for 28 weeks treatment;
(q) for HSD pharmaceutical benefits that have the drug omalizumab, for initial PBS‑subsidised treatment of uncontrolled severe allergic asthma in a patient who has previously received non‑PBS‑subsidised therapy with omalizumab (grandfather patients)—a quantity of units that are sufficient to provide for 24 weeks treatment;
(r) for HSD pharmaceutical benefits that have the drug omalizumab, for continuing treatment—a quantity of units that are sufficient to provide for 24 weeks treatment.
(s) for HSD pharmaceutical benefits that have the drug eltrombopag, for initial PBS‑subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):
(i) with the form Tablet 25 mg (as olamine) – up to 28 tablets;
(ii) with the form Tablet 50 mg (as olamine) – up to 28 tablets;
— a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.
(t) for HSD pharmaceutical benefits that have the drug eltrombopag, for initial PBS‑subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Eltrombopag prior to 1 November 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with Eltrombopag was commenced):
(i) with the form Tablet 25 mg (as olamine) – up to 28 tablets;
(ii) with the form Tablet 50 mg (as olamine) – up to 28 tablets;
— a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.
(u) for HSD pharmaceutical benefits that have the drug eltrombopag, for the first period of continuing treatment or re‑initiation of interrupted PBS subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has displayed a sustained platelet response to treatment with Eltrombopag during the initial period of PBS‑subsidised treatment:
(i) with the form Tablet 25 mg (as olamine) – up to 28 tablets;
(ii) with the form Tablet 50 mg (as olamine) – up to 28 tablets;
— a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.
(v) for HSD pharmaceutical benefits that have the drug eltrombopag, for the second and subsequent periods of continuing treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who continues to display a sustained platelet response to treatment with Eltrombopag:
(i) with the form Tablet 25 mg (as olamine) – up to 28 tablets;
(ii) with the form Tablet 50 mg (as olamine) – up to 28 tablets;
— a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.
(w) for HSD pharmaceutical benefits that have the drug tocilizumab, for the treatment of patients with severe active systemic juvenile idiopathic arthritis—a quantity of units sufficient for up to 1 month of treatment with the drug.
[2] Section 25, HSD pharmaceutical benefits that have CAR drugs—repeat exceptions
Substitute:
25 HSD pharmaceutical benefits that have CAR drugs—repeat exceptions
(1) An eligible medical practitioner may authorise the repeat supply of an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2) only in accordance with the limitations mentioned in subsection (2) for the drug.
(2) The drugs and limitations are as follows:
(a) for bosentan:
(i) if the prescription is for the balance of a 6 month course of initial treatment for a patient who has been issued with an authority prescription for the first month of the 6 month course—up to 4 repeat supplies; or
(ii) if the prescription is for continuing treatment of a patient who has achieved a response to his or her most recent course of PBS‑subsidised treatment—up to 5 repeat supplies;
(b) for etanercept:
(i) for the initial treatment of severe polyarticular course juvenile chronic arthritis—up to 3 repeat supplies; or
(ii) for the continuing treatment of severe polyarticular course juvenile chronic arthritis—up to 5 repeat supplies;
(c) for infliximab, for the treatment of an adult with severe active rheumatoid arthritis:
(i) if the circumstances permit a course of up to a maximum of 22 weeks of treatment to be authorised—up to 3 repeat supplies; or
(ii) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 2 repeat supplies;
(d) for infliximab, for the treatment of an adult with severe active psoriatic arthritis:
(i) if the circumstances permit a course of up to a maximum of 22 weeks of treatment to be authorised—up to 3 repeat supplies; or
(ii) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 2 repeat supplies;
(e) for infliximab, for the treatment of an adult with active ankylosing spondylitis—up to 3 repeat supplies;
(f) for infliximab, for the treatment of a patient with refractory Crohn disease or fistulating Crohn disease—up to 2 repeat supplies;
(g) for infliximab, for the treatment of an adult with severe chronic plaque psoriasis:
(i) if the circumstances permit a course of up to a maximum of 22 weeks of treatment to be authorised—up to 3 repeat supplies; or
(ii) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 2 repeat supplies;
(h) for abatacept, for the treatment of an adult with severe active rheumatoid arthritis:
(i) if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 4 repeat supplies; or
(ii) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies;
(i) for rituximab—1 repeat supply;
(j) for ambrisentan:
(i) for the initial PBS‑subsidised treatment of a patient who was receiving non‑PBS‑subsidised treatment with ambrisentan for less than 6 months before 1 December 2009—sufficient repeat supplies to allow the patient to complete a period of combined PBS‑subsidised and non‑PBS‑subsidised therapy of up to 6 months duration in total; or
(ii) if subparagraph (i) does not apply—up to 5 repeat supplies;
(k) for lenalidomide, for the treatment of a patient with multiple myeloma—up to 2 repeat supplies;
(l) for lenalidomide, for the treatment of a patient with myelodysplastic syndrome—up to 3 repeat supplies;
(m) for epoprostenol, iloprost, sildenafil, or tadalafil—up to 5 repeat supplies;
(n) for tocilizumab, for the treatment of adults with severe active rheumatoid arthritis:
(i) if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 3 repeat supplies;
(ii) If the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies;
(o) for adalimumab for the treatment of a patient with juvenile idiopathic arthritis:
(i) if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 3 repeat supplies;
(ii) if the circumstances permit a course of up to a maximum of 24 weeks treatment to be authorised—up to 5 repeat supplies;
(p) for azacitidine:
(i) for initial treatment—up to 2 repeat supplies;
(ii) for continuing treatment—up to 5 repeat supplies.
(q) for romiplostim for initial treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):
(i) at the time of the initial written authority application—1 repeat supply;
(ii) during the initial period of dose titration—1 repeat supply;
(iii) for a patient whose dose has been stable for a period of 4 weeks—up to 4 repeat supplies.
(r) for romiplostim for initial PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Romiplostim prior to 1 April 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with romplostin was commenced:
(i) at the time of the initial written authority application—1 repeat supply;
(ii) during the initial period of dose titration—1 repeat supply;
(iii) for a patient in the titration phase of treatment whose dose has been stable for a period of 4 weeks—up to 4 repeat supplies;
(iv) for a patient whose dose had been stable for a period of at least 4 weeks at the time of the initial application for PBS‑subsidy—up to 5 repeat supplies.
(s) for romiplostim for the first period of continuing treatment or re‑initiation of interrupted PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who has displayed a sustained platelet response to treatment with Romiplostim during the initial period of PBS‑subsidised treatment:
(i) at the time of the initial written authority application—up to 5 repeat supplies;
(ii) where less than 5 repeat supplies are requested in the initial written authority application—sufficient repeat supplies to complete a maximum of 24 weeks treatment.
(t) for romiplostim for the second and subsequent periods of continuing treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who continues to display a sustained platelet response to treatment with Romiplostim—up to 5 repeat supplies.
(u) for omalizumab—where fewer than the required number of repeats to complete 24 weeks of treatment are requested at the time of the authority application—sufficient repeat supplies to complete 24 weeks of treatment.
(v) for omalizumab—where at least 24 weeks treatment was requested at the time of the application—0 repeat supplies.
(w) for eltrombopag for initial treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):
(i) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies.
(x) for eltrombopag for initial PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with eltrombopag prior to 1 November 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with eltrombopag was commenced:
(i) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies.
(y) for eltrombopag for the first period of continuing treatment or re‑initiation of interrupted PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who has displayed a sustained platelet response to treatment with eltrombopag during the initial period of PBS‑subsidised treatment:
(i) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies;
(ii) where less than 5 repeat supplies are requested in the initial written authority application—sufficient repeat supplies to complete a maximum of 24 weeks treatment.
(z) for eltrombopag for the second and subsequent periods of continuing treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who continues to display a sustained platelet response to treatment with eltrombopag—up to 5 repeat supplies.
(za) for tocilizumab, for the treatment of patients with severe active systemic juvenile idiopathic arthritis:
(i) if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 3 repeat supplies;
(ii) If the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies.
(3) In this section, circumstances means circumstances mentioned in Schedule 3 for the circumstances code mentioned in the column in Schedule 1 headed ‘Circumstances’ for the HSD pharmaceutical benefit that has the drug.
[3] Schedule 1, entry for Lenalidomide in the form Capsule 5 mg, manner of administration Oral
substitute:
Capsule 5 mg
Oral
Revlimid
CJ
EMP
C4090 C4091 C4282 C4287
See Note 1
See Note 2
D
[4] Schedule 1, entry for Lenalidomide in the form Capsule 10 mg, manner of administration Oral
substitute:
Capsule 10 mg
Oral
Revlimid
CJ
EMP
C4090 C4091 C4282 C4287
See Note 1
See Note 2
D
[5] Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL, manner of administration injection
omit:
Pamidronate Strides
YA
EMP
C1500 C3341
2
2
C
[6] Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL, manner of administration injection
omit:
Pamidronate Strides
YA
EMP
C1035 C1233 C1500 C3341 C3342 C3343
1
11
PB
[7] Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with the manner of administration Oral and brand Zelitrex
omit from the column headed ‘Responsible Person’: GM substitute: UA
[8] Schedule 2 – Responsible Person Codes
substitute:
Schedule 2 – Responsible Person Codes
Code
Responsible Person
Australian Business Number
AB
Abbott Australasia Pty Ltd
95 000 180 389
AF
Alphapharm Pty Ltd
93 002 359 739
AN
Amgen Australia Pty Limited
31 051 057 428
AS
Aspen Pharmacare Australia Pty Ltd
51 096 236 985
AT
Actelion Pharmaceuticals Australia Pty Ltd
32 097 278 512
BD
Biogen Idec Australia Pty Ltd
30 095 760 115
BN
Bayer Australia Ltd
22 000 138 714
BQ
Bristol‑Myers Squibb Australia Pty Ltd
33 004 333 322
BU
Bausch & Lomb (Australia) Pty Ltd
34 000 650 251
BY
Boehringer Ingelheim Pty Ltd
52 000 452 308
CJ
Celgene Pty Limited
42 118 998 771
CR
Pharmacor Pty Limited
58 121 020 835
GI
Gilead Sciences Pty Limited
71 072 611 708
GK
GlaxoSmithKline Australia Pty Ltd
47 100 162 481
GQ
Generic Health Pty Ltd
93 110 617 859
GZ
Genzyme Australasia Pty Ltd
24 083 420 526
HH
Hospira Pty Limited
13 107 058 328
IS
Ipsen Pty Ltd
47 095 036 909
IX
Clinect Pty Ltd
76 150 558 473
JC
Janssen‑Cilag Pty Ltd
47 000 129 975
LY
Eli Lilly Australia Pty Ltd
39 000 233 992
MK
Merck Sharp & Dohme (Australia) Pty Ltd
14 000 173 508
NV
Novartis Pharmaceuticals Australia Pty Limited
18 004 244 160
OA
Orphan Australia Pty Ltd
11 067 189 342
PF
Pfizer Australia Pty Ltd
50 008 422 348
QA
Aspen Pharma Pty Ltd
88 004 118 594
RA
Ranbaxy Australia Pty Ltd
17 110 871 826
RO
Roche Products Pty Ltd
70 000 132 865
SZ
Sandoz Pty Ltd
60 075 449 553
TX
Apotex Pty Ltd
52 096 916 148
UA
Actavis Pty Ltd
17 003 854 626
VE
AbbVie Pty Ltd
48 156 384 262
VI
ViiV Healthcare Pty Ltd
46 138 687 448
XA
Pharmaxis Ltd
75 082 811 630
YA
Agila Australasia Pty Ltd
12 154 055 339
ZF
Sun Pharmaceutical Industries (Australia) Pty Ltd
64 130 119 603
ZI
Shire Australia Pty Limited
29 128 941 819
[9] Schedule 3, entry for Lenalidomide
insert in numerical order:
C4282
Where the patient is receiving treatment at/from a private or public hospital
Myelodysplastic syndrome
Treatment Phase: Continuing treatment
Patient must be classified as Low risk or Intermediate-1 according to the International Prognostic Scoring System (IPSS)
Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities
Patient must have received PBS-subsidised initial therapy with lenalidomide for myelodysplastic syndrome
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
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 modified Authority Required procedures
C4287
Where the patient is receiving treatment at/from a private or public hospital
Myelodysplastic syndrome
Treatment Phase: Initial treatment
The treatment must be limited to a maximum duration of 16 weeks
Patient must be classified as Low risk or Intermediate-1 according to the International Prognostic Scoring System (IPSS)
Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities
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 modified Authority Required procedures
