National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 10) (Cth)

Case

PB 85 of 2022

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 10)

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 sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated   29 September 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 (Listing of Pharmaceutical Benefits) Instrument 2012
(PB 71 of 2012).   2

  1. Name

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 10).

(2)This Instrument may also be cited as PB 85 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 October 2022 1 October 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Note:          This table relates only to the provisions of this instrument as originally made.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 sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

4       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 (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

  1. Schedule 1, Part 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); Tablet 40 mg (as calcium); and Tablet 80 mg (as calcium)

(a)omit:

a ATOMED DZ MP NP 30 5 30

(b)omit:

a ATOMED DZ MP P7598 30 11 30

  1. Schedule 1, Part 1, entry for Avelumab

insert in numerical order in the column headed “Circumstances”: C13290 C13303 C13313

  1. Schedule 1, Part 1, entry for Bortezomib in each of the forms: Solution for injection 2.5 mg in 1 mL; and Solution for injection 3.5 mg in 1.4 mL

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

Bortezomib Accord OC MP C11099 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Brolucizumab

omit from the column headed “Circumstances”: C12312

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

omit:

Jevtana SW MP C13207 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Chorionic gonadotrophin 

(a)omit:

Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 Injection Pregnyl OQ MP C6991 1 0 1 C(100)
MP C6979 C6987 C6989 C6990 C6995 1 5 1

(b)omit:

Powder for injection 5,000 units with solvent Injection Pregnyl OQ MP C6991 2 0 1 PB(100)

  1. Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 100 mg

insert:

Decitabine with cedazuridine Tablet containing decitabine 35 mg with cedazuridine 100 mg Oral Inqovi 35/100 OS MP C13165 C13205 C13241 C13257 C13258 C13267 P13205 P13241 P13267 5 2 5
MP C13165 C13205 C13241 C13257 C13258 C13267 P13165 P13257 P13258 5 5 5

  1. Schedule 1, Part 1, entry for Domperidone

omit from the column headed “Responsible Person”: JC         substitute: JT

  1. Schedule 1, Part 1, entry for Enzalutamide

substitute:

Enzalutamide Capsule 40 mg Oral Xtandi LL MP C12895 C12937 P12937 112 2 112
MP C12895 C12937 P12895 112 5 112

  1. Schedule 1, Part 1, after entry for Ethosuximide in the form Capsule 250 mg

insert:

Capsule 250 mg (s19A) Oral Ethosuximide Essential Generics IX MP NP 200 2 56

  1. Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 48 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

a Fenofibrate Viatris AL MP NP 60 5 60

  1. Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 48 mg [Maximum Quantity: 60; Number of Repeats: 11]

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

a Fenofibrate Viatris AL MP P7640 60 11 60

  1. Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

a Fenofibrate Viatris AL MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 11]

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

a Fenofibrate Viatris AL MP P7640 30 11 30

  1. Schedule 1, Part 1, entry for Fremanezumab

insert as first entry:

Solution for injection 225 mg in 1.5 mL single dose pre-filled pen Injection Ajovy TB MP C12029 C12064 P12064 1 2 1
MP C12029 C12064 P12029 1 5 1

  1. Schedule 1, Part 1, entry for Glatiramer

omit from the column headed “Schedule Equivalent” (all instances): a

  1. Schedule 1, Part 1, entry for Lurasidone in each of the forms: Tablet containing lurasidone hydrochloride 40 mg; and Tablet containing lurasidone hydrochloride 80 mg

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

a Lavione AF MP NP C4246 30 5 30

  1. Schedule 1, Part 1, after entry for Maraviroc in the form Tablet 300 mg

insert:

Mecasermin Solution for injection 40 mg in 4 mL (10 mg per mL) Injection Increlex IS MP C13293 C13317 C13320 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Metronidazole in the form Tablet 200 mg

substitute:

Tablet 200 mg Oral Metrogyl 200 AF PDP 21 0 21
MP NP 21 1 21

  1. Schedule 1, Part 1, entry for Mometasone in the form Cream containing mometasone furoate 1 mg per g, 15 g

omit from the column headed “Brand” (all instances): Momasone                substitute: Momasone Alcohol Free

  1. Schedule 1, Part 1, entry for Moxonidine in the form Tablet 200 micrograms

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

a Moxonidine Viatris AL MP NP C4944 30 5 30

  1. Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

insert in numerical order in the column headed “Circumstances”: C13280

  1. Schedule 1, Part 1, entry for Ofatumumab in the form Solution for injection 20 mg in 0.4 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C12224

(b)omit from the column headed “Purposes”: P12224

  1. Schedule 1, Part 1, entry for Ofatumumab in the form Solution for injection 20 mg in 0.4 mL pre-filled pen [Maximum Quantity: 3; Number of Repeats: 0]

omit from the column headed “Circumstances”: C12224

  1. Schedule 1, Part 1, entry for Pembrolizumab

(a)omit from the column headed “Circumstances”: C9894 C9921

(b)insert in numerical order in the column headed “Circumstances”: C13278 C13279 C13289 C13296 C13316

  1. Schedule 1, Part 1, entry for Plerixafor

(a)insert in the column headed “Schedule Equivalent” for the brand “Mozobil”: a

(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Plerixafor ARX XT MP C4549 C9329 1 1 1 D(100)

  1. Schedule 1, Part 1, entry for Pomalidomide

substitute:

Pomalidomide Capsule 3 mg Oral a Pomalyst CJ MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
a Pomolide JU MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
a Pomalidomide Sandoz SZ MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
Capsule 4 mg Oral a Pomalyst CJ MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
a Pomolide JU MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
a Pomalidomide Sandoz SZ MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)

  1. Schedule 1, Part 1, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 75 mg; Capsule 150 mg; and Capsule 300 mg

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

a NOUMED PREGABALIN VO MP NP C4172 56 5 56

  1. Schedule 1, Part 1, after entry for Sofosbuvir with velpatasvir and voxilaprevir

insert:

Somatrogon Injection 24 mg in 1.2 mL single use pre-filled pen Injection Ngenla PF MP C13282 C13284 C13287 C13288 C13292 C13294 C13297 C13298 C13304 C13308 C13309 C13311 C13312 C13318 See Note 3 See Note 3 1 D(100)
Injection 60 mg in 1.2 mL single use pre-filled pen Injection Ngenla PF MP C13282 C13284 C13287 C13288 C13292 C13294 C13297 C13298 C13304 C13308 C13309 C13311 C13312 C13318 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, after entry for Tenecteplase in the form Powder for injection 50 mg with solvent

insert:

Powder for injection 50 mg with solvent (s19A) Injection TNKase (Canada) QY MP NP C5783 1 0 1

  1. Schedule 1, Part 1, after entry for Triamcinolone with neomycin, gramicidin and nystatin in the form Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g

insert:

Trientine Capsule containing trientine dihydrochloride 250 mg (equivalent to 166.7 mg trientine) Oral Trientine Waymade IX MP NP C13321 200 5 100

  1. Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C12223

(b)omit from the column headed “Circumstances”: C12342

  1. Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 4]

(a)omit from the column headed “Circumstances”: C12223

(b)omit from the column headed “Circumstances”: C12342

  1. Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C12223

(b)omit from the column headed “Circumstances”: C12342

(c)omit from the column headed “Purposes”: P12223 P12342

  1. Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 0]

omit from the column headed “Circumstances”: C12301

  1. Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C12301

(b)omit from the column headed “Purposes”: P12301

  1. Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 2]

omit from the column headed “Circumstances”: C12301

  1. Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 2; Number of Repeats: 0]

omit from the column headed “Circumstances”: C12301

  1. Schedule 1, Part 2, omit entry for Alendronic acid with colecalciferol and calcium

  1. Schedule 1, Part 2, omit entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

  1. Schedule 1, Part 2, omit entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

  1. Schedule 1, Part 2, omit entry for Electrolyte replacement, oral

  1. Schedule 1, Part 2, omit entry for Enfuvirtide

  1. Schedule 1, Part 2, omit entry for Nifedipine

  1. Schedule 1, Part 2, entry for Rituximab

substitute:

Rituximab Solution for I.V. infusion 100 mg in 10 mL Injection Ruxience PF MP C7399 C7400 C9451 C9542 See Note 3 See Note 3 1 D(100)
Riximyo SZ MP C7399 C7400 C9451 C9542 See Note 3 See Note 3 2 D(100)
Truxima EW MP C7399 C7400 C9451 C9542 See Note 3 See Note 3 2 D(100)
Solution for I.V. infusion 500 mg in 50 mL Injection Riximyo SZ MP C7399 C7400 C9451 C9542 See Note 3 See Note 3 1 D(100)
Ruxience PF MP C7399 C7400 C9451 C9542 See Note 3 See Note 3 1 D(100)
Truxima EW MP C7399 C7400 C9451 C9542 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 2, omit entry for Terbutaline

  1. Schedule 4, Part 1, omit entry for Alendronic acid with colecalciferol and calcium

  1. Schedule 4, Part 1, entry for Avelumab

insert in numerical order after existing text:

C13290 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy - 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 being treated with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 13290
C13303 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy - Grandfathering treatment
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 October 2022; AND
Patient must have received first-line platinum-based chemotherapy prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease following first-line platinum-based chemotherapy; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy 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 - Streamlined Authority Code 13303
C13313 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy - Initial treatment
Patient must have received first-line platinum-based chemotherapy; AND
Patient must not have progressive disease following first-line platinum-based chemotherapy; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 13313

  1. Schedule 4, Part 1, entry for Brolucizumab

omit:

C12312 Subfoveal choroidal neovascularisation (CNV)
Grandfather treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
Patient must have persistent macular exudation, as determined clinically and/or by optical coherence tomography or fluorescein angiography, despite at least 6 months of treatment with: 1. Aflibercept and/or 2. Ranibizumab; AND
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2021; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A patient may qualify for PBS-subsidised treatment under this restriction once only per eye.
The first authority application for each eye must be made in writing.
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - Grandfather Application Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, after entry for Dasatinib

insert:

Decitabine with cedazuridine C13165 P13165 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
C13205 P13205 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.
No more than 3 cycles will be authorised under this restriction in a patient's lifetime.
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 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).
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 		Compliance with Written Authority Required procedures
C13241 P13241 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
C13257 P13257 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
C13258 P13258 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 13258
C13267 P13267 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); AND
The condition must have up to 20% marrow blasts according to World Health Organisation (WHO) Classification.
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 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR
(b) 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR
(c) 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
(d) 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR
(e) 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) 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
(b) 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

  1. Schedule 4, Part 1, entry for Electrolyte replacement, oral

omit:

C6786 Rehydration in intestinal failure Compliance with Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Enfuvirtide

  1. Schedule 4, Part 1, entry for Enzalutamide

substitute:

Enzalutamide C12895 P12895 Castration resistant non-metastatic carcinoma of the prostate
The condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition; AND
The condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR
Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.
Patient must be undergoing concurrent treatment with androgen deprivation therapy.
Prescribing instructions:
Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient's medical records - do not submit copies of these with this authority application.
The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading. 		Compliance with Authority Required procedures
C12937 P12937 Castration resistant metastatic carcinoma of the prostate
The treatment must not be used in combination with chemotherapy; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR
Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, after entry for Maraviroc

insert:

Mecasermin C13293 Severe growth failure with primary insulin-like growth factor-1 deficiency
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have a bone age of less than 13.5 years (females); OR
Patient must have a bone age of less than 15.5 years (males); AND
The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND
The condition must be responsive to this drug treatment as evidenced by each of: (i) patient is showing catch-up for height standard deviation score against Laron syndrome (growth hormone insensitivity syndrome) growth charts, (ii) patient has a growth velocity of greater than 2 cm per year (extrapolated for time on treatment) at the time of this continuing authority application; OR
The condition must be yet to respond to this drug treatment only for the reason of sub-optimal dosing.
Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; OR
Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician.
Patient must be aged from 2 years up until their 18 th birthday.
The continuing treatment 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:
(1) The patient's height (cm);
(2) Where this authority application seeks to continue treatment where there has been an inadequate response to treatment due to sub-optimal dosing, state each of:
(i) the most recently prescribed dose (mg/kg) that resulted in an inadequate response;
(ii) the dose (mg/kg) (between 0.04 to 0.12) that was/will be subsequently prescribed to address the inadequate response;
(3) The patient's weight (kg);
(4) The patient's growth velocity in response to the preceding supply of drug (cm/year; extrapolated for time on treatment);
(5) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.
Height, growth velocity and weight measurements must not be more than three months old at the time of application.
Document growth improvements 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
C13317 Severe growth failure with primary insulin-like growth factor-1 deficiency
Transitioning from non-PBS to PBS-subsidised supply - Grandfather patient
Patient must have commenced non-PBS-subsidised treatment with this drug prior to 1 October 2022; AND
The condition must be caused by severe primary insulin-like growth factor-1 deficiency (IGFD), with IGFD deficiency for the purpose of PBS subsidy defined as a basal IGF-1 level (measured any time prior to initiating treatment with this drug) below the 2.5 th percentile adjusted for each of: (i) age, (ii) gender; AND
The condition must have resulted in the patient experiencing short stature, with short stature for the purpose of PBS subsidy defined as the patient's height (measured any time prior to initiating treatment with this drug) being at least 3 standard deviations below the norm, adjusted for each of: (i) age, (ii) gender; AND
Patient must have had a growth velocity below the 25 th percentile for bone age plus sex measured over a 12 month interval (a 6 month interval for an older child) at the time the non-PBS-subsidised supply commenced; AND
The condition must not be caused by growth hormone deficiency; AND
Patient must have a bone age of less than 13.5 years (females); OR
Patient must have a bone age of less than 15.5 years (males); AND
The condition must not be caused by secondary causes of IGFD - prior to initiating treatment with this drug, the treating physician has at least excluded each of the following: (i) malnutrition, (ii) hypopituitarism, (iii) hypothyroidism, (iv) medication side effects; AND
The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing).
Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; OR
Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician; AND
Patient must be undergoing both: (i) continuing treatment with this drug, (ii) treatment that is yet to exceed 6 months of continuous treatment; OR
Patient must be undergoing each of: (i) continuing treatment with this drug, (ii) treatment that has exceeded 6 months duration, (iii) treatment that has resulted in both: (a) the patient showing catch-up for height standard deviation score against Laron syndrome (growth hormone insensitivity syndrome) growth charts, (b) a growth velocity of greater than 2 cm per year (extrapolated for time on treatment) at the time of this authority application; OR
Patient must be undergoing each of: (i) continuing treatment with this drug, (ii) treatment that has exceeded 6 months duration, (iii) treatment that is yet to establish the optimal dose.
Patient must be aged from 2 years up until their 18 th birthday.
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 the following:
(1) Date of commencing non-PBS-subsidised treatment:
State the month and year (mm/yy) that the first non-PBS-subsidised dose of this drug was administered.
(2) Insulin-like growth factor-1 deficiency:
State each of: (a) a basal IGF-1 level (ng/mL) measured prior to initiating non-PBS-subsidised treatment, (b) the measurement date (dd/mm/yy), (c) the name of the pathology result provider.
(3) Short stature:
State each of: (a) the patient's height (cm) at the time non-PBS-subsidised treatment was started, (b) the patient's current height (cm).
(4) Normal growth hormone levels:
State a growth hormone level measurement in mcg/L for this patient prior to having initiated non-PBS-subsidised treatment with this drug - this figure must be greater than 6.6 mcg/L.
(5) Bone age (where the patient had a chronological age of at least 2.5 years at the time of commencing non-PBS-subsidised treatment):
State each of: (a) the most recent bone age in numerical figures for this patient prior to initiating non-PBS-subsidised treatment with this drug, (b) the date (dd/mm/yy) of this determination that is within 12 months prior to initiating non-PBS-subsidised treatment with this drug;
(6) The patient's current growth velocity (cm/year) where there has been at least 6 months of non-PBS-subsidised treatment;
(7) The patient's current weight (kg);
(8) The prescribed dose (mg/kg) (between 0.04 to 0.12) that is sought for this authority application;
(9) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.
Current height, growth velocity and weight measurements must not be more than three months old at the time of application.
Document growth improvements 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
C13320 Severe growth failure with primary insulin-like growth factor-1 deficiency
Initial treatment
The condition must be caused by severe primary insulin-like growth factor-1 deficiency (IGFD), with IGFD deficiency for the purpose of PBS subsidy defined as a basal IGF-1 level (measured any time prior to initiating treatment with this drug) below the 2.5 th percentile adjusted for each of: (i) age, (ii) gender; AND
The condition must have resulted in the patient experiencing short stature, with short stature for the purpose of PBS subsidy defined as the patient's height (measured any time prior to initiating treatment with this drug) being at least 3 standard deviations below the norm, adjusted for each of: (i) age, (ii) gender; AND
Patient must have a growth velocity below the 25 th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); AND
The condition must not be caused by growth hormone deficiency; AND
Patient must have a bone age of less than 13.5 years (females); OR
Patient must have a bone age of less than 15.5 years (males); AND
The condition must not be caused by secondary causes of IGFD - prior to initiating treatment with this drug, the treating physician has at least excluded each of the following: (i) malnutrition, (ii) hypopituitarism, (iii) hypothyroidism, (iv) medication side effects; AND
The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing).
Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; OR
Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician.
Patient must be aged from 2 years up until their 18 th birthday.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The initial treatment 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 the following:
(1) Insulin-like growth factor-1 deficiency:
State each of: (a) the patient's most recent basal IGF-1 level measured (ng/mL), (b) the measurement date (dd/mm/yy), (c) the name of the pathology result provider;
(2) Short stature:
State the patient's height (cm);
(3) Normal growth hormone levels:
State the patient's most recent growth hormone level measurement (mcg/L) - this figure must be greater than 6.6 mcg/L;
(4) Bone age: (where the patient has a chronological age of at least 2.5 years):
State each of: (a) the patient's bone age in numerical figures at the time when it was most recently determined, (b) the date (dd/mm/yy) of this determination that is within 12 months of this authority application;
(5) The patient's weight (kg);
(6) The prescribed dose (mg/kg) (between 0.04 to 0.12);
(7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.
Height, growth velocity and weight measurements must not be more than three months old at the time of application.
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

  1. Schedule 4, Part 1, entry for Nivolumab

insert in numerical order after existing text:

C13280 Advanced or metastatic gastro-oesophageal cancers
The condition must be a gastro-oesophageal cancer type as specified in the drug's 'Indications' section of the approved Australian Product Information; AND
The treatment must be prescribed in accordance with the drug's 'Indications' section of the approved Australian Production Information with respect to each of: (i) concomitant drugs/therapies, (ii) line of therapy (i.e. prior treatments, if any); AND
Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1.
Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs. 		Compliance with Authority Required procedures - Streamlined Authority Code 13280

  1. Schedule 4, Part 1, entry for Ofatumumab

omit:

C12224 P12224 Multiple sclerosis
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
The condition must have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
The condition must have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years prior to initiation of this drug; AND
Patient must have been ambulatory (without assistance or support) prior to having initiated treatment with this drug for this condition; AND
Patient must have been receiving treatment with this drug for this condition prior to 1 October 2021; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 12224

  1. Schedule 4, Part 1, entry for Pembrolizumab

(a)omit:

C9894 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 9894
C9921 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy; OR
The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must not exceed a total of 7 doses under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 9921

(b)insert in numerical order after existing text:

C13278 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Initial treatment
The condition must be incurable by local therapies in the locally advanced setting; AND
Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating PBS-subsidised treatment with this drug for this condition; AND
Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if previously treated in the locally advanced setting; AND
Patient must have had a WHO performance status of 0 or 1; AND
The treatment must be either: (i) the sole PBS-subsidised therapy where the condition expresses programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND
The treatment must not exceed a total of 7 doses under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 13278
C13279 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
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 being treated with this drug for this condition; AND
The treatment must not exceed a total of 35 doses or up to 24 months of combined initial and continuing treatment in a lifetime for this condition whichever comes first. 		Compliance with Authority Required procedures - Streamlined Authority Code 13279
C13289 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 13289
C13296 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy; OR
The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must not exceed a total of 7 doses under this restriction; 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 13296
C13316 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2022; AND
Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if treated in the locally advanced setting prior to non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must have been initiated as non-PBS-subsidised therapy as either: (i) the sole therapy where the condition expressed programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 doses, or up to 24 months, of combined non-PBS-subsidised and PBS-subsidised treatment under the Grandfather and Continuing treatment restrictions in a lifetime. 		Compliance with Authority Required procedures - Streamlined Authority Code 13316

  1. Schedule 4, Part 1, entry for Rituximab

(a)omit:

C9446 Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The measurement of response to the prior course of therapy must be documented in the patient’s medical notes.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 9446

(b)omit:

C9611 Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The measurement of response to the prior course of therapy must be documented in the patient’s medical notes.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 9611
C10227 Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Re-induction therapy
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total. 		Compliance with Authority Required procedures - Streamlined Authority Code 10227

  1. Schedule 4, Part 1, after entry for Sofosbuvir with velpatasvir and voxilaprevir

insert:

Somatrogon C13282 Short stature and slow growth
Recommencement of treatment as a reclassified patient
Patient must be undergoing treatment that is simultaneously: (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone.
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height no higher than the 1 st percentile for age plus sex at the time treatment first commenced; AND
Patient must have had a growth velocity below the 25 th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; OR
Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment.
2. Recent growth data (height and weight, not older than three months).
3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13284 Short stature and slow growth
Initial treatment
Patient must have a current height at or below the 1 st percentile for age and sex; AND
Patient must have a growth velocity below the 25 th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; OR
Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
3. Confirmation of the patient's maturational or constitutional delay status.
4. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1 st adult height percentile.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13287 Short stature associated with biochemical growth hormone deficiency
Continuing treatment as a reclassified patient
Patient must be undergoing continuing PBS-subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously.
The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height at or below the 1 st percentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25 th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1 st percentile for age plus sex immediately prior to commencing treatment.
2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
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).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13288 Short stature associated with biochemical growth hormone deficiency
Change of drug
Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication.
Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; OR
Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; OR
Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Definition:
An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:
(a) The 50 th percentile growth velocity for bone age,
(b) An increase in height standard deviation score for chronological age,
(c) A minimum growth velocity of 4 cm per year,
(d) A mid-parental height standard deviation score.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
Where growth data been supplied within 3 months of this authority application, do not resupply this data.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13292 Short stature associated with biochemical growth hormone deficiency
Initial treatment
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must have a current height at or below the 1 st percentile for age and sex; OR
Patient must have a current height above the 1 st and at or below the 25 th percentiles for age and sex and a growth velocity below the 25 th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1 st and at or below the 25 th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1 st and at or below the 25 th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; or
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1 st percentile for age and sex.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
3. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13294 Short stature associated with biochemical growth hormone deficiency
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime.
The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height at or below the 1 st percentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25 th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1 st percentile for age plus sex immediately prior to commencing treatment.
2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.
C13297 Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment
Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication.
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not be for the purposes of resuming treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Recent growth data (height and weight, not older than three months).
2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13298 Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment as a reclassified patient
Patient must be undergoing treatment that is simultaneously: (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone.
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height at or below the 1 st percentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25 th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1 st percentile for age plus sex immediately prior to commencing treatment.
2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13304 Short stature and slow growth
Recommencement of treatment
Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication.
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not be for the purposes of resuming treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Recent growth data (height and weight, not older than three months).
2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13308 Short stature and slow growth
Continuing treatment
Patient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication.
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND
Patient must have achieved the 50 th percentile growth velocity for bone age plus sex following the most recent supply; OR
Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; OR
Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; OR
Patient must have achieved a mid-parental height standard deviation score following the most recent supply; OR
The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
3. The final adult height (in cm) of the patient's mother and father (where available).
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13309 Short stature and slow growth
Change of drug
Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication.
Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; OR
Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; OR
Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Definition:
An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:
(a) The 50 th percentile growth velocity for bone age,
(b) An increase in height standard deviation score for chronological age,
(c) A minimum growth velocity of 4 cm per year,
(d) A mid-parental height standard deviation score.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
Where growth data been supplied within 3 months of this authority application, do not resupply this data.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13311 Short stature associated with biochemical growth hormone deficiency
Continuing treatment
Patient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication.
Patient must have achieved the 50 th percentile growth velocity for bone age plus sex following the most recent supply; OR
Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; OR
Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; OR
Patient must have achieved a mid-parental height standard deviation score following the most recent supply; OR
The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
3. The final adult height (in cm) of the patient's mother and father (where available).
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13312 Short stature and slow growth
Continuing treatment as a reclassified patient
Patient must be undergoing continuing PBS-subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously.
The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height no higher than the 1 st percentile for age plus sex at the time treatment first commenced; AND
Patient must have had a growth velocity below the 25 th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; OR
Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment.
2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures
C13318 Short stature and slow growth
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime.
The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height no higher than the 1 st percentile for age plus sex at the time treatment first commenced; AND
Patient must have had a growth velocity below the 25 th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; OR
Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment; OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1 st percentile for age plus sex immediately prior to commencing treatment.
2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
3. A bone age result performed within the last 12 months where the patient has chronological age greater than 2.5 years.
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).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, after entry for Triamcinolone

insert:

Trientine C13321 Chelation of elevated copper levels
Patient must have a diagnosis of Wilson disease; AND
Patient must be intolerant to penicillamine.
Must be treated by a specialist medical practitioner, where this authority application is to initiate treatment with this drug, of the following type: (i) gastroenterologist, (ii) hepatologist, (iii) neurologist; the authority prescription must be completed by the specialist prescriber; OR
Must be treated by a medical practitioner (of any type), where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types; OR
Must be treated by a nurse practitioner where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types.
Prior to seeking the initial authority approval, establish evidence of excess copper levels based on at least one of: (i) clinical symptoms, (ii) measured serum copper levels, (iii) measured urinary copper levels.
Document what these findings were in the patient's medical records. Do not supply them in this authority application.
Refer to the following definitions if in doubt over what constitutes an acceptable intolerance to penicillamine:
Side effects of penicillamine occurring soon after initiation (within first few weeks/months):
(i) fever, (ii) rash, (iii) enlarged lymph nodes, (iv) neutropenia, (v) thrombocytopenia, (vi) proteinuria, (vii) severe, persistent nausea.
Side effects of penicillamine developing later:
(i) nephrotic syndrome, (ii) glomerulonephritis, (iii) total bone marrow aplasia, (iv) skin changes (cutis laxa, elastosis perforans serpiginosa, pemphigus), (v) myasthenia gravis, (vi) polymyositis, (vii) Goodpasture syndrome, (viii) optic neuritis, (ix) proteinuria (1-2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus-like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia.
At the time of the first authority application for this drug, document the details (date of reaction, severity of reaction, dose of penicillamine, etc) of the penicillamine intolerance, if not already done, in the patient's medical records. Do not supply these details in this authority application. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Upadacitinib

(a)omit:

C12223 P12223 Ankylosing spondylitis
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received treatment with this drug for this PBS indication prior to 1 October 2021; AND
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must have had at least 2 of the following prior to initiating treatment with this drug for this condition: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have had failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response to NSAIDs and must have been demonstrated prior to initiation of non-PBS subsidised treatment with this biological medicine for this condition:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and ESR or CRP level must have been determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. If the above requirement to demonstrate an elevated ESR or CRP could not be met, the application must state the reason this criterion could not be satisfied.
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) which includes the following:
(i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) baseline ESR and/or CRP level.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A Grandfathered 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 Written Authority Required procedures

(b)omit:

C12342 P12342 Severe psoriatic arthritis
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received treatment with this drug for this PBS indication prior to 1 October 2021; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response following at least 12 weeks of non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A Grandfathered 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.
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); and
(3) the date of commencement of this drug; and
(4) results of the baseline patient assessment prior to initiation of non-PBS subsidised therapy with this drug. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Ustekinumab

(a)insert in the column headed “Authority Requirements (part of Circumstances: or Conditions)” for Circumstances Code “C12285”: Compliance with Authority Required procedures

(b)insert in the column headed “Authority Requirements (part of Circumstances: or Conditions)” for Circumstances Code “C12293”: Compliance with Written Authority Required procedures

(c)insert in the column headed “Authority Requirements (part of Circumstances: or Conditions)” for Circumstances Code “C12294”: Compliance with Written Authority Required procedures

(d)omit:

C12301 P12301 Severe chronic plaque psoriasis
Transitioning from non-PBS to PBS-subsidised supply (Whole body) - 'Grandfather' arrangements
Must be treated by a dermatologist.
Patient must be receiving treatment with this biological medicine at the time of this application, with initiation of this biological medicine having commenced prior to 1 October 2021; AND
The treatment must be in a patient who prior to initiating treatment with non-PBS subsidised treatment with this biological medicine, was each of: (i) treatment-naive to this biological medicine, (ii) had psoriatic lesions present for at least 6 months from the time of initial diagnosis; AND
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must have, prior to having initiated non-PBS-subsidised treatment with this biological medicine, failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks.
Patient must be under 18 years of age.
Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.
Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Services Australia website.
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).
The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:
(a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy.
A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. State in this authority application, each of:
(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;
(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);
(iii) the PASI score that followed each prior therapy trialled;
(iv) the date the PASI scores were determined
State a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.

(e)        insert in the column headed “Authority Requirements (part of Circumstances: or Conditions)” for Circumstances Code “C12302”: Compliance with Written Authority Required procedures

(f)         insert in the column headed “Authority Requirements (part of Circumstances: or Conditions)” for Circumstances Code “C12311”: Compliance with Written Authority Required procedures

(g)        insert in the column headed “Authority Requirements (part of Circumstances: or Conditions)” for Circumstances Code “C12323”: Compliance with Written Authority Required procedures

(h)        insert in the column headed “Authority Requirements (part of Circumstances: or Conditions)” for Circumstances Code “C12332”: Compliance with Written Authority Required procedures

(i)         insert in the column headed “Authority Requirements (part of Circumstances: or Conditions)” for Circumstances Code “C12333”: Compliance with Written Authority Required procedures

(j)         insert in the column headed “Authority Requirements (part of Circumstances: or Conditions)” for Circumstances Code “C12334”: Compliance with Authority Required procedures

(k)        insert in the column headed “Authority Requirements (part of Circumstances: or Conditions)” for Circumstances Code “C12341”: Compliance with Written Authority Required procedures

  1. Schedule 5, omit entry for Chorionic gonadotrophin

  1. Schedule 5, after entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [GRP-26183]

insert:

Ethosuximide GRP-23067 Capsule 250 mg Oral Zarontin
Capsule 250 mg (s19A) Oral Ethosuximide Essential Generics

  1. Schedule 5, after entry for Filgrastim in the form Injection 480 micrograms in 1.6 mL [GRP-23385]

insert:

Fremanezumab GRP-26651 Solution for injection 225 mg in 1.5 mL single dose pre-filled pen Injection Ajovy
Solution for injection 225 mg in 1.5 mL single dose pre-filled syringe Injection Ajovy

  1. Schedule 5, after entry for Fremanezumab in the form Solution for injection 225 mg in 1.5 mL single dose pre-filled syringe

insert:

Glatiramer GRP-26552 Injection containing glatiramer acetate 40 mg in 1 mL single dose pre-filled pen Injection Copaxone
Injection containing glatiramer acetate 40 mg in 1 mL single dose pre-filled syringe Injection Copaxone
GLATIRAMER ACETATE-TEVA
Glatira

  1. Schedule 5, after entry for Sumatriptan in the form Tablet 50 mg (as succinate)

insert:

Tenecteplase GRP-26656 Powder for injection 50 mg with solvent Injection Metalyse
Powder for injection 50 mg with solvent (s19A) Injection TNKase (Canada)
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