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PB 4 of 2020 Arrangements as made
The instrument amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to add, delete and make changes to drugs, forms, manners of administration, brands, responsible person codes, authorised prescribers, maximum quantities and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 31 Jan 2020
Tabling HistoryDate
Tabled HR04-Feb-2020
Tabled Senate04-Feb-2020
To be repealed 14 Aug 2020
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

PB 4 of 2020

 

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 1)

 

National Health Act 1953

___________________________________________________________________________

 

I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

 

Dated              29 January 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BEN SLADIC

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health


 

 

___________________________________________________________________________

1          Name of Instrument

(1)          This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 1).

(2)          This Instrument may also be cited as PB 4 of 2020.

2          Commencement

This Instrument commences on 1 February 2020.

3          Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

 

 


Schedule 1     Amendments

[1]        Part 5, Division 2, subsection 39(1)(a)(ii)(B)

omit the text: the the          substitute: the

[2]        Part 5, Division 2, subsection 39(1)(b)(ii)(B)

omit the text: the the          substitute: the

[3]        Part 5, Division 2, subsection 39(1)(c)(iii)(B)

omit the text: the the          substitute: the

[4]        Schedule 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)

omit:

 

 

 

BOSENTAN‑DRLA

RZ

EMP

C4628 C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

[5]        Schedule 1, entry for Bosentan in the form Tablet 125 mg (as monohydrate)

omit:

 

 

 

BOSENTAN‑DRLA

RZ

EMP

C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

[6]        Schedule 1, after entry for Ciclosporin in the form Solution concentrate for I.V. infusion 50 mg in 1 mL

insert:

Cinacalcet

Tablet 30 mg (as hydrochloride)

Oral

Pharmacor Cinacalcet

CR

EMP

C10063 C10067 C10073

 

56

5

C

 

Tablet 60 mg (as hydrochloride)

Oral

Pharmacor Cinacalcet

CR

EMP

C10063 C10067 C10073

 

56

5

C

 

Tablet 90 mg (as hydrochloride)

Oral

Pharmacor Cinacalcet

CR

EMP

C10063 C10067 C10073

 

56

5

C

[7]        Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium)

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

 

 

 

EPOPROSTENOL SUN

RA

EMP

C6123 C6734 C6748 C6945 C6955

 

See Note 1

See Note 2

D

[8]        Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium)

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

 

 

 

EPOPROSTENOL SUN

RA

EMP

C6123 C6734 C6748 C6945 C6955

 

See Note 1

See Note 2

D

[9]        Schedule 1, entry for Lanreotide

omit:

 

Powder for suspension for injection 30 mg (as acetate) with diluent

Injection

Somatuline LA

IS

EMP

C7042 C9225

 

2

11

D

[10]      Schedule 1, entry for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre-filled syringe

(a)        omit from the column headed “Circumstances”: C8260 C9161

(b)        omit from the column headed “Circumstances”: C9323

(c)        insert in numerical order in the column headed “Circumstances”: C10061 C10075 C10077

[11]      Schedule 1, after entry for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre-filled syringe

insert:

 

Powder for suspension for injection 30 mg (as acetate) with diluent

Injection

Somatuline LA

IS

EMP

C7042 C9225

 

2

11

D

[12]      Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg

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

 

 

 

Mycophenolate GH

GQ

EMP

C5554 C5795 C9691 C9693

 

300

5

C

[13]      Schedule 1, entry for Octreotide in the form Injection (modified release) 30 mg (as acetate), vial and diluent syringe

insert in numerical order in the column headed “Circumstances”: C10061 C10075 C10077

[14]      Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 100 mg in 10 mL

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

 

 

 

Truxima

EW

EMP

C7021 C7022 C9336 C9344 C9511 C9539 C9640 C9641

 

See Note 1

See Note 2

PB

[15]      Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL

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

 

 

 

Truxima

EW

EMP

C7021 C7022 C9336 C9340 C9344 C9446 C9448 C9449 C9450 C9511 C9512 C9539 C9611 C9640 C9641

 

See Note 1

See Note 2

PB

[16]      Schedule 1, entry for Sildenafil

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

 

 

 

SILDATIO PHT

RW

EMP

C6089 C6723 C6734 C6736 C6748 C6749

 

See Note 1

See Note 2

D

(b)        omit:

 

 

 

SILDENAFIL‑DRx

RZ

EMP

C6089 C6723 C6734 C6736 C6748 C6749

 

See Note 1

See Note 2

D

[17]      Schedule 1, entry for Tezacaftor with ivacaftor and ivacaftor

(a)        omit from the column headed “Circumstances”: C9846

(b)        omit from the column headed “Circumstances”: C10022

(c)        insert in numerical order in the column headed “Circumstances”: C10064 C10069

[18]      Schedule 2, after details relevant to Responsible Person code EU

insert:

EW

Celltrion Healthcare Australia Pty Ltd

66 625 407 105

[19]      Schedule 3, after entry for Ciclosporin

insert:

Cinacalcet

C10063

 

Secondary hyperparathyroidism
Continuing treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures - Streamlined Authority Code 10063

 

C10067

 

Secondary hyperparathyroidism
Continuing treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures - Streamlined Authority Code 10067

 

C10073

 

Secondary hyperparathyroidism
Initial treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have failed to respond to conventional therapy; AND
Patient must have sustained hyperparathyroidism with iPTH of at least 50 pmol per L; OR
Patient must have sustained hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L.
During the titration phase, intact PTH (iPTH) should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.
During the titration phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures

[20]      Schedule 3, entry for Lanreotide

(a)        omit:

 

C8260

 

Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.
Lanreotide is not PBS‑subsidised for use in combination with everolimus or sunitinib for this condition.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 8260

 

C9161

 

Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.
Lanreotide is not PBS‑subsidised for use in combination with everolimus or sunitinib for this condition.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 9161

(b)        omit:

 

C9323

 

Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.
Lanreotide is not PBS‑subsidised for use in combination with everolimus or sunitinib for this condition.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 9323

(c)        insert in numerical order after existing text:

 

C10061

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10061

 

C10075

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10075

 

C10077

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10077

[21]      Schedule 3, entry for Octreotide

insert in numerical order after existing text:

 

C10061

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10061

 

C10075

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10075

 

C10077

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10077

[22]      Schedule 3, entry for Omalizumab

(a)        omit entry for Circumstances Code “C9886” and substitute:

 

C9886

 

Uncontrolled severe allergic asthma
Continuing treatment
Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be aged 12 years or older.
An adequate response to omalizumab treatment is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR
(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).
All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate must be made at around 18 to 22 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug.
Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.
A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of this biological medicine consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for up to 24 weeks of therapy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Allergic Asthma PBS Authority Application and Supporting Information Form which includes details of maintenance oral corticosteroid dose; or
(c) a completed Asthma Control Questionnaire (ACQ-5) calculation sheet including the date of assessment of the patient's symptoms and is endorsed with the signature of the prescriber; for patients transitioned from the paediatric to the adolescent/adult restrictions an exacerbation calculation sheet may be submitted.

Compliance with Written Authority Required procedures

(b)        omit entry for Circumstances Code “C9916” and substitute:

 

C9916

 

Uncontrolled severe allergic asthma
Initial treatment - Initial 2 (Change of treatment)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND
Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND
Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Allergic Asthma (omalizumab) Initial PBS Authority Application - Supporting Information Form, which includes the following:
(i) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment; and
(iii) the IgE results; and
(iv) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.
An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 26 to 30 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment at around 26 to 30 weeks, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine.
At the time of the authority application, medical practitioners should request an appropriate maximum quantity based on IgE level and body weight (refer to the TGA-approved Product Information) to be administered every 2 to 4 weeks and up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.

Compliance with Written Authority Required procedures

[23]      Schedule 3, entry for Tezacaftor with ivacaftor and ivacaftor

(a)        omit:

 

C9846

 

Cystic fibrosis ‑ one residual function (RF) mutation
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have at least one residual function (RF) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor with ivacaftor; AND
Patient must have F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; AND
The treatment must be the sole PBS‑subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.
Patient must be 12 years of age or older.
The patient must be registered in the Australian Cystic Fibrosis Database Registry.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
For the purposes of this restriction, the list of mutations considered to be responsive to tezacaftor with ivacaftor is defined in the TGA approved product information.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS‑subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis tezacaftor with ivacaftor Authority Application Supporting Information Form; and
(3) a copy of the pathology report detailing the molecular testing for the patient having at least one RF mutation on the CFTR gene; and
(4) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(5) CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(6) height and weight measurements at the time of application; and
(7) a baseline measurement of the number of days of CF‑related hospitalisation (including hospital‑in‑the home) in the previous 12 months.
For patients who have initiated non‑PBS subsidised treatment prior to 1 December 2019, date of initiating treatment, baseline FEV1and hospitalisation dates prior to initiating treatment (where available) should be provided.

Compliance with Written Authority Required procedures

(b)        omit:

 

C10022

 

Cystic fibrosis - one residual function (RF) mutation
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 12 years of age or older.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis tezacaftor with ivacaftor Continuing Authority Application Supporting Information Form; and
(3) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(5) height and weight measurements at the time of application; and
(6) the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 6 months.

Compliance with Written Authority Required procedures

(c)        insert in numerical order after existing text:

 

C10064

 

Cystic fibrosis - one residual function (RF) mutation
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have at least one residual function (RF) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor with ivacaftor; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.
Patient must be 12 years of age or older.
The patient must be registered in the Australian Cystic Fibrosis Database Registry.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
For the purposes of this restriction, PBS subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor and tezacaftor/ivacaftor.
For the purposes of this restriction, the list of mutations considered to be responsive to tezacaftor with ivacaftor is defined in the TGA approved product information.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis tezacaftor with ivacaftor Authority Application Supporting Information Form; and
(3) a copy of the pathology report detailing the molecular testing for the patient having at least one RF mutation on the CFTR gene; and
(4) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(5) CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(6) height and weight measurements at the time of application; and
(7) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.
For patients who have initiated non-PBS subsidised treatment prior to 1 December 2019, date of initiating treatment, baseline FEV1and hospitalisation dates prior to initiating treatment (where available) should be provided.

Compliance with Written Authority Required procedures

 

C10069

 

Cystic fibrosis - one residual function (RF) mutation
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 12 years of age or older.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation.
For the purposes of this restriction, PBS subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor and tezacaftor/ivacaftor.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis tezacaftor with ivacaftor Continuing Authority Application Supporting Information Form; and
(3) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(5) height and weight measurements at the time of application; and
(6) the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 6 months.

Compliance with Written Authority Required procedures