PB 50 of 2015
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015 (No. 6)
 
National Health Act 1953
___________________________________________________________________________
 
 
I, KIM BESSELL, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated      28 May 2015
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KIM BESSELL
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
 
 
1       Name of Instrument
 
(1)                This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015 (No.6).
 
(2)                This Instrument may also be cited as PB 50 of 2015.
 
2              Commencement
This Instrument commences on 1 June 2015.
3              Amendments to PB 116 of 2010
Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).
 
 
Schedule 1       Amendments
[1]           Schedule 1, after entry for Ambrisentan
insert:
Anakinra
Injection 100 mg in 0.67 mL single use pre-filled syringe
Injection
Kineret
FK
EMP
C4920
 
1
5
D
[2]        Schedule 1, entry for Ivacaftor in the form tablet 150 mg
(a)   omit from the column headed “Circumstances”: C4735 C4743 C4769
(b)   insert in numerical order in the column headed “Circumstances”: C4904 C4905 C4931
 
[3]        Schedule 3, entry for Natalizumab item c4454 in the column headed listed drug
insert: Nevirapine
 
[4]        Schedule 3, after entry for Ambrisentan
insert:
Anakinra
C4920
P4920
Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe cryopyrin associated periodic syndromes (CAPS)
Must be treated by a rheumatologist or in consultation with a rheumatologist.
A diagnosis of CAPS must be documented in the patient's medical records.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4920
 
 
[5]           Schedule 3, entry for Ivacaftor
substitute:
Ivacaftor
C4904
P4904
Where the patient is receiving treatment at/from a private or public hospital
Cystic fibrosis
Initial treatment – New patients
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit,
AND
Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR
Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele,
AND
Patient must not receive more than 24 weeks of treatment under this restriction,
AND
The treatment must be given concomitantly with standard therapy for this condition.
Population criteria:
Patient must be 6 years of age or older.
Patients receiving PBS-subsidised ivacaftor 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.
Dosage of ivacaftor must not exceed the dose of 150 mg twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 28 weeks.
Dosage of ivacaftor must not exceed the dose of 150 mg daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 8 weeks.
Ivacaftor is not PBS-subsidised for this condition as a sole therapy.
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, prednisone, rufinamide.
 
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis Ivacaftor Authority Application Supporting Information Form; and
(3) a signed patient acknowledgement; or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) a copy of the pathology report detailing the molecular testing for G551D mutation or other gating (class III) mutation on the CFTR gene; and
(5) the result of a FEV1 measurement 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 FEV1 is measured; and
(6) evidence that the patient has either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; and
(7) a copy of a current medication history, including any CYP3A4 inhibitors and/or CYP3A4 inducers; and
(8) a copy of a sweat chloride result; and
(9) height and weight measurements at the time of application; and
(10) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.
Compliance with modified Authority Required procedures

C4905
P4905
Where the patient is receiving treatment at/from a private or public hospital
Cystic fibrosis
Continuing treatment
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit,
AND
Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition,
AND
Patient must not receive more than 24 weeks of treatment under this restriction,
AND
The treatment must be given concomitantly with standard therapy for this condition.
Population criteria:
Patient must be 6 years of age or older.
Patients receiving PBS-subsidised ivacaftor 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.
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 ivacaftor must not exceed the dose of 150 mg twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 28 weeks.
Dosage of ivacaftor must not exceed the dose of 150 mg daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 8 weeks.
Ivacaftor is not PBS-subsidised for this condition as a sole therapy.
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, prednisone, rufinamide.
 
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis Ivacaftor Authority Continuing Application Supporting Information Form; and
(3) the result of a FEV1 measurement performed within one 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 FEV1 is measured; and
(4) a copy of a current medication history, including any CYP3A4 inhibitors and/or CYP3A4 inducers; and
(5) a recent sweat chloride result; and
(6) height and weight measurements at the time of application; and
(7) a measurement of number of days of CF-related hospitalisation (including hospital in the home) in the previous 6 months.
Compliance with modified Authority Required procedures

 
C4931
P4931
Where the patient is receiving treatment at/from a private or public hospital
Cystic fibrosis
Initial treatment - Grandfather patients
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit,
AND
Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR
Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele,
AND
Patient must have received treatment with ivacaftor for this condition prior to 1 December 2014,
AND
Patient must have received treatment with ivacaftor within the last 6 months at the time of application,
AND
Patient must not receive more than 24 weeks of treatment under this restriction,
AND
The treatment must be given concomitantly with standard therapy for this condition.
Population criteria:
Patient must be 6 years of age or older.
Patients receiving PBS-subsidised ivacaftor 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.
Dosage of ivacaftor must not exceed the dose of 150 mg twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 28 weeks.
Dosage of ivacaftor must not exceed the dose of 150 mg daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 8 weeks.
Ivacaftor is not PBS-subsidised for this condition as a sole therapy.
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, prednisone, rufinamide.
 
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis Ivacaftor Application Supporting Information Form; and
(3) a signed patient acknowledgement; or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) a copy of the pathology report detailing the molecular testing for G551D mutation or other gating (class III) mutation on the CFTR gene performed prior to commencing treatment with ivacaftor; and
(5) the result of a FEV1 measurement performed prior to commencing treatment with ivacaftor for this condition; and
(6) the result of a FEV1 measurement performed within a month prior to date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and
(7) evidence that the patient had either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities prior to commencing treatment with ivacaftor for this condition; and
(8) a copy of a current medication history, including any CYP3A4 inhibitors and/or CYP3A4 inducers; and
(9) a copy of sweat chloride result performed prior to commencing treatment with ivacaftor for this condition; and
(10) a recent sweat chloride result prior to commencing PBS-subsidised ivacaftor; and
(11) height and weight measurements at the time of application; and
(12) height and weight measurements performed immediately prior to commencement of ivacaftor; and
(13) a baseline measurement of number of days of CF-related hospitalisation (including hospital-in-the home) in the 12 months prior to commencement of ivacaftor; and
(14) a measurement of the number of days of CF-related hospitalisation (including hospital-in the home) in the 6 months prior to the date of application; and
(15) dates of prior ivacaftor therapy.
Compliance with modified Authority Required procedures