National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 12) (PB 106 of 2019) (Cth)

PB 106 of 2019

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 12)

National Health Act 1953

___________________________________________________________________________

I, NATASHA PLOENGES, Assistant Secretary (Acting), 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              20 December 2019

NATASHA PLOENGES

Assistant Secretary (Acting)

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 2019 (No. 12).

(2)This Instrument may also be cited as PB 106 of 2019.

1. Commencement

This Instrument commences on 1 January 2020.

1. 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. Schedule 1, entry for Abacavir with Lamivudine in the form Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg

omit:

Abacavir/Lamivudine 600/300 APOTEX TX EMP C4527 C4528 60 5 D

1. Schedule 1, entry for Azacitidine

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

Azacitidine-Teva TB EMP C6132 C6143 C6144 C6177 C6186 C6199 See Note 1 See Note 2 D

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

omit:

Viramune BY EMP C4454 C4512 120 5 D

1. Schedule 1, entry for Tezacaftor with ivacaftor and ivacaftor

(a)omit from the column headed “Circumstances”: C9960

(b)insert in numerical order in the column headed “Circumstances”: C10022

1. Schedule 1, entry for Vedolizumab

omit from the column headed “Circumstances”: C5121 C7146

1. Schedule 3, entry for Tezacaftor with ivacaftor and ivacaftor

(a)omit:

C9960 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 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

(b)insert in numerical order after existing text:

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

1. Schedule 3, entry for Vedolizumab

omit:

C5121	Severe Crohn disease Initial PBS‑subsidised treatment (Grandfather) Patient must have a documented history of severe Crohn disease, AND Patient must have previously received non‑PBS‑subsidised therapy with this drug for this condition prior to 1 August 2015, AND Patient must have had a Crohn s Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with this drug; OR Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, AND Patient must have an adequate response to this drug defined as a reduction in Crohn s Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient, AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and (iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and (iv) the date of the most recent clinical assessment; and (v) the signed patient acknowledgement indicating they understand and acknowledge that the PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment. The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion. Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide sufficient for a single infusion of 300 mg vedolizumab per dose. Up to a maximum of 2 repeats will be authorised. If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase. A patient may qualify for PBS‑subsidised treatment under this restriction once only.	Compliance with Written Authority Required procedures
C7146	Moderate to severe ulcerative colitis Initial PBS‑subsidised treatment (Grandfather patient) Patient must have previously received non‑PBS‑subsidised therapy with this drug for this condition prior to 1 August 2015; AND Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing treatment with this drug; OR Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing treatment with this drug; OR Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced treatment with this drug where a Mayo clinic, partial Mayo clinic baseline assessment is not available; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be 18 years of age or older. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current and baseline Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the date of commencement of this drug; and (iii) the signed patient acknowledgement. The current Mayo clinic or partial Mayo clinic assessment must be no more than 1 month old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug. Where a baseline assessment is not available the prescriber must contact the Department of Human Services to discuss. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose. Up to a maximum of 2 repeats will be authorised. 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 Written Authority Required procedures