National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 7) (PB 77 of 2018) (Cth)
PB 77 of 2018
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 7)
National Health Act 1953
___________________________________________________________________________
I, NATASHA PLOENGES, Acting 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 August 2018
NATASHA PLOENGES
Acting Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 7).
(2)This Instrument may also be cited as PB 77 of 2018.
Commencement
This Instrument commences on 1 September 2018.
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
Schedule 1, entry for Eculizumab [Maximum Quantity: 1; Number of Repeats: 4]
insert in the column headed "Authorised Prescriber": EMP
Schedule 1, entry for Eculizumab [Maximum Quantity: 1; Number of Repeats: 5]
insert in the column headed "Authorised Prescriber": EMP
Schedule 1, entry for Eculizumab [Maximum Quantity: 1; Number of Repeats: 6]
insert in the column headed "Authorised Prescriber": EMP
Schedule 1, entry for Glecaprevir with pibrentasvir [Maximum Quantity: 84; Number of Repeats: 2]
insert in the column headed "Authorised Prescriber": EMP
Schedule 1, entry for Glecaprevir with pibrentasvir [Maximum Quantity: 84; Number of Repeats: 3]
insert in the column headed "Authorised Prescriber": EMP
Schedule 1, entry for Infliximab
(a)omit from the column headed “Circumstances” for the brand “Inflectra”: C5077 C5097 C5103 C5109
(b)insert in numerical order in the column headed “Circumstances” for the brand “Inflectra”: C7886 C7887 C7910 C7922 C7923 C7931
(c)omit from the column headed “Circumstances” for the brand “Remicade”: C5077 C5097 C5103 C5109
(d)insert in numerical order in the column headed “Circumstances” for the brand “Remicade”: C7886 C7910 C7922 C7923 C7928
(e)omit from the column headed “Circumstances” for the brand “Renflexis”: C5077 C5097 C5103 C5109
(f)insert in numerical order in the column headed “Circumstances” for the brand “Renflexis”: C7886 C7887 C7910 C7922 C7923 C7931
Schedule 1, entry for Mepolizumab [Maximum Quantity: 1; Number of Repeats: 7]
omit from the column headed "Purposes": C7456 substitute: P7456
Schedule 1, entry for Peginterferon alfa-2a in the form: Injection 135 micrograms in 0.5 mL single use pre-filled syringe
omit from the column headed "Section 100 only": PB substitute: C
Schedule 1, entry for Peginterferon alfa-2a in the form: Injection 180 micrograms in 0.5 mL single use pre filled syringe [Maximum Quantity: 4; Number of Repeats: 2]
insert in the column headed "Section 100 only": C
Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Tacrograf | RW | EMP | C5569 C5602 | 200 | 5 | C |
Schedule 1, entry for Tacrolimus in the form Capsule 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Tacrograf | RW | EMP | C5569 C5602 | 200 | 5 | C |
Schedule 1, entry for Tacrolimus in the form Capsule 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Tacrograf | RW | EMP | C5569 C5602 | 100 | 5 | C |
Schedule 1, entry for Tenofovir with emtricitabine in all forms
omit from the column headed "Section 100 only": D substitute: C
Schedule 3, entry for Infliximab
(a)omit:
| C5077 | Moderate to severe Crohn disease Continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI Patient must have a documented history of moderate to severe Crohn disease, AND Patient must have previously been issued with an authority prescription for this drug for this condition, AND Patient must have demonstrated an adequate response to treatment with this drug as defined as a reduction in PCDAI Score by at least 15 points as compared to baseline and a total of PCDAI score of 30 points or less with the PCDAI assessment being no more than 1 month old at the time of application. Patient must be aged 6 to 17 years inclusive. Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. 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 [may be downloaded from the Department of Human Services website ( which includes the following: (i) the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition. The PCDAI assessment must be no more than 1 month old at the time of application. If the application is the first application for continuing treatment with this drug, a PCDAI assessment of the patient's response must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. 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 in courses of up to 24 weeks providing they continue to sustain the response. A maximum of 24 weeks treatment will be authorised under this criterion. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 2 repeats will be authorised. Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the 'Balance of Supply' treatment phase PBS restriction. | Compliance with modified Authority Required procedures |
| C5097 | Moderate to severe Crohn disease Initial treatment (new paediatric patient) of Crohn disease in a paediatric patient assessed by PCDAI (Initial 1) Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist, consultant physician, paediatrician or specialist paediatric gastroenterologist, AND Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra‑indication to each of prednisolone (or equivalent), azathioprine, 6‑mercaptopurine and methotrexate, AND Patient must have, at the time of application, disease severity considered to be moderate to severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment and which is no more than 1 month old at the time of application. Patient must be aged 6 to 17 years inclusive. Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription forms; and (b) a completed paediatric Crohn Disease PBS Authority Application ‑Supporting Information Form [may be downloaded from the Department of Human Services website ( which includes the following: (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition; and (ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition; and (iii) the signed patient or guardian 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. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. Details of the accepted toxicities including severity can be found on the Human Services website ( A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. It is recommended that an application for continuing treatment is posted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS‑subsidised treatment with this drug. | Compliance with modified Authority Required procedures |
| C5103 | Moderate to severe Crohn disease Balance of supply for a paediatric patient Patient must have received insufficient therapy with this drug under Initial 1 (new patient or patient recommencing treatment after break of more than 5 years) or Initial 2 (change or recommencement of treatment after a break of less than 5 years) or Continuing treatment to complete the maximum duration of treatment specified in the relevant treatment phase, AND The treatment must provide no more than the balance of up to 3 doses or 2 repeats. Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. | Compliance with modified Authority Required procedures |
| C5109 | Moderate to severe Crohn disease Change or re‑commencement of treatment of Crohn disease in a paediatric patient assessed by PCDAI (Initial 2) Patient must have a documented history of moderate to severe Crohn disease, AND Patient must in this treatment cycle, have received prior PBS‑subsidised treatment with this drug for this condition; OR Patient must in this treatment cycle, have received prior PBS‑subsidised treatment with adalimumab for this condition, AND Patient must not have failed PBS‑subsidised therapy with this drug for this condition more than once in the current treatment cycle. Patient must be aged 6 to 17 years inclusive. Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of TNF‑alfa antagonist therapy within the timeframes specified in the relevant restriction. Where the most recent course of PBS‑subsidised TNF‑alfa antagonist treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. If the response assessment to the previous course of TNF‑alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF‑alfa antagonist. Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed paediatric Crohn Disease PBS Authority Application ‑Supporting Information Form [may be downloaded from the Department of Human Services website ( which includes the following: (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and (ii) details of prior TNF‑alfa antagonist treatment including details of date and duration of treatment. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. It is recommended that an application for continuing treatment is posted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS‑subsidised treatment with this drug. | Compliance with modified Authority Required procedures |
(b)insert in numerical order after existing text:
| C7886 | Moderate to severe Crohn disease Balance of supply Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 treatment (New patient or Recommencement of treatment after more than 5 years break in therapy) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 treatment (Change or Re-commencement of treatment after a break in therapy of less than 5 years ) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment). | Compliance with Authority Required procedures |
| C7887 | Moderate to severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First Continuing treatment restriction; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less. Patient must be aged 6 to 17 years inclusive. The PCDAI assessment must be no more than 1 month old at the time of application. Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Authority Required procedures |
| C7910 | Moderate to severe Crohn disease First continuing treatment Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition. The PCDAI assessment must be no more than 1 month old at the time of application. The application for first continuing treatment with this drug must include a PCDAI assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. A maximum of 24 weeks of treatment with this drug will be authorised under this restriction. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C7922 | Moderate to severe Crohn disease Initial 1 - New patient or recommencement of treatment after more than 5 years break in therapy Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application; and (ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition. The PCDAI score should preferably be obtained whilst on conventional treatment but must be obtained within one month of the last conventional treatment dose. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Department of Human Services website. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures |
| C7923 | Moderate to severe Crohn disease Initial 2 - Change or Re-commencement of treatment after a break in therapy of less than 5 years Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and (ii) details of prior biological medicine treatment including details of date and duration of treatment. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction. Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures |
| C7928 | Moderate to severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First Continuing treatment restriction; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition. Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C7931 | Moderate to severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First Continuing treatment restriction; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less. Patient must be aged 6 to 17 years inclusive. The PCDAI assessment must be no more than 1 month old at the time of prescribing. The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy. Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures - Streamlined Authority Code 7931 |
Schedule 3, Part 1, Section 3 – Treatment regimen
omit table and substitute:
| Item | Kind of patient | Regimen |
| 1 | Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is non-cirrhotic | Either: (a) LEDIPASVIR with SOFOSBUVIR for 8 weeks; or (b) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or (f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (g) GRAZOPREVIR with ELBASVIR for 12 weeks; or (h) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (i) GLECAPREVIR with PIBRENTASVIR for 8 weeks. |
| 2 | Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is non-cirrhotic | Either: (a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or (f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (g) GRAZOPREVIR with ELBASVIR for 12 weeks; or (h) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or (i) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (j) GLECAPREVIR with PIBRENTASVIR for 8 weeks; or (k) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or (l) GLECAPREVIR with PIBRENTASVIR for 16 weeks. |
| 3 | Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is non-cirrhotic | Either: (a) SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 8 weeks. |
| 4 | Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is non-cirrhotic | Either: (a) SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 8 weeks. |
| 5 | Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is non-cirrhotic | Either: (a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (d) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (e) GLECAPREVIR with PIBRENTASVIR for 8 weeks. |
| 6 | Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is non-cirrhotic | Either: (a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (d) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (e) GLECAPREVIR with PIBRENTASVIR for 16 weeks. |
| 7 | Patient: (a) with Genotype 4; and (b) who is treatment naïve; and (c) who is non-cirrhotic | Either: (a) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b) GRAZOPREVIR with ELBASVIR for 12 weeks; or (c) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (d) GLECAPREVIR with PIBRENTASVIR for 8 weeks. |
| 8 | Patient: (a) with Genotype 4; and (b) who is treatment experienced; and (c) who is non-cirrhotic | Either: (a) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b) GRAZOPREVIR with ELBASVIR for 12 weeks; or (c) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or (d) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (e) GLECAPREVIR with PIBRENTASVIR for 8 weeks. |
| 9 | Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment naïve; and (c) who is non-cirrhotic | Either: (a) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 8 weeks. |
| 10 | Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment experienced; and (c) who is non-cirrhotic | Either: (a) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 8 weeks. |
| 11 | Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is cirrhotic | Either: (a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (f) GRAZOPREVIR with ELBASVIR for 12 weeks; or (g) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (h) GLECAPREVIR with PIBRENTASVIR for 12 weeks. |
| 12 | Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is cirrhotic | Either: (a) LEDIPASVIR with SOFOSBUVIR for 24 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 24 weeks; or (g) GRAZOPREVIR with ELBASVIR for 12 weeks; or (h) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or (i) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (j) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or (k) GLECAPREVIR with PIBRENTASVIR for 16 weeks. |
| 13 | Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is cirrhotic | Either: (a) SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 12 weeks. |
| 14 | Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is cirrhotic | Either: (a) SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 12 weeks. |
| 15 | Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is cirrhotic | Either: (a) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (d) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (e) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (f) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (g) GLECAPREVIR with PIBRENTASVIR for 12 weeks. |
| 16 | Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is cirrhotic | Either: (a) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (d) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (e) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (f) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (g) GLECAPREVIR with PIBRENTASVIR for 16 weeks. |
| 17 | Patient: (a) with Genotype 4; and (b) who is treatment naïve; and (c) who is cirrhotic | Either: (a) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b) GRAZOPREVIR with ELBASVIR for 12 weeks; or (c) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (d) GLECAPREVIR with PIBRENTASVIR for 12 weeks. |
| 18 | Patient: (a) with Genotype 4; and (b) who is treatment experienced; and (c) who is cirrhotic | Either: (a) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b) GRAZOPREVIR with ELBASVIR for 12 weeks; or (c) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or (d) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (e) GLECAPREVIR with PIBRENTASVIR for 12 weeks. |
| 19 | Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment naïve; and (c) who is cirrhotic | Either: (a) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 12 weeks. |
| 20 | Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment experienced; and (c) who is cirrhotic | Either: (a) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 12 weeks. |
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