National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 1) (PB 3 of 2019) (Cth)
PB 3 of 2019
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (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 2019
BEN SLADIC
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 2019 (No. 1).
(2)This Instrument may also be cited as PB 3 of 2019.
Commencement
This Instrument commences on 1 February 2019.
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
Part 1, Division 1, Section 4, definition for ‘eligible medical practitioner’, paragraph (c)(ii)
omit:
Paritaprevir with ritonavir with ombitasvir and dasabuvir, Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin,
Schedule 1, entry for Benralizumab [Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8213 substitute: C8499
(b)omit from the column headed “Purposes”: P8213 substitute: P8499
Schedule 1, entry for Benralizumab [Maximum Quantity: 1; Number of Repeats: 4]
omit from the column headed “Circumstances”: C8213 substitute: C8499
Schedule 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Bosentan APO | GX | EMP | C4628 C6089 C6710 C6734 C6748 C6764 C6776 | See Note 1 | See Note 2 | D |
Schedule 1, entry for Bosentan in the form Tablet 125 mg (as monohydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Bosentan APO | GX | EMP | C6089 C6710 C6734 C6748 C6764 C6776 | See Note 1 | See Note 2 | D |
Schedule 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed “Purposes”: P7372 P7384
(f)omit from the column headed “Purposes”: P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed “Purposes”: P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed “Purposes”: P7372 P7384
(f)omit from the column headed “Purposes”: P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed “Purposes”: P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed “Purposes”: P7372 P7384
(f)omit from the column headed “Purposes”: P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed “Purposes”: P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 125 mg [Maximum Quantity: 168; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed “Purposes”: P7372 P7384
(f)omit from the column headed “Purposes”: P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed “Purposes”: P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 125 mg [Maximum Quantity: 168; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 250 mg [Maximum Quantity: 168; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed “Purposes”: P7372 P7384
(f)omit from the column headed “Purposes”: P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed “Purposes”: P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 250 mg [Maximum Quantity: 168; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 500 mg [Maximum Quantity: 168; Number of Repeats: 2]
(a) omit from the column headed “Circumstances”: C7372
(b) omit from the column headed “Circumstances”: C7384
(c) omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d) insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
(e) omit from the column headed “Purposes”: P7372 P7384
(f) omit from the column headed “Purposes”: P7395 P7455 P7469 P7480
(g) insert in numerical order in the column headed “Purposes”: P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 500 mg [Maximum Quantity: 168; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7372
(b)omit from the column headed “Circumstances”: C7384
(c)omit from the column headed “Circumstances”: C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed “Circumstances”: C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Infliximab
(a)omit from the column headed “Circumstances” for the brand “Remicade”: C8272
(b)insert in numerical order in the column headed “Circumstances” for the brand “Remicade”:C8325
Schedule 1, omit entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir
Schedule 1, omit entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin
Schedule 2, after details relevant to Responsible Person code GQ
insert:
| GX | Apotex Pty Ltd | 52 096 916 148 |
Schedule 3, entry for Benralizumab
(a)omit:
| C8213 | P8213 | Uncontrolled severe eosinophilic asthma Grandfathered 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 have received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2018; AND Patient must be receiving treatment with this drug for this condition at the time of application; AND 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 had, prior to commencement of non-PBS subsidised treatment with this drug, a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; AND Patient must have had blood eosinophil count greater than or equal to 300 cells per microlitre prior to commencement of non-PBS subsidised treatment with this drug; AND Patient must have had a duration of asthma of at least 1 year prior to commencement of non-PBS subsidised treatment with this drug; AND Patient must have failed to achieve adequate control with optimised asthma therapy prior to non-PBS subsidised treatment with this drug despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must have demonstrated an adequate response following at least 24 weeks of treatment of non‑PBS subsidised benralizumab for this condition; AND The treatment must not be used in combination with, or within 6 months of treatment with, PBS-subsidised omalizumab or mepolizumab. Patient must be aged 12 years or older. Optimised asthma therapy includes: (i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated; AND (ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, prior to commencing non-PBS subsidised treatment with this drug, unless contraindicated or not tolerated. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. An adequate response to benralizumab 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. A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. A review of the patient's records should be conducted to extract pre- and post-benralizumab data on symptoms, quality of life, medication doses, exacerbations and hospitalisations. Parameters to establish response are: (i) a reduction in Asthma Control Questionnaire (ACQ-5) score of at least 0.5; and/or (ii) maintenance oral corticosteroid dose reduced by at least 25% from baseline and no deterioration in ACQ 5 score from baseline. The assessment of the patient's response to the initial PBS-subsidised course of treatment under this restriction must be made at around 16 weeks after the first dose of PBS-subsidised treatment with 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 same parameters used to establish response to non-PBS subsidised therapy with this drug should be used for the assessment. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted 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 within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. Patients will be eligible to receive continuing courses of treatment with this drug of up to 24 weeks providing they continue to demonstrate an adequate response to treatment. A patient may qualify for PBS-subsidised treatment under this restriction once only. A patient who fails to respond to a course of PBS-subsidised benralizumab for the treatment of uncontrolled severe eosinophilic asthma will not be eligible to receive further PBS-subsidised treatment with benralizumab, omalizumab or mepolizumab within 6 months of the date on which treatment was ceased. At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for a continuing course of benralizumab 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; and (b) a completed Severe Eosinophilic Asthma Grandfather PBS Authority Application - Supporting Information Form, which includes the following: (i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and (ii) details of pre- and post-benralizumab data on symptoms, quality of life, medication doses, severe exacerbation/s and hospitalisations, and (c) a copy of the pre-benralizumab eosinophil pathology report; and (d) a completed Asthma Control Questionnaire (ACQ 5) calculation sheet including the date of assessment of the patient's symptoms; or details of maintenance oral corticosteroid dose. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C8499 | P8499 | Uncontrolled severe eosinophilic asthma Grandfathered 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 have received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2018; AND Patient must be receiving treatment with this drug for this condition at the time of application; AND 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 had, prior to commencement of non-PBS subsidised treatment with this drug, a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; AND Patient must have had blood eosinophil count greater than or equal to 300 cells per microlitre prior to commencement of non-PBS subsidised treatment with this drug; AND Patient must have had a duration of asthma of at least 1 year prior to commencement of non-PBS subsidised treatment with this drug; AND Patient must have failed to achieve adequate control with optimised asthma therapy prior to non-PBS subsidised treatment with this drug despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must have demonstrated an adequate response if the patient has received at least 24 weeks of treatment of non-PBS subsidised benralizumab for this condition; AND The treatment must not be used in combination with, or within 6 months of treatment with, PBS-subsidised omalizumab or mepolizumab. Patient must be aged 12 years or older. Optimised asthma therapy includes: (i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated; AND (ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, prior to commencing non-PBS subsidised treatment with this drug, unless contraindicated or not tolerated. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician. The Asthma Control Questionnaire (5 item version) assessment of the patient must be made at time of application for treatment (to establish baseline score) and again around 20 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 the first continuing therapy to be processed. This assessment at around 24 weeks, which will be used to determine eligibility for the first continuing treatment, must be submitted 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 within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. An adequate response to benralizumab 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. A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. A review of the patient's records should be conducted to extract pre- and post-benralizumab data on symptoms, quality of life, medication doses, exacerbations and hospitalisations. Parameters to establish response are: (i) a reduction in Asthma Control Questionnaire (ACQ-5) score of at least 0.5; and/or (ii) maintenance oral corticosteroid dose reduced by at least 25% from baseline and no deterioration in ACQ 5 score from baseline. The assessment of the patient's response to the initial PBS-subsidised course of treatment under this restriction must be made at around 16 weeks after the first dose of PBS-subsidised treatment with 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 same parameters used to establish response to non-PBS subsidised therapy with this drug should be used for the assessment. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted 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 within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. Patients will be eligible to receive continuing courses of treatment with this drug of up to 24 weeks providing they continue to demonstrate an adequate response to treatment. A patient may qualify for PBS-subsidised treatment under this restriction once only. A patient who fails to respond to a course of PBS-subsidised benralizumab for the treatment of uncontrolled severe eosinophilic asthma will not be eligible to receive further PBS-subsidised treatment with benralizumab, omalizumab or mepolizumab within 6 months of the date on which treatment was ceased. At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for a continuing course of benralizumab 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; and (b) a completed Severe Eosinophilic Asthma Grandfather PBS Authority Application - Supporting Information Form, which includes the following: (i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and (ii) details of pre- and post-benralizumab data on symptoms, quality of life, medication doses, severe exacerbation/s and hospitalisations, and (c) a copy of the pre-benralizumab eosinophil pathology report; and (d) a completed Asthma Control Questionnaire (ACQ 5) calculation sheet including the date of assessment of the patient's symptoms; or details of maintenance oral corticosteroid dose. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Deferasirox
(a)omit:
| C7372 | P7372 | Chronic iron overload Continuing treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 7372 |
(b)omit:
| C7384 | P7384 | Chronic iron overload Continuing treatment Patient must be transfusion dependent; AND Patient must not have a malignant disorder of erythropoiesis; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 7384 |
(c)omit:
| C7395 | P7395 | Chronic iron overload Continuing treatment Patient must be red blood cell transfusion dependent; AND Patient must have a malignant disorder of haemopoieisis; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 7395 |
| C7455 | P7455 | Chronic iron overload Continuing treatment Patient must be red blood cell transfusion dependent; AND Patient must have a malignant disorder of haemopoieisis; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures |
| C7469 | P7469 | Chronic iron overload Continuing treatment Patient must be transfusion dependent; AND Patient must not have a malignant disorder of erythropoiesis; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures |
| C7480 | P7480 | Chronic iron overload Continuing treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures |
(d)insert in numerical order after existing text:
| C8326 | P8326 | Chronic iron overload Continuing treatment Patient must be red blood cell transfusion dependent; AND Patient must have a malignant disorder of haemopoieisis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 8326 |
| C8328 | P8328 | Chronic iron overload Continuing treatment Patient must be transfusion dependent; AND Patient must not have a malignant disorder of erythropoiesis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 8328 |
| C8329 | P8329 | Chronic iron overload Continuing treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 8329 |
| C8444 | P8444 | Chronic iron overload Continuing treatment Patient must be transfusion dependent; AND Patient must not have a malignant disorder of erythropoiesis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures |
| C8445 | P8445 | Chronic iron overload Continuing treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures |
| C8446 | P8446 | Chronic iron overload Continuing treatment Patient must be red blood cell transfusion dependent; AND Patient must have a malignant disorder of haemopoieisis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures |
Schedule 3, entry for Infliximab
(a)omit:
| C8272 | Severe chronic plaque psoriasis Subsequent continuing treatment, Whole body Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have demonstrated an adequate response to treatment with this drug; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline values for this treatment cycle. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. The most recent PASI assessment must be no more than 1 month old at the time of application. The application for continuing treatment must be made following a minimum of 12 weeks of treatment with this drug. This assessment must be conducted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. 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 |
(b)insert in numerical order after existing text:
| C8325 | Severe chronic plaque psoriasis Subsequent continuing treatment, Whole body Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have demonstrated an adequate response to treatment with this drug; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline values for this treatment cycle. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. The most recent PASI assessment must be no more than 1 month old at the time of application. The application for continuing treatment must be made following a minimum of 12 weeks of treatment with this drug. This assessment must be conducted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. 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 |
Schedule 3, omit entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir
Schedule 3, omit entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin
Schedule 3, Part 1, Section 3, table at paragraph (2)
(a)omit from the column headed “Regimen” for item “1”:
(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
(b)omit from the column headed “Regimen” for item “2”:
(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
(c)omit from the column headed “Regimen” for item “11”:
(e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or
(d)omit from the column headed “Regimen” for item “12”:
(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
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0
0