Source: https://www.global-regulation.com/law/australia/216689/national-health-%2528listing-of-pharmaceutical-benefits%2529-amendment-instrument-2015-%2528no.-1%2529-%2528pb-1-of-2015%2529.html
Timestamp: 2018-06-19 00:47:47
Document Index: 220661057

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1']

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 1) (PB 1 of 2015) (Australia)
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 1) (PB 1 of 2015)
Link to law: https://www.comlaw.gov.au/Details/F2015L00040
PB 1 of 2015
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 1).
(2) This Instrument may also be cited as PB 1 of 2015.
This Instrument commences on 1 February 2015.
[1] Schedule 1, entry for Anastrozole
Anastrozole FBM
[2] Schedule 1, entry for Arsenic
omit from the column headed “Circumstances”: C3150 C3891 substitute: C4793
[3] Schedule 1, entry for Baclofen in the form Tablet 10 mg
[4] Schedule 1, entry for Baclofen in the form Tablet 25 mg
[5] Schedule 1, entry for Bevacizumab in the form Solution for I.V. infusion 100 mg in 4 mL
(a) omit from the column headed “Circumstances”: C4585
(b) omit from the column headed “Circumstances”: C4588 C4589
(c) omit from the column headed “Circumstances”: C4597
[6] Schedule 1, entry for Bevacizumab in the form Solution for I.V. infusion 400 mg in 16 mL
omit from the column headed “Circumstances”: C4661
[8] Schedule 1, entry for Carmellose
Mouth spray containing carmellose sodium 10 mg per mL, 25 mL
C3636 C3637
Mouth spray containing carmellose sodium 10 mg per mL, 100 mL
[9] Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 100 mg in 20 mL
(a) omit from the column headed “Circumstances”: C2713 C2714 C2715 C3919 C3920 C3921
(b) omit from the column headed “Circumstances”: C4775
(c) omit from the column headed “Circumstances”: C4780
(d) insert in numerical order: C4785 C4788 C4794
(e) omit from the column headed “Purposes”: See Note 3
[10] Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 500 mg in 100 mL
[11] Schedule 1, entry for Chloramphenicol in the form Eye drops 5 mg per mL, 10 mL
AO MP NP MW
[12] Schedule 1, omit entry for Cidofovir
[13] Schedule 1, entry for Clopidogrel with aspirin
Clopidogrel/ Aspirin Actavis 75/100
C1722 C3219 C3880
[14] Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
omit from the column headed “Circumstances” (twice occurring): C1568 C1795 C1796 C3905 C3910 C3911
substitute: C4786 C4787 C4791
[15] Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL
[16] Schedule 1, entry for Hypromellose
Oral gel 20 mg per g, 100 g
Aquae Gel
[17] Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 1.5 mg (sustained release)
Odaplix SR
[18] Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL
(a) omit from the column headed “Circumstances”: C4235 C4236
(b) omit from the column headed “Circumstances”: C4256
(c) omit from the column headed “Circumstances”: C4265
(d) omit from the column headed “Purposes”: See Note 3
[19] Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 200 mg in 40 mL
[20] Schedule 1, entry for Irbesartan in the form Tablet 150 mg
Irbesartan Actavis 150
[21] Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg
Irbesartan HCT Actavis 300/12.5
[22] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
Irinotecan MYX
[23] Schedule 1, entry for Isotretinoin in the form Capsule 20 mg
[24] Schedule 1, entry for Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL [Maximum Quantity: 3; Number of Repeats: 0]
[25] Schedule 1, entry for Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL [Maximum Quantity: 3; Number of Repeats: 3]
[26] Schedule 1, entry for Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL [Maximum Quantity: 1; Number of Repeats: 5]
[27] Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 1]
[28] Schedule 1, entry for Lansoprazole in the form Tablet 15 mg (orally disintegrating)
C1337 C1533
[29] Schedule 1, entry for Letrozole
Letrozole FBM
[30] Schedule 1, entry for Lignocaine
Injection containing lignocaine hydrochloride 50 mg in 5 mL
D(NP)
[31] Schedule 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 10 mg
Medroxyprogest-erone Sandoz
[32] Schedule 1, entry for Meloxicam in each of the forms: Capsule 7.5 mg; and Capsule 15 mg
C1547 C1848
[33] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
GenRx Metformin
[34] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
[35] Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial
Methotrexate MYX
[36] Schedule 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
[37] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
[38] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
[39] Schedule 1, after entry for Mifepristone
MS-2 Step
[40] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
Oxaliplatin MYX
[41] Schedule 1, entry for Panitumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 400 mg in 20 mL
omit from the column headed “Circumstances”: C4774 C4776
[42] Schedule 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium heptahydrate); and Powder for
I.V. infusion 500 mg (as disodium heptahydrate)
omit from the column headed “Circumstances”: C2957 C2958 C3885 C3886 substitute: C4789 C4792
[43] Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
[44] Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
[45] Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)
[46] Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 100 mg in 10 mL
(a) omit from the column headed “Circumstances”: C4671
(b) omit from the column headed “Circumstances”: C4679
(c) omit from the column headed “Circumstances”: C4687
(d) omit from the column headed “Circumstances”: C4727 C4728 C4752 C4765
[47] Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL
[48] Schedule 1, omit entry for Ticlopidine
[49] Schedule 3, after details relevant to Responsible Person code FM
For Benefit Medicines Pty Ltd
56 155 126 346
[50] Schedule 4, Part 1, entry for Arsenic
Induction and consolidation treatment
The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript; AND
The condition must be relapsed; AND
Patient must be arsenic naive at induction
Compliance with Authority Required procedures – Streamlined Authority Code 4793
[51] Schedule 4, Part 1, entry for Bevacizumab
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4584:
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4587:
The treatment must be in combination with first-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks
(e) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4594:
(f) omit:
Patient must have a WHO performance status of 0 or 1; AND
(g) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4598:
[52] Schedule 4, Part 1, entry for Cabazitaxel
(b) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4662:
[53] Schedule 4, Part 1, entry for Carmellose
Initial supply, for up to 4 months, for a palliative care patient where dry mouth is a symptom
Compliance with Authority Required procedures – Streamlined Authority Code 3636
Continuing supply for a palliative care patient where dry mouth is a symptom
Compliance with Authority Required procedures – Streamlined Authority Code 3637
[54] Schedule 4, Part 1, entry for Cetuximab
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration‑approved Product Information
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated
Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated
Compliance with Authority Required procedures – Streamlined Authority Code 3919
Compliance with Authority Required procedures – Streamlined Authority Code 3920
Compliance with Authority Required procedures – Streamlined Authority Code 3921
(b) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4771:
Patient must have RAS wild-type metastatic colorectal cancer; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
(d) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4779:
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
(f) insert in numerical order following existing text:
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx
The treatment must be in combination with radiotherapy; AND
Patient must be unable to tolerate cisplatin
Compliance with Authority Required procedures - Streamlined Authority Code 4785
Patient must be unable to tolerate cisplatin; OR
Patient must have a contraindication to cisplatin according to the TGA-approved Product Information
Compliance with Authority Required procedures - Streamlined Authority Code 4788
The treatment must be for the week prior to radiotherapy; AND
Compliance with Authority Required procedures - Streamlined Authority Code 4794
[55] Schedule 4, Part 1, omit entry for Cidofovir
[56] Schedule 4, Part 1, entry for Doxorubicin – Pegylated Liposomal
Advanced epithelial ovarian cancer in women who have failed a first‑line platinum‑based chemotherapy regimen
Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane
Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated
Compliance with Authority Required procedures – Streamlined Authority Code 3905
Compliance with Authority Required procedures – Streamlined Authority Code 3910
Compliance with Authority Required procedures – Streamlined Authority Code 3911
Patient must have failed a first-line platinum-based chemotherapy regimen
Compliance with Authority Required procedures - Streamlined Authority Code 4786
C4787
Patient must have a contraindication to therapy with capecitabine and/or a taxane
Compliance with Authority Required procedures - Streamlined Authority Code 4787
Patient must have failed prior therapy which included capecitabine and a taxane
Compliance with Authority Required procedures - Streamlined Authority Code 4791
[57] Schedule 4, Part 1, entry for Hypromellose
[58] Schedule 4, Part 1, entry for Ipilimumab
Unresectable Stage III or Stage IV malignant melanoma
Patient must not have received prior treatment with ipilimumab;
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks
The patient’s body weight must be documented in the patient’s medical records at the time treatment is initiated
Re‑induction treatment
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re‑induction);
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response
The patient’s body weight must be documented in the patient’s medical records at the time treatment with ipilimumab is initiated
Completion of re‑induction treatment
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re‑induction) received prior to 1 August 2013;
The treatment must be for completion of re‑induction treatment in a patient who commenced re‑induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS‑subsidised and non‑PBS‑subsidised) at a maximum dose of 3 mg per kg every 3 weeks
For patients who commenced re‑induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a maximum of 4 doses of ipilimumab (combined PBS‑subsidised and non‑PBS‑subsidised)
Completion of induction treatment
The treatment must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013;
For patients who commenced induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a total of 4 doses of ipilimumab (combined PBS‑subsidised and non‑PBS subsidised)
[59] Schedule 4, Part 1, after entry for Mifepristone
The condition must be an intra-uterine pregnancy of up to 63 days of gestation
Must be treated by a prescriber who is registered with the MS 2 Step Prescribing Program
[60] Schedule 4, Part 1, entry for Panitumumab
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab
(b) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4783 and C4784:
[61] Schedule 4, Part 1, entry for Pemetrexed
The treatment must be in combination with cisplatin
The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated
Doses greater than 500 mg per metre squared BSA are not PBS-subsidised
Compliance with Authority Required procedures - Streamlined Authority Code 4789
Patient must have received prior treatment with platinum-based chemotherapy
Compliance with Authority Required procedures - Streamlined Authority Code 4792
[62] Schedule 4, Part 1, entry for Rituximab
The treatment must be in combination with chemotherapy
(b) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4674, C4677 and C4678:
Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction
(d) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4686:
C4687
Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
The treatment must be in combination with chemotherapy; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses under this restriction
(f) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4706 and C4726:
(g) omit:
Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma
Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction
Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Re-induction treatment
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses under this restriction
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma
[63] Schedule 4, Part 1, omit entry for Ticlopidine