National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 1) (PB 1 of 2015) (Cth)

Case

PB 1 of 2015

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 1)


National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 12th January 2015

FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health

1          Name of Instrument

(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.

2          Commencement

This Instrument commences on 1 February 2015.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1     Amendments

  1. Schedule 1, entry for Anastrozole

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

Anastrozole FBM FO MP NP C2213 30 5 30

  1. Schedule 1, entry for Arsenic

    omit from the column headed “Circumstances”:       C3150  C3891     substitute:             C4793 

  2. Schedule 1, entry for Baclofen in the form Tablet 10 mg

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

Chem mart Baclofen CH MP NP 100 5 100

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

GenRx Baclofen GX MP NP 100 5 100

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

Terry White Chemists Baclofen TW MP NP 100 5 100

  1. Schedule 1, entry for Baclofen in the form Tablet 25 mg

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

Chem mart Baclofen CH MP NP 100 5 100

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

GenRx Baclofen GX MP NP 100 5 100

  1. 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

  2. Schedule 1, entry for Bevacizumab in the form Solution for I.V. infusion 400 mg in 16 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

  3. Schedule 1, entry for Cabazitaxel

    omit from the column headed “Circumstances”:         C4661

  4. Schedule 1, entry for Carmellose

    omit:

Mouth spray containing carmellose sodium 10 mg per mL, 25 mL Oral application Aquae IA MP NP C3636 C3637 P3637 1 0 1
MP NP C3636 C3637 P3636 1 3 1
Mouth spray containing carmellose sodium 10 mg per mL, 100 mL Oral application Aquae IA MP NP C3636 C3637 P3637 1 0 1
MP NP C3636 C3637 P3636 1 3 1

  1. 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

  2. Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 500 mg in 100 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

  3. Schedule 1, entry for Chloramphenicol in the form Eye drops 5 mg per mL, 10 mL

    (a)omit:

Chloromycetin PF PDP 1 0 1

(b)omit:

Chloromycetin PF AO MP NP MW 1 2 1

  1. Schedule 1, omit entry for Cidofovir

  2. Schedule 1, entry for Clopidogrel with aspirin

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

Clopidogrel/ Aspirin Actavis 75/100 GN MP NP C1722 C3219 C3880 30 5 30

  1. 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

  2. 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

    omit from the column headed “Circumstances” (twice occurring):          C1568  C1795  C1796  C3905  C3910  C3911        

    substitute:              C4786  C4787  C4791

  3. Schedule 1, entry for Hypromellose

    omit:

Oral gel 20 mg per g, 100 g Oral application Aquae Gel IA MP NP C3636 C3637 P3637 1 0 1
MP NP C3636 C3637 P3636 1 3 1

  1. Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 1.5 mg (sustained release)

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

Odaplix SR AF MP NP 90 1 90

  1. 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

  2. Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 200 mg in 40 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

  3. Schedule 1, entry for Irbesartan in the form Tablet 150 mg

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

Irbesartan Actavis 150 UA MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg

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

Irbesartan HCT Actavis 300/12.5 UA MP NP C4374 30 5 30

  1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

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

Irinotecan MYX YN MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Isotretinoin in the form Capsule 20 mg

    omit:

GenRx Isotretinoin GX MP C1354 60 3 60

  1. 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]

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

Dulose FM MP NP C1150 C1613 C3642 C3643 P3643 3 0 1

  1. 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]

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

Dulose FM MP NP C1150 C1613 C3642 C3643 P3642 3 3 1

  1. 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]

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

Dulose FM MP NP C1150 C1613 C3642 C3643 P1150 P1613 1 5 1

  1. Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 1]

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

Lansoprazole ODT GH GQ MP NP C1177 28 1 28

  1. Schedule 1, entry for Lansoprazole in the form Tablet 15 mg (orally disintegrating)

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

Lansoprazole ODT GH GQ MP NP C1337 C1533 28 5 28

  1. Schedule 1, entry for Letrozole

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

Letrozole FBM FO MP NP C1608 C2691 C2692 30 5 30

  1. Schedule 1, entry for Lignocaine

    insert as first item in the columns in the order indicated:

Injection containing lignocaine hydrochloride 50 mg in 5 mL Injection Pfizer Australia Pty Ltd PF MP NP
See Note 4 		See Note 4 See Note 4 1 1 D(MP)
D(NP)

  1. Schedule 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 10 mg

    omit:

Medroxyprogest-erone Sandoz SZ MP NP 30 2 30

  1. Schedule 1, entry for Meloxicam in each of the forms: Capsule 7.5 mg; and Capsule 15 mg

    omit:

Meloxicam Sandoz SZ MP NP C1547 C1848 30 3 30

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

    omit:

GenRx Metformin GX MP NP 100 5 100

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

    omit:

GenRx Metformin GX MP NP 60 5 60

  1. Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial

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

Methotrexate MYX YN MP See Note 2 5
See Note 2 		5
See
Note 2 		1

  1. Schedule 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial

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

Methotrexate MYX YN MP See Note 3 See Note 3 See
Note 3 		1 PB(100)

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg

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

APO-Metoprolol TX MP NP 100 5 100

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg

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

APO-Metoprolol TX MP NP 60 5 60

  1. Schedule 1, after entry for Mifepristone

    insert:

Mifepristone and misoprostol Pack containing 1 tablet mifepristone 200 mg and 4 tablets misoprostol 200 micrograms Oral MS-2 Step XH MP C4790 1 0 1

  1. Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL

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

Oxaliplatin MYX YN MP See Note 3 See
Note 3 		1 D(100)

  1. 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

  2. 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

  3. Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

    omit:

Sequase PM MP NP C4385 C4391 C4396 60 0 60

  1. Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

    omit:

Sequase PM MP NP C1589 C2044 C2765 90 5 90

  1. Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)

    omit:

Sequase PM MP NP C1589 C2044 C2765 60 5 60

  1. 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

  2. Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 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

  3. Schedule 1, omit entry for Ticlopidine

  4. Schedule 3, after details relevant to Responsible Person code FM

    insert:

FO For Benefit Medicines Pty Ltd  56 155 126 346

  1. Schedule 4, Part 1, entry for Arsenic

    substitute:

Arsenic C4793

Acute promyelocytic leukaemia

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

  1. Schedule 4, Part 1, entry for Bevacizumab

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4584:

Where the patient is receiving treatment at/from a Public Hospital

(b)omit:

C4585

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Continuing treatment

Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer

 Compliance with Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4587:

Where the patient is receiving treatment at/from a Public Hospital

(d)omit:

C4588

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Metastatic colorectal cancer
Continuing treatment

Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
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

 Compliance with Authority Required procedures
C4589

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Initial treatment

The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm); AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer

The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated

 Compliance with Authority Required procedures

(e)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4594:

Where the patient is receiving treatment at/from a Public Hospital

(f)omit:

C4597

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Metastatic colorectal cancer
Initial treatment

The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
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

 Compliance with Authority Required procedures

(g)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4598:

Where the patient is receiving treatment at/from a Public Hospital

  1. Schedule 4, Part 1, entry for Cabazitaxel

    (a)omit:

C4661

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Castration resistant metastatic carcinoma of the prostate

The treatment must be in combination with prednisone or prednisolone; AND
The treatment must not be used in combination with abiraterone; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel

 Compliance with Authority Required procedures

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4662:

Where the patient is receiving treatment at/from a Public Hospital

  1. Schedule 4, Part 1, entry for Carmellose

    omit:

C3636 P3636 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
C3637 P3637 Continuing supply for a palliative care patient where dry mouth is a symptom Compliance with Authority Required procedures – Streamlined Authority Code 3637

  1. Schedule 4, Part 1, entry for Cetuximab

    (a)omit:

C2713

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

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

 Compliance with Authority Required procedures
C2714

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

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

 Compliance with Authority Required procedures
C2715

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

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
C3919

Where the patient is receiving treatment at/from a Public Hospital

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

 Compliance with Authority Required procedures – Streamlined Authority Code 3919
C3920

Where the patient is receiving treatment at/from a Public Hospital

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

 Compliance with Authority Required procedures – Streamlined Authority Code 3920
C3921

Where the patient is receiving treatment at/from a Public Hospital

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 3921

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4771:

Where the patient is receiving treatment at/from a Public Hospital

(c)omit:

C4775

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Metastatic colorectal cancer
Initial treatment

Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; 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

 Compliance with Authority Required procedures

(d)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4779:

Where the patient is receiving treatment at/from a Public Hospital

(e)omit:

C4780

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Metastatic colorectal cancer
Continuing treatment

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
Patient must not have progressive disease; 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

 Compliance with Authority Required procedures

(f)insert in numerical order following existing text:

C4785

Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx

Initial treatment

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
C4788

Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx

Continuing treatment

The treatment must be in combination with radiotherapy; AND
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
C4794

Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx

Initial treatment

The treatment must be for the week prior to radiotherapy; AND
Patient must have a contraindication to cisplatin according to the TGA-approved Product Information

 Compliance with Authority Required procedures - Streamlined Authority Code 4794

  1. Schedule 4, Part 1, omit entry for Cidofovir

  1. Schedule 4, Part 1, entry for Doxorubicin – Pegylated Liposomal

    (a)omit:

C1568

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Advanced epithelial ovarian cancer in women who have failed a first‑line platinum‑based chemotherapy regimen

 Compliance with Authority Required procedures
C1795

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane

 Compliance with Authority Required procedures
C1796

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated

 Compliance with Authority Required procedures

(b)omit:

C3905

Where the patient is receiving treatment at/from a Public Hospital

Advanced epithelial ovarian cancer in women who have failed a first‑line platinum‑based chemotherapy regimen

 Compliance with Authority Required procedures – Streamlined Authority Code 3905
C3910

Where the patient is receiving treatment at/from a Public Hospital

Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane

 Compliance with Authority Required procedures – Streamlined Authority Code 3910
C3911

Where the patient is receiving treatment at/from a Public Hospital

Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated

 Compliance with Authority Required procedures – Streamlined Authority Code 3911

(c)insert in numerical order following existing text:

C4786

Advanced epithelial ovarian cancer

Patient must have failed a first-line platinum-based chemotherapy regimen

 Compliance with Authority Required procedures - Streamlined Authority Code 4786
C4787

Metastatic breast cancer

The treatment must be as monotherapy; AND
Patient must have a contraindication to therapy with capecitabine and/or a taxane

 Compliance with Authority Required procedures - Streamlined Authority Code 4787
C4791

Metastatic breast cancer

The treatment must be as monotherapy; AND
Patient must have failed prior therapy which included capecitabine and a taxane

 Compliance with Authority Required procedures - Streamlined Authority Code 4791

  1. Schedule 4, Part 1, entry for Hypromellose

    omit:

C3636 P3636 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
C3637 P3637 Continuing supply for a palliative care patient where dry mouth is a symptom Compliance with Authority Required procedures – Streamlined Authority Code 3637

  1. Schedule 4, Part 1, entry for Ipilimumab

    (a)omit:

C4235

Unresectable Stage III or Stage IV malignant melanoma

Induction treatment

The treatment must be as monotherapy;
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

 Compliance with Authority Required procedures
C4236

Unresectable Stage III or Stage IV malignant melanoma

Re‑induction treatment

The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re‑induction);
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks

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

 Compliance with Authority Required procedures

(b)omit:

C4256

Unresectable Stage III or Stage IV malignant melanoma

Completion of re‑induction treatment

The treatment must be as monotherapy;
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

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

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)

 Compliance with Authority Required procedures

(c)omit:

C4265

Unresectable Stage III or Stage IV malignant melanoma

Completion of induction treatment

The treatment must be as monotherapy;
The treatment must be for completion of induction treatment in a patient who commenced 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

The patient’s body weight must be documented in the patient’s medical records at the time treatment is initiated

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)

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, after entry for Mifepristone

    insert:

Mifepristone and misoprostol C4790

Termination of an intra-uterine pregnancy

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

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Panitumumab

    (a)omit:

C4774

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Metastatic colorectal cancer
Continuing treatment

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
Patient must not have progressive disease; 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 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

 Compliance with Authority Required procedures
C4776

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Metastatic colorectal cancer
Initial treatment

Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; 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 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

 Compliance with Authority Required procedures

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4783 and C4784:

Where the patient is receiving treatment at/from a Public Hospital

  1. Schedule 4, Part 1, entry for Pemetrexed

    substitute:

Pemetrexed C4789

Mesothelioma

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
C4792

Locally advanced or metastatic non-small cell lung cancer

Patient must have received prior treatment with platinum-based chemotherapy

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 4792

  1. Schedule 4, Part 1, entry for Rituximab

    (a)omit:

C4671

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Chronic lymphocytic leukaemia (CLL)

The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
The treatment must be in combination with chemotherapy

 Compliance with Authority Required procedures

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4674, C4677 and C4678:

Where the patient is receiving treatment at/from a Public Hospital

(c)omit:

C4679

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

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

 Compliance with Authority Required procedures

(d)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4686:

Where the patient is receiving treatment at/from a Public Hospital

(e)omit:

C4687

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; 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

 Compliance with Authority Required procedures

(f)omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4706 and C4726:

Where the patient is receiving treatment at/from a Public Hospital

(g)omit:

C4727

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; 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

 Compliance with Authority Required procedures
C4728

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
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

 Compliance with Authority Required procedures
C4752

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

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

 Compliance with Authority Required procedures
C4765

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Relapsed or refractory low-grade 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

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Ticlopidine

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