National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 11) (PB 101 of 2017) (Cth)

PB 101 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 11)

National Health Act 1953

I, JULIANNE QUAINE, First Assistant Secretary (Acting), Technology Assessment and Access 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 13 December 2017

JULIANNE QUAINE

First Assistant Secretary (Acting)

Technology Assessment and Access Division

Department of Health

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2017 (No. 11).

(2)        This Instrument may also be cited as PB 101 of 2017.

2          Commencement

This Instrument commences on 1 January 2018.

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, after entry for Albendazole in the form Tablet 400 mg

insert:

Alectinib Capsule 150 mg Oral Alecensa RO MP C7345 C7346 C7353 224 1 224

[2]       Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine

omit:

Sachets containing oral powder 18.2 g, 60 (add-ins) Oral add-ins SB MP NP C4295 3 5 1

[3]       Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg

(a)insert in the column headed “Schedule Equivalent” for all brands:             a

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

a APO-Amiodarone TX MP NP C5665 30 5 30

[4]Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats: 0]

omit:

Augmentin AS PDP C5833 C5894 1 0 1

[5]Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats: 1]

omit:

Augmentin AS MP NP C5832 C5893 1 1 1

[6]       Schedule 1, entry for Atenolol in the form Tablet 50 mg

omit:

a Atenolol RBX RA MP NP 30 5 30

[7]       Schedule 1, after entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL [Brand: Hospira Pty Limited]

insert:

Carfilzomib	Powder for injection 30 mg	Injection	Kyprolis	AN	MP	C7344 C7348 C7355	See Note 3	See Note 3	1	D(100)
Powder for injection 60 mg	Injection	Kyprolis	AN	MP	C7344 C7348 C7355	See Note 3	See Note 3	1	D(100)

[8]       Schedule 1, entry for Cephalexin in form Capsule 250 mg (anhydrous)

(a)omit:

Ialex LN PDP 20 0 20

(b)omit:

Ialex LN MP NP MW 20 1 20

(c)omit:

a Ialex LN MP P4243 40 CN4243 2
CN4243 20

[9]       Schedule 1, entry for Cephalexin in form Capsule 500 mg (anhydrous)

(a)omit:

Ialex LN PDP 20 0 20

(b)omit:

Ialex LN MP NP MW 20 1 20

(c)omit:

a Ialex LN MP P6188 40
CN6188 1
CN6188 20

[10]Schedule 1, entry for Cephalexin in each of the forms: Granules for oral suspension 125 mg per 5 mL, 100 mL; and Granules for oral suspension 250 mg per 5 mL, 100 mL

(a)omit:

Ialex LN PDP 1 0 1

(b)omit:

Ialex LN MP NP 1 1 1

[11]      Schedule 1, entry for Ceritinib

omit from the column headed “Circumstances”:          C6824

insert in numerical order in the column headed “Circumstances”:         C7369

[12]      Schedule 1, entry for Codeine with Paracetamol

(a)insert in the column headed “Schedule Equivalent” for all brands:             a

(b)omit from the column headed “Brand”(twice occurring):               Codapane Forte            substitute:             Codapane Forte 500/30

[13]      Schedule 1, entry for Crizotinib in each of the forms: Capsule 200 mg; and Capsule 250 mg

omit from the column headed “Circumstances”:          C6981

insert in numerical order in the column headed “Circumstances”:         C7359

[14]      Schedule 1, entry for Cromoglycic Acid

omit:

Eye drops containing sodium cromoglycate 20 mg per mL, 10 mL Application to the eye Opticrom SW MP NP AO C6088 1 5 1

[15]Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50; Number of Repeats: 0]

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

a Pharmacor Diclofenac 50 CR PDP C6256 C6282 50 0 50

[16]Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50; Number of Repeats: 3]

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

a Pharmacor Diclofenac 50 CR MP NP C6149 C6214  C6283 50 3 50

[17]      Schedule 1, entry for Docetaxel

omit:

Solution concentrate for I.V. infusion 140 mg in 7 mL Injection Oncotaxel 140 EA MP See Note 3 See
Note 3 1 D(100)

[18]Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 1]

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

Esomeprazole SZ HX MP NP C4988 C5029 C5030 C5039 P4988 30 1 30

[19]Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 5]

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

Esomeprazole SZ HX MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30

[20]Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 1]

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

Esomeprazole SZ HX MP NP C5011 C5021 C5028 P5028 30 1 30

[21]Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 5]

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

Esomeprazole SZ HX MP NP C5011 C5021 C5028 P5011 P5021 30 5 30

[22]      Schedule 1, entry for Gemcitabine

omit:

Powder for I.V. infusion 2 g (as hydrochloride) Injection Gemcitabine Actavis 2000 EA MP See Note 3 See
Note 3 1 D(100)

[23]      Schedule 1, entry for Hydroxychloroquine in the form Tablet containing hydroxychloroquine sulfate 200 mg

(a)omit:

a Chem mart Hydroxychloroquine CH MP NP 100 1 100

(b)omit:

a Terry White Chemists Hydroxychloroquine TW MP NP 100 1 100

[24]      Schedule 1, entry for Irinotecan

omit:

I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL Injection Irinotecan Ebewe SZ MP See Note 3 See
Note 3 1 D(100)

[25]Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg

omit:

a Lamidus RA MP NP C5138 56 5 56

[26]      Schedule 1, entry for Levetiracetam in the form Tablet 250 mg

omit from the column headed “Brand”:         Kevtam substitute:             Kevtam 250

[27]      Schedule 1, entry for Levetiracetam in the form Tablet 500 mg

omit from the column headed “Brand”:         Kevtam substitute:             Kevtam 500

[28]      Schedule 1, entry for Mannitol

omit from the column headed “Circumstances”:          C5658 C5799                 substitute:             C7349 C7362 C7364 C7367

[29]      Schedule 1, entry for Memantine in the form Tablet containing memantine hydrochloride 10 mg

omit:

Memantine RBX RA MP NP C4214 C4218 C4221 56 5 56

[30]      Schedule 1, entry for Memantine in the form Tablet containing memantine hydrochloride 20 mg

omit:

Memantine RBX RA MP NP C4214 C4218 C4221 28 5 28

[31]      Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

omit:

a Metformin Ranbaxy RA MP NP 100 5 100

[32]Schedule 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besylate)

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

a APO-Olmesartan/ Amlodipine 20/5 TX MP NP C4373 30 5 30

[33]Schedule 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate)

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

a APO-Olmesartan/ Amlodipine 40/5 TX MP NP C4373 30 5 30

[34]Schedule 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate)

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

a APO-Olmesartan/ Amlodipine 40/10 TX MP NP C4373 30 5 30

[35]      Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 1]

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

Pharmacor Omeprazole CR MP NP C4074 C4075 C4089 C4152 P4074 30 1 30

[36]      Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Pharmacor Omeprazole CR MP NP C4074 C4075 C4089 C4152 P4075 P4089 P4152 30 5 30

[37]      Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a	Pharmacor Rosuvastatin 5	CR	MP	C4225 C4226 C4238 C4263	P4226 P4263	30	5	30
NP	C4226 C4263	30	5	30

[38]      Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a Pharmacor Rosuvastatin 5 CR MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

[39]      Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a	Pharmacor Rosuvastatin 10	CR	MP	C4225 C4226 C4238 C4263	P4226 P4263	30	5	30
NP	C4226 C4263	30	5	30

[40]      Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a Pharmacor Rosuvastatin 10 CR MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

[41]      Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a	Pharmacor Rosuvastatin 20	CR	MP	C4225 C4226 C4238 C4263	P4226 P4263	30	5	30
NP	C4226 C4263	30	5	30

[42]      Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a Pharmacor Rosuvastatin 20 CR MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

[43]      Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a	Pharmacor Rosuvastatin 40	CR	MP	C4225 C4226 C4238 C4263	P4226 P4263	30	5	30
NP	C4226 C4263	30	5	30

[44]      Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a Pharmacor Rosuvastatin 40 CR MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

[45]      Schedule 1, entry for Testosterone

omit:

Transdermal solution (pump pack) 30 mg per 1.5 mL dose, 60 doses Transdermal Axiron LY MP C6324 C6910 C6919 C6933 C6934 1 5 1

[46]      Schedule 1, entry for Valproic Acid in the form Tablet (enteric coated) containing sodium valproate 200 mg

(a)insert in the column headed “Schedule Equivalent” for all brands:             a

(b)omit from the column headed “Brand”:               Valpro 200        substitute:             Valpro EC 200

[47]      Schedule 1, entry for Valproic Acid in the form Tablet (enteric coated) containing sodium valproate 500 mg

(a)insert in the column headed “Schedule Equivalent” for all brands:             a

(b)omit from the column headed “Brand”:               Valpro 500        substitute:             Valpro EC 500

[48]      Schedule 3

omit:

JJ Johnson & Johnson Medical Pty Ltd  85 000 160 403

[49]      Schedule 4, Part 1, after the entry for Albendazole

insert:

Alectinib	C7345	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less. Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.	Compliance with Authority Required procedures
C7346	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
C7353	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 January 2018; AND The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must not have progressive disease while receiving treatment with this drug for this condition. Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures

[50]      Schedule 4, Part 1, after entry for Carbomer 974

insert:

Carfilzomib	C7344	Multiple myeloma Grandfathering Patient must have received treatment with this drug for this condition prior to 1 January 2018; AND Patient must have a documented histological diagnosis; AND The treatment must be in combination with dexamethasone; AND Patient must have had documented progressive disease after at least one prior therapy prior to commencing non-PBS subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must have undergone or be ineligible for a stem cell transplant; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND Patient must not receive more than three cycles of treatment under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures
C7348	Multiple myeloma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with dexamethasone; AND Patient must not develop disease progression while receiving treatment with this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
C7355	Multiple myeloma Initial treatment The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a stem cell transplant; AND Patient must not have previously received this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND Patient must not receive more than three cycles of treatment under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures

[51]      Schedule 4, Part 1, entry for Ceritinib

omit:

C6824 Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease. Compliance with Authority Required procedures

insert in numerical order after existing text:

C7369 Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition. Compliance with Authority Required procedures

[52]      Schedule 4, Part 1, entry for Crizotinib

omit:

C6981 Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease. Compliance with Authority Required procedures

insert in numerical order after existing text:

C7359 Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition. Compliance with Authority Required procedures

[53]      Schedule 4, Part 1, omit entry for Cromoglycic acid

[54]      Schedule 4, Part 1, entry for Mannitol

substitute:

Mannitol	C7349	Cystic fibrosis The treatment must be as monotherapy; AND Patient must be intolerant or inadequately responsive to dornase alfa. Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures
C7362	Cystic fibrosis The treatment must be as monotherapy; AND Patient must be intolerant or inadequately responsive to dornase alfa. Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 7362
C7364	Cystic fibrosis The treatment must be in combination with dornase alfa; AND Patient must be inadequately responsive to dornase alfa; AND Patient must have trialled hypertonic saline for this condition. Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures
C7367	Cystic fibrosis The treatment must be in combination with dornase alfa; AND Patient must be inadequately responsive to dornase alfa; AND Patient must have trialled hypertonic saline for this condition. Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 7367

[55]Schedule 5, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [GRP-17188]

insert in alphabetical order in the column headed “Brand”:   Esomeprazole SZ

[56]Schedule 5, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [GRP-17061]

insert in alphabetical order in the column headed “Brand”:   Esomeprazole SZ

[57]Schedule 5, after entry for Olanzapine [GRP-15723]

insert:

Omeprazole	GRP-14650	Capsule 20 mg	Oral	Maxor Probitor APO-Omeprazole Pemzo Pharmacor Omeprazole 20 Omeprazole Sandoz
Tablet 20 mg	Oral	Meprazol Chem mart Omeprazole Terry White Chemists Omeprazole Omeprazole AN APO-Omeprazole Ozmep Omeprazole generichealth Pharmacor Omeprazole
Tablet 20 mg (as magnesium)	Oral	Omepral Losec Tablets Acimax Tablets Omeprazole Sandoz