COMMONWEALTH OF AUSTRALIA
Instrument number PB 63 of 2009
Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953
I, LINDA JACKSON, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.
Dated 6 July 2009
 
LINDA JACKSON
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
 
Amendment determination — pharmaceutical benefits
1              Commencement
                This instrument commences on 1 August 2009.
2              Amendment of PB 114 of 2008
                Schedule 1 amends PB 114 of 2008.
Schedule 1        Amendments
 
[1]               Part 1 of Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
in the column headed “Brand” insert in alphabetical order:
        APO-Amoxycillin/Clavulanic Acid 500/125
[2]               Part 1 of Schedule 1, item dealing with 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
in the column headed “Brand” insert in alphabetical order:
        Curam
[3]               Part 1 of Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL,
60 mL
in the column headed “Brand” insert in alphabetical order:
        Curam Duo
[4]               Part 1 of Schedule 1, after item dealing with Aripiprazole
insert in the columns in the order indicated:
 
Arsenic
Injection concentrate containing arsenic trioxide 10 mg in
10 mL
Injection
60
2
Phenasen
[5]               Part 1 of Schedule 1, item dealing with Azithromycin in the form Tablet 500 mg (as dihydrate)
in the column headed “Brand” insert in alphabetical order:
        Azithromycin Sandoz
[6]               Part 1 of Schedule 1, after item dealing with Bimatoprost
insert in the columns in the order indicated:
 
Bimatoprost with timolol
Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL
Application to the eye
1
5
Ganfort 0.3/5
[7]               Part 1 of Schedule 1, item dealing with Bisacodyl in the form Suppositories 10 mg, 12
omit from the column headed “Brand”:
Fleet Laxative Suppositories
[8]               Part 1 of Schedule 1, item dealing with Bisoprolol in the form Tablet containing bisoprolol fumarate 2.5 mg
(a) in the column headed “Brand” insert in alphabetical order:
        Bisoprolol Sandoz
(b) in the column headed “Brand” insert in alphabetical order:
        Bispro 2.5
[9]               Part 1 of Schedule 1, item dealing with Bisoprolol in the form Tablet containing bisoprolol fumarate 5 mg
(a) in the column headed “Brand” insert in alphabetical order:
        Bisoprolol Sandoz
(b) in the column headed “Brand” insert in alphabetical order:
        Bispro 5
[10]          Part 1 of Schedule 1, item dealing with Bisoprolol in the form Tablet containing bisoprolol fumarate 10 mg
(a) in the column headed “Brand” insert in alphabetical order:
        Bisoprolol Sandoz
(b) in the column headed “Brand” insert in alphabetical order:
        Bispro 10
[11]          Part 1 of Schedule 1, item dealing with Cabergoline in the form Tablet 500 micrograms
in the column headed “Brand” insert in alphabetical order:
        Tinexa
[12]          Part 1 of Schedule 1, item dealing with Cabergoline in the form Tablet 1 mg
in the column headed “Brand” insert in alphabetical order:
        Bergoline 1
[13]          Part 1 of Schedule 1, item dealing with Cabergoline in the form Tablet 2 mg
in the column headed “Brand” insert in alphabetical order:
        Bergoline 2
[14]          Part 1 of Schedule 1, item dealing with Chorionic Gonadotrophin
omit from the columns in the order indicated:
 
 
Injection set containing 3 ampoules powder for injection
500 units and 3 ampoules solvent 1 mL
Injection
1
5
Pregnyl
[15]          Part 1 of Schedule 1, item dealing with Citalopram in the form Tablet 20 mg (as hydrobromide)
in the column headed “Brand” insert in alphabetical order:
        APO-Citalopram
[16]          Part 1 of Schedule 1, item dealing with Clarithromycin in the form Tablet 250 mg
in the column headed “Brand” insert in alphabetical order:
        APO-Clarithromycin
[17]          Part 1 of Schedule 1, item dealing with Codeine with Paracetamol in the form Tablet containing codeine
phosphate 30 mg with paracetamol 500 mg
in the column headed “Brand” insert in alphabetical order:
        APO-Paracetamol/Codeine 500/30
[18]          Part 1 of Schedule 1, item dealing with Escitalopram in the form Tablet 10 mg (as oxalate)
in the column headed “Brand” insert in alphabetical order:
        Lexam 10
[19]          Part 1 of Schedule 1, item dealing with Escitalopram in the form Tablet 20 mg (as oxalate)
in the column headed “Brand” insert in alphabetical order:
        Lexam 20
[20]          Part 1 of Schedule 1, after item dealing with Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4
insert in the columns in the order indicated:
 
 
Injection 50 mg in 1 mL single use injection pen, 4
Injection
1
3
Enbrel
[21]          Part 1 of Schedule 1, after item dealing with Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL
insert in the columns in the order indicated:
 
 
Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL
Injection
4
2
Gemcitabine Ebewe
[22]          Part 1 of Schedule 1, item dealing with Glucose
insert as first entries in the columns in the order indicated:
 

 
I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL
Injection
5
1
B. Braun Australia Pty Ltd

 
I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
1
B. Braun Australia Pty Ltd
Pharmatel Fresenius Kabi Pty Limited

 
I.V. infusion 278 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
1
Pharmatel Fresenius Kabi Pty Limited

[23]          Part 1 of Schedule 1, item dealing with Glucose in the form I.V. infusion 278 mmol (anhydrous) per L, 1 L
in the column headed “Brand” insert in alphabetical order:
B. Braun Australia Pty Ltd
[24]          Part 1 of Schedule 1, after item dealing with Glucose Indicator―Blood in the form Electrode strips, 50
(MWD Pen Sensor Strips)
insert in the columns in the order indicated:
 
 
Electrode strips, 50 (MyGlucoHealth)
For external use
2
5
MyGlucoHealth
[25]          Part 1 of Schedule 1, item dealing with Glucose Indicator―Blood
omit from the columns in the order indicated:
 
 
Electrode strips, 100 (TrueSense)
For external use
1
5
TrueSense
[26]          Part 1 of Schedule 1, after item dealing with Hexamine
insert in the columns in the order indicated:
 
High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
Oral powder 300 g (KetoCal)
Oral
24
5
KetoCal
[27]          Part 1 of Schedule 1, item dealing with Insulin Lispro in the form Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5
omit from the column headed “Brand”:
Humalog Pen
and substitute:
Humalog KwikPen
[28]          Part 1 of Schedule 1, item dealing with Insulin Lispro with Insulin Lispro Protamine Suspension in the form Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5
omit from the column headed “Brand”:
Humalog Mix25 Pen
and substitute:
Humalog Mix25 KwikPen
[29]          Part 1 of Schedule 1, item dealing with Insulin Lispro with Insulin Lispro Protamine Suspension in the form Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5
omit from the column headed “Brand”:
Humalog Mix50 Pen
and substitute:
Humalog Mix50 KwikPen
[30]          Part 1 of Schedule 1, item dealing with Lisinopril in the form Tablet 20 mg
in the column headed “Brand” insert in alphabetical order:
Lisinopril Sandoz
[31]          Part 1 of Schedule 1, item dealing with Morphine in the form Tablet containing morphine sulfate 10 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 10
[32]          Part 1 of Schedule 1, item dealing with Morphine in the form Tablet containing morphine sulfate 30 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 30
[33]          Part 1 of Schedule 1, item dealing with Morphine in the form Tablet containing morphine sulfate 60 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 60
[34]          Part 1 of Schedule 1, item dealing with Morphine in the form Tablet containing morphine sulfate 100 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 100
[35]          Part 1 of Schedule 1, item dealing with Nifedipine in the forms Tablet 30 mg (controlled release) and Tablet 60 mg (controlled release)
in the column headed “Brand” insert in alphabetical order:
APO-Nifedipine XR
[36]          Part 1 of Schedule 1, after item dealing with Oxybutynin in the form Tablet containing oxybutynin hydrochloride
5 mg
insert in the columns in the order indicated:
 
 
Transdermal patches 36 mg, 8
Transdermal
1
5
Oxytrol
[37]          Part 1 of Schedule 1, item dealing with Paclitaxel in the forms Solution concentrate for I.V. infusion 30 mg in 5 mL, Solution concentrate for I.V. infusion 100 mg in 16.7 mL, Solution concentrate for I.V. infusion 150 mg in 25 mL and Solution concentrate for I.V. infusion 300 mg in 50 mL
in the column headed “Brand” insert in alphabetical order:
        Paclitaxel Actavis
[38]          Part 1 of Schedule 1, item dealing with Paracetamol in the form Tablet 500 mg
(a) in the column headed “Brand” insert in alphabetical order:
        APO-Paracetamol
(b) omit from the column headed “Brand”:
        Parmol
[39]          Part 1 of Schedule 1, item dealing with Paroxetine in the form Tablet 20 mg (as hydrochloride)
in the column headed “Brand” insert in alphabetical order:
        Paroxetine-GA
[40]          Part 1 of Schedule 1, after item dealing with Pravastatin
insert in the columns in the order indicated:
 
Praziquantel
Tablet 600 mg
Oral
8
. .
Biltricide
[41]          Part 1 of Schedule 1, item dealing with Ramipril in the forms Tablet 1.25 mg, Tablet 2.5 mg, Tablet 5 mg and
Tablet 10 mg
(a) in the column headed “Brand” insert in alphabetical order:
        APO-Ramipril
(b) in the column headed “Brand” insert in alphabetical order:
        Chem mart Ramipril
(c) in the column headed “Brand” insert in alphabetical order:
        Terry White Chemists Ramipril
[42]          Part 1 of Schedule 1, after item dealing with Rituximab
insert in the columns in the order indicated:
 

Rivaroxaban
Tablet 10 mg, 30
Oral
1
..
Xarelto

 
Tablet 10 mg
Oral
10
..
Xarelto

 
Tablet 10 mg, 15
Oral
1
..
Xarelto

[43]          Part 1 of Schedule 1, after item dealing with Sitagliptin
insert in the columns in the order indicated:
 

Sitagliptin with metformin
Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride
Oral
56
5
Janumet

 
Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride
Oral
56
5
Janumet

 
Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
Oral
56
5
Janumet

[44]          Part 1 of Schedule 1, after item dealing with Sodium Chloride in the form Injection 9 mg per mL, 10 mL
insert in the columns in the order indicated:
 

 
I.V. infusion 38.5 mmol per 250 mL, 250 mL
Injection
5
1
B. Braun Australia Pty Ltd

 
I.V. infusion 77 mmol per 500 mL, 500 mL
Injection
5
1
B. Braun Australia Pty Ltd
Pharmatel Fresenius Kabi Pty Limited

[45]          Part 1 of Schedule 1, item dealing with Sodium Chloride in the form I.V. infusion 154 mmol per L, 1 L
in the column headed “Brand” insert in alphabetical order:
B. Braun Australia Pty Ltd
[46]          Part 1 of Schedule 1, item dealing with Sodium Lactate Compound in the form I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride), 0.9 mmol calcium
(as chloride), 14 mmol bicarbonate (as lactate) and 56 mmol chloride per 500 mL, 500 mL
in the column headed “Brand” insert in alphabetical order:
Pharmatel Fresenius Kabi Pty Limited
[47]          Part 1 of Schedule 1, item dealing with Sodium Lactate Compound in the form I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium
(as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L
in the column headed “Brand” insert in alphabetical order:
B. Braun Australia Pty Ltd
[48]          Part 1 of Schedule 1, after item dealing with Sotalol
insert in the columns in the order indicated:
 
Soy lecithin
Eye spray 10 mg per mL, 10 mL
Application
2
5
tearsagain
[49]          Part 1 of Schedule 1, item dealing with Temazepam
in the column headed “Brand” insert in alphabetical order:
APO-Temazepam
[50]          Part 1 of Schedule 1, item dealing with Teriparatide
omit from the column headed “Form”:
3 mL
and substitute:
2.4 mL
[51]          Part 1 of Schedule 1, after item dealing with Voriconazole in the form Tablet 200 mg
insert in the columns in the order indicated:
 
 
Powder for oral suspension 40 mg per mL, 70 mL
Oral
1
. .
Vfend
[52]          Part 2 of Schedule 1, item dealing with Azithromycin
in the column headed “Brand” insert in alphabetical order:
        Azithromycin Sandoz
[53]          Part 2 of Schedule 1, item dealing with Cabergoline
in the column headed “Brand” insert in alphabetical order:
        Tinexa
[54]          Part 2 of Schedule 1, omit item dealing with Chorionic Gonadotrophin
[55]          Part 2 of Schedule 1, item dealing with Codeine with Paracetamol
in the column headed “Brand” insert in alphabetical order:
        APO-Paracetamol/Codeine 500/30
[56]          Part 2 of Schedule 1, item dealing with Escitalopram in the form Tablet 10 mg (as oxalate)
in the column headed “Brand” insert in alphabetical order:
        Lexam 10
[57]          Part 2 of Schedule 1, item dealing with Escitalopram in the form Tablet 20 mg (as oxalate)
in the column headed “Brand” insert in alphabetical order:
        Lexam 20
[58]          Part 2 of Schedule 1, item dealing with Etanercept
insert in the columns in the order indicated immediately after the last entry:
 

 
Injection 50 mg in 1 mL single use injection pen, 4
 
Ankylosing spondylitis
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
Injection
1
3
Enbrel

 
 
 
 
 
 
 

 
 
 
 (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
 
 
 
 

 
 
 
 (b) who has at least 2 of the following:
 
 
 
 

 
 
 
 (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
 
 
 
 

 
 
 
 (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
 
 
 
 

 
 
 
 (iii) limitation of chest expansion relative to normal values for age and gender; and
 
 
 
 

 
 
 
 (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
 
 
 
 

 
 
 
 (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response is demonstrated by:
 
 
 
 

 
 
 
 (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
 
 
 
 

 
 
 
 (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
 
 
 
 

 
 
 
 both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
 
 
 
 

 
 
 
 if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
 
 
 
 

 
 
 
 if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
 
 
 
 

 
 
 
 an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
 
 
 
 

 
 
 
 if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
 
 
 
 

 
 
 
 the application for authorisation includes:
 
 
 
 

 
 
 
 (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
 
 
 
 

 
 
 
 (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
 
 
 
 

 
 
 
 (ii) a completed BASDAI Assessment Form; and
 
 
 
 

 
 
 
 (iii) a signed patient acknowledgment form; and
 
 
 
 

 
 
 
 (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
 
 
 
 

 
 
 
 a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
Ankylosing spondylitis
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with etanercept; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;
 
 
 
 

 
 
 
 the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and
 
 
 
 

 
 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
 
 
 
 

 
 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
 
 
 
 

 
 
 
 if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
Injection 50 mg in 1 mL single use injection pen, 4
 
Ankylosing spondylitis
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and
Injection
1
5
Enbrel

 
 
 
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
 
 
 
 

 
 
 
 (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
 
 
 
 

 
 
 
 (c) an ESR or CRP measurement reduced by at least 20% from baseline;
 
 
 
 

 
 
 
 if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:
 
 
 
 

 
 
 
 (a) an ESR measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a CRP measurement no greater than 10 mg per L;
 
 
 
 

 
 
 
 all measurements provided are no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;
 
 
 
 

 
 
 
 patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
 
 
 
 

 
 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
Injection 50 mg in 1 mL single use injection pen, 4
 
Psoriatic arthritis
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
Injection
1
3
Enbrel

 
 
 
 
 
 
 

 
 
 
 (1) have severe active psoriatic arthritis; and
 
 
 
 

 
 
 
 (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
 
 
 
 

 
 
 
 (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and
 
 
 
 

 
 
 
 (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;
 
 
 
 

 
 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
Psoriatic arthritis
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
 
 
 
 

 
 
 
 (1) have a documented history of severe active psoriatic arthritis; and
 
 
 
 

 
 
 
 (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and
 
 
 
 

 
 
 
 (3) have not failed treatment with etanercept during the current Treatment Cycle; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
 
 
 
 

 
 
 
 patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and
 
 
 
 

 
 
 
 (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
 
 
 
 

 
 
 
 (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
Injection 50 mg in 1 mL single use injection pen, 4
 
Psoriatic arthritis
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who:
Injection
1
5
Enbrel

 
 
 
 
 
 
 

 
 
 
 (1) have a documented history of severe active psoriatic arthritis; and
 
 
 
 

 
 
 
 (2) were receiving treatment with etanercept prior to 17 March 2005; and
 
 
 
 

 
 
 
 (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and
 
 
 
 

 
 
 
 (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment;
 
 
 
 

 
 
 
 patients are eligible for PBS-subsidised treatment under the above criteria once only
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
Psoriatic arthritis
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
 
 
 
 

 
 
 
 (1) who have a documented history of severe active psoriatic arthritis; and
 
 
 
 

 
 
 
 (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and
 
 
 
 

 
 
 
 (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
Injection 50 mg in 1 mL single use injection pen, 4
 
Rheumatoid arthritis
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
Injection
1
3
Enbrel

 
 
 
 
 
 
 

 
 
 
 (a) have severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and
 
 
 
 

 
 
 
 (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and
 
 
 
 

 
 
 
 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;
 
 
 
 

 
 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
Rheumatoid arthritis
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
 
 
 
 

 
 
 
 (a) have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and
 
 
 
 

 
 
 
 (c) have not failed previous PBS-subsidised treatment with etanercept during this Treatment Cycle; and
 
 
 
 

 
 
 
 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;
 
 
 
 

 
 
 
 patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle;
 
 
 
 

 
 
 
 patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised etanercept treatment; and
 
 
 
 

 
 
 
 (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
 
 
 
 

 
 
 
 (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised etanercept therapy;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
Rheumatoid arthritis
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and
 
 
 
 

 
 
 
 where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as swollen and tender);
 
 
 
 

 
 
 
 — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment;
 
 
 
 

 
 
 
 where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy
 
 
 
 

 
Injection 50 mg in 1 mL single use injection pen, 4
 
Rheumatoid arthritis
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment with etanercept within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
Injection
1
5
Enbrel

 
 
 
 
 
 
 

 
 
 
 (a) who have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) who have demonstrated an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and
 
 
 
 

 
 
 
 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;
 
 
 
 

 
 
 
 an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of etanercept therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 the patient has not failed to demonstrate response to a course of PBS-subsidised etanercept in this Treatment Cycle;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
Rheumatoid arthritis
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient
 
 
 
 

 

 
 
 
Rheumatoid arthritis
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as swollen and tender);
 
 
 
 

 
 
 
 — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient;
 
 
 
 

 
 
 
 patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment;
 
 
 
 

 
 
 
 authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course
 
 
 
 

 

 
Injection 50 mg in 1 mL single use injection pen, 4
 
Chronic plaque psoriasis (whole body) — continuing treatment
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
Injection
1
5
Enbrel

 
 
 
 
 
 
 

 
 
 
 (a) who have a documented history of severe chronic plaque psoriasis; and
 
 
 
 

 
 
 
 (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and
 
 
 
 

 
 
 
 (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and
 
 
 
 

 
 
 
 where biological agent means adalimumab, etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 an adequate response to etanercept 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 pre-biological treatment baseline value for this Treatment Cycle;
 
 
 
 

 
 
 
 the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
 
 
 
 

 
 
 
 the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
 
 
 
 

 
 
 
 where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
 
 
 
 

 
 
 
 the most recent PASI assessment is no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
Chronic plaque psoriasis (face, hand, foot) — continuing treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
 
 
 
 

 
 
 
 (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
 
 
 
 

 
 
 
 (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and
 
 
 
 

 
 
 
 (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and
 
 
 
 

 
 
 
 where biological agent means adalimumab, etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
 
 
 
 

 
 
 
 (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
 
 
 
 

 
 
 
 (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;
 
 
 
 

 
 
 
 the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
 
 
 
 

 
 
 
 the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
 
 
 
 

 
 
 
 where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate 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 along with the date of the assessment of the patient's condition;
 
 
 
 

 
 
 
 the most recent PASI assessment is no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

[59]          Part 2 of Schedule 1, after item dealing with Glucose Indicator―Blood in the form Electrode strips, 50
(MWD Pen Sensor Strips)
insert in the columns in the order indicated:
 
 
Electrode strips, 50 (MyGlucoHealth)
 
For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements
For external use
2
11
MyGlucoHealth
 
[60]          Part 2 of Schedule 1, item dealing with Glucose Indicator―Blood
omit from the columns in the order indicated:
 
 
Electrode strips, 100 (TrueSense)
 
For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements
For external use
1
11
TrueSense
[61]          Part 2 of Schedule 1, item dealing with Morphine in the form Tablet containing morphine sulfate 10 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 10
[62]          Part 2 of Schedule 1, item dealing with Morphine in the form Tablet containing morphine sulfate 30 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 30
[63]          Part 2 of Schedule 1, item dealing with Morphine in the form Tablet containing morphine sulfate 60 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 60
[64]          Part 2 of Schedule 1, item dealing with Morphine in the form Tablet containing morphine sulfate 100 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 100
 
[65]          Part 2 of Schedule 1, item dealing with Paracetamol
(a) in the column headed “Brand” insert in alphabetical order:
        APO-Paracetamol
(b) omit from the column headed “Brand”:
        Parmol
[66]          Part 2 of Schedule 1, after item dealing with Rituximab
insert in the columns in the order indicated:
 

Rivaroxaban
Tablet 10 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Prevention of venous thromboembolism in a patient undergoing total hip replacement
Oral
10
1
Xarelto

 
Tablet 10 mg, 15
 
In compliance with authority procedures set out in subparagraph 11 (d):
Prevention of venous thromboembolism in a patient undergoing total hip replacement
Oral
1
1
Xarelto

[67]          Part 2 of Schedule 1, item dealing with Temazepam
in the column headed “Brand” insert in alphabetical order:
APO-Temazepam
[68]          Part 1 of Schedule 2, item dealing with Bisacodyl in the form Suppositories 10 mg, 12
omit from the column headed “Brand”:
Fleet Laxative Suppositories
 
 
[69]          Part 1 of Schedule 2, after item dealing with Hyoscine
insert in the columns in the order indicated:
 
Hypromellose
Oral gel 20 mg per g, 100 g
Oral application
1
. .
Aquae Gel
[70]          Part 1 of Schedule 2, item dealing with Temazepam
in the column headed “Brand” insert in alphabetical order:
APO-Temazepam
[71]          Part 2 of Schedule 2, item dealing with Bisacodyl in the form Suppositories 10 mg, 12
omit from the column headed “Brand”:
Fleet Laxative Suppositories
[72]          Part 2 of Schedule 2, after item dealing with Hyoscine
insert in the columns in the order indicated:
 
Hypromellose
Oral gel 20 mg per g, 100 g
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom
Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred
Oral application
1
3
Aquae Gel
[73]          Part 2 of Schedule 2, item dealing with Temazepam
in the column headed “Brand” insert in alphabetical order:
APO-Temazepam
[74]          Part 1 of Schedule 3, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
in the column headed “Brand” insert in alphabetical order:
        APO-Amoxycillin/Clavulanic Acid 500/125
[75]          Part 1 of Schedule 3, item dealing with 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
in the column headed “Brand” insert in alphabetical order:
        Curam
[76]          Part 1 of Schedule 3, item dealing with Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL,
60 mL
in the column headed “Brand” insert in alphabetical order:
        Curam Duo
[77]          Part 1 of Schedule 3, item dealing with Codeine with Paracetamol in the form Tablet containing codeine
phosphate 30 mg with paracetamol 500 mg
in the column headed “Brand” insert in alphabetical order:
        APO-Paracetamol/Codeine 500/30
[78]          Part 1 of Schedule 3, item dealing with Glucose
insert as first entry in the columns in the order indicated:
 
 
I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
. .
B. Braun Australia Pty Ltd
Pharmatel Fresenius Kabi Pty Limited
[79]          Part 1 of Schedule 3, item dealing with Glucose in the form I.V. infusion 278 mmol (anhydrous) per L, 1 L
in the column headed “Brand” insert in alphabetical order:
B. Braun Australia Pty Ltd
[80]          Part 1 of Schedule 3, item dealing with Morphine in the form Tablet containing morphine sulfate 10 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 10
[81]          Part 1 of Schedule 3, item dealing with Morphine in the form Tablet containing morphine sulfate 30 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 30
[82]          Part 1 of Schedule 3, item dealing with Morphine in the form Tablet containing morphine sulfate 60 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 60
[83]          Part 1 of Schedule 3, item dealing with Morphine in the form Tablet containing morphine sulfate 100 mg
(controlled release)
in the column headed “Brand” insert in alphabetical order:
Momex SR 100
[84]          Part 1 of Schedule 3, item dealing with Paracetamol in the form Tablet 500 mg
(a) in the column headed “Brand” insert in alphabetical order:
        APO-Paracetamol
(b) omit from the column headed “Brand”:
        Parmol
[85]          Part 1 of Schedule 3, after item dealing with Sodium Chloride in the form Injection 9 mg per mL, 10 mL
insert in the columns in the order indicated:
 
 
I.V. infusion 77 mmol per 500 mL, 500 mL
Injection
5
. .
B. Braun Australia Pty Ltd
Pharmatel Fresenius Kabi Pty Limited
[86]          Part 1 of Schedule 3, item dealing with Sodium Chloride in the form I.V. infusion 154 mmol per L, 1 L
in the column headed “Brand” insert in alphabetical order:
B. Braun Australia Pty Ltd
[87]          Part 1 of Schedule 3, item dealing with Temazepam
in the column headed “Brand” insert in alphabetical order:
APO-Temazepam
[88]          Part 2 of Schedule 3, item dealing with Paracetamol
(a) in the column headed “Brand” insert in alphabetical order:
        APO-Paracetamol
(b) omit from the column headed “Brand”:
        Parmol