National Health Act 1953 Determinations under sections 85, 85A and 88 (No. PB 38 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

National Health Act 1953

PHARMACEUTICAL BENEFITS

DETERMINATIONS UNDER SECTIONS 85, 85A AND 88

No. PB 38 of 2007

I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to sections 85, 85A and 88 of the National Health Act 1953, hereby make the following Determinations:

1.  These Determinations commence on 1 June 2007.

2.  The Determinations (No. PB 31 of 2007) under sections 85, 85A and 88 of the National Health Act 1953 made on 30 March 2007 with effect from 1 May 2007 are, in these Determinations, referred to as the Principal Determinations.

3.  Paragraph 14 of the Principal Determinations is amended:

(a)   by inserting, immediately after the details in respect of the manufacturer Chemists’ Own Pty Ltd A member of Sigma Group of Companies, the following details:

Letters	Manufacturer's Name
CR	Pharmacor Limited

(b)   by inserting, immediately after the details in respect of the manufacturer Contact Lens Centre Australia Pty Ltd, the following details:

Letters	Manufacturer's Name
DB	Diabetes Association of Australia

(c)   by omitting the following details:

Letters	Manufacturer's Name
SL	SBPA A Division of Sandoz Pty Ltd

4. The First Schedule — Part 1 to the Principal Determinations is amended:

(a)in respect of the pharmaceutical benefit Aciclovir tablet 800 mg, by inserting “CR,” immediately after “AF,” in the column headed “Brand”;

(b)in respect of the pharmaceutical benefit Bupropion Hydrochloride tablet 150 mg (sustained release), by inserting “AF,” immediately before “GK,” in the column headed “Brand”;

(c)in respect of the pharmaceutical benefits Carbamazepine tablet 100 mg and tablet 200 mg, by omitting “BG,” from the column headed “Brand”;

(d)in respect of the pharmaceutical benefit Cholestyramine, by omitting the details in respect of the form Sachets containing 9.4 g oral powder (equivalent to 8 g cholestyramine), 50;

(e)in respect of the pharmaceutical benefit Citalopram Hydrobromide tablet equivalent to 20 mg citalopram, by omitting “SL,” from the column headed “Brand” and inserting “,WA” immediately after “TW” in the same column;

(f)in respect of the pharmaceutical benefits Enalapril Maleate tablet 5 mg, tablet 10 mg and tablet 20 mg, by omitting “SL,” from the column headed “Brand” and inserting “,WA” immediately after “TW’ in the same column;

(g)in respect of the pharmaceutical benefit Etanercept, by inserting, immediately below the details in respect of the form Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL, the following details:

Name of pharmaceutical benefit	Form (strength, type, size, etc.)	Manner of adminis-tration	Maxi-mum quantity	Maximum number of repeats	Brand
Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	1	2	WY

(h)in respect of the pharmaceutical benefits Famotidine tablet 20 mg and tablet 40 mg, by omitting “HX,” from the column headed “Brand” and inserting “SZ,” immediately after “MK,” in the same column;

1. in respect of the pharmaceutical benefit Gabapentin capsule 400 mg, by inserting “CR,” immediately after “AW,” in the column headed “Brand”;

(j)in respect of the pharmaceutical benefit Gliclazide tablet 30 mg (modified release), by inserting “RA,” immediately before “SE” in the column headed “Brand”;

(k)in respect of the pharmaceutical benefit Glucose Indicator – Blood, by inserting, immediately below the details in respect of the form Electrode strips, 50 (Freestyle Papillon), the following details:

Name of pharmaceutical benefit	Form (strength, type, size, etc.)	Manner of adminis-tration	Maxi-mum quantity	Maximum number of repeats	Brand
Electrode strips, 50 (Glucoboy)	2	5	DB

(l)    in respect of the pharmaceutical benefit Moclobemide tablet 150 mg, by omitting “HX,” from the column headed “Brand” and inserting “SZ,” immediately after “RO,” in the same column;

(m)  in respect of the pharmaceutical benefit Moclobemide tablet 300 mg, by omitting “HX,” from the column headed “Brand” and inserting “SZ,” immediately after “SI,” in the same column;

(n)   by inserting, immediately below the details in respect of the pharmaceutical benefit Olanzapine, the following details:

Name of pharmaceutical benefit	Form (strength, type, size, etc.)	Manner of adminis-tration	Maxi-mum quantity	Maximum number of repeats	Brand
Olmesartan Medoxomil	Tablet 20 mg Tablet 40 mg	Oral Oral	30 30	5 5	SH SH
Olmesartan Medoxomil with Hydrochlorothiazide	Tablet 20 mg-12.5 mg Tablet 40 mg-12.5 mg Tablet 40 mg-25 mg	Oral Oral Oral	30 30 30	5 5 5	SH SH SH

(o)   in respect of the pharmaceutical benefit Paroxetine Hydrochloride tablet equivalent to 20 mg paroxetine, by inserting “CR,” immediately after “CH,” in the column headed “Brand”;

(p)   in respect of the pharmaceutical benefits Pravastatin Sodium tablet 10 mg, tablet 20 mg and tablet 40 mg, by inserting “CR,” immediately after “CH,”, and by inserting “,WA” immediately after “TW”, in the column headed “Brand”;

(q)   in respect of the pharmaceutical benefits Ramipril tablet 1.25 mg, tablet 2.5 mg, tablet 5 mg and capsule 10 mg, by inserting “AW,” immediately after “AV,” in the column headed “Brand”;

(r)   in respect of the pharmaceutical benefits Roxithromycin tablet 150 mg and tablet 300 mg, by omitting “HX,” from the column headed “Brand” and inserting “,SZ” immediately after “SW” in the same column;

(s)   in respect of the pharmaceutical benefits Sertraline Hydrochloride tablet equivalent to 50 mg sertraline and tablet equivalent to 100 mg sertraline, by omitting “SL,” from the column headed “Brand” and inserting “,WA” immediately after “TW” in the same column;

(t)    in respect of the pharmaceutical benefit Simvastatin tablet 5 mg, by inserting “CR,” immediately after “BF,”, and by replacing “SL” with “WA”, in the column headed “Brand”;

(u)   in respect of the pharmaceutical benefits Simvastatin tablet 10 mg, tablet 20 mg, tablet 40 mg and tablet 80 mg, by omitting “SL,” from the column headed “Brand”, and by inserting “CR,” immediately after “CH,”, and inserting “,WA” immediately after “TW”, in the same column;

(v)   in respect of the pharmaceutical benefit Terbinafine Hydrochloride tablet equivalent to 250 mg terbinafine, by inserting “CR,” immediately after “AW,” in the column headed “Brand”.

5.  The First Schedule — Part 2 to the Principal Determinations is amended:

(a)in respect of the pharmaceutical benefit Aciclovir tablet 200 mg, by inserting “CR,” immediately after “CH,” in the column headed “Brand”;

(b)in respect of the pharmaceutical benefit Bupropion Hydrochloride tablet 150 mg (sustained release), by inserting “AF,” immediately before “GK,” in the column headed “Brand”;

(c)in respect of the pharmaceutical benefit Etanercept, by inserting, immediately below the details in respect of the form Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL, the following details:

Form (strength, type, size, etc.):

Injections 50 mg in 1 mL single use pre-filled syringes, 4

Purposes:

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:

 (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

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

Manner of administration:

Injection

Maximum quantity:

1

Maximum number of repeats:

3

Brand:

WY

Form (strength, type, size, etc.):

Injections 50 mg in 1 mL single use pre-filled syringes, 4

Purposes:

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

 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

Manner of administration:

Injection

Maximum quantity:

1

Maximum number of repeats:

5

Brand:

WY

Form (strength, type, size, etc.):

Injections 50 mg in 1 mL single use pre-filled syringes, 4

Purposes:

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:

 (1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; 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 sulfasalazine at a dose of at least 2 g per day 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 either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and

 (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and

 (5) 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 with a record of rheumatoid factor negative status within the last 12 months, 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

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 with a record of rheumatoid factor negative status within the last 12 months; 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 with a record of rheumatoid factor negative status within the last 12 months, 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

Manner of administration:

Injection

Maximum quantity:

1

Maximum number of repeats:

3

Brand:

WY

Form (strength, type, size, etc.):

Injections 50 mg in 1 mL single use pre-filled syringes, 4

Purposes:

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:

 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; 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 with a record of rheumatoid factor negative status within the last 12 months, 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

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 with a record of rheumatoid factor negative status; 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 with a record of rheumatoid factor negative status, 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

Manner of administration:

Injection

Maximum quantity:

1

Maximum number of repeats:

5

Brand:

WY

Form (strength, type, size, etc.):

Injections 50 mg in 1 mL single use pre-filled syringes, 4

Purposes:

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Initial treatment in 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 with severe active rheumatoid arthritis, and:

 (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or

 (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and

 (b) who 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 leflunomidein combination with methotrexate or with cyclosporin alone, unless:

 (i) 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 that particular agent (or agents) only; or

 (ii) 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

 (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD 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 bDMARD means a drug included in the following list of drugs:

 adalimumab, anakinra, etanercept or infliximab; 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 (b) 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);

 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;

 where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;

 the authority application includes a completed copy of the appropriate Biological DMARD 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 treatment 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

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

 Initial treatment or recommencement of 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 severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and

 where bDMARD means a drug included in the following list of drugs:

 adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;

 patients are eligible to commence therapy with etanercept within this bDMARD 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, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable;

 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 if:

 (i) they have demonstrated an adequate response 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 when the most recent course of PBS-subsidised treatment was an initial 16 week course; and

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

 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 authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy;

 a course of treatment 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, 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 severe active rheumatoid arthritis 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

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

Manner of administration:

Injection

Maximum quantity:

1

Maximum number of repeats:

3

Brand:

WY

Form (strength, type, size, etc.):

Injections 50 mg in 1 mL single use pre-filled syringes, 4

Purposes:

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and

 where bDMARD means a drug included in the following list of drugs:

 adalimumab, anakinra, etanercept or infliximab; 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:

 the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;

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

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

 Continuing treatment 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 with severe active rheumatoid arthritis, and:

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

 (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and

 where bDMARD means a drug included in the following list of drugs:

 adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;

 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;

 the authority application includes a completed copy of the appropriate Biological DMARD 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 an initial 16 week 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 treatment 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 severe active rheumatoid arthritis 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

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

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

Manner of administration:

Injection

Maximum quantity:

1

Maximum number of repeats:

5

Brand:

WY

1. The Third Schedule — Part 1 to the Principal Determinations is amended in respect of the pharmaceutical benefits Carbamazepine tablet 100 mg and tablet 200 mg, by omitting “BG,” from the column headed “Brand”.

Dated this 26 day of April 2007.

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing