COMMONWEALTH OF AUSTRALIA
Instrument number PB 60 of 2008
Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953
I, ANDREW MITCHELL, Acting 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                                                                           3 JUNE            2008
 
ANDREW MITCHELL
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
 
Amendment determination — pharmaceutical benefits
1              Commencement
                This instrument commences on 1 July 2008.
2              Amendment of PB 89 of 2007
                Schedule 1 amends PB 89 of 2007.
Schedule 1        Amendments
 
[1]       Part 1 of Schedule 1, item dealing with Amlodipine in the form Tablet 5 mg (as besylate)
in the column headed “Brand” insert in alphabetical order:
        Amlodipine generichealth
[2]       Part 1 of Schedule 1, item dealing with Amlodipine in the form Tablet 10 mg (as besylate)
in the column headed “Brand” insert in alphabetical order:
        Amlodipine generichealth
[3]       Part 1 of Schedule 1, after item dealing with Calcipotriol in the form Cream 50 micrograms (as monohydrate)
per g, 30 g
insert in the columns in the order indicated:
 
 
Scalp solution 50 micrograms (as monohydrate) per mL,
30 mL
Application
1
1
Daivonex
[4]       Part 1 of Schedule 1, after items dealing with Cimetidine
insert in the columns in the order indicated:
 

Cinacalcet
Tablet 30 mg (as hydrochloride)
Oral
28
5
Sensipar

 
Tablet 60 mg (as hydrochloride)
Oral
28
5
Sensipar

 
Tablet 90 mg (as hydrochloride)
Oral
28
5
Sensipar

 
[5]       Part 1 of Schedule 1, after items dealing with Cyproterone
insert in the columns in the order indicated:
 
Cystine with carbohydrate
Sachets of oral powder 4 g containing 500 mg cystine, 30
(Cystine Amino Acid Supplement)
Oral
4
5
Cystine Amino Acid Supplement
[6]       Part 1 of Schedule 1, item dealing with Dexamethasone
omit from the columns in the order indicated:
 
 
Injection containing dexamethasone sodium phosphate equivalent to 120 mg dexamethasone phosphate in 5 mL
Injection
1
..
Hospira Australia Pty Ltd
[7]       Part 1 of Schedule 1, item dealing with Folinic acid
omit from the column headed “Brand” (wherever occurring):
        Leucovorin (Hospira Australia Pty Ltd)
and substitute:
        Leucovorin (Hospira Pty Limited)
[8]       Part 1 of Schedule 1, item dealing with Hydroxocobalamin
omit from the columns in the order indicated:
 
 
Injection 1 mg (as acetate) in 1 mL
Injection
5
..
Goldshield Hydroxocobalamin
 
[9]       Part 1 of Schedule 1, item dealing with Influenza Vaccine in the form Injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/Solomon Islands/3/2006 (H1N1)-like strain 7.5 micrograms haemagglutinin; A/Brisbane/10/2007 (H3N2)-like strain
7.5 micrograms haemagglutinin; B/Florida/4/2006-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe
in the column headed “Brand” insert in alphabetical order:
Fluvax Junior
[10]     Part 1 of Schedule 1, after item dealing with Melphalan
insert in the columns in the order indicated:
 

Memantine
Tablet containing memantine hydrochloride 10 mg
Oral
56
5
Ebixa

 
Oral drops containing memantine hydrochloride 10 mg per g, 50 g
Oral
1
5
Ebixa

[11]     Part 1 of Schedule 1, item dealing with Mesalazine in the form Tablet 500 mg (enteric coated)
omit from the column headed “Maximum quantity”:
        100
and substitute:
        200
[12]     Part 1 of Schedule 1, item dealing with Mesalazine in the form Sachet containing granules, 500 mg per sachet
omit from the column headed “Maximum quantity”:
        100
and substitute:
        200
[13]     Part 1 of Schedule 1, item dealing with Metronidazole in the form I.V. infusion 500 mg in 100 mL
in the column headed “Brand” insert in alphabetical order:
        DBL Metronidazole Intravenous Infusion
[14]     Part 1 of Schedule 1, item dealing with Oestradiol in the form Transdermal patches 2 mg, 4
omit from the column headed “Brand”:
        Femtran 25
[15]     Part 1 of Schedule 1, item dealing with Oestradiol in the form Transdermal patches 3.8 mg, 4
omit from the column headed “Brand”:
        Femtran 50
[16]     Part 1 of Schedule 1, item dealing with Oestradiol in the form Transdermal patches 7.6 mg, 4
omit from the column headed “Brand”:
        Femtran 100
[17]     Part 1 of Schedule 1, item dealing with Oestradiol and Oestradiol with Norethisterone in the form Pack containing
4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate
omit from the column headed “Form (strength, type, size, etc.)”:
        4.33 mg
and substitute:
        780 micrograms
[18]     Part 1 of Schedule 1, item dealing with Oestradiol and Oestradiol with Norethisterone in the form Pack containing
4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate
omit from the column headed “Form (strength, type, size, etc.)”:
        4.33 mg
and substitute:
        780 micrograms
[19]     Part 1 of Schedule 1, item dealing with Perindopril in the form Tablet containing perindopril erbumine 2 mg
in the column headed “Brand” insert in alphabetical order:
        Indopril 2
[20]     Part 1 of Schedule 1, item dealing with Perindopril in the form Tablet containing perindopril erbumine 4 mg
in the column headed “Brand” insert in alphabetical order:
        Indopril 4
[21]     Part 1 of Schedule 1, item dealing with Perindopril in the form Tablet containing perindopril erbumine 8 mg
in the column headed “Brand” insert in alphabetical order:
        Indopril 8
[22]     Part 1 of Schedule 1, item dealing with Phenoxymethylpenicillin
omit from the columns in the order indicated:
 

 
Oral suspension 125 mg (as benzathine) per 5 mL, 100 mL
Oral
2
..
Abbocillin-V
Cilicaine V

 
Oral suspension 250 mg (as benzathine) per 5 mL, 100 mL
Oral
2
..
Abbocillin-V
Cilicaine V

[23]     Part 1 of Schedule 1, after item dealing with Rivastigmine in the form Oral solution 2 mg (as hydrogen tartrate)
per mL, 120 mL
insert in the columns in the order indicated:
 

 
Transdermal patch 9 mg
Transdermal
30
5
Exelon Patch 5

 
Transdermal patch 18 mg
Transdermal
30
5
Exelon Patch 10

[24]     Part 1 of Schedule 1, after item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride)
insert in the columns in the order indicated:
 
 
Cream containing terbinafine hydrochloride 10 mg per g,
15 g
Application
2
3
Lamisil
[25]     Part 1 of Schedule 1, after item dealing with Tropisetron
insert in the columns in the order indicated:
 
Tyrosine with carbohydrate
Sachets of oral powder 4 g containing 1 g tyrosine, 30
(Tyrosine Amino Acid Supplement)
Oral
4
5
Tyrosine Amino Acid Supplement
[26]     Part 1 of Schedule 1, wherever Hospira Australia Pty Ltd appears in the column headed “Brand”
 
                 omit:
        Hospira Australia Pty Ltd
 
                 and substitute:
                        Hospira Pty Limited
[27]     Part 2 of Schedule 1, item dealing with Adalimumab in the second instance of the form Injection 40 mg in 0.8 mL pre-filled syringe
omit all text from the column headed “Purposes” and substitute:
 

 
 
 
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; 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 demonstrate failure 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 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 at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 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, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with adalimumab 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 adalimumab 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 adalimumab 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 adalimumab, to their most recent course of PBS-subsidised adalimumab 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 at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 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 adalimumab 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, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

[28]     Part 2 of Schedule 1, item dealing with Adalimumab in the third instance of the form Injection 40 mg in 0.8 mL
pre-filled syringe
omit all text from the column headed “Purposes” and substitute:
 

 
 
 
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 adalimumab for continuing treatment, 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) were receiving treatment with adalimumab prior to 16 March 2006; and
 
 
 
 

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

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;
 
 
 
 

 
 
 
 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 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, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
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 adalimumab; and
 
 
 
 

 
 
 
 (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; 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 adalimumab 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 adalimumab, 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 adalimumab 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 at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 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, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

[29]     Part 2 of Schedule 1, item dealing with Adalimumab in the second instance of the form Injection 40 mg in 0.8 mL pre-filled pen
omit all text from the column headed “Purposes” and substitute:
 

 
 
 
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; 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 demonstrate failure 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 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 at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 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, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with adalimumab 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 adalimumab 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 adalimumab 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 adalimumab, to their most recent course of PBS-subsidised adalimumab 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 at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 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 adalimumab 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, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
[30]     Part 2 of Schedule 1, item dealing with Adalimumab in the third instance of the form Injection 40 mg in 0.8 mL
pre-filled pen
omit all text from the column headed “Purposes” and substitute:
 

 
 
 
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 adalimumab for continuing treatment, 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) were receiving treatment with adalimumab prior to 16 March 2006; and
 
 
 
 

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

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;
 
 
 
 

 
 
 
 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 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, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
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 adalimumab; and
 
 
 
 

 
 
 
 (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; 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 adalimumab 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 adalimumab, 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 adalimumab 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 at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 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, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
[31]     Part 2 of Schedule 1, item dealing with Etanercept in the third instance of the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
omit all text from the column headed “Purposes” and substitute:
 

 
 
 
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; 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 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 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; 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
 
 
 
 

[32]     Part 2 of Schedule 1, item dealing with Etanercept in the fourth instance of the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
omit all text from the column headed “Purposes” and substitute:
 

 
 
 
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; 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
 
 
 
 

 
 
 
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
 
 
 
 

[33]     Part 2 of Schedule 1, item dealing with Etanercept in the third instance of the form Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
omit all text from the column headed “Purposes” and substitute:
 

 
 
 
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; 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 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 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; 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
 
 
 
 

[34]     Part 2 of Schedule 1, item dealing with Etanercept in the fourth instance of the form Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
omit all text from the column headed “Purposes” and substitute:
 

 
 
 
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; 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
 
 
 
 

 
 
 
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
 
 
 
 

[35]     Part 2 of Schedule 1, item dealing with Etanercept in the third instance of the form Injections 50 mg in 1 mL single use pre-filled syringes, 4
omit all text from the column headed “Purposes” and substitute:
 

 
 
 
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; 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 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 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; 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
 
 
 
 

 
[36]     Part 2 of Schedule 1, item dealing with Etanercept in the fourth instance of the form Injections 50 mg in 1 mL single use pre-filled syringes, 4
omit all text from the column headed “Purposes” and substitute:
 

 
 
 
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; 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
 
 
 
 

 
 
 
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
 
 
 
 

[37]     Part 2 of Schedule 1, item dealing with Vancomycin
omit from the column headed “Brand” (twice occurring):
        Hospira Australia Pty Ltd
and substitute:
        Hospira Pty Limited
[38]     Part 1 of Schedule 3, item dealing with Metronidazole in the form I.V. infusion 500 mg in 100 mL
in the column headed “Brand” insert in alphabetical order:
        DBL Metronidazole Intravenous Infusion
[39]     Part 1 of Schedule 3, item dealing with Phenoxymethylpenicillin
omit from the columns in the order indicated:
 

 
Oral suspension 125 mg (as benzathine) per 5 mL, 100 mL
Oral
2
..
Abbocillin-V
Cilicaine V

 
Oral suspension 250 mg (as benzathine) per 5 mL, 100 mL
Oral
2
..
Abbocillin-V
Cilicaine V

[40]     Part 1 of Schedule 3, wherever Hospira Australia Pty Ltd appears in the column headed “Brand”
 
                 omit:
        Hospira Australia Pty Ltd
 
                 and substitute:
                        Hospira Pty Limited