National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 5 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 5 of 2010

Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953

I, ADRIANA PLATONA, 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 2 February 2010

ADRIANA PLATONA

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1              Commencement

This instrument commences on 1 March 2010.

2              Amendment of PB 114 of 2008

Schedule 1 amends PB 114 of 2008.

Schedule 1            Amendments

1. Part 1 of Schedule 1, item dealing with Alprazolam in the form Tablet 1 mg

(a)insert in alphabetical order in the column headed “Brand”: Alprazolam Sandoz

(b)omit from the column headed “Brand”: Zamhexal 1.0mg

1. Part 1 of Schedule 1, item dealing with Alprazolam in the form Tablet 2 mg

(a)insert in alphabetical order in the column headed “Brand”: Alprazolam Sandoz

(b)omit from the column headed “Brand”: Zamhexal 2mg

1. Part 1 of Schedule 1, item dealing with Amoxycillin in the form Capsule 250 mg (as trihydrate)

insert in alphabetical order in the column headed “Brand”: Amoxycillin-GA

1. Part 1 of Schedule 1, item dealing with Calcitriol

insert in alphabetical order in the column headed “Brand”: Calcitriol-GA

1. Part 1 of Schedule 1, after item dealing with Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg

insert in the columns in the order indicated:

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg	Oral	30	5	Atacand Plus 32/12.5
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg	Oral	30	5	Atacand Plus 32/25

1. Part 1 of Schedule 1, item dealing with Captopril in the form Tablet 12.5 mg

omit from the column headed “Brand”: Acenorm 12.5 mg

1. Part 1 of Schedule 1, item dealing with Captopril in the form Tablet 25 mg

omit from the column headed “Brand”: Acenorm 25 mg

1. Part 1 of Schedule 1, item dealing with Captopril in the form Tablet 50 mg

omit from the column headed “Brand”: Acenorm 50 mg

1. Part 1 of Schedule 1, item dealing with Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)

insert in alphabetical order in the column headed “Brand”: Ciprofloxacin-GA

1. Part 1 of Schedule 1, item dealing with Citalopram in the form Tablet 20 mg (as hydrobromide)

(a)insert in alphabetical order in the column headed “Brand”: Citalopram Sandoz

(b)omit from the column headed “Brand”: Talohexal

1. Part 1 of Schedule 1, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg

omit from the column headed “Brand”: GenRx Diclofenac

1. Part 1 of Schedule 1, item dealing with Dicloxacillin in the form Capsule 250 mg (as sodium)

omit from the column headed “Brand”: Diclocil

1. Part 1 of Schedule 1, item dealing with Gabapentin in the form Capsule 300 mg

insert in alphabetical order in the column headed “Brand”: Gabapentin-GA

1. Part 1 of Schedule 1, after item dealing with Gliclazide in the form Tablet 30 mg (modified release)

insert in the columns in the order indicated:

Tablet 60 mg (modified release) Oral 60 5 Diamicron 60mg MR

1. Part 1 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 51 (Accu-Chek Integra)

insert in the columns in the order indicated:

Test strips, 50 (Accu-Chek Mobile) For external use 2 5 Accu-Chek Mobile

1. Part 1 of Schedule 1, item dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Test strips, 50 (Glucoboy) For external use 2 5 Glucoboy

1. Part 1 of Schedule 1, omit item dealing with Influenza Vaccine

1. Part 1 of Schedule 1, item dealing with Lisinopril in the form Tablet 5 mg

insert in alphabetical order in the column headed “Brand”: Lisinopril-GA

1. Part 1 of Schedule 1, after item dealing with Memantine in the form Tablet containing memantine hydrochloride 10 mg

insert in the columns in the order indicated:

Tablet containing memantine hydrochloride 20 mg Oral 28 5 Ebixa

1. Part 1 of Schedule 1, item dealing with Mesalazine in the forms Suppositories 1 g, 28, Enemas 1 g in 100 mL, 7, Enemas 2 g in 60 mL, 7,
   Enemas 4 g in 60 mL, 7 and Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g

omit from the column headed “Maximum number of repeats”:            . .        and substitute:    1

1. Part 1 of Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg

insert in alphabetical order in the column headed “Brand”: Metformin-GA

1. Part 1 of Schedule 1, after item dealing with Naratriptan

insert in the columns in the order indicated:

Nebivolol	Tablet 1.25 mg (as hydrochloride), 28	Oral	1	5	Nebilet
Tablet 1.25 mg (as hydrochloride)	Oral	56	5	Nebilet
Tablet 5 mg (as hydrochloride)	Oral	28	5	Nebilet
Tablet 10 mg (as hydrochloride)	Oral	28	5	Nebilet

1. Part 1 of Schedule 1, after item dealing with Olanzapine in the form Powder for injection 300 mg (as pamoate monohydrate) with diluent

insert in the columns in the order indicated:

Powder for injection 405 mg (as pamoate monohydrate) with diluent Injection 1 5 Zyprexa Relprevv

1. Part 1 of Schedule 1, item dealing with Oxaliplatin in the form Powder for I.V. infusion 100 mg

insert in alphabetical order in the column headed “Brand”: Oxaliplatin Link

1. Part 1 of Schedule 1, item dealing with Paracetamol in the form Tablet 500 mg

insert in alphabetical order in the column headed “Brand”: Generic Health Pty Ltd

1. Part 1 of Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 80 mg

insert in alphabetical order in the column headed “Brand”: Pravastatin Sandoz

1. Part 1 of Schedule 1, item dealing with Quinapril in the form Tablet 20 mg (as hydrochloride)

omit from the column headed “Brand”: Quinapril-DP

1. Part 1 of Schedule 1, after item dealing with Rivastigmine

insert in the columns in the order indicated:

Rizatriptan Wafer 10 mg (as benzoate) Oral 4 5 Maxalt

1. Part 1 of Schedule 1, item dealing with Sodium Chloride in the form Injection 9 mg per mL, 10 mL

omit from the column headed “Manner of administration”: Injection          and substitute:    Injection/solvent for injectables

1. Part 1 of Schedule 1, item dealing with Sotalol in the form Tablet containing sotalol hydrochloride 160 mg

omit from the column headed “Brand”: Sotahexal          and substitute:    Sotalol Sandoz

1. Part 1 of Schedule 1, after item dealing with Trifluoperazine

insert in the columns in the order indicated:

Triglycerides, long chain with glucose polymer	Oral liquid 250 mL, 18 (ProZero)	Oral	6	5	ProZero
Oral liquid 1 L, 6 (ProZero)	Oral	4	5	ProZero

1. Part 1 of Schedule 1, after item dealing with Ursodeoxycholic Acid

insert in the columns in the order indicated:

Ustekinumab Injection 45 mg in 0.5 mL Injection 1 1 Stelara

1. Part 2 of Schedule 1, item dealing with Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe

under the headings:

Chronic plaque psoriasis (whole body) — initial treatment 1

Chronic plaque psoriasis (whole body) — initial treatment 2

Chronic plaque psoriasis (face, hand, foot) — initial treatment 1

Chronic plaque psoriasis (face, hand, foot) — initial treatment 2

Chronic plaque psoriasis (whole body) — initial treatment 3

Chronic plaque psoriasis (whole body) — continuing treatment

Chronic plaque psoriasis (face, hand, foot) — initial treatment 3

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

omit from the column headed “Purposes”:

 where biological agent means adalimumab, etanercept or infliximab; and

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

and substitute:

 where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and

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

1. Part 2 of Schedule 1, item dealing with Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen

under the headings:

Chronic plaque psoriasis (whole body) — initial treatment 1

Chronic plaque psoriasis (whole body) — initial treatment 2

Chronic plaque psoriasis (face, hand, foot) — initial treatment 1

Chronic plaque psoriasis (face, hand, foot) — initial treatment 2

Chronic plaque psoriasis (whole body) — initial treatment 3

Chronic plaque psoriasis (whole body) — continuing treatment

Chronic plaque psoriasis (face, hand, foot) — initial treatment 3

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

omit from the column headed “Purposes”:

 where biological agent means adalimumab, etanercept or infliximab; and

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

and substitute:

 where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and

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

1. Part 2 of Schedule 1, item dealing with Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL

under the headings:

Chronic plaque psoriasis (whole body) — continuing treatment

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

omit from the column headed “Purposes”:

 where biological agent means adalimumab, etanercept or infliximab; and

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

and substitute:

 where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and

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

1. Part 2 of Schedule 1, item dealing with Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4

under the headings:

Chronic plaque psoriasis (whole body) — continuing treatment

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

omit from the column headed “Purposes”:

 where biological agent means adalimumab, etanercept or infliximab; and

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

and substitute:

 where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and

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

1. Part 2 of Schedule 1, item dealing with Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4

under the headings:

Chronic plaque psoriasis (whole body) — continuing treatment

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

omit from the column headed “Purposes”:

 where biological agent means adalimumab, etanercept or infliximab; and

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

and substitute:

 where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and

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

1. Part 2 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 51 (Accu-Chek Integra)

insert in the columns in the order indicated:

Test strips, 50 (Accu-Chek Mobile) For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements For external use 2 11 Accu-Chek Mobile

1. Part 2 of Schedule 1, item dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Test strips, 50 (Glucoboy) For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements For external use 2 11 Glucoboy

1. Part 2 of Schedule 1, item dealing with Paracetamol in the form Tablet 500 mg

insert in alphabetical order in the column headed “Brand”: Generic Health Pty Ltd

1. Part 2 of Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 80 mg

insert in alphabetical order in the column headed “Brand”: Pravastatin Sandoz

1. Part 2 of Schedule 1, after item dealing with Tramadol

insert in the columns in the order indicated:

Ustekinumab	Injection 45 mg in 0.5 mL	Chronic plaque psoriasis (whole body) — initial treatment 1  In compliance with authority procedures set out in subsubparagraph 11 (d) (i):  Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:	Injection	1	2	Stelara
(a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior 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
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
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 at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 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 is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) 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 application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 28 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):  Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with ustekinumab for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total
Chronic plaque psoriasis (whole body) — initial treatment 2
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):  Initial treatment, or recommencement of treatment, with ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis; and
(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS-subsidised therapy with ustekinumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 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 who have previously demonstrated a response to PBS-subsidised treatment with ustekinumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised ustekinumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 28 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 ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — initial treatment 1
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):  Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior 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
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
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 at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 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 is demonstrated in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) 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 application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 28 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):  Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with ustekinumab for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — initial treatment 2
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):  Initial treatment, or recommencement of treatment, with ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS-subsidised therapy with ustekinumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 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 who have previously demonstrated a response to PBS-subsidised treatment with ustekinumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised ustekinumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 28 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 ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total

1. Part 1 of Schedule 2, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg

omit from the column headed “Brand”: GenRx Diclofenac

1. Part 1 of Schedule 2, after item dealing with Methadone

insert in the columns in the order indicated:

Methylnaltrexone Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL Injection 3 . . Relistor

1. Part 2 of Schedule 2, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg

omit from the column headed “Brand”: GenRx Diclofenac

1. Part 2 of Schedule 2, after item dealing with Methadone

insert in the columns in the order indicated:

Methylnaltrexone	Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL	In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone Second and subsequent continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone, and where consultation with a palliative care specialist or service has occurred	Injection	7	3	Relistor
Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL	In compliance with authority procedures set out in subparagraph 11 (d): Continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone	Injection	7	..	Relistor

1. Part 1 of Schedule 3, item dealing with Amoxycillin in the form Capsule 250 mg (as trihydrate)

insert in alphabetical order in the column headed “Brand”: Amoxycillin-GA

1. Part 1 of Schedule 3, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg

omit from the column headed “Brand”: GenRx Diclofenac

1. Part 1 of Schedule 3, item dealing with Dicloxacillin in the form Capsule 250 mg (as sodium)

omit from the column headed “Brand”: Diclocil

1. Part 1 of Schedule 3, item dealing with Paracetamol in the form Tablet 500 mg

insert in alphabetical order in the column headed “Brand”: Generic Health Pty Ltd

1. Part 1 of Schedule 3, item dealing with Sodium Chloride in the form Injection 9 mg per mL, 10 mL

omit from the column headed “Manner of administration”: Injection          and substitute:    Injection/solvent for injectables

1. Part 2 of Schedule 3, item dealing with Paracetamol in the form Tablet 500 mg

insert in alphabetical order in the column headed “Brand”: Generic Health Pty Ltd