COMMONWEALTH OF AUSTRALIA
Instrument number PB 40 of 2009
Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953
I, LINDA JACKSON, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.
Dated 1 May 2009
LINDA JACKSON
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment determination — pharmaceutical benefits
1 Commencement
This instrument commences on 1 June 2009.
2 Amendment of PB 114 of 2008
Schedule 1 amends PB 114 of 2008.
Schedule 1 Amendments
[1] Part 1 of Schedule 1, item dealing with Amoxycillin in the form Capsule 250 mg (as trihydrate)
in the column headed “Brand” insert in alphabetical order:
Amoxycillin Sandoz
[2] Part 1 of Schedule 1, item dealing with Citalopram in the form Tablet 20 mg (as hydrobromide)
omit from the column headed “Brand”:
Citalopram Winthrop
[3] Part 1 of Schedule 1, omit item dealing with Efalizumab
[4] Part 1 of Schedule 1, item dealing with Enalapril in the form Tablet containing enalapril maleate 20 mg
omit from the column headed “Brand”:
Enalapril Winthrop
[5] Part 1 of Schedule 1, item dealing with Escitalopram in the forms Tablet 10 mg (as oxalate) and Tablet 20 mg
(as oxalate)
in the column headed “Brand” insert in alphabetical order:
Esitalo
[6] Part 1 of Schedule 1, item dealing with Etanercept in the forms Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL, Injection set containing 4 vials powder for injection 50 mg and
4 pre-filled syringes solvent 1 mL and Injections 50 mg in 1 mL single use pre-filled syringes, 4
omit from the column headed “Maximum Number of Repeats”:
2
and substitute:
3
[7] Part 1 of Schedule 1, item dealing with Fosinopril in the forms Tablet containing fosinopril sodium 10 mg and Tablet containing fosinopril sodium 20 mg
omit from the column headed “Brand”:
Fosinopril Winthrop
[8] Part 1 of Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing
fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg
omit from the column headed “Brand”:
Fosinopril/HCT Winthrop 10mg/12.5mg
[9] Part 1 of Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing
fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg
omit from the column headed “Brand”:
Fosinopril/HCT Winthrop 20mg/12.5mg
[10] Part 1 of Schedule 1, item dealing with Glucose Indicator―Blood
omit from the columns in the order indicated:
Electrode strips, 50 (GlucoCare Super Sensor)
For external use
2
5
GlucoCare Super Sensor
[11] Part 1 of Schedule 1, item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
in the column headed “Brand” insert in alphabetical order:
Omegapharm Irinotecan
[12] Part 1 of Schedule 1, item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
in the column headed “Brand” insert in alphabetical order:
Omegapharm Irinotecan
[13] Part 1 of Schedule 1, item dealing with Isotretinoin in the form Capsule 20 mg
(a) omit from the column headed “Brand”:
Chem mart Isotretinoin
(b) omit from the column headed “Brand”:
Terry White Chemists Isotretinoin
[14] Part 1 of Schedule 1, item dealing with Lisinopril in the forms Tablet 5 mg, Tablet 10 mg and Tablet 20 mg
in the column headed “Brand” insert in alphabetical order:
Lisinopril Ranbaxy
[15] Part 1 of Schedule 1, item dealing with Metoprolol succinate
omit from the columns in the order indicated:
Pack containing 15 tablets 23.75 mg (controlled release),
15 tablets 47.5 mg (controlled release) and 15 tablets
95 mg (controlled release)
Oral
1
. .
Toprol-XL Titration Pack
[16] Part 1 of Schedule 1, omit item dealing with Oestrogens―Conjugated
[17] Part 1 of Schedule 1, omit item dealing with Oestrogens―Conjugated with Medroxyprogesterone
[18] Part 1 of Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
insert in the columns in the order indicated:
Sachet containing granules 40 mg (as sodium sesquihydrate)
Oral
30
2
Somac
[19] Part 1 of Schedule 1, item dealing with Phenoxymethylpenicillin in the forms Capsule 250 mg phenoxymethylpenicillin (as potassium) and Capsule 500 mg phenoxymethylpenicillin (as potassium)
omit from the column headed “Brand”:
Penhexal VK
[20] Part 1 of Schedule 1, item dealing with Pravastatin in the forms Tablet containing pravastatin sodium 20 mg
and Tablet containing pravastatin sodium 40 mg
in the column headed “Brand” insert in alphabetical order:
APO-Pravastatin
[21] Part 1 of Schedule 1, item dealing with Propylthiouracil
omit from the column headed “Brand”:
Virgo Unit Trust
and substitute:
PTU
[22] Part 1 of Schedule 1, item dealing with Roxithromycin in the forms Tablet 150 mg and Tablet 300 mg
(a) in the column headed “Brand” insert in alphabetical order:
APO-Roxithromycin
(b) in the column headed “Brand” insert in alphabetical order:
Chem mart Roxithromycin
(c) in the column headed “Brand” insert in alphabetical order:
Terry White Chemists Roxithromycin
[23] Part 1 of Schedule 1, item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride)
in the column headed “Brand” insert in alphabetical order:
Sebifin 250
[24] Part 1 of Schedule 1, item dealing with Vinorelbine in the form Solution for I.V. infusion 10 mg (as tartrate) in 1 mL
omit from the column headed “Brand”:
Vinorelbine 10 Link
and substitute:
Vinorelbine Link
[25] Part 1 of Schedule 1, item dealing with Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL
omit from the column headed “Brand”:
Vinorelbine 50 Link
and substitute:
Vinorelbine Link
[26] Part 2 of Schedule 1, item dealing with Adalimumab, after the last instance of the form Injection 40 mg in 0.8 mL
pre-filled syringe and immediately before the first instance of the form Injection 40 mg in 0.8 mL
pre-filled pen
insert in the columns in the order indicated:
Injection 40 mg in 0.8 mL pre-filled syringe
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
2
4
Humira
(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 or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 16 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 adalimumab 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
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 adalimumab 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 adalimumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab 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 adalimumab 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 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 adalimumab 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 16 weeks, and where approval of the application would enable the patient to complete a course of 16 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 or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 16 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 adalimumab 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
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 adalimumab 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 adalimumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab 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 adalimumab 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 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 adalimumab 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 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Injection 40 mg in 0.8 mL pre-filled syringe
Chronic plaque psoriasis (whole body) — initial treatment 3
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 as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who:
Injection
2
5
Humira
(a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with adalimumab prior to 1 March 2009; and
(b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with adalimumab; 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 demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with adalimumab of psoriasis affecting the whole body; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition at baseline (prior to initiation of adalimumab therapy) and the most recent PASI assessment; 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;
the most recent PASI assessment is no more than 1 month old at the time of application;
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 as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and were receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (whole body) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — initial treatment 3
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 as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with adalimumab prior to 1 March 2009; and
(b) whose disease, prior to treatment with adalimumab, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and
(c) who 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) who have demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with adalimumab of psoriasis affecting the face, hand or foot; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of adalimumab therapy) and the most recent PASI assessment; 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;
the most recent PASI assessment is no more than 1 month old at the time of application;
the PASI assessment is performed on the same affected body area as assessed at baseline or prior to initiation of adalimumab treatment;
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 as systemic monotherapy (other than methotrexate) 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 were receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab 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
[27] Part 2 of Schedule 1, item dealing with Adalimumab, after the last instance of the form Injection 40 mg in
0.8 mL pre-filled pen and immediately before the item dealing with Adrenaline
insert in the columns in the order indicated:
Injection 40 mg in 0.8 mL pre-filled pen
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
2
4
Humira
(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 or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 16 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 adalimumab 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
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 adalimumab 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 adalimumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab 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 adalimumab 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 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 adalimumab 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 16 weeks, and where approval of the application would enable the patient to complete a course of 16 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 or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 16 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 adalimumab 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
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 adalimumab 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 adalimumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab 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 adalimumab 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 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 adalimumab 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 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Injection 40 mg in 0.8 mL pre-filled pen
Chronic plaque psoriasis (whole body) — initial treatment 3
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 as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who:
Injection
2
5
Humira
(a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with adalimumab prior to 1 March 2009; and
(b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with adalimumab; 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 demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with adalimumab of psoriasis affecting the whole body; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition at baseline (prior to initiation of adalimumab therapy) and the most recent PASI assessment; 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;
the most recent PASI assessment is no more than 1 month old at the time of application;
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 as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and were receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (whole body) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — initial treatment 3
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 as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with adalimumab prior to 1 March 2009; and
(b) whose disease, prior to treatment with adalimumab, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and
(c) who 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) who have demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with adalimumab of psoriasis affecting the face, hand or foot; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of adalimumab therapy) and the most recent PASI assessment; 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;
the most recent PASI assessment is no more than 1 month old at the time of application;
the PASI assessment is performed on the same affected body area as assessed at baseline or prior to initiation of adalimumab treatment;
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 as systemic monotherapy (other than methotrexate) 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 were receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab 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
[28] Part 2 of Schedule 1, omit item dealing with Efalizumab
[29] Part 2 of Schedule 1, item dealing with Etanercept, after the last instance of the form Injection set containing
4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL and immediately before the first instance of the form Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
insert in the columns in the order indicated:
Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
Chronic plaque psoriasis (whole body) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
Injection
2
5
Enbrel
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and
(c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and
(c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
[30] Part 2 of Schedule 1, item dealing with Etanercept, after the last instance of the form Injection set containing
4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL and immediately before the first instance of the form Injections 50 mg in 1 mL single use pre-filled syringes, 4
insert in the columns in the order indicated:
Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
Chronic plaque psoriasis (whole body) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
Injection
1
5
Enbrel
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and
(c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and
(c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
[31] Part 2 of Schedule 1, item dealing with Etanercept, after the last instance of the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 and immediately before the item dealing with Famciclovir
insert in the columns in the order indicated:
Injections 50 mg in
1 mL single use pre-filled syringes, 4
Chronic plaque psoriasis (whole body) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
Injection
1
5
Enbrel
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and
(c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and
(c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and
where biological agent means adalimumab, etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
[32] Part 2 of Schedule 1, item dealing with Glucose Indicator―Blood
omit from the columns in the order indicated:
Electrode strips, 50 (GlucoCare Super Sensor)
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
GlucoCare Super Sensor
[33] Part 2 of Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
insert in the columns in the order indicated:
Sachet containing granules 40 mg (as sodium sesquihydrate)
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
Oral
30
5
Somac
[34] Part 2 of Schedule 1, item dealing with Phenoxymethylpenicillin in the form Capsule 250 mg phenoxymethylpenicillin (as potassium)
omit fom the column headed “Brand”:
Penhexal VK
[35] Part 2 of Schedule 1, item dealing with Pravastatin in the forms Tablet containing pravastatin sodium 20 mg
and Tablet containing pravastatin sodium 40 mg
in the column headed “Brand” insert in alphabetical order:
APO-Pravastatin
[36] Part 2 of Schedule 1, item dealing with Terbinafine
in the column headed “Brand” insert in alphabetical order:
Sebifin 250
[37] Part 1 of Schedule 3, item dealing with Amoxycillin in the form Capsule 250 mg (as trihydrate)
in the column headed “Brand” insert in alphabetical order:
Amoxycillin Sandoz
[38] Part 1 of Schedule 3, item dealing with Phenoxymethylpenicillin in the forms Capsule 250 mg phenoxymethylpenicillin (as potassium) and Capsule 500 mg phenoxymethylpenicillin (as potassium)
omit from the column headed “Brand”:
Penhexal VK
