COMMONWEALTH OF AUSTRALIA
Instrument number PB 39 of 2009
Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953
Amendment determination under subsection 85(2A) 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 subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.
Dated 1 May 2009
 
 
 
LINDA JACKSON
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
 
Amendment declaration and determination — drugs and medicinal preparations
1              Commencement
                This instrument commences on 1 June 2009.
2              Amendment of PB 113 of 2008
                Schedule 1 amends PB 113 of 2008.
Schedule 1        Amendments
 
 
[1]               Schedule 1, item dealing with Adalimumab
in the column headed “Circumstances” insert after the existing text:
 

 
 
Chronic plaque psoriasis (whole body) — initial treatment 1

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 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 14 (d) (i) or 14 (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 14 (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 14 (d) (i) or 14 (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 (whole body) — initial treatment 3

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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:

 
 
 (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 14 (d) (i) or 14 (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 14 (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 14 (d) (i) or 14 (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 1

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 14 (d) (i) or 14 (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 14 (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 14 (d) (i) or 14 (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

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

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 14 (d) (i) or 14 (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 14 (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 14 (d) (i) or 14 (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

 
[2]               Schedule 1, omit item dealing with Efalizumab
[3]               Schedule 1, item dealing with Etanercept
omit from the column headed “Circumstances”:
 

 
 
Chronic plaque psoriasis

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 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 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 relevant restriction for continuing PBS-subsidised treatment; 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 efalizumab, 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 demonstrable 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 acknowledgement;

 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 12 weeks of treatment

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (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 this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total

 
 
Chronic plaque psoriasis

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept 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 etanercept for the treatment of this condition in the current Treatment Cycle; and

 
 
 where biological agent means efalizumab, 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 etanercept 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 12-week course of PBS-subsidised etanercept 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 12 weeks of treatment

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept 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 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total

 
 
Chronic plaque psoriasis

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 etanercept; and

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

 
 
 where biological agent means efalizumab, 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 baseline value for this Treatment Cycle established prior to biological agent treatment;

 
 
 the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;

 
 
 the assessment of response is conducted at the completion of the 12-week treatment course and is submitted to the Medicare Australia CEO no later than 1 month from the date the course of treatment ceased;

 
 
 patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless the response assessment is undertaken and submitted to the Medicare Australia CEO within the timeframes specified above;

 
 
 patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept are not eligible to commence further treatment with etanercept until they have completed a period free from PBS-subsidised biological agent therapy of at least 12 weeks duration, immediately following cessation of that course of 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 completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;

 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 12 weeks of treatment

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (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 this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total

 
 
Chronic plaque psoriasis

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 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 relevant restriction for continuing PBS-subsidised treatment; 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 efalizumab, 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 demonstrable 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 acknowledgement;

 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 12 weeks of treatment

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (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 this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total

 
 
Chronic plaque psoriasis

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept 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 etanercept for the treatment of this condition in the current Treatment Cycle; and

 
 
 where biological agent means efalizumab, 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 etanercept 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 12-week course of PBS-subsidised etanercept 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 12 weeks of treatment

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept 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 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total

 
 
Chronic plaque psoriasis

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 efalizumab, 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 baseline values established prior to biological agent treatment; or

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

 
 
 the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;

 
 
 the assessment of response is conducted at the completion of the 12-week treatment course and is submitted to the Medicare Australia CEO no later than 1 month from the date the course of treatment ceased;

 
 
 patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless the response assessment is undertaken and submitted to the Medicare Australia CEO within the timeframes specified above;

 
 
 patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept are not eligible to commence further treatment with etanercept until they have completed a period free from PBS-subsidised biological agent therapy of at least 12 weeks duration, immediately following cessation of that course of 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 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;

 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 12 weeks of treatment

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (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 this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total

 
and substitute:
 

 
 
Chronic plaque psoriasis (whole body) — initial treatment 1

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 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 14 (d) (i) or 14 (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 etanercept 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 14 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept 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 etanercept 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 etanercept 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 etanercept 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 14 (d) (i) or 14 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept 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 (whole body) — continuing treatment

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 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 14 (d) (i) or 14 (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) — initial treatment 1

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 14 (d) (i) or 14 (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 etanercept 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 14 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept 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 etanercept 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 etanercept 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 etanercept 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 14 (d) (i) or 14 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept 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

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

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (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 14 (d) (i) or 14 (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

 
[4]               Schedule 1, item dealing with Glucose Indicator—Blood
omit from the column headed “Circumstances”:
electrode strips, 50 (GlucoCare Super Sensor),   
[5]               Schedule 1, omit item dealing with Oestrogens—Conjugated
[6]               Schedule 1, omit item dealing with Oestrogens—Conjugated with Medroxyprogesterone
[7]               Schedule 1, item dealing with Pantoprazole
omit from the column headed “Circumstances”:
 
 
 
In respect of the tablet (enteric coated) 40 mg (as sodium sesquihydrate):
and substitute :
 
 
 
In respect of the tablet (enteric coated) 40 mg (as sodium sesquihydrate) and sachet containing granules 40 mg (as sodium sesquihydrate):
[8]       Schedule 2A, item dealing with Carbomer
move from its current position and insert below the item dealing with Brinzolamide
[9]       Schedule 3, omit item dealing with Medroxyprogesterone
[10]     Schedule 3, omit item dealing with Oestrogens—Conjugated