National Health (Highly specialised drugs program for public hospitals) Special Arrangements Amendment Instrument 2010 (No. 4) (No. PB 101 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 101 of 2010

National Health (Highly specialised drugs program for public hospitals) Special Arrangements Amendment Instrument 2010 (No. 4)

I, DAVID LEARMONTH, Deputy Secretary, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.

Dated 29^th October 2010

DAVID LEARMONTH

Deputy Secretary

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program for Public Hospitals

1 Commencement

This instrument commences on 1 November 2010.

2 Amendment of PB 63 of 2010

Schedule 1 amends PB 63 of 2010.

Schedule 1 Amendments

Section 3(1)
omit:

CAR drug (Complex Authority Required drug) means any of the following highly specialised drugs:

(a) abatacept;

(b) ambrisentan;

(c) bosentan;

(d) epoprostenol;

(e) etanercept;

(f) iloprost;

(g) infliximab;

(h) lenalidomide;

(i) rituximab;

(j) sildenafil;

(k) sitaxentan;

(l) tocilizumab.

and substitute:

CAR drug(Complex Authority Required drug) means any of the following highly specialised drugs:

(a) abatacept;

(b) adalimumab;

(c) ambrisentan;

(d) bosentan;

(e) epoprostenol;

(f) etanercept;

(g) iloprost;

(h) infliximab;

(i) lenalidomide;

(j) rituximab;

(k) sildenafil;

(l) sitaxentan;

(m) tocilizumab.

Section 8

After the words ‘A medical practitioner’

omit:

at a public hospital

Section 21(2)(g)

omit the fullstop and substitute a semicolon

After Section 21(2)(g)

insert the following paragraph:

(h) for adalimumab - a quantity of units that are sufficient, based on the weight of the patient, to provide for two doses.

Section 23(2)(a)

Omit:

(a)for etanercept:

(i)for the initial treatment of severe polyarticular course juvenile chronic arthritis – up to 3 repeat supplies; or

(ii)for the continuing treatment of severe polyarticular course juvenile chronic arthritis – up to 5 repeat supplies;

and substitute:

(a)for etanercept for the treatment of a patient with juvenile idiopathic arthritis in accordance with the circumstances mentioned in Schedule 1:

(i)if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised - up to 3 repeat supplies; or

(ii)If the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised - up to 5 repeat supplies;

Section 23(2)(l)

omit the fullstop and substitute a semicolon

After Section 23(2)(l)

insert the following paragraphs:

(m) for adalimumab for the treatment of a patient with juvenile idiopathic arthritis in accordance with the circumstances mentioned in Schedule 1:

(i)if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised - up to 3 repeat supplies; or

(ii)if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised - up to 5 repeat supplies.

Section 27(1)(a)

Omit:

abatacept, ambrisentan,

and substitute:

abatacept, adalimumab, ambrisentan,

Section 39(2)

Omit:

A paperless claim under this Subdivision does not apply to a claim for a prescription for an increased maximum quantity of a non-CAR drug or a repeat prescription for a non-CAR drug.

and substitute:

A paperless claim under this Subdivision does not apply to a claim for a prescription for more than the maximum quantity, or more than the maximum number of repeats, for a non-CAR drug.

Schedule 1, after item dealing with Abatacept

insert in the columns in the order indicated:

Adalimumab	Juvenile idiopathic arthritis — initial treatment 1 (new patient or patient recommencing after a break of more than 12 months)
Initial treatment commencing a treatment cycle, by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years:
(a) who has severe active juvenile idiopathic arthritis; and
(b) whose parent or authorised guardian has signed a patient acknowledgement; and
(c) who has not received PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(d) who has demonstrated either:
(i) severe intolerance of, or toxicity due to, methotrexate; or
(ii) failure to achieve an adequate response to 1 or more of the following treatment regimens:
— oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or
— oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
severe intolerance is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours;
toxicity is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis;
if treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application provides details of the contraindication;
if intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, the authority application provides details of this toxicity;
failure to achieve an adequate response is indicated by the following criteria and must be demonstrated in all patients at the time of the authority application:
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count assessment is performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and an acknowledgement signed by a parent or authorised guardian;
a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of adalimumab provided a minimum of 12 months have elapsed between the date the last PBS-subsidised bDMARD was stopped and the date of the first application under the new treatment cycle;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone
Juvenile idiopathic arthritis — initial treatment 2 (change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years who:
(a) has a documented history of severe active juvenile idiopathic arthritis; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with adalimumab in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS-subsidised adalimumab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone
Juvenile idiopathic arthritis — initial treatment 3
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years who:
(a) has a documented history of severe active juvenile idiopathic arthritis; and
(b) was receiving treatment with adalimumab prior to 1 March 2010; and
(c) has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and
(d) is receiving treatment with adalimumab at the time of application; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and an acknowledgement signed by a parent or authorised guardian;
the course of treatment is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone;
a patient is eligible for PBS-subsidised treatment under the above criteria once only
Juvenile idiopathic arthritis — continuing treatment
Continuing PBS-subsidised treatment with adalimumab within an ongoing treatment cycle, by a rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient:
(a) who has a documented history of severe active juvenile idiopathic arthritis; and
(b) who has demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle was with adalimumab; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
an adequate response to treatment is defined as:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same joints assessed to establish baseline joint count at the commencement of an initial course of treatment are assessed to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;
if the most recent course of adalimumab therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

Schedule 1, omit item dealing with Etanercept

and substitute:

Etanercept	In respect of the injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL:
Juvenile idiopathic arthritis — initial treatment 1 (new patient or patient recommencing after a break of more than 12 months)
Initial treatment commencing a treatment cycle, by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years:
(a) who has severe active juvenile idiopathic arthritis; and
(b) whose parent or authorised guardian has signed a patient acknowledgement; and
(c) who has not received PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(d) who has demonstrated either:
(i) severe intolerance of, or toxicity due to, methotrexate; or
(ii) failure to achieve an adequate response to 1 or more of the following treatment regimens:
— oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or
— oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
severe intolerance is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours;
toxicity is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis;
if treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application provides details of the contraindication;
if intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, the authority application provides details of this toxicity;
failure to achieve an adequate response is indicated by the following criteria and must be demonstrated in all patients at the time of the authority application:
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count assessment is performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and an acknowledgement signed by a parent or authorised guardian;
a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of etanercept provided a minimum of 12 months have elapsed between the date the last PBS-subsidised bDMARD was stopped and the date of the first application under the new treatment cycle;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone
Juvenile idiopathic arthritis — initial treatment 2 (change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years who:
(a) has a documented history of severe active juvenile idiopathic arthritis; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and
(c) has not failed PBS-subsidised therapy with etanercept for this condition more than once in the current treatment cycle; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with etanercept in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS-subsidised etanercept treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone
Juvenile idiopathic arthritis — continuing treatment
Continuing PBS-subsidised treatment with etanercept within an ongoing treatment cycle, by a rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient:
(a) who has a documented history of severe active juvenile idiopathic arthritis; and
(b) who has demonstrated an adequate response to treatment with etanercept; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle was with etanercept; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
an adequate response to treatment is defined as:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same joints assessed to establish baseline joint count at the commencement of an initial course of treatment are assessed to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;
if the most recent course of etanercept therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone
In respect of the injections 50 mg in 1 mL single use pre-filled syringes, 4 and the injection 50 mg in 1 mL single use auto-injector, 4:
Juvenile idiopathic arthritis — continuing treatment (patient 18 years or older)
Continuing PBS-subsidised treatment with etanercept within an ongoing treatment cycle, by a rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient 18 years or older:
(a) who has a documented history of severe active juvenile idiopathic arthritis; and
(b) who has demonstrated an adequate response to treatment with etanercept; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle was with etanercept; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
an adequate response to treatment is defined as:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same joints assessed to establish baseline joint count at the commencement of an initial course of treatment are assessed to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;
if the most recent course of etanercept therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

Schedule 2, after item dealing with Abatacept

insert in the columns in the order indicated:

Adalimumab	Injection 20 mg in 0.4 mL pre-filled syringe	Injection	2	. .	Humira
Injection 40 mg in 0.8 mL pre-filled syringe	Injection	2	. .	Humira
Injection 40 mg in 0.8 mL pre-filled pen	Injection	2	. .	Humira

Schedule 2, after item dealing with Tacrolimus in the form of Capsule 5 mg

insert in the columns in the order indicated:

Tacrolimus	Capsule 500 micrograms	Oral	60	5	Prograf XL
Capsule 1 mg	Oral	120	5	Prograf XL
Capsule 5 mg	Oral	60	5	Prograf XL

Schedule 2, after item dealing with Thalidomide in the form Capsule 50 mg

omit from the columns in the order indicated:

Capsule 100 mg

Oral

. .

Thalomid

Schedule 3, item dealing with Cyclosporin in the form Capsule 25 mg

omit from the column headed “Price claimed by manufacturer”:

40.93

and substitute:

40.11

Schedule 3, item dealing with Cyclosporin in the form Capsule 50 mg

omit from the column headed “Price claimed by manufacturer”:

84.20

and substitute:

82.52

Schedule 3, item dealing with Cyclosporin in the form Capsule 100 mg

omit from the column headed “Price claimed by manufacturer”:

170.50

and substitute:

167.09

Note

All legislative instruments and compilations are registered on the Federal Register of

Legislative Instruments kept under the Legislative Instruments Act 2003.

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Citations

National Health (Highly specialised drugs program for public hospitals) Special Arrangements Amendment Instrument 2010 (No. 4) (No. PB 101 of 2010) (Cth)

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