National Health Act 1953 - Amendment Special Arrangements under subsection 100(1) - Highly specialised drugs program (No. PB 73 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 73 of 2007

Amendment special arrangements under subsection 100(1) of the National Health Act 1953

I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.

Dated 6 Sept. 2007

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program

1 Commencement

This instrument commences on 1 October 2007.

2 Amendment of PB 53 of 2007

Schedule 1 amends PB 53 of 2007.

Schedule 1 Amendments

(section 2)

[1] Omit paragraph 14A(d)

and substitute with

(d) in the case of a prescription for the highly specialised drug “infliximab” for the treatment of patients with refractory Crohn’s disease, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for a single dose of 5 mg per kg;

(e) in the case of a prescription for the highly specialised drug “rituximab”, the supply of either two or four 500 mg vials of solution for intravenous infusion.

[2] Paragraph 14B

insert after paragraph 14B(g):

(h) in the case of a prescription for the highly specialised drug "infliximab" for the treatment of patients with refractory Crohn’s disease, up to 2 repeat supplies of the highly specialised drug.

[3] Schedule 1, item dealing with Infliximab

insert in the column headed “Circumstances” immediately after the existing circumstances:

Initial PBS-subsidised treatment by a gastroenterologist or paediatrician of a patient aged 6 to 17 years inclusive with moderate to severe refractory Crohn’s disease who satisfies the following criteria:
(a) has confirmed Crohn’s disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist; and
(b) whose parent or authorised guardian has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if the patient does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(c) has failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period;
(ii) an 8 week course of enteral nutrition;
(iii) immunosuppressive therapy including:
― azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
― 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
― methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens mentioned at (c) 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;
failure to achieve an adequate response is indicated by severity of disease activity which results in a Paediatric Crohn’s Disease Activity Index (PCDAI) Score greater than or equal to 30, 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;
the most recent PCDAI assessment is no more than 1 month old at the time of application;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn’s Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn’s Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient’s condition; and
(ii) details of previous systemic drug therapy (dosage, date of commencement and duration of therapy), or dates of enteral nutrition; and
(iii) the signed patient acknowledgement;
a course of initial treatment is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;
if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone;
a PCDAI assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course;
where a response assessment is not undertaken and submitted to the Medicare Australia CEO within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab
Continuing PBS-subsidised treatment by a gastroenterologist, paediatrician or consultant physician in consultation with a gastroenterologist, of a patient who:
	(a) has a documented history of moderate to severe refractory Crohn’s disease; and
(b) has demonstrated or sustained an adequate response to treatment with infliximab; and
(c) qualified for initial PBS-subsidised therapy as a paediatric patient aged from 6 to 17 years inclusive; and
where the following conditions apply:
an adequate response to infliximab treatment is defined as a reduction in Paediatric Crohn’s Disease Activity Index (PCDAI) Score by at least 15 points as compared to baseline and a total PCDAI score of 30 points or less;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn’s Disease PBS Authority Application - Supporting Information Form which includes the completed Paediatric Crohn’s Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient’s condition;
the PCDAI assessment is no more than 1 month old at the time of application;
if the application is the first application for continuing treatment with infliximab a PCDAI assessment of the patient’s response to the initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of this initial course of treatment;
the assessment of the patient’s response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;
where an assessment is not submitted to the Medicare Australia CEO within these timeframes the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab, despite demonstrating a response as defined above;
a course of continuing 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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;
patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response;
patients who fail to demonstrate or sustain a response to treatment with infliximab for Crohn’s disease as specified in the criteria for continuing treatment with infliximab are not eligible to receive PBS-subsidised treatment with this drug within 12 months of the date on which treatment was ceased
Initial PBS-subsidised supply for continuing treatment by a gastroenterologist, paediatrician or consultant physician in consultation with a gastroenterologist, of a patient aged 6 to 17 years inclusive who:
(a) has a documented history of moderate to severe refractory Crohn’s disease and was receiving treatment with infliximab prior to 4 July 2007; and
(b) had a Paediatric Crohn’s Disease Activity Index (PCDAI) Score of greater than 30 prior to commencing treatment with infliximab; and
(c) whose parent or authorised guardian has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the patient does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has demonstrated or sustained an adequate response to treatment with infliximab; and
where the following conditions apply:
an adequate response to infliximab treatment is defined as a reduction in Paediatric Crohn’s Disease Activity Index (PCDAI) Score by at least 15 points as compared to baseline and a total PCDAI score of 30 points or less;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn’s Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and baseline Paediatric Crohn’s Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient’s condition; and
(ii) the signed patient acknowledgement;
the current PCDAI assessment is no more than 1 month old at the time of application;
the baseline PCDAI assessment is from immediately prior to commencing treatment with infliximab;
where a baseline PCDAI assessment is not available the medical practitioner should telephone the Medicare Australia CEO to discuss;
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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;
a patient may qualify for PBS-subsidised treatment under this restriction once only;
the assessment of the patient’s response to this course of therapy must be made within the 4 weeks prior to completion of the course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;
where an assessment is not submitted to the Medicare Australia CEO within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab
Initial PBS-subsidised treatment by a gastroenterologist of a patient with severe refractory Crohn’s disease who satisfies the following criteria:

(a) has confirmed Crohn’s disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist; and

(b) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and

(ii) immunosuppressive therapy including:

― azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or

― 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or

― methotrexate at a dose of at least 15 mg weekly for 3 or more months; and

where the following conditions apply:

if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens mentioned at (c) 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;

failure to achieve an adequate response is indicated by a severity of disease activity which results in a Crohn’s Disease Activity Index (CDAI) Score greater than or equal to 300 as assessed, and is demonstrated in the patient at the time of the authority application;

all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;

the most recent CDAI assessment is no more than 1 month old at the time of application.

(i) the completed current Crohn’s Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient’s condition; and

(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and

(iii) the signed patient acknowledgement;

a course of initial treatment is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone;

a CDAI assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course;

where a response assessment is not undertaken and submitted to the Medicare Australia CEO within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab

Continuing PBS-subsidised treatment by a gastroenterologist, or consultant physician in consultation with a gastroenterologist, of a patient who:

(a) has a documented history of severe refractory Crohn’s disease; and

(b) has demonstrated or sustained an adequate response to treatment with infliximab; and

where the following conditions apply:

an adequate response to infliximab treatment is defined as a reduction in Crohn’s Disease Activity Index (CDAI) Score to a level no greater than 150;

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn’s Disease PBS Authority Application - Supporting Information Form which includes the completed Crohn’s Disease Activity Index (CDAI) Score calculation sheet along with the date of the assessment of the patient’s condition;

the CDAI assessment is no more than 1 month old at the time of application;

if the application is the first application for continuing treatment with infliximab a CDAI assessment of the patient’s response to the initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of this initial course of treatment;

the assessment of the patient’s response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;

where an assessment is not submitted to the Medicare Australia CEO within these timeframes the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab, despite demonstrating a response as defined above;

a course of continuing 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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response;

patients who fail to demonstrate or sustain a response to treatment with infliximab for Crohn’s disease as specified in the criteria for continuing treatment with infliximab are not eligible to receive PBS-subsidised treatment with this drug within 12 months of the date on which treatment was ceased

Initial PBS-subsidised treatment by a gastroenterologist of a patient with severe refractory Crohn’s disease who satisfies the following criteria:

(a) has confirmed Crohn’s disease defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist; and

(b) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy; and

(d) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

(e) has failed to achieve an adequate response to prior systemic drug therapy including:

(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and

(ii) immunosuppressive therapy including:

― azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or

― 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or

― methotrexate at a dose of at least 15 mg weekly for 3 or more months; and

where the following conditions apply:

if treatment with any of the drugs mentioned at (e) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens mentioned at (e) 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;

failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:

(a) have evidence of intestinal inflammation, including:

(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; and/or

(ii) faeces: higher than normal lactoferrin or calprotectin level; and/or

(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or

(b) be assessed clinically as being in a high faecal output state; and/or

(c) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of infliximab;

all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;

any 1 of the above criteria indicating failure to achieve an adequate response to prior therapy may be used to determine response to an initial course of infliximab treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction;

the same baseline criterion used to determine response to the initial course of infliximab treatment must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy;

(i) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and

(ii) reports and dates of the pathology or diagnostic imaging test or tests nominated as the response criterion, if relevant; and

(iii) date of the most recent clinical assessment; and

(iv) the signed patient acknowledgement;

all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;

a course of initial treatment is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

the assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course;

where a response assessment is not undertaken and submitted to the Medicare Australia CEO within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab

Continuing PBS-subsidised treatment by a gastroenterologist, or consultant physician in consultation with a gastroenterologist, of a patient who:

(a) has a documented history of severe refractory Crohn’s disease with intestinal inflammation and with short gut syndrome or with an ileostomy or colostomy; and

(b) has demonstrated or sustained an adequate response to treatment with infliximab; and

where the following conditions apply:

an adequate response to infliximab treatment is defined as:

(a) improvement of intestinal inflammation as demonstrated by:

(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or

(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or

(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or

(b) reversal of high faecal output state; or

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn’s Disease PBS Authority Application - Supporting Information Form which includes the reports and dates of the pathology or diagnostic imaging test or tests used to assess response to therapy or the date of clinical assessment;

the patient’s assessment is no more than 1 month old at the time of application;

if the application is the first application for continuing treatment with infliximab an assessment of the patient’s response to the initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of this initial course of treatment;

any 1 of the criteria indicating failure to achieve an adequate response to prior therapy may be used to determine response to an initial course of infliximab treatment and eligibility for continued therapy;

the same baseline criterion used to determine response to the initial course of infliximab treatment must be used to determine response, and thus eligibility for continued PBS-subsidised therapy, to all subsequent courses of continuing treatment;

a course of continuing treatment is limited to a maximum of 24 weeks of treatment;

patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response;

patients who fail to demonstrate or sustain a response to treatment with infliximab for Crohn’s disease as specified in the criteria for continuing treatment with infliximab are not eligible to recommence PBS-subsidised treatment with this drug within 12 months of the date on which treatment was ceased

Initial PBS-subsidised treatment by a gastroenterologist of a patient with severe refractory Crohn’s disease who satisfies the following criteria:

(a) has confirmed Crohn’s disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist; and

(b) has extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; and

(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

(d) has failed to achieve an adequate response to prior systemic therapy including:

(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and

(ii) immunosuppressive therapy including:

― azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or

― 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or

― methotrexate at a dose of at least 15 mg weekly for 3 or more months; and

where the following conditions apply:

if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens mentioned 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;

failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:

(a) have severity of disease activity which results in a Crohn’s Disease Activity Index (CDAI) Score greater than or equal to 220; and/or

(b) have evidence of active intestinal inflammation, including:

(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; and/or

(ii) faeces: higher than normal lactoferrin or calprotectin level; and/or

(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or

(d) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of infliximab;

all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;

(i) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and

(ii) (1) reports and dates of the pathology or diagnostic imaging test or tests nominated as the response criterion, if relevant; or

(2) the completed current Crohn’s Disease Activity Index (CDAI) calculation sheets including the dates of assessment of the patient’s condition, if relevant; and

(iii) date of the most recent clinical assessment; and

(iv) the signed patient acknowledgement;

all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;

a course of initial treatment is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

where a response assessment is not undertaken and submitted to the Medicare Australia CEO within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab

Continuing PBS-subsidised treatment by a gastroenterologist, or consultant physician in consultation with a gastroenterologist, of a patient who:

(a) has a documented history of severe refractory Crohn’s disease with extensive intestinal inflammation affecting more than 50cm of the small intestine; and

(b) has demonstrated or sustained an adequate response to treatment with infliximab; and

where the following conditions apply:

an adequate response to infliximab treatment is defined as:

(a) a reduction in Crohn’s Disease Activity Index (CDAI) Score to no greater than 150; or

(b) improvement of intestinal inflammation as demonstrated by:

(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or

(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or

(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or

(d) avoidance of the need for surgery or total parenteral nutrition (TPN);

(i) the completed Crohn’s Disease Activity Index (CDAI) Score calculation sheet along with the date of the assessment of the patient’s condition; or

(ii) the reports and dates of the pathology test or diagnostic imaging test or tests used to assess response to therapy; or

(iii) the date of clinical assessment;

the CDAI assessment, where relevant, is no more than 1 month old at the time of application;

a course of continuing treatment is limited to a maximum of 24 weeks of treatment;

patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response;

patients who fail to demonstrate or sustain a response to treatment with infliximab for Crohn’s disease as specified in the criteria for continuing treatment with infliximab are not eligible to recommence PBS-subsidised treatment with this drug within 12 months of the date on which treatment was ceased

Initial PBS-subsidised supply for continuing treatment by a gastroenterologist, or consultant physician in consultation with a gastroenterologist, of a patient who:

(a) has a documented history of severe refractory Crohn’s disease and was receiving treatment with infliximab prior to 7 March 2007; and

(b) had a Crohn’s Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with infliximab; and

(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

(d) has demonstrated or sustained an adequate response to treatment with infliximab; and

where the following conditions apply:

an adequate response to infliximab treatment is defined as a reduction in Crohn’s Disease Activity Index (CDAI) Score to no greater than 150;

(i) the completed current and baseline Crohn’s Disease Activity Index (CDAI) Score calculation sheet along with the date of the assessment of the patient’s condition; and

(ii) the signed patient acknowledgment;

the current CDAI assessment is no more than 1 month old at the time of application;

the baseline CDAI assessment is from immediately prior to commencing treatment with infliximab;

where a baseline CDAI assessment is not available the medical practitioner should telephone the Medicare Australia CEO to discuss;

the course of treatment is limited to a maximum of 24 weeks of treatment;

a patient may qualify for PBS-subsidised treatment under this restriction once only;

the assessment of the patient’s response to this course of therapy must be made within the 4 weeks prior to completion of the course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;

where an assessment is not submitted to the Medicare Australia CEO within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab

Initial PBS-subsidised supply for continuing treatment by a gastroenterologist, or consultant physician in consultation with a gastroenterologist, of a patient who:

(a) has a documented history of severe refractory Crohn’s disease and was receiving treatment with infliximab prior to 7 March 2007; and

(b) (1) has a history of extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; or

(2) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy with a documented history of intestinal inflammation; and

(d) has demonstrated or sustained an adequate response to treatment with infliximab according to the criteria included in the relevant continuation restriction; and

where the following conditions apply:

an adequate response to infliximab treatment is defined as:

(a) a reduction in Crohn’s Disease Activity Index (CDAI) Score to no greater then 150; or

(b) improvement of intestinal inflammation as demonstrated by:

(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or

(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or

(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or

(d) avoidance of the need for surgery or total parenteral nutrition (TPN);

the same criteria used to determine an inadequate response to prior treatment at baseline are used to determine response to treatment and eligibility for continuing therapy, according to the criteria included in the continuing treatment restriction;

(i) (1) the completed current and baseline Crohn’s Disease Activity Index (CDAI) Score calculation sheet, where relevant, along with the date of the assessment of the patient’s condition; or

(2) the reports and dates of the current and baseline pathology or diagnostic imaging tests in order to assess response to therapy; or

(3) the date of clinical assessment or assessments; and

(ii) the signed patient acknowledgement;

the patient’s assessment is no more than 1 month old at the time of application;

the baseline CDAI assessment, where applicable, is from immediately prior to

commencing treatment with infliximab;

where a baseline CDAI assessment is not available the medical practitioner should telephone the Medicare Australia CEO to discuss;

the course of treatment is limited to a maximum of 24 weeks of treatment;

a patient may qualify for PBS-subsidised treatment under this restriction once only;

[4] Schedule 2, item dealing with Clozapine in the forms Tablet 25 mg and Tablet 100 mg

omit from the column headed “Brand”

CloSyn