National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 6) (PB 67 of 2018) (Cth)

PB 67 of 2018

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 6)

National Health Act 1953

___________________________________________________________________________

I, JULIANNE QUAINE, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

Dated 30 JULY 2018

JULIANNE QUAINE

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 6).

(2)This Instrument may also be cited as PB 67 of 2018.

Commencement

This Instrument commences on 1 August 2018.

Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule 1 Amendments

Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 20 mg in 2 mL

omit from the column headed “Form”: Injection containing apomorphine hydrochloride 20 mg in 2 mL

substitute: Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL

Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL

omit from the column headed “Form”: Injection containing apomorphine hydrochloride 50 mg in 5 mL

substitute: Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 100 mg in 20 mL

omit from the column headed “Form”: Injection containing apomorphine hydrochloride 100 mg in 20 mL

substitute: Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL

Schedule 1, entry for Apomorphine in the form Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre filled syringe

omit from the column headed “Form”: Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre filled syringe

substitute: Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre filled syringe

Schedule 1, entry for Clozapine in the form Oral liquid 50 mg per mL, 100 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Versacloz PF EMP C4998 C5001 C5015 1 0 D

Schedule 1, after entry for Ganciclovir

insert:

Glecaprevir with pibrentasvir Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir Oral Maviret VE EMP C7593 C7594 C7615 P7593 84 1

C7593 C7594 C7615 P7615 84 2

C7593 C7594 C7615 P7594 84 3

Schedule 1, entry for Infliximab

(a)omit from the column headed “Circumstances” for the brand “Inflectra”: C7008 C7009 C7010 C7011

(b)insert in numerical order in the column headed “Circumstances” for the brand “Inflectra”: C7774 C7777 C7778 C7810 C7811 C7847

(c)omit from the column headed “Circumstances” for the brand “Remicade”: C7008 C7009 C7010 C7011

(d)insert in numerical order in the column headed “Circumstances” for the brand “Remicade”: C7777 C7778 C7788 C7810 C7811

(e)omit from the column headed “Circumstances” for the brand “Renflexis”: C7008 C7009 C7010 C7011

(f)insert in numerical order in the column headed “Circumstances” for the brand “Renflexis”: C7774 C7777 C7778 C7810 C7811 C7847

Schedule 1, entry for Lenalidomide in each of the forms: Capsule 5 mg; Capsule 10 mg; Capsule 15 mg; and Capsule 25 mg

(a)omit from the column headed “Circumstances”: C7380

(b)omit from the column headed “Circumstances”: C7404

(c)insert in numerical order in the column headed “Circumstances”: C7807 C7808

Schedule 1, entry for Levodopa with Carbidopa

omit from the column headed “Form”: Intestinal gel 20 mg-5 mg per mL ,100 mL

substitute: Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL

Schedule 1, entry for Nusinersen [Maximum Quantity: 1; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C7627 C7649 C7650 substitute: C7848 C7849 C7870

(b)omit from the column headed “Purposes”: P7627 P7649 substitute: P7848 P7870

Schedule 1, entry for Nusinersen [Maximum Quantity: 1; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C7627 C7649 C7650 substitute: C7848 C7849 C7870

(b)omit from the column headed “Purposes”: P7650 substitute: P7849

(c)omit from the column headed “Number of Repeats”: 1 substitute: 3

Schedule 1, entry for Pegfilgrastim

(a)omit from the column headed “Circumstances” (all brands): C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555

(b)insert in numerical order in the column headed “Circumstances” (all brands): C7822 C7823 C7843 C7862

Schedule 1, entry for Pomalidomide in each of the forms: Capsule 3 mg; and Capsule 4 mg

omit from the column headed “Circumstances”: C7391 C7407 substitute: C7791 C7792

Schedule 3, after entry for Ganciclovir

insert:

Glecaprevir with pibrentasvir C7593 P7593
Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 8 weeks.
Compliance with Authority Required procedures

C7594 P7594
Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 16 weeks.
Compliance with Authority Required procedures

C7615 P7615
Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.
Compliance with Authority Required procedures

Schedule 3, entry for Infliximab

(a)omit:

C7008 Fistulising Crohn disease — initial treatment 1
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has an externally draining enterocutaneous or rectovaginal fistula; 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 criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the most recent fistula assessment is no more than 1 month old at the time of application;
a course of initial treatment commencing a treatment cycle 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, subsequent authority applications for supplies sufficient to enable the patient to complete the initial course of 3 doses may be submitted by telephone
The authority application must be made in writing Compliance with Written Authority Required procedures

C7009 Fistulising Crohn disease — initial treatment 3
(previous infliximab treatment non-PBS-subsidised)
Commencement of a treatment cycle with an initial PBS-subsidised course of infliximab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who satisfies the following criteria:
(a) has a documented history of complex refractory fistulising Crohn disease and was receiving treatment with infliximab prior to 1 March 2010; and
(b) had a draining enterocutaneous or rectovaginal fistula(e) 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 criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) is receiving treatment with infliximab at the time of application; and
(e) has demonstrated or sustained an adequate response to treatment with infliximab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), 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 infliximab treatment is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;
the application for authorisation is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current and baseline Fistula Assessment form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the current fistula assessment is no more than 1 month old at the time of application;
the baseline fistula assessment is from immediately prior to commencing treatment with infliximab;
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 this restriction once only
The authority application must be made in writing Compliance with Written Authority Required procedures

C7010 Fistulising Crohn disease — initial treatment 2
(change or recommencement of PBS-subsidised treatment)
Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or infliximab for a draining enterocutaneous or rectovaginal fistula; and
(c) has not failed PBS-subsidised therapy with infliximab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where TNF-alfa antagonist means adalimumab or infliximab; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment;
the most recent fistula assessment is no more than 1 month old at the time of application;
to demonstrate a response to treatment the application must be accompanied by the results of the patient's most recent course of TNF-alfa antagonist therapy;
the assessment of response to the most recent course of TNF-alfa antagonist therapy must:
(a) be provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and
(b) have been made following a minimum of 12 weeks of treatment if the course of therapy was a 16-week initial course of adalimumab, and up to 12 weeks after the first dose (6 weeks following the third dose) if the course of therapy was a 3 dose initial course of infliximab;
if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF-alfa antagonist;
a course of initial treatment within an ongoing treatment cycle 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, subsequent authority applications for supplies sufficient to enable the patient to complete the initial course of 3 doses may be submitted by telephone
The authority application must be made in writing Compliance with Written Authority Required procedures

C7011 Fistulising Crohn disease — continuing treatment
Continuing PBS-subsidised treatment with infliximab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) has demonstrated or sustained an adequate response to treatment with infliximab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), 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 is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition;
the fistula assessment is no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 3 dose initial course, the assessment is made up to 12 weeks after the first dose (up to 6 weeks following the third dose);
where an assessment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab;
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;
patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response
The authority application must be made in writing Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C7774
Complex refractory Fistulising Crohn disease

Subsequent continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment.
Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
Compliance with Authority Required procedures

C7777
Complex refractory Fistulising Crohn disease

Balance of supply

Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment).
Compliance with Authority Required procedures

C7778
Complex refractory Fistulising Crohn disease

Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)

Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
The most recent fistula assessment must be no more than 1 month old at the time of application.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Compliance with Written Authority Required procedures

C7788
Complex refractory Fistulising Crohn disease

Subsequent continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
Compliance with Written Authority Required procedures

C7810
Complex refractory Fistulising Crohn disease

Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)

Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Compliance with Written Authority Required procedures

C7811
Complex refractory Fistulising Crohn disease

First continuing treatment

Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.
Up to a maximum of 2 repeats will be authorised.
Compliance with Written Authority Required procedures

C7847
Complex refractory Fistulising Crohn disease

Subsequent continuing treatment

Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
Compliance with Authority Required procedures - Streamlined Authority Code 7847

Schedule 3, entry for Lenalidomide

(a)omit:

C7380 Multiple myeloma
Continuing PBS-subsidised treatment
Patient must have previously received PBS-subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with dexamethasone; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues.
Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program. Compliance with Authority Required procedures

(b)omit:

C7404 Multiple myeloma
Initial PBS-subsidised treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma lenalidomide Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and
(3) a signed patient acknowledgment.
To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.
Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program. Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C7807
Multiple myeloma

Continuing PBS-subsidised treatment

Patient must have previously received PBS-subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with dexamethasone; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, carfilzomib or thalidomide or its analogues.
Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program.
Compliance with Authority Required procedures

C7808
Multiple myeloma

Initial PBS-subsidised treatment

The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, carfilzomib or thalidomide or its analogues.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma lenalidomide Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and
(3) a signed patient acknowledgment.
To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.
Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program.
Compliance with Written Authority Required procedures

Schedule 3, entry for Nusinersen

substitute:

Nusinersen C7848 P7848
Spinal muscular atrophy (SMA)

Grandfather patients

Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA.
Patient must have previously received non-PBS-subsidised treatment for this condition with this drug prior to 1 June 2018; AND
The condition must 5q homozygous deletion, mutation of, or compound heterozygous mutation in the SMN1 gene of type I, II or IIIa; AND
Patient must have had experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND
Patient must have previously received at least one of the four loading doses at days 0, 14, 28 and 63; AND
The treatment must be given concomitantly with standard of care for this condition; AND
The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.
Patient must have been 18 years of age or under at the time treatment with this drug was initiated for this condition; OR
Patient must have previously received treatment with this drug for this condition under the care of clinicians with the authorised prescriber number of AP17/83146.
Defined signs and symptoms of type I SMA are:
i) Onset before 6 months of age; and
ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or
iii) Proximal weakness; or
iv) Hypotonia; or
v) Absence of deep tendon reflexes; or
vi) Failure to gain weight appropriate for age; or
vii) Any active chronic neurogenic changes; or
viii) A compound muscle action potential below normative values for an age-matched child.
Defined signs and symptoms of type II SMA are:
i) Onset between 6 and 18 months; and
ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or
iii) Proximal weakness; or
iv) Weakness in trunk righting/derotation; or
v) Hypotonia; or
vi) Absence of deep tendon reflexes; or
vii) Failure to gain weight appropriate for age; or
viii) Any active chronic neurogenic changes; or
ix) A compound muscle action potential below normative values for an age-matched child.
Defined signs and symptoms of type IIIa SMA are:
i) Onset between 18 months and 3 years of age; and
ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or
iii) Proximal weakness; or
iv) Hypotonia; or
v) Absence of deep tendon reflexes; or
vi) Failure to gain weight appropriate for age; or
vii) Any active chronic neurogenic changes; or
viii) A compound muscle action potential below normative values for an age-matched child.
Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.
Recognised hospitals in the management of SMA are Lady Cilento Children's Hospital (Brisbane), Royal Children's Hospital Melbourne, Monash Children's Hospital (Melbourne), John Hunter Hospital (Newcastle), Sydney Children's Hospital Randwick, Children's Hospital at Westmead, Adelaide Women and Children's Hospital and Perth Children's Hospital.
Application for authorisation of grandfathering treatment must be in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Spinal muscular atrophy PBS Authority Application for Grandfather patients - Supporting Information Form which includes the following:
(i) specification of SMA type (I, II or IIIa); and
(ii) sign(s) and symptom(s) that the patient has experienced; and
(iii) patient's age at the onset of sign(s) and symptom(s); and
(iv) if relevant, a copy of a TGA-approval letter to clinician with the authorised prescriber number of AP17/83146.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
Compliance with Written Authority Required procedures

C7849 P7849
Spinal muscular atrophy (SMA)

Initial treatment - Loading doses

Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA.
The condition must 5q homozygous deletion, mutation of, or compound heterozygous mutation in the SMN1 gene of type I, II or IIIa; AND
Patient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND
The treatment must be given concomitantly with standard of care for this condition; AND
The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction.
Patient must be 18 years of age or under.
Defined signs and symptoms of type I SMA are:
i) Onset before 6 months of age; and
ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or
iii) Proximal weakness; or
iv) Hypotonia; or
v) Absence of deep tendon reflexes; or
vi) Failure to gain weight appropriate for age; or
vii) Any active chronic neurogenic changes; or
viii) A compound muscle action potential below normative values for an age-matched child.
Defined signs and symptoms of type II SMA are:
i) Onset between 6 and 18 months; and
ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or
iii) Proximal weakness; or
iv) Weakness in trunk righting/derotation; or
v) Hypotonia; or
vi) Absence of deep tendon reflexes; or
vii) Failure to gain weight appropriate for age; or
viii) Any active chronic neurogenic changes; or
ix) A compound muscle action potential below normative values for an age-matched child.
Defined signs and symptoms of type IIIa SMA are:
i) Onset between 18 months and 3 years of age; and
ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or
iii) Proximal weakness; or
iv) Hypotonia; or
v) Absence of deep tendon reflexes; or
vi) Failure to gain weight appropriate for age; or
vii) Any active chronic neurogenic changes; or
viii) A compound muscle action potential below normative values for an age-matched child.
Recognised hospitals in the management of SMA are Lady Cilento Children's Hospital (Brisbane), Royal Children's Hospital Melbourne, Monash Children's Hospital (Melbourne), John Hunter Hospital (Newcastle), Sydney Children's Hospital Randwick, Children's Hospital at Westmead, Adelaide Women and Children's Hospital and Perth Children's Hospital.
Application for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Spinal muscular atrophy PBS Authority Application - Supporting Information Form which includes the following:
i) specification of SMA type (I, II or IIIa); and
(ii) sign(s) and symptom(s) that the patient has experienced; and
(iii) patient's age at the onset of sign(s) and symptom(s).
Compliance with Written Authority Required procedures

C7870 C7870
Spinal muscular atrophy (SMA)

Continuing treatment - Maintenance

Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be given concomitantly with standard of care for this condition; AND
The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.
Recognised hospitals in the management of SMA are Lady Cilento Children's Hospital (Brisbane), Royal Children's Hospital Melbourne, Monash Children's Hospital (Melbourne), John Hunter Hospital (Newcastle), Sydney Children's Hospital Randwick, Children's Hospital at Westmead, Adelaide Women and Children's Hospital and Perth Children's Hospital.
Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.
Compliance with Written Authority Required procedures

Schedule 3, entry for Pegfilgrastim

substitute:

Pegfilgrastim C7822
Chemotherapy-induced neutropenia

Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.
Compliance with Authority Required procedures - Streamlined Authority Code 7822

C7823
Chemotherapy-induced neutropenia

Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.
Compliance with Authority Required procedures

C7843
Chemotherapy-induced neutropenia

Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.
Compliance with Authority Required procedures - Streamlined Authority Code 7843

C7862
Chemotherapy-induced neutropenia

Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.
Compliance with Authority Required procedures

Schedule 3, entry for Pomalidomide

substitute:

Pomalidomide C7791
Multiple myeloma

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease; AND
The treatment must be in combination with dexamethasone; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, carfilzomib or thalidomide or its analogues.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Patients receiving this drug under the PBS listing must be registered in the i-access risk management program.
Compliance with Authority Required procedures

C7792
Multiple myeloma

Initial treatment

The treatment must be in combination with dexamethasone; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must have experienced treatment failure with lenalidomide; AND
Patient must have experienced treatment failure with bortezomib; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, carfilzomib or thalidomide or its analogues.
Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma pomalidomide Authority Application Supporting Information form; and
(3) reports demonstrating the patient has failed treatment with lenalidomide and bortezomib.
Patients receiving this drug under the PBS listing must be registered in the i-access risk management program.
Compliance with Written Authority Required procedures

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Citations

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 6) (PB 67 of 2018) (Cth)

Cases Citing This Decision

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Cases Cited

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Statutory Material Cited

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Glecaprevir with pibrentasvir	Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir	Oral	Maviret	VE	EMP	C7593 C7594 C7615	P7593	84	1
						C7593 C7594 C7615	P7615	84	2
						C7593 C7594 C7615	P7594	84	3

C7008	Fistulising Crohn disease — initial treatment 1 Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who: (a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and (b) has an externally draining enterocutaneous or rectovaginal fistula; 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 criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and (ii) a signed patient acknowledgement; the most recent fistula assessment is no more than 1 month old at the time of application; a course of initial treatment commencing a treatment cycle 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, subsequent authority applications for supplies sufficient to enable the patient to complete the initial course of 3 doses may be submitted by telephone The authority application must be made in writing	Compliance with Written Authority Required procedures
C7009	Fistulising Crohn disease — initial treatment 3 (previous infliximab treatment non-PBS-subsidised) Commencement of a treatment cycle with an initial PBS-subsidised course of infliximab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who satisfies the following criteria: (a) has a documented history of complex refractory fistulising Crohn disease and was receiving treatment with infliximab prior to 1 March 2010; and (b) had a draining enterocutaneous or rectovaginal fistula(e) 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 criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and (d) is receiving treatment with infliximab at the time of application; and (e) has demonstrated or sustained an adequate response to treatment with infliximab; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), 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 infliximab treatment is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient; the application for authorisation is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) a completed current and baseline Fistula Assessment form including the date of assessment of the patient's condition; and (ii) a signed patient acknowledgement; the current fistula assessment is no more than 1 month old at the time of application; the baseline fistula assessment is from immediately prior to commencing treatment with infliximab; 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 this restriction once only The authority application must be made in writing	Compliance with Written Authority Required procedures
C7010	Fistulising Crohn disease — initial treatment 2 (change or recommencement of PBS-subsidised treatment) Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who: (a) has a documented history of complex refractory fistulising Crohn disease; and (b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or infliximab for a draining enterocutaneous or rectovaginal fistula; and (c) has not failed PBS-subsidised therapy with infliximab for this condition more than once in the current treatment cycle; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where TNF-alfa antagonist means adalimumab or infliximab; and where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and (ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment; the most recent fistula assessment is no more than 1 month old at the time of application; to demonstrate a response to treatment the application must be accompanied by the results of the patient's most recent course of TNF-alfa antagonist therapy; the assessment of response to the most recent course of TNF-alfa antagonist therapy must: (a) be provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and (b) have been made following a minimum of 12 weeks of treatment if the course of therapy was a 16-week initial course of adalimumab, and up to 12 weeks after the first dose (6 weeks following the third dose) if the course of therapy was a 3 dose initial course of infliximab; if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF-alfa antagonist; a course of initial treatment within an ongoing treatment cycle 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, subsequent authority applications for supplies sufficient to enable the patient to complete the initial course of 3 doses may be submitted by telephone The authority application must be made in writing	Compliance with Written Authority Required procedures
C7011	Fistulising Crohn disease — continuing treatment Continuing PBS-subsidised treatment with infliximab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who: (a) has a documented history of complex refractory fistulising Crohn disease; and (b) has demonstrated or sustained an adequate response to treatment with infliximab; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), 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 is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient; the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition; the fistula assessment is no more than 1 month old at the time of application; the assessment of the patient's response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 3 dose initial course, the assessment is made up to 12 weeks after the first dose (up to 6 weeks following the third dose); where an assessment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab; 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; patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response The authority application must be made in writing	Compliance with Written Authority Required procedures

C7774	Complex refractory Fistulising Crohn disease Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.	Compliance with Authority Required procedures
C7777	Complex refractory Fistulising Crohn disease Balance of supply Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received insufficient therapy with this drug for this condition under the Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment).	Compliance with Authority Required procedures
C7778	Complex refractory Fistulising Crohn disease Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and (ii) details of prior biological medicine treatment including details of date and duration of treatment. The most recent fistula assessment must be no more than 1 month old at the time of application. Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction. If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.	Compliance with Written Authority Required procedures
C7788	Complex refractory Fistulising Crohn disease Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition. The most recent fistula assessment must be no more than 1 month old at the time of application. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.	Compliance with Written Authority Required procedures
C7810	Complex refractory Fistulising Crohn disease Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have an externally draining enterocutaneous or rectovaginal fistula. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and (ii) a signed patient acknowledgement. The most recent fistula assessment must be no more than 1 month old at the time of application. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.	Compliance with Written Authority Required procedures
C7811	Complex refractory Fistulising Crohn disease First continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition. The most recent fistula assessment must be no more than 1 month old at the time of application. The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. A maximum of 24 weeks of treatment with this drug will be authorised under this restriction. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.	Compliance with Written Authority Required procedures
C7847	Complex refractory Fistulising Crohn disease Subsequent continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND Patient must have demonstrated an adequate response to treatment with this drug. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.	Compliance with Authority Required procedures - Streamlined Authority Code 7847

Pegfilgrastim	C7822	Chemotherapy-induced neutropenia Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND Patient must be at greater than 20% risk of developing febrile neutropenia; OR Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 7822
C7823	Chemotherapy-induced neutropenia Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND Patient must be at greater than 20% risk of developing febrile neutropenia; OR Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures
C7843	Chemotherapy-induced neutropenia Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 7843
C7862	Chemotherapy-induced neutropenia Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures