Moderate to severe ulcerative colitis
Treatment Phase: Initial treatment - Initial 1 (new patient)
Clinical criteria:
AND
-
Patient must have failed to achieve an adequate response to azathioprine at a dose
of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance
necessitating permanent treatment withdrawal; OR
-
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a
dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance
necessitating permanent treatment withdrawal; OR
-
Patient must have failed to achieve an adequate response to a tapered course of oral
steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over
a 6 week period or have intolerance necessitating permanent treatment withdrawal,
and followed by a failure to achieve an adequate response to 3 or more consecutive
months of treatment of an appropriately dosed thiopurine agent,
AND
-
Patient must have a Mayo clinic score greater than or equal to 6; OR
-
Patient must have a partial Mayo clinic score greater than or equal to 6, provided
the rectal bleeding and stool frequency subscores are both greater than or equal to
2 (endoscopy subscore is not required for a partial Mayo clinic score).
Treatment criteria:
-
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)].
The authority application must be made in writing and must include:
(1) details of the proposed prescription; and
(2) a completed authority application form relevant to the indication and treatment
phase (the latest version is located on the website specified in the Administrative
Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic 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).
All tests and assessments should be performed preferably whilst still on treatment,
but no longer than 4 weeks following cessation of the most recent prior conventional
treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks
old at the time of application.
An assessment of a patient's response to this initial course of treatment must be
conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient
will be deemed to have failed to respond to treatment with this drug, unless the patient
has experienced a serious adverse reaction of a severity resulting in the necessity
for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will
not be eligible to receive further PBS-subsidised treatment with this drug for this
condition within this treatment cycle. Serious adverse reaction of a severity resulting
in the necessity for permanent withdrawal of treatment is not considered as a treatment
failure.
If treatment with any of the above-mentioned drugs is contraindicated according to
the relevant TGA-approved Product Information, details must be provided at the time
of application.
If intolerance to treatment develops during the relevant period of use, which is of
a severity necessitating permanent treatment withdrawal, details of this toxicity
must be provided at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Note
TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
The following information applies to Pharmaceutical Benefits Scheme (PBS) benefits
for the indication of moderate to severe ulcerative colitis (MSUC). Patients are eligible
for one PBS-subsidised drug treatment indicated for MSUC at any one time.
Where the term 'biological medicine' appears in this note and restrictions, it refers
to any PBS benefit indicated for MSUC.
Some benefits are not biological medicines, but are small molecules. However, for
practical purposes, these benefits are included within the term 'biological medicine'.
From 1 July 2021, under the PBS, all adult patients will be able to commence a treatment
cycle where they may trial PBS-subsidised biological medicine without having to experience
a disease flare when swapping to one of the alternate agents. Under these arrangements,
within a single treatment cycle, a patient may continue to receive long-term treatment
with a PBS-subsidised biological medicine while they continue to show a response to
therapy.
A patient who received PBS-subsidised biological medicine treatment prior to 1 July
2021 is considered to have started their first cycle as of 1 July 2021. Within the
same treatment cycle, the same biological medicine cannot be trialled twice. Where
3 biological medicines have failed to provide the patient with an adequate response
a treatment cycle is considered complete. There must be a 5-year break in PBS-subsidised
therapy before starting the next cycle. The 5-year break is measured from the date
of the last approval for PBS-subsidised biological medicine treatment in the most
recent cycle to the date of the first application for Initial treatment with a PBS-subsidised
biological medicine under the new treatment cycle.
A serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment, including serious infusion or injection related reactions,
Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal
leukoencephalopathy and malignancy related to treatment with the biological medicine,
is not considered as a treatment failure.
Selecting the correct treatment phase listing when applying for authority approval:
(1) Initial treatment.
Apply under an Initial 1 treatment listing where the patient has never received a
biological medicine.
(2) Continuing treatment.
Under no circumstance is Continuing treatment to precede Initial treatment. An authority
application for Continuing treatment is not to be made on the same day as Initial
treatment.
(3) Changing therapy.
Apply under an Initial 2 treatment listing. The indices of disease severity (i.e.
Mayo clinic score or partial Mayo clinic score), or the prior corticosteroid therapy
and immunosuppressive therapy will not need to be restated. A patient may trial an
alternate biological medicine treatment at any time, regardless of whether they are
receiving therapy (initial or continuing) at the time of the application. However,
they cannot change to a particular biological medicine if they have failed to respond
to prior treatment with that drug once within the same treatment cycle. A response
assessment to the preceding supply of biological medicine must accompany this Initial
2 treatment authority application.
(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.
Apply under an Initial 3 treatment listing. Prior corticosteroid and immunosuppressive
therapies need not be re-trialled.
(5) Balance of supply.
Where the full number of repeat prescriptions have not been requested under any initial
or continuing listing, apply for the balance of the supply of the repeats under any
treatment phase listing containing the words "balance of supply".
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Special Pricing Arrangements apply.
Note
The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities,
including severity, which will be accepted where one is claimed.
Note
Any queries concerning the arrangements to prescribe may be directed to Services Australia
on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).
Prescribing information (including Authority Application forms and other relevant
documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au
Applications for authority to prescribe should be submitted online using the form
upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos
Or mailed to:
Services Australia
Complex Drugs
Reply Paid 9826
HOBART TAS 7001
Moderate to severe ulcerative colitis
Treatment Phase: Initial treatment - Initial 2 (change or recommencement of treatment
after a break in biological medicine of less than 5 years)
Clinical criteria:
AND
Treatment criteria:
-
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)].
The authority application must be made in writing and must include:
(1) details of the proposed prescription; and
(2) a completed authority application form relevant to the indication and treatment
phase (the latest version is located on the website specified in the Administrative
Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including
the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date
and duration of treatment.
An assessment of a patient's response to this initial course of treatment must be
conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient
will be deemed to have failed to respond to treatment with this drug, unless the patient
has experienced a serious adverse reaction of a severity resulting in the necessity
for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will
not be eligible to receive further PBS-subsidised treatment with this drug for this
condition within this treatment cycle. Serious adverse reaction of a severity resulting
in the necessity for permanent withdrawal of treatment is not considered as a treatment
failure.
A patient who fails to demonstrate a response to treatment with this drug under this
restriction will not be eligible to receive further PBS-subsidised treatment with
this drug in this treatment cycle. A patient may re-trial this drug after a minimum
of 5 years have elapsed between the date the last prescription for a PBS-subsidised
biological medicine was approved in this cycle and the date of the first application
under a new cycle under the initial 3 treatment restriction.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Note
TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
The following information applies to Pharmaceutical Benefits Scheme (PBS) benefits
for the indication of moderate to severe ulcerative colitis (MSUC). Patients are eligible
for one PBS-subsidised drug treatment indicated for MSUC at any one time.
Where the term 'biological medicine' appears in this note and restrictions, it refers
to any PBS benefit indicated for MSUC.
Some benefits are not biological medicines, but are small molecules. However, for
practical purposes, these benefits are included within the term 'biological medicine'.
From 1 July 2021, under the PBS, all adult patients will be able to commence a treatment
cycle where they may trial PBS-subsidised biological medicine without having to experience
a disease flare when swapping to one of the alternate agents. Under these arrangements,
within a single treatment cycle, a patient may continue to receive long-term treatment
with a PBS-subsidised biological medicine while they continue to show a response to
therapy.
A patient who received PBS-subsidised biological medicine treatment prior to 1 July
2021 is considered to have started their first cycle as of 1 July 2021. Within the
same treatment cycle, the same biological medicine cannot be trialled twice. Where
3 biological medicines have failed to provide the patient with an adequate response
a treatment cycle is considered complete. There must be a 5-year break in PBS-subsidised
therapy before starting the next cycle. The 5-year break is measured from the date
of the last approval for PBS-subsidised biological medicine treatment in the most
recent cycle to the date of the first application for Initial treatment with a PBS-subsidised
biological medicine under the new treatment cycle.
A serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment, including serious infusion or injection related reactions,
Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal
leukoencephalopathy and malignancy related to treatment with the biological medicine,
is not considered as a treatment failure.
Selecting the correct treatment phase listing when applying for authority approval:
(1) Initial treatment.
Apply under an Initial 1 treatment listing where the patient has never received a
biological medicine.
(2) Continuing treatment.
Under no circumstance is Continuing treatment to precede Initial treatment. An authority
application for Continuing treatment is not to be made on the same day as Initial
treatment.
(3) Changing therapy.
Apply under an Initial 2 treatment listing. The indices of disease severity (i.e.
Mayo clinic score or partial Mayo clinic score), or the prior corticosteroid therapy
and immunosuppressive therapy will not need to be restated. A patient may trial an
alternate biological medicine treatment at any time, regardless of whether they are
receiving therapy (initial or continuing) at the time of the application. However,
they cannot change to a particular biological medicine if they have failed to respond
to prior treatment with that drug once within the same treatment cycle. A response
assessment to the preceding supply of biological medicine must accompany this Initial
2 treatment authority application.
(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.
Apply under an Initial 3 treatment listing. Prior corticosteroid and immunosuppressive
therapies need not be re-trialled.
(5) Balance of supply.
Where the full number of repeat prescriptions have not been requested under any initial
or continuing listing, apply for the balance of the supply of the repeats under any
treatment phase listing containing the words "balance of supply".
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Special Pricing Arrangements apply.
Note
Any queries concerning the arrangements to prescribe may be directed to Services Australia
on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).
Prescribing information (including Authority Application forms and other relevant
documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au
Applications for authority to prescribe should be submitted online using the form
upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos
Or mailed to:
Services Australia
Complex Drugs
Reply Paid 9826
HOBART TAS 7001
Moderate to severe ulcerative colitis
Treatment Phase: Initial treatment - Initial 3 (recommencement of treatment after
a break in biological medicine of more than 5 years)
Clinical criteria:
AND
AND
-
Patient must have a Mayo clinic score greater than or equal to 6; OR
-
Patient must have a partial Mayo clinic score greater than or equal to 6, provided
the rectal bleeding and stool frequency subscores are both greater than or equal to
2 (endoscopy subscore is not required for a partial Mayo clinic score).
Treatment criteria:
-
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)].
The authority application must be made in writing and must include:
(1) details of the proposed prescription; and
(2) a completed authority application form relevant to the indication and treatment
phase (the latest version is located on the website specified in the Administrative
Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including
the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date
and duration of treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks
old at the time of application.
An assessment of a patient's response to this initial course of treatment must be
conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient
will be deemed to have failed to respond to treatment with this drug, unless the patient
has experienced a serious adverse reaction of a severity resulting in the necessity
for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will
not be eligible to receive further PBS-subsidised treatment with this drug for this
condition within this treatment cycle. Serious adverse reaction of a severity resulting
in the necessity for permanent withdrawal of treatment is not considered as a treatment
failure.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Note
TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
The following information applies to Pharmaceutical Benefits Scheme (PBS) benefits
for the indication of moderate to severe ulcerative colitis (MSUC). Patients are eligible
for one PBS-subsidised drug treatment indicated for MSUC at any one time.
Where the term 'biological medicine' appears in this note and restrictions, it refers
to any PBS benefit indicated for MSUC.
Some benefits are not biological medicines, but are small molecules. However, for
practical purposes, these benefits are included within the term 'biological medicine'.
From 1 July 2021, under the PBS, all adult patients will be able to commence a treatment
cycle where they may trial PBS-subsidised biological medicine without having to experience
a disease flare when swapping to one of the alternate agents. Under these arrangements,
within a single treatment cycle, a patient may continue to receive long-term treatment
with a PBS-subsidised biological medicine while they continue to show a response to
therapy.
A patient who received PBS-subsidised biological medicine treatment prior to 1 July
2021 is considered to have started their first cycle as of 1 July 2021. Within the
same treatment cycle, the same biological medicine cannot be trialled twice. Where
3 biological medicines have failed to provide the patient with an adequate response
a treatment cycle is considered complete. There must be a 5-year break in PBS-subsidised
therapy before starting the next cycle. The 5-year break is measured from the date
of the last approval for PBS-subsidised biological medicine treatment in the most
recent cycle to the date of the first application for Initial treatment with a PBS-subsidised
biological medicine under the new treatment cycle.
A serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment, including serious infusion or injection related reactions,
Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal
leukoencephalopathy and malignancy related to treatment with the biological medicine,
is not considered as a treatment failure.
Selecting the correct treatment phase listing when applying for authority approval:
(1) Initial treatment.
Apply under an Initial 1 treatment listing where the patient has never received a
biological medicine.
(2) Continuing treatment.
Under no circumstance is Continuing treatment to precede Initial treatment. An authority
application for Continuing treatment is not to be made on the same day as Initial
treatment.
(3) Changing therapy.
Apply under an Initial 2 treatment listing. The indices of disease severity (i.e.
Mayo clinic score or partial Mayo clinic score), or the prior corticosteroid therapy
and immunosuppressive therapy will not need to be restated. A patient may trial an
alternate biological medicine treatment at any time, regardless of whether they are
receiving therapy (initial or continuing) at the time of the application. However,
they cannot change to a particular biological medicine if they have failed to respond
to prior treatment with that drug once within the same treatment cycle. A response
assessment to the preceding supply of biological medicine must accompany this Initial
2 treatment authority application.
(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.
Apply under an Initial 3 treatment listing. Prior corticosteroid and immunosuppressive
therapies need not be re-trialled.
(5) Balance of supply.
Where the full number of repeat prescriptions have not been requested under any initial
or continuing listing, apply for the balance of the supply of the repeats under any
treatment phase listing containing the words "balance of supply".
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Special Pricing Arrangements apply.
Note
Any queries concerning the arrangements to prescribe may be directed to Services Australia
on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).
Prescribing information (including Authority Application forms and other relevant
documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au
Applications for authority to prescribe should be submitted online using the form
upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos
Or mailed to:
Services Australia
Complex Drugs
Reply Paid 9826
HOBART TAS 7001
Moderate to severe ulcerative colitis
Treatment Phase: Initial 1 (new patient) or Initial 2 (change or recommencement of
treatment after a break in biological medicine of less than 5 years) or Initial 3
(recommencement of treatment after a break in biological medicine of more than 5 years)
- balance of supply
Clinical criteria:
-
Patient must have received insufficient therapy with this drug for this condition
under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
-
Patient must have received insufficient therapy with this drug for this condition
under the Initial 2 (change or recommencement of treatment after a break in biological
medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
-
Patient must have received insufficient therapy with this drug for this condition
under the Initial 3 (recommencement of treatment after a break in biological medicine
of more than 5 years) restriction to complete 16 weeks treatment,
AND
Treatment criteria:
-
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)].
Note
TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
The following information applies to Pharmaceutical Benefits Scheme (PBS) benefits
for the indication of moderate to severe ulcerative colitis (MSUC). Patients are eligible
for one PBS-subsidised drug treatment indicated for MSUC at any one time.
Where the term 'biological medicine' appears in this note and restrictions, it refers
to any PBS benefit indicated for MSUC.
Some benefits are not biological medicines, but are small molecules. However, for
practical purposes, these benefits are included within the term 'biological medicine'.
From 1 July 2021, under the PBS, all adult patients will be able to commence a treatment
cycle where they may trial PBS-subsidised biological medicine without having to experience
a disease flare when swapping to one of the alternate agents. Under these arrangements,
within a single treatment cycle, a patient may continue to receive long-term treatment
with a PBS-subsidised biological medicine while they continue to show a response to
therapy.
A patient who received PBS-subsidised biological medicine treatment prior to 1 July
2021 is considered to have started their first cycle as of 1 July 2021. Within the
same treatment cycle, the same biological medicine cannot be trialled twice. Where
3 biological medicines have failed to provide the patient with an adequate response
a treatment cycle is considered complete. There must be a 5-year break in PBS-subsidised
therapy before starting the next cycle. The 5-year break is measured from the date
of the last approval for PBS-subsidised biological medicine treatment in the most
recent cycle to the date of the first application for Initial treatment with a PBS-subsidised
biological medicine under the new treatment cycle.
A serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment, including serious infusion or injection related reactions,
Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal
leukoencephalopathy and malignancy related to treatment with the biological medicine,
is not considered as a treatment failure.
Selecting the correct treatment phase listing when applying for authority approval:
(1) Initial treatment.
Apply under an Initial 1 treatment listing where the patient has never received a
biological medicine.
(2) Continuing treatment.
Under no circumstance is Continuing treatment to precede Initial treatment. An authority
application for Continuing treatment is not to be made on the same day as Initial
treatment.
(3) Changing therapy.
Apply under an Initial 2 treatment listing. The indices of disease severity (i.e.
Mayo clinic score or partial Mayo clinic score), or the prior corticosteroid therapy
and immunosuppressive therapy will not need to be restated. A patient may trial an
alternate biological medicine treatment at any time, regardless of whether they are
receiving therapy (initial or continuing) at the time of the application. However,
they cannot change to a particular biological medicine if they have failed to respond
to prior treatment with that drug once within the same treatment cycle. A response
assessment to the preceding supply of biological medicine must accompany this Initial
2 treatment authority application.
(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.
Apply under an Initial 3 treatment listing. Prior corticosteroid and immunosuppressive
therapies need not be re-trialled.
(5) Balance of supply.
Where the full number of repeat prescriptions have not been requested under any initial
or continuing listing, apply for the balance of the supply of the repeats under any
treatment phase listing containing the words "balance of supply".
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Special Pricing Arrangements apply.
Note
Applications for authorisation under this restriction may be made in real time using
the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone
by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m.
Monday to Friday).