Severe active rheumatoid arthritis
Treatment Phase: Initial treatment - Initial 1 (new patient)
Treatment criteria:
Clinical criteria:
AND
-
Patient must have failed, in the 24 months immediately prior to the date of the application,
to achieve an adequate response to a trial of at least 6 months of intensive treatment
with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3
months continuous treatment with at least 2 DMARDs, one of which must be methotrexate
at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine
at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily;
(iii) sulfasalazine at a dose of at least 2 g daily; OR
-
Patient must have failed, in the 24 months immediately prior to the date of the application,
to achieve an adequate response to a trial of at least 6 months of intensive treatment
with DMARDs which, if methotrexate is contraindicated according to the Therapeutic
Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20
mg weekly dose, must include at least 3 months continuous treatment with at least
2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily;
(ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose
of at least 2 g daily; OR
-
Patient must have failed, in the 24 months immediately prior to the date of the application,
to achieve an adequate response to a trial of at least 3 months of continuous treatment
with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine,
are contraindicated according to the relevant TGA-approved Product Information/cannot
be tolerated at the doses specified above in addition to having a contraindication
or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at
a minimum dose as mentioned above; OR
-
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate,
(ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide
details for each of the contraindications/severe intolerances claimed in the authority
application,
AND
Population criteria:
If methotrexate is contraindicated according to the TGA-approved product information
or cannot be tolerated at a 20 mg weekly dose, the application must include details
of the contraindication or intolerance including severity to methotrexate. The maximum
tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration
of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can
be met using single agents sequentially or by using one or more combinations of DMARDs,
however the time on treatment must be at least 6 months.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs
cannot be met because of contraindications and/or intolerances of a severity necessitating
permanent treatment withdrawal to all of the DMARDs specified above, details of the
contraindication or intolerance including severity and dose for each DMARD must be
provided in the authority application.
The following criteria indicate failure to achieve an adequate response to DMARD treatment
and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or
a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints;
or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of
passive movement, where pain and limitation of movement are due to active disease
and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month
intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no
more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application
must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone
dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the
past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable
reason.
Where the baseline active joint count is based on total active joints (i.e. more than
20 active joints), response must be determined according to the reduction in the total
number of active joints. Where the baseline is determined on total number of major
joints, the response must be determined on the total number of major joints. If only
an ESR or CRP level is provided with the initial application, the same marker must
be used to determine response.
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).
An assessment of a patient's response to this initial course of treatment must be
conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior
the completion of this course of treatment.
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 under this
restriction they will not be eligible to receive further PBS-subsidised treatment
with this drug for this condition.
Note
PBS AUTHORITY APPLICATIONS FOR SEVERE ACTIVE RHEUMATOID ARTHRITIS
The following information applies to Pharmaceutical Benefits Scheme (PBS) subsidy
of the biological medicines for adults with severe active rheumatoid arthritis. Where
the term biological medicine appears in the following notes and restrictions it refers
to all PBS benefits with the specific PBS indication of: 'severe active rheumatoid
arthritis'.
Some benefits are not biological medicines, but are small molecules. However, for
practical purposes, these benefits are included within the term 'biological medicine'.
Only one biological medicine is to be PBS-subsidised at any one time for rheumatoid
arthritis.
Upon 5 inadequate responses to biological medicines with the specific PBS indication
of 'severe active rheumatoid arthritis', further subsidy is to cease. Where a particular
biological medicine has provided an inadequate response, it must not be subsidised
again.
A serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment, including serious infusion or injection related reactions,
Stevens Johnson Syndrome, development of a demyelinating lesion, progressive multifocal
leukoencephalopathy and malignancy related to treatment with the biological medicine,
is not considered a treatment failure.
(1) Selecting the correct 'Treatment phase' listing to apply under
Initiating subsidy:
(i) Apply through 'Initial 1 treatment' where a patient has received no prior PBS-subsidised
biological medicine treatment; or
(ii) Apply through 'Initial 2 treatment' where one of the following occurs: (a) PBS-subsidised
treatment has at least been initiated through any Initial 1 listing, but the prescribed
biological medicine is changing, (b) there has been a break in biological medicine
of less than 24 months, but resumption of treatment is with the same biological medicine
last prescribed, (c) there has been a break in biological medicine of less than 24
months and resumption of treatment is with a different biological medicine to that
last prescribed, (d) treatment with rituximab has occurred within the past 24 months
and is the most recent therapy prescribed leading up to this authority application,
irrespective of the length in time elapsed between the 2 non-rituximab bDMARDs administered
before and after rituximab.
Initial 2 does not require markers of inflammation/joint count to be re-established
- those recorded in the first Initial 1 application can remain as baseline measures.
Prerequisite DMARD treatments need not be re-proven to be inadequate.
The prescribed biological medicine may be changed at any time, regardless of whether
the current prescribed biological medicine has been obtained through Initial treatment
or Continuing treatment. However, the change in biological medicine cannot be back
to the same biological medicine where that medicine has provided an inadequate response.
(iii) Apply through 'Initial 3 treatment' where treatment is recommencing following
a break in PBS-subsidised therapy of at least 24 months. Initial 3 requires current
markers of inflammation/joint count to be re-established. Prerequisite DMARD treatments
need not be re-proven to be inadequate. PBS-subsidised therapy in this instance can
include rituximab where prescribed as the most recent treatment - the 24 month break
in therapy is from the second dose of the prior rituximab course.
Response assessment to any course of PBS-subsidised biological therapy must follow
a minimum of 12 weeks of therapy. Applications made on the same day for Initial treatment
and Continuing treatment clearly do reflect this requirement.
Where a response assessment is not conducted with a 'Continuing treatment' application,
the biological medicine will be assumed to have failed, unless the patient has experienced
a serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment. Authority applications for patients who experienced adverse
reaction necessitating permanent treatment withdrawal should be submitted through
'Initial 2 treatment' or 'Initial 3 treatment'. Indicate where the adverse reaction
has occurred in the authority application.
Continuing subsidy:
Apply under a 'Continuing treatment' phase listing only where treatment has initiated
through an 'Initial treatment' listing and measures of disease control (i.e. ESR/CRP/joint
count) demonstrate response following at least 12 weeks of treatment. Continuing treatment
should never precede Initial treatment where the same biological medicine is being
prescribed.
The description of 'Continuing treatment' means 'Continuing treatment of severe rheumatoid
arthritis with the same biological medicine'. Where treatment of severe rheumatoid
arthritis is continuing with a different biological medicine, 'Continuing treatment'
is not to be interpreted as meaning 'Continuing treatment of severe rheumatoid arthritis
with a different biological medicine' - see 'Initial 2 treatment' where continuing
treatment is with a different biological medicine.
'Continuing treatment' is to be accessed repeatedly until the prescribed biological
medicine is either changed, stops providing an adequate response, or the patient takes
a break in treatment.
Where continuing treatment is divided into 'First continuing' and 'Subsequent continuing',
the next authority application following immediately after any 'Initial treatment'
authority application is to be through 'First continuing'. Following this, the next
authority application is to occur under the 'Subsequent continuing' treatment phase.
Assuming the drug continues to provide an adequate response, 'Subsequent continuing'
is to be accessed repeatedly until the prescribed biological medicine is either changed,
stops providing an adequate response, or the patient takes a break in treatment.
Balance of Supply listings:
Maximum quantities and the number of repeats stated in a PBS-listing are values that
prescribers may seek up to, but are not obligated to prescribe. From time to time,
there may be particular reasons why a prescriber may elect not to request the full
maximum quantity listed, or, the full number of repeat prescriptions. Where this occurs,
the intent of Balance of Supply treatment phase listings is to circumvent the need
for another written-only authority application to be completed, as a written-only
authority application may not be practical in terms of providing timely access to
continued treatment.
Apply under a 'Balance of Supply' treatment phase (where available) when either the
full maximum quantity or repeat prescriptions available under a particular treatment
phase, was not requested and where the biological medicine has had insufficient time
to demonstrate an adequate response. Where the preceding supply has been adequate
to provide at least 12 weeks of treatment and has resulted in an adequate response,
it may be more practical to access further treatment under 'Continuing treatment'.
(2) Baseline measurements to determine response.
Determination of response to treatment must be based on baseline measurements of the
joint count, ESR and/or CRP provided with the first authority application for a biological
medicine. However, prescribers may provide new baseline measurements demonstrating
elevation of both joint count and markers of inflammation any time that an initial
treatment authority application is provided and the eligibility for continuing treatment
must be assessed according to these revised baseline measurements.
To ensure consistency in determining response, the same indices of disease severity
used to establish baseline must be used for all subsequent continuing treatment applications.
Therefore, where an ESR or CRP level is provided at baseline, an ESR or CRP level
respectively must be used to determine response. Similarly, where the baseline active
joint count is based on total active joints (i.e. more than 20 active joints), response
must be determined according to the reduction in the total number of active joints.
Where the baseline is determined on total number of major joints, the response must
be determined on the total number of major joints.
Applications under the Initial 1 treatment restriction for a new patient must include
a joint count and ESR and/or CRP measured at the completion of the 6 month intensive
DMARD trial, but prior to ceasing DMARD therapy. The results must be no more than
4 weeks old at the time of application.
Applications under the Initial 3 treatment restriction for recommencement of treatment
after a break in biological medicine of more than 24 months must include a joint count
and ESR and/or CRP measurement that is no more than 4 weeks old at the time of application.
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
Severe active rheumatoid arthritis
Treatment Phase: Initial treatment - Initial 2 (change or recommencement of treatment
after a break in biological medicine of less than 24 months)
Treatment criteria:
Clinical criteria:
-
Patient must have received prior PBS-subsidised treatment with a biological medicine
for this condition; OR
-
Patient must have received prior PBS-subsidised treatment with a biological medicine
under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile
idiopathic arthritis indication,
AND
AND
AND
Population criteria:
Patients who have received PBS-subsided treatment for paediatric Severe active juvenile
idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition
has progressed to Rheumatoid arthritis may receive treatment through this restriction
using existing baseline scores.
Where a patient is changing from a biosimilar medicine for the treatment of this condition,
the prescriber must provide baseline disease severity indicators with this application,
in addition to the response assessment outlined below.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or
either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50%
from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by
at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of
passive movement, where pain and limitation of movement are due to active disease
and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who is either changing treatment from another biological
medicine to this drug or recommencing therapy with this drug after a treatment break
of less than 24 months, must be accompanied with details of the evidence of a response
to the patient's most recent course of PBS-subsidised biological medicine, within
the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the
assessment of response, conducted following a minimum of 12 weeks of therapy and no
later than 4 weeks from cessation of the most recent course of biological medicine.
It is recommended that an application for the continuing treatment be submitted no
later than 4 weeks from the date of completion of the most recent course of treatment.
This is to ensure treatment continuity for those who meet the continuing restriction.
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.
Where the baseline active joint count is based on total active joints (i.e. more than
20 active joints), response must be determined according to the reduction in the total
number of active joints. Where the baseline is determined on total number of major
joints, the response must be determined on the total number of major joints. If only
an ESR or CRP level is provided with the initial application, the same marker must
be used to determine response.
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).
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.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised
biological therapy treatment-free period of at least 22 weeks, immediately following
the second infusion, before swapping to an alternate biological medicine.
Note
PBS AUTHORITY APPLICATIONS FOR SEVERE ACTIVE RHEUMATOID ARTHRITIS
The following information applies to Pharmaceutical Benefits Scheme (PBS) subsidy
of the biological medicines for adults with severe active rheumatoid arthritis. Where
the term biological medicine appears in the following notes and restrictions it refers
to all PBS benefits with the specific PBS indication of: 'severe active rheumatoid
arthritis'.
Some benefits are not biological medicines, but are small molecules. However, for
practical purposes, these benefits are included within the term 'biological medicine'.
Only one biological medicine is to be PBS-subsidised at any one time for rheumatoid
arthritis.
Upon 5 inadequate responses to biological medicines with the specific PBS indication
of 'severe active rheumatoid arthritis', further subsidy is to cease. Where a particular
biological medicine has provided an inadequate response, it must not be subsidised
again.
A serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment, including serious infusion or injection related reactions,
Stevens Johnson Syndrome, development of a demyelinating lesion, progressive multifocal
leukoencephalopathy and malignancy related to treatment with the biological medicine,
is not considered a treatment failure.
(1) Selecting the correct 'Treatment phase' listing to apply under
Initiating subsidy:
(i) Apply through 'Initial 1 treatment' where a patient has received no prior PBS-subsidised
biological medicine treatment; or
(ii) Apply through 'Initial 2 treatment' where one of the following occurs: (a) PBS-subsidised
treatment has at least been initiated through any Initial 1 listing, but the prescribed
biological medicine is changing, (b) there has been a break in biological medicine
of less than 24 months, but resumption of treatment is with the same biological medicine
last prescribed, (c) there has been a break in biological medicine of less than 24
months and resumption of treatment is with a different biological medicine to that
last prescribed, (d) treatment with rituximab has occurred within the past 24 months
and is the most recent therapy prescribed leading up to this authority application,
irrespective of the length in time elapsed between the 2 non-rituximab bDMARDs administered
before and after rituximab.
Initial 2 does not require markers of inflammation/joint count to be re-established
- those recorded in the first Initial 1 application can remain as baseline measures.
Prerequisite DMARD treatments need not be re-proven to be inadequate.
The prescribed biological medicine may be changed at any time, regardless of whether
the current prescribed biological medicine has been obtained through Initial treatment
or Continuing treatment. However, the change in biological medicine cannot be back
to the same biological medicine where that medicine has provided an inadequate response.
(iii) Apply through 'Initial 3 treatment' where treatment is recommencing following
a break in PBS-subsidised therapy of at least 24 months. Initial 3 requires current
markers of inflammation/joint count to be re-established. Prerequisite DMARD treatments
need not be re-proven to be inadequate. PBS-subsidised therapy in this instance can
include rituximab where prescribed as the most recent treatment - the 24 month break
in therapy is from the second dose of the prior rituximab course.
Response assessment to any course of PBS-subsidised biological therapy must follow
a minimum of 12 weeks of therapy. Applications made on the same day for Initial treatment
and Continuing treatment clearly do reflect this requirement.
Where a response assessment is not conducted with a 'Continuing treatment' application,
the biological medicine will be assumed to have failed, unless the patient has experienced
a serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment. Authority applications for patients who experienced adverse
reaction necessitating permanent treatment withdrawal should be submitted through
'Initial 2 treatment' or 'Initial 3 treatment'. Indicate where the adverse reaction
has occurred in the authority application.
Continuing subsidy:
Apply under a 'Continuing treatment' phase listing only where treatment has initiated
through an 'Initial treatment' listing and measures of disease control (i.e. ESR/CRP/joint
count) demonstrate response following at least 12 weeks of treatment. Continuing treatment
should never precede Initial treatment where the same biological medicine is being
prescribed.
The description of 'Continuing treatment' means 'Continuing treatment of severe rheumatoid
arthritis with the same biological medicine'. Where treatment of severe rheumatoid
arthritis is continuing with a different biological medicine, 'Continuing treatment'
is not to be interpreted as meaning 'Continuing treatment of severe rheumatoid arthritis
with a different biological medicine' - see 'Initial 2 treatment' where continuing
treatment is with a different biological medicine.
'Continuing treatment' is to be accessed repeatedly until the prescribed biological
medicine is either changed, stops providing an adequate response, or the patient takes
a break in treatment.
Where continuing treatment is divided into 'First continuing' and 'Subsequent continuing',
the next authority application following immediately after any 'Initial treatment'
authority application is to be through 'First continuing'. Following this, the next
authority application is to occur under the 'Subsequent continuing' treatment phase.
Assuming the drug continues to provide an adequate response, 'Subsequent continuing'
is to be accessed repeatedly until the prescribed biological medicine is either changed,
stops providing an adequate response, or the patient takes a break in treatment.
Balance of Supply listings:
Maximum quantities and the number of repeats stated in a PBS-listing are values that
prescribers may seek up to, but are not obligated to prescribe. From time to time,
there may be particular reasons why a prescriber may elect not to request the full
maximum quantity listed, or, the full number of repeat prescriptions. Where this occurs,
the intent of Balance of Supply treatment phase listings is to circumvent the need
for another written-only authority application to be completed, as a written-only
authority application may not be practical in terms of providing timely access to
continued treatment.
Apply under a 'Balance of Supply' treatment phase (where available) when either the
full maximum quantity or repeat prescriptions available under a particular treatment
phase, was not requested and where the biological medicine has had insufficient time
to demonstrate an adequate response. Where the preceding supply has been adequate
to provide at least 12 weeks of treatment and has resulted in an adequate response,
it may be more practical to access further treatment under 'Continuing treatment'.
(2) Baseline measurements to determine response.
Determination of response to treatment must be based on baseline measurements of the
joint count, ESR and/or CRP provided with the first authority application for a biological
medicine. However, prescribers may provide new baseline measurements demonstrating
elevation of both joint count and markers of inflammation any time that an initial
treatment authority application is provided and the eligibility for continuing treatment
must be assessed according to these revised baseline measurements.
To ensure consistency in determining response, the same indices of disease severity
used to establish baseline must be used for all subsequent continuing treatment applications.
Therefore, where an ESR or CRP level is provided at baseline, an ESR or CRP level
respectively must be used to determine response. Similarly, where the baseline active
joint count is based on total active joints (i.e. more than 20 active joints), response
must be determined according to the reduction in the total number of active joints.
Where the baseline is determined on total number of major joints, the response must
be determined on the total number of major joints.
Applications under the Initial 1 treatment restriction for a new patient must include
a joint count and ESR and/or CRP measured at the completion of the 6 month intensive
DMARD trial, but prior to ceasing DMARD therapy. The results must be no more than
4 weeks old at the time of application.
Applications under the Initial 3 treatment restriction for recommencement of treatment
after a break in biological medicine of more than 24 months must include a joint count
and ESR and/or CRP measurement that is no more than 4 weeks old at the time of application.
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
Severe active rheumatoid arthritis
Treatment Phase: Initial treatment - Initial 3 (recommencement of treatment after
a break in biological medicine of more than 24 months)
Treatment criteria:
Clinical criteria:
AND
AND
AND
AND
-
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than
25 mm per hour; OR
-
The condition must have a C-reactive protein (CRP) level greater than 15 mg per L,
AND
AND
Population criteria:
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen
and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement
and restriction of passive movement, where pain and limitation of movement are due
to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at
the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application
must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone
dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the
past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable
reason.
Where the baseline active joint count is based on total active joints (i.e. more than
20 active joints), response must be determined according to the reduction in the total
number of active joints. Where the baseline is determined on total number of major
joints, the response must be determined on the total number of major joints. If only
an ESR or CRP level is provided with the initial application, the same marker must
be used to determine response.
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).
To demonstrate a response to treatment the application must be accompanied with the
assessment of response, conducted following a minimum of 12 weeks of therapy and no
later than 4 weeks from cessation of the most recent course of biological medicine.
It is recommended that an application for the continuing treatment be submitted no
later than 4 weeks from the date of completion of the most recent course of treatment.
This is to ensure treatment continuity for those who meet the continuing restriction.
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 under this
restriction they will not be eligible to receive further PBS-subsidised treatment
with this drug for this condition.
Note
PBS AUTHORITY APPLICATIONS FOR SEVERE ACTIVE RHEUMATOID ARTHRITIS
The following information applies to Pharmaceutical Benefits Scheme (PBS) subsidy
of the biological medicines for adults with severe active rheumatoid arthritis. Where
the term biological medicine appears in the following notes and restrictions it refers
to all PBS benefits with the specific PBS indication of: 'severe active rheumatoid
arthritis'.
Some benefits are not biological medicines, but are small molecules. However, for
practical purposes, these benefits are included within the term 'biological medicine'.
Only one biological medicine is to be PBS-subsidised at any one time for rheumatoid
arthritis.
Upon 5 inadequate responses to biological medicines with the specific PBS indication
of 'severe active rheumatoid arthritis', further subsidy is to cease. Where a particular
biological medicine has provided an inadequate response, it must not be subsidised
again.
A serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment, including serious infusion or injection related reactions,
Stevens Johnson Syndrome, development of a demyelinating lesion, progressive multifocal
leukoencephalopathy and malignancy related to treatment with the biological medicine,
is not considered a treatment failure.
(1) Selecting the correct 'Treatment phase' listing to apply under
Initiating subsidy:
(i) Apply through 'Initial 1 treatment' where a patient has received no prior PBS-subsidised
biological medicine treatment; or
(ii) Apply through 'Initial 2 treatment' where one of the following occurs: (a) PBS-subsidised
treatment has at least been initiated through any Initial 1 listing, but the prescribed
biological medicine is changing, (b) there has been a break in biological medicine
of less than 24 months, but resumption of treatment is with the same biological medicine
last prescribed, (c) there has been a break in biological medicine of less than 24
months and resumption of treatment is with a different biological medicine to that
last prescribed, (d) treatment with rituximab has occurred within the past 24 months
and is the most recent therapy prescribed leading up to this authority application,
irrespective of the length in time elapsed between the 2 non-rituximab bDMARDs administered
before and after rituximab.
Initial 2 does not require markers of inflammation/joint count to be re-established
- those recorded in the first Initial 1 application can remain as baseline measures.
Prerequisite DMARD treatments need not be re-proven to be inadequate.
The prescribed biological medicine may be changed at any time, regardless of whether
the current prescribed biological medicine has been obtained through Initial treatment
or Continuing treatment. However, the change in biological medicine cannot be back
to the same biological medicine where that medicine has provided an inadequate response.
(iii) Apply through 'Initial 3 treatment' where treatment is recommencing following
a break in PBS-subsidised therapy of at least 24 months. Initial 3 requires current
markers of inflammation/joint count to be re-established. Prerequisite DMARD treatments
need not be re-proven to be inadequate. PBS-subsidised therapy in this instance can
include rituximab where prescribed as the most recent treatment - the 24 month break
in therapy is from the second dose of the prior rituximab course.
Response assessment to any course of PBS-subsidised biological therapy must follow
a minimum of 12 weeks of therapy. Applications made on the same day for Initial treatment
and Continuing treatment clearly do reflect this requirement.
Where a response assessment is not conducted with a 'Continuing treatment' application,
the biological medicine will be assumed to have failed, unless the patient has experienced
a serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment. Authority applications for patients who experienced adverse
reaction necessitating permanent treatment withdrawal should be submitted through
'Initial 2 treatment' or 'Initial 3 treatment'. Indicate where the adverse reaction
has occurred in the authority application.
Continuing subsidy:
Apply under a 'Continuing treatment' phase listing only where treatment has initiated
through an 'Initial treatment' listing and measures of disease control (i.e. ESR/CRP/joint
count) demonstrate response following at least 12 weeks of treatment. Continuing treatment
should never precede Initial treatment where the same biological medicine is being
prescribed.
The description of 'Continuing treatment' means 'Continuing treatment of severe rheumatoid
arthritis with the same biological medicine'. Where treatment of severe rheumatoid
arthritis is continuing with a different biological medicine, 'Continuing treatment'
is not to be interpreted as meaning 'Continuing treatment of severe rheumatoid arthritis
with a different biological medicine' - see 'Initial 2 treatment' where continuing
treatment is with a different biological medicine.
'Continuing treatment' is to be accessed repeatedly until the prescribed biological
medicine is either changed, stops providing an adequate response, or the patient takes
a break in treatment.
Where continuing treatment is divided into 'First continuing' and 'Subsequent continuing',
the next authority application following immediately after any 'Initial treatment'
authority application is to be through 'First continuing'. Following this, the next
authority application is to occur under the 'Subsequent continuing' treatment phase.
Assuming the drug continues to provide an adequate response, 'Subsequent continuing'
is to be accessed repeatedly until the prescribed biological medicine is either changed,
stops providing an adequate response, or the patient takes a break in treatment.
Balance of Supply listings:
Maximum quantities and the number of repeats stated in a PBS-listing are values that
prescribers may seek up to, but are not obligated to prescribe. From time to time,
there may be particular reasons why a prescriber may elect not to request the full
maximum quantity listed, or, the full number of repeat prescriptions. Where this occurs,
the intent of Balance of Supply treatment phase listings is to circumvent the need
for another written-only authority application to be completed, as a written-only
authority application may not be practical in terms of providing timely access to
continued treatment.
Apply under a 'Balance of Supply' treatment phase (where available) when either the
full maximum quantity or repeat prescriptions available under a particular treatment
phase, was not requested and where the biological medicine has had insufficient time
to demonstrate an adequate response. Where the preceding supply has been adequate
to provide at least 12 weeks of treatment and has resulted in an adequate response,
it may be more practical to access further treatment under 'Continuing treatment'.
(2) Baseline measurements to determine response.
Determination of response to treatment must be based on baseline measurements of the
joint count, ESR and/or CRP provided with the first authority application for a biological
medicine. However, prescribers may provide new baseline measurements demonstrating
elevation of both joint count and markers of inflammation any time that an initial
treatment authority application is provided and the eligibility for continuing treatment
must be assessed according to these revised baseline measurements.
To ensure consistency in determining response, the same indices of disease severity
used to establish baseline must be used for all subsequent continuing treatment applications.
Therefore, where an ESR or CRP level is provided at baseline, an ESR or CRP level
respectively must be used to determine response. Similarly, where the baseline active
joint count is based on total active joints (i.e. more than 20 active joints), response
must be determined according to the reduction in the total number of active joints.
Where the baseline is determined on total number of major joints, the response must
be determined on the total number of major joints.
Applications under the Initial 1 treatment restriction for a new patient must include
a joint count and ESR and/or CRP measured at the completion of the 6 month intensive
DMARD trial, but prior to ceasing DMARD therapy. The results must be no more than
4 weeks old at the time of application.
Applications under the Initial 3 treatment restriction for recommencement of treatment
after a break in biological medicine of more than 24 months must include a joint count
and ESR and/or CRP measurement that is no more than 4 weeks old at the time of application.
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
Severe active rheumatoid arthritis
Treatment Phase: Balance of supply - Initial 1 (new patient) or Initial 2 (change
or recommencement of treatment after a break in biological medicine of less than 24
months) or Initial 3 (recommencement of treatment after a break in biological medicine
of more than 24 months)
Treatment criteria:
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 24 months) 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 24 months) to complete 16 weeks of treatment,
AND
Note
PBS AUTHORITY APPLICATIONS FOR SEVERE ACTIVE RHEUMATOID ARTHRITIS
The following information applies to Pharmaceutical Benefits Scheme (PBS) subsidy
of the biological medicines for adults with severe active rheumatoid arthritis. Where
the term biological medicine appears in the following notes and restrictions it refers
to all PBS benefits with the specific PBS indication of: 'severe active rheumatoid
arthritis'.
Some benefits are not biological medicines, but are small molecules. However, for
practical purposes, these benefits are included within the term 'biological medicine'.
Only one biological medicine is to be PBS-subsidised at any one time for rheumatoid
arthritis.
Upon 5 inadequate responses to biological medicines with the specific PBS indication
of 'severe active rheumatoid arthritis', further subsidy is to cease. Where a particular
biological medicine has provided an inadequate response, it must not be subsidised
again.
A serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment, including serious infusion or injection related reactions,
Stevens Johnson Syndrome, development of a demyelinating lesion, progressive multifocal
leukoencephalopathy and malignancy related to treatment with the biological medicine,
is not considered a treatment failure.
(1) Selecting the correct 'Treatment phase' listing to apply under
Initiating subsidy:
(i) Apply through 'Initial 1 treatment' where a patient has received no prior PBS-subsidised
biological medicine treatment; or
(ii) Apply through 'Initial 2 treatment' where one of the following occurs: (a) PBS-subsidised
treatment has at least been initiated through any Initial 1 listing, but the prescribed
biological medicine is changing, (b) there has been a break in biological medicine
of less than 24 months, but resumption of treatment is with the same biological medicine
last prescribed, (c) there has been a break in biological medicine of less than 24
months and resumption of treatment is with a different biological medicine to that
last prescribed, (d) treatment with rituximab has occurred within the past 24 months
and is the most recent therapy prescribed leading up to this authority application,
irrespective of the length in time elapsed between the 2 non-rituximab bDMARDs administered
before and after rituximab.
Initial 2 does not require markers of inflammation/joint count to be re-established
- those recorded in the first Initial 1 application can remain as baseline measures.
Prerequisite DMARD treatments need not be re-proven to be inadequate.
The prescribed biological medicine may be changed at any time, regardless of whether
the current prescribed biological medicine has been obtained through Initial treatment
or Continuing treatment. However, the change in biological medicine cannot be back
to the same biological medicine where that medicine has provided an inadequate response.
(iii) Apply through 'Initial 3 treatment' where treatment is recommencing following
a break in PBS-subsidised therapy of at least 24 months. Initial 3 requires current
markers of inflammation/joint count to be re-established. Prerequisite DMARD treatments
need not be re-proven to be inadequate. PBS-subsidised therapy in this instance can
include rituximab where prescribed as the most recent treatment - the 24 month break
in therapy is from the second dose of the prior rituximab course.
Response assessment to any course of PBS-subsidised biological therapy must follow
a minimum of 12 weeks of therapy. Applications made on the same day for Initial treatment
and Continuing treatment clearly do reflect this requirement.
Where a response assessment is not conducted with a 'Continuing treatment' application,
the biological medicine will be assumed to have failed, unless the patient has experienced
a serious adverse reaction of a severity resulting in the necessity for permanent
withdrawal of treatment. Authority applications for patients who experienced adverse
reaction necessitating permanent treatment withdrawal should be submitted through
'Initial 2 treatment' or 'Initial 3 treatment'. Indicate where the adverse reaction
has occurred in the authority application.
Continuing subsidy:
Apply under a 'Continuing treatment' phase listing only where treatment has initiated
through an 'Initial treatment' listing and measures of disease control (i.e. ESR/CRP/joint
count) demonstrate response following at least 12 weeks of treatment. Continuing treatment
should never precede Initial treatment where the same biological medicine is being
prescribed.
The description of 'Continuing treatment' means 'Continuing treatment of severe rheumatoid
arthritis with the same biological medicine'. Where treatment of severe rheumatoid
arthritis is continuing with a different biological medicine, 'Continuing treatment'
is not to be interpreted as meaning 'Continuing treatment of severe rheumatoid arthritis
with a different biological medicine' - see 'Initial 2 treatment' where continuing
treatment is with a different biological medicine.
'Continuing treatment' is to be accessed repeatedly until the prescribed biological
medicine is either changed, stops providing an adequate response, or the patient takes
a break in treatment.
Where continuing treatment is divided into 'First continuing' and 'Subsequent continuing',
the next authority application following immediately after any 'Initial treatment'
authority application is to be through 'First continuing'. Following this, the next
authority application is to occur under the 'Subsequent continuing' treatment phase.
Assuming the drug continues to provide an adequate response, 'Subsequent continuing'
is to be accessed repeatedly until the prescribed biological medicine is either changed,
stops providing an adequate response, or the patient takes a break in treatment.
Balance of Supply listings:
Maximum quantities and the number of repeats stated in a PBS-listing are values that
prescribers may seek up to, but are not obligated to prescribe. From time to time,
there may be particular reasons why a prescriber may elect not to request the full
maximum quantity listed, or, the full number of repeat prescriptions. Where this occurs,
the intent of Balance of Supply treatment phase listings is to circumvent the need
for another written-only authority application to be completed, as a written-only
authority application may not be practical in terms of providing timely access to
continued treatment.
Apply under a 'Balance of Supply' treatment phase (where available) when either the
full maximum quantity or repeat prescriptions available under a particular treatment
phase, was not requested and where the biological medicine has had insufficient time
to demonstrate an adequate response. Where the preceding supply has been adequate
to provide at least 12 weeks of treatment and has resulted in an adequate response,
it may be more practical to access further treatment under 'Continuing treatment'.
(2) Baseline measurements to determine response.
Determination of response to treatment must be based on baseline measurements of the
joint count, ESR and/or CRP provided with the first authority application for a biological
medicine. However, prescribers may provide new baseline measurements demonstrating
elevation of both joint count and markers of inflammation any time that an initial
treatment authority application is provided and the eligibility for continuing treatment
must be assessed according to these revised baseline measurements.
To ensure consistency in determining response, the same indices of disease severity
used to establish baseline must be used for all subsequent continuing treatment applications.
Therefore, where an ESR or CRP level is provided at baseline, an ESR or CRP level
respectively must be used to determine response. Similarly, where the baseline active
joint count is based on total active joints (i.e. more than 20 active joints), response
must be determined according to the reduction in the total number of active joints.
Where the baseline is determined on total number of major joints, the response must
be determined on the total number of major joints.
Applications under the Initial 1 treatment restriction for a new patient must include
a joint count and ESR and/or CRP measured at the completion of the 6 month intensive
DMARD trial, but prior to ceasing DMARD therapy. The results must be no more than
4 weeks old at the time of application.
Applications under the Initial 3 treatment restriction for recommencement of treatment
after a break in biological medicine of more than 24 months must include a joint count
and ESR and/or CRP measurement that is no more than 4 weeks old at the time of application.
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).