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Item |
Description |
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1 |
Can a patient under 18 on etanercept be approved for continuing treatment?
No. A patient under 18 can be approved for initial 16 weeks of treatment and then 8 weeks of completion of course. There is no ongoing continuing treatment.
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2 |
Does the patient need 12 weeks of treatment before a first continuing application?
Yes. The patient needs to have at least 12 weeks of treatment to demonstrate a response. The onus is on the prescriber to indicate that the assessment has been performed within the correct timeframe. OPA approval/dispensing history can be used to answer a timeframe question in OPA if this is the only information that has not been provided.
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3 |
Is there a limit of treatment failures with a biologic medicine for a patient with this condition?
Yes. For this condition, if a patient fails or ceases to respond to a PBS-subsidised biologic medicine 3 times, they will be ineligible to receive further PBS-subsidised treatment for 5 years from their last approval.
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4 |
Can a patient who has been on treatment overseas be approved for continuing PBS treatment?
No. All patients must be able to meet the initial PBS criteria at the time of application. Refer all enquiries to a Pharmaceutical Adviser.
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5 |
Does a switch from infliximab i.v. to infliximab s.c. require a change application?
No. Switching formulation is not considered a change of medication. Where there is already an approved authority prescription for the IV formulation, an authority application for the SC can be made under either:
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Balance of Supply - if the treatment phase (Initial, First Continuing, or Subsequent Continuing) is yet to be completed; the following authority application is to be under the Continuing treatment. This request can be made in real time using the Online PBS Authorities (OPA) system or by phone
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Continuing treatment - if a treatment phase is concluding/has concluded and an assessment of the patient has been completed. This request can be made using OPA system or in writing using the Severe chronic plaque psoriasis - continuing authority application form (PB113)
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6 |
What is the maximum dose for infliximab i.v.?
5 mg/kg every 8 weeks after the initial load.
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7 |
Can a patient start PBS infliximab treatment with the SC form?
No, patient must have a concurrent PBS authority application for the IV form of infliximab that is approved or to be approved.
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8 |
Can new baselines be sent at any time?
Yes, if a patient fails to respond to an agent and is changing therapy, new baselines can be submitted.
Note: Psoriasis Area and Severity Index (PASI) scores for whole body or PASI calculations for face, hand and foot (FHF) must be provided in order to set new baselines.
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9 |
If a patient takes a break in therapy of more than 5 years, do they have to trial the prior therapies again in order to recommence therapy?
No, prior therapies do not need to be re-trialled. However, new baselines must be submitted.
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10 |
How many prescriptions are required for an initial/change/recommencement application for secukinumab?
Two prescriptions are needed:
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One for the loading, written for a quantity of 8 and no repeats. This prescription must be included with the initial, change or recommencement request
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The second one for the balance with a quantity of 2 and 2 repeats. This request can be made in real time using the OPA system or by phone if not provided with the initial, change or recommencement request
If no loading regimen is requested, approve a quantity 2 doses of 150mg and 0 repeat using the item code for loading (10910F). The prescriber will need to use BoS for additional doses to reach the timeframe to demonstrate a response. Escalate to a PA if unsure.
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11 |
There are symbols like >, <, ≥ or ≤ in Q&A and on application forms. What do these symbols stand for?
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> means ‘greater than’
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< means ‘less than’
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≥ is the combination of > and =; which means ‘greater than or equal to’ or ‘at least’
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≤ is the combination of < and =; which means ‘less than or equal to’, ‘up to’ or ‘at maximum’
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12 |
Without a database, how is the patient assessed for response?
The onus is on the prescriber to provide the correct assessment that shows a response to treatment as compared to the patient’s baselines which they must store in the patient’s medical records.
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13 |
Can an older version of the form be accepted if all required information has been provided?
Prescribers will need to use the most recent version of the form to allow all required Q&As to be answered. If the only Q&A that cannot be addressed is the timeframe, check the OPA approval/dispensing history. Escalate to PA if unsure.
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14 |
Can a patient have a medical break in therapy?
No, a “medical break” can no longer be accepted as this is not supported by the restriction. Prescriber will need to document a demonstration of response in the patient’s records.
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15 |
Does the prescriber have to provide the patient’s baselines with each continuing application under the whole body restriction?
No. The baseline does not need to be provided if the current PASI score is under the threshold of 3.75 or less.
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16 |
Does the prescriber have to provide the patient’s baselines with each continuing application under the FHF restriction?
No. The baseline does not need to be provided if, on the same affected area assessed at baseline:
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all 3 PASI symptom subscores reduced to 0 or 1, or
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the current skin area affected is under the threshold of 7.5% or less
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17 |
If a prescriber calls requesting information about baseline, failure or response, are we able to help?
The database will no longer be used for any application dated on or after 1 September 2025. It will remain as view only for a period of time; however, it will not be updated. Therefore, we cannot guarantee that we are providing the most up to date information to the prescriber. Refer to a PA if unsure.
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18 |
What are the required prior therapies for an initial application?
Treatment options (in order of preference) are as follows:
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PASI failure to 2 agents
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PASI failure to 1 agent + intolerance to another
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Intolerance to 2 agents
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PASI failure to 1 agent + contraindication to the rest 5 agents
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Contraindications to all 6 agents
Patients must trial at least 2 agents and demonstrate failure via:
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whole body PASI >15, or
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qualifying FHF PASI scores, or
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toxicity requiring permanent treatment withdrawal
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19 |
Must the PASI assessment for continuing treatment be performed on the same affected area assessed at baseline?
Yes. If the baseline provided was whole body, the patient’s response must be assessed on the whole body. If the baseline provided was FHF, the patient’s response must be assessed on the FHF. The onus is on the prescriber to retain this information.
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20 |
Are PASI calculation sheets required to be provided?
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For applications submitted in writing (via HPOS form upload or mail):
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the completed PASI calculation sheet(s) must be attached for all treatment phase requests, including initial, change, recommence or continuing applications
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details of the PASI assessment need to be entered in OPA. Refer to a PA if unsure how to enter
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For self-serve applications in OPA:
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the completed PASI calculation sheet(s) are required only for adult patients’ initial applications
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these sheets must be uploaded into OPA by prescribers and will trigger a delayed assessment
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check the attachment to ensure the total PASI scores (for whole body), or symptom subscores / percentage of area affected (for FHF) match what has been entered in OPA.
Note: calculation of the PASI score by service officers is not required
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of other treatment phases (that is, change, recommence or continuing), PASI calculation details are captured in DQAs; therefore, attaching the sheet is not required
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21 |
Can a paediatric patient remain on the paediatric program after they turn 18?
Yes, the continuing restrictions state the patient must have been under 18 years of age at the time of initial treatment with this drug. After turning 18, treatment can continue to be prescribed under the paediatric item codes.
Prescribers can also choose to apply under the adult change or continuing criteria without the need to stop treatment. OPA will reject these requests, a history check will need to be performed and if there is any history of paediatric treatment, the rejections can be overridden.
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22 |
On an initial application, if the prescriber indicates in the prior therapies that the dose of apremilast is 30mg, how is this entered in OPA?
The restriction requires a dose of 60mg. Providing the prescriber ticks the box that the treatment is at a dose of 30 mg twice a day, then this can be entered in OPA as 60mg.
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Expand all
PBS PSOR restriction and item codes