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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. Measure 12 weeks from the date of last PBS approval for initial/change/recommencement treatment.
Note: the date of test results cannot be greater than 4 weeks from cessation of the most recent course of treatment.
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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. An initial application form must be submitted with a cover letter. 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 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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PBS PSOR restriction and item codes