Ankylosing spondylitis (AS) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051102

Item

Description

1

Does the first continuing have to be after 12 weeks?

Yes, the patient needs to have at least 12 weeks of treatment to demonstrate a response to treatment. 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.

2

Does an exercise program self-certification need to be provided for an initial application?

Yes. A completed exercise program must be provided and uploaded into OPA. Service officers must make sure that the form is for the correct patient and has been completed in full. Refer to PA if unsure.

3

Does an X-Ray report need to be provided?

No. Details of the report must be provided on the form, but the actual report is not required.

4

Is there an age restriction for patients applying for this program?

Yes. Patients must be aged 18 years or older.

5

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.

6

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.

7

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:

• 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
• 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 Ankylosing spondylitis - continuing authority application form (PB074)

8

What is the maximum dose for infliximab i.v.?

5 mg/kg every 6 weeks after the initial load.

9

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.

10

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: both BASDAI score and qualifying blood markers (ESR and/or CRP) must be provided in order to set new baselines.

11

Must baselines be submitted if a patient is changing from a biosimilar medicine?

Yes. Where a patient is changing from a biosimilar medicine, the prescriber must submit either the existing or a new baseline.

12

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.

13

How many prescriptions are required for an initial/change/recommencement application for certolizumab?

When there is:

• a loading regimen intended - two prescriptions are needed:
• One for the loading, written for a quantity of 6 (of 200mg) and no repeats. This prescription must be included with the initial/change/recommence request
• The second one for the balance with 2 doses of 200mg 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/recommence request
• no loading dose requested - one prescription for a quantity of 2 doses of 200mg and up to 2 repeats. However, item codes for loading (10904X for syringe or 11319R for pen) must be used

14

How many prescriptions are required for an initial/change/recommencement application for secukinumab?

When there is:

• a loading regimen intended - two prescriptions are needed:
• for 150 mg dose:
  One loading script written for a quantity of 4 (of 150mg pen) and no repeats. This prescription must be included with the initial/change/recommence request.
  The second one for the balance with 1 (of 150mg pen) 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/recommence request
• for 300 mg dose:
  One loading script written for a quantity of either 8 (of 150mg pen) or 4 (of 300mg pen) and no repeats. This prescription must be included with the initial/change/recommence request.
  The second one for the balance with either 2 (of 150mg pen) or 1 (of 300mg pen) 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/recommence request
• no loading dose requested - one prescription using item code for loading
• for 150 mg dose: a quantity of 1 (of 150mg pen) and up to 3 repeats (item code 10890E must be used)
• for 300 mg dose, either:
  a quantity of 2 (of 150mg pen) and up to 3 repeats (item code 10890E must be used)
  a quantity of 1 (of 300mg pen) and up to 3 repeats (item code 14957F must be used)

15

There are symbols like >, <, ≥ or ≤ in Q&A and on application forms. What do these symbols stand for?

• > means ‘greater than’
• < means ‘less than’
• ≥ is the combination of > and =; which means ‘greater than or equal to’ or ‘at least’
• ≤ is the combination of < and =; which means ‘less than or equal to’, ‘up to’ or ‘at maximum’

16

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.

17

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.

18

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.

19

Does the prescriber have to provide the patient’s baselines with each continuing application?

No. For each continuing application:

• the baseline BASDAI score does not need to be provided if the current BASDAI score is ≤ 2
• the baseline blood marker does not need to be provided if the current blood is under the threshold (i.e. ESR ≤ 25 if ESR is recorded at baseline, CRP is ≤ 10 if CRP is recorded at baseline). Only one of ESR and CRP needs to be responding if both recorded at baseline

20

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 October 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.