Rheumatoid arthritis (RA) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051134

Item

Description

1

Does the first continuing have to be after 12 weeks?

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

2

The prescriber provided both Erythrocyte Sedimentation Rate (ESR) or C-Reactive Protein (CRP) at baseline but is only responding on CRP currently. Is this ok?

Yes. As long as both bloods were qualifying at baseline, only one has to be responding in order to meet the continuing criteria.

3

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 Rheumatoid arthritis - continuing authority application form (PB111)

4

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

3 mg/kg every 8 weeks after the initial load.

5

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 200 mg) and no repeats. This prescription must be included with the initial, change or recommencement request
• The second one for the balance with 2 doses of 200 mg 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
• no loading dose requested - one prescription for a quantity of 2 doses of 200 mg and up to 3 repeats; however, item codes for loading (10905Y for syringe or 11322X for pen) must be used

6

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.

7

What medications are required to be taken in combination with at least 7.5mg of methotrexate per week?

Infliximab, golimumab and abatacept. Reject any requests where this detail has not been included on the form.

8

What is the difference between major and total joint count?

Major joints are the large joints:

• shoulders
• elbows
• wrists
• hips
• knees, and
• ankles

Patients must have at least 4 major joints to meet initial criteria.

Total joint count is based on major joints and all the small joints in the hands and feet. Patients must have at least 20 joints to meet initial criteria.

The same joints (major only or total) must be assessed for continuing treatment.

9

Can a patient qualify for initial treatment with only one blood marker? ESR or CRP?

Yes, only one qualifying blood marker (either ESR or CRP) is required to meet initial PBS criteria. However, if only one is provided at baseline, then the same blood marker must be submitted for all future requests.

10

Can new baselines be set at any time?

Yes, if a patient fails to respond to an agent and is changing therapy, new baselines can be submitted.

Note: both qualifying bloods and joints must be provided in order to set new baselines.

11

If a patient takes a break in therapy of more than 24 months, 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 (qualifying bloods and joints) must be submitted.

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.

13

Can an older version of the form be accepted if all required information have 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 you are unsure.

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.

15

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

No, if the patient continues to respond with results below the thresholds, then baselines will not need to be provided.

16

What are the required prior therapies for an initial application?

Treatment options (in order of preference) are as follows:

• Methotrexate 20mg per week + one other DMARD - 3 months each, total treatment time 6 months, within the last 24 months
• Methotrexate cannot be tolerated at 20mg per week - 2 other DMARDs - 3 months each, total treatment time 6 months, within the last 24 months
• Only one DMARD can be tolerated - at least 3 months
• Toxicity/Contraindication to all 4 prior therapies

Treatment with 2 DMARDs can be sequential or concurrent but each agent must be for 3 months, and total treatment time must be at least 6 months.

Patient must be on at least one prior therapy at the time of application, unless all 4 are contraindicated or not tolerated previously.

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 June 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 you are unsure.