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. Measure 12 weeks from approval date.

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 must be 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 a change application to certolizumab?

Two.

• One for the loading, written for a quantity of 6 (of 200 mg) and no repeats. This prescription must be included with the Rheumatoid arthritis - change, recommencement or demonstration of response authority application form (PB247)
• 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 change or recommencement application

6

Can a patient start PBS infliximab treatment with the SC form?

No, patients must get at least 2 IV doses before SC treatment can start.

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 information has not been included on the form unless:

• prescriber indicates a toxicity to methotrexate, or
• there is a note on the database in the patient comments

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 meeting 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 or CRP) is required to meet initial PBS criteria. However, if only one is provided at baseline, then 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.