Systemic lupus erythematosus (SLE) Program in Pharmaceutical Benefits Scheme (PBS) 012-24060528

Item

Description

1

Are hospital details required for an approval for PBS-subsidised anifrolumab to treat systemic lupus erythematosus (SLE)?

Yes. Hospital details:

• are required because anifrolumab is PBS-subsidised under Section 100 (S100) arrangements for Highly Specialised Drugs (HSD) Program
• must be provided for each application for S100 HSD

2

When does a patient have to demonstrate a response to PBS-subsidised treatment of SLE?

A demonstration of response is required for each approval after the patient has had 12 months of therapy. However, a patient history check is not required when processing the continuing application in Online PBS Authorities (OPA) system. The onus is on the prescriber to provide this information while answering questions populated in OPA.

3

If a patient takes a break in therapy, how will their prescriber re-apply for the treatment?

If the break in therapy:

• is < 12 months, the prescriber can re-apply under the continuing or recommencement of treatment (within 12 months of a treatment break) restriction. The date of cessation of the previous treatment course must be provided
• is > 12 months, the prescriber can re-apply under the initial restriction. The patient must meet all initial restriction criteria including ‘currently receiving’ therapies unless contraindicated/intolerant necessitating treatment withdrawal, as if they were treatment naïve

4

Can increased quantity and/or repeats be authorised for anifrolumab?

No increase (NO INC) in the PBS-listed quantity of 1 vial and repeats of 5 are allowed for this item.