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

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This document outlines details of PBS-subsidised anifrolumab for patients with systemic lupus erythematosus (SLE).

For information on how to process a PBS Authority, see Processing Complex Authority Required Listings.

On this page:

Systemic lupus erythematosus (SLE) quick reference

Contraindication to prior therapy for SLE patients

Delayed assessment for SLE patients

Systemic lupus erythematosus (SLE) quick reference

Table 1

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

PB365 form

Written

Electronic

S100:

anifrolumab

No

OPA

Must be treated by a:

  • specialist physician experienced in the management of SLE

Yes - immediate or delayed assessment (delayed if free text field used)

Continuing

or

Recommencement (after a break < 12 months)

Telephone

Electronic

S100:

anifrolumab

No

OPA

Must be treated by a:

  • specialist physician experienced in the management of SLE

Yes

Contraindication to prior therapy for SLE patients

Table 2: this table lists the details of contraindication to each of the current systemic treatments according to the relevant Therapeutic Goods Administration (TGA) approved Product Information.

Escalate to a Pharmaceutical Adviser (PA) if not sure.

Prior therapy

Contraindication

prednisolone (or equivalent)
  • Uncontrolled infections
  • Known hypersensitivity to prednisone or prednisolone, or any of the excipients

hydroxychloroquine
  • Pre-existing maculopathy of the eye
  • Known hypersensitivity to 4-aminoquinoline compounds
  • Long-term therapy in children
  • Children under 6 years of age

methotrexate
  • Hypersensitivity
  • Pregnancy
  • Breastfeeding
  • Severe hepatic impairment
  • Severe renal impairment
  • Alcoholism or alcoholic liver disease
  • Overt or laboratory evidence of immunodeficiency syndromes
  • Bone marrow depression or pre-existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or anaemia
  • Serious, acute or chronic infections
  • Peptic ulcer disease or ulcerative colitis
  • Concurrent vaccinations with live vaccines
  • Concomitant administration with retinoids such as acitretin

azathioprine
  • Hypersensitivity to any of the ingredients
  • Hypersensitivity to 6-mercaptopurine
  • Patients with rheumatoid arthritis previously treated with alkylating agents
  • Pregnancy or planning pregnancy

mycophenolate
  • Hypersensitivity to any of the ingredients
  • Pregnancy or planning pregnancy
  • Breastfeeding

Delayed assessment for SLE patients

Table 3: this table lists the details of what to check for the delayed assessment due to intolerance to prior therapy and common acronyms.

Service Officers to assess that free text is:

Examples

Outcome

Relevant to the question

Intolerances to prior therapies:

  • Heart condition
  • Worsened renal failure
  • Nausea and vomiting
  • Elevated or deranged etc., liver function test
  • Gastrointestinal toxicity

Approve

Random text
  • Happy Birthday
  • Patient did not want to take
  • Ikasditbn

Reject

Non-descriptive
  • Toxicity (no details)
  • Intolerance
  • Ineffective

Reject

Common acronyms

  • LFT - Liver function tests
  • GI toxicity - Gastrointestinal
  • N+V - Nausea and vomiting

Escalate to a Pharmaceutical Adviser (PA) by phone if not sure of the acronym used.