Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Systemic lupus erythematosus

Initial treatment

Patient must have a confirmed and documented diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) SLE Classification Criteria 2019; AND

Patient must have persistent disease activity as supported by a SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 10 points; AND

Patient must be currently receiving hydroxychloroquine, with treatment received for at least 12 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; AND

Patient must be currently receiving immunosuppressant medication, with treatment received for at least 12 weeks, with either: (i) minimum dose of methotrexate 20 mg per week, (ii) azathioprine 100 mg per day, (iii) mycophenolate 1,000 mg per day unless contraindicated/intolerant necessitating treatment withdrawal; AND

Patient must be currently receiving prednisolone or equivalent of at least 7.5 mg per day, with treatment received for at least 4 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; AND

Patient must not have either: (i) severe active lupus nephritis, (ii) severe active central nervous system systemic lupus erythematosus; AND

Must be treated by a specialist physician experienced in the management of this condition.

If prednisolone or equivalent is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated of at least 7.5 mg per day, the patient must have received at least 12 weeks of continuous treatment with each of at least 2 of the following: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day.

Where two of: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; or (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to prednisolone or equivalent: at least one of the remaining tolerated therapies must be trialled at a minimum dose as mentioned above.

If the patient has a contraindication/severe intolerance to each of: (i) prednisolone or equivalent of at least 7.5 mg per day; (ii) hydroxychloroquine; (iii) methotrexate at a dose of at least 20 mg per week; (iv) azathioprine at a dose of at least 100 mg per day; (v) mycophenolate at a dose of at least 1,000 mg per day; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application.

The authority application must be made in writing via HPOS form upload or mail and must include:

(a) details of the ACR/EULAR SLE Classification Criteria 2019 confirming diagnosis of SLE;

(b) details (date and score) of the completed SLEDAI-2K score sheet;

(c) details of current systemic therapy used (dosage, date of commencement and duration of therapy including prior anifrolumab use);

(d) details of contraindication/intolerances to prior therapies (drug name, the degree of toxicity and dose).

All the reports must be documented in the patient's medical records.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Systemic lupus erythematosus

Continuing or recommencement of treatment (within 12 months of a treatment break)

Patient must have previously been issued with an authority prescription for this drug for this condition; AND

Patient must be responding to treatment if they have received less than 12 months of treatment with this drug for this condition; or

Patient must have attained a Lupus Low Disease Activity State (LLDAS) and maintained this state while on treatment; AND

Must be treated by a specialist physician experienced in the management of this condition.

Lupus Low Disease Activity State (LLDAS) is defined as:

(a) Total SLEDAI-2K of not greater than 4, with no major activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever); and

(b) No new features of lupus disease activity compared with the previous assessment, and

(c) Physician Global Assessment (PGA) of not greater than 1, and

(d) Current prednisolone (or equivalent) dose of not greater than 7.5 mg daily, and

(e) Well tolerated standard maintenance doses of anti-malarial and immunosuppressive drugs are allowed.

Where retreatment with anifrolumab after a break in PBS-subsidised treatment with anifrolumab is being sought, the date of cessation of the previous treatment course with anifrolumab must be included in the application. Recommencement of treatment with anifrolumab for severe SLE is within 12 months from the date that treatment was ceased.