Chronic treatment of hereditary angioedema Types 1 or 2

Treatment Phase: Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)

Clinical criteria:

• Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug,

AND

• Patient must not have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema at the time of application,

AND

• The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab.

Treatment criteria:

• Must be treated by a clinical immunologist or a specialist allergist.

Population criteria:

• Patient must be aged 12 years or older.

For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate

The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application.

Chronic treatment of hereditary angioedema Types 1 or 2

Treatment Phase: Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)

Clinical criteria:

• Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving lanadelumab,

AND

• The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab.

Treatment criteria:

• Must be treated by a clinical immunologist or a specialist allergist.

Population criteria:

• Patient must be aged 12 years or older.

Chronic treatment of hereditary angioedema Types 1 or 2

Treatment Phase: Initial 3: New patient (transitioning from PBS-subsidised garadacimab)

Clinical criteria:

• Patient must have been receiving garadacimab through the PBS as routine prophylaxis for hereditary angioedema immediately prior to receiving this drug,

AND

• The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab.

Treatment criteria:

• Must be treated by a clinical immunologist or a specialist allergist.

Population criteria:

• Patient must be aged 12 years or older.

Chronic treatment of hereditary angioedema Types 1 or 2

Treatment Phase: Continuing preventative treatment

Clinical criteria:

• Patient must have previously received PBS-subsidised treatment with this drug for this condition,

AND

• Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition,

AND

• The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab.

Treatment criteria:

• Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.

Population criteria:

• Patient must be aged 12 years or older.

Patients who have successfully transitioned to a lower dosing frequency should be reviewed every 6 months to ensure they continue to demonstrate a sustained response

For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient's medical records for auditing purposes.