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

Chronic treatment of hereditary angioedema Types 1 or 2

Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis), Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) or Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis) restriction to complete 24 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) restriction to complete 24 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) restriction to complete 24 weeks treatment; AND

The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND

The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND

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

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.