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

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply of first-line therapy

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2024; AND

Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND

The condition must have been untreated with drug treatment at the time of the first dose of this drug; or

Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line treatment of CLL/SLL at the time of receiving non-PBS-subsidised treatment with this drug for this condition; AND

The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND

The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses).

A patient may qualify for PBS-subsidised treatment under this restriction once only.

For continuing PBS-subsidised treatment, a 'Grandfathered' patient must qualify under the next relevant treatment phase.

There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).