Chronic lymphocytic leukaemia (CLL)
The PBS subsidises obinutuzumab for patients with chronic lymphocytic leukaemia.
Authority to provide PBS subsidised obinutuzumab to patients with chronic lymphocytic leukaemia is available under Section 100 of the National Health Act 1953.
The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing obinutuzumab Gazyva®.
Applications for initial treatment must be submitted in writing by the treating medical practitioner. A patient may only qualify for PBS subsidised treatment under this restriction once in a lifetime.
If you want your patients to start initial treatment with obinutuzumab Gazyva®, they must have:
- previously untreated CD20 positive chronic lymphocytic leukaemia (CLL)
- a creatinine clearance ≥ 30 mL/min, and
- a completed total cumulative illness rating scale (CIRS) demonstrating that the patient has a score of greater than 6, excluding CLL-induced illness or organ damage, or documentation that the patient has a creatinine clearance of less than 70 mL/min
- be inappropriate for fludarabine based chemo immunotherapy, and
- treatment will be in combination with chlorambucil
Treatment must be discontinued in patients who experience disease progression while on treatment.
Obinutuzumab Gazyva®, is not PBS subsidised if used as monotherapy or in combination with anti-cancer drugs other than chlorambucil.
A copy of the pathology report confirming the patient has CD20 positive CLL. Flow cytometry pathology report from blood or bone marrow and the patient’s creatinine clearance must be provided. A completed CIRS score is also required for patients with a creatinine clearance ≥ 70 mL/min.
Schedule item details
Obinutuzumab Gazyva®, is available as a solution for intravenous infusion 1000 mg in 40 mL. Prescriptions should be written for a maximum quantity up to 1000 mg with 7 repeats.
Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the PBS.
Lodging an application
All written applications for initial PBS authorisation of obinutuzumab (Gazyva®) must include a completed:
- authority prescription form
- Chronic lymphocytic leukaemia initial and Continuing PBS authority application Supporting Information Form (PB159)
Send all written applications to the Complex Drugs address on the contact us page.
For more information contact the Complex Drugs Programs enquiry line.