Proposal to fund venetoclax (Venclexta) for chronic lymphocytic leukaemia

A decision has been made

Read the notification of PHARMAC's decision to fund venetoclax

Special Authority for Subsidy – Retail Pharmacy – Specialist

Initial application (relapsed/refractory chronic lymphocytic leukaemia) - only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 7 months for applications meeting the following criteria:

All of the following:

1. Patient has chronic lymphocytic leukaemia requiring treatment; and
2. Patient has received at least one prior therapy for chronic lymphocytic leukaemia; and
3. Patient has not previously received venetoclax; and
4. The patient’s disease has relapsed within 36 months of previous treatment; and
5. Venetoclax to be used in combination with six 28-day cycles of rituximab commencing after the 5-week dose titration schedule with venetoclax; and
6. Patient has an ECOG performance status of 0-2.

Renewal application (relapsed/refractory chronic lymphocytic leukaemia) - only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Treatment remains clinically appropriate and the patient is benefitting from and tolerating treatment; and
2. Venetoclax is to be discontinued after a maximum of 24 months of treatment following the titration schedule unless earlier discontinuation is required due to disease progression or unacceptable toxicity. 

Initial application (previously untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation*) - only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Patient has previously untreated chronic lymphocytic leukaemia; and 
2. There is documentation confirming that patient has 17p deletion by FISH testing or TP53 mutation by sequencing; and
3. Patient has an ECOG performance status of 0-2.

Renewal application (previously untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation*) - only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

1. Treatment remains clinically appropriate and the patient is benefitting from and tolerating treatment.

Note: ‘Chronic lymphocytic leukaemia (CLL)’ includes small lymphocytic lymphoma (SLL). Indication marked with * is an unapproved indication.

Special Authority for Subsidy

Initial application — (Chronic lymphocytic leukaemia) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient has progressive Binet stage A, B or C chronic lymphocytic leukaemia (CLL) requiring treatment; and
2. Either:
   1. The patient is rituximab treatment naive; and
      1. Either:
         1. The patient is chemotherapy treatment naive; or
         2. Both:
            1.  The patient's disease has relapsed following no more than three prior lines of chemotherapy treatment; and
            2.  The patient has had a treatment-free interval of 12 months or more if previously treated with fludarabine and cyclophosphamide chemotherapy; and or
   2. The patient’s disease has relapsed within 36 months of previous treatment and rituximab treatment is to be used in combination with funded venetoclax; and
3. The patient has good performance status; and
4. Either:
   1. The patient does not have chromosome 17p deletion CLL; and or
   2. Rituximab treatment is to be used in combination with funded venetoclax for relapsed/refractory chronic lymphocytic leukaemia; and
5. Rituximab to be administered in combination with fludarabine and cyclophosphamide, or   bendamustine or venetoclax for a maximum of 6 treatment cycles; and
6. It is planned that the patient receives full dose fludarabine and cyclophosphamide (orally or dose equivalent intravenous administration), or bendamustine or venetoclax.

Renewal — (Chronic lymphocytic leukaemia) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Both:

1. Either:
   1. The patient’s disease has relapsed within 36 months of previous treatment and rituximab treatment is to be used in combination with funded venetoclax; or
   2. All of the following:
      1. The patient's disease has relapsed following no more than one prior line of treatment with rituximab for CLL; and
      2. The patient has had an interval of 36 months or more since commencement of initial rituximab treatment; and
      3. The patient does not have chromosome 17p deletion CLL; and
      4. It is planned that the patient receives full dose fludarabine and cyclophosphamide (orally or dose equivalent intravenous administration) or bendamustine; and
2. Rituximab to be administered in combination with fludarabine and cyclophosphamide, or bendamustine or venetoclax for a maximum of 6 treatment cycles.

Note: 'Chronic lymphocytic leukaemia (CLL)' includes small lymphocytic lymphoma. A line of chemotherapy treatment is considered to comprise a known standard therapeutic chemotherapy regimen and supportive treatments. 'Good performance status' means ECOG score of 0-1, however, in patients temporarily debilitated by their CLL disease symptoms a higher ECOG (2 or 3) is acceptable where treatment with rituximab is expected to improve symptoms and improve ECOG score to < 2.