Proposal to list bendamustine

Special Authority for Subsidy

Initial application — (treatment naïve CLL) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient has Binet stage B or C, or progressive stage A chronic lymphocytic leukaemia requiring treatment; and
2. The patient is chemotherapy treatment naive; and
3. The patient is unable to tolerate toxicity of full-dose FCR; and
4. Patient has ECOG performance status 0-2, and
5. Patient has a Cumulative Illness Rating Scale (CIRS) score of <6; and
6. Bendamustine is to be administered at a maximum dose of 100mg/m2 on days 1 and 2 every 4 weeks for a maximum of 6 cycles.

Note: ‘Chronic lymphocytic leukaemia (CLL) includes small lymphocytic lymphoma (SLL). Chemotherapy treatment is considered to comprise a known standard therapeutic chemotherapy regimen and supportive treatments.

Initial application — (Indolent, Low-grade lymphomas) – only from a relevant specialist or any other medical practitioner on the recommendation of a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

1. The patient has indolent low grade CD20+ NHL requiring treatment; and
2. Patient has a WHO performance status of 0-2; and
3. Either:
   1. Both:
      1. Patient is treatment naïve; and
      2. Bendamustine is to be administered in combination with rituximab for a maximum of 6 cycles; or
   2. All of the following:
      1. Patient has relapsed refractory disease following prior chemotherapy; and
      2. The patient has not received prior bendamustine therapy; and
      3. Either:
         1. Both:
            1. Bendamustine is to be administered in combination with rituximab for a maximum of 6 cycles in relapsed patients, and
            2. Patient has had a rituximab treatment-free interval of 12 months or more; or
         2. Bendamustine is to be administered as a monotherapy for a maximum of 6 cycles in rituximab refractory patients.

Renewal — (Indolent, Low-grade lymphomas) – Applications only from a relevant specialist or any other medical practitioner on the recommendation of a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:

Both:

1. Patients have not received a bendamustine regimen within the last 12 months; and
2. Either:
   1. Both:
      1. Bendamustine is to be administered in combination with rituximab for a maximum of 6 cycles in relapsed patients; and
      2. Patient has had a rituximab treatment-free interval of 12 months or more; or
   2. Bendamustine is to be administered as a monotherapy for a maximum of 6 cycles in rituximab refractory patients.

Note: ‘indolent, low-grade lymphomas’ includes follicular, mantle cell, marginal zone and lymphoplasmacytic/ Waldenström’s macroglobulinaemia.

• The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
• The initial Special Authority criteria for rituximab for chronic lymphocytic leukaemia would be amended in Section B and H of the Pharmaceutical Schedule from 1 July 2017 as follows to allow its use in combination with bendamustine (additions in bold):

Initial application — (Chronic lymphocytic leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. 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. The patient is rituximab treatment naïve; and
3. Either:
   1. The patient is chemotherapy treatment naïve; 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
4. The patient has good performance status; and
5. The patient has good renal function (creatinine clearance ≥ 30 ml/min); and
6. The patient does not have chromosome 17p deletion CLL; and
7. Rituximab to be administered in combination with fludarabine and cyclophosphamide or bendamustine for a maximum of 6 treatment cycles; and
8. It is planned that the patient receives full dose fludarabine and cyclophosphamide (orally or dose equivalent intravenous administration) or bendamustine.

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.

Renewal application – (Chronic lymphocytic leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patients disease has relapsed following no more than one prior line of treatment with rituximab for CLL; and
2. The patient has had a rituximab treatment–free interval of 36 months or more; 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
5. Rituximab to be administered in combination with fludarabine and cyclophosphamide or bendamustine 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.