APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

Transcription

1 Page 1 Rituximab INITIAL APPLICATION - Post-transplant The patient has B-cell post-transplant lymphoproliferative disder* To be used f a maximum of 8 treatment cycles Indications marked with * are Unapproved Indications. INITIAL APPLICATION - Indolent, Low-grade lymphomas hairy cell leukaemia* Applications only from a relevant specialist any other medical practitioner on the recommendation of a relevant specialist. Approvals valid f 9 The patient has indolent low grade NHL hairy cell leukaemia* with relapsed disease following pri chemotherapy The patient has indolent, low grade lymphoma hairy cell leukaemia* requiring first-line systemic chemotherapy 'Indolent, low-grade lymphomas' includes follicular, mantle, marginal zone lymphoplasmacytic/waldenstrom macroglobulinaemia. *Hairy cell leukaemia includes hairy cell leukaemia variant *Unapproved indication. See also: INITIAL APPLICATION - Aggressive CD20 positive NHL p2, INITIAL APPLICATION - Chronic Lymphocytic Leukaemia p3, RENEWAL - Post-transplant p4, RENEWAL - Indolent, Low-grade lymphomas hairy cell leukaemia* p4, RENEWAL - Aggressive CD20 positive NHL p5 RENEWAL - Chronic Lymphocytic Leukaemia p5 I confirm the above details are crect that in signing this fm I underst I may be audited.

2 Page 2 INITIAL APPLICATION - Aggressive CD20 positive NHL The patient has treatment naive aggressive CD20 positive NHL To be used with a multi-agent chemotherapy regimen given with curative intent To be used f a maximum of 8 treatment cycles The patient has aggressive CD20 positive NHL with relapsed disease following pri chemotherapy 'Aggressive CD20 positive NHL' includes large B-cell lymphoma Burkitt's lymphoma/leukaemia See also: INITIAL APPLICATION - Chronic Lymphocytic Leukaemia p3, RENEWAL - Post-transplant p4, RENEWAL - Indolent, Low-grade lymphomas hairy cell leukaemia* p4, RENEWAL - Aggressive CD20 positive NHL p5 RENEWAL - Chronic Lymphocytic Leukaemia p5 I confirm the above details are crect that in signing this fm I underst I may be audited.

3 Page 3 INITIAL APPLICATION - Chronic Lymphocytic Leukaemia The patient has progressive Binet stage A, B C chronic lymphocytic leukaemia (CLL) requiring treatment The patient is rituximab treatment naive The patient is chemotherapy treatment naive The patient's disease has relapsed following no me than three pri lines of chemotherapy treatment The patient has had a treatment-free interval of 12 months me if previously treated with fludarabine cyclophosphamide chemotherapy The patient has good perfmance status The patient does not have chromosome 17p deletion CLL Rituximab to be administered in combination with fludarabine cyclophosphamide bendamustine f a maximum of 6 treatment cycles It is planned that the patient receives full dose fludarabine cyclophosphamide (ally dose equivalent intravenous administration) bendamustine 'Chronic lymphocytic leukaemia (CLL)' includes small lymphocytic lymphoma. A line of chemotherapy treatment is considered to comprise a known stard therapeutic chemotherapy regimen supptive treatments. 'Good perfmance status' means ECOG sce of 0-1, however, in patients temparily debilitated by their CLL disease symptoms a higher ECOG (2 3) is acceptable where treatment with rituximab is expected to improve symptoms improve ECOG sce to <2. See also: RENEWAL - Post-transplant p4, RENEWAL - Indolent, Low-grade lymphomas hairy cell leukaemia* p4, RENEWAL - Aggressive CD20 positive NHL p5 RENEWAL - Chronic Lymphocytic Leukaemia p5 I confirm the above details are crect that in signing this fm I underst I may be audited.

4 Page 4 RENEWAL - Post-transplant Applications only from a relevant specialist any other medical practitioner on the recommendation of a relevant specialist. Approvals valid f 9 The patient has had a rituximab treatment-free interval of 12 months me The patient has B-cell post-transplant lymphoproliferative disder* To be used f no me than 6 treatment cycles Indications marked with * are Unapproved Indications. RENEWAL - Indolent, Low-grade lymphomas hairy cell leukaemia* Applications only from a relevant specialist any other medical practitioner on the recommendation of a relevant specialist. Approvals valid f 9 The patient has had a rituximab treatment-free interval of 12 months me The patient has indolent, low-grade NHL hairy cell leukaemia* with relapsed disease following pri chemotherapy To be used f no me than 6 treatment cycles 'Indolent, low-grade lymphomas' includes follicular, mantle, marginal zone lymphoplasmacytic/waldenstrom macroglobulinaemia. *Hairy cell leukaemia includes hairy cell leukaemia variant *Unapproved indication. See also: RENEWAL - Aggressive CD20 positive NHL p5 RENEWAL - Chronic Lymphocytic Leukaemia p5 I confirm the above details are crect that in signing this fm I underst I may be audited.

5 Page 5 RENEWAL - Aggressive CD20 positive NHL The patient has had a rituximab treatment-free interval of 12 months me The patient has relapsed refracty/aggressive CD20 positive NHL To be used with a multi-agent chemotherapy regimen given with curative intent To be used f a maximum of 4 treatment cycles 'Aggressive CD20 positive NHL' includes large B-cell lymphoma Burkitt's lymphoma/leukaemia RENEWAL - Chronic Lymphocytic Leukaemia The patient's disease has relapsed following no me than one pri line of treatment with rituximab f CLL The patient has had an interval of 36 months me since commencement of initial rituximab treatment The patient does not have chromosome 17p deletion CLL It is planned that the patient receives full dose fludarabine cyclophosphamide (ally dose equivalent intravenous administration) bendamustine Rituximab to be administered in combination with fludarabine cyclophosphamide bendamustine f a maximum of 6 treatment cycles 'Chronic lymphocytic leukaemia (CLL)' includes small lymphocytic lymphoma. A line of chemotherapy treatment is considered to comprise a known stard therapeutic chemotherapy regimen supptive treatments. I confirm the above details are crect that in signing this fm I underst I may be audited.