Our submissions to MSAC and PBAC

Advocating for improved healthcare and treatment access

The Leukaemia Foundation engages with governments at all levels to improve access to appropriate testing and affordable treatments for people living with blood cancer.

Our advocacy includes submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) and the Medical Services Advisory Committee (MSAC) when they are considering recommending a new blood cancer test (diagnostic) or therapy to be listed on the Pharmaceutical Benefits Scheme (PBS) or Medicare Benefits Scheme (MBS). These submissions are informed by the lived experiences of people with blood cancer.

Once listed on the PBS or MBS, tests, medicines and treatments are subsidised by the government and less expensive for patients. As blood cancer has high mortality rates, significantly impacts quality of life and is costly to treat, it’s vital that new and improved blood cancer treatments can be easily accessed by the people who need them.

Since 2019, the Leukaemia Foundation has made several submissions to PBAC and MSAC urging them to consider recommending the following therapies for listing on the PBS and MBS.

Pharmaceutical Benefits Scheme

• Acalabrutinib
  • For the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma considered unsuitable for treatment with a purine analogue
  • Either as monotherapy or in combination with obinutuzumab, with previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma considered unsuitable for treatment with a purine analogue (a second request was for use only in the subgroup of patients with a 17p deletion)
  • For the treatment of patients with relapsed and/or refractory mantle cell lymphoma who have received at least one prior therapy or who have developed an intolerance to another Bruton’s tyrosine kinase inhibitor
  • For previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma patients who are considered unsuitable for treatment with fludarabine-based chemoimmunotherapy, or who develop intolerance to venetoclax in combination with obinutuzumab necessitating permanent treatment withdrawal
  • In combination with bendamustine and rituximab for patients with previously untreated Stage III or IV mantle cell lymphoma who are ineligible for stem cell transplantation

• Asciminib for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase previously treated with two or more tyrosine kinase inhibitors

• Azacitidine for maintenance therapy in certain patients with acute myeloid leukaemia who are not candidates for, including those who choose not to proceed to, haematopoietic stem cell transplantation

• Blinatumomab
  • For the treatment of patients with B-cell precursor acute lymphoblastic leukaemia in patients in haematological complete remission with minimal residual disease following chemotherapy
  • For the treatment of newly diagnosed B-acute lymphoblastic leukaemia in patients who are minimal residual disease-negative after initial induction chemotherapy

• Brentuximab Vedotin
  • For the first-line treatment of CD30 positive peripheral T-cell lymphoma
  • For the first-line treatment of advanced classical Hodgkin lymphoma

• Carfilzomib for use in combination with lenalidomide and dexamethasone for the treatment of relapsed and/or refractory multiple myeloma

• Daratumumab in combination with bortezomib and dexamethasone
  • For the treatment of relapsed or refractory multiple myeloma in patients who have progressive disease after at least one prior therapy or as monotherapy for highly treatment experienced and refractory patients
  • For the treatment of second-line multiple myeloma
  • In combination with cyclophosphamide, bortezomib and dexamethasone, for the treatment of patients with newly diagnosed AL amyloidosis

• Dasatinib for the treatment of Philadelphia chromosome positive acute lymphoblastic leukaemia to include newly diagnosed patients

• Daunorubicin with cytarabine forthe treatment of therapy-related acute myeloid leukaemia and acute myeloid leukaemia with myelodysplasia-related changes

• Decitabine and cedazuridine for the treatment of high-risk myelodysplastic syndromes and chronic myelomonocytic leukaemia

• Denosumab for the treatment of patients with multiple myeloma who have renal impairment

• Elotuzumab in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma

• Elranatamab for the treatment of relapsed and/or refractory multiple myeloma in patients who have received at least three prior therapies

• Epcoritamab for the treatment of relapsed and/or refractory diffuse large B-cell lymphoma

• Fedratinib for the treatment of patients with intermediate-2/high-risk myelofibrosis

• Gemtuzumab ozogamicin
  • For the treatment of de novo CD33-positive acute myeloid leukaemia
  • For use in combination with standard intensive chemotherapy, for patients with previously untreated de novo CD33-positive acute myeloid leukaemia, except acute promyelocytic leukaemia, who do not have an unfavourable cytogenetic profile

• Gilteritinib
  • For the treatment of relapsed or refractory FLT3 mutation-positive acute myeloid leukaemia
  • For the treatment of relapsed or refractory FMS-like FLT3 mutation-positive acute myeloid leukaemia

• Glofitamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma

• Ibrutinib
  • For the treatment of patients with previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma with evidence of one or more 17p chromosomal deletions
  • For use in combination with venetoclax for the treatment of previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma

• Ixazomib in combination with lenalidomide and dexamethasone
  • For patients with relapsed or refractory multiple myeloma
  • For the treatment of relapsed and/or refractory multiple myeloma in patients who have received at least two prior therapies

• Lenalidomide
  • For the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone an autologous stem cell transplant
  • In combination with bortezomib and dexamethasone, for patients with newly diagnosed multiple myeloma who are ineligible for a primary stem cell transplant

• Lertermovir for the prophylaxis of cytomegalovirus infection or disease in adult cytomegalovirus-seropositive [R+] recipients of an allogeneic haematopoietic stem cell transplant

• Mogamulizumab for patients with relapsed or refractory cutaneous T-cell lymphoma who have been previously treated with at least one prior systemic therapy

• Momelotinib for continuing treatment of intermediate or high-risk primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis in patients with moderate to severe anaemia and who are Janus kinase inhibitor naïve or have been treated with ruxolitinib

• Pembrolizumab for the treatment of patients with relapsed or refractory primary mediastinal B-cell lymphoma who meet certain conditions

• Plitidepsin in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who meet certain conditions

• Polatuzumab vedotin
  • For the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for stem cell transplantation
  • For use in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of previously untreated diffuse large B-cell lymphoma

• Pomalidomide in combination with bortezomib and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen (including lenalidomide)

• Ravulizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria

• Ruxolitinib
  • For the treatment of patients with polycythaemia vera who are resistant to or intolerant of hydroxycabamide (hydroxyurea)
  • For the treatment of patients aged 12 years and older with Grade II to Grade IV acute graft versus host disease or moderate to severe chronic graft versus host disease who are refractory to, dependent on or intolerant of corticosteroids

• Selinexor
  • For the treatment of relapsed and/or refractory diffuse large B-cell lymphoma in patients who have received at least two lines of systemic therapy
  • In combination with bortezomib and dexamethasone, for the treatment of relapsed and/or refractory multiple myeloma
  • In combination with dexamethasone, for the treatment of triple class refractory/penta-refractory multiple myeloma in patients who have received at least four prior therapies
  • In combination with dexamethasone for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody

• Tafamidis for the treatment of transthyretin amyloid cardiomyopathy
• Venetoclax
  • In combination with obinutuzumab for the first-line treatment of patients with chronic lymphocytic leukaemia who have co-existing conditions and are unsuitable for fludarabine based chemotherapy
  • For the treatment of acute myeloid leukaemia
  • For the treatment of patients with newly diagnosed acute myeloid leukaemia who are ineligible for standard intensive remission induction chemotherapy

• Vutrisiran for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy

• Zanubrutinib
  • For the treatment of relapsed and/or refractory mantle cell lymphoma
  • For the treatment of adult patients with Waldenstrom’s macroglobulinemia
  • For the treatment of treatment naive chronic lymphocytic leukaemia or small lymphocytic lymphoma

Medical Services Advisory Committee

• Axicabtagene ciloleucel
  • For the treatment of relapsed or refractory large B-cell lymphoma
  • For the treatment of relapsed or refractory follicular lymphoma
  • For the treatment of adult patients with Grade 1, Grade 2 or Grade 3a follicular lymphoma and relapsed or refractory disease after two or more lines of therapy

• Ciltacabtagene autoleucel (cilta-cel)
  • For the treatment of relapsed and/or efractory multiple myeloma in adult patients who have received at least three prior lines of therapy
  • For the treatment of relapsed/refractory multiple myeloma as a fifth line plus therapy

• Brexucabtagene autoleucel
  • Brexucabtagene autoleucel for the treatment of adult patients (≥ 18 years of age) with relapsed or refractory B-precursor acute lymphoblastic leukaemia
  • For the treatment of adult patients (≥26 years of age) with relapsed or refractory B-precursor adult acute lymphoblastic leukaemia

• Expansion of genetic testing for myeloproliferative neoplasms under MBS item 73325

• Integrated, closed-system, extracorporeal photopheresis systems for patients with chronic graft versus host disease following haematopoietic stem cell transplantation who are steroid-refractory or steroid-dependent or steroid-intolerant
• Genetic testing for variants associated with haematological malignancies for patients/persons with clinically suspected myeloid or lymphoid neoplasm where accurate diagnosis sufficient for treatment planning is not achieved using conventional testing
• Minimal residual disease testing in patients with acute lymphoblastic leukaemia