Published

March 4, 2025

Blinatumomab [BLI5]

Blinatumomab for treating ADULT patients in first morphological complete remission and without minimal residual disease after 1st line intensive induction and intensification chemotherapy for Philadelphia chromosome negative B-cell precursor acute lymphoblastic leukaemia where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with blinatumomab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient is an adult.
  3. The patient has Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL).
  4. The patient has been previously treated with intensive 1st line induction and intensification combination chemotherapy.
  5. The patient is in a morphological complete remission of ALL.
  6. The prescribing clinician understands that this NICE recommendation for blinatumomab uses the E1910 trial definition of minimal residual disease negativity as the bone marrow exhibiting <0.01% (<10-4) leukaemic cells confirmed in a validated assay and I confirm that this patient’s level of minimal residual disease fulfils this definition. Note: the company’s case for the clinical and cost effectiveness of blinatumomab in this indication was based on the evidence base of the E1910 trial which in the key randomisation only included patients who had MRD negativity defined as being <0.01%. Note: a level of minimal residual disease (MRD) of ≥0.01% means that blinatumomab is not recommended by NICE in this indication and is not funded by NHS England. Blinatumomab is however potentially funded in a MRD positive indication which can be accessed via form BLI3.
  7. Blinatumomab will only be requested by and administered in either bone marrow transplant centres or in major haematological centres that regularly treat patients with MRD negative ALL and who have close and regular ALL multi-disciplinary team meetings and links with bone marrow transplant centres.
  8. The patient has an ECOG performance status of 0-2.
  9. The treatment intent for this patient is to be potentially treated with a maximum of 4 cycles of blinatumomab given as cycles 1, 2, 6 and 8 of consolidation treatment with chemotherapy planned to be given in cycles 3, 4, 5 and 7 of consolidation treatment. Note: NHS England understands that patients in the E1910 trial could proceed to allogeneic transplantation after completing at least cycles 1 and 2 of the above potential program consolidation therapy.
  10. The patient has not yet commenced any consolidation therapy i.e. the patient has just finished the sequence of induction and intensification therapies. Note: the company’s case for the clinical and cost effectiveness of blinatumomab in this indication was based on the evidence base of the E1910 trial which only included patients who had not started any consolidation therapy.
  11. Blinatumomab will be used as monotherapy in cycles 1, 2, 6 and 8 of consolidation therapy.
  12. The presciribng clinician understands that given the scheduling timetable of a potential maximum of 4 cycles of blinatumomab given interspersed with cycles of chemotherapy, indication is exempted from NHS England’s treatment break policy.
  13. Blinatumomab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 01 March 2025

Form version:

CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

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