Published

June 27, 2025

Blinatumomab [BLI5]

The treatment of ADULT patients in first morphological complete remission and without minimal residual disease after line intensive induction and intensification chemotherapy for Philadelphia chromosome negative B-cell precursor acute lymphoblastic leukaemiawhere all the following criteria are 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. 4
  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- ) leukaemic cells confirmed 4 in a validated assay and the prescibing clinician confirms that this patient’s level of minimal residual disease fulfils this definition. For those patients in whom an assay sensitivity or QR of 10- is not reached but sufficient to report minimal residual disease negativity to the maximum sensitivity of the available assay, blinatumomab will also be permitted. 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. 1st
  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 whether given in cycles 1, 2, 6 and 8 of consolidation treatment with chemotherapy planned to be given in cycles 3, 4, 5 and 7 of an 8 cycle consolidation treatment program or blinatumomab given in cycles 1, 2, 6 and 7 and chemotherapy in cycles 3, 4 and 5 of a 7 cycle consolidation treatment program or blinatumomab as sequenced with chemotherapy in other approved UK ALL Research Network consolidation treatment protocols. 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 of 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 administered as monotherapy in accordance with treatment criterion 9 above.
  12. The prescribing clinician understands that given the scheduling timetable of a potential maximum of 4 cycles of blinatumomab given interspersed with cycles of chemotherapy, this 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).

NHS funded From: 24 June 2025

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA589 (26 March 2025)

Current Form Version

Note

The data on this page was produced using version 1.367 of the CDF list, downloaded from NHS England’s website on 27 June 2025 at 18:00.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

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