Blinatumomab [BLI6]
The treatment of POST PUBESCENT CHILDREN in first morphological complete remission and without minimal residual disease after 1st line intensive induction and any indicated intensification chemotherapy for Philadelphia chromosome negative B-cell precursor acute lymphoblastic leukaemia where the following criteria have been met:
- 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.
- The patient is a post pubescent child.
- The patient has Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL).
- The patient has been previously treated with intensive 1st line induction and any indicated cytoreductive combination chemotherapy.
- The patient is in a morphological complete remission of ALL. 4
- 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 BLI4.
- Blinatumomab will only be requested by, prescribed, and initially administered in, principal treatment centres (PTCs) who have close and regular ALL multi-disciplinary team meetings and links with bone marrow transplant centres. Subsequent cycles of blinatumomab (including the latter part of the first 28-day treatment cycle) may be administered at PTCs or in close partnership with enhanced POSCUs under the direction of PTCs and in agreement with relevant Operational Delivery Networks.
- The patient has a Karnofsky/Lansky performance score of at least 60. all
- The treatment intent for this patient is to be potentially treated with a maximum of 4 cycles of blinatumomab as sequenced with chemotherapy in accordance with UK nationally approved CCLG protocols/guidelines. Note: NHS England understands that patients in the E1910 trial could proceed to allogeneic transplantation after completing at least cycles 1 and 2 of blinatumomab consolidation therapy.
- The patient has not yet commenced any consolidation therapy i.e. the patient has just finished the sequence of induction and any indicated cytoreductive 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.
- Blinatumomab will be administered as systemic monotherapy in accordance with treatment criterion 9 above. Note: intrathecal chemotherapy may continue as planned during blinatumomab cycles.
- 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 the NHS England’s treatment break policy.
- Trust policy regarding unlicensed treatments has been followed as blinatumomab is not licensed in this indication in post pubescent children.
NHS funded From: 24 June 2025
Additional information
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.