Blinatumomab [BLI4]

The treatment of patients in first complete haematological remission and with minimal residual disease post 1st line induction chemotherapy in B-precursor acute lymphoblastic leukaemia in CHILD patients where all the following criteria have been met:

  1. I confirm that this application has been 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. I confirm that the patient is a child* and please mark as to whether pre- or post-pubescent:
  • is post-pubescent or
  • is pre-pubescent and will receive blinatumomab at the paediatric dosage described in the blinatumomab summary of product characteristics (SmPC). *note there is a separate Blueteq form to be used for blinatumomab in this indication in adults.
  1. I confirm that the patient has CD19 positive acute lymphoblastic leukaemia (ALL). Please indicate below whether the patient has Philadelphia negative or positive ALL:
  • Philadelphia negative ALL or
  • Philadelphia positive ALL
  1. I confirm that the patient has been previously treated with 1st line intensive combination chemotherapy as initial induction treatment.
  2. I confirm that the patient is in complete haematological remission of ALL.
  3. I confirm that the patient has been shown to have minimal residual disease of ≥ 0.1% (≥10-3) confirmed in a validated assay with a minimum sensitivity of 10-4. Note: a level of minimal residual disease (MRD) of less than 0.1% is not recommended by NICE and not funded.
  4. I confirm that blinatumomab will only be requested by and administered in principal treatment centres.
  5. I confirm that the patient has a performance status of 0–2.
  6. I confirm that the patient will be treated with 1 cycle of induction blinatumomab and the potential benefits and risks associated with continued treatment after the 1st cycle of blinatumomab in patients who do not show haematological benefit will be assessed.
  7. I confirm that a maximum of 4 cycles of treatment with blinatumomab will be administered.
  8. I confirm the use of the blinatumomab has been discussed at a multi-disciplinary team (MDT) meeting which must include at least two consultants in the subspecialty with active and credible expertise in the relevant field of whom at least one must be a consultant paediatrician. The MDT should include a paediatric pharmacist and other professional groups appropriate to the disease area.
  9. I confirm that blinatumomab will be used as monotherapy
  10. I confirm that no planned treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve).* *Requests for continuation of treatment after unplanned treatment breaks over this duration should be made via the treatment break approval process
  11. I confirm that Trust policy regarding unlicensed treatments has been followed as blinatumomab is not licensed in this indication in children.
  12. I confirm that blinatumomab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 22 October 2019

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CDF Managed Access: NA

NICE Technology Appraisal: TA589 (24 July 2019)

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