Published

May 16, 2025

Asciminib [ASC1]

For the treatment of patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukaemia previously treated with two or more tyrosine kinase inhibitors where the following criteria have been met:

  1. This application for asciminib is being made by and the first cycle of systemic anti-cancer therapy with asciminib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has Philadelphia chromosome-positive chronic myeloid leukaemia (CML).
  3. The CML remains in chronic phase.
  4. The patient has received previous treatment with 2 or more TKIs for CML. Please tick the appropriate option below as to the total number of different TKIs received by this patient:
  • 2 previous different TKIs
  • 3 previous different TKIs
  • 4 or more previous different TKIs
  1. The patient has been previously treated with ponatinib or not:
  • the patient has received treatment with ponatinib
  • the patient has not received treatment with ponatinib
  1. The last line of TKI therapy was either discontinued due to resistant disease in which case the T315I mutation test has been done and is negative or the last line of therapy was stopped due to patient intolerance of treatment in which case the previous T315I mutation test was negative.:
  • the patient had resistant disease on the last line of TKI therapy and the T315I mutation test is negative
  • the patient was intolerant of the last line of TKI therapy and the previous T315I mutation test was negative
  1. The patient has an ECOG performance status score of 0 or 1.
  2. The patient has not received prior treatment with asciminib unless the patient has started treatment via the EAMS scheme or via the Novartis compassionate use scheme and all other treatment criteria on this form are fulfilled. Please mark below which of these 3 clinical scenarios applies to this patient
  • the patient has NOT received prior treatment with asciminib
  • the patient started treatment with asciminib via the EAMS scheme and all other treatment criteria on this form are fulfilled
  • the patient started treatment with asciminib via the Novartis compassionate use scheme and all other treatment criteria on this form are fulfilled
  1. Asciminib will be given until the development of disease resistance or patient intolerance or withdrawal of patient consent.
  2. The prescribing clinician understands that the daily dose of asciminib at the initiation of treatment for this indication is 80mg daily.
  3. The prescribing clinician is aware of the potential drug interactions of asciminib with CYP3A4 inhibitors, CYP3A4 inducers, certain CYP3A4 substrates, CYP2C9 substrates and certain P-gp substrates.
  4. The prescribing clinician is aware that asciminib absorption and bioavailability may be significantly reduced by concurrent administration with food (in particular high fat meals) and by some drugs (e.g. itraconazole) as described in asciminib’ s Summary of Product Characteristics).
  5. A formal medical review as to how asciminib is being tolerated and whether treatment with asciminib should continue or not will be scheduled to occur at least by the end of the second 4-weekly cycle of treatment.
  6. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
  7. Asciminib will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 02 September 2022

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA813 (03 August 2022)

Current Form Version

Note

The data on this page was produced using version 1.363 of the CDF list, downloaded from an archive of NHS England’s website on 16 May 2025 at 14:00.

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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