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. A test for T315I mutation has been done and is negative.
5. 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

6. 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

7. The last line of TKI therapy was discontinued due to resistant disease or due to patient intolerance of treatment:

• the patient had resistant disease on the last line of TKI therapy
• the of the last line of TKI therapy patient was intolerant status score 8. The patient has an ECOG performance of 0 or 1.

9. 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

10. Asciminib will be given until the development of disease resistance or patient intolerance or withdrawal of patient consent.
11. The prescribing clinician understands that the daily dose of asciminib at the initiation of treatment for this indication is 80mg daily.
12. 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.
13. 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).
14. 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.
15. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID 19.
16. Asciminib will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 02 September 2022

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA813 (03 August 2022)

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• ASC1_prior_to_cdf_1.361