Prescribing TKIs for the treatment of chronic myeloid leukaemia looks set to become a little more straightforward, after listing reforms were endorsed by the Pharmaceutical Benefits Advisory Committee.
The proposed changes would impact all forms and strengths of ponatinib, asciminib, dasatinib, imatinib and nilotinib, although the recommendations differ somewhat between each drug.
Firstly, the PBAC recommended removing ‘accelerated phase’ from the PBS restriction criteria for all five TKIs to align with the latest World Health Organization classification.
However, it did stress that ‘not blast phase (BP)’ continue to be included in the restriction criteria for asciminib, and that prescribers should be referred to the WHO website for the current definition of BP.
In addition, for ponatinib, it called for the removal of the criteria specifying the patient “must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis”.
It also supported changes to the PBS restriction criteria for the imatinib, dasatinib and nilotinib listings for CML:
- remove specification of line of treatment and phase
- allow all strengths of nilotinib to be available for dose titration regardless of line of therapy.
The recommendations were made at an intracycle meeting of the committee, held late last year and released last week (link here).
In an outcome statement, the committee also advised removing prescribing and administrative advice from the criteria, as well as the definition of nonresponse, given the select group of clinicians – i.e. specialist haematologists – who prescribed these targeted therapies.