Coverage stance: asciminib (Scemblix) is covered with criteria. The policy defines medical necessity criteria, prior authorization requirements, dosing limits, approved FDA and selected off‑label indications, exclusions for specific mutations, generic preference, and approval durations.
FDA‑approved indications included in coverage: previously treated Ph+ CML in chronic phase (CP) and Ph+ CML in CP with the T315I mutation; the policy was also updated to add the newly diagnosed Ph+ CML in CP indication. Selected off‑label NCCN‑recommended indications are addressed (e.g., CML in accelerated phase and myeloid/lymphoid neoplasm with eosinophilia) with criteria and required documentation.
Exclusions and mutation restrictions: members must not have the following mutations: A337T, P465S (P46SS), M244V, F359V/I/C as listed by the policy per NCCN updates.
Dosing limits and tablet limits: for Ph+ CML without T315I, dose must be ≤ 80 mg per day and ≤ 2 tablets per day; for Ph+ CML with T315I, dose must be ≤ 400 mg per day and ≤ 8 tablets per day. (Policy also documents dosing for T315I in dosage table.)
Approval durations and prior authorization: initial approvals are limited to 6 months; continuation approvals are limited to 12 months (continuation requires documentation of ≥ 30 days on therapy and clinical response). Requests must be prescribed by or in consultation with an oncologist or hematologist and are subject to prior authorization; the provider must submit supporting clinical documentation.
Formulation and prescribing preferences: the policy requires use of generic asciminib, if available, unless contraindicated or clinically significant adverse effects occur. A new 100 mg tablet strength is documented in product availability.