SCEMBLIX (asciminib)

SCEMBLIX (asciminib)

Self-Administration – oral

Diagnosis considered for coverage:

• Treatment of adults with Ph+ CML in chronic phase, previously treated with ≥ 2 TKIs
• Ph+ CML in chronic phase with the T315I mutation

Coverage Criteria:

1. For diagnosis of adults with Ph+ chronic phase CML:

• Dose does not exceed 80 mg per day (can be split into two equal doses of 40 mg twice daily); AND
• Patient is ≥ 18 years of age; AND
• Prescribed by or in consultation with an oncologist or hematologist; AND
• Diagnosis of chronic myelogenous/myeloid leukemia (CML); AND
• Disease is Philadelphia chromosome-positive (Ph+); AND
• Disease is in chronic phase; AND
• Patient has been previously treated with two or more alternative tyrosine kinase inhibitors (TKI) [e.g., Bosulif (bosutinib), imatinib, Sprycel (dasatinib), Tasigna (nilotinib), Iclusig (ponatinib)]

2. For diagnosis of adult patients with T315I-positive CML:

• Dose does not exceed 200 mg twice daily; AND
• Patient is ≥ 18 years of age; AND
• Prescribed by or in consultation with an oncologist or hematologist; AND
• Disease is T315I mutation-positive; AND
• Diagnosis of chronic myelogenous/myeloid leukemia (CML); AND
• Disease is Philadelphia chromosome-positive (Ph+); AND
• Disease is in chronic phase; AND
• Patient has been previously treated with two or more alternative tyrosine kinase inhibitors (TKI) [e.g., Bosulif (bosutinib), imatinib, Sprycel (dasatinib), Tasigna (nilotinib), Iclusig (ponatinib)]

Reauthorization Criteria:

1. For diagnosis of adults with Ph+ chronic phase CML:

• Dose does not exceed 80 mg per day (can be split into two equal doses of 40 mg twice daily); AND
• Patient does not show evidence of progressive disease while on therapy

2. For diagnosis of adult patients with T315I-positive CML:

• Dose does not exceed 200 mg twice daily; AND
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• The NCCN CML clinical practice guidelines state patients who fail to achieve response on first-line TKI therapy should be considered for alternate treatment options/second-line TKI therapy.
• Asciminib, ponatinib, and omacetaxine (non-TKI protein synthesis inhibitors) are options for patients with the T315I mutation and for those with disease that has not responded to ≥ 2 prior TKIs. The use of an alternate second-generation TKI after treatment failure with 2 prior TKIs, including a second-generation TKI, is not associated with durable responses except in occasional patients with chronic phase CML.
• Safety of asciminib: rash and related conditions, increased triglycerides, blood chemistry disturbances, pain (general), diarrhea, nausea, fatigue, increased ALT and AST, upper respiratory tract infection, anemia, lymphopenia, neutropenia, thrombocytopenia
• Grade 3/4 AEs: neutropenia, thrombocytopenia
• Warnings and precautions: myelosuppression, pancreatic toxicity, hypertension, hypersensitivity, cardiovascular toxicity, embryo-fetal toxicity
• Administration:
  • Swallow tablets whole.  Do not break. Crush or chew the tablets

Policy Updates:

• 5/17/2022 – New policy approved by P&T

References:

1. Scemblix [prescribing information]. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation. October 2021.
2. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Acute Lymphoblastic Leukemia. V3.2021. December 16, 2021(b). NCCN Web site.  https://www.nccn.org/.