Scemblix – NC Standard

Restricted Product(s)

• Scemblix® (asciminib)

FDA Approved Use

• For the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in chronic phase (CP). 
• For the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in chronic phase (CP), previously treated. 
• For the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in chronic phase (CP) with the T315I mutation.

Criteria for Approval of Restricted Product(s)

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is 18 years of age or older; AND 
3. The patient is being managed by or in consultation with an oncologist; AND 
4. The patient has been diagnosed with one of the following diagnoses (medical record documentation required):
   1. The patient has newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP); AND 
      1. The patient has tried and had an inadequate response, intolerance, or hypersensitivity to ONE of the following: generic imatinib or dasatinib (medical record documentation required); OR
         1. The patient has an FDA labeled contraindication to ALL the following: generic imatinib or dasatinib (medical record documentation required); AND 
      2. The request is for 80mg or less; OR
   2. The patient has Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in chronic phase (CP) with the T315I mutation (medical record documentation required); AND  
      1. The patient has tried and had an inadequate response, intolerance, or hypersensitivity to Iclusig (medical record documentation required); OR 
         1. The patient has an FDA labeled contraindication to Iclusig (medical record documentation required); AND
5. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. Medical records and references/evidence must be provided; AND
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90-day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

November 2024: Criteria change: Added expanded indication for the treatment of adult patients with newly diagnosed Philadelphia chromosome−positive chronic myeloid leukemia in chronic phase. Updated indication for Ph+CML in chronic phase (CP), previously treated to remove the requirement for use of two or more tyrosine kinase inhibitors (TKIs).
July 2024: Criteria update: Added new 100mg Scemblix tablet to QL chart. Removed QL exception criteria for dosing ≥ 80 mg and added to initial criteria given 100mg tablet is now available.
July 2022: Criteria change: Dosing ≥ 80 mg requires a positive T315I mutation. Additional step through Iclusig for Scemblix with T315I mutation. Changed QL to 2 tablets unless documented positive T315I mutation.

February 2022: Criteria change for intermediate to high risk chronic CML
November 2021: Original utilization management policy issued.