Sprycel - NC Standard

Restricted Product(s):

• Sprycel® (dasatinib)

FDA Approved Use:

• Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
• Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
• Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
• Pediatric patients one year of age and older with Ph+ CML in chronic phase.
• Pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

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 being managed by or in consultation with an oncologist; AND
3. If the request is for brand Sprycel,
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic dasatinib (medical record documentation required); AND
4. The patient has a confirmed diagnosis of ONE of the following (medical record documentation required):
   1. Adult patient 18 years of age or older with:
      1. Newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase; OR
      2. Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the accelerated, chronic, myeloid, or lymphoid blast phase with resistance or intolerance to prior therapy; OR
      3. Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy; OR
   2. Pediatric patient 1 year of age or older, but less than 18 years of age with:
      1. Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; OR
      2. Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL); AND
         1. The patient will be taking in combination with chemotherapy; 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 Limitations:

Quantity limitations apply to brand and associated generic products.

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.

September 2024: Criteria Update: Added statement that restriction applies to brand and generic products. Added statement to require usage of generic medication unless patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication.

July 2023: Criteria change: Criteria review and formatting changes. Clarified patient age for indication.

April 2021: Criteria change: Removed requirement of a trial of generic imatinib.

November 2020: Criteria change: Medical record documentation required for the trial and failure or inability to use imatinib

September 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic (if available).

Jan 2019: Added expanded indication for newly diagnosed Ph+ ALL in combination with chemotherapy

May 2018: Added exemption for intermediate to high risk chronic CML patients

January 2018: Removed age restriction

April 2017: Original utilization management criteria issued.