SPRYCEL (dasatinib)

SPRYCEL (dasatinib)

Self Administration - Oral

Indications for Prior Authorization:

• Treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
• Treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
• Treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
• Treatment of pediatrics 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
• Treatment of pediatrics 1 year of age and older with Ph+ CML in chronic phase.

Coverage Criteria:

For diagnosis of Ph+/BCR-ABL Chronic Myelogenous/Myeloid Leukemia (CML):

• Adults, dose does not exceed 180 mg once daily. Pediatrics dose does not exceed the weight-based dosing, AND
• Diagnosis of Ph+ (BCR-ABL1-Positive) CML, AND
• Prescribed by or in consultation with an oncologist or hematologist
   

For diagnosis of Philadelphia chromosome-positive/BCR-ABL positive (Ph+/BCR-ABL) Acute Lymphoblastic Leukemia/Acute Lymphoblastic Lymphoma (ALL):

• Adults, dose does not exceed 180 mg once daily. Pediatrics dose does not exceed the weight-based dosing, AND
• Diagnosis of Ph+ (BCR-ABL1-Positive) ALL, AND
• Prescribed by or in consultation with an oncologist or hematologist, AND
• One of the following:
  • Resistance or intolerance to any prior therapy, OR
  • Both of the following:
    • Pediatric patient (under 18 years of age) with newly diagnosed disease, AND
    • Used in combination with chemotherapy

Reauthorization Criteria:

For diagnosis of Ph+/BCR-ABL Chronic Myelogenous/Myeloid Leukemia (CML):

• Adults, dose does not exceed 180 mg once daily. Pediatrics dose does not exceed the weight-based dosing, AND
• Patient does not show evidence of progressive disease while on therapy

For diagnosis of Philadelphia chromosome-positive/BCR-ABL positive (Ph+/BCR-ABL) Acute Lymphoblastic Leukemia/Acute Lymphoblastic Lymphoma (ALL):

• Adults, dose does not exceed 180 mg once daily. Pediatrics dose does not exceed the weight-based dosing, 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.

Dosing:

• Adults
  • CML – Chronic Phase: 100 - 140 mg daily
  • CML – Accelerated or Blast Phase: 140 – 180 mg daily
  • ALL: 140 – 180 mg daily
• Pediatrics
  • CML: Weight-Based Dosing:
    • 10 – <20 kg: 40mg
      • Can be escalated to 50 mg
    • 20 – <30 kg: 60mg
      • Can be escalated to 70 mg
    • 30 – <45 kg: 70mg
      • Can be escalated to 90 mg
    • >45 kg: 100mg
      • Can be escalated to 120 mg
  • ALL: Weight-Based Dosing:
    • 10 – <20 kg: 40mg
    • 20 – <30 kg: 60mg
    • 30 – <45 kg: 70mg
    • >45 kg: 100mg

Additional Information:

• Warnings and Precautions
  • Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia, and anemia may occur. Use caution if used concomitantly with medications that inhibit platelet function or anticoagulants. Monitor complete blood counts regularly. Transfuse and interrupt Sprycel when indicated.
  • Fluid Retention: Fluid retention, sometimes severe, including pleural effusions. Manage with supportive care measures and/or dose modification.
  • Cardiac Dysfunction: Monitor patients for signs or symptoms and treat appropriately.
  • Pulmonary Arterial Hypertension (PAH): Sprycel may increase the risk of developing PAH which may be reversible on discontinuation. Consider baseline risk and evaluate patients for signs and symptoms of PAH during treatment. Stop Sprycel if PAH is confirmed
  • QT Prolongation: Use Sprycel with caution in patients who have or may develop prolongation of the QT interval.
  • Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain adequate hydration and correct uric acid levels prior to initiating therapy with Sprycel.
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to fetus and avoid pregnancy.
  • Effects on Growth and Development in Pediatric Patients: epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported. Monitor bone growth and development in pediatric patients.
• Drug Interactions
  • Strong CYP3A4 Inhibitors: Dose reduction may be necessary.
  • Strong CYP3A4 Inducers: Dose increase may be necessary.
  • Antacids: Avoid simultaneous administration.
  • H2 Antagonists and Proton Pump Inhibitors: Avoid coadministration.

Policy Updates:

• 8/17/2021 – New policy approved by P&T

References:

• Sprycel Prescribing Information. Bristol-Myers Squibb Company. Princeton, NJ. December 2018.
• National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Chronic Myelogenous Leukemia v.1.2020. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. Accessed January 1, 2020