Pharmacy Prior Authorization Criteria

Sprycel (dasatinib)

Indications for Prior Authorization

Sprycel (dasatinib)

• For diagnosis of Newly diagnosed Chronic Myeloid Leukemia
  Indicated for the treatment of adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

• For diagnosis of Resistant or intolerant Chronic Myeloid Leukemia
  Indicated for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.

• For diagnosis of Acute Lymphoblastic Leukemia (ALL)
  Indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

• For diagnosis of Pediatric ALL
  Indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

• For diagnosis of Pediatric Patients with Ph+ CML
  Indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase.

Criteria

Brand Sprycel, generic dasatinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Philadelphia chromosome-positive/BCR ABL positive (Ph+/BCR ABL) Acute Lymphoblastic Leukemia/Acute Lymphoblastic Lymphoma (ALL)

• Diagnosis of Ph+/BCR ABL acute lymphoblastic leukemia (ALL)
AND
• Trial and failure, or intolerance to generic dasatinib (applies to Brand Sprycel only)
AND
• One of the following (applies to Brand Sprycel only)
• Trial and failure, contraindication, or intolerance to generic imatinib
OR
• Continuation of prior therapy

Brand Sprycel, generic dasatinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Ph+/BCR ABL Chronic Myelogenous/Myeloid Leukemia (CML)

• Diagnosis of Ph+/BCR ABL chronic myelogenous/myeloid leukemia (CML)
AND
• Trial and failure, or intolerance to generic dasatinib (applies to Brand Sprycel only)
AND
• One of the following: (applies to Brand Sprycel only)
• Trial and failure, contraindication, or intolerance to generic imatinib
OR
• Continuation of prior therapy

Brand Sprycel, generic dasatinib

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial and failure, or intolerance to generic dasatinib (applies to Brand Sprycel only)
AND
• One of the following: (applies to Brand Sprycel only)
• Trial and failure, contraindication, or intolerance to generic imatinib
OR
• Continuation of prior therapy

P & T Revisions

2024-11-06, 2024-10-24, 2024-10-02, 2024-02-14, 2023-06-15, 2023-04-28, 2023-01-09, 2022-01-28, 2021-09-27, 2021-05-26, 2021-05-25, 2021-04-09, 2020-01-22, 2019-07-30

References

1. Sprycel [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; February 2023.
2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Chronic Myeloid Leukemia v.1.2023. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. Accessed January 9, 2023.

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End Notes

1. According to National Comprehensive Cancer Network (NCCN) recommendations, imatinib, dasatinib, bosutinib, and nilotinib are first-line therapies for chronic myelogenous/myeloid leukemia. In settings where all 4 agents are appropriate as a first-line option, a step through any of the 4 products is inappropriate. [2]
2. According to NCCN recommendations, patients with disease that is resistant to first-line imatinib should be treated with nilotinib, dasatinib, or bosutinib in the second-line setting, taking into account BCR::ABL1 kinase domain mutation status. Patients with disease that is resistant to first-line treatment with bosutinib, nilotinib, or dasatinib could be treated with an alternate TKI (other than imatinib) in the second-line setting, taking into account BCR::ABL1 kinase domain mutation status. Dasatinib and nilotinib are effective against a majority of mutations resistant to imatinib, except for the T315I mutation. Consider clinical trial, asciminib, ponatinib, omacetaxine, or hematopoietic cell transplantation (HCT) for patients with a T315I mutation. [2]

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Revision History

• 2024-11-06: Update to add t/f requirement
• 2024-10-24: Update to add t/f requirement
• 2024-10-02: Added new generic dasatinib
• 2024-02-14: 2024 Annual Review - No criteria changes. Background updates to align with FDA label and consolidated reauth criteria into one bucket for all indications listed.
• 2023-06-15: Removal of specialist requirement
• 2023-04-28: Program update to remove criteria and just leave the diagnosis and specialist requirements.
• 2023-01-09: Annual review: No criteria changes. Updated references and background.
• 2022-01-28: 2022 Annual Review - Updated pediatric age criteria to 1 year of age and older, updated background information.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-09: Updated GPIs
• 2020-01-22: updated references
• 2019-07-30: Removal of Criteria 2 for CML indication Patient does not have the T315I, F317L, and V299L mutation due to consultant feedback that these mutation are not routinely tested for in practice first line (Dr Sinha and Dr Gandhi)

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