Pharmacy Prior Authorization Criteria

Imatinib Products - PA, NF

Indications for Prior Authorization

Gleevec (imatinib mesylate), Imkeldi

• For diagnosis of Chronic myelogenous/myeloid leukemia (CML)
  1) Indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase. 2) Indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy.

• For diagnosis of Acute lymphoblastic leukemia/ Acute lymphoblastic lymphoma (ALL)
  1) Indicated for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). 2) Indicated for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

• For diagnosis of Myelodysplastic/myeloproliferative diseases (MDS/MPD)
  Indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements.

• For diagnosis of Aggressive systemic mastocytosis (ASM)
  Indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.

• For diagnosis of Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL)
  Indicated for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRa fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown.

• For diagnosis of Dermatofibrosarcoma protuberans (DFSP)
  Indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

• For diagnosis of Gastrointestinal stromal tumors (GIST)
  1) Indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). 2) Indicated for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.

Criteria

Brand Gleevec

Prior Authorization (Initial Authorization)

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

• Diagnosis of Philadelphia chromosome/BCR ABL-positive (Ph+/BCR ABL+) chronic myelogenous/myeloid leukemia (CML)
AND
• Trial and failure, or intolerance to generic imatinib

Brand Gleevec

Non Formulary

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

• Diagnosis of Philadelphia chromosome/BCR ABL-positive (Ph+/BCR ABL+) chronic myelogenous/myeloid leukemia (CML)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to generic imatinib

Generic imatinib

Prior Authorization (Initial Authorization)

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

• Diagnosis of Philadelphia chromosome/BCR ABL-positive (Ph+/BCR ABL+) chronic myelogenous/myeloid leukemia (CML)

Imkeldi

Prior Authorization (Initial Authorization)

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

• Diagnosis of Philadelphia chromosome/BCR ABL-positive (Ph+/BCR ABL+) chronic myelogenous/myeloid leukemia (CML)
AND
• Patient is unable to swallow generic imatinib tablet due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube

Brand Gleevec

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Acute lymphoblastic leukemia/ Acute lymphoblastic lymphoma (ALL)

• Diagnosis of Ph+/BCR ABL+ acute lymphoblastic leukemia (ALL)
AND
• Trial and failure, or intolerance to generic imatinib

Brand Gleevec

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Acute lymphoblastic leukemia/ Acute lymphoblastic lymphoma (ALL)

• Diagnosis of Ph+/BCR ABL+ acute lymphoblastic leukemia (ALL)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to generic imatinib

Generic imatinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Acute lymphoblastic leukemia/ Acute lymphoblastic lymphoma (ALL)

• Diagnosis of Ph+/BCR ABL+ acute lymphoblastic leukemia (ALL)

Imkeldi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Acute lymphoblastic leukemia/ Acute lymphoblastic lymphoma (ALL)

• Diagnosis of Ph+/BCR ABL+ acute lymphoblastic leukemia (ALL)
AND
• Patient is unable to swallow generic imatinib tablet due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube

Brand Gleevec

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Disease (MDS)/Myeloproliferative Disease (MPD)

• Diagnosis of myelodysplastic/myeloproliferative disease (MDS/MPD)
AND
• Trial and failure, or intolerance to generic imatinib

Brand Gleevec

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Disease (MDS)/Myeloproliferative Disease (MPD)

• Diagnosis of myelodysplastic/myeloproliferative disease (MDS/MPD)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to generic imatinib

Generic imatinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Disease (MDS)/Myeloproliferative Disease (MPD)

• Diagnosis of myelodysplastic/myeloproliferative disease (MDS/MPD)

Imkeldi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Disease (MDS)/Myeloproliferative Disease (MPD)

• Diagnosis of myelodysplastic/myeloproliferative disease (MDS/MPD)
AND
• Patient is unable to swallow generic imatinib tablet due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube

Brand Gleevec

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Aggressive Systemic Mastocytosis (ASM)

• Diagnosis of aggressive systemic mastocytosis (ASM)
AND
• Trial and failure, or intolerance to generic imatinib

Brand Gleevec

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Aggressive Systemic Mastocytosis (ASM)

• Diagnosis of aggressive systemic mastocytosis (ASM)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to generic imatinib

Generic imatinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Aggressive Systemic Mastocytosis (ASM)

• Diagnosis of aggressive systemic mastocytosis (ASM)

Imkeldi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Aggressive Systemic Mastocytosis (ASM)

• Diagnosis of aggressive systemic mastocytosis (ASM)
AND
• Patient is unable to swallow generic imatinib tablet due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube

Brand Gleevec

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)

• Diagnosis of at least one of the following:
• Hypereosinophilic syndrome (HES)
• Chronic eosinophilic leukemia (CEL)
AND
• Trial and failure, or intolerance to generic imatinib

Brand Gleevec

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)

• Diagnosis of at least one of the following:
• Hypereosinophilic syndrome (HES)
• Chronic eosinophilic leukemia (CEL)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to generic imatinib

Generic imatinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)

• Diagnosis of at least one of the following:
• Hypereosinophilic syndrome (HES)
• Chronic eosinophilic leukemia (CEL)

Imkeldi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)

• Diagnosis of at least one of the following:
• Hypereosinophilic syndrome (HES)
• Chronic eosinophilic leukemia (CEL)
AND
• Patient is unable to swallow generic imatinib tablet due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube

Brand Gleevec

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Dermatofibrosarcoma Protuberans (DFSP)

• Diagnosis of unresectable, recurrent, or metastatic dermatofibrosarcoma protuberans (DFSP)
AND
• Trial and failure, or intolerance to generic imatinib

Brand Gleevec

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Dermatofibrosarcoma Protuberans (DFSP)

• Diagnosis of unresectable, recurrent, or metastatic dermatofibrosarcoma protuberans (DFSP)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to generic imatinib

Generic imatinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Dermatofibrosarcoma Protuberans (DFSP)

• Diagnosis of unresectable, recurrent, or metastatic dermatofibrosarcoma protuberans (DFSP)

Imkeldi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Dermatofibrosarcoma Protuberans (DFSP)

• Diagnosis of unresectable, recurrent, or metastatic dermatofibrosarcoma protuberans (DFSP)
AND
• Patient is unable to swallow generic imatinib tablet due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube

Brand Gleevec

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumors (GIST)

• Diagnosis of gastrointestinal stromal tumors (GIST)
AND
• Trial and failure, or intolerance to generic imatinib

Brand Gleevec

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumors (GIST)

• Diagnosis of gastrointestinal stromal tumors (GIST)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to generic imatinib

Generic imatinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumors (GIST)

• Diagnosis of gastrointestinal stromal tumors (GIST)

Imkeldi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumors (GIST)

• Diagnosis of gastrointestinal stromal tumors (GIST)
AND
• Patient is unable to swallow generic imatinib tablet due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube

Brand Gleevec, Generic imatinib, Imkeldi

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

P & T Revisions

2025-02-05, 2024-09-02, 2023-08-31, 2023-07-11, 2023-04-28, 2022-09-08, 2022-02-18, 2021-08-30, 2021-05-19, 2021-04-14, 2019-11-06, 2019-07-31, 2019-07-31

References

1. Gleevec Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. March 2024
2. Imkeldi Prescribing Information. Shorla Oncology Inc. Cambridge, MA 02142, USA. November 2024

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Revision History

• 2025-02-05: Addition of Imkeldi to guideline. Changed guideline name from "Gleevec (imatinib mesylate) - PA, NF" to "Imatinib Products - PA, NF".
• 2024-09-02: Annual Review 2024. No criteria changes. Background updates only.
• 2023-08-31: Annual Review - no criteria changes
• 2023-07-11: Removed specialist requirement
• 2023-04-28: Program update to for MDS/MPD, ASM, GIST criteria to remove requirement associated with genetic status.
• 2022-09-08: Annual Review - Provider Updates
• 2022-02-18: Addition of NF sections for Brand Gleevec
• 2021-08-30: 2021 Annual Review - No criteria changes
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-14: Updated product list due to new GPIs
• 2019-11-06: For consistency updating this same language for the other indications throughout the guideline "Removal of "contraindication" from criteria across all indications" effective date 12/01/2019
• 2019-07-31: Patient does not show evidence of progressive disease while on Gleevec therapy removed while on Gleevec therapy to streamline so we don't have to specify if brand or generic
• 2019-07-31: Edited criteria 3 on CML indication to remove contraindication based on consultant feedback 3 Trial and failure, [contraindication] , or intolerance to generic imatinib

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