GLEEVEC (imatinib)

Self-Administration – oral

Diagnosis considered for coverage:

Chronic myelogenous/myeloid leukemia (CML)
- Indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase. Gleevec is also 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.
Acute lymphoblastic leukemia/ Acute lymphoblastic lymphoma (ALL)
- Indicated for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Gleevec is also indicated for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
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.
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
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 FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown.
Dermatofibrosarcoma protuberans (DFSP)
- Indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
Gastrointestinal stromal tumors (GIST)
- Indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). Gleevec is also indicated for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.

Coverage Criteria:

For diagnosis of Chronic Myelogenous/Myeloid Leukemia (CML):

Dose does not exceed:
- Adults:
  - Chronic phase: 600 mg/day
  - Accelerated phase or blast crisis: 800 mg (given as 400 mg twice daily)
- Pediatrics: chronic phase: 340 mg/m2/day (not to exceed 600 mg), AND
Prescribed by or in consultation with a hematologist/oncologist, AND
Chart note documentation provided confirms diagnosis of Philadelphia chromosome/BCR ABL-positive (Ph+/BCR ABL+) chronic myelogenous/myeloid leukemia (CML), AND
For brand Gleevec tablets only: Trial and failure, contraindication, or intolerance to generic Gleevec (imatinib) tablets

For diagnosis of Acute lymphoblastic leukemia/ Acute lymphoblastic lymphoma (ALL):

Dose does not exceed:
- Adults: 600 mg/day
- Pediatrics: 340 mg/m2/day (not to exceed 600 mg), AND
Prescribed by or in consultation with a hematologist/oncologist, AND
Chart note documentation provided confirms diagnosis of Ph+/BCR ABL+ acute lymphoblastic leukemia (ALL), 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
For brand Gleevec tablets only: Trial and failure, contraindication, or intolerance to generic Gleevec (imatinib) tablets

For diagnosis of Myelodysplastic Disease (MDS)/Myeloproliferative Disease (MPD):

Dose does not exceed 400 mg/day, AND
Patient is 18 years of age or older, AND
Prescribed by or in consultation with a hematologist/oncologist, AND
Chart note documentation provided confirms diagnosis of myelodysplastic/myeloproliferative disease (MDS/MPD), AND
Disease is associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements, AND
For brand Gleevec tablets only: Trial and failure, contraindication, or intolerance to generic Gleevec (imatinib) tablets

For diagnosis of Aggressive Systemic Mastocytosis (ASM):

Dose does not exceed 400 mg/day, AND
Patient is 18 years of age or older, AND
Prescribed by or in consultation with a hematologist/oncologist, AND
Chart note documentation provided confirms diagnosis of aggressive systemic mastocytosis (ASM), AND
One of the following (A OR B):
- A. Patient is without the D816V c-Kit mutation
- B. c-Kit mutational status is unknown, AND
For brand Gleevec tablets only: Trial and failure, contraindication, or intolerance to generic Gleevec (imatinib) tablets

For diagnosis of Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL):

Dose does not exceed 400 mg/day, AND
Patient is 18 years of age or older, AND
Prescribed by or in consultation with a hematologist/oncologist, AND
Chart note documentation provided confirms diagnosis of hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL), AND
For brand Gleevec tablets only: Trial and failure, contraindication, or intolerance to generic Gleevec (imatinib) tablets

For diagnosis of Dermatofibrosarcoma Protuberans (DFSP):

Dose does not exceed 800 mg/day, AND
Patient is 18 years of age or older, AND
Prescribed by or in consultation with a hematologist/oncologist, AND
Chart note documentation provided confirms diagnosis of unresectable, recurrent, or metastatic dermatofibrosarcoma protuberans (DFSP), AND
For brand Gleevec tablets only: Trial and failure, contraindication, or intolerance to generic Gleevec (imatinib) tablets

For diagnosis of Gastrointestinal Stromal Tumors (GIST):

Dose does not exceed:
- Unresectable and/or metastatic, malignant: 800 mg/day
- Adjuvant treatment following complete gross resection of GIST: 400 mg/day, AND
Patient is 18 years of age or older, AND
Prescribed by or in consultation with an oncologist, AND
Chart note documentation provided confirms diagnosis of gastrointestinal stromal tumors (GIST), AND
One of the following (A OR B):
- A. Patient has documented c-KIT (CD117) positive unresectable or metastatic malignant GIST
- B. Both of the following (i AND ii)
  - i. Patient had resection of c-KIT (CD117) positive GIST, and
  - ii. Gleevec (imatinib) will be used as adjuvant therapy, AND
For brand Gleevec tablets only: Trial and failure, contraindication, or intolerance to generic Gleevec (imatinib) tablets

Reauthorization Criteria:

For diagnosis of all diagnoses listed above:

Dose does not exceed FDA approved maximum doses as listed above, 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.

Additional Information:

The prescribed dose should be administered orally, with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day.
For daily dosing of 800 mg and above, dosing should be accomplished using the 400-mg tablet to reduce exposure to iron.
For Myelodysplastic Disease (MDS)/Myeloproliferative Disease (MPD): Determine PDGFRb gene rearrangements status prior to initiating treatment.
For Aggressive Systemic Mastocytosis (ASM):
- Determine D816V c-Kit mutation status prior to initiating treatment.
- The recommended dose of Gleevec is 400 mg/day for adult patients with ASM without the D816V c-Kit mutation. If c-Kit mutational status is not known or unavailable, treatment with Gleevec 400 mg/day may be considered for patients with ASM not responding satisfactorily to other therapies. For patients with ASM associated with eosinophilia, a clonal hematological disease related to the fusion kinase FIP1L1-PDGFRα, a starting dose of 100 mg/day is recommended. Dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
For Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL): For HES/CEL patients with demonstrated FIP1L1-PDGFRα fusion kinase, a starting dose of 100 mg/day is recommended. Dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.

Policy Updates:

08/16/2022 – New policy approved by P&T.

References:

1. Gleevec Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. July 2021

Last review date: August 16, 2022