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PrGLEEVEC* (imatinib) Reimbursement/ Coverage
GLEEVEC* (imatinib mesylate) Tablets
DINs 02253275 (100 mg tablets), 02253283 (400 mg tablets)
GLEEVEC* Product Monograph
GLEEVEC* is an eligible benefit through most private insurance plans, provincial drug benefit programs/ provincial cancer agencies and federal drug programs. The sidebar menu allows you to access specific information on coverage of GLEEVEC* including coverage/ reimbursement criteria and guidelines, limited use codes and criteria, special authorization forms, instructions and other resources.
Click on the plan or program name on the left side bar for more information.
 |  | | 1 877 CML-ALLI or 1 877 265 2554 | 1 866 996-GIST or 1 866 996 4478 | CML ALLIANCETM and GLEEVEC ALLIANCETM
Designed to provide support and peace of mind for your patients.
Specialized patient support programs designed to provide health information and financial support for patients who have been prescribed GLEEVEC* or PrTASIGNA* (nilotinib). To register for these specialized patient support programs, the following form must be completed:
CML ALLIANCE* — Patient Registration Form
GIST ALLIANCE* — Patient Registration Form
Indications:
GLEEVEC* indicated for- the treatment of adult and pediatric patients with newly diagnosed, Philadelphia-chromosome-positive, chronic myeloid leukemia (CML) in chronic phase.
- Conditional approval in newly diagnosed CML, was based on hematologic and cytogenetic response rates (surrogate endpoints) that are reasonably likely to predict clinical benefit. There are no controlled trials that demonstrate clinical benefit in pediatric patients.
- the treatment of adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
- Conditional approval in gastrointestinal stromal tumors (GIST) was based on objective response rates (surrogate endpoints) that are reasonably likely to predict clinical benefit. There are no controlled trials demonstrating clinical benefit such as improvement in disease-related symptoms or increased survival.
- has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit. Patients should be advised of the nature of the authorization.
- the adjuvant treatment of adult patients who are at intermediate to high risk of relapse following complete resection of Kit (CD117) positive GIST.
- Conditional approval in the adjuvant GIST indication was based on recurrence free survival after one year of adjuvant therapy. The optimal treatment duration with GLEEVEC* is not known. Overall survival data are not available.
GLEEVEC* has been issued non-conditional approval for the indications of:- Adult patients with Philadelphia chromosome-positive CML in blast crisis, accelerated phase or chronic phase (after failure of interferon-alpha therapy).
- Non conditional approval in Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase (after failure of interferon alpha therapy) was based on hematologic and cytogenetic response rates (surrogate endpoints), which have shown to be sustained for at least two years.
- For use as a single agent for induction phase therapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL)
- Non conditional approval for use as a single agent for induction phase therapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) was based on hematologic response rates (surrogate endpoints).
- Adult patients with relapsed or refractory Ph+ ALL as monotherapy.
- Non conditional approval in adult patients with relapsed or refractory Ph+ ALL as monotherapy was based on hematologic and cytogenetic response rates (surrogate endpoints).
- Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
- Non conditional approval in adult patients with myelodysplastic/myeloproliferativediseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements was based on hematologic and cytogenetic response rates (surrogate endpoints).
- Adult patients with aggressive sub-types of systemic mastocytosis (ASM and SM-AHNMD1) without the D816V c-Kit mutation. If c-Kit mutational status in patients with ASM or SM-AHNMD1 is not know or unavailable, treatment with GLEEVEC may be considered if there is no satisfactory response to other therapies.
- Non conditional approval in adult patients with aggressive sub-types of systemic mastocytosis (ASM and SM-AHNMD1) without the D816V c-Kit mutation and in adult patients with ASM or SM-AHNMD1 where c-Kit mutational status is not known or unavailable, and if there is no satisfactory response to other therapies was based on hematologic response rates (surrogate endpoints).
- Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with FIP1L1-PDGFRa rearrangement.
- Non conditional approval in adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with FIP1L1-PDGFRá rearrangement was based on hematologic and cytogenetic response rates (surrogate endpoints).
- Adult patients with unresectable, recurrent and/or metastic dermatofibrosarcoma protuberans (DFSP).
- Non conditional approval in adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) was based on objective response rate (surrogate endpoints).
1 ASM: Aggressive systemic mastocytosis; SM-AHNMD: Systemic mastocytosis with an associated clonal hematological non-mast-cell disorder.
Further details are contained in the GLEEVEC* Product Monograph.
GLEEVEC* (imatinib mesylate) is contraindicated in patients with hypersensitivity to imatinib or to any other component of GLEEVEC*.
Serious Warnings and Precautions - Severe congestive heart failure (CHF) and reduction of left ventricular ejection fraction (LVEF) have been observed (see “Cardiovascular” section under WARNINGS and PRECAUTIONS in Product Monograph).
- Rhabdomyolysis has been rarely observed. (See “Adverse Reactions from Post-Marketing reports” section under ADVERSE REACTIONS in Product Monograph).
- Severe hemorrhages may occur (See “Hemorrhage” section under WARNINGS and PRECAUTIONS in Product Monograph).
- Fluid retention may occur (See ‘Fluid Retention’ section under ‘WARNINGS AND PRECAUTIONS in Product Monograph).
- Liver failure (in some cases, fatal) may occur (See “Hepatic/Biliary/Pancreatic” section under ‘WARNINGS AND PRECAUTIONS’).
- Gastrointestinal perforation (in some cases, fatal) may occur (See “Gastrointestinal” section under WARNINGS AND PRECAUTIONS).
GLEEVEC* should only be administered under the supervision of a physician experienced with the use of chemotherapy and with treatment of hematological malignancies or malignant sarcomas including gastrointestinal stromal tumors (GISTs) and dermatofibrosarcoma protuberans (DFSP).
Please refer to the product monograph for important information regarding contraindications, warnings, precautions, adverse reactions, dosing, and patient selection.
GLEEVEC* Product Monograph
TASIGNA* (nilotinib capsules), indicated for, - the treatment of accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib,
has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit. Patients should be advised of the conditional nature of the authorization. Conditional approval of TASIGNA* is based on the interim analysis of the confirmed hematologic response rate. TASIGNA* should only be administered under the supervision of a physician experienced with the use of chemotherapy and with treatment of chronic myeloid leukemia.
Please refer to the product monograph for important information regarding contraindications, warnings, precautions, adverse reactions, dosing, and patient selection.
*Tasigna Product Monograph
Resources for Healthcare Professionals and Your Patients
The following websites are external links. DrugCoverage assumes no responsibility for the content of these sites.
Chronic Myeloid Leukemia
National Comprehensive Cancer Network (NCCN) Website (requires password / login)
Once logged in, click on NCCN Clinical Practice Guidelines in OncologyTM.
Scroll down to "guidelines for Supportive Care" to find:
Chronic Myelogenous Leukemia V.2 2010
CML Society of Canada
The Leukemia & Lymphoma Society of Canada
CMLSource - A publication of the Leukemia & Lymphoma Society of Canada
Gastrointestinal Stromal Tumours
National Comprehensive Cancer Network (NCCN) Website (requires password / login)
Once logged in, click on NCCN Clinical Practice Guidelines in OncologyTM.
Scroll down to "guidelines for Primary Peritoneal Cancer" to find:
Soft Tissue Sarcoma, V.2 2010
GIST Support International
The Life Raft Group - ensuring no one has to face GIST alone
*GLEEVEC and TASIGNA are registered trademarks
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