Medical Policy

Effective Date:01/07/2007 Title:Imatinib (Gleevec)
Revision Date:01/01/2017 Document:BI178:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Imatinib requires pre-authorization.

2)    Imatinib is an oral drug used for treating different types of cancer.

3)    Imatinib is covered under the pharmacy benefit as a specialty drug.

Medical Statement

1)    Imatinib is eligible for coverage for adult members with Chronic Myelogenous Leukemia (CML) (C92.10 – C92.20). It is eligible for coverage for members meeting the following criteria:

a)    Members who are Philadelphia chromosome-positive (Ph+) and

b)    Members in chronic phase who are not candidates for high dose chemotherapy and allogeneic stem cell infusion; or

c)     Members with CML in the accelerated phase who have failed interferon therapy.

2)    Imatinib is eligible for coverage for KIT (CD 117) positive metastatic or un-resectable Gastrointestinal Stromal Tumors (GIST) in members 18 years of age and older.

a)    Eligible ICD-10CM code(s): C49.9 – Malignant neoplasm connective and soft tissue

3) Imatinib is eligible for coverage for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in members 15 years of age and older

4) Imatinib is eligible for coverage for recurrent bone cancer (Chordomas)

5) Imatinib is eligible for coverage for metastatic or unresectable melanoma with activating mutations of C-KIT as second-line or subsequent therapy for disease progression or after maximum clinical benefit from BRAF targeted therapy for patients with performance status 0-2.

6) Imatinib is eligible for coverage for adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements.

7) Imatinib is eligible for coverage for soft tissue sarcoma (desmoids tumors) for primary, recurrent, or progressive disease.

8) Imatinib is eligible for coverage for soft tissue sarcoma (pigmented villonodular synovitis / tenosynovial giant cell tumor (PVNS/TGCT) as single agent therapy

9) Imatinib is eligible for coverage for adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP), or for adjuvant therapy

10) Imatinib is eligible for coverage for non-Hodgkin’s Lymphoblastic lymphoma for induction or re-induction therapy for Philadelphia chromosome-positive stage I-IV disease as a component of HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine) regiment with rituximab in CD20-positive disease.

Limits

1)    Gleevec (brand name) is not covered; only generic formulation is covered.

Reference
  1. Novartis Oncology. Gleevec (imatinib mesylate). Prescribing Information. East Hanover, NJ: Novartis; January 2002. Available at: http://www.gleevec.com/hcp/page/hcp
  2. Garcia-Manero G, Faderl S, O`Brien S, et al. Chronic myelogenous leukemia: A review and update of therapeutic strategies. Cancer. 2003; 98(3):437-457.
  3. National Comprehensive Cancer Network (NCCN). Drugs and Biologic Compendium. Imatinib.  Accessed online November 22, 2016.
  4. Dalziel K, Round A, Stein K, et al. Effectiveness and cost-effectiveness of imatinib for first-line treatment of chronic myeloid leukemia in chronic phase: a systematic review and economic analysis. Health Technology Assess. 2004; 8(28):1-134.
  5. FDA Talk Paper; FDA approves Gleevec to treat gastrointestinal stromal cancer Feb 2002 at: http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01134.html
  6. Gleevec Prescribing information at: http://www.fda.gov/cder/foi/label/2006/021588s009lbl.pdf.

Addendum:

Effective 01/01/2017: Updated covered diagnoses and noted that brand Gleevec is not covered (only generic is covered).

Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.


Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.