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09-J1000-46

Original Effective Date: 01/01/12

Reviewed: 02/08/17

Revised: 10/01/17

Subject: Imatinib Mesylate (Gleevec®) Tablets

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Imatinib mesylate (Gleevec®) was the first tyrosine kinase inhibitor (TKI) to receive approval by the US Food and Drug Administration (FDA) for the treatment of persons with chronic myelogenous leukemia (CML) in chronic phase in 2001. Following initial approval, imatinib was approved in 2002 for the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors (GIST) and in 2006 for treatment of five rare diseases: dermatofibrosarcoma protuberans (DFSB), Philadelphia chromosome-positive (Ph+) acute lymphocytic leukemia (ALL), certain types of myelodysplastic/myeloproliferative disorders (MDS/MPD), hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL), and aggressive systemic mastocytosis (ASM). The FDA granted orphan designation to imatinib for the treatment of CML and GIST in 2001; and for the treatment of Ph+ ALL, DFSB, systemic mastocytosis without the D816V c-kit mutation, idiopathic hypereosinophilic syndrome including acute and chronic eosinophilic leukemia, and MDS/MPD associated with platelet-derived growth factor gene re-arrangements in 2005.

Imatinib exerts is mechanism of action through competitive inhibition at the ATP-binding site of the BCR-ABL protein, which results in inhibition of phosphorylation of proteins involved in cell signal transduction. In addition, imatinib blocks the platelet-derived growth factor receptor (PGDFR), as well as the c-KIT tyrosine kinase. Clinical practice guidelines from the National Comprehensive Cancer Network (NCCN) provide recommendations for the use of imatinib in a variety of settings, including FDA-approved indications. Additional off-label uses supported by NCCN include treatment of chordoma, a form of bone cancer, melanoma, certain soft tissue sarcomas, and lymphoblastic lymphoma, which is a type of non-Hodgkin’s lymphoma (NHL).

Chronic myelogenous leukemia (CML) is a hematopoietic stem cell disease characterized by a reciprocal translocation between chromosomes 9 and 22, resulting in the formation of the Philadelphia (Ph) chromosome. CML occurs in three different phases (chronic, accelerated, and blast phase) and is usually diagnosed in the chronic phase. The median age of disease on is 67 years, but CML occurs in all age groups. Untreated chronic phase CML will eventually progress to advanced phase disease in 3 to 5 years. The introduction of small molecule tyrosine kinase inhibitors (TKIs) changed the treatment armamentarium and this “targeted” approach has dramatically altered the natural history of the disease and improved 10-year overall survival from approximately 20% to 80 to 90%. The National Comprehensive Cancer Network (NCCN) guidelines for CML (Version 2.2017) list imatinib (Gleevec), nilotinib (Tasigna®), or dasatinib (Sprycel®) as category 1 options for the treatment of chronic phase CML in patients with a low-risk Sokal or Hasford score. For patients with an intermediate- or high-risk score, the three TKIs are all listed as category 2A options; however, dasatinib and nilotinib are labeled as preferred. Age, tolerance of adverse effects, and comorbid conditions also may affect initial choice of treatment. For example, nilotinib may be preferred in in individuals prone to fluid retention; dasatinib may be preferred in persons with liver disease. Despite positive outcomes observed with TKIs in the treatment of CML, drug resistance has been identified. One of the most common mechanisms of resistance involves point mutations in the kinase domain of BCR-ABL, which impairs the activity of TKIs. One important mutation, the T315I, is known as the “gatekeeper” mutation, as it displays resistance to all TKIs, with the exception of ponatinib (Iclusig®).

POSITION STATEMENT:

Comparative Effectiveness

The FDA has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Initiation of imatinib meets the definition of medical necessity when ALL of the following criteria are met;

1. Imatinib is used to treat ANY of the indications listed in Table 1.

2. ALL of the indication-specific criteria are met.

3. For brand Gleevec® only: member has had a failure, contraindication, or intolerance to generic imatinib - the specific intolerance or contraindication must be provided.

4. The member is NOT taking another tyrosine kinase inhibitor (TKIs) (i.e., dasatinib, nilotinib, bosutinib, or ponatinib) or omacetaxine mepesuccinate (Synribo®) concurrently with imatinib.

5. The dosage does not exceed 800 mg daily and will be achieved using the fewest number of tablets per day.

Table 1

Indications and Specific Criteria

Indication

Criteria

Acute Lymphoblastic Leukemia (ALL)

When BOTH of the following are met:

1. ALL is Philadelphia chromosome-positive (Ph+),

AND

2. Imatinib is used as a component of chemotherapy for induction, consolidation, or maintenance therapy.

Aggressive Systemic Mastocytosis (ASM)

When BOTH of the following are met:

1. Diagnosis is specific for the aggressive systemic form of mastocytosis (i.e., NOT cutaneous or indolent systemic mastocytosis),

AND

2. Patient is without the D816V c-Kit mutation OR the c-Kit mutational status is unknown

Bone Cancer - Chordoma

When BOTH of the following are met:

1. Treatment is for recurrent disease only (includes both local and metastatic disease). Use is NOT for initial treatment.

AND

2. Imatinib is used in accordance with ANY of the following:

a) As monotherapy

b) In combination with cisplatin (Platinol®)

c) In combination with sirolimus (Rapamune®)

Chronic Myelogenous Leukemia (CML)

CML is Ph+

Chronic Myelomonocytic Leukemia (CMML) [a subtype of myelodysplastic/ myeloproliferative neoplasms (MDS/MPN)]

Members CMML is associated with the platelet-derived growth factor receptor (PDGFR) beta gene rearrangement (documentation of mutation must be submitted)

Dermatofibrosarcoma Protuberans (DFSP)

When BOTH of the following are met:

1. Tumor is positive for the t(17;22) translocation (documentation of mutation must be submitted),

AND

2. Any ONE of the following (a, b, or c):

a) Tumor is unresectable (due to unacceptable functional or cosmetic outcomes)

b) Tumor is metastatic

c) ALL of the following:

i. There are positive surgical margins following excision,

ii. Re-resection is not possible

iii. Radiation therapy needs to be avoided

Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)

Proof of diagnosis only

Lymphoblastic Lymphoma

When BOTH of the following are met:

1. The lymphoblastic lymphoma is Philadelphia chromosome-positive (Ph+),

AND

2. Imatinib is used as a component of chemotherapy for induction, consolidation, or maintenance therapy

Melanoma

When ALL of the following are met:

1. Imatinib is used as monotherapy for the melanoma treatment

2. Tumor expresses the c-KIT mutation (documentation of mutation must be submitted)

3. Member has metastatic or unresectable disease

4. Imatinib is being used as second-line or subsequent therapy

5. Member has an ECOG performance status of 0 to 2

Soft Tissue Sarcoma (STS) - Desmoid Tumors (Aggressive Fibromatosis)

Diagnosis only.

STS - Gastrointestinal Stromal Tumors (GIST)

Diagnosis only.

STS - Pigmented Villonodular Synovitis/ Tenosynovial Giant Cell Tumor (PVNS/TGCT)

Imatinib is used as a single agent.

Approval duration: 6 months

The continuation of imatinib meets the definition of medical necessity when ALL of the following criteria are met:

1. The member has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of a condition listed in Table 1, OR the member has previously met all indication-specific criteria.

2. Member’s disease has not progressed during treatment with imatinib,

OR

Member’s disease has progressed but the dosage is being increased up to a maximum dosage of 800 mg per day.

3. For brand Gleevec® only: member has had a failure, contraindication, or intolerance to generic imatinib - the specific intolerance or contraindication must be provided.

4. Member is NOT taking another TKI (i.e., dasatinib, nilotinib, bosutinib, or ponatinib) or omacetaxine concurrently with imatinib.

5. Dosage of imatinib does not exceed 800 mg daily and will be achieved using the fewest number of capsules per day.

Approval duration: 1 year

NOTE: Quest Diagnostics® can perform the BCR-ABL kinase domain mutation test, PDGFR-beta gene arrangement test, and c-KIT mutation tests. Current guidelines recommend checking mutational analysis in the following situations: if there is inadequate initial response, any sign of loss of response, and in disease progression to accelerate-phase or blast-phase CML (CML-AP and CML-BP, respectively).

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: Imatinib is indicated for the treatment of several indications which are listed in Table 2. The recommended dosing is specific to the indication. All doses of imatinib should be administered with a meal and a large class of water. Doses of 400 or 600 mg should be administered once daily, whereas doses of 800 mg should 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 (i.e., do NOT use eight 100-mg tablets). Imatinib can be dispersed in water or apple juice for members having difficulty swallowing.

Table 2

FDA-approved Indications and Recommended Dosing

Indication

Recommended Dose

Adults

Ph+ CML-CP (adults)

400 mg/day (may increase to 600 mg/day)

Ph+ CML-AP or CML-BC

600 mg/day (may increase to 800 mg/day)

Ph+ ALL (adults)

600 mg/day

Myelodysplastic/Myeloproliferative Disease (MDS/MPD)

400 mg/day

Aggressive Systemic Mastocytosis (ASM)

100 or 400 mg/day (100 mg/day if ASM associated with eosinophilia; may increase to 400 mg/day)

Hypereosinophilic Syndrome and/or Chronic Eosinophilic Leukemia (HES/CEL)

100 or 400 mg/day (100 mg/day if presence of FIP1L1-PDGFRα fusion kinase; may increase to 400 mg/day)

Dermatofibrosarcoma Protuberans (DFSP)

800 mg/day

Gastrointestinal Stromal Tumor (GIST)

400 mg/day (may increase up to 800 mg/day if for metastatic or unresectable disease)

Pediatrics

Ph+ CML CP

340 mg/m2/day (not to exceed 600 mg)

Ph+ ALL

340 mg/m2/day (not to exceed 600 mg)

Dose Modifications

Hepatic Impairment: Members with severe hepatic impairment (Child-Pugh Class C) should receive a 25% reduction in the recommended dose.

Renal Impairment

o Mild Renal Impairment: Doses should not exceed 600 mg/day in members with mild renal impairment (creatinine clearance [CrCl] 40-59 ml/min).

o Moderate Renal Impairment: members with moderate renal impairment (CrCl 20-39 ml/min) should receive a 50% decrease in the recommended starting dose; future doses can be increased as tolerated.

o Severe Renal Impairment: Use with caution in members with severe renal impairment. A dose of 100 mg may be reasonable based on limited data.

Concomitant Strong CYP3A4 Inducers: Avoid concomitant use with strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, dexamethasone, rifampin, rifabutin, rifampacin, phenobarbital). If concomitant use cannot be avoided, the dosage of imatinib should be reduced by at least 50% and clinical response should be carefully monitored.

Dose Adjustments for Adverse Reactions

o Hepatotoxicity: If elevations in bilirubin greater than 3-times upper limit of normal (ULN) (for laboratory performing the test) or in liver transaminases greater than 5-times the ULN occur, imatinib should be withheld until bilirubin levels are less than 1.5-times ULN and transaminase levels are less than 2.5-times ULN.

­ Adults: Reinitiate at a reduced daily dose (i.e., 400 mg to 300 mg, 600 mg to 400 mg, or 800 mg to 600 mg).

­ Children: Reinitiate at a reduced dose (i.e., 340 mg/m2/day to 260 mg/m2/day).

Severe Non-Hematologic Adverse Reactions: Withhold imatinib until the event has resolved; thereafter, treatment can be resumed as appropriate depending on the initial severity of the event.

Hematologic Adverse Reactions: Dose reductions or treatment interruptions for severe neutropenia and thrombocytopenia are recommended as indicated in Table 3.

Table 3

Dose Adjustments for Neutropenia and Thrombocytopenia

Indication

Laboratory Value

Dosing Recommendation

ASL Associated with Eosinophilia, or HES/CEL with FIP1L1-PDGFR-alpha fusion kinase

(starting dose of 100 mg)

ANC <1,000/mcL

and/or

platelets <50,000/mcL

1. Stop imatinib until ANC ≥1,500/mcL and platelets ≥75,000/mcL

2. Resume treatment with imatinib at previous dose (i.e., dose before severe adverse reaction)

Chronic-phase CML, or

MDS/MPD, or

ASM, or

HES/CEL, or

GIST

(starting dose 400 mg)

ANC <1,000/mcL

and/or

platelets <50,000/mcL

1. Stop imatinib until ANC ≥1,500/mcL and platelets ≥75,000

2. Resume at 400 mg dose (original starting dose)

3. if recurrence of ANC <1,000/mcL and/or platelets <50,000/mcL, repeat step 1 and resume at reduced dose of 300 mg

Accelerated-phase and Blast-crisis Ph+ CML, or

Ph+ ALL

(starting dose of 600 mg)

ANC <500/mcL

and/or

platelets <10,000/mcL

1. Check if cytopenia is related to leukemia (marrow aspirate or biopsy)

2. If cytopenia is unrelated to leukemia, reduce dose of imatinib to 400 mg

3. If cytopenia persists 2 weeks, reduce further to 300 mg

4. If cytopenia persists 4 weeks and is still unrelated to leukemia, stop imatinib until ANC ≥1,000/mcL and platelets ≥20,000/mcL and then resume treatment at 300 mg

Dermatofibrosarcoma Protuberans

(starting dose 800 mg)

ANC <1,000/mcL

and/or

platelets <50,000/mcL

1. Stop imatinib until ANC ≥1,500 and platelets ≥75,000

2. Resume at 600 mg dose 3. If recurrence of ANC <1,000/mcL and/or platelets <50,000/mcL, repeat step 1 and resume at reduced dose of 400 mg

Pediatric patient with newly diagnosed CML-CP

(starting dose 340 mg/m2)

ANC <1,000/mcL

and/or

platelets <50,000/mcL

1. Stop imatinib until ANC ≥1,500/mcL and platelets ≥75,000/mcL

2. Resume at previous dose (i.e., dose before severe adverse reaction)

3. If recurrence of ANC <1,000/mcL and/or platelets <50,000/mcL, repeat step 1 and resume at reduced dose of 260 mg/m2/day

ANC, absolute neutrophil count; CML-CP, chronic myelogenous leukemia chronic phase; GIST, gastrointestinal stromal tumor; Ph+, Philadelphia chromosome positive; CML-AP, CML accelerated phase; ALL, acute lymphoblastic lymphoma.

Drug Availability: imatinib is available as 100- and 400 mg scored tablets.

PRECAUTIONS:

CONTRAINDICATIONS

• None

WARNINGS

Fluid Retention: Edema and severe fluid retention have occurred. Weigh members regularly and manage unexpected rapid weight gain by drug interruption and diuretics.

Myelosuppression: Cytopenias, particularly anemia, neutropenia, and thrombocytopenia, have occurred. Manage with dose reduction or dose interruption and in rare cases discontinuation of treatment. Perform complete blood counts weekly for the first month, biweekly for the second month, and periodically thereafter (e.g., every 2 to 3 months).

Cardiovascular: Severe congestive heart failure and left ventricular dysfunction have been reported, particularly in persons with comorbidities and risk factors. Members with cardiac disease or risk factors for cardiac failure should be monitored and treated.

Hepatotoxicity: Severe hepatotoxicity including fatalities may occur. Assess liver function before initiation of treatment and monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy known to be associated with liver dysfunction.

Hemorrhage: Grade 3/4 hemorrhage has been reported in clinical studies in persons with newly diagnosed CML and with GIST. GI tumor sites may be the source of GI bleeds in GIST. Monitor for GI symptoms at the start of therapy.

Gastrointestinal Perforations: Gastrointestinal perforations, some fatal, have been reported.

Cardiogenic Shock/Left Ventricular Dysfunction: has been associated with the initiation of imatinib in persons with conditions associated with high eosinophil levels (e.g., HES, MDS/MPD and ASM).

Dermatologic Reactions: Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have been reported with the use of imatinib.

Endocrine: Hypothyroidism has been reported in thyroidectomy patients undergoing levothyroxine replacement. Closely monitor TSH levels in such members.

Long-Term Use: Consider potential toxicities, specifically, liver, kidney, and cardiac toxicity, and immunosuppression from long-term use.

Tumor Lysis Syndrome: Close monitoring is recommended.

Driving and Using Machinery: Reports of motor vehicle accidents have been reported in persons administered imatinib. Caution members about driving a car or operating machinery.

• Special Populations

o Growth retardation occurring in children and pre-adolescents administered imatinib has been reported. Close monitoring of growth in children under imatinib treatment is recommended.

o Imatinib is classified as pregnancy category D. Fetal harm can occur when administered to pregnant women. Advise female members of childbearing age of the potential harms to a fetus.

BILLING/CODING INFORMATION:

HCPCS Coding

S0088

Imatinib, 100 MG

ICD-10 Diagnoses Codes That Support Medical Necessity

C43.0

Malignant melanoma of lip

C43.10 – C43.12

Malignant melanoma of eyelid, including canthus

C43.20 – C43.22

Malignant melanoma of ear and external auricular canal

C43.30 – C43.32

Malignant melanoma of other and unspecified parts of face

C43.4

Malignant melanoma of scalp and neck

C43.51

Malignant melanoma of anal skin

C43.52

Malignant melanoma of skin of breast

C43.53

Malignant melanoma of other part of trunk

C43.60 – C43.62

Malignant melanoma of upper limb, including shoulder

C43.70 – C43.72

Malignant melanoma of lower limb, including hip

C43.8

Malignant melanoma of overlapping sites of skin

C43.9

Malignant melanoma of skin, unspecified

C47.8

Malignant neoplasm of overlapping sites of peripheral nerves and autonomic nervous system

C49.4

Malignant neoplasm of connective and soft tissue of abdomen

C49.8

Malignant neoplasm of overlapping sites of connective and soft tissue

C49.9

Malignant neoplasm of connective and soft tissue, unspecified

C49.A0 – C49.A9

Gastrointestinal stromal tumor

C72.0

Malignant neoplasm of spinal cord

C72.1

Malignant neoplasm of cauda equina

C79.31

Secondary malignant neoplasm of brain

C80.0

Disseminated malignant neoplasm, unspecified

C80.1

Malignant (primary) neoplasm, unspecified

C83.50

Lymphoblastic (diffuse) lymphoma, unspecified site

C83.51

Lymphoblastic (diffuse) lymphoma, lymph nodes of head, face, and neck

C83.52

Lymphoblastic (diffuse) lymphoma, intrathoracic lymph nodes

C83.53

Lymphoblastic (diffuse) lymphoma, intra-abdominal lymph nodes

C83.54

Lymphoblastic (diffuse) lymphoma, lymph nodes of axilla and upper limb

C83.55

Lymphoblastic (diffuse) lymphoma, lymph nodes of inguinal region and lower limb

C83.56

Lymphoblastic (diffuse) lymphoma, intrapelvic lymph nodes

C83.57

Lymphoblastic (diffuse) lymphoma, spleen

C83.58

Lymphoblastic (diffuse) lymphoma, lymph nodes of multiple sites

C83.59

Lymphoblastic (diffuse) lymphoma, extranodal and solid organ sites

C91.00

Acute lymphoblastic leukemia not having achieved remission

C91.01

Acute lymphoblastic leukemia, in remission

C91.02

Acute lymphoblastic leukemia, in relapse

C92.10

Chronic myeloid leukemia, bcr/abl-positive, not having achieved remission

C92.11

Chronic myeloid leukemia, bcr/abl-positive, in remission

C92.12

Chronic myeloid leukemia, bcr/abl-positive, in relapse

C96.21

Aggressive systemic mastocytosis

D48.1

Neoplasm of uncertain behavior of connective and other soft tissue

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

Acute lymphoblastic leukemia: an aggressive (fast-growing) type of leukemia (blood cancer) in which too many immature white blood cells are found in the blood and bone marrow. Also called acute lymphocytic leukemia and ALL.

Aggressive systemic mastocytosis: A rare disease in which too many mast cells (a type of immune system cell) are found in the skin, bones, joints, lymph nodes, liver, spleen, and gastrointestinal tract. Mast cells give off chemicals such as histamine that can cause flushing (a hot, red face), itching, abdominal cramps, muscle pain, nausea, vomiting, diarrhea, low blood pressure, and shock

Chordoma: A type of bone cancer that usually starts in the lower spinal column or at the base of the skull

Chronic myelogenous leukemia: also known as chronic granulocytic leukemia (CGL), is a cancer of the white blood cells. It is a form of leukemia characterized by the increased and unregulated growth of predominantly myeloid cells in the bone marrow and the accumulation of these cells in the blood

c-KIT: a type III receptor tyrosine kinase; the interaction between c-KIT and its ligand, stem cell factor (SCF), plays a key role in regulating mast cell proliferation, maturation, adhesion, chemotaxis, and survival.

Dermatofibrosarcoma Protuberans: A type of tumor that begins as a hard nodule and grows slowly. These tumors are usually found in the dermis (the inner layer of the two main layers of tissue that make up the skin) of the limbs or trunk of the body. They can grow into surrounding tissue but do not spread to other parts of the body. These tumors are related to giant cell fibroblastomas

Hypereosinophilic syndrome: a myeloproliferative disorder characterized by persistent eosinophilia that is associated with damage to multiple organs.

Melanoma: A form of cancer that begins in melanocytes (cells that make the pigment melanin). It may begin in a mole (skin melanoma), but can also begin in other pigmented tissues, such as in the eye or in the intestines

Myelodysplastic syndrome: A group of diseases in which the bone marrow does not make enough healthy blood cells.

Myeloproliferative disorder: a heterogenous group of disorders characterized by cellular proliferation of one or more hematologic cell lines in the peripheral blood, distinct from acute leukemia.

Philadelphia chromosome or Philadelphia translocation: is a specific chromosomal abnormality that is associated CML or ALL.

RELATED GUIDELINES:

Allogeneic Bone Marrow and Stem Cell Transplantation, 02-38240-01
Autologous Bone Marrow and Stem Cell Transplantation, 02-38241-01

Azacitidine (Vidaza®) Injection, 09-J0000-84

Bosutinib (Bosulif®) Tablets, 09-J1000-84

Cytogenetic Studies (Chromosomal Studies), 05-82000-18

Dasatinib (Sprycel®) Tablets, 09-J1000-43

Erythropoiesis Stimulating Agents, 09-J0000-31

Immune Globulin Therapy, 09-J0000-06

Interferon alfa-n3 (Alferon N Injection®), 09-J0000-33

Interferons for Oncology Use, 09-J1000-37

Nilotinib (Tasigna®) Capsules, 09-J1000-48

Omacetaxine (Synribo®) Injection, 09-J1000-87

Ponatinib (Iclusig®) Tablet, 09-J1000-89

Positron Emission Tomography (PET Scans) Oncologic Application, 04-78000-17

Regorafenib (Stivarga®), 09-J1000-83

Sunitinib Malate (Sutent®) Capsules, 09-J1000-51

OTHER:

None

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2017. Available at: www.clinicalpharmacilogy-ip.com. Accessed 1/12/17.
  2. Gleevec (imatinib) [package insert]. Novartis. East Hanover (NJ): September 2016.
  3. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 1/12/17.
  4. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 1/12/17.
  5. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology Version 2.2016. Acute Lymphoblastic Leukemia. Available at http://www.nccn.org/professionals/physician_gls/PDF/all.pdf. Accessed 1/25/17.
  6. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology Version 2.2017. Bone Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/bone.pdf. Accessed 1/25/17.
  7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology Version 2.2017. Chronic Myelogenous Leukemia. Available at http://www.nccn.org/professionals/physician_gls/PDF/cml.pdf. Accessed 1/25/17.
  8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology Version 2.2017. Myelodysplastic Syndromes. Available at http://www.nccn.org/professionals/physician_gls/PDF/mds.pdf. Accessed 1/25/17.
  9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology Version 1.2017. Dermatofibrosarcoma Protuberans. Available at http://www.nccn.org/professionals/physician_gls/PDF/dfsp.pdf. Accessed 1/25/17.
  10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology Version 1.2017. Melanoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf. Accessed 1/25/17.
  11. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology Version 1.2017. Soft Tissue Sarcoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/sarcoma.pdf. Accessed1/25/17.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 02/08/17.

GUIDELINE UPDATE INFORMATION:

01/01/12

New Medical Coverage Guideline.

11/15/12

Review and revision to guideline; consisting of updating position statement, dosage and administration, added contraindications, update coding, exceptions, related guidelines and references.

03/15/13

Review and revision to guideline; consisting of revising and reformatting position statement; revising and reformatting description, dosage/administration, and precautions sections; updating references and coding; adding pertinent definitions and related guidelines.

03/15/14

Review and revision to guideline; consisting of reformatting position statement and adding approval duration, updating dosage/administration, references, coding, and program exceptions.

03/15/15

Review and revision to guideline; consisting of revising position statement and updating the description, dosage/administration, warnings, and references.

07/15/15

Revision to guideline; updated coding.

11/01/15

Revision: ICD-9 Codes deleted.

03/15/16

Review and revision to guideline consisting of description, position statement, definitions, and references.

10/01/16

Revision: ICD-10 code updates.

03/15/17

Review and revision to guideline consisting of updates to description, position statement, and references sections.

10/01/17

New ICD-10 codes,

Date Printed: December 16, 2017: 09:20 PM