Date Printed: December 17, 2017: 04:39 PM

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Original Effective Date: 11/15/17

Reviewed: 10/11/17

Revised: 00/00/00

Next Review: 11/14/18

Subject: Tisagenlecleucel (Kymriah) Infusion


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


Tisagenlecleucel (Kymriah) is a CD19-directed, genetically-modified autologous T cell immunotherapy that was first approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. The approval marked a historic moment being the first gene therapy and first chimeric antigen receptor (CAR) T-cell therapy approved by the FDA. Tisagenlecleucel was previously granted orphan designation by the FDA for the treatment of ALL in January 2014 and for the treatment of diffuse large B-cell lymphoma (DLBCL) in February 2015. Tisagenlecleucel works by reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal B cells. The CAR is comprised of a murine single-chain antibody fragment which recognizes CD19 and is fused to intracellular signaling domains. Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T-cell expansion, activation, target cell elimination, and persistence of the tisagenlecleucel cells. Treatment involves removing, genetically modifying, and then re-infusing a patient’s own T-cells. During the manufacturing process, a lentiviral vector encodes the CAR molecule via transduction; the vector enters the cell and becomes integrated into the chromosomes of T cells and directs transcription of the tisagenlecleucel CAR.

Acute lymphoblastic leukemia (ALL) is heterogenous hematological disease characterized by the proliferation of immature lymphoid cells in the bone marrow, peripheral blood, and other organs. The median age of diagnosis is 15 years with 57% of patients diagnosed at younger than 20 years of age. ALL represents 75 to 80% of acute leukemias among children, making it the most common form of childhood leukemia. The overall incidence of pediatric ALL (up to 20 years of age) is 34 cases per 1 million persons (as observed from 2001 to 2014). ALL is broadly classified in 3 groups based on immunophenotype, which include precursor B-cell ALL, mature B-cell ALL (a.k.a., Burkitt leukemia/lymphoma), and T-cell ALL. In children, B-cell lineage ALL constitutes about 88% of cases. Philadelphia chromosome (Ph)-positive ALL is rare in children (i.e., less than 15 years) with ALL, occurring in only 3% of cases (vs. 25% in adults). Adolescent and young adults (AYA) aged 15 to 39 years have a Ph-ALL rate of 5 to 7%. Cure rates and survival outcomes have improved dramatically over the past several decades due to advances in understanding molecular genetics and pathogenesis of the disease, incorporation of risk-adapted therapy, and advent of new targeted agents. The 5-year overall survival (OS) rate for children is 86 to 89%. However, despite major advances in the treatment of childhood ALL, about 20% of pediatric patients experience relapse after an initial complete response (CR) to frontline treatment. Among those who experience relapse, only 30% experience long-term remission with subsequent therapies. The treatment of ALL represents one of the most complex and intensive program in cancer therapy. Treatment varies depending on subtype, age, and treatment history. In general, the treatment phases can be largely grouped into induction, consolidation, and maintenance. The National Comprehensive Cancer Network (NCCN) guidelines for ALL (Version 3.2017) list single-agent tisagenlecleucel therapy as a Category 2A recommendation for: (1) relapsed/refractory Ph+ B-ALL in patients ≤25 years and with refractory disease or ≥2 relapses and failure of 2 tyrosine kinase inhibitors (TKIs), and for (2) relapsed/refractory Ph- B-ALL in patients ≤25 years and with refractory disease or ≥2 relapses.

The safety and efficacy of tisagenlecleucel leading to FDA approval was evaluated in an open-label, multicenter, single-arm phase 2 trial (ELIANA; a.k.a., Study 1 in the package insert) of pediatric and young adults with relapsed or refractory B-cell precursor ALL. A total of 107 patients were screened, 88 were enrolled, 68 were treated, and 63 were evaluable for efficacy. Eight subjects (9%) did not received treatment due to manufacturing failure. The 63 evaluable patients included 35 males and 28 females of median age 12 years (range, 3 to 23 years). Six (10%) had primary refractory disease, 30 (48%) had one prior stem cell transplantation, and 5 patients (8%) had two stem cell transplantations. The median number of prior lines of therapy was 3 (range 1 to 8). Treatment consisted of lymphodepleting chemotherapy (fludarabine 30 mg/m2 daily for 4 days and cyclophosphamide 500 mg/m2 daily for 2 days) followed by a single dose of tisagenlecleucel. Of the 22 patients who had a WBC count less than 1,000/mcL, 20 received lymphodepleting chemotherapy prior to tisagenlecleucel while 2 received tisagenlecleucel infusion without lymphodepleting chemotherapy. Fifty-three patients received bridging chemotherapy between time of enrollment and lymphodepleting chemotherapy. Efficacy was established on the basis of complete remission (CR) or complete remission with incomplete blood count recovery (CRi) within 3 months after infusion, the duration of CR/CRi, and proportion of patients with CR/CRi and minimal residual disease (MRD)-negative (i.e., <0.01% by flow cytometry).

Among the 63 infused patients, 52 (83%) achieved CR/CRi, all of which were MRD-negative. With a median follow-up of 4.8 months from response, the median duration of CR/CRi was not reached (range: 1.2 to 14.1+ months). Median time to onset of CR/CRi was 29 days with onset of CR/CRi between 26 and 31 days for 50/52 (96%) responders. The stem cell transplantation rate among those who achieved CR/CRi was 12% (6/52). Adverse events (AEs) were common. The incidence of serious AEs within 8 weeks of infusion was 69%. Cytokine release syndrome (CRS occurred in 78% of patients (21% grade 3; 27% grade 4); no CRS-associated deaths occurred. Tocilizumab for treatment of CRS was given to 38% of patients. The most common grade 3 or 4 non-hematologic adverse events (>15%), other than CRS, were hypotension (22%), hypoxia (18%), and increased aspartate aminotransferase (16%). Grade 3 neuropsychiatric AEs occurred in 15% of patients, with no grade 4 events and no cerebral edema reported. Grade 3 or 4 neutropenia with high (>38.3˚C) fever occurred in 60% of patients.


Initiation of tisagenlecleucel (Kymriah) meets the definition of medical necessity when ALL of the following criteria are met:

1. The member has a confirmed diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL)

2. The member is positive for CD19 tumor expression in bone marrow or peripheral blood as detected by flow cytometry – confirmatory laboratory documentation must be submitted

3. EITHER of the following (“a” or “b”):

a. Member has refractory disease defined as the inability to achieve a complete response (CR) at the end of induction chemotherapy

b. Member has experienced TWO or more disease relapses (after achieving CR) following recommended chemotherapies. For members with Ph+ ALL, treatment must have included at least two different tyrosine kinase inhibitors (TKIs) unless TKI use was contraindicated (the specific contraindication must be provided).

4. The member will receive a lymphodepleting chemotherapy regimen (e.g., fludarabine and cyclophosphamide) to be completed 2 to 14 days prior to the administration of tisagenlecleucel, OR the treating physician attests that a lymphodepleting regimen is not appropriate due to profound leukopenia

5. Following the completion of lymphodepleting chemotherapy (as needed), tisagenlecleucel will be used as single-agent therapy (i.e., not used in combination with maintenance chemotherapy)

6. The member is less than or equal to 25 years of age

7. The member does not have active, uncontrolled infection(s)

8. The member has not previously received chimeric antigen receptor (CAR) T-cell therapy in their lifetime for the treatment of ALL

9. The dose of tisagenlecleucel will not exceed the following based on the member’s body weight at the time of leukapheresis:

a. 50 kg or less: 0.2 to 5.0 x 106 CAR-positive viable T cells per kg

b. Greater than 50 kg: administer 0.1 to 2.5 x 108 CAR-positive viable T cells (non-weight based)

Approval duration: One month to allow for a one-time infusion of therapy

Tisagenlecleucel (Kymriah) is considered experimental or investigational for all other indications [with the exception of diffuse large B-cell lymphoma (DLBCL)], including but not limited to following, due to the lack of scientific peer-reviewed literature demonstrating improvement in health outcomes:

• T-cell ALL

• Burkitt's lymphoma/leukemia (i.e., patients with mature B-cell ALL)




• For the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

• One treatment course consists of fludarabine and cyclophosphamide lymphodepleting chemotherapy followed by infusion of tisagenlecleucel. Premedicate patients with acetaminophen and an H1-antihistamine. Tocilizumab (Actemra) and emergency equipment should be available prior to infusion and during the recovery period.

o For patients 50 kg or less: administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight reported at the time of leukapheresis

o For patients above 50 kg: administer 0.1 to 2.5 x 108 CAR-positive viable T cells (non-weight based)

• Lymphodepleting chemotherapy consists of fludarabine (30 mg/m2 intravenous daily for 4 days) and cyclophosphamide (500 mg/m2 intravenous daily for 2 days starting with the first dose of fludarabine). Infuse tisagenlecleucel 2 to 14 days after completion of the lymphodepleting chemotherapy. Infusion rate is 10 mL to 20 mL per minute, adjusted as appropriate for smaller children and smaller volumes. Delay the infusion if the patient has unresolved serious adverse reactions (including pulmonary reactions, cardiac reactions, or hypotension) from preceding chemotherapies, active uncontrolled infection, active graft versus host disease (GVHD), or worsening of leukemia burden following lymphodepleting chemotherapy.

• Consult the package labeling for specific directions on the preparation and administration of tisagenlecleucel.

Dose Adjustments

• Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

• Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Availability

• Supplied as a frozen suspension of genetically modified autologous T cells in one infusion bag labeled for the specific recipient. Product is shipped directly to the cell lab associated with the infusion center in a liquid nitrogen Dewar. Product and patient-specific labels are located inside the Dewar.

• Based on the patient’s weight reported at the time of leukapheresis, one of two possible dose ranges will be prepared for the patient:

o For patients 50 kg or less: 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight

o For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T cells

• The actual number of CAR-positive T cells in the product is reported on the Certificate of Analysis (CoA) that is shipped with the product. The volume of CAR-positive viable T cells in an infusion bag ranges from 10 mL to 50 mL.


Boxed Warning


• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving tisagenlecleucel. Do not administer tisagenlecleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab.

• Neurological toxicities, which may be severe or life-threatening, can occur following treatment with tisagenlecleucel, including concurrently with CRS. Monitor for neurological events after treatment with tisagenlecleucel. Provide supportive care as needed.

• Tisagenlecleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS.


• None


Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with tisagenlecleucel. In Study 1, CRS occurred in 79% (54/68) of patients, including Grade 3 or 4 (Penn grading system1) CRS in 49% (33/68) of patients. The median time to onset of CRS was 3 days (range: 1 to 22 days). Of the 54 patients with CRS, 27 (50%) received tocilizumab; 7 (13%) patients received two doses of tocilizumab, 3 (6%) patients received three doses of tocilizumab, and 14 (26%) patients received addition of corticosteroids (e.g., methylprednisolone). The median time to resolution of CRS was 8 days (range: 1 to 36 days). Key manifestations of CRS include high fever, lower than normal blood pressure, difficulty breathing, and may be associated with hepatic, renal, and cardiac dysfunction, and coagulopathy. Risk factors for severe CRS are high pre-infusion tumor burden (greater than 50% blasts in bone marrow), uncontrolled or accelerating tumor burden following lymphodepleting chemotherapy, active infections, and/or inflammatory processes. Ensure that tocilizumab is available on site prior to infusion. Monitor patients for signs or symptoms of CRS for at least 4 weeks after treatment. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. Refer to the package labeling for detailed recommendation on the management of CRS.

Neurological Toxicities: Neurological toxicities, which may be severe or life-threatening, can occur following treatment with tisagenlecleucel. The majority of neurological toxicities occurred within 8 weeks following infusion. In Study 1, neurological toxicities within 8 weeks occurred in 65% of patients, including Grade 3 or 4 neurological toxicities in 18% of patients, and the 75% of events resolved within 12 days. The most common neurological toxicities were headache (37%), encephalopathy (34%), delirium (21%), anxiety (13%), and tremor (9%). Other manifestations of neurological toxicities included disturbances in consciousness, disorientation, confusion, agitation, seizures, mutism and aphasia. Onset of neurological toxicity can be concurrent with CRS, following resolution of CRS or in the absence of CRS. Monitor patients for neurological events and exclude other causes for neurological symptoms. Provide supportive care as needed.

KYMRIAH REMS to Mitigate Cytokine Release Syndrome and Neurological Toxicities: Because of the risk of CRS and neurological toxicities, tisagenlecleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS. The required components of the KYMRIAH REMS are: (1) Healthcare facilities that dispense and administer tisagenlecleucel must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of two doses of tocilizumab are available for each patient for administration within 2 hours after tisagenlecleucel infusion, if needed for treatment of CRS. (2) Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer tisagenlecleucel are trained about the management of CRS and neurological toxicities.

• Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) or dextran 40.

• Serious Infections: Serious infections, including life-threatening or fatal infections, occurred in patients after infusion. In Study 1, infections (all Grades) after tisagenlecleucel infusion occurred in 40 patients (59%), including 24 patients (35%) with Grade 3-4 infections and 2 patients (3%) with fatal infections. Infections with an unknown pathogen occurred in 41% of patients, viral infections in 26%, bacterial infections in 19%, and fungal infections in 13%. Prior to tisagenlecleucel infusion, infection prophylaxis should follow local guidelines. Monitor patients for signs and symptoms of infection; treat appropriately.

• Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following tisagenlecleucel infusion. Prolonged neutropenia has been associated with increased risk of infection.

• Hypogammaglobulinemia: Hypogammaglobulinemia and agammaglobulinemia (IgG) can occur in patients with a complete remission (CR) after infusion. In Study 1, 43% of patients had hypogammaglobulinemia. Monitor and provide replacement therapy until resolution. Assess immunoglobulin levels in newborns of mothers treated with tisagenlecleucel.

• Secondary Malignancies: Patients treated with tisagenlecleucel may develop secondary malignancies or recurrence of their leukemia. Monitor life-long for secondary malignancies In the event that a secondary malignancy occurs after treatment with tisagenlecleucel, contact Novartis Pharmaceuticals Corporation at 1-844-4KYMRIA

• Effects on Ability to Drive and Use Machines: Due to the potential for neurological events, including altered mental status or seizures, patients receiving tisagenlecleucel are at risk for altered or decreased consciousness or coordination. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks after receiving tisagenlecleucel.

• HIV Testing: HIV and the lentivirus used to make tisagenlecleucel have limited, short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid test (NAT) tests may yield false-positive results in patients who have received tisagenlecleucel.

• Prenancy: There are no available data with use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted and it is not known if tisagenlecleucel has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia. Therefore, tisagenlecleucel is not recommended for women who are pregnant.


The collection of leukapheresis provides the starting material for the manufacturing of tisagenlecleucel and should NOT be billed separately.

HCPCS Coding


Not otherwise classified, antineoplastic drugs

ICD-10 Diagnoses Codes That Support Medical Necessity


Acute lymphoblastic leukemia not having achieved remission


Acute lymphoblastic leukemia, in relapse


Refer to section entitled POSITION STATEMENT.


Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

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

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


Autologous: Cells or tissues obtained from the same individual (as opposed to from a different person).

CD19: Cluster of Differentiation 19 is a protein found on the surface of B-cells in humans. Fully differentiated plasma cells no longer express CD19.

Chimeric antigen receptor (CAR) T-cell therapy: A type of treatment in which a patient's T cells are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient’s blood. Then the gene for a special receptor that binds to a certain protein on the patient’s cancer cells is added in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion.

Complete response (CR) (in ALL): (1) no circulating blast or extramedullary disease including no lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass, or CNS involvement (2) trilineage hematopoiesis (TLH) and <5% blasts, (3) absolute neutrophil count (ANC) >1,000/mcL, (4) platelets >100,000/mcL, and (5) no recurrence for 4 weeks

Complete response with incomplete blood count recovery (CRi) (in ALL): Same criteria for CR except platelet count and/or ANC.

Gene therapy: The therapeutic delivery of nucleic acid polymers into a patient's cells as a drug to treat disease.

Minimal Residual Disease (MRD): The presence of leukemic cells below the threshold of detection by conventional morphologic methods. Patients who achieved a CR by morphologic assessment alone can potentially harbor a large number of leukemic cells in the bone morrow. There is a strong correlation between MRD and risk for relapse. Current methods for MDR assessment include multicolor flow cytometry assays specifically designed to detect abnormal MRD immunophenotypes, real-time quantitative PCR assays, and next-generation sequencing-based assays. Current multicolor flow cytometry or PCR methods can detect leukemic cells at a sensitivity threshold of <1 X 10-4 (<0.01%) bone marrow mononuclear cells.

Progressive ALL: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or the development of extramedullary disease.

Refractory ALL: Failure to achieve a CR at the end of induction therapy.

Relapsed ALL: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR.


Allogeneic Bone Marrow and Stem Cell Transplantation, 02-38240-01
Asparaginase (Erwinaze™) Injection, 09-J1000-70

Blinatumomab (Blincyto) IV, 09-J2000-26

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

Imatinib Mesylate (Gleevec®) Tablets, 09-J1000-46

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

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




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This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 10/11/17.



New Medical Coverage Guideline.

Date Printed: December 17, 2017: 04:39 PM