LCD L37606: Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases

Acute Myelogenous Leukemia (AML)

Indications

Genomic Sequential Analysis Panel will be considered reasonable and necessary in the evaluation of blood or bone marrow samples in the following clinical circumstances:

• Genomic Sequential Analysis Panel will be considered reasonable and necessary in the evaluation of blood or bone marrow samples for newly diagnosed or relapsed/refractory AML patients who are candidates for treatment, regardless of karyotype findings.

• Previously diagnosed patients with AML, who have not responded to induction chemotherapy, or who have progressed following induction. The patient must be a candidate for transplantation at the time of the testing.

• Patients with AML, who have responded to treatment, either chemotherapy or transplantation, with evidence of relapse.

Myelodysplastic Syndromes (MDS)

Indications

Genomic Sequential Analysis Panel will be considered reasonable and necessary in the evaluation of blood or bone marrow samples in the following clinical circumstances:

• Patients with clinical signs or symptoms of myelodysplastic syndromes (MDS) or myelodysplastic/myeloproliferative overlap syndromes (MDS/MPN), in whom clinical, laboratory, and pathologic assessment are nondiagnostic.

• Newly diagnosed MDS or MDS/MPN patients either

• stratified by the IPSS or IPSS-R as intermediate risk, or

• in MDS with ringed sideroblasts/RARS.

• Repeat Genomic Sequential Analysis Panel testing is considered reasonable and necessary in MDS after initial diagnosis and risk stratification.

Myeloproliferative Neoplasms (MPN)

Indications and Limitations of Coverage

Genomic Sequential Analysis Panel will be considered reasonable and necessary in the evaluation of blood or bone marrow samples in the following circumstances:

• Diagnosis: Clinical signs or symptoms of myeloproliferative neoplasm (MPN) or myelodysplastic/myeloproliferative overlap syndromes (MDS/MPN) when

• clinical, laboratory, and pathologic assessment are nondiagnostic; and

• CML excluded (BCR-ABL1 negative) 1,2

• Risk Stratification: Newly diagnosed PMF not already classified as high-risk by Dynamic International Prognostic Scoring System (DIPSS) Plus 1,3,4

• Monitoring: Higher-risk MF (INT-1, INT-2, High-Risk) with progression on therapy 1

Acute Myelogenous Leukemia (AML)

Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy characterized by the clonal expansion of myeloid blasts, primarily in the peripheral blood and bone marrow. The American Cancer Society estimates that approximately 60,000 new cases of leukemia will be diagnosed in 2016, with one-third classified as acute myelogenous leukemia (AML). It accounts for the most annual deaths from leukemia in the United States. The median age of diagnosis is 67, with 54% diagnosed at 65 years or older (and approximately one third diagnosed at 75 years of age or older). Moreover, AML lies at one end of a spectrum of neoplastic myeloid diseases that includes myelodysplastic syndromes (MDS), which often progress to AML, and which are even more common in patients of advanced age, with an incidence of approximately 1/5000 patients over the age of 70.

AML is an aggressive disease that requires immediate diagnosis and treatment, with an average 5 yr survival rate of 28%, depending on a number of clinical and biologic variables, including acquired genetic alterations within the leukemic cells. Early treatment of AML generally consists of high-dose cytotoxic chemotherapy to induce remission, followed by consolidation (i.e., post-remission) chemotherapy and/or bone marrow transplantation.

Steadily accumulating genomic evidence shows that certain acquired genetic alterations within the leukemic cells are strong predictors of prognosis in AML and, accordingly, are essential factors in the decision whether a patient should undergo bone marrow transplantation (1-4). These alterations have been set aside as determinants of independent diagnostic categories in WHO AML guidelines, and as essential for AML management in NCCN guidelines (5,6).