Chronic Lymphocytic Leukemia: when insurers say no, reviewers often say yes

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for genetic testing (CPT 81450). Findings: Two of the three physician reviewers found that chronic lymphocytic leukemia is characterized as an indolent leukemia, but a patient’s individual clinical course is not predictable. It is impacted by stage at presentation and certain biomarkers. Among these, mutations in TP53, NOTCH1, BIRC3, and SF3B1 have been shown to be helpful to categorize patients into prognostic groups. Thus, mutational analysis has been adopted by many oncologists at the time of chronic lymphocytic leukemia diagnosis. In addition to this indication, mutational analysis may also be needed in the case of treatment resistance.

Nature of Statutory Criteria/ Case Summary: The patient has requested authorization and coverage for Intravenous Immunoglobulin (IVIG) Administration at an Outpatient Hospital Infusion Center. She has Stage 3 Chronic Lymphocytic Leukemia (CLL) and is enrolled in a clinical trial for the CLL using ibrutinib and venetoclax. Oncology notes indicate she is immunosuppressed. She has also been getting IVIG infusions and has had infusion reactions with skin infections. After the first IVIG transfusion, she developed pneumonia and then olecranon bursitis with Pseudomonas infection. She had been receiving the IVIG at an infusion center. However, the health plan denied coverage indicating that she needed to have home infusion services. Her physician indicates the patient has had several issues that were handled in the infusion center and home health infusion is not recommended for this patient.

Where the denial was upheld

Physician 1: The patient was diagnosed with chronic lymphocytic leukemia (CLL) in 2000. He was initially treated with chemotherapy and immunotherapy. A bone marrow biopsy in June 2005 revealed relapse of the CLL as well as myelodysplasia. It was recommended that he undergo bone marrow transplantation but no HLA-identical match, either related or unrelated could be found. The patient then went to Israel and received a haploidentical graft from his daughter. The patient died in October 2005.At issue is whether haploidentical stem cell transplantation was likely to be more beneficial for the patient than any available standard therapy.The standard transplant for myelodysplasia is an allogeneic transplant with HLA-identical stem cells, either from a relative or an unrelated donor. Unfortunately, no such match can be found in many patients, as was the case here.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Gazyva, cycles 7-12. Findings: The physician reviewer found that Stage at presentation and certain biomarkers in CLL affect an individual patient’s clinical course. Imbruvica is a tyrosine kinase inhibitor with some specificity toward the Bruton tyrosine kinase. The Bruton tyrosine kinase-signaling pathway is important for normal B-cell function and B-cell neoplasms. Thus, Bruton tyrosine kinase inhibition is a reasonable treatment choice for patients with diverse B-cell malignancies. Imbruvica has been tested against CLL in phase Ib-II clinical trials (Byrd, et al). The authors found that Imbruvica induced durable remissions in patients with relapsed and refractory CLL with minimal side effects.

These outcomes come from California’s external review program — an independent physician panel whose decision binds the insurer. Every state has an equivalent, and internal appeals succeed even more often. If your care for chronic lymphocytic leukemia was denied, the published record says the denial is worth fighting.