Acute Myeloid Leukemia denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1The patient is a 57-year-old male with well-controlled HIV who is on highly active antiretroviral therapy. The patient has acute myeloid leukemia (AML) and possible antecedent MDS. He is now being considered for consolidation of first remission with a peripheral stem cell transplant. The Health Plan has denied authorization and coverage for the requested therapy on the basis it is considered experimental.Further data regarding this patient’s AML, AHD, and cytogenetics is needed to help define where he falls in the National Comprehensive Cancer Network guidelines. The decision to pursue treatment should rest on those data and not on his HIV positivity. As such, cytogenetic results and additional hematologic data should be obtained. Unless the patient’s HIV is poorly controlled, his HIV status does not preclude stem cell transplantation.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for fertility preservation (ovarian stimulation, oocyte retrieval, oocyte fertilization, and storage of oocytes and/or embryos) who has been diagnosed with acute myeloid leukemia. Findings: The physician reviewer found that egg retrieval and freezing (cryopreservation) is now a recognized option for women who have cancer and who are undergoing treatment that can render them infertile in the future by being toxic to their ovaries/eggs. This option allows these patients to have children in the future. Technically, they are not infertile when undergoing the procedure, as the goal is to protect their gametes from the effect of the chemotherapy. This procedure is a treatment that is appropriate to discuss and offer to such patients.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Tibsovo 250 mg two (2) tablets daily. The U.S. Food and Drug Administration indicates that Tibsovo, an isocitrate dehydrogenase-1 (IDH1) inhibitor, is appropriate for the treatment of advanced acute myeloid leukemia. While researchersfound that ivosidenib was well-tolerated with no dose-limiting toxicities in a phase I trial of 66 patients with advanced IDH1-mutant astrocytoma, oligodendroglioma, or glioblastoma, the National Comprehensive Cancer Network recommends several other treatment options. In this case, the patient has only been treated with surgery, and the documentation does not reflect other attempted therapies or treatment options, including possible resection, radiation, temozolomide, Lomustine or carmustine, and platinum-based regimens.

A 57-year-old male enrollee has requested for Gleevec (imatinib) for treatment of his Acute Myeloid Leukemia (AML). Findings: The physician reviewer found that there is very little data regarding the use of Gleevec in AML, even those with c-kit mutation. There have only been small studies published over the past few years that do indicate some degree of activity in this situation (see Kindler, et al.). However, Chevallier, et al. published a particularly negative trial. Therefore, there is no convincing evidence that there is a sufficient likelihood of benefit from Gleevec for this patient when used as a maintenance therapy.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving acute myeloid leukemia, then check the rights and deadlines that apply to your plan.