Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Chronic Myeloid Leukemia BCR/ABL-positive

Treatment:  Gleevec (imatinib mesylate)

The insurer denied coverage for Gleevec (imatinib mesylate).  The denial upheld.

This patient is a male diagnosed with chronic myeloid leukemia (CML) in 2018 and treated with imatinib.  The office visit states that the patient was followed up 2 weeks after starting imatinib and was tolerating it well with some decrease in the white blood cell (WBC) count.  Another office visit states that the patient continues on imatinib 400 mg daily, was tolerating it well, and already had a significant decrease in the total WBC, polymerase chain reaction (PCR) BCR-ABL pending.  A third office visit note states that patient is tolerating imatinib with near major molecular response.

Treatment plan with the use of Gleevec is for BCR-ABL to be non-detectable after 18 months.  It is not clear whether progress is being made toward this goal.  While the white counts have decreased, the rapid drop in BCR-ABL PCR is not properly documented.  Therefore, the request for Gleevec is not considered medically necessary for this patient.

According to Jabbour, E., Kantarjian, H. (2018), "CML is characterized by a balanced genetic translocation, t(9;22)(q34;q11.2), involving a fusion of the Abelson gene (ABL1) from chromosome 9q34 with the breakpoint cluster region (BCR) gene on chromosome 22q11.2.  This rearrangement is known as the Philadelphia chromosome.  The molecular consequence of this translocation is the generation of a BCR-ABL1 fusion oncogene, which in turn translates into a BCR-ABL1 oncoprotein.  According to Kotas. V.K. et al.  (2017), "The second-generation tyrosine kinase inhibitors (TKIs) (2G-TKIs) dasatinib (DAS) and nilotinib (NIL) yield faster responses in newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML) as compared with imatinib (IM); however, long-term safety of these agents is a growing concern.  We identified 20 patients with CP-CML diagnosed between August 2013 and October 2016 who initiated 2G-TKIs and were then switched after optimal response at 3 months to IM.  Second-generation TKIs initiated were DAS (n = 15), NIL (n = 3), or both sequentially due to intolerance (n = 1). . . .  In conclusion, this retrospective analysis shows that IM can be safely and effectively administered following optimal response to 2G-TKIs.  A prospective trial exploring this approach is currently enrolling and will be needed to confirm the safety and efficacy of this therapeutic approach."

The documentation submitted does not indicate that the patient's BCR-BCL 1 level dropped to 10% or lower within the first 12 months of treatment.  There is no documentation for what it was at the onset of treatment.  This indicates no drop and actually an increase in white counts.  The documentation submitted for review states that the patient presented with "a very high blood count", which "significantly improved" on imatinib.  Notes write that BCR/ABL PCR will be checked, but values are not documented, and no lab results of the BCR/ABLE are provided.  The only results are dated early-2019, at 36%.                                                       

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.  The carrier's denial of coverage for Gleevec (imatinib mesylate) is upheld.  The medical necessity is not substantiated.