Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Diffuse Large B-cell Lymphoma (DLBCLC). 
Treatment: Blincyto 35 microgram (mcg) VL W-Stabilizer. 

The insurer denied coverage for Blincyto 35 mcg VL W-Stabilizer. 

The denial is upheld. 

According to the medical records, the patient is a male with relapsed diffuse large B-cell lymphoma (DLBCLC) following chimeric antigen receptor (CAR) T-cell therapy. The attending provider (AP) has requested the use of Blincyto. He has received prior rituximab, cyclophosphamide, vincristine, doxorubicin and prednisone (R-CHOP) and R-bendamustine/polatuzumab.

The medical records do not identify specific available formulary drugs; however this patient has not tried and failed the available standard treatments listed by the National Comprehensive Cancer Network (NCCN) for this clinical scenario. The standard NCCN options include gemcitabine-oxaliplatin (GEMOX) +/- rituximab, tafasitamab +revlimid, brentuximab if cd30+, ibrutinib and lenalidomide +/-rituximab. The NCCN does not recognize the use of Blincyto for this patient's indication. This has only been evaluated in phase I/II studies and is not currently an accepted therapy option for DLBCL. 

The formulary drugs are not likely to cause the patient an adverse reaction. These are no more likely to cause adverse reactions than Blincyto.      

"BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adults and children with: B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Relapsed or refractory B-cell precursor ALL." (BLINCYTO HIGHLIGHTS OF PRESCRIBING INFORMATION 2016) 

"Few patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) achieve prolonged disease-free survival. Blinatumomab, a bispecific T-cell engaging antibody construct, transiently links CD3-positive T cells to CD19-positive B cells. This phase 2 study evaluated stepwise (9-28-112 g/d with weekly dose increases; n = 23) or flat (112 g/d; n = 2) dosing of blinatumomab by continuous infusion, with dexamethasone prophylaxis, in patients with relapsed/refractory DLBCL. Patients received a median of 3 prior lines of therapy. Median time since last regimen was 1.5 months. Seventeen patients ended treatment in cycle 1 (induction), 7 in cycle 2 (consolidation), and 1 in retreatment. Among 21 evaluable patients, the overall response rate after 1 blinatumomab cycle was 43%, including complete responses (CRs) in 19%. Three patients had late CR in follow-up without other treatment. The most common adverse events with stepwise dosing were tremor (48%), pyrexia (44%), fatigue (26%), and edema (26%). Grade 3 neurologic events with stepwise dosing were encephalopathy and aphasia (each 9%) and tremor, speech disorder, dizziness, somnolence, and disorientation (each 4%). Of 5 (22%) patients who discontinued stepwise dosing because of adverse events, 4 (17%) had neurologic events. Most neurologic events resolved. The flat-dose cohort was stopped because of grade 3 neurologic events in both patients. Blinatumomab monotherapy appears effective in patients with relapsed/refractory DLBCL, a heavily pretreated patient population with a high unmet medical need. Further studies need to define the optimal approach to achieve the target dose without early dropout. The study was registered at www.clinicaltrials.gov as #NCT01741792." (Viardot, A. et al.2016) 

There is no evidence that this drug is more effective that standard NCCN options.  

The healthcare plan acted reasonably and with sound medical judgment in the best interest of the patient. 

The insurer's denial of coverage for Blincyto 35 mcg VL W-Stabilizer is upheld. Medical necessity is not substantiated.