Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mantle Cell Lymphoma (MCL).
Treatment: Filgrastim (Neupogen).

The insurer denied Filgrastim (Neupogen).  The denial was upheld.  

This is a patient who is taking myelosuppressive chemotherapy (ALR - Acalabrutinib/Revlimid and Rituxan) on study for stage IV marginal zone lymphoma.  His cycle 4 day 1 chemotherapy was held due to grade 3 neutropenia.  He had had a recent pneumonia. His dose of Acalabrutinib was decreased due to neutropenia. In early 2020 cycle 6 day 1 chemotherapy was held due to neutropenia.  At that time, with an ANC of 1333, there was a one level dose reduction in Acalabrutinib due to neutropenia.  One month later the ANC was 800 and several days later the ANC was 794. Brand name neupogen was recommended instead of preffered alternatives such as Zarxio or Nivestym.  

Per Awad et al. (2017), "Neutropenia is a condition that, if left untreated, can result in significant health consequences.  With its FDA approval, Zarxio is the first biosimilar to provide an alternative to Neupogen that is similar in safety and efficacy."  

Per Smith, T. et al. (2015), "Prophylactic use of CSFs to reduce the risk of febrile neutropenia is warranted when the risk of febrile neutropenia is approximately 20% or higher and no other equally effective and safe regimen that does not require CSFs is available.  Primary prophylaxis is recommended for the prevention of febrile neutropenia in patients who are at high risk on the basis of age, medical history, disease characteristics, and myelotoxicity of the chemotherapy regimen.  Dose-dense regimens that require CSFs should only be used within an appropriately designed clinical trial or if supported by convincing efficacy data.  Current recommendations for the management of patients exposed to lethal doses of total-body radiotherapy, but not doses high enough to lead to certain death as a result of injury to other organs, include the prompt administration of CSFs."  

Per Zecchini J1. et al. (2017), "The NCCN Clinical Practice Guidelines has incorporated filgrastim-sndz into its recommendations as a category 1 recommendation for use in settings of febrile neutropenia, myelosuppressive chemotherapy administration, and post-hematopoietic stem cell transplant (HSCT).    A study of hospitalized adults compared the outcome in patients who received either filgrastim or filgrastim-sndz either for prophylaxis of chemotherapy-induced myelosuppression or for neutrophil recovery after autologous HSCT.  The data showed no differences in duration of G-CSF therapy (7.96 vs. 8.5 days, P = 0.36), white blood count (WBC) (8.99 vs. 8.04, P = 0.28), absolute neutrophil count (ANC) (7.62 vs. 6.91  109/L, P = 0.36) at the time of granulocyte-colony stimulating factor (G-CSF) discontinuation, or safety of filgrastim and filgrastim-sndz.  The efficacy and safety of filgrastim and filgrastim-sndz were similar for prophylaxis of chemotherapy-induced neutropenia and neutrophil recovery post-autologous HSCT."  (Zecchini, et al.)  

The Filgrastim (Neupogen) brand is not medically necessary for this patient.  One of the insurer's alternatives would be acceptable and within the standard of care.  Based on current peer review Neupogen is not superior to preferred alternatives.  
                
The health plan acted reasonably and with sound judgement in the best interest of the patient.  

The carrier's denial of coverage for Filgrastim (Neupogen) is upheld.  The medical necessity is not substantiated.