Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Metastatic rectosigmoid cancer.
Treatment: Pegfilgrastim (Neulasta) injection to treat rectosigmoid cancer.
The insurer denied coverage for Pegfilgrastim (Neulasta) injection to treat rectosigmoid cancer.
The denial is upheld. 

This is a female patient who has metastatic rectosigmoid cancer. In an appeal letter, the patient's Oncologist stated that the patient's "neutrophil count was 1.4. This result was below parameters to safely provide treatment." The Oncologist noted the patient was started on Onpro to stimulate the growth of "healthy" white blood cells (WBC) in the bone marrow and to keep the patient's WBC count within a safe range.

Per Becker, P. S., et al., (2020), "Management of febrile neutropenia (FN) is an integral part of supportive care for patients undergoing cancer treatment. The NCCN [National Comprehensive Cancer Network] Guidelines for Hematopoietic Growth Factors provide suggestions for appropriate evaluation, risk determination, prophylaxis, and management of FN. These NCCN Guidelines are intended to guide clinicians in the appropriate use of growth factors for select patients undergoing treatment of nonmyeloid malignancies. These NCCN Guidelines Insights highlight important updates to the NCCN Guidelines regarding the incorporation of newly FDA[Food and Drug Administration]-approved granulocyte-colony stimulating factor biosimilars for the prevention and treatment of FN."

Per Smith, T. J., et al (2015), "Prophylactic use of CSFs [colony-stimulating factors] 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." 

The health care plan did act reasonably and with sound medical judgment, and in the best interest of the patient.

While an absolute neutrophil count (ANC) of 1.4 may be concerning, it is not defined as neutropenia, and does not require prophylaxis. The infectious disease guideline defines neutropenia "as an ANC of <500 or an ANC that is expected to decrease to <500 during the next 48 hrs[hours]." Furthermore, in metastatic, in other words, a palliative setting, guidelines now recommend dose reduction, rather than granulocyte colony-stimulating factor (G-CSF) support to continue chemotherapy.      

The patient did not meet guidelines of the NCCN guidelines, for approval of this medication, because of lower than accepted risk of neutropenia of this regimen. The patient did not have febrile neutropenia, and had not become neutropenic, and has the alternative of dose reduction. Therefore, the use of Neulasta is not medically necessary.    
                                                     
The insurer's denial of coverage for Pegfilgrastim (Neulasta) injection to treat rectosigmoid cancer is upheld. Medical Necessity is not substantiated.