Appeal type: Step-Therapy
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Neupogen (CPT code J1442), Fosaprepitant (CPT code 
J1453) and Palonosetron HCL (CPT code J2469). 
 
You asked the Plan to pre-approve the medication. You say that the medication is necessary. The Plan denied 
your request. The Plan says the medication is not necessary. 
 
Medicare covers Part B medications when they are reasonable and necessary but allows health plans to 
implement step therapy criteria. The Plan's contract indicates that it has implemented such criteria for certain 
Part B medications. 
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve the medication. Our physician reviewer 
found the provider asked for Aloxi (Palonosetron) and ondansetron Emend (Fosaprepitant) as a supporting 
therapy for chemotherapy induced nausea. The Plan decides if the use of a drug follows accepted standards of 
care on a case-by-case basis. We follow Medicare rules and use the Medicare reference guides, medical 
journals, and treatment guidelines to determine reasonable use. The use of this drug in this case requires, 
requires a highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). The 
documentation supports that the Fosaprepitant and Palonosetron is medically reasonable and necessary for the 
patient. The documentation does not support that the Fosaprepitant and Palonosetron is safe and effective for 
the patient. In addition, the provider asked for Neupogen (Filgrastim) as a supporting therapy for febrile 
neutropenia. The Plan decides if the use of a drug follows accepted standards of care on a case-by-case basis. 
The use of this drug requires one or more of the following risk factors: risk of febrile neutropenia (FN) of 
greater than 20 percent based on current chemotherapy regimen (as listed in current ASCO and NCCN 
guidelines for myeloid growth factors); previous neutropenic fever complication from a prior cycle of similar 
chemotherapy; receiving a dose-dense chemotherapy regimen; or risk of febrile neutropenia of 10-20% based 
on chemotherapy regimen and one or more of the following applies: prior chemotherapy or radiation therapy, 
persistant neutropenia (defined as neutrophil count less than 500 neutrophils/ mcL or less than 1,000 
neutrophils/mcL and a predicted decline to less than or equal to 500 neutrophils/mcL over next 48 hours), bone 
marrow involvement by tumor, recent surgery and/or open wounds, liver dysfunction (bilirubin greater than 2.0 
mg/dL), kidney dysfunction (creatinine clearance less than 50 mL/min), or age greater than 65 receiving full 
chemotherapy dose intensity.. Based on available information, the enrollee does not meet these requirements. 
The review has determined that the requested use of Neupogen is not FDA-approved for the enrollees 
diagnosis. Its use is not supported by one of the major drug compendia or by clinical research that appears in a 
CMS-approved medical journal (see appendix for list of CMS-approved journals). 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the medication have not been met. Therefore, we decided that the Plan does not 
have to pre-approve Neupogen (CPT code J1442), Fosaprepitant (CPT code J1453) and Palonosetron HCL 
(CPT code J2469).