Appeal type: Drugs
Decision: Partially Favorable

 
We decided that the Plan has to pre-approve Pemetrexed. We decided that the Plan does not have to pre-
approve Pegfilgrastim and Pembrolizumab.  
 
You asked the Plan to pre-approve Pegfilgrastim, Pemetrexed, and Pembrolizumab. You say that the enrollee 
has non-small adenocarcinoma of the lung, and it is urgent that he get started on treatment. The Plan says that 
the requested drugs are not medically necessary.  
 
We decided that the Plan has to pre-approve Pemetrexed.  
 The Plan must follow Medicare rules. The rules say that Medicare pays for a drug or biological only if it is safe 
and effective and otherwise reasonable and necessary. The rules also say that Medicare may pay for unlabeled 
uses for anti-cancer drugs if they are medically accepted as safe and effective or appropriate for the particular 
use.  
 
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 Pemetrexed. Our reviewer says that the 
criteria for coverage of Pemetrexed has been met. Our physician reviewer found that the enrollee has metastatic 
non-squamous non-small-cell lung carcinoma. Our physician reviewer found that Pemetrexed (also called 
Alimta) is supported for use in the enrollees situation, per the National Comprehensive Cancer Network 
(NCCN) compendia.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Pemetrexed have been met. Therefore, we decided that the Plan has to pre-
approve Pemetrexed.  
 
We also decided that the Plan does not have to pre-approve Pegfilgrastim and Pembrolizumab. 
 
The Plan must follow Medicare rules. The rules say that Medicare pays for a drug or biological only if it is safe 
and effective and otherwise reasonable and necessary. The rules also say that Medicare may pay for unlabeled 
uses for anti-cancer drugs if they are medically accepted as safe and effective or appropriate for the particular 
use. Therefore, we decided that the Plan has to pre-approve.  
 
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 Pegfilgrastim and Pembrolizumab. Our 
reviewer says that the criteria for coverage of these two drugs have not been met. Our physician reviewer found 
epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALk) laboratory results are 
pending. Our physician reviewer found that the use of Pembrolizumab (also called Keytruda) is not supported 
until EGFR and ALk results are available. Our physician reviewer also found that the use of Pegfilgrastim (also 
called Neulasta) is not supported because the enrollees risk of febrile neutropenia is less than 20%. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Pegfilgrastim and Pembrolizumab not been met. Therefore, we decided that the 
Plan does not have to pre-approve Pegfilgrastim and Pembrolizumab. 
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.