Appeal type: Drugs
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Keytruda (J9271), Pemetrexed (J9305), Bevacizumab - 
AWWB (Q5107), Dexamethasone Sodium Phosphate (J1100), Thiamine HCL (J3411), Vitamin B-12 
Cyanocobalamin (J3420), Magnesium Sulfate (J3475), Potassium Chloride (J3480), and Alteplase 
Recombinant (J2997). 
 You asked the Plan to pre-approve Keytruda, Pemetrexed, Bevacizumab - AWWB, Dexamethasone Sodium 
Phosphate, Thiamine HCL, Vitamin B-12 Cyanocobalamin, Magnesium Sulfate, Potassium Chloride, and 
Alteplase Recombinant. The Plan denied your request. The Plan says the requested regimen is not a medically 
accepted regimen for the enrollee's clinical scenario. 
 
The Plan must follow Medicare rules. The rules 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 Keytruda, Pemetrexed, Bevacizumab - 
AWWB, Dexamethasone Sodium Phosphate, Thiamine HCL, Vitamin B-12 Cyanocobalamin, Magnesium 
Sulfate, Potassium Chloride, and Alteplase Recombinant. Our reviewer says that the requested drug regimen is 
not medically reasonable and necessary for the enrollee. Our physician reviewer found this drug regimen is not 
FDA-approved for the enrollee's diagnosis of metastatic adenocarcinoma of the vulva (no actionable mutations 
with low tumor mutational burden and no detectable programmed cell death ligand 1) with a history of 
treatment with paclitaxel and carboplatin. The requested regimen is not supported by one of the major drug 
compendia or by clinical research that appears in a Centers for Medicare & Medicaid Services (CMS) approved 
medical journal for treatment of the enrollee's diagnosis. Our reviewer found that the requested regimen is not 
indicated, supported or recommended in any of the compendia for treatment of metastatic adenocarcinoma of 
the vulva (no actionable mutations with low tumor mutational burden and no detectable programmed cell death 
ligand 1) with a history of treatment with paclitaxel and carboplatin. Our physician reviewer also found that the 
documentation does not support that the requested regimen meets Medicare criteria for safe and effective and 
otherwise reasonable and necessary for this enrollee. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Keytruda, Pemetrexed, Bevacizumab - AWWB, Dexamethasone Sodium 
Phosphate, Thiamine HCL, Vitamin B-12 Cyanocobalamin, Magnesium Sulfate, Potassium Chloride, and 
Alteplase Recombinant have not been met. Therefore, we decided that the Plan does not have to pre-approve 
Keytruda (J9271), Pemetrexed (J9305), Bevacizumab - AWWB (Q5107), Dexamethasone Sodium Phosphate 
(J1100), Thiamine HCL (J3411), Vitamin B-12 Cyanocobalamin (J3420), Magnesium Sulfate (J3475), 
Potassium Chloride (J3480), and Alteplase Recombinant (J2997).