Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for medications, Gamunex 70 grams intravenous (IV) and rituximab 800 mg IV for treatment of the enrollee who has a history of failed kidney transplants.  Findings:  The physician reviewer found that The patient is with a fourth kidney transplant.  His end stage renal disease (ESRD) is attributed to chronic glomerulonephritis. His first three transplants were lost to immunologic problems, presumably acute and chronic rejection. He is highly sensitized against human leukocyte antigens (HLA). The currently functioning transplant was the result of a paired exchange program. He received an ABO incompatible and HLA incompatible organ. Desensitization was performed with plasmapheresis and intravenous immunoglobulins (IVIG) plus rituximab. Donor specific antibody (DSA) was negative immediately after engraftment with a live donor kidney.  A biopsy shortly after transplant was unremarkable. Four years into the post transplant course the patient has developed asymptomatic proteinuria (464 mg/dL) and the serum creatinine has varied between 1.2 and 1.4 mg/dL. An allograft biopsy showed C4d staining (considered non specific in this case) glomerulitis, and peritubular capillaritis. DSA is now positive. The patient has features consistent with chronic antibody mediated rejection (AMR). As such, she has requested authorization and coverage for medications, Gamunex 70 grams intravenous (IV) and rituximab 800 mg IV. The Health Plan denied the request on the basis that the requested medications are investigational for treatment of this patients medical condition.The medical evidence have shown that chronic AMR leads to graft loss. There are very limited randomized control trials available to guide therapy for this condition.  However, if left untreated, this patient will likely need ESRD dialysis. Therapy with IVIG, rituximab would offer the best possibility of eliminating DSA which has developed in this patient.  There is very limited treatment alternatives any anecdotal or proven benefit for this medical condition.  Therefore, Gamunex 70 grams IV and rituximab 800 mg IV is likely to be more effective than any other standard options for treatment of this patients medial condition. Final Result: Two of three reviewers determined that the requested medications are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in nephrology and with expertise in renal transplantation and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in nephrology and with expertise in renal transplantation and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in nephrology and with expertise in renal transplantation and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.