Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  This patient is a 43-year-old female who underwent renal transplant in 1992 due to focal segmental glomerulosclerosis (FSGS). She is on now on dialysis and requires a second renal transplant. A live donor is available; however the patient is highly sensitized and had a positive crossmatch with the potential donor. The patients transplant specialist recommends desensitization with IVIG and Rituxan prior to transplant, and indicates that plasmapheresis may also be required. The providers request for authorization of the desensitization protocols was denied by the Health Plan citing the experimental nature of the therapies.The proposed therapies are considered to be the standard of care and are not investigational. Several expert conferences on the topic have described strategies for antibody removal in this setting and the providers recommendations are consistent with the recommendations of experts in the field. Additionally, there are no alternative therapies available that would allow the patient to proceed with transplant.  Without the proposed desensitization therapies, the alternatives are either prolonged dialysis or inevitable kidney rejection, neither of which is advantageous. Therefore, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 2:  The patient is a 43-year-old female who developed end-stage renal disease (ESRD) due to focal segmental glomerulosclerosis (FSGS). She underwent a kidney transplant in 1992 which lasted until December 2005, when she resumed dialysis. A living unrelated donor has been identified as a potential kidney donor; however, the patient has a positive crossmatch with the donor. The transplant center proposes to use IVIG and Rituxan, and possibly plasmapheresis, to remove the antibodies and decrease further production of antibodies that would likely lead to early rejection. The Health Plan has classified this approach as experimental/investigational and denied the request for authorization.In general, most patients who receive a kidney transplant feel better than those on dialysis and may live up to three times as long as those who stay on dialysis. Until recently, potential donors who had a positive crossmatch with the recipient could not donate due to the high rate of early humoral rejection. Several strategies have been applied to desensitize those recipients with positive crossmatches. These strategies have included IVIG, plasmapheresis, immunoabsorption, Rituxan, splenectomy and thymoglobulin. IVIG alone or in combination with plasmapheresis is widely used for desensitization and is no longer considered investigational. Although the use of Rituxan in this setting is still investigational, there is data dating back to 1993 showing that it can be used safely in a situation like this one. More recently, there are an increasing numbers of studies reporting the benefits of Rituxan in transplant desensitization therapy. Rituxan has even been used to successfully perform kidney transplant across the ABO blood type barrier. The patient is at high risk for rejection of the kidney from the identified donor. Aggressive desensitization is her best chance of staving off rejection. Rituxan has been used safely in this setting, and is likely to offer a more prolonged beneficial effect than IVIG alone or with plasmapheresis. Based upon these facts, I have determined that the requested therapies are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3:  The patient is a 43-year-old highly sensitized female who is awaiting a kidney transplant at a major transplant center. There is a potential living kidney donor, but she has a positive crossmatch (CDC and flow) with this donor. The transplant center has developed techniques to reduce the deleterious anti-HLA antibodies and to improve successful transplantation rates among this population that was previously not considered transplantable.  The primary desensitization protocol involves IVIG and Rituxan, and plasmapheresis will only be done if absolutely necessary. The patients request for authorization of IVIG and Rituxan along with possible plasmapheresis was denied by the Health Plan based upon a determination that the proposed therapies are  experimental/investigational for patients such as this one.The standard therapy for kidney transplant is cadaveric donation. This option may not be possible for a highly sensitized kidney transplant recipient like this patient because her pre-transplant crossmatch may never be negative. In short, she may never be eligible for another deceased-donor kidney transplant. The proposed desensitization treatments are no longer considered experimental/investigational in most large academic kidney transplant programs. Desensitization with IVIG/Rituxan and possibly plasmapheresis, can make transplant a viable option for a highly sensitized recipient with positive CDC and flow crossmatches such as this patient. For these reasons, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.