Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1The patient is a 57-year-old male with well-controlled HIV who is on highly active antiretroviral therapy. The patient has acute myeloid leukemia (AML) and possible antecedent MDS. He is now being considered for consolidation of first remission with a peripheral stem cell transplant. The Health Plan has denied authorization and coverage for the requested therapy on the basis it is considered experimental.Further data regarding this patients AML, AHD, and cytogenetics is needed to help define where he falls in the National Comprehensive Cancer Network guidelines. The decision to pursue treatment should rest on those data and not on his HIV positivity. As such, cytogenetic results and additional hematologic data should be obtained. Unless the patients HIV is poorly controlled, his HIV status does not preclude stem cell transplantation. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy at this time. The Health Plans denial should be upheld at this time. Physician 2The patient is a 57-year-old male who was diagnosed with acute myeloid leukemia (AML) in May 2004. He was induced into complete remission in the standard fashion and has undergone one cycle of consolidation chemotherapy. He also has a history of being HIV positive. That aspect of his medical condition appears to be under good control. Specifically, his viral load is quite low and his peripheral CD4 count is good. He has been under treatment for his HIV infection for approximately five years. Bone marrow examination on 8/12/04 was essentially normal with no increase of leukemia blasts.It has been recommended that the patient undergo high dose chemotherapy with autologous stem cell transplantation as further treatment of his AML. The Health Plan has denied authorization and coverage for the requested therapy on the basis that it is considered experimental for patients such as this patient.Review of the medical literature reveals that autologous stem cell transplantation after high dose chemotherapy is an appropriate treatment for AML in first remission, usually after one course of consolidation chemotherapy, as has been done for this patient. The complicating issue in this case is the fact that the patient has been HIV positive for the past five years. Though there may be some concern that HIV positive patients do not have the immune and marrow reserve necessary to undergo the treatment, there is increasing evidence that HIV patients who are in good condition in terms of viral load and CD4 counts, can and should undergo whatever potentially curative treatments are available to other patients. While there is little literature regarding this approach, there is enough precedent to indicate the patient will tolerate the treatment satisfactorily. Furthermore, high dose chemotherapy and stem cell transplant in AML does appear to be associated with the best chance for long-term leukemia-free survival. Based upon the information set forth above, 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 3The patient is a 57-year-old male with acute myeloid leukemia (AML) who is in remission with chemotherapy. He is also HIV positive and well controlled with highly active antiretroviral therapy (HAART). The patients provider recommends the patient undergo high-dose chemotherapy and stem cell rescue as consolidation for his leukemia. It appears from the records provided that the patient is in remission and if he cannot proceed to stem cell transplant, additional consideration therapy will be needed. The Health Plan has denied authorization and coverage for the requested therapy on the basis that it is considered experimental.There is no clear standard of care for the specific combination of clinical issues involved in this case (AML and HIV). In patients who are not HIV positive and who have AML, there is controversy regarding the role of stem cell transplantation versus multiple courses of consolidation chemotherapy. AML is not commonly seen in HIV positive patients; therefore, there is not much literature about its treatment. The safety of stem cell transplantation in a fairly healthy HIV positive patient has been demonstrated. In addition, the patients morbidity/mortality may be greater with repeated cycles of consolidation therapy than with one stem cell transplant. It appears one additional period of myclosuppression from stem cell transplantation will ultimately be safer than multiple periods of myclosuppression from consolidation, particularly given the patients mild immunosuppression. Thus, although there is little data available at this time, the requested therapy is a rational and safe approach to management of this patient and is likely to be of greater benefit than additional consolidation therapy.Based upon the information set forth above, 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.