Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 40-year-old woman who achieved pregnancy through in vitro fertilization. She has a history of polycystic ovary syndrome. The patient has an elevated antinuclear antibody (ANA) titer of 2.3 and is on progesterone. There is an apparent history of miscarriage; however, there are no details regarding the number of miscarriages, at what gestational age, and whether there were previous successful pregnancies. A request has been made for intravenous immune globulin (IVIG) therapy. The Health Plan has denied authorization for IVIG therapy on the basis it is considered experimental.IVIG therapy is unproven in the treatment of recurrent miscarriage. It has not yet been shown to be beneficial in randomized, controlled studies. In addition, there is no evidence that this patients prior loss is in relation to the autoimmune event. She has other risk factors for spontaneous abortion. Thus, there is no evidence that IVIG therapy would be of any benefit to this patient. 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. The Health Plans denial should be upheld.Physician 2The patient is a 40-year-old female with a history of miscarriage. A detailed history regarding the patients previous miscarriages has not been provided. The patient has polycystic ovarian syndrome. She has conceived through in vitro fertilization (IVF) and is currently six weeks pregnant. The patient has also been classified as having an immune disorder and has been advised to receive intravenous immune globulin (IVIG) therapy throughout her pregnancy. The Health Plan has denied authorization for IVIG therapy on the basis it is considered experimental.Review of the relevant scientific literature does not demonstrate that the requested therapy is efficacious for patients such as this patient. The Cochrane review analyzed seven trials where IVIG therapy was administered to women with a history of recurrent miscarriage. The quality of these studies was felt to be high since only randomized controlled trials were included. The analysis concluded that IVIG therapy did not result in a significant increase in live births when compared to the control group, with an odds ratio of 0.98 and 95% CI 0.61 to 1.58. Dr. Scott concluded in the Cochrane review: Neither immunization with paternal mononuclear cells nor treatment with intravenous immune globulin improve the live birth rate in women with unexpected miscarriage. The Cochrane analysis is also in agreement with a fairly recent meta-analysis of six trials, which indicated that IVIG treatment had no clinically meaningful effect on live birth rate (Daya, 1998). Unfortunately, there are no proven treatments for unexplained recurrent miscarriages (i.e., assuming genetic and anatomical abnormalities have been ruled out) other than IVF with early pregnancy hormonal support, which the patient is currently receiving. 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. The Health Plans denial should be upheld.Physician 3The patient is a 40-year-old female with a history of repeated pregnancy loss who is now pregnant as a result of in vitro fertilization. The pregnancy is in the early first trimester. The patient and her treating physician have requested authorization for intravenous immune globulin (IVIG) therapy to suppress abnormal immune response. The Health Plan has denied the request indicating IVIG therapy is considered investigational for treatment of the patients medical condition.Upon review of the medical literature it is clear that IVIG is unproven or ineffective for repeat pregnancy loss. A study by Branch, et al., concluded there is no information available about the need for or efficacy of treatment in women found to be positive for antibiotics other than LA (lupus anticoagulant) or ACL (anticardiolipin antibody). Therefore, we do not currently recommend treatment in this group. Furthermore, a study by Stovall and Voorhis recommended against the use of IVIG in patients with unexplained recurrent pregnancy loss and indicated that IVIG should only be used in a research setting to treat patients with anticoagulant-associated recurrent pregnancy loss. Thus, IVIG for treatment of recurrent pregnancy loss is not within generally accepted standards of medical practice and is not indicated for this patient.Based upon the information set forth above, 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. The Health Plans denial should be upheld.