Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 36-year-old woman who is six weeks pregnant. She has five prior spontaneous abortions ranging from five to seven weeks. Autoimmune workup revealed an elevated ANA and SSA/Ro, + dsDNA L, lupus anticoagulant. The patient lacks protective blocking antibodies. She has high natural killer cells. The patients provider has recommended IVIG therapy, aspirin, Lovenox and prednisone. The Health Plan has denied authorization and coverage for IVIG therapy indicating that it is considered investigational.The patient has had recurrent spontaneous abortions. She has evidence of autoimmune disorder and she lacks blocking antibodies. The patient may fit the category of antiphospholipid antibody syndrome though fetal losses are more typically greater than 10 weeks. There is some evidence that low molecular weight heparin and baby aspirin is useful in this group of patients though there can be side effects. The addition of IVIG to this regimen has not proven useful or beneficial in the literature. In women with recurrent early spontaneous abortion only, no improvement in live birth rate was noted. In women with antiphospholipid antibody syndrome, there appeared to be no benefit in pregnancy outcome when IVIG was added to a regimen of heparin and baby aspirin. In summary, IVIG remains unproven in the treatment of recurrent spontaneous abortion (even in the face of high numbers of natural killer cells) and in antiphospholipid antibody syndrome. 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.Physician 2The patient is a 36-year-old female who is at six weeks gestation. She has reportedly experienced five miscarriages since 2002. These loses were very early (3-7 weeks) and a viable fetus was never identified. Only the second loss required a D&C and it does not appear that a cytogenetic evaluation from that loss was performed. Three of the losses were at three weeks, which is as early as pregnancy can be diagnosed and most likely represented biochemical pregnancy.Laboratory evaluation revealed a positive ANA; a positive double stranded DNA; and a positive SSA/Ro antibody. Evaluation for lupus anticoagulant, IgG anticardiolipins and other thrombophilias has been negative. Parental karyotypes have also been reported as normal. The patient is otherwise asymptomatic and healthy. Overall, evaluation reveals a non-specific autoimmune process and embryonic losses. A request has been made for IVIG therapy. The Health Plan has denied the request indicating that the requested therapy is considered investigational.Review of the current medical literature demonstrates that there is no convincing data that IVIG therapy is beneficial in treatment of recurrent pregnancy loss. In addition, the patients very early losses (3-7 weeks) are not typical of an autoimmune process. In light of this, there is no evidence that IVIG therapy will be of benefit to the 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 3The patient is a 36-year-old female with a history of five miscarriages in the first trimester. She has normal patient karyotypes. The patients fifth pregnancy was treated with Lovenox/aspirin. The patient has a history of positive antinuclear antibody. Recent testing indicated high levels of natural killer cell activity. The patient is pregnant, and is receiving aspirin, Lovenox, and glucocorticoids. The patient has requested authorization and coverage for IVIG therapy. The Health Plan has denied the request on the basis that IVIG therapy is considered investigational. This patient fits the diagnosis of habitual aborter and very likely has an autoimmune etiology. According to the American College of Obstetricians and Gynecologists and the American Society of Reproductive Medicine, the efficacy of IVIG therapy has not been established for treatment of patients such as this patient. Due to the lack of evidence that IVIG is effective in this clinical setting, IVIG therapy is not indicated for the 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.