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PreTreatment with IVIg Letter to InsuranceLast Updated: August 2, 2004
TEMPLATE LETTER OF PRE-TREATMENT MEDICAL NECESS
AND/OR POST-TREATMENT ROUTINE APPEAL
High dose intravenous immunoglobulin (IVIg) therapy is clinically beneficial and not experimental in a variety of immune disorders associated with human reproductive failure and pregnancy. Examples include: autoimmune diseases, Rh sensitization, hypogammaglobulinemia, recurrent fetal loss and infertility associated with antiphospholipid antibodies, intrauterine growth retardation and idiopathic thrombocytopenia. The effects of high dose immunoglobulin infusion include:
· Feedback inhibition of antibody synthesis
· Down regulation of EDGE Fcg receptor
· Blockage of placental transport of maternal endogenous Edge
· Regulation of idiotype network
· Alteration of T and B lymphocyte functions
· Down regulation of natural killer cell function and tumor necrosis factor secretion.
The beneficial effects of this medication are documented in the literature involving treatment for autoimmune disorders, organ transplant and bone marrow rejection and autoimmune disorders associated with infertility and pregnancy. Therefore, its use can no longer be labeled as experimental.
Women with the autoimmune disorder antiphospholipid antibody syndrome are at risk of infertility and should they conceive, will often experience recurrent pregnancy losses, intrauterine growth retardation, intrauterine fetal death, and maternal complications such as thrombosis (arterial and venous), stroke and transient ischemic episodes. More than one third of infertile women have circulating antiphospholipid antibodies and antithyroid antibodies that may prevent or impair implantation by compromising syncitalization of the early trophoblast and/or causing local venous and arterial thrombosis. The administration of IVIg in association with infertility treatment and during subsequent pregnancy is often the only method by which reproductive failure can be avoided.
Women at risk of pregnancy complications show alterations in their immunophenotype lymphocyte sets particularly in elevations in CD56+ natural killer cells that secrete tumor necrosis factor (TNF). This factor results in decidual necrosis, death of the placental cells, coagulopathy and eventual death of the infant. The only medication effective in reducing these natural killer cells and TNF secretion is IVIg. Other corticosteroids or immunosuppressants are either ineffective or contraindicated during pregnancy.
This patient will continue to be at risk of serious complications without IVIg therapy.
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