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IVIG - BMC HealthNet Plan

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Gamimune N, a brand of <strong>IVIG</strong> that has been discontinued, was FDA-approved for<br />

pediatric HIV infection to decrease the frequency of serious and minor bacterial<br />

infections and the frequency of hospitalization and to increase the time free of<br />

serious bacterial infection. 43 Currently marketed <strong>IVIG</strong> products do not have this<br />

indication. There is no evidence that <strong>IVIG</strong> confers incremental benefit to<br />

antiretroviral therapy and prophylactic antibiotics given according to current<br />

standards of practice. 1 In children with advanced HIV disease who are receiving<br />

zidovudine, <strong>IVIG</strong> decreases the risk of serious bacterial infections, but this benefit<br />

is apparent only in children who are not receiving TMP-SMZ as prophylaxis and<br />

for children with CD4 T lymphocyte counts > 200 to 400 cells/mm 3 .<br />

8. Adult Still’s disease. Approve for 12 months if the patient has tried a corticosteroid<br />

and methotrexate and a biologic agent (e.g., etanercept, infliximab, or anakinra) or if<br />

these therapies are contraindicated. No controlled trials are available using <strong>IVIG</strong>. 27,51<br />

Case reports indicate <strong>IVIG</strong> may be effective in some patients who do not respond to<br />

nonsteroidal anti-inflammatory drugs and in the treatment of flares in recent onset of<br />

disease.<br />

9. Autoimmune hemolytic anemia (AIHA). Approve for 12 months in patients with<br />

warm-antibody AIHA who have tried corticosteroids or had a splenectomy or if these<br />

treatments are contraindicated. Evidence does not support routine use of <strong>IVIG</strong>, but<br />

<strong>IVIG</strong> may have a role in patients with warm-type AIHA that does not respond to<br />

corticosteroids or splenectomy. 24,30<br />

10. Autoimmune mucocutaneous blistering diseases (pemphigus vulgaris,<br />

pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid<br />

[cicatricial pemphigoid], and epidermolysis bullosa acquisita). Approve for 12<br />

months in patients who meet one of the following criteria (a, b, c, or d):<br />

A. Patient has tried conventional therapy (systemic corticosteroids [e.g.,<br />

prednisone] AND an immunosuppressive agent [e.g., azathioprine,<br />

cyclophosphamide, dapsone, methotrexate, cyclosporine, mycophenolate<br />

mofetil (Cellcept ® ), etanercept (Enbrel ® )], tacrolimus), or<br />

B. Patient has contraindications to or has had significant adverse effects from<br />

conventional therapy [for corticosteroids e.g., poorly controlled diabetes,<br />

advanced osteoporosis, severe infections, prior GI bleeding; for<br />

immunosuppressives e.g., infections, bone marrow suppression) 52 , or<br />

C. The disease is rapidly progressive, extensive, or debilitating (cannot be<br />

controlled with conventional therapy), 52-55 or<br />

D. The disease is so serious that there is inadequate time for conventional therapy<br />

to have rapid enough effect.<br />

Conventional therapy is started at the same time or before <strong>IVIG</strong>. Many case<br />

reports and uncontrolled case series suggest benefit of <strong>IVIG</strong> in patients with<br />

This guideline provides information on <strong>BMC</strong> <strong>HealthNet</strong> <strong>Plan</strong> claims adjudication processing guidelines. The use of this<br />

guideline is not a guarantee of payment and will not determine how a specific claim(s) will be paid. Reimbursement is<br />

based on member benefits and eligibility, medical necessity review, where applicable, coordination of benefits, adherence<br />

to <strong>Plan</strong> policies, clinical coding criteria, and the <strong>BMC</strong> <strong>HealthNet</strong> <strong>Plan</strong> agreement with the rendering or dispensing provider.<br />

Reimbursement policies may be amended at <strong>BMC</strong> <strong>HealthNet</strong> <strong>Plan</strong>’s discretion. <strong>BMC</strong> <strong>HealthNet</strong> <strong>Plan</strong> will always use the<br />

most recent CPT and HCPCS coding guidelines.<br />

<strong>BMC</strong> <strong>HealthNet</strong> <strong>Plan</strong> – <strong>IVIG</strong><br />

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