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IVIG - BMC HealthNet Plan

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do not require treatment with <strong>IVIG</strong>, high-dose corticosteroids or any other specific<br />

therapy. 17 Splenectomy should be considered in children with symptomatic, severe<br />

thrombocytopenia for at least one year. 13-14 In Rh-positive children who relapse after<br />

initial therapy, Rh0 [D] immune globulin is preferred, if it is effective, over <strong>IVIG</strong>. Longterm<br />

corticosteroids are usually unacceptable in children due to adverse effects and<br />

responses are not durable. Only 5% of children with ITP still have thrombocytopenia that<br />

requires therapy after one year.<br />

B-cell chronic lymphocytic leukemia (CLL) for prevention of bacterial infections in<br />

patients with hypogammaglobulinemia and/or recurrent bacterial infections. 5 In one<br />

placebo-controlled study, <strong>IVIG</strong> significantly reduced bacterial infections and the median<br />

time to first bacterial infection for the <strong>IVIG</strong> patients was greater than 365 days vs. 192<br />

days with placebo. The number of viral and fungal infections was not different between<br />

the two groups.<br />

Kawasaki disease for the prevention of coronary artery aneurysm. 5 Efficacy of <strong>IVIG</strong> in<br />

conjunction with aspirin given in the acute phase of Kawasaki disease in reducing the<br />

prevalence of coronary artery abnormalities is well-established. 18<br />

Chronic inflammatory demyelinating polyneuropathy (CIDP) to improve<br />

neuromuscular disability and impairment and for maintenance therapy to prevent<br />

relapse. 6,19 Efficacy of <strong>IVIG</strong> was established in a multi-center, double-blind trial using<br />

immune globulin intravenous caprylate/chromatography purified (Gamunex). Patients<br />

with CIDP were randomized to <strong>IVIG</strong> or placebo given as a loading dose at baseline over<br />

2 to 4 consecutive days and then a maintenance dose every 3 weeks for up to 24 weeks.<br />

Patients who did not improve and maintain this improvement for 24 weeks were crossed<br />

over to the alternate study drug (rescue). Significantly more patients responded to <strong>IVIG</strong><br />

47.5% vs. 22.4% with placebo (25% difference; 95% confidence interval [CI] 7% - 43%;<br />

P = 0.006). This study included patients who were <strong>IVIG</strong> naïve and subjects who had<br />

previously received <strong>IVIG</strong>. See table 1. In an extension phase, time to relapse was<br />

evaluated in the subset of patients who previously responded to <strong>IVIG</strong>, i.e., patients who<br />

completed the efficacy phase or rescue phase for 24 weeks; 31 were randomly reassigned<br />

to continue with <strong>IVIG</strong> and 26 were reassigned to placebo (withdrawal period) for 24<br />

weeks. Subjects who continued on <strong>IVIG</strong> had a significantly longer time to relapse vs.<br />

patient on placebo (P = 0.011). The probability of relapse was 13% with <strong>IVIG</strong> vs. 45%<br />

with placebo (hazard ratio, 0.19 [95% CI, 0.05, 0.70]).<br />

Table 1. Outcomes in Intent-to-Treat Population Efficacy Period (24 weeks). 6<br />

<strong>IVIG</strong><br />

Placebo<br />

Efficacy Period Responder* Non- Responder* Non- P-<br />

Responder<br />

Responder Value**<br />

All subjects 28/59 (47.5%) 31/59 (52.5%) 13/58 (22.4%) 45/58 (77.6%) 0.006<br />

<strong>IVIG</strong> naïve 17/39 (43/6%) 22/39 (56.4%) 13/46 (28.3%) 33/46 (71.7%) 0.174<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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