Clinical and economic outcomes of a "high-touch" clinical management program for intravenous immunoglobulin therapy

Abstract

ObjectiveTo compare clinical and economic outcomes of patients who received intravenous immunoglobulin (IVIG) therapies and were managed by a clinical management program vs the outcomes of matched controls using administrative claim data.MethodsThis retrospective cohort study used the PharMetrics Plus™ claim database between September 1, 2011 and June 30, 2014. Patients in the intervention group were from a “high-touch” IVIG clinical management program administered by a home infusion specialty pharmacy. A greedy propensity score matching algorithm was used to identify a control group from non-program patients. Generalized estimating equation models were employed to evaluate differences between cohorts who were followed for 1 year.ResultsClinical outcomes were measured as infections and infusion-related adverse events. The proportion of patients who had serious bacterial infections was significantly lower (4.13% vs 7.75%, P=0.049) in the intervention group (n=242) compared to the control group (n=968). Other clinical outcomes assessed were not different between cohorts (P>0.050). The economic outcomes were measured as healthcare costs. The annual adjusted mean total health care costs of patients in the program were $26,522 lower compared to matched controls, representing a 20% lower cost ($109,476 vs $135,998, P=0.002). A major contribution to this difference ($17,269) was IVIG-related total outpatient cost (intervention vs control groups: $64,080 vs $81,349, P=0.001).ConclusionThe patients in this high-touch IVIG clinical management program appeared to have comparable infections or adverse event rates and significantly lower total health costs compared to their matched controls.

Safety of intravenous immune globulin in an outpatient setting for patients with neuromuscular disease

“…however, the IVIg dose used is typically lower in immune deficiency states than in neuromuscular disorders. 17,52,53 Third, the lower AE rate could be the result of a shorter follow-up period in our study. The…”

“…Home administration of IVIg is cost effective because it eliminates the cost of a hospital stay or hospital outpatient infusion center visit and costs less per gram compared with hospital inpatient or outpatient settings . Analysis of the impact of site of care (place of service) on the cost of IVIg treatment has shown that home infusion patients, compared with all others, have significantly lower IVIg‐related costs …”

“…16 Analysis of the impact of site of care (place of service) on the cost of IVIg treatment has shown that home infusion patients, compared with all others, have significantly lower IVIg-related costs. 17 Adverse events occur in 1% to 15% of patients who receive IVIg regardless of whether they are receiving treatment in an inpatient or outpatient setting 42,43 ; in some studies, AEs have been reported in more than 50% of patients. 44,45 Advanced patient age, preexisting renal failure, diabetes, and the use of sucrose as a stabilizing agent are associated with higher rates of IVIg infusion-related complications.…”

Latent therapeutic demand model for the immunoglobulin replacement therapy of primary immune deficiency disorders in the USA

“…Despite multiple studies to try to assess outcomes in patients with PIDDs , patient outcomes of mortality and morbidity have not been fully developed for PIDDs making them more difficult still to relate to particular dosing of IgGRT. What we do know is that IgGRT is a lifesaving treatment, and it has been shown to decrease morbidity and possibly mortality in CVID , lung infections can promote bronchiectasis, noninfectious disease complications predict shortened life span and infections can impair HrQOL .…”

Outcome evaluation of a subcutaneous immunoglobulin clinical management program

“…Within each autoimmune disease status category, the control group was selected from patients who were not in the program and matched 1:4 using greedy propensity score match without replacement in the PMTX + database. [20] The propensity scores were obtained by regressing the following covariates into a logistic model: age at index date, gender, patient's proximity to 102 IG treatment centers (the list of treatment centers is not included due to space limitation), four geographic regions, Charlson Comorbidity Index score,[21] and 6-month pre-index total health-care costs [Table 1]. The covariates were selected based on the interests of outcome variables through literation review and clinical judgment of our internal and external clinical experts.…”