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Supplements Examining the Application of Immunoglobulin in Multiple Disease States: A Review of Evidence
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Elena E. Perez, MD, PhD
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Managing Cost of Care and Healthcare Utilization in Patients Using Immunoglobulin Agents
Leslie J. Vaughan, BS, RPh

Managing Cost of Care and Healthcare Utilization in Patients Using Immunoglobulin Agents

Leslie J. Vaughan, BS, RPh
The introduction of human immunoglobulin (Ig) therapies 40 years ago reduced the risk of often life-threatening infections for individuals with one of several immune-related conditions known as primary immunodeficiencies. Since then, the use of Ig has expanded to numerous other conditions. However, even though less than 1% of covered lives under Medicare or commercial insurers require Ig, it is in the top 5 drug categories in terms of annual spending. The cost of Ig is directly related to the type of delivery method used and the site of care. Numerous studies attest to the efficacy and cost savings of shifting Ig to the home setting, as well as shifting patients from intravenous Ig (IVIG) to subcutaneous Ig (SCIG). In addition, surveys find that patients with primary immunodeficiencies prefer home delivery, with patient evaluations also finding a preference for SCIG. Payers have numerous options to ensure Ig is used appropriately for the right patient in the right setting. These include formulary management, site-of-care programs, education for providers and patients on the possibility of switching from IVIG to SCIG, preauthorization policies that restrict the use of Ig to certain specialties for specific indications, implementation of evidence-based coverage criteria, and shifting coverage from the medical to the pharmacy benefit.

Am J Manag Care. 2019;25:-S0
Introduction

Primary immunodeficiencies are a heterogenous group of immune-related conditions in which individuals exposed to pathogens risk severe and often life-threatening infections. The first patient with primary immunodeficiency was treated with subcutaneous human immunoglobulin (Ig) in 1952, transforming the outlook for these patients.1 The use of Ig has since been shown to reduce the risk of infection, antibiotic use, and hospital admissions, while leading to improved growth in pediatric populations and the maintenance of normal pulmonary function, thus dramatically improving quality of life and prognosis.2,3

Today, Ig is also used on- and off-label for the chronic and acute treatment of numerous other conditions, including chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN); to prevent bacterial infections in patients with certain hematologic malignancies, pediatric HIV, chronic lymphocytic leukemia, or following bone marrow transplantation; to increase platelet count in patients with idiopathic thrombocytopenic purpura; for certain autoimmune diseases, such as myasthenia gravis, immune-mediated inflammatory myopathies, immune-mediated blistering diseases, stiff person syndrome, and others; and to treat immunologic deficiencies in patients receiving B-cell–depleting targeted therapies.4,5 Ig is primarily used in its intravenous (IVIG) and subcutaneous (SCIG) formulations. Both can be delivered via an infusion pump; this often provides greater ease and convenience for patients and their families.4

Igs are one of the most complex specialty drugs for payers to manage. There are several reasons for this, including the large number of products currently on the market, which all have various doses, formulations, and indications; off-label uses; and adverse effects (AEs). Other important factors include patient and family education, the administrative support required, and site-of-care issues related to product delivery.6,7

The use of Ig is also increasing as diagnoses of primary immunodeficiencies and neurologic conditions increase, the population ages, and new uses are identified.8,9 For instance, the number of Medicare beneficiaries with primary immunodeficiencies receiving IVIG grew 60% between 2010 and 2014, with 25% of patients being younger than 65 years.10 In 2016, the Jeffrey Modell Foundation reported a 19% global increase in the number of patients receiving Ig between 2013 and 2015, with a 7% increase in those receiving IVIG and a 100% increase in those receiving SCIG. In the United States, the number of people with primary immunodeficiencies receiving Ig increased 11.5% during that time, with a 10% increase in IVIG administration and a 39.3% increase in SCIG administration.11 However, primary immunodeficiencies still remain undiagnosed, underdiagnosed, or misdiagnosed. Not only does this increase the risk of mortality for patients, but it also results in higher costs for payers.11,12

Economic Burden of Chronic Immunodeficiency Diseases

A 2017 report from the Jeffrey Modell Foundation that used the IMS database containing medical and pharmaceutical claims for more than 60 million patients from 90 US health plans found that annual treatment costs for patients with primary immunodeficiencies declined from $111,053 per patient before diagnosis to $25,271 per patient after diagnosis, even before Ig treatment.13 Even accounting for an annual $30,000 per patient cost of Ig, total cost savings post diagnosis were $55,882 (Table 113).  

A retrospective analysis of a large commercial database identified 1388 patients undiagnosed with primary immunodeficiencies for at least 5 years (84 for at least 10 years). Patients had a mean 39% increase in pneumonia, 20.4% in sinusitis, 20.2% in bronchitis, and 14.2% in otitis in the 10 years before diagnosis. In addition, there was a 29.1% average annual increase in hospitalizations, 10.5% in outpatient visits, and 5.3% in outpatient drug utilization.14

Other studies highlight the costs of other conditions for which Ig is used. One analysis of 31,451 medical records estimated the cost of hospitalizations for CIDP between 2010 and 2012 at $2.1 billion. Each CIDP hospitalization cost an average of $68,231, which was higher than that of a matched cohort, although the authors did not specify the cost of hospitalization for controls. The patients with CIDP also had lengths of stay 50% longer than controls.15

Cost of Immunoglobulin

In 2016, commercial payers spent an average of $2.00 per member per month (PMPM) on Ig (average claim $4154), a 16% increase over the previous year. The category represented the third highest drug category for payers at 8% of total drug spending, even though fewer than 1% of members (0.41 per 1000) required Ig treatment.16

Ig represents the fourth highest drug spending for Medicare Advantage plans, with an average PMPM of $2.82 in 2016 and an average cost per claim of $3282, representing 6% of overall Medicare Advantage prescription drug spending that year. The number of Medicare Advantage beneficiaries utilizing Ig, although higher than the commercial population, is still less than 1% (0.97, per 1000).16

Site of Care

When it was first approved, IVIG was typically delivered in the hospital setting as that was considered a safer place to manage AEs. Today, however, IVIG and SCIG may also be delivered in the home or physician office setting.17 The Jeffrey Modell Foundation estimated that 38% of US patients with primary immunodeficiencies received IVIG in a clinic setting in 2015 and 30% received IVIG in the home setting, whereas 28% of patients received SCIG (Table 2).11 Since then, many payers have instituted site-of-care policies, so these percentages are likely higher.18,19 Guidelines from the American Academy of Allergy, Asthma and Immunology note that the decision as to where to infuse the drug should be based on clinical considerations, including patient experience, patient comorbid conditions, and circumstance.20

In 2015, 48% of IVIG covered by commercial payers was delivered in the home or specialty pharmacy setting, 30% in the hospital outpatient setting, and 24% in the physician office setting, which represents a slight decline in hospital setting delivery from 2014 (33% to 30%). Under Medicare Advantage, 36% was delivered in the home or specialty pharmacy setting, 38% in physician offices, and 26% in hospital outpatient settings. This represents a significantly higher decline in hospital outpatient delivery between 2014 and 2015 (35% to 26%) in the managed care Medicare environment.21

The outpatient hospital setting can be the most expensive site for delivery of IVIG for commercial payers (Figure 1).17 This is because reimbursement is typically based on a percentage of billed charges plus a facility fee. Reimbursement in physician offices and nonhospital-owned clinics, however, is based on the cost of the drug plus an administrative fee, whereas home infusions are typically paid at average wholesale price minus any discounts or average sales price plus a percentage, plus equipment and nursing reimbursement.22 It is important to keep in mind that there are multiple reimbursement scenarios in each site of care (hospital, hospital outpatient, physician office, home), which vary based on the payer and the route of administration.

SCIG products may be more expensive than IVIG agents when considered on a per-gram basis. Although this is important to factor in, there are various considerations to examine when analyzing cost-effectiveness. Several analyses discuss substantial savings when IVIG administration shifts to the home setting and/or when patients switch from IVIG to SCIG formulations. A French analysis of IVIG costs in 24 patients (9 with MMN, 8 with CIDP, and 7 with Lewis-Sumner syndrome) found 1-year costs of $54,914 for patients treated in the home versus $104,608 for those treated in the outpatient hospital setting (P <.0001). The authors estimated that 20% of current patients with CIDP could benefit from the switch, with the number as high as 80% among stable patients.23

Another retrospective review of a claim database covering nearly 43 million participants in a commercial health plan also found lower overall costs for home infusions, with the cost per infusion per patient to be 31% less in the home setting than in the outpatient setting ($3293 vs $4745; P <.0001) (Figure 1).17 Overall, the investigators estimated that delivering IVIG in the home setting could provide annual savings of $18,876 to $26,136 for each patient receiving 13 to 18 infusions per year. The analysis also found lower non-Ig costs (Table 317) and improved adherence in patients who received home infusions (47% vs 22%; P <.001) based on the recommended 13 to 18 infusions per year. A significantly greater number of patients with fewer than 7 infusions per year were in the outpatient hospital versus the home setting (39% vs 29%; P <.0001).17

Ye et al used a large commercial claims database to identify patients with at least 3 months of continuous IVIG and compared costs of care among the home, outpatient hospital, or clinic setting. Eighty-three patients switched their IVIG site between clinic and home, and 79 switched between outpatient hospital to home. Switching from the outpatient hospital setting to the home setting led to significantly lower median costs ($6916 vs $4188; P <.0001), although there were no significant differences in costs between the clinic and home setting.24

 
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