Coverage of Intravenous Immunoglobulin for Autoimmune Blistering Diseases Among US Insurers

Abstract

In this study, the authors examine coverage for IVIG to treat autoimmune blistering diseases by public and private insurers in the United States.

Treatment of autoimmune blistering diseases (AIBDs) has historically relied on systemic corticosteroids, but intravenous immunoglobulin (IVIG) has been shown in randomized clinical trials to be safe and highly effective in the treatment of pemphigus vulgaris and bullous pemphigoid. Despite its efficacy, the cost of IVIG remains a deterrent to its use. However, owing to the decrease in associated infections, complications, and hospitalizations, cost studies in the United States indicate that IVIG is an overall cost-saving therapy in the treatment of AIBD compared with traditional immunosuppressive treatment.

Coverage for rituximab for AIBDs varies greatly, with Medicaid providing the most limited coverage. Given the growing body of high-quality evidence supporting IVIG’s efficacy and safety in the treatment of AIBDs, we sought to similarly evaluate coverage policies among selected private and public payers in the United States.

Methods

To determine coverage policies for IVIG, we used a modification of the protocol described by Wang et al. We identified coverage policies using the websites of each state’s Medicaid program and the Centers for Medicare and Medicaid Services. We identified the top 10 private health insurance providers by market share using the National Association of Insurance Commissioners 2015 market share report. Institutional review board approval was not required according to the Basic HHS Policy for Protection of Human Research Subjects (45 CFR 46). The search was performed in April 2017.

The US Department of Commerce, Economics and Statistics Administration report on health insurance coverage in the United States for 2015 was used to determine the number of Americans covered by private insurance, Medicaid, and Medicare. The report demonstrated 201 million privately insured individuals as well as 49 million individuals with Medicare and 54.9 million with Medicaid. Nine of the 10 private payers listed policies regarding the use of IVIG for AIBDs, accounting for 41.06% of the private market share or 82.5 million covered individuals. The Kaiser system was excluded, as it is a closed system. All Medicaid and Medicare databases were assessed. Thus, data apply to 186.4 million of 304.9 million total covered individuals (61.1%).

Results

All 9 of the private payers assessed listed AIBD as a covered disease. Data from private insurance companies are shown in the Table. Of the 51 Medicaid state or district providers, 48 were assessed. Data for New Mexico, Oklahoma, and South Dakota were not readily available. Eleven state Medicaid websites listed AIBD as an acceptable indication for the use of IVIG. In October 2002, the Centers for Medicare and Medicaid Services issued a National Coverage Determination on IVIG for AIBD, directing all Medicare vendors to cover IVIG for AIBD.

Table. Coverage of IVIG Treatment for AIBDs by the Top 10 Private US Insurers by Market Share^a.

Rank	Insurer	Market Share, %b	Estimated Covered Individuals, Millions	Policy on IVIG for ABID
1	United HealthCare	12.20	24.5	Medically necessary if Diagnosis of AIBD; Extensive or debilitating disease; History of failure, contraindication, or intolerance to systemic corticosteroids with concurrent immunosuppressive drugs; IVIG dose not to exceed 1-2 g/kg/mo; and Documentation of titration and minimum dose/frequency needed to maintain a sustained clinical effect for long-term treatment
2	Kaiser Permanente	7.51	15.1	NAc
3	Anthem	6.13	12.3	AIBD that are refractory
4	Humana	5.67	11.4	Trial and failure of conventional therapy, contraindication to conventional therapy, or rapidly progressive disease in which a clinical response could not be effected quickly enough using conventional agents
5	Aetna	5.6	11.3	Failure or contraindication to conventional therapy or rapidly progressive disease in which a clinical response could not be effected quickly enough using conventional agents; short-term use only
6	HCSC	3.58	7.2	Failure, intolerance, or contraindication to standard treatment
7	Cigna	2.51	5.0	Failure, intolerance, or contraindication to corticosteroid therapy
8	Centene	2.10	4.2	AIBD
9	Blue Cross of California	1.64	3.3	AIBD
10	Highmark	1.63	2.3	When standard therapies fail, become intolerable, or are contraindicated

Abbreviations: AIBDs, autoimmune blistering diseases; HCSC, Health Care Service Corporation; IVIG, intravenous immunoglobulin; NA, not applicable.

^aInsurer rank determined by market share as reported by the National Association of Insurance Commissioners.

^bPercentages reflect the share of the private insurance market.

^cN/A: Kaiser is a closed system, and therefore was not analyzed.

Discussion

We herein demonstrate that although IVIG is, overall, accessible to patients with AIBD covered by private insurance or Medicare, patients with AIBD who are insured by Medicaid are often limited in their ability to receive coverage for IVIG. Because current data support IVIG as an overall cost-saving and efficacious therapy for the treatment of AIBD, Medicaid coverage of IVIG should match the policies of private payers and Medicare.