MMIT Reality Check on Immune Globulin (PID)

Payer Coverage:

A review of market access for treatments of primary humoral immunodeficiency (PID) disease shows that under the pharmacy benefit, about 49% of the lives under commercial formularies are covered with utilization management restrictions. Around 25% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Under the medical benefit, about 76% of the lives under commercial policies are covered with utilization management restrictions. Almost 68% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

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For about 90% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 4% require multiple steps. Around 78% of payer-controlled pharmacy benefit covered lives require prior authorization, with 12% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

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Trends:

FDA Expands Cutaquig

In December 2021, the FDA expanded the label of Octapharma USA’s Cutaquig (immune globulin subcutaneous [human]-hipp 16.5% solution) to include the treatment of pediatric patients at least 2 years old with primary humoral immunodeficiency. Dosing of the subcutaneous injectable may be every other week, every week or more frequently; it is based on a person’s pharmacokinetic and clinical response and the desired immune globulin trough level. Drugs.com lists the price of 48 milliliters of 165 mg/mL solution as $1,640.91.

FDA Approves Xembify

In July 2019, the FDA approved Grifols’ Xembify (immune globulin subcutaneous human-klhw) to treat primary humoral immunodeficiency disease in people at least 2 years old. Dosing and dosing intervals for the subcutaneous infusion are based on a patient’s serum IgG trough level and weight.

FDA Approves Bivigam’s Re-Entry

In May 2019, the FDA approved ADMA Biologics, Inc.’s Bivigam (immune globulin intravenous [human] 10% liquid) for re-entry onto the U.S. market for the treatment of people with primary humoral immunodeficiency. The agency initially approved the drug in 2012, when it was a Biotest Pharmaceuticals Corp. product. That company voluntarily halted commercial production of the drug in 2016. In June 2017, ADMA acquired the assets of the Biotest therapy business unit, of which Bivigam was a part. ADMA resumed production of the therapy in late 2017.

Key Findings:

Market Events Drive Changes

In December 2021, the FDA expanded the label of Octapharma USA’s Cutaquig (immune globulin subcutaneous [human]-hipp 16.5% solution) to include the treatment of pediatric patients at least 2 years old with primary humoral immunodeficiency (PID). In July 2019, the agency approved Grifols’ Xembify (immune globulin subcutaneous human-klhw) to treat PID disease in people at least 2 years old. In May 2019, the agency approved ADMA Biologics, Inc.’s Bivigam (immune globulin intravenous [human] 10% liquid) for re-entry onto the U.S. market for the treatment of people with PID. The agency initially approved the drug in December 2012, when it was a Biotest Pharmaceuticals Corp. product. That company voluntarily halted commercial production of the drug in December 2016. In June 2017, ADMA acquired the assets of the Biotest therapy business unit, of which Bivigam was a part. ADMA resumed production of the therapy in late 2017 and manufactured three conformance lots, paving the way for the company’s submission and approval of a Prior Approval Supplement.

Competitive Market Landscape

Most health plans consider immune globulin products as undifferentiated brands, therefore finding them hard to manage. The lack of product differentiation, off-label use and provider preference for specific products contribute to limited contracting. To control costs, a few plans, such as CVS Health Corp.’s Aetna and Anthem, Inc., specify preferred brands in their policies.

Pharmacy, Medical Benefit Implications

Subcutaneous immune globulin coverage is common under the pharmacy benefit, while intravenous immune globulin coverage is under both the pharmacy and medical benefits. Few plans have shifted towards specialty pharmacy procurement for immunoglobulin products. Since CMS allowed a step therapy in Medicare Part B in 2019, many plans implemented a step therapy strategy that includes immunoglobulin therapy.

Key Players in Market:

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AIS Health Staff

AIS Health Staff

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