Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced that the Centers for Medicare and Medicaid Services (CMS) have expanded coverage to include in-home use of Hyqvia [immune globulin infusion 10 per cent (human) with recombinant human hyaluronidase], a treatment for adults with primary immunodeficiency (PI).

PI is the name for a group of more than 200 diseases wherein part of the person’s immune system is missing or not functioning correctly. People with PI may be more likely to get infections, take longer to recover from infections and have recurring infections. Hyqvia offers a demonstrated safety and efficacy profile while delivering a full dose of treatment via one needle, one infusion site, once per month.

Following the US Food and Drug Administration (FDA)’s approval of Hyqvia in 2014, CMS covered both provider facility and in-office treatment with Hyqvia. This new decision expands its provisions to include durable medical equipment (DME) coverage of the infusion pump required to administer Hyqvia, better enabling an at-home, self-administration option for patients.

According to treatment preferences stated by PI patients who participated the clinical trial for Hyqvia, the majority of patients expressed a desire for the ability to administer infusions at home.

“It is important that patients have the option to be treated at the site that works best for their personal needs, and many people with PI have voiced a preference for in-home care,” said Dr. Amy Darter of the Oklahoma Institute of Allergy & Asthma. “This decision to expand coverage is a critical step forward in meeting their needs and equipping them to better manage their disease.”

“Today’s decision from CMS reinforces the value of Hyqvia and will help expand access to even more people who can benefit from the flexibility of self-administering Hyqvia in their own homes,” said Jacopo Leonardi, executive vice president and president, immunology, Baxalta. “This coverage expansion allows for Medicare patients and their physicians to select the site of care for Hyqvia that best fits their treatment needs and lifestyle, which may be valuable for many of the more than 10,000 PI patients in the Medicare system.”

Hyqvia is an immune globulin with a recombinant human hyaluronidase indicated for the treatment of primary immunodeficiency in adults. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Primary immunodeficiencies are a group of more than 200 disorders in which part of the body's immune system is missing or does not function properly. Normally, the immune system protects the body from pathogenic microorganisms like bacteria, viruses, and fungi, which can cause infectious diseases. When any part of a person's immune system is absent or dysfunctional, they are susceptible to infections and may take longer to recover from infections. When a defect in the immune system is inherited, it is called primary immune deficiency. It is estimated that as many as six million children and adults are affected by PI worldwide.