Keywords
Diseases & therapies
Immunology
Octapharma USA Announces Medicare Part B Approval of cutaquig® 16.5% for Adult PI Patients
PARAMUS, N.J.
2020-09-15
Press release
Cutaquig® 16.5% Part B Approval for Infusions with Electric and Mechanical Pumps Started September 6th
Octapharma USA today announced the Centers for Medicare & Medicaid Services (CMS) has modified the External Infusion Pump Local Coverage Determination to include cutaquig® 16.5%, the company’s subcutaneous immunoglobulin (SCIg), for use with electric and mechanical pumps. The Medicare Part B coverage determination is effective September 6, 2020.
“Cutaquig® is an important CMS-approved addition to the available supply of SCIg products for adult primary immune disease patients,” said Octapharma USA President Flemming Nielsen. “As the supply of immunoglobulin products faces challenges in the near future, the addition of cutaquig® to the list of products available for Medicare patients comes at the right time. Octapharma has increased its production of cutaquig® by more than 45 percent over the last year so we have strong supply to meet patient needs.”
For any item to be covered by Medicare Part B, it must be eligible for a Medicare benefit category, and meet all other applicable Medicare statutory and regulatory requirements. Since cutaquig® is administered through an external infusion pump, an item of durable medical equipment, it is covered for Medicare beneficiaries with Primary Immune Deficiency under the Part B, Durable Medical Equipment (DME) benefit of the Social Security Act.
“As skyrocketing demand looms on the horizon and more geriatric patients and others on Medicare are being treated independently at home, it is essential that this group have access to an SCIg product which has been demonstrated in clinical studies to be well-tolerated, safe and effective,” said Roger H. Kobayashi, M.D., Clinical Professor UCLA School of Medicine and National Consultant, Immune Deficiency Foundation.
About cutaquig®
Cutaquig® (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults.
WARNING: THROMBOSIS
Thrombosis may occur with immune globulin products, including cutaquig®. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
For patients at risk of thrombosis, administer cutaquig® at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
Please see full prescribing information for complete boxed warning and other important information at cutaquigus.com.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Paramus, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please www.octapharmausa.com.