Xolair OK for Self-Injection Will Help Keep People Safe at Home

As the COVID-19 pandemic continues, many people — particularly those with certain preexisting conditions such as moderate to severe asthma — are trying to stay home and avoid places where they could be exposed to the virus, including health care provider offices. The FDA’s recent approval of self-administration of Roche Group member Genentech USA, Inc. and Novartis Pharmaceuticals Corp.’s Xolair (omalizumab) will assist in that effort. Payers and providers expect in-home self-administration to increase this year due to the pandemic, according to Zitter Insights.

On April 12, the FDA approved Xolair prefilled syringe for self-injection across all its approved U.S. indications: the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria and nasal polyps. The drug, initially approved on June 20, 2003, had been indicated in the U.S. for administration by a health care provider in a health care setting. (The European Commission approved self-administration of the drug on Dec. 13, 2018.)

However, in April 2020, Genentech, after consultation with the FDA, notified providers that due to the pandemic, they could allow certain patients to self-
administer the drug temporarily. This approval makes that decision permanent. Patients must have no history of anaphylaxis and be closely observed by a provider for at least three injections with no allergic reactions.

For the Managed Care Biologics and Injectables Index: Q4 2020, from Dec. 2, 2020, to Jan. 7, 2021, Zitter Insights polled 40 commercial payers with 130.8 million covered lives. Among the 17 payers covering 82.9 million lives that use preferred sites of care for infusions, those with 84% of lives said they anticipate self-administration in patients’ homes for nononcology therapies to increase in 2021 as a result of COVID-19.

Zitter Insights and AIS Health are MMIT companies.

The company also polled 50 physicians during the same time frame. Of the 19 that that used a payer-preferred site of care for infusions, more than two-thirds expected in-home self-administration to increase in 2021 due to the pandemic (see chart below).

For more information on the Zitter data, contact Jill Brown Kettler at jbrown@aishealth.com.

© 2024 MMIT
Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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