SOUTH SAN FRANCISCO, CA – October 16, 2025: Genentech, a member of the Roche Group, has introduced its first Direct-to-Patient (DTP) program for Xofluza® (baloxavir marboxil), a single-dose oral antiviral medication for treating and preventing influenza. This initiative aims to enhance accessibility and affordability for underinsured, uninsured, or self-pay patients in the U.S., offering a $50 cash pay option, significantly lower than the list price.
Science Significance
Xofluza is a first-in-class antiviral with a unique mechanism of action that inhibits the cap-dependent endonuclease protein, reducing viral replication. It has demonstrated efficacy against various influenza strains, including oseltamivir-resistant and avian strains (H7N9, H5N1) in non-clinical studies. Approved in over 80 countries, Xofluza represents a significant advancement in influenza treatment, offering a novel therapeutic option for patients aged five and older.
Regulatory Significance
Xofluza is approved by the U.S. FDA for the treatment of uncomplicated influenza types A and B in individuals aged five years and older who have been symptomatic for no more than 48 hours and are otherwise healthy or at high risk of developing influenza-related complications. It is also approved for post-exposure prophylaxis in individuals aged five years and older following contact with a person who has influenza. The new DTP program complies with FDA regulations, ensuring safe and effective delivery of the medication to eligible patients.
Business Significance
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This program marks a strategic move by Genentech to expand the market reach of Xofluza, particularly among underinsured and uninsured populations. By partnering with pharmacies like Alto Pharmacy Powered by Fuze Health, Amazon Pharmacy, and Mark Cuban Cost Plus Drug Company, PBC, Genentech aims to increase market penetration and brand visibility. The $50 cash pay option and same-day home delivery services are expected to enhance customer satisfaction and brand loyalty, potentially leading to increased sales and market share.
Patients’ Significance
For patients, this initiative offers improved access to a clinically effective influenza treatment at a reduced cost. The $50 cash pay option, available through select pharmacies, is 70% lower than the list price, making Xofluza more affordable for those without insurance or with limited coverage. The same-day home delivery service in select markets adds convenience, ensuring timely access to the medication, which is crucial during the flu season.
Policy Significance
The launch of this DTP program aligns with broader healthcare policy goals aimed at reducing medication costs and improving access to essential treatments. By providing a more affordable option for influenza treatment, Genentech supports public health initiatives to reduce the burden of flu-related illnesses and hospitalizations. This move also reflects a commitment to health equity, ensuring that all patients, regardless of their insurance status, have access to necessary medications.
Transaction Highlights
Genentech’s Direct-to-Patient program for Xofluza represents a significant step towards enhancing access to innovative influenza treatments. By offering a cost-effective, convenient, and patient-centered solution, Genentech addresses the needs of underinsured and uninsured populations, aligning with public health objectives and regulatory standards. This initiative underscores the company’s commitment to improving patient outcomes and supporting healthcare policies that promote affordable access to essential medications.
Source: Genentech Press Release
