TORONTO, ON, July 9, 2026 – Arcutis Canada, Inc., a commercial stage company focused on delivering meaningful innovations in immunodermatology, is raising concerns about recent reimbursement recommendations from Canada’s Drug Agency (CDA-AMC) and Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) for ^PrZORYVE^® (roflumilast) cream 0.15% for the treatment of mild to moderate atopic dermatitis for patients 6 years of age and older.

The recommendations against publicly reimbursing ZORYVE will impact access for Canadians relying on public drug plans. They also highlight broader gaps in access to newer, steroid-free treatment options, contributing to widening disparities between therapies approved by Health Canada, therapies reimbursed by private insurers and those accessible through publicly funded programs.

Positive reimbursement recommendations are an important step toward improving access to innovative therapies. In this context, the recommendations for ZORYVE reinforce the current public care pathway where many Canadians living with atopic dermatitis requiring treatment will need to continue to resort to outdated therapies despite evolving clinical practice and newer treatment options. The CDA-AMC and INESSS recommendations also appear at odds with growing recognition of limitations associated with long-term reliance on topical corticosteroids. This includes a Health Canada safety reminder about rare but severe topical corticosteroid withdrawal reactions which may occur upon discontinuation after prolonged and/or inappropriate use of mostly moderate to high potency topical steroids.

“Just because atopic dermatitis can be mild to moderate, this does not mean that this disease does not have significant impact on patients’ lives and on their caregivers. It can be challenging to manage atopic dermatitis when we have very few non-steroidal options for patients who do not have private coverage to access the newer, effective medications that may be appropriate for their individual needs,” said Toronto-based dermatologist, Dr. Perla Lansang. “Topical steroids have their limitations, and the publicly funded non-steroidal options are sometimes not suitable for all patients. More recent therapies like ZORYVE are supported by clinical evidence and expand the range of treatment options available for chronic diseases that need long-term management. Ensuring that all patients, not only those with private coverage, can access these medications is so important.”

In addressing the burden of atopic dermatitis, many patients remain limited to steroid-based topical therapies that have long played an important role in disease management but may present considerations related to sustained use or use on certain areas of the body. In long-term use, topical corticosteroids may be associated with side effects, including skin atrophy, discoloration, and stria. In addition, treatment regimens for atopic dermatitis using older, established options often require the use of multiple topical therapies with different formulations and application schedules, which can be complex, time-consuming, and difficult to maintain consistently.

Patients who are unable to achieve adequate disease control with topical therapies are often escalated to more complex and higher-cost treatment options, including phototherapy, systemic therapies, or biologics—approaches that may require ongoing monitoring, additional healthcare resources, and can place greater burden on patients, caregivers, and the healthcare system.

“Advancing innovation for Canadians living with chronic skin conditions is a core focus for Arcutis, particularly as symptoms can affect daily comfort, confidence and quality of life,” said Jamie Lewis, Vice President & General Manager, Arcutis Canada. “Arcutis remains committed to delivering needed therapies to help address the real-world impact and ongoing burden of dermatological conditions such as atopic dermatitis while also supporting healthcare providers in the management of these complex conditions.”

Atopic dermatitis is a chronic, inflammatory disease characterized by persistent, unpredictable, and often debilitating itch with recurrent flares that can significantly disrupt sleep, impair daily functioning, and affect emotional well-being and quality of life.

“As the most common form of eczema, atopic dermatitis is a challenging chronic condition to live with, and the itch, pain, and visible symptoms can impact quality of life for patients and caregivers,” said Amanda Cresswell-Melville, Executive Director of the Eczema Society of Canada. “Canadian eczema patients continue to face unmet treatment needs to manage this complex condition. Unfortunately, managing atopic dermatitis can be very difficult, and it is frustrating to see reimbursement decisions that minimize the effect this condition can have on daily life, including disruptive itch, loss of sleep, and missed work and school.”

ZORYVE is a selective phosphodiesterase‑4 (PDE4) inhibitor available in multiple topical formulations in approved in Canada for topical dermatological use. ZORYVE cream 0.15% is approved by Health Canada for the treatment of mild to moderate atopic dermatitis in individuals 6 years of age and older.

ZORYVE cream and foam formulations are not currently reimbursed under public drug plans in Canada, though patients may be eligible for coverage through private insurance plans. Arcutis Canada will continue to engage with federal, provincial, and territorial stakeholders, as well as the clinical and patient communities, to advance understanding of the unmet patient needs and explore pathways to support public reimbursement and equitable access for Canadians.

Please consult the Canadian product monograph here for complete prescribing and safety information.

About Arcutis                                                                                                                       

Arcutis Canada, Inc. is a subsidiary of Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.ca.

Contacts:

Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Brian Schoelkopf, Head of Investor Relations

ir@arcutis.com