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Arcutis’ ZORYVE® (Roflumilast) Cream 0.3% Added to Express Scripts, Inc.® National Formularies in the United States

By: Arcutis Biotherapeutics, Inc. via GlobeNewswire

November 17, 2022 at 08:00 AM EST

ZORYVE is now on formulary for one of the top pharmacy benefit managers serving commercially insured patients, effective November 18, 2022
ZORYVE is a once-daily non-steroidal cream and the first and only topical PDE4 inhibitor approved for use in plaque psoriasis, including all affected areas of the body, on July 29
Arcutis announced the commercial launch of ZORYVE on August 10

WESTLAKE VILLAGE, Calif., Nov. 17, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that ZORYVE^® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in adults and adolescents is now on Express Scripts national formularies for commercial benefit plans, effective November 18. Express Scripts’ commercial national formularies provide access to more than 26 million commercial lives in the United States.

“Ensuring affordable access to ZORYVE is of the utmost priority for Arcutis. The inclusion of ZORYVE on Express Scripts’ national formularies means that our next-generation topical PDE4 inhibitor is now available as a new topical treatment option for millions of adults and adolescents in the United States living with plaque psoriasis,” said Frank Watanabe, President and CEO of Arcutis. “We priced ZORYVE to unlock broad, high-quality access and believe this first major payer formulary acceptance supports our approach. We’re excited by our progress to date and our ability to secure this coverage for ZORYVE with Express Scripts’ national formularies prior to the end of the year. We believe coverage will continue to ramp up as we engage with other payers to further expand commercial formulary access.”

In the Company’s third quarter earnings call, Arcutis reported the signing of this payer agreement. In addition to working with payers, Arcutis is committed to providing affordable access to ZORYVE through responsible pricing, ZORYVE Direct™, a patient access support and saving program^†, and the Arcutis Cares™ patient assistance program, which provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.^‡

ZORYVE is available by prescription only. For more information about ZORYVE visit zoryve.com.

About ZORYVE^®
ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION
The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

The most common adverse reactions (≥1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).

Please see full Prescribing Information.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is 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 harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp psoriasis, atopic dermatitis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.

Forward-Looking Statements
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for ZORYVE to simplify disease management for care of plaque psoriasis; the potential of real-world use results of roflumilast cream, the commercial launch of ZORYVE in plaque psoriasis, and access and continued expansion in commercial coverage with payors. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 22, 2022, as amended, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

^{† Uninsured patients and patients with government insurance are not eligible for the ZORYVE Direct savings program; Other terms and restrictions apply}

^{‡ Subject to financial eligibility requirements. Other terms and restrictions apply}