Arcutis Announces ZORYVE® (Roflumilast) Cream 0.3% Has Been Included in a Preferred Position on National Formularies for CVS Caremark

• Coverage at CVS Caremark, the largest pharmacy benefit manager (PBM) in the United States was effective July 5
• All three of the largest pharmacy benefit managers in the United States have now included ZORYVE on formulary, providing access to 80% of commercial lives
• ZORYVE is a once-daily, steroid-free cream for adults and adolescents with plaque psoriasis, including all affected areas of the body and for long-term use
  
  

WESTLAKE VILLAGE, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that ZORYVE^® (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous psoriasis in adults and adolescents, is now covered as a preferred tier product on CVS Caremark’s largest national commercial formularies effective July 5. These national formularies provide access to an additional 20 million commercial lives in the United States.

ZORYVE is covered for individuals with plaque psoriasis and a prior history of use of a topical steroid, although no prior steroid therapy is required for individuals with plaque psoriasis in sensitive skin areas.

“This is the largest U.S. pharmacy benefit manager, and the third to include ZORYVE on its national formularies since we launched less than a year ago. We have now unlocked broad high-quality access for a total of 131 million commercially insured patients, representing 80% of covered lives in the United States. Notably, in line with our access goals, more than 90% of the 130 million covered commercial patients have access to ZORYVE without a prior authorization,” said Frank Watanabe, President and CEO of Arcutis. “The placement of ZORYVE in a preferred tier position aligns with our focus on ensuring affordable access to ZORYVE so that adults and adolescents with plaque psoriasis can benefit from our effective and well-tolerated therapy.”

The vast majority of individuals with plaque psoriasis use topical therapies, and until recently there were few steroid-free options. ZORYVE, a once-daily, steroid-free phosphodiesterase-4 (PDE4) inhibitor cream, provides rapid results for both hard-to-treat areas, such as knees and elbows, as well as sensitive areas, such as the face, intertriginous areas, and genitalia.

In addition to working with payers, the company is committed to providing affordable access to ZORYVE through responsible pricing, , a patient access support and saving program^*, and the ™ 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 .

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%).

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About Arcutis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early commercial-stage 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 that 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 and body psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia areata. For more information, visit  or follow Arcutis on , , and .

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 payers. 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 28, 2023, 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

Investors

Eric McIntyre, Head of Investor Relations

^{* 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}