Arcutis Announces New Coverage for ZORYVE® (Roflumilast) Cream 0.3% with National and Regional Health Plan Formularies, Bringing Total Commercial Covered Lives to Over 110 Million

Rhea-AI Summary

Arcutis Biotherapeutics (Nasdaq: ARQT) announced ZORYVE's coverage expansion for plaque psoriasis, with eight additional national and regional health plans now covering the treatment without prior authorization, effective April 1, 2023. This brings commercial coverage to over 110 million lives in the U.S. ZORYVE, a steroid-free topical cream, is designed for all affected body areas and offers rapid results for difficult regions. The company's responsible pricing strategy is gaining traction among payers, and they aim to enhance dermatology adoption. ZORYVE is available by prescription only, with patient assistance programs in place for eligible uninsured or underinsured patients.

Positive

• ZORYVE's coverage expanded to eight additional health plans, enhancing accessibility.
• Over 110 million lives now have access to ZORYVE in the U.S.
• The treatment is steroid-free, providing a rapid solution for plaque psoriasis.

Negative

• None.

• Eight additional national and regional health plans are now covering ZORYVE for plaque psoriasis
  
• ZORYVE is a once-daily, steroid-free cream approved for use in both adults and adolescents with plaque psoriasis, including all affected areas of the body
  

WESTLAKE VILLAGE, Calif., April 05, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (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 being covered without prior authorizations by an additional eight national and regional health plans effective April 1. Combined with the previously announced coverage from two of the three largest national pharmacy benefit managers and several large national health plans, commercial coverage for ZORYVE for plaque psoriasis now exceeds 110 million commercially covered lives in the United States.

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 PDE4 inhibitor cream, provides rapid results for both hard-to-treat areas, such as knees and elbows, and sensitive areas such as the face, intertriginous areas, and genitalia.

“We are thrilled by the inclusion of ZORYVE on these additional national health plans, and by our rapid progress in unlocking high quality access to ensure our next-generation topical PDE4 inhibitor is available to even more adults and adolescents with plaque psoriasis in the United States. This commercial coverage, which requires no prior authorization, provides a further proof point that our responsible pricing strategy is resonating with payers,” said Frank Watanabe, President and CEO of Arcutis. “We are actively engaging with other payers to further increase coverage, while continuing to accelerate the adoption of ZORYVE by dermatologists and individuals with plaque psoriasis.”  

In addition to working with payers, the company 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 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 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 and long-term 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 the 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
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}

FAQ

What is ZORYVE and how is it used for plaque psoriasis?

ZORYVE is a steroid-free topical cream approved for treating plaque psoriasis in adults and adolescents, used once daily on all body areas.

How many lives are covered by ZORYVE in the United States?

ZORYVE is now covered for over 110 million commercially covered lives in the United States.

What recent changes occurred in ZORYVE's coverage?

Eight additional national and regional health plans began covering ZORYVE without prior authorization effective April 1, 2023.

Is there financial assistance available for ZORYVE?

Yes, Arcutis offers patient assistance programs for eligible uninsured or underinsured patients to access ZORYVE at no cost.