Express Scripts Adds Zoryve to National Formulary

Launched in August, Zoryve is a once-daily, steroid-free cream and is the first topical PDE4 inhibitor approved to treat plaque psoriasis in patients 12 years of age or older.

Effective Nov. 18, 2022, Express Scripts has included Zoryve (roflumilast) to its national formulary. Zoryve, developed by Arcutis Biotherapeutics, is a once-daily, steroid-free cream and is the first topical phosphodiesterase-4 (PDE4) inhibitor approved to treat plaque psoriasis in patients 12 years of age or older.

Express Scripts will not require prior authorization. However, it will require two prior steps before patients are eligible, including use of a generic steroid and a vitamin D analog, a spokesperson from Arcutis told Formulary Watch.

“We priced Zoryve to unlock broad, high-quality access and believe this first major payer formulary acceptance supports our approach,” Frank Watanabe, president and chief executive officer of Arcutis, said in a press release. “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.”

Zoryve’s wholesale acquisition cost is $825 per tube. Those with commercial drug insurance may be eligible for the Zoryve Direct Savings Card. Patients may pay as little as $25 if their commercial drug insurance covers Zoryve, and $75 if their commercial drug insurance currently does not. It is also available through Arcutis Cares patient assistance program, which provides Zoryve at no cost for financially eligible patients who are uninsured or underinsured or for those who have Medicaid or Medicare Part D prescription coverage and cannot afford their medication

Related: Arcutis Launches Steroid-Free Psoriasis Therapy Zoryve

The FDA approved Zoryve in July 2022, and the company launched the therapy in August 2022. It was approved based on pivotal DERMIS-1 and DERMIS-2 phase 3 studies. In these trials, more patients experienced improvement with Zoryve. It also improved the severity and impact of itch.

Arcutis also recently announced the completion of enrollment in INTEGUMENT-1 and INTEGUMENT-2, the two pivotal phase 3 trials of Zoryve for the treatment of atopic dermatitis in subjects six years of age or older. Topline data. are expected by the end of 2022. Patient enrollment continues in INTEGUMENT-PED, the third pivotal phase 3 trial in patients aged two to five years old. Topline data from are anticipated are expected in 2023.