Formulary placement is crucial to the commercial success of newly approved products, so Acrutis put out a press release last week announcing that Express Scripts had put Zoryve (roflumilast), the company's PDE4 inhibitor cream for plaque psoriasis, on its formulary.
Zoryve (roflumilast) developed by Arcutis Biotherapeutics, is a once-daily, steroid-free cream and the first topical phosphodiesterase-4 (PDE4) inhibitor approved to treat plaque psoriasis in patients 12 years of age or older. PDE4 inhibitors work by suppressing the immune system and lowering inflammation. Psoriasis is a common immune system-mediated skin disease that affects about 9 million people in the United States.
The FDA approved Zoryve back in July but how often it will be prescribed by clinicians and used by patients will unfold over time. One of the crucial factors will be whether the PDE4-inhibor cream will be among the drugs that pharmacy benefit managers (PBMs) cover, a list known as the formulary.
The importance that formulary placement has for companies plying newly approved drugs was signaled last week when Arcutis chose to issue a press release to announce that Express Scripts had put Zoryve on its formulary. Express Scripts, which is a subsidiary of Cigna, is one of the three PBMs that control about 80% of the PBM market. The other two are CVS Caremark, a subsidiary of CVS Health, and OptumRx, a subsidiary of UnitedHealth Group.
According to an Arcutis spokesperson, the PBM will not require prior authorization. But before patients are eligible for coverage, they must try other treatments first, including use of a generic steroid and a vitamin D analog, the spokesman said.
“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.
Zoryve’s wholesale acquisition cost is $825 per tube, according to the Acrutis spokesperson.
Those with commercial drug insurance may be eligible for the Zoryve Direct Savings Card, according to the Arcutis website. 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.
Other PDE4 inhibitors on the market include Otezla (apremalist), an oral drug that has been approved as a treatment for psoriatic arthritis, plaque psorias and Behçet’s disease, and Eucrisa (crisaborole), an PDE4 inhibitor ointment that has been approved as a treatment for milld to moderate atopic dermatitis.