FDA Approved The launch of the new Arcutis Biotherapeutics drug for plaque psoriasis allows the company to launch a strategy it believes will win payers and patients — lower prices.
Arcutis set a wholesale price of $825 per tube for its topical drug roflumilast, which will be sold under the “Zoryve” brand. By comparison, Deravant Sciences’ new plaque psoriasis drug Vtama sells for $1,325 a tube at wholesale.when Vtama was approved in Maywhich is strategically priced below the $1,950 wholesale price of Incyte’s Opzelura.
“We’re doing some experiments around our product pricing, and I’d say it’s a bold experiment,” Chief Executive Frank Watanabe said on a conference call Monday. “Our list price is 40% to 60% lower than the recently approved brand theme, which is very intentional. We are very confident that with the lower list price we set, we will get good coverage for this product.”
While $825 is the wholesale price, patients with commercial insurance covering the drug will only pay a $25 copay. Those with insurance but excluding drugs will pay $75. These copays don’t change over the life of the product, said Ken Lock, Arcutis’ chief commercial officer.
The rationale for these dollar figures is accessibility. Lock explained that the lower price is designed to help the drug get reviewed and approved by insurance companies more quickly. Broader coverage should reduce dermatologists’ prescribing barriers. The strategy also aims to avoid prior authorization, the health insurance requirement that doctors obtain approval from a patient’s health plan before the cost of expensive drugs is covered by the plan. As for copays, Arcutis conducts price modeling studies to come up with reasonable numbers that patients can expect to pay.
“It’s not zero,” Locke said. “Sometimes a zero-dollar copay isn’t always the best because it devalues the product. It’s a well-known fact that patients may not actually be in the game to use your product.
Westlake Village, Calif.-based Arcutis is now entering a crowded field of products for plaque psoriasis, an inflammatory disease in which the immune system attacks the body’s cells and causes red patches to appear on the skin. In addition to their unsightly appearance, these plaques are often itchy and painful. Anti-inflammatory drugs such as steroids offer a treatment option. But long-term use of steroids can thin the skin. These drugs can also cause problems in sensitive areas, such as the face and genitals. Biopharmaceuticals in the systemic circulation provide another treatment option. These expensive drugs carry other risks of side effects.
Zoryve is a different version of AstraZeneca’s older COPD drug. The FDA approved this once-daily tablet for reducing the exacerbation of symptoms of chronic lung disease. The small molecule blocked PDE4, an enzyme that regulates signaling proteins involved in the inflammatory response. Pfizer’s topical cream Eucrisa and Amgen’s oral drug Otezla have addressed the same goals for inflammatory skin conditions. Aructis believes Zorvye provides a more potent effect than either of these drugs. Arcutis obtained the rights to roflumilast for dermatological use from AstraZeneca. The company developed its own intellectual property for formulating the drug into topical creams. Watanabe said the IP will be extended until 2037.
The FDA’s approval decision was based on results from two Phase 3 studies that compared the Arcutis drug to a topical cream without the active pharmaceutical ingredient. In these studies, 42% and 37% of patients, respectively, achieved clear or nearly clear skin appearance scores after 8 weeks of treatment. The results also showed an improvement in itching scores. The most common adverse reactions reported in the study included diarrhea, headache, insomnia, and application site pain.
The regulatory decision covers the once-daily use of the drug in the affected area in patients 12 years of age and older. The drug’s label includes applying the cream to the rubbing site, which is the surface of the skin where the skin area comes into contact with other skin areas, such as the groin and armpits. The number of tubes needed will vary depending on the severity of the disease, but Watanabe said the company estimates patients will need three to four tubes a year. Lock said Zoryve should be available within two weeks.
Arcutis’ ambitions for Zorvye go beyond plaque psoriasis.Preliminary Phase 3 data for the drug used to treat seborrheic dermatitis are report in June. Watanabe said the company expects to report data from separate Phase 3 tests in scalp psoriasis and atopic dermatitis later this year.
Photography: Arcutis Biotherapeutics
