FDA approval of Arcutis Biotherapeutics’ new drug for plaque psoriasis allows the company to implement a strategy it believes will win both payers and patients — lower prices.
Arcutis has set a wholesale price of $825 for each tube of its topical drug roflumilast, which will be marketed under the brand name “Zoryve.” By comparison, Dermavant Sciences’ new plaque psoriasis drug Vtama has a wholesale price of $1,325 per tube. When Vtama won its approval in Mayit was strategically priced below the $1,950 wholesale price of Incyte’s Opzelura.
“We are engaged in a bit of an experiment, a bold experiment, I would say, around the pricing of our products,” CEO Frank Watanabe said, speaking on a conference call Monday. “We’re somewhere between 40 and 60 percent lower in our list price than the recently approved brand-new products, and that was very intentional. We feel very confident that with the lower list price we have set, we will get very good coverage for this product.”
While $825 is the wholesale price, patients with commercial insurance that covers the drug will only pay a $25 copay. Those with insurance that does not cover the drug will pay $75. Those surcharges won’t change throughout the product’s life cycle, said Ken Locke, Arcutis chief commercial officer.
The rationale for these dollar figures is affordability. The lower price is intended to help the drug be more quickly reviewed and approved for coverage by insurance companies, Locke explained. Broader coverage should reduce barriers for dermatologists to prescribe. The strategy also aims to avoid prior authorizations, health insurance’s requirement that a doctor get approval from a patient’s health plan before that plan covers the cost of expensive drugs. As for co-payments, Arcutis did a price modeling study to come up with a reasonable amount that patients should expect to pay.
“It’s not zero,” Locke said. “Sometimes a zero dollar surcharge is not always the best as it devalues the product. Patients may not have the proverbial willingness to invest in accepting your product.
Westlake Village, Calif.-based Arcutis is now entering a crowded field of products for plaque psoriasis, an inflammatory condition in which the immune system attacks the body’s cells and causes red patches on the skin. In addition to their unsightly appearance, these plaques are also often itchy and painful. Anti-inflammatory drugs, such as steroids, offer one treatment option. But long-term steroid use can thin the skin. These drugs can also cause problems in sensitive areas such as the face and genitals. Biologic drugs that circulate systemically offer another treatment option. These expensive drugs come with other risks of side effects.
Zoryve is a different version of an older chronic obstructive pulmonary disease drug from AstraZeneca. The FDA has approved this once-daily tablet to reduce the worsening of symptoms of chronic lung disease. The small molecule blocks PDE4, an enzyme that regulates signaling proteins involved in inflammatory responses. The same target is already being targeted for inflammatory skin diseases by Pfizer’s topical cream, Eucrisa, and Amgen’s oral drug, Otezla. Aructis claims that Zorvye offers a more potent effect than either of these drugs. Arcutis has licensed rights to roflumilast for dermatological use from AstraZeneca. The company developed its own intellectual property to formulate the drug as a topical cream. Watanabe said the IP lasts until 2037.
The FDA based its approval decision on the results of two phase 3 studies that compared the drug Arcutis with a topical cream without an active pharmaceutical ingredient. In these studies, 42% and 37% of patients, respectively, achieved skin appearance scores of clear or nearly clear after eight weeks of treatment. The results also showed an improvement in itching scores. The most common side effects reported in the studies included diarrhea, headache, insomnia, and pain at the application site.
The regulatory decision covers the use of the drug once a day on the affected areas in patients aged 12 years and older. The drug’s label includes using the cream on intertriginous areas, which are skin surfaces where areas of skin come into contact with other areas of skin, such as in 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 commercially available within two weeks.
Arcutis’ ambitions for Zorvye go beyond plaque psoriasis. Preliminary phase 3 data for the drug in seborrheic dermatitis were reported in June. Watanabe said the company expects to report data from separate Phase 3 trials for scalp psoriasis and atopic dermatitis later this year.
Photo by Arcutis Biotherapeutics