As payers struggle to provide comprehensive pharmacy benefits at a reasonable cost, they must increasingly be more diligent about curating their formularies to assure that marginal products are eliminated or at the very least aggressively managed.
To that end, I have developed a list that I call Jim’s Silly Drugs. Silly drugs have been approved by the FDA, but demonstrate marginal clinical benefit and provide marginal disease mediation.
In today’s JAMA dermatology I came across another drug that makes the Silly list – roflumilast topical foam/cream (ZORYVE) with an Average Wholesale Price of $1113.61 for a month supply!
Overview of roflumilast
Before we get into the value prop, here is a quick overview of roflumilast. Roflumilast was first approved in February of 2011 as Daliresp (AstraZeneca) in patients with severe or unresponsive congestive obstructive pulmonary disease (it was not effective in mild to moderate COPD). Roflumilast is an oral phosphodiesterase (PDE)-4 inhibitor that increases the levels of a substance in the lungs called cyclic AMP, which, in turn, relaxes the muscles in the airways and reduces the amount of swelling (inflammation) in the lungs. The oral tablet is now available generically for less than $20 for a one month supply.
In 2018, Arcutis Biotherapeutics licensed the exclusive worldwide rights to all topical dermatological uses of roflumilast and introduced a cream formulation in 2022. In 2024, a foam formulation was released – foam is more cosmetically elegant than cream when applied to hairy areas.
So does a thousand dollars of foam get you more than just a fluffy coif?
The Case Against Roflumilast topical: Why This “Breakthrough” Treatment Falls Short on Value
The FDA’s approval of roflumilast cream and then foam (ZORYVE) for dermatitis and psoriasis was hailed as a breakthrough—the first non-steroidal prescription treatment for this common skin condition. However, does the value live up to the marketing fanfare?
The Cost
The most glaring issue with roflumilast foam is its cost. At over $1000 for a month supply (wholesale acquisition cost), this medication commands a premium price that’s difficult to justify given the treatment landscape for the indicated dermatitis. For context, effective first-line treatments for these types of dermatitis are widely available at a fraction of this cost. Generic ketoconazole shampoo and hydrocortisone cream have provided reliable relief for decades at prices measured in tens of dollars, not thousands. Moreover, we know it’s not the active ingredient that contributes to this price. It’s worth repeating, that an oral generic is out there at less than $20 per month. Finally, as any compounding pharmacist will tell you it’s not a formulation issue. If a roflumilast prescription cream or foam were to be custom compounded it would likely be $50 or less.
Modest Efficacy Gains
The clinical data supporting roflumilast foam, while statistically significant, reveals only modest improvements over existing treatments. In the pivotal Phase 3 STRATUM study, approximately 80% of patients achieved “IGA Success” (Investigator Global Assessment of clear or almost clear) at week 8, compared to about 41% with vehicle only (no drug just foam or cream). While this 39 percentage point difference sounds impressive you have to recognize that this difference is in comparison to PLACEBO! Roflumilast was not compared to less expensive first line agents.
Also the study’s primary endpoint was clearing or near-clearing of symptoms—not complete cure or long-term remission. Many patients still experienced residual symptoms, and the durability of these improvements remains unclear. These dermatitis’s are chronic condition that typically require ongoing management. So you can expect patients to be tagging the pharmacy benefit monthly.
The “Steroid-Free” Marketing Myth
Much of roflumilast’s marketing emphasizes its “steroid-free” formulation, implying that existing corticosteroid treatments are inherently problematic. This messaging exploits patient fears about topical steroids while ignoring decades of safety data supporting their judicious use for dermatitis. Modern topical corticosteroids, when used as directed, have excellent safety profiles for dermatitis treatment. The theoretical advantages of avoiding steroids must be weighed against the practical reality that effective, safe, and affordable steroid options already exist. The slight reduction in potential side effects doesn’t justify a 10-20x price increase, particularly when many patients achieve excellent results with conventional therapy.
Limited Real-World Evidence
The clinical trials supporting roflumilast foam were conducted under idealized conditions with carefully selected patient populations. Real-world effectiveness may differ significantly from these controlled studies. Furthermore, the studies were relatively short-term, lasting only 8-12 weeks. As mentioned, dermatitis is a chronic condition requiring long-term management. Without robust long-term safety and efficacy data, patients and providers are essentially conducting a costly experiment with uncertain outcomes.
Opportunity Cost – Your Responsibility as a Fiduciary
Every healthcare dollar spent on pricy treatments like roflumilast foam represents resources that could be allocated more effectively elsewhere. The thousands of dollars spent on a single patient’s annual supply of this medication could fund multiple courses of effective conventional therapy for several patients. Prioritizing expensive treatments with marginal benefits over proven, affordable alternatives represents poor stewardship of limited healthcare resources.
A Poor Value Proposition
Roflumilast fails the fundamental test of healthcare value. Its marginal benefits over existing treatments cannot justify its premium pricing, particularly when effective, affordable alternatives remain available.
Patients, providers, and payers should approach this medication with skepticism. Until roflumilast foam’s pricing reflects its modest clinical advantages over existing treatments, it should be aggressively managed in the pharmacy benefit.
For more insight into how to adjust your pharmacy benefit to address Silly drugs don’t hesitate to reach out.
PS. Legacy PA is not up to the task.
Jim Notaro, a PharmD, is a seasoned managed care professional with extensive experience in pharmacy. He has worked across multiple plans overseeing Pharmacy and in 2000 founded CSS Health, a provider of medication therapy management and quality metric improvement software and services, eventually selling it to Clarest Health.