The recently approved biologic drug dupilumab (Dupixent), Regeneron/Sanofi’s treatment for atopic dermatitis (eczema), is getting a positive reception from payers despite its $37,000 annual price tag.
Dupilumab was approved on March 28, 2017, for the treatment of adults with moderate to severe atopic dermatitis that cannot be controlled by topical treatments. Regeneron/Sanofi has asserted that the twice-monthly subcutaneous injection will deliver value and improve health outcomes for patients with few options. According to analysts, initial responses from pharmacy benefit managers (PBMs) suggest potentially strong uptake of the new drug because it fills an unmet need.
Atopic dermatitis, which causes severe itching, pain, visible skin lesions, sleep disturbances, and mental health effects, is prevalent in 5%-20% of children worldwide and approximately 11% of children and an estimated 3%-7% of adults in the United States. Current therapies for atopic dermatitis include nonpharmacologic interventions such as moisturizers, bathing and wet wraps, and topical drug treatments such as corticosteroids, calcineurin inhibitors, and phototherapy. These require up to an hour of skin care per day. Systemic treatments include immunosuppressants such as methotrexate, cyclosporine, and azathioprine—none of which are FDA approved for eczema.
Clinical trials that evaluated dupilumab suggest that it is at least as effective as cyclosporine and more effective than phototherapy in controlling atopic dermatitis. Approximately 70% of patients who took the drug every week or every 2 weeks saw improvement in their skin disorder, and approximately 37% of patients showed clearing or near-clearing of skin lesions. With respect to safety, dupilumab may be safer than cyclosporine, which carries a possible risk of infections, cancer, and phototherapy, which can cause burns, premature skin aging, and skin cancer.
Sanofi has reported that 2500 prescriptions for dupilumab have been written by 1200 physicians in the first month itself since the product was launched. IMS suggests 200 prescriptions were filled in the fourth week following product launch, promising rates which compare favorably with other successful recent drug launches, such as the psoriasis drug Otezla.
In its recent draft report, the Institute for Clinical and Economic Review (ICER) noted that most topical corticosteroids were covered by private carriers with preferred drug status. ICER reported variable coverage of topical calcineurin inhibitors tacrolimus (Protopic) and pimecrolimus (Elidel); for more severe disease, cyclosporine was often covered as a preferred agent with no requirements for step therapy or prior authorization. Targeted phototherapy was covered by all plans when patients didn’t respond to any topical treatments. ICER further reported that since most patients with atopic dermatitis who are candidates for systemic therapy don’t receive it, dupilumab will likely be used in patients who have not been offered other systemic therapies.
Importantly, ICER concluded that at a net price of $30,000 per patient per year for dupilumab, the cost per additional Quality Adjusted Life Year (QALY) was approximately $97,600. For patients with severe atopic dermatitis, the cost per QALY was $75,100 and for those with moderate disease the cost was $125,500.
Analyst Geoffrey Porges of Leerink pointed out that the cost per QALY was below the usually accepted willingness-to-pay threshold of $150,000 per QALY, so that regardless of price, ICER found that dupilumab would be more likely to improve health outcomes compared with usual and existing care, but would do so with additional cost. At a net cost of $16,000 per patient per year, Porges says, he assumes rapid adoption in severe atopic dermatitis and significant adoption in moderate disease.
Initial responses from pharmacy benefit managers are positive. Express Scripts has included dupilumab on its National Preferred Formulary. Spokesperson Jennifer Luddy explained that there are other, less effective treatments that cost more than Dupixent, and there are treatments that cost much less but may not help patients with the most severe form of atopic dermatitis. She praised Regeneron/Sanofi’s work to engage payers early and get their input. “Regeneron and Sanofi did reach out early, and we had a good amount of education on both sides about the product and about the need to ensure appropriate access for patients.” Prime Therapeutics LLC is negotiating with Sanofi/Regeneron to finalize formulary strategy, reviewing clinical data for Dupixent and evaluating safety and efficacy and determining formulary position.
Regeneron/Sanofi will seek an indication for dupilumab for patients younger than age 12, and a phase 3 study for that began this quarter.