Incyte’s Opzelura (ruxolitinib) cream to treat atopic dermatitis came to market with a classwide black box warning about potential side effects from JAK inhibitors. But to hear the company tell it, dermatologists are comfortable prescribing the new eczema drug, despite facing initial pushback from health insurers.
Patient access is currently the biggest roadblock facing Opzelura, which was approved by the FDA to treat atopic dermatitis in late September. But Incyte is making progress and expects to have broad coverage for the topical drug in the first quarter next year, Barry Flannelly, Incyte’s general manager of North America, told investors during its third-quarter earnings call Tuesday.
Incyte officially rolled out Opzelura on Oct. 11. The company expects to ship 3,000 tubes of the drug to pharmacies in the first full four weeks of the launch and hopes that will translate into 3,000 prescriptions. That would make it on par with or better than the last two launches in atopic dermatitis, Flannelly noted.
Early payer hurdles aren't unusual, he added. Big pharmacy benefit managers typically block newly launched drugs, especially in dermatology, for six months or more, he said.
“When they start a new year is really when you want to ensure your formulary is fully blown out and your customers know exactly what’s going to be covered and what’s on the formulary,” the exec said.
Opzelura bears a classwide warning the FDA recently slapped on oral JAK inhibitors. It warns of serious infections, death, cancer, heart-related events and blood clots. Still, doctors aren’t balking at the high-profile warning, Flannelly said.
Dermatologists are accustomed to having to explain to patients the difference between a systemic product and a topical product, and they understand that the safety profile differs between oral JAK inhibitors and topical Opzelura, Flannelly added.
Feedback from physicians showed “there really hasn’t been a pushback on the types of patients" who should receive Opzelura, Flannelly said. The drug is currently approved for mild to moderate eczema patients 12 years or older, and that’s the patient group for which dermatologists indicated they would prescribe Opzelura, he added.
With a pair of phase 3 wins, Incyte is now targeting vitiligo as a new indication for Opzelura. While an eczema patient would be expected to use three tubes of Opzelura a year on average, a vitiligo patient would need 10 to 11 tubes of the drug annually, the company expects.
“We know from the 52-week and 104-week long-term follow-up on our phase 2 studies that one of the phenomenons with treating vitiligo is continued improvement over time,” Steven Stein, M.D., Incyte’s chief medical officer, said during the call. Most of the patients elected to join a long-term safety extension trial "because of continued improvement,” he added.
Incyte's other JAK inhibitor, Jakafi, reeled in $547 million in revenue in the third quarter. That was up 12% year over year but slightly below analysts' expectations.