The government said it included Kolon Pharma’s psoriasis oral treatment Skilarence (ingredient: dimethyl fumarate) in the list of patented drugs.
Industry officials are paying attention to Skilarence’s prescription sales, as the drug won health insurance benefits early this year.
The Ministry of Food and Drug Safety said it registered Kolon’s Skilarence Enteric Coated Tab. 120mg and Skilarence Enteric Coated Tab. 30mg in the list of patented medicines on Monday.
The patent title is “Pharmaceutical Compositions Comprising Dimethyl Fumarate (patent number: 10-2335289-0000).”
Kolon introduced Skilarence, an oral treatment for psoriasis, from Spanish drugmaker Almirall S.A. in 2018. The treatment won marketing approval in May 2020 with the indication for systemic treatment of adult patients with moderate-to-severe plaque psoriasis. It is recommended as the second drug in the long-term treatment or when systemic therapy fails.
Almirall, the original developer, registered the patent of Skilarence in Korea late last year through the Patent Cooperation Treaty (PCT). The patent expires on Dec. 5, 2034. Kolon Pharm submitted the patent registration, and Almirall is the patent holder.
In January, the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee granted reimbursement for Skilarence, and the benefits took effect in February. The price of Skilarence is 448 won ($0.37) per 30mg, and 1,120 won per 120mg.
Alternative drugs for Skilarence selected by the health and welfare ministry are Chong Kun Dang’s Cipol-N Soft Cap. (cyclosporine), Yuhan Corp.’s Methotrexate Tab. Yuhan (methotrexate), Korea United Pharm’s Methotrexate Tab. KoreaUnited (methotrexate), and Chong Kun Dang’s Neotigason Cap. (acitretin spray-dried 25 percent). Among them, cyclosporine and methotrexate are immunosuppressive agents.
When Kolon signed the deal with Almirall for the exclusive sale of Skilarence in Korea, Kolon emphasized that Skilarence had less risk of kidney and liver toxic side effects than conventional immunosuppressive drugs for psoriasis.
According to the Health Insurance Policy Deliberation Committee, the Korean Dermatological Association suggested that Skilarence’s effect was similar to existing systemic therapies. The Health Insurance Review and Assessment Service (HIRA)’s Drug Benefit Review Committee also said Skilarence proved non-inferiority to alternative agents.
Kolon and the National Health Insurance Service (NHIS) agreed that Skilarence health insurance claims are expected to be 2.8 billion won considering the market size and the clinical usefulness.
Industry officials pay attention to how Skilarence reimbursement will affect the psoriasis treatment market.