HLB's liver cancer treatment drug, Lenvatinib, and Yuhan Corporation's lung cancer treatment drug, Lekraza, are expected to receive approval from the U.S. Food and Drug Administration (FDA) this year. Along with this, the entry of domestic new drugs, including Celltrion's soon-to-be-launched autoimmune disease treatment drug, Jimpenetra, into the U.S. market is becoming more tangible, raising expectations for insurance listing as well.
According to industry sources on the 8th, Jimpenetra will be officially launched in the U.S. market in mid-month. HLB's Lenvatinib is expected to have FDA approval decided by May, and Yuhan Corporation's Lekraza by August, making it possible for them to be launched within the year at the earliest.
A key challenge for entering the U.S. pharmaceutical market is whether the drug is listed in the formulary managed by Pharmacy Benefit Managers (PBMs). This is because the U.S. pharmaceutical market structure is very different from Korea's, and rebates, which are illegal in Korea, are allowed in the U.S. PBMs negotiate drug prices and rebate levels with pharmaceutical companies on behalf of private insurers and manage the 'formulary,' a list of drugs that can be prescribed at pharmacies. Many public insurance programs also outsource related tasks to PBMs.
In particular, the U.S. PBM market is dominated by three major PBMs?CVS Caremark, Express Scripts, and OptumRx?which control about 80% of the market, while other small and medium PBMs hold single-digit market shares. In other words, if a drug is not listed in a PBM's formulary, it is virtually impossible to sell it in the U.S., and it is difficult to gain a high market share without being listed in the formularies of the three major PBMs.
Among these, OptumRx and the small PBM SubU Rx recently released lists of drugs expected to be marketed soon, which include many domestic new drugs, raising expectations. OptumRx mentioned drugs with FDA approval deadlines this year, including Lenvatinib, which has an FDA approval decision deadline of May 16, and Lekraza, with a deadline of August 22. Also included were Camrelizumab from China's Hansoh Pharmaceutical, a combination drug with Lenvatinib, and Botulax, a botulinum toxin from Hugel that received approval last month. Meanwhile, SubU Rx included Lenvatinib, Lekraza, and the upcoming launch of Jimpenetra in its schedule.
An HLB official said, "It is positive news that major PBMs have directly organized and disclosed the drugs expected to be approved and launched within this year," adding, "Since Lenvatinib is classified as a specialty drug, which refers to high-cost prescription drugs, we expect more significant negotiations with PBMs in the future."
However, an industry insider noted, "This data still appears to be a 'market analysis report' compiled by PBMs listing major drugs expected to be approved and launched," and added, "Listing in PBM formularies is practically unlikely before product approval, and discussions only begin in earnest after approval and drug pricing are decided, so it is not yet the stage to talk about listing possibilities."
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