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Cash cow ‘bepotastine’ to face reimb re-evaluation
by Chon, Seung-Hyun Mar 06, 2024 06:02am
In facing re-evaluation of ‘bepotastine’ for reimbursement in the upcoming year, pharmaceutical companies fear its impact. The market size for bepotastine has increased by more than 50% in just two years during the pandemic and endemic, labeling bepotastine as a new cash cow. However, there are concerns that the companies may face financial loss if drugs containing bepotastine as an active ingredient receive negative results from the re-evaluation, such as reduced reimbursement or removal. According to industry on the 6th, the Ministry of Health and Welfare (MOHW) recently held the Health Insurance Policy Review Committee, where they reported on drugs that will be re-evaluated for reimbursement appropriateness in 2025. Next year, the reimbursement appropriateness of eight active ingredients, including olopatadine, clematis radix plus trichosanthes root plus prunella spike, bepotastine, spherical adsorptive carbon, artemisia Herb extract, L-ornithine- L-aspartate, and chenodeoxycholic acid-ursodeoxycholic acid, will be determined through the re-evaluation. The MOHW explained, “We have selected eight active ingredients. Five active ingredients have been listed for an extended time, and three active ingredients are currently under clinical re-evaluation by the Ministry of Food and Drug Safety (MFDS)." The MOHW will perform a comprehensive analysis and evaluation of drugs based on clinical research article results, clinical usefulness, cost-effectiveness compared to substitute drugs, and the overall increase in insurance benefits for society. The compiled data will be reviewed by experts, and the MOHW will decide whether to maintain, reduce, or remove reimbursement. The industry is particularly interested in hearing results from the MOHW’s re-evaluation of the appropriateness of reimbursement for bepotastine because the market has expanded significantly recently. Pharmaceutical companies may face financial loss if the drugs containing bepotastine receive negative results from the re-evaluation, such as reduced reimbursement or removal of indication. Annual outpatient prescription sales for bepotastine (unit: 100 million won, source: UBIST). Bepotastine is a drug used to treat perennial allergic rhinitis, chronic hives, and pruritus accompanied by skin disorders. The prescription market for bepotastine experienced rapid growth during COVID-19 and endemic. According to UBIST, a pharmaceutical market research agency, the out-patient prescription market size for bepotastine was 70.2 billion won last year, an increase of 17.7% from the previous year. The prescription market size for bepotastine stayed mainly the same between 2018 and 2021, generating 45.3 billion won and 45.3 billion, respectively. However, it reached 59.7 billion won in 2022, showing a growth of 31.8%, and even greater last year. The prescription market size for bepotastine expanded to 55.2% in the past two years. Since the end of 2021, there has been a significant surge in demand for nasal discharge treatment, which is one of the remedies to alleviate symptoms of COVID-19. This is due to the increasing number of people testing positive for COVID-19, with hundreds of thousands of new cases daily. Even after the pandemic, there are still many COVID-19-positive patients and growing patients with influenza or the common cold, leading to even greater demand for bepotastine. Dong-A Pharmaceutical’s Twolion dominates the prescription market for bepotastine. Twolion’s prescription sales were 10.7 billion won, up 11.7% from the previous year. In two years, it has increased 33.1% from 8.1 billion won in 2021. Mitsubishi Tanabe Pharma’s Talion is the original medicine with bepotastine as an active ingredient. Initially, Dong-A ST marketed Talion, but Mitsubishi Tanabe Pharma withdrew from the Korean market after its patent expired at the end of July. Since then, Dong-A Pharmaceutical received approval for Twolion, a generic version of Talion, and Dong-A ST is responsible for its marketing. Daewon Pharm’s Bepostarbi recorded 4.9 billion won in prescription sales last year, a 29.1% increase in just two years since making 3.8 billion in 2021. Dong Kook Pharmaceutical’s Bepotan accumulated 3.7 billion won in prescription sales, up 47.0% from two years ago. The prescription sales for Medica Korea’s Galion were merely 1.4 billion in 2021 but recorded 3.3 billion won last year, more than doubling the size. Only two of the eight active ingredients survived the reimbursement re-evaluation conducted last year by the MOHW. The MOHW conducted re-evaluation of reimbursement on eight ingredients, including rebamipide, levosulpiride, loxoprofen sodium, limaprost alfadex, epinastine hydrochloride, oxiracetam, acetyl-L-carnitine hydrochloride, and hyaluronic acid (HA) eye drops. Only two of the ingredients, rebamipide and levosulpiride, maintained their reimbursement prices since the drugs proved clinical usefulness. Loxoprofen sodium, limaprost alfadex, and epinastine hydrochloride are the three active ingredients receiving reimbursement cuts. Loxoprofen sodium’s indication, ‘Reducing fever and pain relief for acute upper respiratory inflammation,’ will be excluded from receiving the reimbursement. For limaprost alfadex, the reimbursement will not cover its indication, one of the two, for ‘Improving ischemic symptoms such as ulcer, pain, and cold sensation that are associated with thromboangitis obliterans.’ Oxiracetam and acetyl-L-carnitine hydrochloride were excluded from the current re-evaluation because the MOHW had already stopped allowing reimbursement for those two ingredients due to inadequate demonstration of their effectiveness based on the MFDS’s clinical re-assessment. The decision for hyaluronic acid (HA) eye drops has been postponed until reimbursement criteria for all disposable eye drops are established.