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Maviret takes up 83% of HCV treatment market share
by
Byun Kyung A
Oct 31, 2019 09:41am
Maviret product image Abbvie broke through the hepatitis C virus (HCV) treatment market and dominated 83 percent of oral outpatient prescription market only with its pan-genotype HCV treatment, Maviret, launched last year. Gilead once dominated the market with two items, but their prescription ratio shriveled down to 12 percent. On Oct. 30, a pharmaceutical market research agency, UBIST reported this year’s third quarter outpatient prescription sales of eight direct-acting antiviral (DAA) regimen HCV treatments recorded 13.2 billion won, soaring 41.4 percent from last year’s third quarter at 9.3 billion won. Abbvie’s Maviret prescription skyrocketed from the launch in last year September, and brought back up then descending total volume of HCV outpatient prescription market. The market had plummeted to 9.3 billion won in September last year, but turned around with Maviret’s launch. Outpatient prescription sales trend of major hepatitis C virus treatments (Unit: KRW 1 million) Source: UBIST This year’s third quarter outpatient prescription sales of Maviret reached 10.9 billion won. The sales easily doubled since last year’s fourth quarter with 4.2 billion won. As its accumulated prescription sales this year marked 31.1 billion won, Maviret is projected to make over 40 billion won by the end of the year. Taking up 82.9 percent of the eight DAA regimen treatments’ outpatient prescription sales, Maviret affirmed its unmatched position in the market. Maviret is the first treatment approved in Korea for chronic HCV infection in adults across all major genotypes. It is a pan-genotype ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets. Industry insiders view Maviret rapidly took over the market as it shortened drug treatment period by a month, compared to other DAA regimen. The treatment also mainly targets for patients without cirrhosis and who are new to treatment, the condition most of hepatitis C patients have. Recently, Maviret was able to improve consumption convenience as FDA approved of the drug shortening treatment period of chronic hepatitis C patients with cirrhosis and who are new to treatment, from 12 weeks to eight weeks. Sources also report Ministry of Food and Drug Safety’s approval on the expanded indication is imminent as related application has been submitted. However, due to the fact number of HCV patients is limited and the virus has fairly high full recovery rate, it is unclear if Maviret’s golden days would last long. In fact, Maviret’s prescription sales growth has turned from the third quarter. The total prescription soared every quarter since its launch and peaked in the second quarter, but it’s the figure dropped 9.1 percent in just about three months. Meanwhile, a former HCV treatment market leader, Gilead Sciences seems to have lost a big cut from its own market share. Sovaldi marked 18.1 billion won in last year’s first quarter, but its third quarter prescription sales in this year plunged to 4.68 billion won. Two top selling products of Gilead, Sovaldi and Harvoni, made total prescription of 1.5 billion won. The two drugs combined accumulated prescription sales of 5 billion won, merely taking up 11.7 percent of the whole hepatitis C treatment market. BMS’ Daklinza and Sunvepra combined marked outpatient prescription sales of 4.5 billion won in the third quarter, which is about one-tenth of what they had made last year same quarter. Launched around same season in the second quarter of 2017, MSD’s Zepatier and Abbvie’s Viekira and Exviera watched their sales continue dropping after the launch of Maviret and had short period of sales peak. In the third quarter, Zepatier marked prescription sales of 700 million won, whereas prescription sales for Viekira and Exviera were not even counted from last July. Abbvie insider commented, “Demand for Viekira and Exviera has decreased after Maviret was launched. There isn’t any issue with supply from the company”.
Product
Government likely to list Zejula in December
by
Byun Kyung A
Oct 31, 2019 09:36am
Sources predict Zejula, an ovarian cancer treatment, would get listed for healthcare reimbursement in coming December. According to an industry insider on Oct. 16, Takeda Pharmaceuticals Korea is waiting for Health Insurance Policy Deliberation Committee’s (HIPDC) deliberation, after recently reaching an agreement with National Health Insurance Service (NHIS) on drug pricing of Zejula (niraparib), a poly (ADP-ribose) polymerase (PARP) inhibitor. The niraparib treatment has been passed by Drug Reimbursement Evaluation Committee of Health Insurance Review and Assessment Service (HIRA) only after four months it was approved in last July. Zejula can be prescribed as a maintenance treatment for adult patients with recurrent epithelial ovarian cancer, including fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. However, the National Health Insurance (NHI) reimbursement would be first available for BRCA mutation patients only. Zejula was approved based on results of Phase 3 trials (ENGOT-OV16/NOVA). Progression-free survival (PFS) of patients taking Zejula, with or without BRCA mutation, showed a meaningful extension than the the control group. Moreover, the treatment proved its efficacy through PRIMA trial testing as a first-line treatment for ovarian cancer, regardless of BRCA mutation. In Korea, AstraZeneca’s Lynparza was listed for NHI reimbursement as a first PARP inhibitor. Lynparza was exempted from pharmacoeconomic analysis and was listed as reimbursed drug with expenditure cap risk sharing agreement (RSA) in October, 2017. However, the reimbursement benefit was suspended for some patients from last January as it was initially listed as post-chemotherapy maintenance therapy up to 15 months. From then on, AstraZeneca underwent reimbursement expansion talks with Korean government and lifted limitation on the fixed period of 15-month since last May.
Product
MOHW to unveil list of 4K items subject to price cuts in JAN
by
Kim JiEun
The South Korean government plans to pre-release a list of approximately 4,000 pharmaceutical products subject to price reductions effective January 1, 2026. The price reduction is due to the adjustment of the ceiling price of the actual transaction price.On December 17, an official from the Ministry of Health and Welfare (MOHW) confirmed to DailyPharm that the list of related items and their respective reduction rates will be provided to relevant associations within this week.Earlier this month, the MOHW issued an official notice, announcing 'a temporary allowance for paperwork-only returns when reporting of supply records following the price cuts', to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KBPMA), the Korea Pharmaceutical Distribution Association, and the Korean Pharmaceutical Association.The notice also informed that the ceiling prices of insurance price tags of approximately 4,000 pharmaceutical products are subject to price reductions effective January 1, 2026.However, concerns have been raised across the industry after the announcement. With less than 15 days remaining until the massive price cut of 4,000 pharmaceutical products takes effect, pharmacies and distributors lacked the specific data, such as exact items, quantities, and reduction percentages, needed to prepare.In response, the MOHW decided to provide the pre-list, including items subject to price cuts due to the actual transaction price ceiling price increase and the reduction rate, to minimize field confusion. Although the price reduction is scheduled to be officially announced on December 24, the MOHW plans to provide the list five days ahead, on December 20.An MOHW official said, "We are aware of the related issue in the distribution industry and pharmacies," and added, "For actual transaction price reduction, the MOHW plans to take administrative response in a way that minimize the field confusion."The official further added, "The affected documents are according to the official notice, but the MOHW will pre-lease the list of affected products to institutions," and added, "It will be announced by this Friday."In 2023, when over 7,600 items were subject to price reductions, the MOHW similarly pre-released the list after the field confusion.At that time, affected organizations, including the Korea KBPMA, the Korea Pharmaceutical Distribution Association, the Korean Pharmaceutical Association, and HIRA, received the pre-lease list files. Pharmacies could verify affected stocks through billing software integration and prepare for the financial impact well in advance.Meanwhile, affected organizations have argued that this pre-release of data to affected parties should be formalized, given the recurring large-scale price reductions.Regarding this issue, the MOHW announced that it is preparing to reform the current actual transaction price-based price reduction system. The ministry acknowledged that the current system imposes an excessive administrative burden on the field relative to its actual impact on health insurance financial savings, primarily because of the vast number of affected items.An MOHW official explained, "In the case of an actual transaction price survey, the number of products subject to investigation is immense, yet the predictability regarding which specific drugs will actually face a price cut is low, which appears to be confusing the field," and added, "For the actual transaction price investigation, we are looking to redesign the entire system of drug pricing and post-management instead of the current method of simple price reductions. We expect this will enhance predictability for the field."
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