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Lixiana joins NOAC market race late but takes the lead
by
Byun Kyung A
Oct 31, 2019 09:59am
(Clockwise from upper left) Images of Lixiana, Pradaxa, Xarelto, and Eliquis A follow-on drug in the non-vitamin K antagonist oral anticoagulant (NOAC) market, Lixiana, continues to lead the market. The treatment took the lead from Xarelto in last January for the first time, and it has been the most prescribed drug in the market for nine consecutive months. Pfizer and Bristol-Myers Squibb’s Eliquis had to face a Korean-made generic as a competitor, but its sales performance was unaffected with its original price maintained. On Oct. 28, UBIST, a pharmaceutical market data research firm, reproted Lixiana (edoxaban) marked an accumulated prescription of KRW 40.1 billion in the third quarter. The figure skyrocketed by 68.5 percent from last year same period. Lixiana recorded prescription sale of 14.9 billion won in the third quarter only and marked its record-breaking quarterly performance. The treatment reached outpatient prescription sale of 4 billion won in last January and beat Xarelto’s (rivaroxaban) prescription sale of 3.8 billion won, for the first time. The top spot in the NOAC prescription market has been solidified for nine months straight. The total sale gap between Lixiana and Xarelto’s prescription marked 6.6 billion won and was widened in the third quarter, due Xarelto’s sale dropping 0.2 percent in the third quarter than the year before. The treatment was ranked on second place in the market with 33.5 billion won accumulated prescription sale. Outpatient prescription sales trend of four NOAC items by month (Unit: KRW1 million) Source: UBIST Both internal and external factors played a part in shuffling the NOAC market rank. Bayer’s German production plant issue prolonged the unstable supply management in Korean market, and also the revised pharmaceutical product labeling regulation required all dosage containers to be reprocessed and slowed down Xarelto’s come back. In the meantime, Daiichi Sankyo and Daewoong’s co-promotion revved up the prescription sales of a follow-on drug, Lixiana. Insider from Daiichi Sankyo evaluated, “The healthcare providers and patients were positive about Lixiana’s better drug compliance with once-daily regimen, and improved safety for patients backed by Phase 3. The long-lasting co-promotion partnership with Daewoong, started from Sevika HCT deal, also created a great synergy effect boosting the sales performance”. Monthly prescription sales trend for Eliquis and apixaban generics (Unit: KRW) Source: UBIST Eliquis cumulated 31.3 billion won prescription sales this year, showing 32.1 percent surge than the year before. As of the third quarter, difference in accumulated prescription sales between Xarelto and Eliquis is only about 2.1 billion won. Eliquis was the first NOAC original to compete against generics, but its sales were not influenced as it maintained its original price. After the Korean Supreme Court in last June invalidated drug patent protecting Eliquis, the drug now has Korean-made generics competitors from Chong Kun Dang, Yoo Young, Yuhan, Huons, and Hanmi. But as Ministry of Health and Welfare has decided to defer Eliquis’ price reduction until the final decision on the treatment’s substance patent case is to be made on coming Dec. 31. Currently, the drug still maintains its initial price of 1,185 won per tablet. On the other hand, Chong Kun Dang’s competing generic with the highest content apixaban is about half the price of Eliquis. Boehringer Ingel Heim’s Pradaxa (dabigatran) marked accumulated prescription sales of 12.4 billion won in the quarter. The company sought for a significant increase in market share with a co-promotion deal with Boryung, but the sales performance did not show much increase than last year with 12.3 billion won.
Product
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.
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