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- 2025-12-27 05:14:55
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- KRPIA-MOHW meeting rescheduled on May 28
- by Eo, Yun-Ho May 27, 2020 06:05am
- Korean Research-based Pharmaceutical Industry Association (KRPIA) and Ministry of Health and Welfare (MOHW) have rescheduled their meeting canceled last week due to a confirmed case of COVID-19. According to a pharmaceutical industry source, a meeting between MOHW Pharmaceutical Benefits Division and KRPIA Market Access (MA) and Government Affair (GA) representatives is to be convened on coming Thursday. The new Director of Pharmaceutical Benefits Division, Yang Yoon Seok, would officially meet with KRPIA representatives for the first time. Also, Senior Deputy Director Lee Seon-joo and Deputy Director Choi Kyung-ho would accompany Director Yang at the meeting to listen to the industry’s opinion and discuss prospective approach on the drug pricing policy. KRPIA representatives are expected to address their perspective on the government’s plan to revise the drug pricing system. The industry source reported the regulation on the National Health Insurance (NHI) healthcare reimbursement would be the focus of the talk. The industry organization would likely to raise voice regarding the government setting down detailed principles and prioritizing the order of pharmaceutical reimbursement listing to take account of the NHI finance status. In particular, the organization would question the government officials about the ‘detailed principles,’ specific standard of prioritization, and exempting the negotiation period from the currently aimed duration of 150 days. Moreover, the industry organization would ask the government officials to provide information on specified negotiation and its procedure for projected claim amount of drugs, and prospective listing procedure and required listing period for negotiation-exempted drug with pricing lower than weighted average price. On May 21, KRPIA started working from home as a confirmed case of COVID-19 was reported from the Twin City Namsan building, where its office is located. The organization resumed their regular work from May 25.
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- Prevenar13 by Pfizer sales increased 50%
- by An, Kyung-Jin May 26, 2020 06:05am
- Prevenar13 Pfizer's pneumococcal vaccine 'Prevenar 13' had a high sales. It is evaluated that reflex profits appeared as anticipation for the effect of preventing pneumonia increased due to prolongation of COVID-19 outbreak. According to the drug research agency IQVIA on the 21st, 'Prevenar 13' sales in the first quarter increased 52.2% to ₩17.6 billion, compared to ₩11.6 billiona year earlier. After the fourth quarter of last year, the quarterly sales exceeded ₩17 billion for the second consecutive quarter. Privenar 13 peaked in sales in the fourth quarter, when demand for vaccination increased, and repeated the pattern of decreasing in the first quarter. However, in the first quarter of this year, sales increased rather than the fourth quarter of last year. This is the first time that Privenar 13's sales in the first quarter increased from the fourth quarter of the previous year. In contrast, sales of pneumococcal vaccine Synflorix pfs, which is prescribed to children, fell 37.6% YoY, and sales of pneumococcal vaccine Prodiax 23 for adults increased 4.3% YoY. Trend of quarterly sales of major pneumococcal vaccines (Unit: ₩1 million, Source: IQVIA) 'Prevenar 13' is a 13-valent protein conjugate vaccine (PCV13) that prevents infection against 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Pfizer was granted 'Prevenar' (PCV7) in 2010 to prevent pneumococcal disease caused by 7 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F) in 2010. Six years of serotypes (1, 3, 5, 6A, 7F, and 19A) have been added to 'Prevenar 13'. It is a product that can be inoculated at any age over 6 weeks of age. Chong Kun Dang is in charge of distribution nationwide for adults, and for infants and toddlers, Korea vaccine is in distribution. It seems that the situation in COVID-19 had some influence on 'Prevenar' setting a new record in the first quarter. Although prevenar does not prevent COVID-19 caused pneumonia, Some experts argue that it can help weaken the symptoms of pneumonia. It is an analysis that the demand for inoculation in adults has increased. At the time of the first quarter of April, Pfizer's head office announced, "As the COVID-19 pandemic has reduced the number of patients visiting hospitals, most vaccination rates have decreased. On the other hand, sales of some medicines used for the purpose of preventing infection or treating symptoms of COVID-19 have increased, including 'Prevenar 13', sterilized injection products, and anti-infective agents. Currently, no vaccine is available to prevent COVID-19. As a result, overseas academia is actively recommending that high-risk groups vulnerable to COVID-19 follow the national immunization guidelines such as pneumococcal vaccine. The American Heart Association (ACC) recommended that patients with cardiovascular disease be considered for the simultaneous inoculation of pneumococcal vaccines and influenza vaccines to prevent secondary bacterial infections. The World Health Organization (WHO) has issued guidelines to provide flu vaccines and pneumococcal conjugate vaccines to workers in long-term care institutions such as rehabilitation centers. The reason for long-term care is that the elderly and high-risk patients are relatively vulnerable to infection.
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- Improving access to Lenvima and its later-line treatment
- by Eo, Yun-Ho May 25, 2020 06:27am
- #1 The Korean pharmaceutical industry is keeping a close eye on the Cancer Deliberation Committee’s June meeting to discuss the coverage on later-line treatment following Lenvima treating liver cancer. The pharmaceutical industry sources reported the Cancer Deliberation Committee could talk about extending the access of patient with hepatocelluar carcinoma on Eisai’s Lenvima (lenvatinib) to second-line treatment. The medical experts have been in a heated dispute over the access of second-line treatment against liver cancer. When a patient is to choose Lenvima over Bayer’s Nexavar (sorafenib) for the NHI-covered first-line treatment, there is no later-line treatment with the NHI coverage. Before the launch of Lenvima, Nexavar was the only option for treating patients with liver cancer. Over a decade, Nexavar has been the only hope as many pharmaceutical companies have failed developing another treatment option. And then along came Lenvima that conducted head-to-head clinical study against Nexavar and demonstrated improved overall response rate (ORR) and progression-free survival (PFS). But its overall survival (OS) was not a significant improvement against sorafenib. Regardless of the OS result, Lenvima’s clinical evidences were meaningful. A novel treatment option for liver cancer is rare. For many years, sunitinib, brivanib, linifanib and erlotinib have challenged against sorafenib’s position to treat patients with liver cancer who cannot easily expect five-year survival. And eventually, they all have failed. , But Lenvima still lacks a second-line treatment option. On the contrary, Bayer has released liver cancer treatment Stivarga (regorafenib) and even received NHI reimbursement in Korea. Stivarga’s indication and reimbursement standard focus on ‘patients who have failed treatment through Nexavar.’ Basically, Lenvima threatened Nexavar’s position with superior ORR and PFS outcomes, but Nexavar has provided a later-line option in case it fails. Accordingly, the recently updated 2018 Korean Liver Cancer Association-National Cancer Center Korea Practice Guidelines for the Management of Hepatocelluar Carcinoa lowered the recommendation class of Lenvima than Nexavar. It caused a fierce conflict within the academic society, but the conclusion has been made. Although the U.S. and European medical experts recommend two drugs at a same class, the Korean healthcare professions have decided otherwise. Surely, there were many Korean specialists who argued the two treatments should be at a same level, and other academic society with reliable prescription experience has submitted a formal statement. Professor Lim Ho Yeong of Hematology and Oncology Department at Samsung Medical Center commented, “As the liver cancer does not have so optimistic prognosis, access on covered later-line treatments are integral and urgent. A treatment option with promising effect having a limitation, only because it lacks later-line treatment option, is regrettable.” Moreover, the professor added, “A retrospective analysis has recently confirmed Lenvima effectively prolonging OR in patients who have continued with later-line treatment after frontline Lenvima treatment. As a result, academic societies are also raising their voice again to enhance patients’ access to the treatment.”
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- Erectile dysfunction treatment market suffered from COVID-19
- by An, Kyung-Jin May 25, 2020 06:26am
- (Clockwise from top left) Product of Palpal, Viagra, Gugu, and Cendom The well-established domestic erectile dysfunction treatment market was stagnant. As the sales of large products sold by Hanmi Pharm, Chong Kun Dang, and Pfizer decreased, the overall market size was lowered. According to the analysis, the market for erectile dysfunction treatment, which has a relatively low disease severity, has been suffered from the spread of COVID-19. According to the drug research agency IQVIA on the 25th, the size of the domestic erectile dysfunction drug market in the first quarter was ₩26.9 billion, a 4.8% decrease from the previous year's ₩28.2 billion. It was 9.5% lower than ₩29.7 billion in the previous quarter, showing the lowest level in a year and a half. COVID-19 outbreak seems to have had some impact on the contraction of the erectile dysfunction market, which has maintained quarterly sales of around ₩29 billion since the fourth quarter of 2018. It is said that the prolonged COVID-19 situation led to a decrease in patients' visits to the hospital and restrictions on sales and marketing activities, which prompted the market to stagnate. Quarterly sales of major erectile dysfunction treatments (Unit: ₩1 million, Source: IQVIA) Looking at the sales of major erectile dysfunction treatments, sales of large items such as Hanmi Pharm's 'Palpal', Chong Kundang's 'Cendom', and Pfizer's 'Viagra' decreased significantly. In the first quarter of the year, sales amount of Palpal was ₩5 billion, down 7.8% from the same period of the previous year. Sales fell by ₩1 billion (15.5%) from the previous quarter. 'Palpal' is a generic for Sildenafil released by Hanmi Pharm immediately after the expiration of Viagra in 2012. After defeating Viagra in 2013 and Cialis in 2015, it is selling well. The market share of all erectile dysfunction drugs in the first quarter was 18.6%. The decline in sales was bigger for 'Cendom'. 'Cendom' maintained the second place in sales in the first quarter of last year, selling ₩2.4 billion, down 11.2% year-on-year. Cendom (Tadalafil) is a generic for of Cialis that was released after the patent expired in September 2015. Since its launch, the market share has gradually increased, surpassing the original Cialis in the fourth quarter of 2017. In the 4th quarter of last year, it is surpassing the sales of 'Viagra' and is following the leading 'Palpal'. Despite the overall market shrinking, domestically developed generic products were relatively stronger than those of multinational pharmaceutical companies. 'Viagra' by Pfizer had a 15.8% year-on-year decrease in sales in the first quarter, with ₩2.1 billion, which widened the gap with the second place 'Cendom'. The sales of Cialis' of Lilly in the first quarter was ₩1.5 billion, down 10.6% from the same period last year. This is about a quarter of sales in the first quarter of 2015. Since February 2018, after dealing with Cialis' domestic distribution, marketing, and sales activities in February 2018, Handok’s sales has not been rebounded. This is in contrast to the sales of another generic product, Hanmi’s Gugu and Donga ST's 'Zydena' (Udenafil), which increased slightly compared to the same period last year. In the first quarter, 'Gugu' took the fourth place, selling ₩1.8 billion, a 6.8% increase over the same period last year. In the same period, 'Zydena' sales rose 3.1% YoY to ₩1.6 billion, surpassing 'Cialis' and took the 5th place. The industry says that the erectile dysfunction treatment market is less vulnerable to external factors such as infectious disease epidemics because it has a lower severity and less essential nature than chronic diseases such as hypertension and diabetes. According to a recent analysis by Korea IQVIA, cardiovascular products such as angiotensin receptor blockers (ARB) hypertension drugs and lipid lowering agents have maintained unchanged growth before and before the COVID-19 epidemic, whereas systemic anti-infective agents, musculoskeletal systems, and urinary system drugs are all pharmaceuticals. It was found that it did not reach the market growth rate. An official from IQVIA in Korea said, “In the first quarter, the entire pharmaceutical market recorded sales and growth that were more than expected, but the urinary genital market had a slower growth rate than usual. "The main reason is that quarterly sales growth was not as good as before, and sales of hormone-related products decreased in the outpatient market."
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- Pfizer stopped Duavive due to quality problems
- by Kim, Jin-Gu May 25, 2020 06:26am
- DuavivePfizer Pharmaceuticals voluntarily recovers its own menopausal treatment drug Duavive. This is based on the identification of potential quality problems in the results of self-investigation. On the 21st, Pfizer Pharmaceuticals requested each drug distributor to discontinue certain lot numbers of Duavive 0.45mg / 20mg folowing as ▲DC5278 ▲CW7990 ▲CG3243 ▲AG5438 ▲AG6437 ▲X34636 ▲W78860 ▲W78858 ▲T42330 ▲T34122 etc. Duavive is a medicine used to prevent osteoporosis and treat menopause symptoms. According to the drug research institute IQVIA, the sales amount last year was about ₩ 6.9 billion. Pfizer confirmed the potential impact on product quality and said the reason for asking to stop shipping. Next, the company said, “The product with the corresponding manufacturing lot number will be voluntarily recovered as soon as possible and the shipment would be stopped to minimize the distribution of the manufacturing number before proceeding with the recovery”. In this regard, an official from Pfizer Korea said, “It is not related to the safety and effectiveness of the drug, and I think there were some problems in manufacturing the product with the corresponding manufacturing number in a factory located in Ireland.”
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- Alvogen Korea secures domestic rights for Seroquel
- by An, Kyung-Jin May 25, 2020 06:26am
- Alvogen Korea took over the domestic rights of the drug 'Seroquel' (Quetiapine), a treatment for schizophrenia. Alvogen Korea announced on the 21st that it has signed an exclusive distribution and marketing contract for 'Seroquel' and 'Seroquel XR' with Luye Pharma in China, and approval of the domestic license has been completed. Seroquel and Seroquel XR are atypical antipsychotic drugs with antidepressant properties. It is used alone or in combination therapy to treat schizophrenia and bipolar disorder. During the drug investigation period, the total sales of Seroquel last year were ₩12.9 billion, based on the IQVIA. Alvogen Korea has been supplying Seroquel and Seroquel XR to the domestic market since 2015 through exclusive domestic sales contracts with Astrazeneca Korea. Astrazeneca sold two products to Luye Pharma in 2018, and this agreement will allow Alvogen Korea to secure all rights to the license, exclusive distribution and marketing in Korea. Alvogen Korea plans to strengthen its position in the central nervous system (CNS) treatment market. Lee Jun-su, CEO of Alvogen Korea, expects stable and continuous growth in the market while securing expertise in the area of central nervous system treatment with this agreement. He said the company will try to contribute to improving the treatment of patients suffering from the spread of COVID-19.
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- Qsymia puts a brake on Saxenda in Q1 obesity drug market
- by An, Kyung-Jin May 22, 2020 06:17am
- Product images of Saxenda (left) and Qsymia The Korean obesity treatment market has fluctuated significantly in the year. The so-called ‘Gangnam Diet Injection,’ Saxenda lost its solid market leadership and now shares the top spot with Qsymia. Saxenda’s sales has halved as soon as Qsymia entered the market and took over a significant part of it. On May 20, pharmaceutical market research firm IQVIA reported the Korean obesity treatment market in the first quarter showed noticeable changes among the top sellers. In the first quarter of 2020, Novo Nordisk’s Saxenda has generated 5.9 billion won, decreased by 44.4 percent against the same time last year. Launched in March 2018, Saxenda has made over 10 billion won in the first quarter last year and has been easily leading the market until the fourth quarter last year. But now its top spot is challenged by a new comer taking away half of its sales in a quarter. Quarterly sales performance of top selling anti-obesity treatments in Korea (Unit: KRW 1 million) Source: IQVIA Saxenda (liraglutide 3.0 mg) is the world’s first glucagon-like peptide-1 (GLP-1) receptor agonist approved as an obesity treatment. GLP-1 hormone, naturally secreted in human body after food intake, binds to receptors in the hypothalamus and reduces hunger while increasing the feeling of satiety. Saxenda shares the same substances as a treatment prescribed to patients with type 2 diabetes, Victoza (liraglutide 1.8 mg), but they differ in dose and administration method. Working in the same mechanism as GLP-1 in human body, liraglutide lessens appetite and induces weight-loss effect. Saxenda’s promising market leadership was crippled when Qsymia stepped into the Korean market in last January. In only three months, Qsymia generated 4.3 billion won in the quarter and ranked itself on the second place. The narrow sales gap between the two is 1.6 billion won. The newly launched drug sold more than double the amount of Daewoong Pharmaceutical’s Dietamin, which used to come in second after Saxenda until the fourth quarter last year. In 2017, Alvogen Korea shook hands with the U.S.-based Vivus and won the sales and marketing right over Qsymia (phentermine hydrochloride plus topiramate) in Korea. At the end of last year, Alvogen Korea also signed a co-marketing deal with Chong Kun Dang and started their first sales and marketing activity from early this year. Alvogen Korea’s rich experience in the anti-obesity medication market gained through Furing and Furimin seems to have been boosted by Chong Kun Dang’s massive sales power. Besides Qsymia, other obesity drugs generally showed stagnating performance. Except for Alvogen Korea’s Furimin, products with average quarterly sales of 1 billion won have slipped in the first quarter compared to the previous quarter. Furimin’s sales have increased by 15.7 percent in the first quarter against the same time last year by making 1.0 billion won. On the contrary, Daewoong Pharmaceutical’s Dietamin generated 2.2 billion won in the first quarter, taking 4.6 percent dip compared to the same time last year. Huons’ Hutermin (1.4 billion won) and Alvogen Korea’s Furing (1.2 billion won) have also made 0.2 percent and 3.8 percent less than the year before. The anti-obesity medication market was expecting a fierce competition as Belviq that used to make 10 billion won a year was removed from the shelf due to cancer risk. Regardless, the COVID-19 outbreak and Qsymia have put a hard brake on other products in the market.
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- MOHW-KRPIA meeting canceled as confirmed COVID-19 reported
- by Eo, Yun-Ho May 22, 2020 06:16am
- A confirmed case of COVID-19 was reported from Twin City Namsan building that houses the office of Korean Research-based Pharmaceutical Industry Association (KRPIA). Accordingly, the meeting originally scheduled on May 21 to convene Ministry of Health and Welfare (MOHW) Division of Pharmaceutical Benefits officials and KRPIA and multinational pharmaceutical companies’ market access and government affair executives have been canceled. KRPIA sent back their employees home and started working from home immediately after they received the news. The recently appointed Director Yang Yoon Seok of Pharmaceutical Benefits Division was supposed to meet with KRPIA officially for the first time. Deputy Director Choi Kyung Ho was to accompany Director Yoon to hear the industry officials’ opinion and discuss prospective approach of the drug pricing policy. The industry organization official commented, “It is regrettable the meeting with MOHW official had to be canceled due to an unfortunate circumstance. KRPIA was planning to talk about recommendations on the revised risk sharing agreement (RSA) and the pricing reduction on original product undergone corporate restructuring. We have agreed to reschedule the meeting soon.” The confirmed case has reportedly came into office until May 19, but went into a self-isolation after finding out on May 20 that the individual came in contact with other confirmed case. Around 8 a.m. on the same day, the self-quarantined individual was confirmed to have contracted the disease.
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- Promising shingles vaccine market halved by COVID-19
- by Chon, Seung-Hyun May 21, 2020 06:01am
- Product images of Sky Zoster (left) and Zostavax The Korean shingles prevention vaccine market has halved this year. SK Bioscience' Sky Zoster has been maintaining high growth since its launch in 2018, but the market itself plummeted recently due to the COVID-19 outbreak. According to pharmaceutical market research firm IQVIA, this year’s first quarter shingles vaccine market marked 12.2 billion won taking a 37.8-percent fall from last year’s first quarter generating 19.7 billion won. Compared to last year’s fourth quarter making 27.9 billion won, the overall shingles vaccine market shrunk by 56.1 percent. Currently, Zostavax by MSD and Sky Zoster by SK Bioscience are the only two shingles preventive vaccines in Korea. Zostavax was dominating the market initially, until Sky Zoster came about in the market in late 2017. The first quarter shingles vaccine market has hit a historic low since Sky Zoster was launched. Quarterly review on shingles vaccine market (Unit: KRW 1 million) Source: IQVIA Apparently, the spread of COVID-19 has significantly impacted the preventive vaccine market. First, the vaccine recipients refrained from visiting healthcare institutes and lowered the number of vaccination. And the fact that it was not an urgent treatment, but a preventive vaccine could have influenced the users avoiding the vaccination. After Sky Zoster was introduced, the shingles vaccine market continued to grow. The market volume skyrocketed by 16.3 percent in merely two years from 24 billion won in the fourth quarter of 2017 to 27.9 billion won in the fourth quarter of 2019. As Sky Zoster is priced about 10 percent lower than Zostavax, the market had even bigger surge in use. But the volume plunged when COVID-19 started disturbing the market. Quarterly review on Zostavax and Sky Zoster sales (Unit: KRW 1 million) Source: IQVIA The research firm reported both Zostavax and Sky Zoster took a steep fall in sales volume. Zostavax made 7.3 billion won in the first quarter, which was 39.3 percent less than last year first quarter and 56.9 percent less than the last fourth quarter. Sky Zoster made 4.9 billion won, generating 35.5 percent less than last year. From the last fourth quarter, the Korean-made vaccine took a sharp 55.0 percent dip. Taking the steep fall together, Zostavax and Sky Zoster respectively maintained about the same market share as previous quarter. Sky Zoster’s first quarter market share marked 40.3 percent, when the previous quarter marked 39.3 percent.
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- Anti-smoking treatment at public health centers was stopped
- by 박상준 May 20, 2020 06:12am
- From this year, the provision of smoking cessation treatments, such as Champix, through smoking cessation clinics in public health centers will disappear. The MOHW recently removed the provision of anti-smoking treatment Bupropion and Varenicline services from smoking cessation clinics in public health centers by revising the guidelines for the '2020 Community Integrated Health Promotion Project' (Non-Smoking). This is to prevent confusion and prescription of smoking cessation drugs through hospitals and clinics. #The MOHW established a new nicotine supplement policy through smoking cessation clinics in the public health center. However, if the target patient was prescribed a non-smoking treatment drug at a health center or clinics, the prescription of nicotine supplements was restricted. It is a policy to establish a system linkage to check whether smoking treatment has been prescribed before supplements are prescribed. .An official from the Health Promotion Section ( Section chief Young-Ki Jeong) said, "The guidelines have been revised because there has been confusion about the provision of smoking cessation drugs at smoking cessation clinics and health centers registered in the hospital's smoking cessation treatment business can prescribe smoking cessation treatments by doctors." However, the number of non-smoking patients who visited medical institutions due to the COVID-19 crisis has plummeted .As a result of the Medical Times coverage, the number of patients who quit smoking in hospitals in February and March this year has dropped by nearly 40% .Of the 14,000 hospitals registered for the NHIS' smoking cessation treatment business, 18, 811 patients registered in February, and 15,683 in March .#This is a decrease of 26.2% and 39.7%, respectively, compared to 25,496 in February and 25,972 in March from the previous year (2019) The prescription of anti-smoking drugs for Bupropion and Varenicline prescribed by the hospital should be reduced .According to data released by National Assembly Auditor Seung-hee Kim of the United Future Party in September of last year, the prescription amount of 'Champix' (Varenicline, Pfizer), the absolute strongest in anti-smoking treatment, In 2016, decreased from ₩39.1 billion to ₩50.7 billion in 2017, ₩37.2 billion in 2018, and ₩9.9 billion in January-June 2019 .Combined prescription amount of 'Wellbutrin SR 150mg' (GSK, Bupropion) and 'Nicopion SR 150mg' (Hanmi, Bupropion), another cessation treatment drugs are ₩1.2 billion in 2016, ₩680 million in 2017 , ₩810 million in 2018, and ₩3.3 billion in January-June 2019 .Patches, gums, etc .were only ₩350 million in 2016, ₩280 million in 2017, ₩240 million in 2018, and ₩100 million in January-June 2019 .An official from the Insurance Benefits Division (Section chief Jung-gyu Lee) said that patients who quit smoking in hospitals have decreased due to the unexpected COVID-19 situation, and it is expected that the amount of prescription for smoking cessation treatment will also be reduced .also he added that the exact numbers will need to be calculated .The MOHW is currently in the process of researching the smoking cessation treatment business as the NHIS as research director .An official in charge of the Insurance Benefits Division added, "The research service project is struggling due to the decrease in the number of non-smoking patients .We will decide the policy direction based on the research results such as improving the success rate of smoking cessation and improving patient incentives." It is pointed out that in the medical community, in order to improve the effectiveness of the smoking cessation treatment business, the treatment consultations fee needs to be improved, and various measures should be taken, such as expanding the scope of prescriptions for anti-smoking treatments such as patches .
