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- 2026-04-16 01:49:55
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- Can HPV vaccine for men be included in the NIP?
- by Eo, Yun-Ho Nov 30, 2020 06:21am
- It is worth paying attention to whether vaccinating men with HPV vaccine can be included in the National Immunization Program (NIP). Earlier this month, Hye-young Choi, a member of Democratic Party of Korea said that the human papillomavirus (HPV) vaccine NIP, which is currently being conducted only for 12-year-old girls, includes both men and women under 18 years of age. Representatively initiated the 'Amendment of the Act on the Act'. HPV is a virus that is transmitted through sexual contact and can be infected by both sexes, regardless of gender. Most of them disappear naturally when infected with HPV, but if they are continuously infected, women can develop cervical cancer, vulvar cancer, and vaginal cancer, and anal cancer and genital warts can appear in both men and women. The HPV vaccine, which is well known as a cervical cancer vaccine, is a necessity that if inoculated to men, it can prevent the occurrence of penile cancer, oral cancer, oropharyngeal cancer, anal cancer, and genital warts related to HPV 16 and 18 as well as preventing female cervical cancer. .In fact, Korean academia also recommends HPV vaccination for both men and women .In 2019, the Korean Society of Infectious Diseases revised the guidelines for adult vaccination after 7 years, adding males to the HPV vaccination recommendations .Cancer centers designated by the World Health Organization (WHO), American Cancer Society (ACS), and National Cancer Institute (NCI) prevent HPV in male and female adolescents aged 13 to 15 by 2020 with the goal of eradicating cancer caused by HPV, regardless of gender .It announced a plan to increase the inoculation rate to 80% .In addition, 20 out of 37 OECD countries include boys for HPV vaccination .However, the current domestic NIP includes only 12-year-old female adolescents who are eligible for free HPV vaccination .Woong Ju, professor of obstetrics and gynecology at Ewha University Seoul Hospital, said, "As a result of an active policy that includes boys in the HPV vaccine NIP in 2013 in Australia, the annual cervical cancer mortality rate is expected to drop to 1 per 100,000 population in 2034 ."It is necessary to expand the target of domestic NIP policy to both men and women, and to carry out active HPV prevention projects." Last August, at the Korean Gynecological Oncology Spring Association, Sohn Gyeong-bok at Ewha Womans University College of Pharmacy, presented the theme of 'A Study on Economic Evaluation of HPV Vaccine 12-year-old Male and Female Vaccination.' He confirmed that HPV vaccine vaccination for men and women at the age of 12 is more cost-effective than the current NIP and non-vaccinated groups .When both men and women were vaccinated with the HPV vaccine, the number of HPV-related cancer patients decreased by 30% in both men and women .Currently, Korea's NIP is asking one of the two-valent vaccines 'Cervarix' and the tetravalent vaccine 'Gardasil' to be inoculated as a cervical cancer vaccine.
- Company
- The market share of GLP-1 diabetes drug Trulicity is 99%
- by An, Kyung-Jin Nov 30, 2020 06:21am
- TrulicityTrulicity, a diabetic treatment administered once a week, continues to dominate in the GLP-1 analog market. Despite the confusion of COVID-19 outbreak, it has set a new quarterly sales record, reaching ₩40 billion in annual sales. It is leading the market expansion by recording a market share of over 99% with only a single item. According to the drug market research agency IQVIA on the 26th, four GLP-1 analogues such as Trulicity (Dulaglutide), Lyxumia (Lixisenatide), Victoza (Liraglutide), and Byetta (Exenatide) in the third quarter made ₩11 billion in sales. This is an increase of 7.8% from ₩10.2 billion in the same period last year. The GLP-1 analog is a drug developed using the hormone GLP-1 (Glucagon-Like Peptide-1), which is involved in the regulation of blood sugar in the body. GLP-1 hormone promotes insulin secretion immediately after a meal, thereby lowering blood sugar, and when blood sugar falls below a certain level, it reduces insulin secretion and helps prevent hypoglycemia. Trulicity, the latest release, virtually ranked the entire market with 99.4% market share. The sales of Trulicity in the third quarter were ₩10.9 billion, a 9.8% increase from ₩10 billion a year earlier. Excluding Trulicity, the quarterly sales of the three items did not reach ₩70 million. The accumulated sales of Trulicity in the third quarter of this year amounted to ₩30.8 billion. Trulicity is the only long-lasting drug administered once a week among GLP-1 analogs on the market. Despite the fact that it was released to the market as the latest among the drugs of the same class in May 2016, sales continued to rise sharply every quarter, increasing its influence in the GLP-1 analog market. It started with ₩1.4 billion in the first year of its launch and exceeded the high of ₩12.2 billion the following year, and the sales in 2018 were ₩27 billion and ₩37.5 billion in 2019, causing a blast. If the current trend continues, annual sales could exceed ₩40 billion. Quarterly sales and Trulicity share of major GLP-1 analogues (Unit: ₩million, %, Source: IQVIA) Lilly Korea has been conducting joint sales activities with Boryung since the launch of Trulicity. It is with the intent to expand the partnership that has been built up through the anticancer drug GemZar into the area of diabetes. With the synergy between the two companies' partnership, Trulicity accounts for about one-third of Boryung's sales after 4 years of release. The quarterly sales of three GLP-1 analogues such as VIctoza, Byetta, and Lyxumia were around ₩3 billion, but the total market size expanded rapidly after the release of Trulicity. It was 2.5 times larger than ₩4.4 billion in the first quarter of 2016, just before the release of Trulicity. Unlike the existing GLP-1 analogue, which had to be injected once or twice a day due to a fast-acting mechanism, the number of injections was reduced once a week, and the convenience was improved with a pen-type formulation. The fact that the recommended level of GLP-1 analogues was raised in domestic and foreign diabetes treatment guidelines, and that the combination therapy with basal insulin was recognized as a benefit at the end of 2017 also acted as a catalyst for the increase in sales. On the other hand, the GLP-1 analog administered once a day continues to be sluggish. Sanofi's Lyxumia is in the process of withdrawing from the market. Sanofi formalized a plan to withdraw two formulations of Lyxumia earlier this year. The total amount of ₩152 million until the third quarter of this year is the inventory that was previously held by wholesalers. At the time, no specific reason was disclosed, but the fact that the company decided to reduce investment in the diabetes business unit was pointed out as the background for the withdrawal of the permit, as sales decreased rapidly after the emergence of competitive products. AstraZeneca's Byetta has a cumulative sales of ₩2 million this year. Novo Nordisk's Victoza barely exceeded ₩150 million in sales for 9 months. Unlike the obesity treatment Saxenda, which differs only in dosage with the same ingredient, it does not show its presence in the market. As a variable for the GLP-1 analog market in the future, Novo Nordisk's generics can be discussed. Novo Nordisk is in fierce competition with Trulicity in the global market as it obtained the approval of the U.S. Food and Drug Administration (FDA) for the GLP-1 analog Ozempic(Semaglutide) administered once a week at the end of 2017. In September of last year, Rybelsus, which converted Ozempic to oral use, received FDA approval. It is an analysis that the market can be reorganized depending on the timing of the two products being released in Korea.
- Company
- First generic release isn't related to original price cuts
- by Kim, Jin-Gu Nov 30, 2020 06:20am
- The Supreme Court of South Korea finally ruled that the company that launched First Generic due to the success of its patent strategy had no reason to be responsible for lowering the drug price of the original drug. The results of the Zyprexa (Olanzapine) lawsuit came out after 10 years. The result of this lawsuit received great attention from domestic companies in that the strategy for early release of generics was decided. On the 26th, the Supreme Court's Civil Affairs Division dismissed Lilly's appeal in a lawsuit against Hanmi for drug price cuts. The Supreme Court's Civil Part 3, which was held at the same time, also took the side of Myungin in a lawsuit for damages that Myungin filed against Lilly Korea. This complicated lawsuit, which has lasted more than 10 years, began in 2008 when a trial was filed for invalidation of the patent for Lilly's schizophrenia treatment Zyprexa. At that time, Hanmi claimed Zyprexa's patent invalidation trial and won the second trial, and then released Olanza, generic for Zyprexa in 2011. Myungin, which confirmed this judgment result, later released Neurozapine, generic for Zyprexa, too. However, the Supreme Court overturned the second trial, and Lilly filed damages to both companies (Hanmi and Myungin) on the basis of this. It was intended to compensate for the profits obtained from selling generics. However, Lilly also filed a lawsuit against Hanmi and Myungin to compensate for damages as the drug price of Zyprex was lowered due to the release of the generic. It was the first in Korea to claim damages for the price cut of the original drug. The cost of the lawsuit was ₩1.5 billion to Hanmi and ₩47 million to Myungin. In this case, Hanmi won both the first and second trials, but Myungin lost both. Regarding Hanmi, the court ruled in favor of both the first and second trials, saying, "Hanmi released the generics through a legitimate patent challenge, and the drug price cut is due to exercise of the discretion of the MOHW and no causal relationship is formed. On the other hand, for Myungin, the court ruled against defeat with the effect of "since it released generics after recognizing the drug price cut of Zyprexa, it must compensate for the damages caused by the drug price cut." In 2016, Lilly appealed to Hanmi and Myungin appealed to Lilly. The Supreme Court's ruling on this day is the final result of a lawsuit that has been going on for the past 10 years. It is the first lawsuit in Korea to dispute whether or not to compensate for the price cut of the original drug, and as a result of this, the first-generic strategy of generic pharmaceutical companies itself could collapse, which attracted great attention from the industry. In fact, if domestic companies lose, they could suffer from cost cuts of the original product, which could amount to tens of billions of billions of won. However, the final decision of the Supreme Court provided an opportunity for domestic pharmaceutical companies to actively pursue patent challenges for the early release of generics. Kim Yoon-ho, chairman of The KPPI (Korea Pharmaceutical Patent Institution), said, "We have completely escaped from a situation where domestic companies' patent challenges for the launch of first generics may be reduced." In particular, he said, "It is a meaningful decision that not only establishes an active patent strategy, but also reduces the burden of health insurance finances and drug costs for patients."
- Company
- Prevenar and Sky Cellflu soar, Keytruda tops again
- by Chon, Seung-Hyun Nov 30, 2020 06:20am
- The novel coronavirus infection (COVID-19) has shuffled the top pharmaceutical market leader board. While immunotherapy Keytruda topped the market again, the sales in a pneumococcal 13-valent conjugate vaccine Prevenar 13 and a flu vaccine Sky Cellflu 4 surged dramatically. The sales in innovative new drugs like Tagrisso and Prolia also grew noticeably. According to a pharmaceutical market research firm IQVIA on Nov. 25, MSD’s Keytruda generated 41.6 billion won in last third quarter. Compared to the same quarter last year, the figure soared by 25.9 percent and topped the market for three consecutive quarters, pushing Lipitor down. Top ten pharmaceutical sales in the third quarter of 2020 (Source: IQVIA) Keytruda took the lead for the first time in last first quarter by making 34.7 billion won and approximately 40 million won difference with cholesterol-lowering Lipitor. In the second and third quarters, Keytruda widened the gap with Lipitor. At the third quarter point, Keytruda accumulated sales of 113.8 billion won, which was 8.6 billion won more than Lipitor with 105.2 billion won. If the drug continues the trend, it is highly likely to take the top spot this year, when it marks the sixth year of launch. Released to the South Korean market in 2015, Keytruda is an immune checkpoint inhibitor that blocks PD-L1 receptor from biding with PD-1 pathway on the surface of T-cell and activates immune cells to treat the tumor cells. Immediately after the market release, Keytruda’s sales have remained around 3 billion won, but the figure grew rapidly since the second half of 2017. The demand on the drug has surged as the healthcare insurance coverage was granted from August 2017 as a second-line therapy treating patients with non-small cell lung cancer (NSCLC). Keytruda’s sales in the first quarter of 2018 surpassed 10 billion won, and climbed up to the 20 billion won-line in the following fourth quarter. From the second quarter last year, it has reached the 30 billion won-line, and exceeded 40 billion won in this year’s third quarter. The demand for Keytruda in the prescription market continued to grow amid COVID-19. A pneumonia vaccine Prevenar 13 had an exponential growth. In the third quarter, the vaccine made 24.2 billion won, doubling last year third quarter’s sales. Prevnar 13 is a pneumococcal conjugate vaccine (PCV13) that prevents infection from 13 types of pneumococcal pneumonia (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Provided to all age groups older than 6-week-old, the vaccines for adults are distributed by Chong Kun Dang, whereas Korea Vaccine is in charge of distributing vaccine for children and infants. Prevenar 13’s sales usually peak in the fourth quarter, when typically the demand for vaccination surges, and drop in the first quarter. This year’s first quarter sales grew more than the previous quarter, making 17.6 billion won, and its growth continued on for the second and third quarters, surpassing the quarterly sales 20 billion won-line for the first time. Quarterly sales growth of Prevenar 13 (Unit: KRW 1 million) Source: IQVIA The sources analyze Prevenar 13’s sales soared due to COVID-19. They evaluate the use of the vaccine in adults has leapt sharply as many were convinced by a number of experts claiming the vaccine can weakened the pneumonia symptoms induced from COVID-19, although it cannot prevent the pneumonia itself. Besides Prevenar 13, Sky Cellflu 4 also entered the top ten as it generated 21.1 billion won amid COVID-19. Sky Cellflu Quadrivalent by SK Bioscience Sky Cellflu is an influenza vaccine solely developed by SK Bioscience that earned the health authority’s approval in 2015. Unlike typical egg-based vaccine, the Korean-made quadrivalent vaccine is produced with top-of-the-line aseptic culture system, which does not require preservative. As all flu vaccines for this year were quadrivalent and the supply for the vaccines increased with COVID-19, Sky Cellflu 4’s sales skyrocketed. The amount of influenza vaccines distributed to the South Korean in this influenza season was about 29.5 million doses with an increase of 20 percent from last year. The Korean company raised the Korean market distribution volume as it predicted the surge in flu vaccine demand due to COVID-19. SK Bioscience shipped about 9 million doses with 70 percent jump compared to last year. AstraZeneca’s anticancer treatment Tagrisso continued to generate significant sales. The third quarter sales were 32.4 percent higher than last year, as it generated 27.9 billion won. Tagrisso is a second-line treatment prescribed to NSCLC patients who developed tolerance in EGFR tyrosine kinase inhibitors (TKIs) like Iressa, Tarceva and Giotrif. The medicine is considered a third-generation treatment that overcame EGFR-TKI tolerance. After receiving the healthcare reimbursement from December 2017, Tagrisso has been growing consistently in South Korea. The sales in the third quarter of 2017 marked 2.7 billion won, but it grew by tenfold in just two years time. Amgen’s osteoporosis treatment joined the top ten by making 20 billion won in the third quarter. Released to the South Korean market in November 2016, Prolia is a biologic osteoporosis treatment directed against receptor activator of nuclear factor-κB ligand (RANKL), which interferes with the formation, activation, and survival of osteoclasts. The drug’s sales started taking off since it was listed for reimbursement in 2017 as a second-line treatment. And Prolia’s sales exploded when it successfully expanded the reimbursement as a first-line treatment from April last year. Also its sales partnership with Chong Kun Dang gave a boost as well.
- Product
- High risk in bone fracture found with long-term GCs use
- by Lee, in-bok Nov 30, 2020 06:20am
- A study claims a long-term prescription of glucocorticoid (GCs) could raise the risk of osteoporosis and bone fracture even in South Koreans. The researchers found the bone density dips significantly and the risk goes up high three months into the prescription. So far, there were studies condudcted in the U.S. and Europe warning such risks, but the latest study in South Korea is a first large-scale monitoring research using epidemiologic data collected from Korean patients. First research evaluating the correlations between glucocorticoid and fracture risk in South Korea The 35th edition of Korean Endocrine Society’s (KES) international journal Endocrinology and Metabolism published a report on “Effects of Systemic Glucocorticoid Use on Fracture Risk: A Population-Based Study (doi.org/10.3803/EnM.2020.659)” that focused on the Korean patients. # In the U.S. (Arthritis Care Res. 2013;65:294-8) and Europe (Rheumatology. 2011;50:1982-90), population-based studies on a long-term use of glucocorticoid have been published to raise an issue in the increasing risk of osteoporosis and bone fracture. However, an epidemiologic data-based correlation study for patients in South Korea has never been reported before. A literature published in 2016 (PLoS One 2016;11:e0158918), by the researchers of the latest study, was the only similar kind. Accordingly, a professor of internal medicine at University of Ulsan College of Medicine, Kim Ha Young led a group of researchers to extend the 2016 study and reviewed the relationship between epidemiologic data of population-based glucocorticoid use and risk in osteoporosis and bone fracture. The researchers pointed out the studies on glucocorticoids published so far have been limited to oral drugs, and left ambiguity as the studies used different indicators in daily dose, cumulative amount and prescription duration. The researchers then have decided to lessen the ambiguity by calculating the total amount of glucocorticoids prescribed based on the defined daily dose (DDD), adding all oral, parenteral and high-dose formulation of glucocorticoids, and analyzing the relationship between the total amount of systematic glucocorticoid use. For instance, prescribing 5 mg of prednisolone, which has 10 mg of DDD, for 90 days would be calculated to 45 DDD as total amount of systematic glucocorticoid use. Risk of bone fracture soared compared to non-user by maximum 3.28 times The researchers randomly selected 1,896,159 patients, who had been prescribed with the drug, analyzed their cases of hip and vertebral fractures to confirm the relationship between the use glucocorticoid and risk of bone fracture. The subjects were categorized into four groups according to total glucocorticoid DDDs: non-users (DDDs=0), low-dose users (0< DDDs ≤45), intermediate-dose users (45< DDDs ≤90), and high-dose users (90< DDDs). The study followed the groups for two years. After two years, 3,988 out of 1,896,159 participants fractured their bone. And the risk of bone fracture was higher in glucocorticoid users with 80 cases per 10,000, whereas non-user group only had 14 cases per 10,000. The use volume was the same as well. As glucocorticoid use increased, the cases of hip fracture also increased. And in all the groups, more vertebral fractures were noticed than hip fractures. Excluding other factors affecting a bone fracture, the results were the same even with Cox proportional hazards model. Compared against the non-users, the vertebral fracture risk was 1.39 times higher in the low-dose user group. Also, the intermediate-dose user group showed risk 1.94 times higher and the high-dose user group was 2.43 times higher. The same results were apparent with the risk of hip fractures. The risk of hip fracture was 3.2 times higher in high-dose users than in non-users. And apparently, the risk of the fractures surges from the three-month point of the prescription, and it peaks at the six-month point. The researchers explained, using the study result, the healthcare providers can predict the risk of bone fractures sustained for at least two years even after a patient stops using the drug. Accordingly, the researchers advised the healthcare providers should project the risk of bone fractures by calculating the use of glucocorticoid for six months, based on the found evidences. The researchers said, “The study was meaningful as it was a first large-scale research on the correlation between the use of glucocorticoid and the risk of bone fracture. In order to prevent fractures, it is necessary for the healthcare providers to evaluate the total amount of glucocorticoid prescribed to the patient and to provide appropriate treatment.” They added, “The low-dose group did not demonstrate high surge in hip fracture risk, but the vertebral fracture risk was 1.39 times higher. As we found glucocorticoid was causing the loss in bone density, specifically in cancellous bones like vertebrae, follow-up studies are needed to seek the cut-off value in the glucocorticoid prescription.”
- Policy
- NA urges for more COVID-19 vaccine, MOHW to take a survey
- by Lee, Jeong-Hwan Nov 27, 2020 06:29am
- The National Assembly Health and Welfare Committee pressured the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) to focus their capacity to seek access to investigational COVID-19 vaccines around the world. Also they ordered the South Korean government to extinguish the people’s concerns about the vaccines by proactively disclosing the corporate collaboration and contract information with a developer. MOHW then answered the ministry would put more efforts to get access to COVID-19 vaccine, while it would survey the people’s perception on the immunization. On Nov. 26, the National Assembly Health and Welfare Committee convened a general meeting and deliberated the bills the first and second Bill Examination Committees reviewed with questions to the government officials. People Power Party Lawmaker Kang Giyun pointed out the MOHW’s next year budget plan does not include the COVID-19 vaccine procuring cost. The lawmaker also reprimanded the ruling party’s responsibility as the Budget and Accounting Evaluation Subcommittee allocated 965 billion won for procuring the vaccines, but the Health and Welfare Committee did not pass it. Moreover, Lawmaker Kang raised an issue on the government signing the contract with AstraZeneca with 70-percent effective vaccine, when Pfizer and Moderna are developing 94.5-percent and 90.0-percent effective vaccines, respectively. Also he criticized the government for neglecting to proactively announce the detail. Lawmaker Kang said he cannot agree with the MOHW’s policy to generate herd immunity by procuring 30 million doses, which would cover 60 percent of the people nationwide, and advised the Ministries to focus on getting access to over 50 million doses for the people. Lawmaker Kang urged, “I cannot comprehend the reason why the government would sign a deal with AstraZeneca, when its vaccine is less effective than Pfizer’s and Moderna’s. The news of locally manufacturing the vaccine should have come from a ministry’s official channel, and not from a news media. Inexpensive price is important, but the vaccine quality and efficacy are more crucial. And I do not believe securing the vaccines for only 60 percent of the population would get us to reach herd immunity. Please get access to enough vaccines.” MOHW agreed with the lawmaker’s criticism about the government should put more effort, and answered it would seek access to vaccines with the efficacy and safety as much as possible. But also the ministry said it would soon conduct a nationwide survey to grasp the people’s perception on the COIVD-19 immunization and to fathom the reasonable doses of vaccines to procure. Minister Park Neung-hoo of Health and Welfare explained, “We have contacted all companies actually capable of manufacturing COVID-19 vaccine, and we are currently negotiating terms and conditions with more than five companies. The deal would be sealed by the end of this year or early next year. The 70 percent effectiveness of AstraZeneca’s vaccine is an average from two testing groups, and as far as I understand the company is manufacturing the 90-percent effective vaccine.” The minister added, “AstraZeneca had an advantage in talking about the procurement contract, as the company manufactures significant amount in South Korea. We would also get access to stable amount of vaccines from Pfizer and Moderna. Stocking too many doses of vaccine causes an issue of disposing unused ones. Although we plan to take the responsibility until the end, we also plan to conduct a thorough survey on the national immunization.” With the third wave of COVID-19 cases in South Korea, with over 500 testing positive in a day, the lawmakers urged the government to approve of using a COVID-19 self-testing kit for the people to test the infection in the comfort of their home. The government officials pleaded for the lawmakers’ understanding by explaining the current legal complications within the medical scene, where either a doctor or nurse has to take the sample for the testing. People Power Party Lawmaker Kim Miae demanded the government officials to answer “why South Korea cannot use the self testing kit, when they can be used in the U.S. with approval by the Food and Drug Administration (FDA).” Democratic Party Lawmaker Shin Hyunyoung also ordered, “Raising the quarantine level higher due to the third wave of COVID-19 frustrates the people. It would be difficult to provide it for all the people, but the government should consider expanding the use of rapid antigen testing kit in places with high risk of community infection, such as hospitals and army bases.” Minister Park answered, “In South Korea, the regulation on rapid testing kit defines the sampling of testing specimen as a medical practice. Any healthcare institute with a doctor or nurse can test a subject, but self-testing by an individual is difficult at the moment.” The minister added, “Even in the U.S., children aged younger than 14 are regulated to must have a healthcare provider to sample the test specimen. In Korea, the regulation allows the primary healthcare institutes to test COVID-19 infection, swiftly.” Minister Kim Gang-lip also elaborated, “The two testing kits with the market approval are all for medical professionals only. The antigen testing kits require the testing specimen to be collected from deep inside of a nasal cavity with a tool. Also the antibody testing kit requires blood to be drawn. So providing access to self-testing kit would be unlikely.” The minister noted, “When a convenient self-testing kit product applies for the market approval, the ministry would review it based on safety and usability. The FDA-approved self-testing kit also needs a doctor’s prescription. Basically, only the specimen sampling can be done at home, after the doctor prescribes the testing kit.”
- Product
- The amount of prescriptions for NSAIDS is increasing rapidly
- by Lee, in-bok Nov 27, 2020 06:29am
- The number of prescriptions for non-steroidal anti-inflammatory drugs (NSAIDS), which are contraindicated for hypertension, asthma patients, and pregnant women, was continuously increasing. Celecoxib took up the most prescription ingredients, and Celebrex recorded the most prescriptions. In particular, Daewon's Pelubi drew attention as it was making significant progress by expanding its indications. NSAIDS prescription volume is increasing every year, increasing the proportion of Celecoxib As a result of the Medical Times' investigation of the NSAIDS prescription status through IQVIA, a drug market research organization, it was analyzed that the amount of prescriptions and sales have been steadily increasing in recent years. Actually, the sales of NSAIDS in Korea exceeded ₩500 billion in 2017, and since then, it has recorded a double-digit increase every year to ₩545 billion in 2018 and ₩560 billion in 2019. As sales from the first half of this year (January to June) have already exceeded ₩265 billion, the sales amount of NSAIDS is expected to exceed ₩500 billion this year. Despite the prolonged COVID-19 pandemic, most drug prescriptions and sales have plummeted to less than 30%, but sales of NSAIDS are significant. As the indications are increased through safety, the prescription of Celecoxib, which is a mechanism of selective cox 2 inhibition, is increasing significantly. Since it recorded ₩59.2 billion in sales in 2017, it has been dominating the market by significantly increasing to ₩68.3 billion in 2018 and ₩75.1 billion in 2019. Although Loxoprofen recorded a sales amount similar to that of Celecoxib at ₩52.1 billionin 2017, it is a significant step forward compared to slowing growth to ₩56.5 billion in 2018 and ₩59.1 billion in 2019. Aceclofenac sold ₩51.3 billion last year, ranking in third place, and Aspirin (ACETYLSALICYLIC ACID sold ₩43.8 billion. Celebrex sales are large and Pelubi's growth is outstanding By product, Celebrex, which is also highly trusted for its safety, was still dominating the market. Since #Celebrex recorded sales of ₩32.6 billion in 2017, it has increased to ₩36.4 billion in 2018 and surpassed ₩40 billion in 2019. Since it has already sold ₩19 billion in the first half of this year alone, and it will exceed ₩40 billion this year. Daewon's Pelubi, followed closely by Celebrex, showed a terrifying growth recently. Pelubi's sales in 2017 were only ₩11 billion, but it nearly doubled to ₩20.8 billion in 2018, a year later, and sold ₩22 billion in 2019, finally overtaking aspirin, which was the undisputed second place. This year, pain after trauma was added as an indication, and Aspirin was ranked at the top. Since Aspirin’s sales surpassed ₩20 billion won in 2017, sales increased to ₩22.2 billion in 2018, but declined to ₩19.1 billion in 2019, giving Pelubi the undisputed second place. In addition, the growth system of domestic drugs was outstanding. Boryung Biopharma's Astrix ranked fourth with ₩14.6 billion in 2019, followed by Hanmi's Naxozol with ₩10.9 billion in the same year. By pharmaceutical company, sales of companies with representative items also stood out. Pfizer Korea, which has Celebrex, is also the highest with sales of ₩40 billion in 2019. Following this, Hanmi recorded ₩28.2 billion in the same year with increased sales of Naxozol and other NSAIDS such as Maxibupen, followed by Daewon with Pelubi at ₩26 billion. Bayer Korea sold ₩20.4 billion to Aspirin, followed by Sinsin at ₩16.4 billion, Huons at ₩15.2 billion, and Boryung Biopharma at ₩14.9 billion.
- Policy
- A second survey of expenditure reports was initiated
- by Lee, chang-jin Nov 27, 2020 06:26am
- A second survey of expenditure reports was initiated that documented the economic benefits that health authorities legally provided to medical personnel. The related industry is straining as meticulous inspections are expected to be carried out in order to strengthen the management of expenditure reports such as indirect rebates pointed out in the state audit. According to the results of the Medical Times interview on the 27th, it was confirmed that the MOHW recently sent an official letter to pharmaceutical companies and medical device companies to submit expenditure reports. The MOHW was initially scheduled to conduct a second survey in the first half of this year, but has delayed the timing of the survey to reflect the industry difficulties arising from COVID-19 incident. The subjects of this survey are pharmaceutical companies and medical device companies, excluding companies that submitted data in the first survey at the end of last year. The first and second survey target companies total 37 domestic and multinational companies. The submission period is about one month, and the company that received the official letter must submit a one-year expenditure report from January to December 2019 to the MOHW in November. Expenditure reports include providing samples, support for academic conferences, support for clinical trials, medical instituitons product presentations, post-marketing investigations, cost discounts (pharmacy), and other economic benefits, and CSO (sales agency) and CRO (clinical trials entrusted by the company) Institutions) Expenditures are included. The list of related medical professionals, pharmacists, conferences, medical instituitons, etc. who received economic benefits from the company should also be specified. The MOHW is known to receive expenditure reports from large companies such as Yuhan, Daewoong Bio, Korea Abbott, and Chong Kun Dang in the first survey and are in the process of checking. The MOHW is pursuing follow-up measures such as the expenditure report management plan pointed out at this year's national audit. Young-in Ko, a member of Democratic Party of Korea based on Abbott's expenditure reports, raised suspicion of indirect rebates, such as excessive academic support from certain academic societies, at the state audit, and Minister Park Neung-hoo promised strict management of expenditure reports. The MOHW said in a written response, "The MOWH agrees with the point that the expenditure reporting system should be operated according to the purpose of introduction to eradicate illegal rebates." Also the MOWH replied, "We will review measures for improvement such as strengthening sanctions when the expenditure report is not prepared so as to increase the effectiveness of the system" The MOHW also said, "We don't think it will be easy to eradicate new rebates as they are done in a more secret and subtle way. We will closely grasp the status of the pharmaceutical field and prepare a plan for improving the expense report system and managing the sales agency (CSO) by collecting expert opinions." The pharmaceutical and medical device industries are paying close attention to the situation in which the expenditure reporting system introduced to promote transparent economic benefits may turn into an illegal rebate crime schedule.
- Policy
- Contracts with modified indications are not terminated
- by Lee, Hye-Kyung Nov 26, 2020 08:58am
- The NHIS said that in the case of drugs that benefit from the RSA drug price negotiations, it cannot unilaterally terminate the existing contract to change the main indication. Based on the provisions of the NHIS on October 8th, the 'Detailed Operation Guidelines for Risk-Sharing Drug Price Negotiations', the contract cannot be terminated if the HIRA recognizes cost effectiveness when the benefits are expanded in the pharmaceutical industry. Nam-seon Choi is explaining the revision of the risk-sharing drug price negotiation guidelines The NHIS held ‘RSA drug price negotiation system and follow-up management online briefing' for more than 100 pharmaceutical companies from 2pm on the 25th. According to the revised guidelines, after the evaluation of the Pharmaceutical Benefits Advisory Committee, the NHIS and the company negotiate the contents of the risk-sharing contract (excluding the risk-sharing contract period) such as the upper limit amount, refund rate, and cap of the drug. In this regard, an official of Pharmaceutical Company A said, "If a drug that has been exempted from Profitability Evaluation with an Expenditure Cap passes the Pharmaceutical Benefits Advisory Committee after proving the cost-effectiveness of an indication other than the existing indication in the process of expanding benefits in the future, will the existing contract be terminated?" For example, the question is whether the existing contract should be maintained even if the scope of benefits expands due to a different area or age change, etc., in which indications and additional indications are exempted from Profitability Evaluation. Nam-seon Choi, head of the NHIS' drug price negotiations, said, "The part where the scope of benefits is expanded by proving cost effectiveness is a form of resetting the cap within the existing contract period, so the existing contract cannot be canceled." Choi said,"At the end of the Expenditure Cap contract, the Pharmaceutical Benefits Advisory Committee evaluation determines whether to maintain or terminate the contract." He added, "There was no real case like this, but if it comes out, we will review it in the negotiations, but we are not thinking about the termination of the existing contract when the scope of benefits is expanded."
- Policy
- RSA's collateral period was reduced by 3 months
- by Lee, Hye-Kyung Nov 26, 2020 08:38am
- The amount of collateral that pharmaceutical companies have to pay when signing an RSA drug is expected to decrease by 25%. According to the 'Detailed Operation Guidelines for Drug Price Negotiation of the Risk Sharing Agreement' revised by The NHIS on October 8, the period of collateral has been changed from 12 months to 9 months. This is because if the actual formula is substituted, the amount of collateral will decrease. The NHIS held a 'RSA drug price negotiation system and follow-up management online briefing' for about 100 pharmaceutical companies from 2 pm on the 25th. "Pharmaceutical companies have made a lot of requests to reduce the amount of collateral that is collectively entered at first," said Oh Se-rim, a team leader in the NHIS Drug Price Negotiation Department, who was in charge of announcing the revised matters. Following that, Team leader Oh said, "It has been shown that the amount of collateral is arithmetically reduced by 25% by reducing the amount of collateral by three months from 12 months to 9 months." In the case of the Refund type, as the amount of collateral is reduced, it becomes 'estimated billing amount (maximum) x refund rate x 130%' to 'estimated billing amount (actual) x refund rate/1-refund rate x 9/12 x 130%'. The reason that the estimated billing amount has changed from the upper limit (indicated price) to the actual price is that, while revising the guidelines, the 'actual fiscal impact criterion' was set in consideration of the refund of the estimated billing amount. Based on the revised guidelines, if the amount of the collateral is calculated assuming a drug with a labeling price of ₩10,000, an actual price of ₩80,000, a refund rate of 20%, and an estimated billing volume of 1 million vials, it was previously '10 billion won (maximum amount) × 20% (refund rate) × It had to pay ₩2.6 billion as '130%', but '₩8 billion (actual) x 20%/(1-20%) (1-refund rate) x 9/12 x 130%' is applied as a change between collateral. If so, it will reduce ₩650 million to ₩1.95 billion. Team leader Oh explained, "The initial guideline was released and there was no change in the formula that was not in the refund rate part, but it was corrected by changing it to the actual price minus the refund rate. There was a reduction in the amount of about 25%." Since its introduction in 2014, RSA has signed a total of 48 drugs and 85 items as of October 30. By type, there are 13 Refund types (26 items), 18 Expenditure Cap types (29 items), 1 Refund type for initial treatment (2 items), and 3 Utilization Cap/Fixed Cost per Patient type (6 items), other type (1 item), and a combination of 12 items (21 items). Expenditure Cap Change = According to the guidelines changed by The NHIS, the Expenditure Cap was changed from 130% to 100% of the estimated billing amount when negotiating the Article 6 risk sharing proposal. At the time this guideline was published, the pharmaceutical industry was most opposed to it. The team leader said, "The omission of Profitability Evaluation changed the total amount based on financial impact." The team leader said, "There is a lot of worries in the pharmaceutical industry. As a result of analyzing Expenditure Cap-type drugs, most of them have reached the 100% standard. It will not have a big impact as expected." In addition, the standard of the estimated billing amount was changed from the upper limit to the actual price. Depending on the nature of the drug, it is possible to set the estimated billing amount based on the upper limit amount, and when monitoring the Price-Volume (PV), they can specify whether the refund amount is included in the agreement. Nam-seon Choi, Director of Drug Price Negotiations, said, "If we assume that an estimated billing amount of ₩20 billion and a refund of ₩5 billion, whether for initial treatment Refund or Utilization Cap/Fixed Cost per Patient, we will set ₩15 billion as the estimated billing amount." "Pharmaceutical companies can decide whether to set it based on the actual fiscal impact excluding the amount of refund or the details of the claim.“ Nam-seon Choi is explaining the amendment to the RSA drug price negotiation guidelines However, in principle, it is only stated in the guidelines that it is based on the actual price. "In the past, only one type was applied," said Choi, "a part that changed as the guidelines were revised and various types were mixed and the standard for the total amount was set together." He explained, "The principle is based on the actual price, but if the actual price cannot be made according to various types, it can be discussed in the negotiation and entered in the agreement." Expenditure Cap contract obligation for phase III conditionally licensed drugs = As risk-sharing targets expanded in this guideline, conditional drugs in phase III clinical trial were also included. This drug will sign an Expenditure Cap contract, and team leader Oh interpreted, "For these drugs, it is not easy to submit profitability evaluation data, but the possibility of benefit registration may have increased" However, the definition of conditional drugs in phase III was specified in accordance with the 'Examination Regulations for Declaration of Product Permission for Drugs', and limited to drugs that were approved by submission of data for phase II and approved under the conditions of clinical data for phase III. Team leader Oh said, "The drugs that have only partially submitted data on conditional drugs in clinical III or whose overall survival rate (OS) is released after approval are not considered conditional, but only drugs according to the review regulations." Expiration of contract term = One of the biggest changes from the revision of this guideline in The NHIS is the treatment method after the RSA contract term expires. In the past, before the expiration of the RSA contract period (4+1 years), the NHIS requested the evaluation of the risk-sharing system of existing RSA drugs in the Pharmaceutical Benefits Advisory Committee of the HIRA However, only the changed guidelines do not allow the Pharmaceutical Benefits Advisory Committee to determine whether or not to be eligible for a risk-sharing system. The clinical usefulness and cost-effectiveness of drugs near the expiration of the RSA contract will be evaluated. And the NHIS will be able to re-contract or terminate the contract by negotiating risk-sharing plans such as the upper limit amount of the drug, the estimated billing amount and the refund rate, and the cap based on the result. The NHIS, the parties to the contract, will have the overall risk-sharing contract. “In the past, the Pharmaceutical Benefits Advisory Committee evaluated whether or not to be eligible for RSA, and the contract was terminated because it was difficult to evaluate most of the risk-sharing when alternative drugs came in.” He added, "In the future, we will see the clinical utility and cost-effectiveness of RSA drugs, rather than evaluating whether the HIRA is subject to risk sharing." It means that if an alternative drug comes in or other issues arise, it will decide whether to continue the contract based on the cost-effective aspect. Team Leader Oh said, “The Leader decides whether to re-contract or negotiate based on the evaluation results of the HIRA, and continues the contract considering the upper limit amount, estimated billing amount, and refund rate in consideration of changes in the clinical environment over the past 4 to 5 years. We will discuss whether or not with a pharmaceutical company."
