- LOGIN
- MemberShip
- 2026-04-18 00:47:28
- Company
- Saxenda easily leads obesity market with KRW 32 bln by 3Q
- by Chon, Seung-Hyun Nov 27, 2019 06:41am
- Novo Nordisk’s Saxenda reaffirmed its unmatched leadership in obesity treatment market. Up to the third quarter this year, the treatment’s accumulated sales surpassed 30 billion won. And also Saxenda’s market share is stabilizing at over 30 percent. According to a pharmaceutical industry research firm IQVIA on Nov. 26, the overall obesity treatment market volume in the third quarter reached 35.4 billion won, about 45.4 percent increase from last year same time. In last two years, the obesity treatment market volume soared by 70 percent from 20.7 billion in the fourth quarter of 2017. Quarterly market volume trend in obesity treatment (Unit: KRW 100 million) Source: IQVIA Since its launch in Korean market, Saxenda has dominated the market and also seems to have elevated the overall market volume. In the third quarter, Saxenda made 11.9 billion won, a sevenfold growth from third quarter last year. Saxenda’s sales was more than a fivefold of Dietamins’, coming in second in the market. Saxenda generated accumulated sales amount of 32 billion won until the third quarter. Released in Korean market last year, Saxenda was the world’s first obesity treatment approved as a glucagon-like peptide 1 (GLP-1) analogue. The GLP-1 hormone is secreted by food intake and reaches activated neurons in brain to regulate appetite. Saxenda has a similar mechanism with the native GLP-1, and induces weight loss by suppressing appetite and food intake. Even before reaching the one year point, Saxenda generated 5.6 billion won in the fourth quarter last year and placed itself on the top of the market. The treatment has made at least 10 billion won each quarter this year. Saxenda and a diabetic treatment Victoza share the same active ingredient, liraglutide, but have different regimen and dosage. As Saxenda verified long-term use safety with Victoza and demonstrates similar mechanism as native hormone GLP-1, consumer’s high trust on the treatment would have affected the skyrocketing demand for it. Saxenda Saxenda’s market share in the overall obesity treatment market has shown steep increase. In the fourth quarter last year, its pie took up more than 20 percent, and in the first quarter this year, the pie expanded out to over 30 percent. By the last third quarter, the figure reached 33.7 percent. Following Saxenda’s strong lead, Daewoong Pharmaceutical’s Dietamin (2.5 billion won), Ildong Pharmaceutical’s Belviq (2.2 billion won), Huon’s Hutermine (1.6 billion won), Alvogen Korea’s Furing (1.3 billion won), and Huon’s Phendi (one billion won) have each generated over one billion won in the last quarter. However, their combined third quarter sales amount was about 8.6 billion won, far under Saxenda’s individual performance.
- Opinion
- [Column]GPP can’t be off anymore
- by Jung, Heung-Jun Nov 27, 2019 06:40am
- GPP is a hot potato in the pharmaceutical society. It is unlikely that a executive of the pharmaceutical association with experience in business would completely deny the introduction of GPP. This is because the government and the public have been asking the pharmaceutical association for decades. But the drive is making slow progress. This is because it is difficult for the Korean pharmaceutical society to roll their arms first for a policy that members are not happy with. Former Executive Committee, Chan-hui Cho held a debate to discuss the GPP, but the members' response was cold. The core of GPP is to elevate pharmacy's work level. This ranges from patient services related to medication to systematic and clean management of pharmacies. It is basic not to make unauthorized persons illegal activities, such as dispensing or selling generic drugs. This system aims to induce improvement by certifying excellent pharmacies through evaluation and to raise the level of work of all pharmacies. But members' response to the GPP is not favorable. They recognize the necessity, but they are not very active in accepting, or even view it as another unnecessary regulations. Some used to run a pharmacy at their convenience, but once the GPP is in place, they have to be more careful to meet the criteria and to include being assessed by an outside agency for certification. Nevertheless, the positive side of the GPP certainly exists. First, they can reduce underage pharmacies which do damage to the entire pharmacist society There are many pharmacies that operate in good faith in accordance with desirable pharmacists, but there are some that do not. Because of these pharmacies, the overall status of the pharmacist society falls. The protection of these pharmacies by the Korean pharmaceutical society is nothing less than the surrender of the rights of the whole members. Second, they can increase public confidence in pharmacies and pharmacists. Support of the public is essential for the pharmacist's petition project such as ingredient prescription. It is important to understand that the current situation with low confidence or expectation in pharmacies is the biggest obstacle to the development of pharmacist functions. Members often avoid GPP because of incorrect information or realistic concerns. The idea is that the GPP is tricky to implement a corporate pharmacy or objectionable because it will cost a lot of interior expense. In particular, there seems to be a misunderstanding that hardware elements such as interior and automatic dispenser are important conditions for becoming a pharmacy. Not like that. In order to provide good service, software factors such as pharmacist knowledge and careful care of patients are more important. And the certification system should be made to reflect these software elements well. This can lead to the development of the pharmacist's function, which is the true purpose of the system. In order for the GPP to be settled in a desirable manner, it is correct that the pharmacist society faithfully carries out these concerns and preemptively implements them. Recently, the Anti-Corruption and Civil Rights Commission recommends that the Ministry of Welfare undertake a study on the implementation of the GPP. It is a pity to respond aggressively to the changes of the times and to the demands of the people. We must abandon the current situation where the pharmacist society seems to stand up to the consumer's demands, and change to the stage where the pharmacists renew and gain the trust of the people. Change is always painful. But the power to change on its own is the driving force to open the future. Even now, we expect the pharmacist society to gather wisdom and courage to be on the right track of change.
- Company
- Talking points on ‘Korea Passing’ in pharma industry
- by Eo, Yun-Ho Nov 27, 2019 06:36am
- The well-known expression ‘Korea Passing’, recently used to describe a phenomenon related to foreign affair discrepancies, does not mean the same in pharmaceutical industry. When it comes down to the Korean pharmaceutical industry, the expression does not indicate the U.S. and North Korea neglecting South Korea during the Korean peninsula nuclear talks. Rather, it indicates multinational pharmaceutical companies neglecting Korean market to protect certain level of pricing in other countries. This is why the South Korean health authority is offended by the industry using the expression, ‘Korea Passing’. However, there have been some clear signs of the phenomenon and a number of alarming cases has been reported. And the issue is around ‘drug’, a product that directly affects people’s health. Increasing number of ‘available but inaccessible drug’ is certainly an issue we need to be concerned of. ◆ The cause and irony of Korea Passing: ‘Drug price in Korea is low’. It’s agreeable to deduce the theory under a number of circumstances, but it cannot be defined as ‘truth’ at the moment. Despite the grievance, the industry also cannot exactly explain it. Countries around the world have different drug pricing systems according to respective calculation model. Tax, actual transaction price, retail price and many other factors play a part. As we are now in the day and age of high-cost drug, growing number of countries are adopting the dual pricing system. A research was criticized by the public because of it, as the research concluded ‘drug price in Korea is at around 45 percent of other OECD member countries’’. Of course, if a specific drug’s insurance listing in Korea has been delayed or withdrawn, then the reason is not because ‘the drug price was too high’. At least there is no doubt the drug price in Korea that more countries would refer to, is the black sheep multinational pharmaceutical companies want to keep it hidden. Multinational drug manufacturers point their fingers at Middle Eastern countries, Japan and even recently China as the biggest reason why Korea Passing is a relevant issue, because those countries take up significant pie in the overall international sales, but also refer to pricing in Korea. Then why are those countries peaking at drug pricing in Korea? It would be truer to say ‘because pricing is transparent’ instead of simply saying ‘pricing is low’. Under the single-payer health insurance system, or the National Health Insurance (NHI), Korean drug pricing system compares drug price with other alternative options, and conducts pharmacoeconomic analysis before a price for drug is set when listing the item on NHI. The system is surely convenient for other countries to use as a reference. Although the risk sharing agreement (RSA) system has been introduced, the ratio of dual pricing in Korea is comparatively lower. However, the actual volume of Korean pharmaceutical market is about 1.5 to 1.7 percent of the entire global market. Because of the transparent pricing system, multinational drug companies ironically started to neglect Korean market. And hence, the industry argues drug prices should be kepts undisclosed. In the same sense, some are demanding ratio of dual pricing should be increased with RSA subject expansion. A market access (MA) expert from a multinational pharmaceutical company stated “Each drug has different circumstances, but the Korean office is feeling the strain as increasing number of foreign countries are referring to drug pricing in Korea. Korea Passing is an issue that the Korean industry and government should talk and seek for solutions”. ◆ Not all Korea Passings are the same: Definitely, Korea should be concerned of and counteract to the Korea Passing phenomenon. But justification for each case should be thoroughly reviewed. The government cannot shrug shoulders every time when multinational companies pull out reimbursement application or give up on their reimbursement listing. For instance, Novartis’ allergic asthma treatment Xolair (omalizumab) is a typical example of Korea Passing the industry is complaining about. In December last year, Novartis pulled out Xolair from drug pricing negotiation with National Health Insurance Service (NHIS) when it was finally passed by Drug Reimbursement Evaluation Committee (DREC) under Health Insurance Review and Assessment Service (HIRA) after being approved in Korea for 11 long years. It was actually China triggering the company’s action. Right around then, China added Korea as one of external reference pricing countries. Novartis headquarters decided to avoid risk of lowering drug price in a market potentially 20 times bigger than Korean market. Some of the Korean industry people named the incident as ‘China Shock’. It wasn’t to say what was a righteous or justifiable. It was simply a good example of what the industry fears—a global company giving up on Korea for a bigger market. Within the business logic, it would be considered as a reasonable case of Korea Passing. However, another case with Mitsubishi Tanabe’s amyotrophic lateral sclerosis (ALS) treatment Radicut (edaravone) was different. The company suddenly withdrew application for refund type RSA on Radicut in last June. It was Canada this time. The refund type RSA was considered Korean industry’s solution to Korea Passing. Some are even arguing the refund type should be excluded from RSA types and shift it as a type of general insurance listing. Mitsubishi Tanabe gave up on listing the drug in Korea, because it was afraid drug price in Canada would be affected by labeled price and not by the actual transaction price. Labeled price is usually proposed by pharmaceutical company. In fact, many multinational companies have their Korean office to go through a process of conducting its own internal and external feasibility evaluation on the labeled price set with DREC, and reporting the result to the headquarters for their confirmation. During the process, the company also keeps track of drug listing schedule in other countries and the foreign country’s external reference pricing system as well. In May 2017, Canada announced it would add Korea on to their list of countries of external reference pricing, and enforced it from the beginning of this year. It was well-known news ever since the global company initiated a talk on RSA in Korea. And actually, Canada dropped Korea from its list recently. The case of Ono Pharmaceutical’s cancer immunotherapy Opdivo (nivolumab) was even worse. The item was listed as both refund and expenditure cap type RSA in August 2017, but the company technically gave up on the Korean market after the pre-negotiation on expanding reimbursed indication for lung cancer second-line therapy fell apart. The negotiation started from last year but it broke down in the first quarter of this year. The Korean health authority proposed for a renegotiation, but Ono Pharmaceutical refused. “The headquarters has made up their mind”, was their answer. A drug, listed with RSA and initially engaged in an indication expansion talk, refused to even negotiate. It was certainly not because of external reference pricing. Xolair, Raicut and Obdivo are all cases of Korea Passing. But they are all different. Xolair was a concerning case, but Radicut and Obdivo were not. They should rather be reprehended. “Without company’s will, there isn’t anything the government can do. The government is also internally reviewing various means to improve new drug accessibility. But a company unilaterally announcing withdrawal of listing and blaming everything on the government is unacceptable”, said Ministry of Health and Welfare official.
- Policy
- Clinical trial coverage on standard therapy and IND
- by Lee, Hye-Kyung Nov 26, 2019 10:52pm
- Insurance coverage would be granted on both investigational new drug and standard treatment simultaneously used in an anticancer treatment clinical trial. Health Insurance Review and Assessment Service (HIRA) presented a revised standard of healthcare insurance reimbursement on anticancer treatment in clinical trial on Nov. 4. From last year, the government has been providing reimbursement within a typical reimbursement provision scope for public-good clinical trials. First, reimbursement would be provided for clinical trial serving the purpose of public good. And also other client-based clinical trials in a need of emergency healthcare reimbursement to counteract public health risk, or serving more public-good purpose focusing on rare disease related study, would be eligible for the reimbursement as well. But to this date, there has been a dispute over providing reimbursement on the existing standard treatment used for comparison arm in anticancer clinical trial. The Korean Cancer Association (KCA) proposed the government to provide healthcare insurance on standard anticancer treatment used during a span of clinical trial, when used to compare results with investigational new drug. At a Clinical Trial Reimbursement Evaluation Committee meeting convened on last Mar. 20, the committee members discussed the said issue, where HIRA decided to grant reimbursement for clinical trial comparing standard anticancer treatment to investigational drug based on Ministry of Health and Welfare’s authoritative interpretation. As a principle, healthcare reimbursement eligibility scope is defined by the standard and procedure of clinical trial healthcare reimbursement provision. When submitting an application for insurance reimbursement on a clinical trial for investigational anticancer treatment, a healthcare institute can now also submit another application to HIRA for reimbursement on standard anticancer treatment. When the application has been submitted, HIRA would report the details to Cancer and Severe Disease Deliberation Committee. The reimbursement decision on the standard treatment would be notified straight to the healthcare institute, separately from the clinical trial reimbursement. HIRA official said, “Clinical trial reimbursement application submitted after Mar. 20, but already has received a review result notice is also eligible, according to the Article 4 of Clinical Trial Reimbursement Standard and Regulation”.
- Policy
- 13 drugs containing Nizatidine were banned for sale
- by Lee, Hye-Kyung Nov 26, 2019 07:15am
- 13 gastrointestinal drugs containing 'Nizatidine' which had been covered by health insurance, now are not available on the 22nd. The MFDS and the HIRA said that on the 22nd, they took action that Nizatidine medicines are not prescribed or dispensed by hospitals, clinics or pharmacies, from the midnight, prescriptions and dispensing were blocked through the DUR (Medical Insurance Information System) of the HIRA to prevent prescriptions from hospitals, clinics and pharmacies. The banned items are 13 items for discontinued benefits and 53 billing codes. When re-prescribing Nizatidine drugs in a hospital or clinic, the new prescription should be given only for the remaining days instead of changing the existing prescription. When re-prescribing, the specific description code 'MT059' should be entered. As the existing prescription is not changed, the date of re-prescription and re-dispensing at the time of patient visit comes to be the prescription (prescription) date. Although the patient's copayment is generated when preparing the bill for re-prescription and re-dispensing, there is no copayment for the re-prescription and re-prescription. Therefore, clinics, hospitals and pharmacies must claim the dispensing fee and prescription fee by writing the type code 'B / 01' for each medical service in 'MT059'. HS Codes and standard codes for 13 banned drugs containing Nizatidine
- InterView
- “Number one in Asia is what we are shooting for”
- by Kim, Jin-Gu Nov 26, 2019 07:15am
- “As far as dermatological treatment business goes, I think we have a shot at becoming the number one in Asian market”, Cho Yong-joon, CEO at Dongkoo Bio & Pharma (“Dongkoo”) commented. The CEO said ‘entering global market’ is the next long-term goal for the company while it gets closer to its 50th anniversary next year. CEO Cho was confident that Dongkoo’s two most prominent business sectors, dermatological treatment and contract manufacturing, would both be competitive in the global market. He explained the recent aggressive investment and company expansion have been executed with the global market in mind. Visiting his office on Nov. 18 for an interview, it has not even been 24 hours since came back from his business trip to the U.S. Apparently, Cho was already making moves for the global market. -What business took you to the U.S.? “It was to dip our toes in the water of global contract manufacturing organization (CMO) market. I shared some positive talks with a U.S. company especially on our strength, the soft capsule manufacturing. When we ink the deal, we would fully disclose the story. Next year would be Dongkoo’s 50th anniversary. Accordingly we would put forth our global market vision”. - Would it be safe to assume the latest Hwaseong plant expansion was a part of the vision? “We have invested ten billion won. The plant started running from this month. Our production capacity would go up half as much again as before or even double. The company’s CMO sector made 21 percent more last year with 33.1 billion won, compared to 15.3 billion won in 2014. We are expecting to make about 40 billion won this year. To date, the manufacturing factory could not catch up with orders pouring in. “When the manufacturing facility stabilizes from next year, the overall sales and profit would rise. Not only did we enhance production capacity, but also we are focusing on developing new technology on soft capsule. We gained expertise in dermatological treatment through our experience”. -After the valsartan incident, many are concerned of CMO industry “Korean CMO industry is faced with crisis and opportunity all at the same time. As the regulator decided to abolish the joint bioequivalence test system, and revived the gradual drug pricing system, I expect the industry would get the blow soon or later. That is what Dongkoo is preparing for. Specialization and differentiation is the key. The government is also encouraging companies to focus on specialized manufacturing. So far, Dongkoo has been doing well with soft capsule and ointment items. “But the opportunity lies in the global market. Korean CMO industry would be competent enough in the global market. I confirmed that at the CPhI Worldwide 2019. From now on production cost would heat up the already competitive generic market. Now it’s a matter of who sources drug the best. Korean companies could also easily source drug from other countries. We all need to target the global market competition”. -What are your visions on Dongkoo’s specialized sector, dermatological and urological treatments? “Not too different from others, we’re aiming for the global market expansion. First, we would tackle the Asian market. The company is carefully preparing for the leap. To be specific, we are considering opening an office in China. In Korea, our dermatological treatment prescription is ranked at the top with, and urological treatment prescription is at eighth place. Why not then go for the top rank in Asia? This is our goal. We have constantly introduced dermatological treatment. Some are ready to be released next year. For the long-run, we are in process of developing new drug and incrementally modified new drug”. -You’ve shown some notable moves not only on facilities but also on venture investment. “We have signed deals with Novacell Technology, D&D Pharmatech and BioNote. D&D Pharmatech is a bio venture led by a group of professors from the Johns Hopkins University School of Medicine. They are developing treatments for Parkinson’s disease, Alzheimer’s disease and rare fibrosis conditions. Dr. Lee Seulki from Johns Hopkins University School of Medicine is leading the R&D and clinical trials. “We have invested 3.1 billion won on D&D Pharmatech. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the venture company’s rare fibrosis treatment. Recently, the company successfully attracted 140 billion won worth of series B funding. We expect the company to go public next year. “Novacell Technology obtained its U.S. patent on atopic dermatitis peptide this year. And BioNote was the first Korean company to develop African Swine Flu diagnosis kit”. -Investment expansion comes with business profit drop. Seems like Dongkoo’s revenue has been falling for last two years. “It was given that operating profit would go down. We have spent much of capital on facility expansion investment, recruitment, clinical investment and marketing. But the actual sales revenue has constantly gone up. It verifies that the business is growing steadily. The last two years of decreased revenue was about preparing for the future ‘quantum jump’. The return on the investment is expected to show even from next year and on". -Some other business expansion on other sectors like cosmetics and medical device has been noticeable as well. “We’ve jumped into cosmetic market. ‘Cell Bloom’ is a brand based on 3D stem cell media skin care products. We are expecting the brand to generate synergy effect with our expertise in dermatological treatment. And we are taking this for a long run. A few home shopping TV channels have offered us a slot, but we turned them down. We could’ve gotten some instant sales hike, but we are planning to build the brand image centering hospitals and duty free shops first. “Besides Cell Bloom, we also have an ongoing development of bio medical device called ‘Smart X’. We are challenging the chronic disease sector with bio technology. There are unmet needs that cannot be resolved with drugs. An example would be diabetic foot (chronic foot condition derived from diabetic mellitus). Not many drugs treat diabetic foot. “Smart X is a convenient stem cell extraction kit. We have observed meaningful effect from extracting stem cell and injecting back into the ulcer on a foot. Clinical trial is in process to receive approval on the new medical technology. It would get approval in first half of next year at earliest, and generate expected sales from the latter half of the year. The approval application reviews are well on their ways in the U.S., China and Russia as well. And it’s already on sale in Spain”. -Celebrating the last 50 years of the business, what’s next for Dongkoo? “Bio sector is where Dongkoo would be investing on for the next 50 years. Cell Bloom and Smart X are on the same track as well. We would not superficially imitate bio technology, but strive for sustainable business with genuine bio technology, as I would reiterate at the company foundation ceremony. "For the goal, Dongkoo aims to transform from pharmaceutical and bio company into a total healthcare company. Dongkoo would generate great synergy effect with dermatological and urological treatments, as well as stem cell-applied healthcare technology, and reborn as a total healthcare company to cover from head to toe with diagnostic, preventive, treatment and maintenance products”.
- Policy
- MOHW lukewarm about Epilepsy Patient Support Bill
- by Lee, Jeong-Hwan Nov 26, 2019 07:12am
- ‘Epilepsy Patient Support Bill’ is at stake due to a dispute over feasibility of a bill specifically accommodating a certain disease. The National Assembly lawmakers and the government are contemplating on passing an individual bill for a disease as it could trigger other patients to demand bills for their disease, and cause confusion in administrative regulation and fairness among diseases. Whereas, patients and neurology healthcare providers are urging for the epilepsy bill to be passed as soon as possible, because the disease significantly shortens patient’s life span and poor social awareness and unfair social stigma are discriminating against patients with epilepsy. The National Assembly Health and Welfare Committee convened a public hearing session on Nov. 22 about the ‘Epilepsy Management and Support Bill’ introduced by Lawmaker Kim Kim Se-Yeon. The point of dispute was on fairness of establishing an independent law solely dedicated a single disease. Epilepsy is a central nervous system disorder that causes abnormal events in brain cells, which leads to sudden and intense spasm and seizure lasting few minutes. Experts say the estimated number of patients with epilepsy in Korea is around 360,000, and the disorder notably lowers not only the patients, but also the patients’ families’ quality of life, along with the huge impact of financial and social burden. The submitted bill mainly aims to stipulate legal grounds of planning and executing epilepsy preventive measures, diagnosis, related research, as well as a patient support program to help the patients recover and become independent. A couple of key objectives of the bill are to establish a policy raising public awareness and discrimination prevention of epilepsy and patients with epilepsy. And also it would form National Epilepsy Patient Management Committee affiliated under Ministry of Health and Welfare (MOHW). Another objective is to set up and operate Central Epilepsy Support Center and regional centers, and to allocate budget for contracted agency and Epilepsy Specializing Clinic Center assigned to manage patients by regional government body. Lawmaker Kim Se-yeon suggested MOHW to lay the bill and urged Korea to stop neglecting patients with epilepsy any more. “Usually, I keep a reserved stance on legislation, but this bill is different. When a healthcare institute with a scale of Samsung Seoul Medical Center struggles with surgery on the disorder, it means the problem is quite serious”, Lawmaker Kim stated. “If the weight of an individual bill accommodating a single disorder is too much, then consider a vision of a comprehensive bill covering three major brain disorders in few decades. As I am not in the place to come back to the 21st National Assembly, I am desperately requesting the ministry to establish the bill”, Lawmaker Kim urged as he would be leaving the next election. On the other hand, Lawmaker Ki Dong-Min pointed out an individual law for epilepsy could bring administrative and legal confusion, like the Deaf-blind Bill or so-called Helen Keller Bill, and also that it could unintentionally promote other patients to demand individual laws for their conditions fairly. “Although we agree with the objective of the bill, the ministry seems to be shy of passing the bill. Please elaborate further on the reality of patients with the disorder and why the bill should be process right now”, commented Lawmaker Ki. Professor Kim Heung-dong of Severance Pediatric Hospital (left) and Professor Hong Seung Bong of Samsung Seoul Medical Center testifying at the public hearing session. Professor Hong Seung Bong of Neurology Department at Samsung Seoul Medical Center and Professor Kim Heung-dong at Severance Pediatric Hospital testified that epilepsy is not only about ‘life or death issue’, but also about its critical impact on patient’s day-to-day life. In particular, the two professors claimed Koreans have little understanding of epilepsy, which induces patient discrimination and hinders the patients to get proper treatment timing, often leaving them in hospital emergency rooms. Apparently, people run away or give an unnecessary CPR to patients having a seizure, and eventually end up with unfortunate accidents like collapsed rib cage, all due to the public’s lack of awareness. Moreover, the testifiers also explained there are only five healthcare institutes in Korea to conduct a proper epilepsy surgery in Korea. Professor Hong Seung Bong explained “As far as individual laws for single disease go, there are ‘Dementia Management Act’, ‘Cancer Disease Support Law’, and ‘Act on Guarantee of Rights of and Support for Persons with Developmental Disabilities’. Epilepsy has been designated as a most common but serious brain disorder by the World Health Organization (WHO). The patient size of epilepsy is about a half of the dementia patients’, but the severity is much graver and the patients’ families often go through posttraumatic stress disorder after experiencing social discrimination”. Professor Hong added, “Epilepsy is the second most severe disorder shortening a patient’s life span. The severity of the disease should be taken more seriously. In Korea, only five hospitals are capable of the disorder surgery. Hospital’s training on doctors and policies are also problematic. Korean people in general are quite ignorant about the disorder. For instance, Australia spends about AUD 20 million to raise public awareness of the disorder”. Professor Kim Heung-dong stated “At the moment, patients with epilepsy are mostly neglected from the existing law, and it is the classic case of “hidden disabilities”, where the patient would not speak up of the disorder. Many people tend to run away from a patient experiencing a seizure, because first, they do not know how to react, and second, the fear of possible death. These factors create intentional ignorance of the disorder”. “Out of goodwill, some people try to give a CRP on a patient having a seizure, but the patient breaks a rib or two and visits emergency room. By educating the people about epilepsy and common knowledge, the patients can finally have their place in the society. If the individual law is not the main issue, then the bill should be processed immediately”, Professor Kim strongly emphasized. MOHW official answered it understands the hardship that the patients go through, but as a government body, processing an individual law for all disease is a stretch, realistically speaking. The ministry also elaborated that epilepsy treatment technology and drugs are mostly covered by National Health Insurance, and other neglected parts are supplemented by existing laws on persons with disabilities and rare disease. The ministry insisted that existing laws are already reasonably managing the epilepsy and patients with the disorder. “Setting a standard for testing feasibility of individual bill on a single disease should be approached carefully. Every case of what patients undergo is extremely unfortunate. But having a loose standard would only create unfairness in treating respective disease as a government body. Soon, other patients would complain why there aren’t laws solely dedicated to chronic respiratory disorder or hepatic cirrhosis and so on”, MOHW official stated. The government official added, “If the patients and their family feel the government support is insufficient now, then they can apply to have the disease designated as an individual disease under the grounds of Public Health and Medical Services Act. The government believes that the epilepsy and patients’ issues should be handled not with an individual law, but with existing law”. Some of Health and Welfare Committee members urged an individual law is needed. Lawmaker Choi Do-ja argued “Excessive legislation of bills is problematic, but law should be amended and bills should be passed when the people are in need of help. That is the purpose of National Assembly. When the patients and their families get the news of what MOHW has said about not needing an individual law for epilepsy, they would be in a deep despair. Law should be made, if need be”. “Korea should change. An individual law dedicated for 360,000 patients with epilepsy should be established for their improved treatment opportunity. If hospitals are not equipped with neurologic diagnosis exam tools, then it should be purchased to treat the patients. Running a daycare center for 31 years and taking care of a child with epilepsy myself, I personally experienced the traumatizing event. This is where the government should step in”, Lawmaker Choi added.
- Policy
- A transition of power? Xofluza landed in Korea
- by Lee, Tak-Sun Nov 26, 2019 07:12am
- Flu medicines, which have been greatly improved in convenience, have landed in Korea. It is Roche's Xofluza (Baloxavir marboxil). It is expected to see the effects of flu treatment with only a single dose. The oseltamivir formulations, represented by conventional Tamiflu, had to be taken for 5 days. With Tamiflu's patent expiration in 2017, the flu drug market has been restructured into a multi-competitive system. It is noteworthy whether Xofluza will regain Roche's glory. The Ministry of Food and Drug Safety approved the 20mg and 40mg of flu medicine, Xofluza by Roche, Korea. Xofluza is a single oral drug administered within 48 hours of symptom onset regardless of food intake. Conventional Roche's Tamiflu should be administered orally for 5 days regardless of adult or child. However, Xofluza can be taken only once after the onset of symptoms. Compared with Tamiflu, the time to symptom improvement was not significantly different, with 73 hours for Xofluza and 81 hours for Tamiflu. Currently, there is a single dose of flu treatment called Peramiflu by GC green cross, but it is intravenous injection type, different from oral preparations such as Tamiflu and Xofluza. However, it is unlikely to replace Tamiflu completely because it is not approved by children. Xofluza is used to treat influenza type A or B virus infections in adults and adolescents 12 years of age and older. The FDA approved the drug in last October and obtained a domestic license in one year.
- Policy
- How much does new drug's R&D Investment cost?
- by Lee, Hye-Kyung Nov 26, 2019 07:11am
- The Organization for Economic Cooperation and Development (OECD) has presented monitoring of project activities to countries as part of future projects. Recent data suggests that a successful R & D cost estimate ranges from at least $ millions to $ 2.6 billion. Dahee Lee, a senior researcher at the Health Insurance Review and Assessment Service, suggested improvement plan about calculating OECD’s drug and medical expenditure information through 'HIRA policy trends'. In Korea, employees of the HIRA are attending the OECD Drug and Medical Device Experts' Group meeting. Dahee Lee, a senior researcher has made an opinion on behalf of Korea at the second meeting held in May. At this meeting, the OECD has published a number of reports that provide estimates of the size of the pharmaceutical market and corporate profits, but it is difficult to assess reliability because the data sources and methodologies are not clear. In particular, as the controversy arises due to the lack of reliable data for the profitability of the pharmaceutical industry, the OECD Secretariat suggests that it is necessary to determine the source of data for a simple index list and to develop an analysis framework and select indicators. For the Performance-Based Managed Entry Agreements, which were discussed at the first group meeting of experts in March 2018, the OECD has carried out the survey of 11 countries including the United Kingdom, Australia, Belgium, Czech Republic, Estonia, Japan, Lithuania, the Netherlands, Norway, Sweden, and the United States. Comprehensive examples of MEAs in six countries responded and found that they are implementing MEA contracts for 24 drugs The OECD has discussed the related management and access to anticancer drugs with some member countries, and 6 key tasks were introduced: key issues including ▲up-front costs, ▲economics and financial sustainability, ▲uncertainties in clinical benefits, cost effectiveness and budgetary impacts, ▲ treatment location, ▲imbalance in access, and ▲patient expectations. At the meeting, the representative of WHO Geneva gave a presentation on the pricing of anticancer drugs, insisting that "drug selection should be directed towards increasing efficiency in drug expenditure and opening and adjusting mutual drug prices to promote transparency". The OECD will finalize its report on anticancer drug management and access by the end of this year. The senior researcher Lee said, "The OECD Secretariat introduced an overview of the challenges raised in access to anticancer drugs and shared procedures and future schedules for solving them" and the senior researcher added, “Anticancer drugs may cause inequality in access because coverage and accessibility vary depending on the level of country, region and institution”. Therefore, Korea needs to cooperate in the process of analyzing how the OECD's health system responds to the challenging task. Lee said, “OECD will carry out the investigation necessary to establish a policy regarding rational use of medicines this year.” The Ministry of Health and Welfare, the Health Insurance Review and Assessment Service, and the Ministry of Food and Drug Safety are expected to actively participate in the policy to encourage the use of medicines and to investigate ways to reduce the prescription of multi-items for the elderly.
- Policy
- HIRA, "price transparency of RSA was reduced"
- by Lee, Hye-Kyung Nov 25, 2019 06:23pm
- The National Health Insurance Service (NHIS) plans to make reasonable efforts to implement the risk sharing agreement (RSA) in consideration of patient treatment access and insurance finance. The NHIS responded to Insoon Nam, a member of the National Assembly at a national audit about the plan to rationalize pharmaceutical expenditures, including high-priced drugs. According to a written response on the 23rd, the National Health Insurance Service said, “It is true that there is concern RSA will reduce price transparency and increase administrative burden”. Although it has helped to increase access to treatments such as expensive anticancer drugs and reduce the burden on patients, there are also concerns. The NHIS said, "The government continues to make improvements to the RSA, but there is a demand for improvement in the scope of application or operation method." Regarding the introduction of a Fixed Budgeting Policy for Pharmaceuticals , which is raised only when the pharmaceutical expenditure-efficiency story comes out, the NHIS said, "we haven't specifically reviewed it.“ In the past, during the Park Geun-hye administration, the NHIS was suspected of introducing a Fixed Budgeting Policy for Pharmaceuticals to reduce the share of drug costs to the OECD level. The NHIS conducted the research service, but did not examine the introduction of the system in detail. When the system is introduced, we will fully share the results of the research service with stakeholders such as the pharmaceutical industry and collect opinions and consult with MOHW. For the management of ultra-high-priced drugs such as immunocancer treatments, only the drugs that have proven effective treatment and cost-effectiveness are covered by careful consideration of the expansion of reimbursement and financial management. The NHIS in consultation with related agencies such as the MOHW, is preparing a follow-up management plan to verify the treatment effect and cost-effectiveness after registration. The NHIS said, “We are preparing a cost-effectiveness evaluation plan, and will review post evaluation targets, methodologies, and institutional roles”. In order to improve price-volume agreement(PVA) negotiation system, some respondents said that they would consult with experts and the Ministry of Welfare to expand the targets in the future by improving the selection and exclusion criteria maintenance. The NHIS said, "The target of PVA negotiation is lower than the usage monitoring, so the selection rate of the negotiation target is only 0.2%, and the improvement of the system by selecting targets and improving exclusion criteria is needed". On the other hand, regarding 'Korea Passing', which has been an issue since last year, they said they would consider both insurance finance and patient access when negotiating drug prices so that the treatment access of medicines needed for future medical care is not reduced. The NHIS said, "Our country is showing a high proportion of drug costs for various reasons, such as the rapid increase in the elderly population, changes in disease structure, the emergence of high-priced drugs such as immunocancer drugs and biological drugs, the frequency of use of medical services, and cultural characteristics related to prescriptions. “by designing the reasonable expense structure, we will lower the share of pharmaceitical expenditure to the OECD level”.
