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- Company
- BMS-Celgene Korea promotes Kim Jinyoung as new CEO
- by Eo, Yun-Ho Nov 28, 2019 10:19am
- 김진영 대표 The decision has been made and it was a promotion from within. Kim Jinyoung (43), a former acting CEO, was appointed as the CEO of merged BMS-Celgene Korea. Kim used to serve as a Head of Legal and Compliance in BMS Korea, but was appointed as an acting CEO after former President Park Hye-sun (49) left the office. Kim had been active as the acting CEO up until recently. With the appointment of a new CEO in merged Korean office, the company is to initiate the integration process with Celgene soon. Including the headquarters, BMS and Celgene are in process of appointing new CEOs in respective regional offices. And those offices with new CEOs are also to immediately kick off the reorganization process. The new CEO at BMS-Celgene Korea, Kim Jinyoung majored in French literature at Ewha Womans University, and passed the New York State bar exam after studying at the Ohio State University Moritz College of Law. Beginning her pharmaceutical industry career as Legal Counsel at Pfizer Korea in 2009, Kim continued her path as Legal and Compliance Lead in Korea, Taiwan and Southeast Asia BMS from August, 2012 to May, 2019. As for BMS, the global pharmaceutical company has decided to acquire a U.S.-based biotechnology company Celgene for USD 74 billion (about 86.40 trillion won) in January this year.
- Company
- Ildong great likelihood to sell strongly 'Otrivin' by GSK
- by Jung, Hye-Jin Nov 28, 2019 06:14am
- Ildong pharmaceuticals has the most potential of otc vendor for 10 GSK items. It is possible that A distributor, Zuellig Pharma Korea will be charge of selling Lamisil. According to the industry on the 26th, GSK, Ildong Pharmaceuticals and Zuellig Pharma Korea are in the last negotiations over the right to sell 10 generic drugs. A retailer said, "Since last September, Ildong Pharmaceuticals is going to distribute GSK products. The industry has already begun. The preparations are almost finished". "Zuellig Pharma Korea has recently been added as a distributor and is in charge of selling Lamisil" he said. GSK and Ildong Pharmaceuticals said, "There is no confirmation yet". However, retailers and pharmacies believe that Ildong Pharmaceuticals was determined to be the main seller of 10 items. The 10 items to be negotiated are Lamisil, Otrivin, Voltaren, Nicotine-L, Theraflu, Sensodyne, Breathe right, Zantac, Polident, and Driclor. Among them, Lamisil is expected to be sold by Zuellig Pharma Korea and Ildong Pharmaceuticals to sell the remaining nine items. However, as negotiations are still underway, each company's products may change. In addition to Lamisil, it is likely that Zuellig Pharma Korea will be responsible for selling more products. An official at GSK said, "We can't formalize anything until the agreement is signed. Nothing has been decided yet." . An official of Ildong Pharmaceuticals said, "We cannot confirm when the contract is finalized. We will announce it after all contracts are concluded". Dong-wha Pharmaceuticals has distributed 10 GSK generic drugs. Originally, the copyright contract was until 2020, but the merger of GSK and Pfizer Healthcare prevented the company from maintaining its existing contract. Dong-wha Pharmaceuticals recently announced that it will end its generic drug supply contract with GSK on Dec 31. Dong-wha Pharmaceuticals is in the process of returning GSK products at pharmacies, and GSK is said to have almost stopped sending out 10 products to which the copyright is transferred. Next year, a new dealer will settle inventory with Dong-wha Pharmaceuticals before supplying the product.
- Company
- MA experts admit headquarters’ “Korea Passing” orders
- by Kim, Jin-Gu Nov 28, 2019 06:14am
- With one phenomenon, there are two interpretations. The government and pharmaceutical industry are showing polarizing views on the current situation and the cause of Korea Passing phenomenon. As if they are speaking in different languages, their prospective and proposed solutions are like parallel lines never crossing each other’s path. So what does pharmaceutical industry fear about in those two words of ‘Korea Passing’? Daily Pharm conducted a survey on 21 Market Access experts from respective affiliation to get a better look into what the industry is trying to convey. Korea Passing is not a myth, but a reality in global pharmaceutical companies First, the survey questionnaire asked if the experts have experienced Korea Passing either directly or indirectly. Except one response, 20 said they have experienced directly or have heard of it. For those have either experienced or heard of it, the survey questioned how many cases of Korea Passing they have come across with. Nine said one case, and other nine said two to three cases. Three answered five or more cases. The average was about 4.2 cases. Sorting by treatment type, chronic disease treatments faced Korea Passing the most with 12 cases (multiple responses allowed). Rare disease and anticancer treatments followed with ten and nine cases, respectively. Immune checkpoint inhibitor and infectious disease treatment each experienced once. So far, allergic asthma treatment Xolair, antidiabetic treatment Victoza, amyotrophic lateral sclerosis (ASL) treatment Radicut, and immunotherapy Obdivo have been mentioned the most when talking of Korea Passing. But the survey revealed more cases. It hinted that more Korea Passing phenomena are happening behind the scenes. "Headquarters ordered a withdrawal at pricing under certain point” The survey delved deeper into the phenomenon. Excluding indirect experience of the phenomenon from word of mouth, the questionnaire asked if they have received an order from global headquarters to drop application or negotiation with government body. 16 out of 21, or about 76 percent of the survey participants answered they have. 11 of them said there was one such case, and four said two or more cases. One did not answer. Apparently, the order was given for seven items before they applied for insurance reimbursement listing, eight during reimbursement feasibility evaluation, and four during drug pricing negotiation. On the details of the ‘order’ regarding Korea Passing, 13 answered the headquarters specifically mentioned the word “withdrawal” or “defer” during a meeting. One said their office was ordered to defer the Ministry of Food and Drug Safety (MFDS) approval application submission. Three items received an order to suspend reimbursement listing application submission, and other three got an order to postpone processing after applying for reimbursement listing Three answered they were given an order to pull out from negotiation when negotiating pricing went under certain price. Moreover, three said their headquarters ordered them to unilaterally withdraw from reimbursement listing. Not a specific order, but even six of the participants said they had to read between the headquarters’ message implying withdrawal or suspension during meetings. Taken at face value, there have been at least 16 cases where a global headquarters has given a direct order to either withdraw or suspend government processing. Multiple responses aside, the survey confirmed many of global headquarters are sensitive about pricing in Korea and also go as far as to directly give an order. All because of Korean government? Industry admits some of their contribution The participants suspected two major reasons were behind the Korea Passing phenomenon. 19 said drug pricing in different countries, and 16 said low reimbursed price in Korea, including multiple responses. Questionnaire asked once again to see if Korean government or pharmaceutical company played any part. None of them said pharmaceutical companies were either entirely or mostly responsible. However, six of them said it was entirely because of the Korean government. Majority of the participants, or ten of them said the Korean government is mostly responsible while pharmaceutical companies were also partially responsible. Five answered the companies and government were responsible 50/50. Majority of the participants, or 13 of them answered China played the biggest role in Korea Passing, as expected. Other regions like the Middle East, A7 countries and others were mentioned by ten, three and two participants, respectively. None of them said Australia. In fact, the industry has growing concern over the “China Risk” since last year. The Chinese government has been completely reforming its pharmaceutical insurance benefit policy for last two years. In the process, the government has decided to include Korea as one of their international reference pricing countries. Previously, the country has been referencing drug prices in Korea unofficially. But when China made it official was the tipping point for the global headquarters to make more drastic decisions. The point in time matches with right around when Korea Passing has become a social issue. Korean pharmaceutical industry is concerned of multinational drug maker headquarters making decisions to postpone or withdraw reimbursement listing application due to Chinese market. Besides China, the Middle East was also played a crucial role in Korea Passing. Among the Middle Eastern countries, Saudi Arabia is reportedly referencing Korean drug pricing. “The notion of Korea Passing is not that new. When Saudi government started referencing Korean pricing, the phenomenon occurred time to time. But it became as big of an issue, because the impact it bring is comparatively more detrimental than before”, an industry insider explained. “Especially after China officially added Korea as one of external reference pricing countries, the industry’s concern on Korea Passing has grown exponentially. Figures may not yet show the impact, but the influence has been substantial”, they added. All agree “Worried about future releases in Korea” All of the survey participants had a same answer for one part. They all agreed they currently have at least one item in risk of Korea Passing. Eight or the majority of them said there are two items. And it was followed by five answering one item, four saying three items, and one saying four, and three saying five to ten items. None of them said ten or more. Then what’s next for Korea Passing? Questioning about their views on the current administration capable of solving the issue, 14 of them answered negatively. Clearly, they are afraid of Korea Passing setting in over the time. But, six said the otherwise. Still some are positive the issue would get resolved, despite their serious concern about Korea Passing. They are hopeful the phenomenon is a temporary occurrence, and the Korean government and pharmaceutical industry would find a solution.
- Company
- Inflximab injection ‘Remsima SC’ good to go in EU
- by Lee, Seok-Jun Nov 27, 2019 11:06pm
- 사진은 램시마 정맥주사형. On Nov. 26, Celltrion announced its hypodermic injection Remsima SC got the green light from European authority. The injection was approved on indication of rheumatoid arthritis in 120 mg dose. Remsima SC is the first subcutaneous formulation of inflximab to have passed by the European regulator. Remsima SC would be available in 31 European countries for sales with the approval. Celltrion plans to extend its indication in the future for treating Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. Celltrion Healthcare, in charge of overseas marketing and distribution of Celltrion product, would be introducing Remsima SC across European markets.
- Policy
- Gazyva applied Moon Care policy’s selective health benefits
- by Lee, Hye-Kyung Nov 27, 2019 11:06pm
- Roche's Gazyva(Obinutuzumab), a non-Hodgkin's lymphoma treatment, will be converted into a selective reimbursement benefit in accordance with Moon Jae-in Care's ‘Non-benefit’ policy. The implementation date is December 15. The Korea Health Insurance Review and Assessment Service announced that it would revise the details of the criteria and methods for applying medical care benefits to drugs prescribed and administered to cancer patients, and will hold an opinion inquiry by 28th. On the 26th, the amendment was made ▲ Gazyva(30/100) +Bendamustine(30/100) combination therapy (2nd or higher) and copayment for non-Hodgkin's lymphoma ▲Gazyva(30/100) Establishment of monotherapy (maintenance therapy) and self deduction rate ▲ Excludes the case where the primary site is the posterior intestine. Gazyva is approved as a monotherapy for maintenance therapy after coadministration with Bendamustine, or when does not respond to Rituximab monotherapy or combination therapy with Rituximab. On May 30 2018, the cancer disease review committee decided that the patient would pay the full amount of the drug within the scope of the permit for reasons such as lack of clinical efficacy and cost effectiveness, but the HIRA reviewed whether the benefits would be extended in accordance with the non-reimbursement benefit policy. After reviewing textbooks, guidelines, and clinical papers, no new additions have been made to the excluded countries' reimbursement standards, but in the additionally analyzed phase 3 study (GADOLIN 2018), the median progression-free survival (25.3 months vs. 14.0 months) compared to the control period until the next treatment (33.6 months vs. 18.0 months). However, there is a lack of evidence to determine the clinical efficacy of maintenance therapy, as further analysis does not provide a numerical value of the median overall survival of Gazyva’s maintenance therapy. In case of non-compliance, there was not enough alternative therapies, so they decided to pay 30% co-payment. Ipsen Korea's 120 mg of Somatuline autogel is approved for the treatment of non-resectable, highly differentiated or moderately differentiated local or metastatic gastric, intestinal and pancreatic neuroendocrine tumors. After reviewing textbooks, guidelines, and clinical papers on the elimination of primary site limitations, the NCCN guidelines recommends the drug as category 2A for gastrointestinal neuroendocrine tumors, and additional clinical studies on clearance studies (CLARINET). The progression-free survival for the posterior ulcer was reported to be 31.0 months in the lanleotide group and 24.4 months in the treatment conversion group. The Health Insurance Review and Assessment Service said, “The number of patients included in the study related to the licensed clinical literature and domestic research has a limitation that it is difficult to prove statistical significance. Given the limited need for medical care, we have decided to remove exclusions if the primary part is the posterior part of the current imbursement standards”.
- Company
- Handok has domestic copyright of Exelon & Trileptal
- by An, Kyung-Jin Nov 27, 2019 06:42am
- Exelon capsules Novartis Korea handed over copyrights of two neurology products including dementia medicine 'Exelon' to Handok pharmaceuticals. The intention is to organize copyrights for four medicines that were in charge of the department of neurology and concentrate sales marketing activities on the company's flagship products, including new products. According to the industry on Nov 26, Novartis Korea signed a domestic sales agreement for Alzheimer's dementia drug, 'Exelon' and anti-intermittent drug, 'Trepttal' with Handok pharmaceuticals. Handok will be in charge of sales activities next year, including the promotion of two products to medical staff and sales operational labor management. It is a condition that Novartis Korea continues to supply products while maintaining the license copyrights. The contract was made in accordance with the company's policy to clean up some of the drugs sold by the CNS department, including treatments for dementia, epilepsy and Parkinson's disease. The intention is to reduce the concentration of relatively unprofitable products and to focus sales marketing activities on the company's flagship products. It is said that the company will focus on promotion of SMA gene therapy drug named 'Zolgensma' and a follow-up product of Gilenia, 'ofatumumab' for relapsing multiple sclerosis. The CNS department in Novartis Korea's Specialty Pharmaceuticals Division, which was in charge of related products, was dissolved. Sales department employees in the department are in the process of transitioning to other departments. The anti-intervention drug 'Tegretol', except for two products signed by the copyright sale contract, will not be pushed forward. Novartis Korea has decided to continue supplying 'Tegretol' but will not deploy any promotion or sales marketing personnel. Parkinson's treatment drugs Stalevo and Comtan will continue to be available for the duration of the existing contract, as Novartis is not the original copyright holder, and will not renew the contract next year. An Novartis official said, “In the process of optimizing our product portfolio strategy, we decided to sell domestic sales marketing rights for some older products to Handok. It is the headquarters decision to increase the concentration of new drugs such as Zolgensma". "We're investigating departments wants to go for CNS staff and we're transitioning. Exelon and Trileptal have recorded prescription sales worth ₩10 billion as of last year. According to drug market researcher UBIST, In 2018, sales of outpatient prescriptions for `` Exelon '' and `` Trileptal '' are estimated at ₩1.7 billion and ₩8.2 billion, respectively. Both products received a six-month suspension from insurance payments for Aug 24 2017 ~ Feb 23 2018 due to illegal rebates for health care workers, which drastically reduced the size of prescriptions. In 2016, before the suspension of wages, the Exelon prescription dropped by 86.7% and 27.3%, respectively.
- 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”.
