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- 2026-05-15 22:37:45
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- Counterattack of Valsartan’s Pharmaceuticals
- by Chon, Seung-Hyun Dec 03, 2019 05:54am
- Pharmaceuticals filed an alleged class action lawsuit against health authorities. A lawsuit was filed preemptively that the government can not accept the Valsartan claim. Cost liability for follow-up of impurity drugs has been determined in court. According to the industry, 36 pharmaceutical companies recently filed a lawsuit to confirm the absence of debt against the National Health Insurance Service in the Seoul Central District Court. It is a lawsuit stating that it is not responsible for the valsartan damages claimed by the National Health Insurance Service. The NHIS asked to pay a donation of ₩2.03 billion to 69 pharmaceutical companies in last October. It is a follow-up to the Ministry of Health and Welfare's decision to return the amount of money invested in pharmacies after exchanging impurity valsartan for the remainder of their prescriptions last year. It is unprecedented that pharmaceutical companies filed a lawsuit against the government in a group. In 2012, the government made a move to file a lawsuit against the collective price cuts of health authorities, but did not lead to a legal workshop. In 2013, the NHIS and pharmaceutical companies filed a lawsuit for damages related to drug substance preferential treatment. However, at this time, the NHIS filed a lawsuit. Originally, pharmaceutical companies considered the joint response to the NHIS 'lawsuit. However, they agreed to take a hard-line response by preemptively bringing up class action. The number of companies participating in litigation is also on the rise. Pharmaceutical companies were the first to discuss whether they would co-operate for the first time immediately after receiving a bill from the NHIS in early October, at that time, 20 companies showed a positive position. When it decided to file a lawsuit last month, it increased to 35 companies, and it was reported that one large pharmaceutical company was willing to join an additional company immediately after submitting the complaint. Most companies with large damages have refused to pay. According to the data submitted to the Democratic Party's member, Nam In-sun, 26 pharmaceutical companies paid ₩440 million in compensation. The payment rate was only 21.5%. The pharmaceuticals refused to pay about 80% of the recourse amount. Pharmaceutical companies are claiming no responsibility for the government-claimed Valsartan damages. The NHIS has proposed a product liability law on the grounds of valsartan compensation. It is judged that there is a defect in the manufacturer's product and safety, and according to the product liability law, it is possible to claim for damages due to the product defect. It is based on Article 3 of the Product Liability Act, which states that 'manufacturers shall reimburse those who suffer damages to life, body or property due to defects of the product'. Pharmaceutical companies stress that there are no manufacturing and design flaws with impurity valsartan. Carcinogen N-nitrosodimethylamine (NDMA), detected in Valsartan’s issue, is a hazardous substance in the valsartan raw material that has no standard. Neither governments nor pharmaceutical companies were aware of the risk of NDMA detection in Valsartan. According to the Product Liability Act, it is clear that if the manufacturer proves that a defect was not found at the level of science and technology at the time the manufacturer supplied the product, it would be liable for damages. After the valsartan’s issue, the MFDS derived a test method for detecting NDMA from Valsartan raw materials and set new standards. The MFDS set the NDMA standard for Valsartan to 0.3 ppm or less by reviewing the guidelines recommended by the International Pharmaceutical Regulatory Coordination Committee (ICH M7), domestic and international data, and expert advice. Moreover, the hazard of impurity Valsartan was not revealed. The MFDS said, “ in last December, based on individual doses and duration of patients actually taking NHA-detected drugs using Valsartan by Huahai , the possibility of additional cancer was negligibly low“ Pharmaceutical companies argue that the National Health Insurance Service does not include claims for damages. The NHIS has charged Valsartan medical fees and dispensing fees, but pharmaceutical companies are not liable for compensation under the Product Liability Act. An official of a pharmaceutical company said, “We took huge losses from the recovery and disposal of products that are not exposed to human hazards, and it is unfair to pay for represription fee and redispensing costs. Following Valsartan, sales of Ranitidine and Nizatidine were stopped, and we decided we need to weigh the injustices of the government action”.
- Company
- ECCK “Revised Pricing Negotiation Guideline Violates FTA"
- by Kim, Jin-Gu Dec 03, 2019 05:53am
- Chair Julien Samson of ECCK Healthcare Committee (VP& General Manager of GSK Korea, fourth from the right) and other ECCK members presented White Paper 2019 and presented recommendations to Korean government. Europe-based global pharmaceutical companies with offshoots in Korea have filed official complaints on ‘additional requirements under side agreement’ added to drug pricing negotiation procedure in Korea. They claim the new changes could violate the principles of Korea-EU Free Trade Agreement (FTA). European Chamber of Commerce in Korea (ECCK) convened a press conference on Nov. 29 at Four Seasons Hotel Seoul, and addressed issues regarding each industry sector and 180 recommendations to the Korean government. ECCK’s Healthcare Committee (Chair Julien Samson, VP & General Manager of GSK Korea) also contributed 34 recommendations. The highlight of the recommendations was the ‘Revising the New Requirements Imposed through Drug Price Agreement.’ National Health Insurance Service (NHIS) imposed several ‘side agreement’, or ‘additional requirements’ to the pharmaceutical companies during the price negotiation since last year and regulated them in June, 2019. ECCK official warned the additional requirements were “regulated without any public comment period. Some of them are overly strict with little relevance to pricing negotiation. This could violate the principles of Korea-EU FTA”. The committee argues Korea-EU FTA stipulates when revising regulation or guideline regarding pharmaceutical pricing or insurance reimbursement, both government bodies should communicate with industry. “It is recommended to consult with the industry stakeholders on any new requirements or revisions in line with the principles of the Korea-EU FTA”, ECCK officially advised. In fact, the side agreement requirements have become the most talked about issue of recent drug pricing negotiation cases. Lipiodol incident was the critical point triggered the Korean government. The change is interpreted as the government’s effort to prevent any other already-listed item refusing to supply products to Korean market. The new requirements impose penalty on pharmaceutical company not fulfilling obligation to supply drug products, and stipulate the companies to provide compensation for patient when suspending supply. Also the side agreement requires both negotiating parties to keep negotiation details non-disclosed. Biogen’s Spinraza, Janssen’s Darzalex, Amgen’s Prolia and other items that completed pricing negotiation this year had to meet the additional requirements. Although it had the negotiation last year, CJ Healthcare’s K-Cab had to fill out the side agreement as well. And three new drug items exempted from negotiation were denied from the last reimbursement review procedure in April, because they were “missing side agreement”. It was unexpected as reimbursement used to be granted usually without an issue for an item passed by Health Insurance Policy Deliberation Committee (HIPDC). At the end, Whanin Pharm’s Agotin, AstraZeneca’s Faslodex and Takeda’s Alunbrig were successfully listed after compiling side agreement. But the happening reaffirmed the gravity of side agreement in the negotiation procedure. In June, the side agreement submission was regulated as a law. NHIS’ revised drug pricing negotiation guideline now requires pharmaceutical companies to submit an agreement about supply obligation, patient protection measures, and confidentiality when negotiating drug pricing. The Article 9 of Drug Pricing Negotiation Guideline was revised and now imposes new requirements to pharmaceutical companies to protect Korean patient, to provide compensation for patient damage, and keep negotiation confidential. The pharmaceutical industry is mainly complaining about the government omitting the industry comment period. For an instance, a global pharmaceutical company organization, or Korean Research-based Pharma Industry Association (KRPIA), submitted an official statement claiming “Imposing of additional requirement or obligation for drug pricing negotiation should come with an administrative notice according to the Administrative Procedure Act”. The organization also reprehended the new requirements are considered as ‘side agreement’, but it actually puts NHIS on an authoritative position for it to unilaterally impose obligations to pharmaceutical companies. The ECCK’s complaint is basically an extension of the criticism. Established in 2012, ECCK has headquarters in Europe and it consists of 360 active member companies. Every year the Chamber represents the voice of European businesses by collecting recommendations and relaying them to the Korean government. Last year, the Chamber has presented ECCK White Paper 2018 with 123 recommendations, and almost 40 percent of the recommendations received positive feedbacks from the Korean Ministry of Trade, Industry and Energy (MOTIE).
- Company
- Drug Committees pass oral Fabry treatment Galafold
- by Eo, Yun-Ho Dec 02, 2019 05:57am
- Galfold (migalastat) The world’s first orally taken Fabry disease treatment ‘Galafold’ is landing its code on tertiary hospital drug list. According to pharmaceutical industry, Handok’s Galafold (migalastat) has been passed by drug committees (DC) in specialized healthcare institutes for rare disease care, like Seoul Asan Medical Center, Ajou University Hospital, and Pusan National University Yangsan Hospital. Other major general hospitals and Big 5 hospitals are also processing the drug code. Galafold is prescribed to patients aged 16 years or older with a confirmed diagnosis of Fabry disease and who have an amenable mutation. The treatment should be taken one capsule every other day. Galafold’s Phase 3 ATTRACT study switched therapy for 57 Fabry disease patients, who had enzyme replacement therapy (ERT) for at least 12 months, with Galafold. The investigational treatment demonstrated statistically equivalent annual change of estimated glomerular filtration rate (eGFR) with 18-month of ERT. While the group who remained on ERT had a decline of left ventricular mass index (LVMi) by -2.0 g/m2 over 18 months, the group who switched from ERT to migalistat had a significant decline in LVMI by -6.6 g/m2 over the same period. Developed by an U.S.-based Amicus Therapeutics, Galafold was approved by the U.S. Food and Drug Administration (FDA) in October, 2018, and it is now available in the U.S., EU, Australian, Canadian, Swiss, Israeli, and Japanese markets. The treatment has been designated as an investigational orphan drug to meet urgent medical needs, and received approval from Korean Ministry of Food and Drug Safety (MFDS) in 2017. Its insurance reimbursement was also granted from last March. Currently, Galafold’s competitive medicine are Sanofi Genzyme’s Fabrazyme (agalsidase beta) and Shire’s Replagal (agalsidase alfa). The two competitors are ERT sharing a similar mechanism in injection formulation. Replagal is injected once every other week into intravenous line with dose of 0.2 mg per kg body weight, whereas Fabrazyme is injected once every other week into intravenous line with dose of 1.0 mg per kg body weight. Fabrazyme is comparatively a high-dose treatment. Another notable difference is that Replagal is produced in a human cell line, and Fabrazyme is produced in Chinese hamster ovary cell line. An official from Korean Society of Medical Genetics and Genomics commented, “Rare disease like Fabry disease has small patient size to begin with, which makes conducting a credible clinical trial quite difficult. Therefore, medical professions are more likely to be loyal to older treatments. However, having more treatment option for the disease is good news”.
- Company
- The Answer is in RSA expansion and undisclosed pricing
- by Kim, Jung-Ju Nov 29, 2019 10:54pm
- Maybe the answer has been before our very eyes all along. If Korea Passing occurs when other foreign countries start referring to Korean drug pricing, then it could be avoided by preventing them from referencing. Otherwise, drug could be price at a moderate level to avoid Korea Passing regardless of other countries. Theoretically they are both simple, but realistically they are not. It is close to impossible for Korea to bring up the pricing level immediately. So the second option of making Korean pricing system unattractive for external reference pricing, or in other words, increasing number of ‘undisclosed drug pricing’ could be a better option. Ultimately, the industry is leaning towards risk sharing agreement (RSA). Daily Pharm’s survey on 21 market access personnel from multinational pharmaceutical companies clearly showed their intention. 16 out of 21 companies suggested ‘RSA expansion or splitting out the refund type’, or ‘undisclosed drug pricing’ as solutions for Korea Passing. RSA has a room to grow, “make the right decision for the people” Increase number of listed drugs with dual pricing to prevent disclosure of actual price. Raise the externally referenced pricing with higher labeled price. Dual pricing for refund type RSA system in Korea undergoes economic evaluation like any other generally listed drug, and receives actual price according to ICER value. In other words, the government may provide dual pricing, but it does not affect National Health Insurance financially. But the civic groups are opposing fiercely and the government cannot blindly ignore it. The government has also shown strong will to expand RSA. Korean Ministry of Health and Welfare (MOHW) recently presented three conditions for RSA application eligibility, regardless of treating ‘life-threatening level of health condition’ or not. Expanding scope of subject disease was one of the most demanded changes the industry has been asking for, besides making follow-on drug eligible. The government, reportedly, has ongoing discussions about additional expansion plan. The industry is welcoming the government’s action for now. But many are still craving for more changes. The pharmaceutical industry is urging the government to increase ratio of undisclosed drug pricing. One change they are pressing on is ‘splitting out the refund type RSA’. The industry demands the refund type RSA should not be a conditional listing route, but another route of general listing procedure. In fact, Korea’s RSA has narrower scope than other countries. On the contrary, foreign countries are deciding to keep more number of drug pricing undisclosed. A common example that multinational companies like to take are Italy and Australia. The European country now has more than 300 drug items with undisclosed pricing, and Australia has 95 items. Taiwan and Malaysia, following Singapore, amended their regulations for pharmaceutical companies to freely apply for dual pricing. Some are also pointing fingers at the labeled price itself. A pharmaceutical company can propose a labeled price in Korea, but under the limitation of ‘less than A7 adjusted average price’. The industry explains the existing labeled pricing model could become a reason for Korea Passing in a long term. A global pharmaceutical company’s market access expert claimed, “Many countries caring about their own people are trying to secure access to new drugs by expanding the ratio of undisclosed drug pricing, despite it being a second best option. Although the title of ‘transparent pricing’ in global community is admirable, Korean government should make a decision for their patients as well”. Views and criticism on Korea Passing All of the arguments mentioned make sense. But accepting all demands at once is impractical. Their demands need a series of discussions to reach a satisfying solution. As the survey study showed, China is playing the most prominent role in the Korea Passing phenomenon the industry is worried about. China refers to Korean drug pricing, but still there are two to three years of gap in point of listing between two countries. But as the gap is narrowing, the pharmaceutical companies are now feeling the pressure. Not all drug items are instantly faced with risk of Korea Passing. Some say RSA expansion is not the only option. MOHW, for instance, recently presented an option of ‘trade-off’. The ministry intends to save expenditure from drug with expired patent, and reinvest the saved finance on securing access to new drug. However, pharmaceutical industry expressed anxiousness as they claimed it is another means of reducing drug price. It makes a sense for companies who have experienced a series of regulatory changes centering drug expenditure control. But, could it be that the companies are more concerned about risking lowered sales profit from their drugs with expired patent? Recently, a company refused to hand in a list of items with expired patent to trade off with a compensation for new drug pricing. The company presented a list of items with expired patent but expected to drop price due to expanded indication. It was basically the company turning down the trade-off offer. “We wonder if RSA is the only option. The current RSA regulation has expanded its subject scope recently, and yet the government is constantly reviewing other means of improving the system, including another expansion of subject. We need put everyone’s heads together for this problem”, a government official said. Surely, there is something wrong with foreign country’s external reference pricing creating uneasy tension and causing Korea Passing. But the multinational pharmaceutical companies are not selling designer bags or luxurious cars. And some drugs are actually priced higher in comparatively less developed country, or countries with weaker negotiation power. World Health Organization (WHO) convened ‘Fair Pricing Forum’ and adopted a resolution on “improving the transparency of markets for medicines, vaccines, and other health products”. What the global community strives to achieve with ‘drug pricing’ may differ from the multinational pharmaceutical companies. Korea Passing should never justify pharmaceutical companies trying to generate a loophole in the reimbursement listing system in Korea. We need to get a clearer view on the matter. Is there a certain headquarters passing the Korean market with a slightest inconvenience? Are executives and MA experts at Korean offshoots indeed trying to convince headquarters while they urge the government to amend regulation? They are some questions to ponder on. Another multinational company’s MA expert said, “It depends on pipelines, but each multinational company’s different nature has also affected Korea Passing. Government regulation should be improved, but it should be backed up by pharmaceutical industry’s effort as well”.
- Company
- PPC signs MOU with Clinerion to shorten clinical period
- by Eo, Yun-Ho Nov 29, 2019 06:32am
- Asia-specific CRO PPC (Protech Pharmaservices Corporation) recently signed an MOU with Clinerion, Switzerland, to shorten the time for clinical institution selection and patient registration. Through this partnership, PPC expects to use Clinerion's Patient Network Explorer platform to accelerate enrollment of subjects in global clinical trials in Korea, China and Taiwan. PPC will encourage hospitals to participate in Clinerion's Patient Network Explorer platform for Real World Data / Real World Evidence (RWD / RWE), which will have more global research opportunities. PPC is a CRO providing services related to Phase 1-4 clinical trials in Asia. In order to develop new products for pharmaceutical companies, we provide all services related to clinical trials (Project Management, Regulatory Affairs, Clinical Monitoring, Biostatistics, Data Management, Medical Writing, and Pharmacovigilance) with high quality in line with global standards. Clinerion uses the Patient Network Explorer platform to connect patients in hospitals with global networks to clinical trials conducted by pharmaceutical companies or researchers conducting research. The system is based on electronic health record (EHR) data, in which the individual patient is not identified, and the individual patient is not identified, thereby protecting the patient's personal information. Clinerion is also working with the Hospital Information System (P-HIS) Development Group to internationalize the next generation of HIS terminology and code standards, share precision medical data and know-how, AI-based knowledge services and related technology exchanges. Michael Stibilj, CEO of PPC Group, said, “We are pleased to provide our customers with a globally integrated subject registration service through the Patient Network Explorer platform. "We will have more opportunities to get involved, and patients will have easier access to new potential therapies." "We expect that increasing access to patient information for clinical trial registration will eventually speed up the clinical trial process and help us develop innovative products."
- Company
- GLP-1 diabetes, Trulicity runs at a high speed
- by An, Kyung-Jin Nov 28, 2019 10:45am
- Trulicity Once-weekly diabetes treatment, Trulicity, overwhelms the GLP-1 analog market. The company's annual sales are over ₩30 billion, exceeding ₩27 billion in nine months. The market grew to more than 98% with a single item, increasing the overall market size. According to the drug market research agency IQVIA on the 28th, Trulicity (Dulaglutide), Lyxumia(Lixisenatide), Victoza(Liraglutide) and Bayetta(Exenatide) Sales of four GLP-1 analogs, totaled ₩10.2 billon. That's a 35.8% increase over the same period last year. GLP-1 analogues are drugs developed using the GLP-1 (Glucago-Like Peptide-1) hormone, which is involved in blood glucose control in the body. GLP-1 hormone stimulates insulin secretion right after meals to lower blood sugar, and when blood sugar drops below a certain level, it reduces insulin secretion to help prevent hypoglycemia. Lilly's Trulicity, launched in 2016, dominates the market and leads the market expansion. Trulicity's revenue in the third quarter was ₩10 billion, up 38.4% YoY. Cumulative sales for the third quarter of this year amounted to ₩27.3billion. Trulicity is the only long-lasting drug administered once a week among GLP-1 analogues in Korea. Since its launch in 2016, Lilly Korea and Boryung Pharmaceuticals jointly sell. Quarterly GLP-1 Analogs Revenue and True Share Market Trend (Unit: ₩ million ,%, Source: IQVIA) Since its launch, Trulicity has established a monopoly in the GLP-1 analogue market, changing its sales record every quarter. Trulicity's sales, which totaled ₩1.4 billion in the first year, exceeded the ₩12 billion mark in the following year. In 2018, revenue was ₩2.2 billion , up 2.2 times from the previous year. This year, the company achieved its sales record set for last year in three quarters. Trulicity accounts for 98.4% of the total sales of the four GLP-1 analogs. It also contributed to the expansion of the GLP-1 analogue market. Quarterly sales of the three GLP-1 analogues, such as 'Victoza', 'Byetta' and 'Lyxumia', amounted to ₩3 billion , but the overall market expanded rapidly after launching Trulicity. It is 23 times larger than the ₩4.4 billion in the first quarter in 2016, just before the launch of Trulicity. Unlike conventional GLP-1 analogues, which had to be injected once or twice daily as a fast-acting mechanism, it was evaluated that the convenience of patients was improved by increasing the interval between injections once a week. In addition, GLP-1 analogues have been revised up in domestic and foreign diabetes care guidelines, and the baseline insulin and combination therapy received reimbursement recognition in late 2017. In contrast, GLP-1 analogs, administered once daily, continue to show negative sales. Sanofi's Lyxumia received a momentum of sales shortly after the launch of Trulicity. In the same period, Novo Nordisk's 'Victoza' and AstraZeneca's 'Byetta' sales were only ₩153 million and ₩35 million , respectively. This is in contrast to Saxenda, an obesity drug that uses only the same ingredients as Victoza, and recorded cumulative sales of ₩32 billion until the third quarter of this year. GLP-1 analogue 'ozempic (semaglutide)' by Novo Nordisk was approved by the US Food and Drug Administration (FDA) at the end of 2017 for the release. In last September, FDA approved Rybelsus which converts ozempil to oral use. but both products are still before permission in Korea.
- 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.
