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- 2026-04-16 04:58:38
- Opinion
- [Reporter's View] Vaccine's Cold Chain& Distribution System
- by Oct 17, 2020 06:36am
- Shinsung Pharm in charge of distribution of the flu vaccine at room temperature is being criticized. Shinsung Pharm itself has acknowledged the fault in the distribution process and is waiting for the disposal of the health authorities. The pharmaceutical distribution industry, which has been mainly dealing with synthetic drugs and OTC drugs, has not been very aware of the cold chain. So, even after putting vaccines that shouldn't be kept at room temperature in a paper box without any preservation devices and leaving them outside for hours, they didn't feel any problem. Will it be resolved if only Shinsung Pharm is punished? This incident is only a lack of awareness of cold chains for biological products. The importance of cold chains has emerged more than ever to distribute COVID-19 vaccine, which must be kept refrigerated and frozen due to COVID-19. In consideration of the health policy and the pharmacy network, the distribution of public masks was ultimately entrusted to the pharmaceutical distribution industry. The situation is different for the COVID-19 vaccine. Unlike a mask that can be carried in a paper box, it is essential to refrigerate or freeze COVID-19 vaccine. In particular, it is known that the mRNA vaccine under development by Moderna or Pfizer should be kept at -20℃ and as low as -70℃. Recombinant protein-based vaccine by Novavax needs to be refrigerated at 2-8℃. If the vaccine to be refrigerated falls below zero, problems such as foreign substances may occur, so it is necessary to separate the reference temperature for each manufacturer. It is considered a more important factor than the hospital network, whether the COVID-19 vaccine can be delivered by strict compliance with the reference temperature throughout the entire transportation process from the factory to the frontline hospital. In particular, if it is produced abroad, it must have the capability to check not only the road but also the air transport process. Can the current drug distribution industry's capabilities affect the level of shipping COVID-19 vaccines? Looking at the seminars and conferences surrounding the recent COVID-19 vaccine, FedEx Korea emphasized the strict cold chain system at BIOplus held last month. FedEx Korea said that it minimizes exposure to room temperature by identifying vehicle entry height restrictions, loading docks, and even forklifts through on-site inspection. In case of land transportation, it is prepared in case of a failure in temperature control with a double safety device, and the real-time temperature is checked through 24-hour monitoring. In the case of air transport, it is identified as a premium cargo so that pharmaceuticals can be managed, and it also prepares for sudden changes in flight. Although the general logistics industry is equipped with cold chains, the pharmaceutical distribution industry is still in its position in the past. The proportion of biologics is increasing rapidly, but changes in the distribution industry are slow. With a few temperature-controlled cars and a few warehouses as before, it cannot outperform the large logistics companies following the international system. In the future, if the drug distribution industry is no longer able to transport biopharmaceuticals due to lack of capacity, the damage may be passed on to the public. It is also the reason why the new distribution philosophy and legalization of the system must be updated due to the vaccine distribution crisis.
- Policy
- 13,000 Allergan breast implant recipient data missing
- by Lee, Hye-Kyung Oct 17, 2020 06:36am
- Apparently, the information on 13,000 patients who received Allergan’s textured breast implant has not been fully surveyed, yet. In August last year, South Korea’s Ministry of Food and Drug Safety (MFDS) has ordered healthcare providers to halt using the implant and recalled the products as a patient, who received the implant, has been diagnosed with a rare cancer, the breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) Democratic Party Lawmaker Nam In-soon quoted the National Assembly audit materials submitted by MFDS on Oct 13 and projected approximately 130,000 of Allergan’s breast implants subject to recall have been sold to 1,242 healthcare institutes, which were implanted to 60,000 to 70,000 people. The information on 46,691 implant recipients treated from 1,023 healthcare institutes have been reportedly collected from affected healthcare institutes and public health center (for closed hospitals) from last January through the end of September. The information collected by 201 healthcare institutes and the contact information records left with the public health center were either incomplete or missing. The 18 healthcare institutes still in business have not submitted the patient follow-up monitoring data. According to the adverse reaction report on the recalled breast implant submitted by MFDS, total 1,670 cases have been reported from 2017 to September this year. Major adverse reactions like BIA-ALCL, capsular contracture, implant rupture, seroma, pain, infection, foreign body sensation, inflammation, foreign body reaction, dislocation, skin wrinkles and edema have been reported so far. A healthcare institute is supposed to register the information of artificial breast-implanted patient, who visited, got tested and diagnosed with BIA-ALCL, to the electronic database. As of Oct. 11, total 88 patients have been registered, where three ALCL-positive patients have been treated, 73 patients tested negative and 12 did not need further testing. Lawmaker Nam stressed, “ALCL-suspicious symptoms include swollen breast, clumps on capsular and skin rash. Any implant recipient seeing these symptoms should get tested and treated at hospital as Allergan is to compensate for the testing and treatment cost.”
- Company
- Different use different price for same substance drugs?
- by Eo, Yun-Ho Oct 15, 2020 06:06am
- One says “Why should drugs cost the same when their effects, target patient sizes and values are different?” Another argues, “Why should I pay more for a drug that shares a common substance with other drugs?” In some way, both of those arguments make sense. And it is considered a conventional conflict of interest between a seller and a consumer. An ‘indication-specific drug pricing’ means granting a pricing on a drug based on each indication with different value of innovation the drug owns to reflect the recent changes in drugs having various indications. So far, an organization representing multinational pharmaceutical companies, the Korean Research-based Pharmaceutical Industry Association (KRPIA), has been focusing on expanding risk sharing agreement (RSA) and pharmacoeconomic evaluation (PE) exemption eligibility. But now it is advocating differentiated pricing based on specific indication of the drug. The industry trend of one drug having numerous indications has been apparent for at least five years, considering the South Korean market only. Lately, various indications not only applicable for different lines of treatment, but also for different disease treatments have been added constantly. But why now? ◆Reactions on expanded RSA: The revised RSA system is the reason why KRPIA and multinational pharmaceutical companies have been closely following the indication-specific drug pricing. On Oct. 8, the industry was relieved to see a follow-on drug now eligible for RSA. The revised regulation provides an option of RSA to cost-effective drug (latecomer) with treatment level equivalent to first-in-class drug. However, the South Korean government also added another clause as well. Although the regulation was alleviated on follow-on drugs, the government now demands for cost-effectiveness confirming evidence (administration cost comparison or PE) from a RSA drug when expanding its reimbursement regardless of having RSA-eligible indication or not. After the said revision was disclosed, KRPIA officially addressed of ‘indication-specific drug pricing’ in an official statement submitted. At the time, KRPIA claimed “The cost-effectiveness evaluation standard’s consistency and predictability of the final price could be improved, if the drug pricing was decided based on indication. The labeled price could be kept the same, but the patients’ treatment access could improve if the contract is signed to apply differentiated indication-specific refund rate based on the actual cost-effective price for each indication.” At a glance, the indication-specific drug pricing and regulation to confirm cost-effectiveness in a drug seeking to expand RSA reimbursement, but it is far from it. Previously, RSA-applied drug coverage expansion was processed by the Health Insurance Review and Assessment Service (HIRA) setting the reimbursement standard without reviewing cost-effectiveness evidence and the National Health Insurance Service (NHIS) negotiating based on increasing patient size and use volume and adjusting the refund rate. Of course, nowadays the Cancer Deliberation Committee is the biggest hurdle for the pharmaceutical companies, but the said course of action was considered typical. But basically, it means the latecomer drugs’ pricing are lowered with the same standard as the first-in-class drug, because the authority grants minimum pricing after comparing against alternative options’ administration cost and PE results. And it creates a synergy effect when overlapped with latecomer’s drug approval, because the lowest pricing goes down as the number of follow-on drug listed with RSA goes up and listed indication expands. In other words, the industry is complaining “Why should the drug pricing always fall and never get raised? If the cost-effectiveness of an added indication is higher than the previously listed induction, then the pricing should be adjusted accordingly.” Various types of novel payment models in other countries◆The basic frame of indication-specific drug pricing as explained by the industry: Their argument is actually not a farfetched idea. The background of KRPIA and the industry’s claim is that the introduction of the indication-specific drug pricing in South Korea would highly likely to be limited to RSA-applied drugs (preferentially considered) that also adjust the refund rate. Currently, Australia, Switzerland and the U.S. are using the indication-specific pricing that mostly maintains the initial labeled price but adjusts the refund rate. And other types of novel payment models (NPM), such as combination-based pricing and over-time payments are used in Australia, Switzerland, the U.S. and Italy to improve access to new drug. The industry experts seem to agree the indication-specific pricing is the most suitable model in the South Korean market. And from the government’s perspective, the notion is not to be dismissed blindly. The self-explanatory term, ‘indication-specific pricing,’ literally means pricing a drug based on the value of each indication. If the system, as described by KRPIA, adjusts the refund rate based on the value of the indication assessed through PE while maintaining the labeled price, the government could find more grounds to lower the drug pricing. It is also important to note that most of new drug’s additional indications tend to be less innovative than their first indication. The industry’s market access associate commented, “At this point, the reimbursement listing of a latecomer drug’s first indication may be easy, but growing number of companies has started to give up on listing additional indications with complications they face. And now the patients are left behind only to watch their access to treatment get further out of reach.”
- Company
- The patent dispute over Otezla is expected to be fierce
- by Kim, Jin-Gu Oct 15, 2020 06:06am
- OtezlaThe patent dispute over the psoriasis treatment 'Otezla (Apremilast)' is expected to be fierce. In 15 days, eight companies had a patent challenge. Considering the fact that this treatment has not yet been officially released in Korea, it is evaluated that it is receiving great attention from domestic companies. According to the pharmaceutical industry on the 14th, four companies including Mothers Pharm, Yuyu, Huons, and Cosmaxpharma challenged two patents related to Otezla on the 13th. A trial for invalidation was filed for use patents expiring in March 2028, and a trial for passive confirmation of scope of rights for formulation patents expiring in December 2032. As a result, a total of eight pharmaceutical companies challenging Otezla patents have increased. After Daewoong and Dong-A ST challenged two patents on the 29th of last month, Chong Kun Dang (5th) and Dongkoo Bio & Pharma (8th) joined. In 15 days, eight companies had a patent challenge. In the industry, there is also a possibility that more pharmaceutical companies will challenge this patent. Interestingly, Otezla has not yet been officially released in the domestic market. Otezla was originally Celgene's item. In November 2017, it was approved in Korea. At the same time, it failed to get on the reimbursed list due to the difference on the price between the insurance authority and the company. With BMS' acquisition of Celgene earlier last year, Otezla's plans to launch in Korea began to become more entangled. Initially, BMS tried to bring Otezla's copyright to it, but the Federal Trade Commission (FTC) caught up. This was the reason that BMS would be concerned about monopoly in the psoriasis treatment market if it acquired the copyright to Otezla. Eventually, BMS sold the Otezla copyright to Amgen. In August of last year, Amgen acquired global copyright for the drug for $13.4 billion. Accordingly, the domestic copyright was transferred to Amgen. It is still unclear whether the reimbursement will be applied. Even though it has not been officially released in the domestic market, companies that have challenged the patent are expecting this treatment to be sufficiently possible in Korea. It is an evaluation that it has already been verified in the global market. Otezla's global sales in 2018 were $1.6 billion (about ₩1.83 trillion). In the industry, global sales are expected to expand to $2.5 billion (about ₩2.86 trillion) by 2023.
- Company
- SK Biopharm, to export technology for XCOPRI to Japan
- by An, Kyung-Jin Oct 15, 2020 06:05am
- XCOPRI SK Biopharm announced on the 13th that it has signed a technology export contract for the development and commercialization of XCOPRI (Cenobamate), a new epilepsy drug, in Japan with Ono Pharma. With this contract, SK Biopharm secured ¥5 billion (approximately ₩54.5 billion) in a down payment without obligation to return it. It is worth ¥48.1 billion (approximately ₩524.3 billion) for technical fees (milestone) by stages according to the achievement of permission and commercialization. Separately guaranteed royalties equivalent to two-digit percent of sales. XCOPRI is a brand for Cenobamate that was independently developed by SK Biopharm and received approval for sale by the US Food and Drug Administration (FDA) in 2019. It is prescribed for adult epilepsy patients with partial seizure symptoms. As a positive allosteric modulator of γ-Aminobutyric acid type A (GABAA) ion channel, it is known to reduce repetitive firing of nerve cells through blocking voltage-translating sodium current, thereby reducing seizure symptoms. SK Biopharm is currently pursuing large-scale phase III clinical trial to commercialize Cenobamate in three Asian countries, including Japan, China, and Korea. In the Japanese market, SK Biopharm plans to perform phase III clinical trial, and the two companies will cooperate in development and product approval. Through this contract, SK Biopharm has also secured a co-promotion option to jointly carry out commercialization with Ono Pharm. Ono Pharm is a research and development-oriented pharmaceutical company headquartered in Osaka, Japan. The main item is 'Opdivo' (Nivolumab), an immune checkpoint inhibitor, and it is focusing on the development of First-in-class drugs for diseases with cancer, immune diseases, and nervous system diseases. CEO Jo Jung-woo of SK Biopharm said, "With this contract, we are expanding SK Biopharm's position in Japan, one of the largest pharmaceutical markets in Asia." Sagara Gyo, CEO of Ono Pharma Korea said, "We are very pleased to be able to cooperate with SK Biopharm to commercialize Cenobamate. We believe that Cenobamate will be a new treatment option for Japanese patients suffering from epilepsy. "
- Policy
- Insurance benefits for Vizimpro·Ferinject were passed
- by Lee, Hye-Kyung Oct 15, 2020 06:05am
- Pfizer Pharmaceutical Korea's non-small cell lung cancer treatment 'Vizimpro (Dacomitinib)' was recognized as reimbursement drug. Eisai Korea's Equfina 50mg (Safinamide mesylate), an adjuvant therapy for Parkinson's disease patients, and JW Pharmaceutical's iron formulation,'Ferinject inj (Ferric hydroxide carboxymaltose complex)', also passed. The HIRA (President Kim Sun-min) released the results of the deliberation on the adequacy of medical treatment benefits for the drugs applied for decision deliberated at the 10th Pharmaceutical Benefits Advisory in 2020. The new drugs that were evaluated for reimbursement adequacy this time are 6 pharmaceutical companies and 6 products. 3 items are recognized as appropriate for reimbursement and drug price negotiations with the NHIS are in progress. It is possible to convert into reimbursed drug for Santen's intraocular pressure-lowering treatment 'EYBELIS 0.002% ophthalmic solution (Omidenepag isopropyl)' and Roche Korea's influenza treatment 'Xofluza 40mg (Baloxavir marboxil)' if the drug companies accept less than the deliberated amount.
- Policy
- The number of generics in Korea is more than 10 times higher
- by Lee, Jeong-Hwan Oct 14, 2020 06:24am
- It is pointed out that the number of generic drugs with the same active ingredient licensed in Korea is “more than 10 times higher” in foreign countries such as the United States and France. This is the result of comparing the top five items with the largest number of domestic marketing generics with overseas cases. In particular, it was added that generic drugs, which are more expensive than original drugs, are being prepared in Korea, and that the activation of generic substitution was necessary. On the 13th, nonpartisan representative Lee Yong-ho analyzed the top five products with the highest number of generic drugs in Korea and revealed as such. The top five items as of September this year were Rosuvastatin, Clopidogrel, Mosapride, Cefaclor, and Fluconazole. In Korea, the number of domestic generics for a drug reached 136 to 143. There were no generic or only 2 to 18 generics in the United States and France. Among these items, the lowest price for Fluconazole is from ₩395, the highest price is ₩1,784, and the original’s price is ₩1,726. The price difference between generics is ₩1,389, and the price of the generic is higher than that of the original. In addition, Rosuvastatin, Clopidogrel, and Mosapride, excluding Cefaclor, were also more expensive than the original drug price. He said, "The number of domestic generics is abnormally higher than that of other countries, and even though it is the exact same drug with proven bioequivalence, there is a large price difference between generics." He pointed out that there are too many, causing inconvenience in the people's prescription, dispensing, and drug selection due to information asymmetry. He said, "There are dozens of drugs that are cheaper than the drugs that the people are taking. Few people will know the facts whether or not the drugs they are taking are original, whether they are generics that are more expensive than the original, and whether they are the most expensive generics of the exact same generics with the same ingredients.” In addition, he said, "If bioequivalence testing and securing public confidence in the quality of generic drugs are preceded, drugs entrusted by the same manufacturing facility are exactly the same. As for the rights that the people need to know, generic substitution should be activated as much as for bioequivalence-approved items."
- Policy
- “Riavax problem even noticeable for incompetent officer"
- by Lee, Jeong-Hwan Oct 14, 2020 06:24am
- Former Clinical Trial Deliberation Committee Member of MFDS Kang Yoon-hee (left) and Professor Park In-geun of Gachon University Gil Medical Center Witnesses at National Assembly annual audit reproached Riavax, the immunotherapeutic peptide for pancreatic cancer treatment revoked from marketing approval, has apparently submitted review materials that every researcher at Ministry of Food and Drug Safety (MFDS) would notice how they were poorly prepared. Regardless of the failure in global Phase 3 clinical trial and clinical data with highly suspicious reliability, they claimed MFDS did not reject the item approval application but decided to approve the product and even ignored the request for post-review approval revocation. At the National Assembly Health and Welfare Committee’ audit session on MFDS conducted on Oct. 13, former Clinical Trial Deliberation Committee Member of MFDS Kang Yoon-hee (M.D.) and Professor Park In-geun of Gachon University Gil Medical Center answered Democratic Party Lawmaker Nam In-soon as witnesses. Lawmaker Nam summoned former Committee Member Kang, who reviewed Riavax approval materials, to point out the faults in Riavax approval review procedure MFDS sloppily handled. Former Committee Member Kang answered, “The submitted evidences were reviewed in August last year, and I sent an email to high-level executives in MFDS in charge of drug approval review to request revocation of the item approval as we found serious issues in the reviewed materials,” because “the eotaxin testing used in the approval review was not approved as itself, and its credibility is so low that it cannot properly prove anything.” She stressed, “The issues found during the review were noticeable even for an incompetent researcher at MFDS. The company submitted an approval application with retrospective analysis based on eotaxin and not a proper clinical trial,” and “it was approved for marketing without credible review standards.” Another witness Professor Park also addressed issues in the Riavax approval review. Professor Park urged, “I suspected there could have been some sort of special treatment for the company, when I read the news the ministry approved of Riavax by retrospectively analyzing eotaxin as a biomarker,” because “eotaxin is irrelevant to Riavax, and using the retrospective analysis on 80 patients out of over 1,000 clinical trial participants as an evidence for the approval was clearly problematic.” “An item approval should be based on evidence to confirm the item whether it would benefit patients in treatment or cause harm to them,” and “Riavax’ effect was weak, and approving these kinds of drugs could eventually take away patients’ treatment opportunity,” Professor Park added. Lawmaker Nam also raised suspicion that the Riavax received special treatment during the approval review as a former director of Review Coordination Division at MFDS was involved. Lawmaker Nam stated, “It is difficult to comprehend how it was possible to accept the result of retrospective analysis as Phase 2 clinical trial to grant an approval with evidence in development,” and “also, it was exceptional for the ministry to approve a treatment supplementary Leukine injection by individually purchasing it when it was not even approved in South Korea. The public criticized how the former director of Review Coordination Division was appointed as a vice-president of GemVax & KAEL and meddled with the review.” The lawmaker demanded, “It is problematic that a MFDS officer takes an executive position at a pharmaceutical company and leads the approval review procedure,” and that “the ministry should hand in results of its self-audit assessing the adequacy of the Riavax approval before the general audit.” A MFDS representative answered the ministry would follow Lawmaker Nam’s order. Minister Lee Eui-kyung said, “Although there was misunderstanding, the transfer of the former director of Review Coordination Division to GemVax & KAEL did not seem to have violated the employment review related regulation,”
- Company
- Law firms hire drug industry personnel to expand clients
- by Eo, Yun-Ho Oct 14, 2020 06:23am
- Former Director Lee Dong Uk (left) and Former Director Yoo Hee-sang Law firms in South Korea are busy scouting pharmaceutical industry specialists to attract pharmaceutical company clients. The related industry sources reported law firms like Kim & Chang, Lee & Ko, Yulchon and Shin & Kim have recruited external experts for their healthcare teams for the last month. Shin & Kim has welcomed a former director in Ministry of Health and Welfare (MOHW) and a former Deputy Minister of Health in Uzbekistan, Lee Dong Uk as a senior adviser. Joining the healthcare team in the firm, Senior Adviser Lee has served in MOHW for three decades as a director of Health Insurance Policy Bureau and a director of Healthcare Policy Bureau and led the National Health Insurance (NHI) and healthcare policies. In particular, he has been revered as the best specialist in NHI reimbursement policy like NHI drug pricing decision and adjustment and drug listing for reimbursement. Lee & Ko appointed Yoo Hee-sang, a former director of Medical Device Management Division at Ministry of Food and Drug Safety (MFDS), as a senior adviser. He used to be in charge of medical device management policy for 16 years in MFDS. His milestones were consigning public agency to review and approve low-risk medical device, compiling a safety management guideline for medical purpose mobile app and exempting business registration, introducing bill to set a separate Medical Devices Act, and exempting heart rate measuring device for sports and leisure activity. Although Lee & Ko shook hands with former Director Yoo, the firm bided farewell to Senior Consultant Byun Young-sik (former Senior Director at AstraZeneca) newly joining Kim & Chang. He began his career in the pharmaceutical industry from Janssen in 1994 and experienced more drug pricing and market access tasks for a decade in AstraZeneca. He was leading the reimbursement listing process for the third generation lung cancer targeted therapy ‘Tagrisso,’ and the first ever pharmacoeconomic evaluation-exempted drug and medullary thyroid cancer treatment, ‘Caprelsa.’ Based on his rich career, Lee & Ko scouted him in 2018. But with his new contract with Kim & Chang, Senior Consultant Byun would rub shoulders with Senior Advisor Lee Byeongil (former director of Pharmaceutical Management Department at Health Insurance Review and Assessment Service) and Senior Consultant Koh Su-kyung (former senior director at Norvatis). In the first half of the year, Yulchon recruited Associate Huh Na Eun (former Legal Counsel of Regulatory Reform and Legislation Division at MOHW), and the company welcomed Consultant Jung Hye Yeon (former Senior Director at Bristol-Myers Squibb) and Patent Attorney Kim Tae Kyung (former director of New Drug Listing Division at HIRA). They are a group of seasoned experts in drug pricing and NHI reimbursement listing. An associate from a multinational company commented, “The law firms are constantly contacting personnel who have experience in healthcare business from both government and the industry. As the firms are committed to expand business in new drug reimbursement consulting, more personnel from pharmaceutical companies would move to those firms in the future.”
- Policy
- What is the result of 759 illegal rebate-related drugs?
- by Lee, Jeong-Hwan Oct 14, 2020 06:23am
- In the last five years, 759 drugs were counted as having received administrative disposition for illegal rebates. Dong-A ST ranked first in the number of rebate disposals with 267 items, while CJ Healthcare ranked second with 114 items and Hanall Biopharma ranked third with 74 items. Among them, only 96 items were suspended from application of medical care benefits. On the 12th, Kwon Chilseung, a member of Democratic Party of Korea analyzed and released the data submitted by the MOHW. According to the data, 759 items of 32 pharmaceutical companies have received illegal rebates over the past five years. Of a total of 759 items, 532 were reduced in drug prices. 96 items were suspended from medical care benefits. The remaining drug disposal details are 94 penalties, 34 drug price cuts and warnings, and 3 warnings. The pharmaceutical company that received the most administrative disposition for drug rebates is Dong-A ST, which includes 267 items. Next, CJ Healthcare followed with 114 items, Hanall Biopharma with 74 items, and Inist Biopharma with 49 items. Kwon Chilseung, a member of Democratic Party of Korea, said, “For the rights that patients and citizens need to know, related information such as rebate providers, related drugs, and recipients should be continuously disclosed.” Also he added that administrative sanctions against providers should be strengthened in order to eradicate rebates.
