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- 2026-04-04 13:41:29
- Policy
- ‘Will raise ICER threshold for innovative new drugs’
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The government has reaffirmed its policy to flexibly evaluate the ICER (incremental cost-effectiveness ratio) threshold for drugs that demonstrate innovativeness in order to strengthen patient access to new drugs. The intent is to increase the ICER threshold of new drugs based on previously announced criteria such as substitutability, prolonged survival outcomes, and whether the drug is a fast-track drug. The government maintained its position that it should be cautious about the need to extend the pharmacoeconomic exemption system to pediatric rare disease drugs and anti-cancer drugs. The Ministry of Health and Welfare's Pharmaceutical Benefits Division explained so in response to a written inquiry made during the NA Audit by Representative Myung-ok Seo of the People Power Party. Rep Seo pointed out the limitations and problems with the economic and non-economic indicators used to evaluate life. Rep. Seo asked whether the MOHW plans to raise the ICER threshold to improve access to new drugs based on analyses of recently listed drugs that have undergone pharmacoeconomic evaluations in comparison to those set in major overseas countries. The MOHW judges the cost-effectiveness of a new drug by comparing its clinical utility, such as the length of patient survival, to the additional cost. The MOHW replied that it revised the relevant regulations in August this year by specifying the ‘innovativeness’ condition among the ICER threshold evaluation factors based on the ‘Measure to Improve the Drug Pricing System Reflecting Innovation Value of New Drugs’ announced in December last year. Based on this, new drugs that satisfy the conditions of innovativeness will have their ICER value adjusted upward. The conditions for innovativeness are: ▲ there is no equivalent product or treatment that is substitutable or therapeutically equivalent; ▲ is recognized for a significant clinical improvement in the final outcome indicator, such as prolongation of survival; or ▲ the drug is a new drug approved under Article 35(4)(2) of the Pharmaceutical Affairs Act as a GIFT or equivalent. The MOHW said, “New drugs that meet the conditions of innovativeness will be flexibly evaluated with ICER thresholds that reflect their fair value. The government will strive to improve public health and ease economic burdens by strengthening patient access to new drugs for serious diseases such as cancer and rare diseases." In addition, the MOHW also plans to support the improvement of patient access to rare disease drugs through policy operations. Specifically, the ministry explained that it has reviewed measures to improve insurance listing of rare disease drugs in accordance with the ‘Specific tasks for improving access to rare disease drug reimbursement benefits’ in the Comprehensive Plan for Rare Diseases to support the prompt registration of treatments. It added that it secured flexibility in the ICER value, a criterion for pharmacoeconomic evaluation by adding 'innovation' to the evaluation factor, and has been implementing a parallel negotiation-evaluation system since January last year and a pilot project for the approval-evaluation-negotiation system since the second half of last year. The MOHW also pointed out that overseas cases such as Canada and the United Kingdom are applying measures such as flexible application of ICER values and expansion of the risk-sharing agreement systems to strengthen access to rare disease treatments, and the MOHW is also promoting policies modeled after them. To expedite the reimbursement of rare disease drugs, the MOHW replied that it will operate a pharmacoeconomic evaluation exemption system and a risk-sharing agreement system, and actively identify improvements to the system by collecting opinions on-site. However, the ministry expressed caution about expanding the pharmacoeconomic evaluation exemption criteria to include rare disease drugs and anti-cancer drugs for children. “In January last year, the MOHW revised the relevant regulations to add new drugs that treat non-life-threatening pediatric diseases but have a small number of patients and are clinically proven to improve quality of life,’ the MOHW said, explaining that “Crysvita Inj, a new drug for treating X-linked hypophosphatemia, which was approved in May last year, is a typical example.” “The pharmacoeconomic evaluation exemption system is operated as an exception that substitutes the cost-effectiveness evaluation by referencing a drug’s listed price in other countries,” the MFDS said, adding, “The proposal to expand the pharmacoeconomic evaluation exemptions to adult patients needs to be carefully promoted through public discussion.”
- Opinion
- [Reporter's view] Expanding NIP to include 9-vHPV
- by Whang, byung-woo Oct 16, 2024 05:50am
- Several treatment-related agenda items were discussed during this year's parliamentary audit of the Ministry of Health and Welfare (MOHW). Various current measures, including improvements to the drug pricing system and blood cancers, have been discussed. One is the necessity of including human immunodeficiency virus (hereafter referred to as, HPV) in the National Immunization Program (NIP). Several argued that Gardasil 9, an HPV9 included in the government's plan, should be included in the NIP. Since 2016, the nationwide HPV vaccination has been provided to girls aged at least 12. Then, since 2022, it has been expanded to include female·juveniles of 12-17 years of age, and low-income females aged at least 18-26. 2-valent‧4-valent vaccines have been included in the program, whereas 9-valent vaccine is not supported. The current issue is whether to expand the vaccination program to male juveniles. During last year's parliamentary audit, Rep. Nam In-soon of the Democratic Party of Korea requested an expanded scope of the NIP for HPV vaccines based on 'The current record of patients undergoing treatments for head and neck cancer or oropharyngeal cancer.' Rep. Suh Myung-ok, a member of the People Power Party, has presented a 'Legislative bill for partial revision of the prevention and management of infectious diseases.' The question of whether the shingles vaccine Shingrix would be included in the NIP program has drawn attention again. The remaining issue is the cost. On average, the cost of a 1-dose vaccination for Gardasil 9 and Shingrix is about KRW 200,000, thereby referred to as 'Premium vaccines.' The majority of opinions is that the problems of cost-effectiveness, regardless of the benefits brought by vaccines, hinder the government's plan to pursue this policy. However, other opinions suggest a different view towards including premium vaccines in the NIP may be necessary. This means that, beyond the cost issue, people need to consider the effects comprehensively since the preventative effects of these vaccines are proven. An effective distribution of funds may be considered because vaccinations for Shingrix have already been supported by local governments, irrespective of the current discussions within the Korea Disease Control and Prevention Agency (KDCA). Kim Yea-ji, a member of the Health and Welfare Committee (People Power Party), and Rep. Nam have emphasized that the inclusion of vaccines, such as Gardasil 9, in the program could reduce people's medical costs in the long term. However, cost-related issues remain a burden on the government, as the Korea Disease Control and Prevention Agency (KDCA)'s budget for the NIP program next year has been markedly reduced. Pharmaceutical companies may need to voice their opinions during discussions about future implementation. Considering the nature of NIP vaccines, a 'good value' approach is inevitable. Vaccines are continuously being developed, and their preventative effects are increasing. Although premium vaccines present a dilemma for NIP inclusion, changes to repeating discussions are demanding. We anticipate the government's varied approaches and discussions.
- Policy
- Govt ‘is considering measures to overcome Korea Passing’
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The government has responded that it will come up with measures to ensure a stable supply of new drugs, including a dual pricing system, to overcome the so-called ‘Korea passing’ phenomenon, in which domestic and foreign pharmaceutical companies avoid launching their drugs in the domestic market and target overseas markets first, citing excessively low drug prices set by the government. The government also said it would consider measures that could boost the development of new drugs targeting chronic diseases. On the 14th, the MOHW responded so to a written inquiry submitted during the NA Audit by Representative Myung-ok Seo of the People Power Party. The lawmaker asked for the MOHW’s opinion on the introduction of a dual pricing system, pointing out that Korean patients' access to new drugs is deteriorating due to the Korea Passing phenomenon. The MOHW said it would take reasonable measures to stabilize the supply of new drugs, including dual pricing, to overcome Korea Passing. The MOHW said it negotiates drug prices in consideration of the impact on insurance finances, but acknowledged that there are cases of pharmaceutical companies abandoning domestic insurance reimbursement listing as it may hinder overseas drug price negotiations when the prices are set low in Korea. “For this reason, we will take reasonable support measures, such as a dual pricing system, to ensure that domestic patients‘ access to new drugs is not compromised,” said the MOHW. The ministry also promised to support policies to encourage the development of new drugs for chronic diseases. First, the MOHW explained that previously, the risk-sharing agreement system was applied to serious diseases that threaten survival with anti-cancer drugs and rare disease treatments that have no substitutes, but from August this year, the system was improved to apply RSA to new drugs for chronic severe diseases that have no substitutes and irreversibly worsen the quality of life and have a large disease burden. This means that severe asthma and atopic dermatitis drugs are also eligible for RSA. The MOHW agreed on the need to develop support measures for the development of new drugs for chronic diseases but said that national health insurance finances should be considered. “Chronic diseases have a large number of patients and varying degrees of severity, so it is necessary to review rational support measures that take into account health insurance finances,” said the MOHW. “We will review the targets of support in consideration of chronic diseases with a large disease burden and come up with rational support measures for the development of new drugs for chronic diseases.”
- Policy
- Stopping illegal online sales·advertisements of 'Wegovy'
- by Lee, Hye-Kyung Oct 16, 2024 05:50am
- Product photo of Wegovy. As 'Wegovy,' a dream treatment for obesity, is set to launch in South Korea, the health authority plans to focus on monitoring online illegal sales and fraudulent advertising. It will also implement post-marketing safety management related to side effects and drug abuse. The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on October 15th of plans to implement intense monitoring of cases of sales·advertising online and SNS for a month aligninig with the launching of the obesity drug, a type of glucagon-like peptide-1 (GLP-1) agonist. A GLP-1 type obesity drug is effective in increasing glucose-dependent insulin secretion, inhibiting glucagon secretion, and delaying hunger and weight loss. The drug is Novo Nordisk Korea's Wegovy. Wegovy is a non-reimbursable drug that is not covered by the health insurance, and the domestic supply price is KRW 372,025 (4-week dose). However, as it is non-reimbursable, the sales price, including prescription fee and distribution, is expected to be about KRW 800,000 to KRW 1 million. Wegovy can be used in obese patients who have a Body Mass Index (BMI) of 30kg/m2 or higher or those who are overweight with early BMI of 27kg/m2 or higher and below 30kg/m2 and have one or more weight-related accompanying diseases, with doctor's prescription and pharmacist's filling·medication counseling. "It is illegal for people who do not have pharmacy license to sell the obesity drug," MFDS stated. "To prevent the potential risk of consumers buying obesity drugs through online·SNS, the MFDS will implement an intense monitoring of individuals selling or advertising the obesity drug online·SNS for a month aligning to the launching date." The MFDS, in collaboration with the Korea Institute of Drug Safety & Risk Management, will also monitor cases of side effects·adverse reactions related to the use of the obesity drugs and organize a monitoring task force to implement necessary safety measures. The MFDS will collaborate with the Health Insurance Review and Assessment Service (HIRA) and review· analyze the supply volume and increasing·decreasing trends in each clinic. It will also conduct on-site monitoring for fraudulent advertisements. "We will ensure people use medicines safely by monitoring domestic and overseas safety information and adverse reaction cases for obesity drugs, and we will also check online sales advertisements and conduct on-site monitoring," the MFDS stated.
- InterView
- "JAK inhibitors bring a paradigm shift to RA treatment"
- by Whang, byung-woo Oct 16, 2024 05:50am
- As patients with autoimmune diseases, including rheumatoid arthritis, have better access to medical care, early diagnosis and treatment have been pointed out as the key. Early diagnosis and treatments previously available in university hospitals are now possible in local clinics. As a result, patient-personalized therapies, even for patients with mild symptoms, through local clinics have become increasingly important. "More patients are visiting clinics at early stages compared to the past," Dr. Won-Suk Lee, Chief of Easy Rheumatis Clinic in Jeonju, said. "It is important to provide personalized treatments to improve patient's daily life." JAK inhibitors for treating rheumatoid arthritis…"We have observed fast treatment effects" Dr. Won-Suk Lee, Chief of Easy Rheumatis Clinic in JeonjuRheumatoid arthritis is an autoimmune diseases in which abnormally activated immune cells invade joints, causing inflammation and pain. In the past, it was regarded as a disease that required treatment at university hospitals. However, without properly treating it at an early stage, repeated inflammation over time can cause joint deformity, leading to loss of function. So, the importance of early diagnosis has been emphasized. Specialists in the field of rheumatoid arthritis have opened clinics all over the nation, improving patient access. "As more specialists in the field of rheumatoid arthritis have opened clinics, patients have better access. More patients now visit clinics at an early stage of the disease compared to the past,"Dr. Lee explained. "There may be differences in disease awareness depending on geographical location, but overall disease awareness has increased." Along with improved disease awareness, doctors have more treatment options to utilize. Janus Kinase (JAK) inhibitor has brought a significant paradigm shift to the treatment of rheumatoid arthritis. "Patients initially begin the treatment with DMARDs, a methotrexate (MTX)-based therapy, but when drug response lowers, patients resort to TNF-α inhibitors or JAK inhibitors," Dr. Lee said. "I have been employing a step-wise increasing prescription in patients of young age, according to the guideline." Dr. Lee quickly switches from prescribing conventional medicine to JAK inhibitors because of the 'effects' and 'convenience.' Compared to conventional medicines, JAK inhibitors have the advantages of requiring less use of steroids and pain killers. They also relieve the patient's administration burden because they are oral drugs. However, in 2021, an issue of cardiovascular system-related side effects of JAK inhibitor was reported, so there are 'safety'-related concerns. At the time, the U.S. Food and Drug Administration (FDA) issued warnings related to cardiovascular disease and cancer for JAK inhibitors. The Korean Ministry of Food and Drug Safety (MFDS) also posted safety documents. Ultimately, the FDA decided to include the safety information, including cardiovascular-related instances, thrombosis, and death, on the box warning label. Dr. Lee commented regarding this issue, "We cannot deny the research, but I have not had cardiovascular-related side effects issues during my years of prescription experience. In my opinion, side effects could be manageable, and the occurrence of shingles is seven times higher in Asia, I explain the vaccination option and prescribe it." Emphasizes the need to improve medication switching for personalized treatment The latest issue for rheumatoid arthritis treatment is obtaining insurance reimbursement authorized for switching between JAK inhibitors. Notification was expected within October, but it has been extended. Dr. Lee commented that we need to consider the criteria for using conventional medicines in addition to the issue of JAK inhibitor switching. "When medication switching is allowed, patients can choose better treatments, which is the most important point," Dr. Lee said. "The current criteria indicate that when a patient uses conventional medicine and does not benefit, one can use JAK inhibitor after six months. However, we should also consider three months amid the early intervention trend." Lastly, Dr. Lee emphasized the need for early diagnosis and personalized treatment for the management of rheumatoid arthritis. "For rheumatoid arthritis, early diagnosis and early treatment are most important, so we focus on treating patients without hindering daily lives, along with pain management," Dr. Lee said. "Rather than repeatedly prescribing the same drug, we need to consider complications and accompanying disease."
- Policy
- 'Will adjust the price of generic drugs through reevals'
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The Ministry of Health and Welfare responded to the NA’s inquiry on the ministry's policy operation plan to realize generic drug prices in Korea, explaining that the MOHW is promoting a plan to reduce and adjust drug prices through ‘external reference pricing re-evaluations.’ This means that the ministry will start the external reference pricing reevaluations, which it has continuously discussed with the pharmaceutical industry. In other words, the ministry has no plans to reduce the price of generic drugs unilaterally and is only considering reviewing the need to reduce or adjust their price by comparing the domestic drug prices with overseas drug prices. On the 15th, the MOHW responded to a written inquiry on generic drug prices from Representative Yoon Kim of the Democratic Party of Korea. Rep Yoon Kim pointed out that the generic drug prices in Korea are excessively high and asked MOHW Minister Kyoo Hong Cho about their policy on reducing the generic drug price during the last NA audit, and made an written inquiry about plans on realizing the generic drug price. The MOHW explained that to properly manage the pharmaceutical expense, a differentiated drug price is set according to the order of entry upon listing and then adjusted through re-evaluations. Specifically, for 19 or fewer listed generic drugs, domestic generic drug prices are calculated at 53.55%, 45.52%, and 38.69% of the original drug’s insurance price cap, depending on each generic drug's fulfillment of standard requirements such as submission of bioequivalence testing data and use of MFDS-registered raw materials, etc. Based on this differentiated generic drug price calculation system, the MOHW has vowed to further reduce and adjust domestic generic drug prices through external reference pricing reevaluations. “To improve the soundness of Korea’s pharmaceutical expenditure structure, we are considering adjusting domestic generic price by comparing and reevaluating the level of domestic generic drug prices with overseas drug prices,” the MOHW said, adding, “We have been collecting on-site opinion through industry meetings since last year, based on which we plan to prepare and implement reasonable measures.”
- Policy
- Amgen starts negotiations to extend reimb of Kyprolis
- by Lee, Tak-Sun Oct 15, 2024 05:50am
- The reimbursement extension process for the multiple myeloma drug Kyprolis (carfilzomib, Amgen) has entered the final stage. Its insurance drug price is being negotiated with the National Health Insurance Service. The discussion is likely for the use of Kyprolis in the Kyprolis+daratumumab+dexamethasone (DKd) regimen, which passed the Cancer Disease Review Committee (Cancer Quality Review) in April. According to industry sources on the 14th, the NHIS started drug pricing negotiations with Amgen for the reimbursement expansion of Kyprolis 60mg this month. The reimbursement standards for Kyprolis Inj was set in April as a ‘combination therapy used with daratumumab and dexamethasone for the treatment of multiple myeloma patients who have received one or more prior therapies’ by the Cancer Disease Deliberation Committee. However, the coinsurance rate for daratumumab is set at 100%, for the patient to pay in full as out-of-pocket price. It is understood that the company has since passed the Drug Reimbursement Evaluation Committee stage and started drug prices with the NHIS. In February 2018, Kyprolis was successfully listed on the reimbursement list as part of the RSA (risk-sharing agreement, refund type) scheme. The covered therapies are KRd therapy (Kyprolis+lenalidomide+dexamethasone) and Kd therapy (Kyprolis+dexamethasone). With the reimbursement, the out-of-pocket cost for the patients was reduced from KRW 10 million to KRW 500 to 600 thousand. The DKd regimen had shown evidence that it was effective in patients exposed to lenalidomide, which is why it is expected to be beneficial to patients if reimbursed. If the pharmaceutical company and the NHIS reach an agreement through negotiations, the final reimbursement list will be approved by the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee. Kyprolis is a blockbuster drug that posted sales of KRW 32.2 billion last year (source: IQVIA). Due to the large amount of claims expected with the drug, the NHIS is expected to negotiate in a way that minimizes the financial expenditure when expanding reimbursement benefits.
- Company
- oHCM drug Camzyos's last hurdle to reimb remains high
- by Eo, Yun-Ho Oct 15, 2024 05:50am
- The reimbursement journey for ‘Camzyos’, which is seeking insurance reimbursement in Korea, is going to be a rocky road until the end. According to industry sources, the drug pricing negotiations between BMS Pharmaceuticals Korea and the National Health Insurance Service (NHIS) for the obstructive hypertrophic cardiomyopathy (oHCM) drug Camzyos (mavacamten) have been extended after failing to finalize the deal within the deadline. The deadline extension was primarily due to a disagreement over the number of patients eligible for Camzyos. Camzyos’ reimbursement journey faced difficulties, receiving a redeliberation decision from the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee. The drug passed the committee and entered pricing negotiations in August, but the negotiations were not concluded within the 60-day deadline. Camzyos is the first and only cardiac myosin inhibitor that specifically targets excess cross-bridge formation of myosin and actin proteins, the main cause of oHCM. It improves left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin, relaxing the overcontracted heart muscle. Due to the lack of a cure, oHC has long been managed with off-label drug use. In fact, the European Society of Cardiology (ESC) revised its HCM guidelines for the first time in 9 years with the introduction of Camzyos. Before then, HCM guidelines have been based on small observational data reported from individual institutions, retrospective analyses, or expert consensus opinions. Therefore, Camzyos was a game-changer in the field. After demonstrating its significant effect in two large-scale Phase III randomized controlled trials (RCTs), Camzyos was recommended at the highest evidence level, A, for the first time among treatment options in the ESC guidelines. The American College of Cardiology (ACC) and American Heart Association (AHA) are also currently preparing to update their guidelines. Based on the Phase III trial data, Camzyos received a breakthrough therapy designation (BTD) and was approved by the US FDA. In the Phase III EXPLORER-HCM trial, which served as the basis for Camzyos’s approval, Camzyos achieved and improved the primary composite endpoint of the proportion of patients with decreased symptom burden (by NYHA class) and functional capacity (peak oxygen consumption, pVO2) by more than 2 times compared with placebo. In particular, 20% of the patients who received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement. Also, the dynamic left ventricular outflow tract obstruction was reduced by over 4 times with the use of Camzyos. 7 out of 10 patients treated with Camzyos improved to the extent that they would not consider surgery, and showed consistent benefits over 30 weeks. “Many patients with oHCM have been anxiously awaiting a new drug due to the lack of a suitable treatment,” said Hyung-Kwan Kim, Professor of Cardiology at Seoul National University Hospital. “In particular, expectations for the drug's reimbursement have increased since it was approved by DREC in July, and we hope that the remaining procedures will be completed as soon as possible so that patients and their caregivers in Korea can benefit from the use of the new drug.”
- Company
- “Market for veterinary drugs expected to grow rapidly”
- by Son, Hyung Min Oct 15, 2024 05:50am
- Seung-Hwan (SH) Jung, General Manager at MSD Animal Health Korea “MSD Animal Health Korea’s clients are animals. We believe that the drug distribution channels for animals should be carefully designed to contribute to the health of animals in Korea. Supplying our products to animals that need them quickly, sufficiently, and safely is the biggest principle in designing our domestic distribution network. Seung-Hwan (SH) Jung, General Manager at MSD Animal Health Korea, emphasized so to reporters about the company’s plans for supplying veterinary drugs in Korea. Over the years, MSD Animal Health Korea has launched various new products and provided technical support to meet the needs on-site. In doing so, the company has prevented and treated diseases in economic and farm animals and contributed to improving the productivity of farmers and the health and welfare of companion animals in Korea. MSD Animal Health Korea's flagship products include the ‘Porcilis PVC M Vaccine,’ which prevents the Porcine Circo Virus (PCV) and M.hyo, and the ‘Prime Pac PRRS Vaccine,’ which prevents Porcine Reproductive and Respiratory Syndrome in the swine industry; ‘Exzolt,’ a parasiticide for chickens that eliminates mites; ‘Nobilis SG9R Vaccine,’ which prevents chicken typhoid. The company also has ‘Bravecto,’ which prevents ectoparasites in pets, and ‘Caninsulin,’ the only insulin for pets in Korea. “The global veterinary drug market is estimated to be around USD 45.8 billion in 2023, of which our sales recorded USD 5.6 billion,’ said Jung. “The animal health sector is generally divided into ruminants, poultry, swine, aquaculture, and companion animals, and MSD Animal Health is the global sales leader in four of these five categories, except for companion animals.” In Korea, the veterinary drug market is estimated to be worth around KRW 1.4 trillion, with two-thirds of the market being domestically produced and one-third being imported. MSD Animal Health Korea generated sales of KRW 45 billion last year. ‘Our main business areas in Korea are swine, poultry, and companion animals,’ says Jung. In terms of total sales, the swine and poultry division accounts for the largest share, but we are also expecting rapid growth in the companion animal and livestock sectors.” “Due to issues such as superbugs, most developed countries, including Korea, have banned the addition of growth-promoting antibiotics to feed, and it is becoming increasingly difficult to use therapeutic antibiotics in livestock,’ he explained. ’Personally, I see this as a positive change that is in line with the concept of One Health, which has a common goal of seeking animal and human health. As a result, I believe the veterinary drug industry is also shifting towards prevention rather than treatment, promoting the use of vaccines rather than antibiotics.’ Jung also sees much growth potential in the domestic animal health market. With the rise in the number of people living with companion animals, the demand for animal healthcare has been growing along with the market. “The sector has been growing at an average annual growth rate of 10% with the rising demand for pet healthcare,” said Jung. “The scale of the swine and poultry industry is also large compared to Korea’s population. In particular, consumer demand is shifting to seeking safe animal products from the abundance of animal products in the past. We believe that the use of veterinary drugs to prevent diseases and promote animal welfare in farm animals, including food poisoning and zoonotic diseases, will continue to increase.” Various channels such as veterinary hospitals and pharmacies...”We plan to distribute ETCs and OTCs separately” MSD Animal Health Korea plans to utilize various distribution channels such as veterinary clinics and pharmacies. The veterinary drug market is being developed similarly to that of human drugs such as digestive and diabetes diseases, using various channels. And many pharmaceutical companies, including MSD Animal Health Korea, are looking to enter the field. “The specialization of veterinary drugs is predictable in the same way as the changes we have seen in human medicines,” said Jung, “and we interpret this as a favorable change for our business because we own many products that are unique to MSD Animal Health that other companies do not have.” ‘MSD Animal Health employees around the world are sensitive to changes in the market and disease outbreaks, and these changes are immediately reported to R&D at headquarters, resulting in new products being developed to respond quickly to changes in the market as well as diseases. We expect this strength to persist.’ MSD Animal Health's mission is ‘The science of healthier animals’. At the end of the day, Jung says, MSD's customers are animals, and providing products for healthy animals is the company's number one goal. “We are considering carefully designing the distribution channels of our medicines to contribute to animal health,” said Jung. “The overarching principle of our distribution network design is to get our products to the animals that need them quickly, sufficiently, and safely.” ‘We plan to establish different distribution networks for specialized and over-the-counter products. We will design a new distribution network in the future based on domestic laws.’
- Policy
- Reduced reimb for medicines-containing choline alfoscerate
- by Lee, Tak-Sun Oct 15, 2024 05:49am
- Complaints have been circulating regarding the decision made by the Health Insurance Review and Assessment Service (HIRA) to reduce reimbursement on medical care reimbursement claims for medicines containing 'choline alfoscerate,' a brain function-improving agent. Medicines-containing choline alfoscerate received selective reimbursement decision during the re-evaluation of reimbursement appropriateness. However, its previous reimbursement criterion is being maintained due to pharmaceutical companies fling lawsuits. However, HIRA requires even stricter criterion by designating medicines-containinig choline alfoscerate as targets for 'intensive screening.' According to industry sources on October 14th, more claim cases of choline alfoscerate have received reduced decisions over the past year. HIRA has designated medicines-containing choline alfoscerate as target items for intensive screening since 2022 and has been managing them. Intensive screening is a preventative screening that pre-notifies items that need improvements in prescriptions and manages them. It is a voluntary system to promote improvement through prior notices and marketing. There have been reports of a significant increase in reduction decisions on medicines-containing choline alfoscerate over the past year. They think that it has intensified following last year's parliamentary audit. Rep. Nam In-soon of the Democratic Party of Korea stated during the last year's parliamentary audit that "The prescription of medicines-containing choline alfoscerate for diseases other than dementia should be restricted for the National Health Insurance finances." "We must actively intervene in the practice of prescriptions of medicines-containing choline alfoscerate, which have not been proven effective to prevent dementia, disguised as dementia prevention drugs and brain health nutrients," Rep. Nam said during this year's parliamentary audit. "The National Health Insurance saved by inhibiting prescriptions related to dementia should be used to expand reimbursement for new anticancer drugs to ease burden of medical costs." Prevailing opinions in clinical practices are that the review of reimbursement claims has become stricter due to requests from the National Assembly. Several have pointed out that more reductions are being made for surpassing criterion for approval and reimbursement despite uses according to the approval criterion. "We received a reduction decision from the HIRA officer because we have not provided documents for the cerebrovascular deficit," a Hospital-A worker said. "We have doubts about HIRA's review criteria because approval criteria do not require submission of documents related to cerebrovascular deficits in case of patients with organic mental disorders related to brain function. According to the current medical care reimbursement criterion, medicines-containing choline alfoscerate are reimbursable when used within the approval criterion. The Ministry of Food and Drug Safety (MFDS) approved medicines-containing choline alfoscerate for 'Secondary symptoms due to cerebrovascular deficit, degeneration, or organic mental disorder related to degenerative brain function: reduced memory and confusion, loss of direction due to reduced drive and spontaneity, reduced drive or spontaneity, and reduced concentration." Doctors have explained that prescribing medicines-containing choline alfoscerate to patients with mental disorders with degenerative brain function who have memory loss and confusion should be no problem for issuing reimbursement, based on the criterion. Several opinions are that before the inclusion of medicines-containing choline alfoscerate were reimbursable in intensive screening, submitting patient records was sufficient. However, not, the HIRA is arguing that documents prepared according to the approval criterion are insufficient. "We were notified by HIRA to submit test results, such as MRI and MMSE, for medical care reimbursement. Neither approval of medicines-containing choline alfoscerate nor medical care reimbursement criterion require such additional tests. We inquired about the reasons for submitting such test results but have not heard a clear answer," a Hospital-B worker said. "HIRA keeps requesting submission of documents, but we are unsure what documents are needed to receive reimbursement." Complaints are circulating against different notifications from the person-in-charge, and requests do not meet reimbursement criteria or approval criteria. However, clinical practices tend not to raise appeals for practice reasons. Due to continued reduction decisions, patients complain because doctors are less likely to prescribe the medicines. "The HIRA has been avoiding providing a clear criterion related to reimbursement for medicines-containing choline alfoscerate," medical industry personnel said. "We need to determine whether patient's healthcare or doctor's prescription rights are limited due to political issues."
