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- 2026-05-03 10:13:34
- Policy
- Revlimid generics also allowed reimb for MDS
- by Lee, Tak-Sun Feb 22, 2023 05:54am
- Boryung’s lenalidomide drug Generic versions of Revlimid Cap that contain the same ingredients will be applied reimbursement for the treatment of myelodysplastic syndrome (MDS) in Korea. This is because the generic versions also obtained approval for the indication in October last year. On the 21st, the Health Insurance Review and Assessment Service preannounced plans to apply the above changes when making amendments to the ‘Notices required according to drugs prescribed and administered to cancer patients.’ The amendment will take effect on March 1. The previous reimbursement standards only allowed reimbursement for the original drug, ‘Revlimid Cap,’ among lenalidomide drugs as a treatment for MDS. The standards had been applied since May 2019. Such a decision was made in consideration of the fact that the indications for the same-ingredient drugs that were approved by the MFDS. In the past, only Revlimid had indications related to MDS syndrome approved by the MFDS. However, its generics – Boryung Pharma’s Leblikin Cap, Kwang-dong Pharm’s Lenaldo Cap, and Samyang Holding’s Lenalid Tab – also gained approval for the indication in October last year. This is why HIRA is amending the standards to apply reimbursement to generics as well. Therefore, patients who receive treatment for MDS within the approved indication and reimbursement standards will be granted reimbursement. Meanwhile, the standards for reimbursement of hematopoietic stem cell transplantation will also be amended to allow reimbursement for hematopoietic stem cell transplantations that were conducted without the prior approval process to be allowed reimbursement if they submit other evidentiary that that is equivalent to prior approvals. For this, the notes on the use of blinatumomab monotherapy (Note 6) and inotuzumab ozogamicin monotherapy (note 8) will be changed for acute lymphoblastic leukemia.
- Policy
- Plan to build an information network to normalize the supply
- by Lee, Hye-Kyung Feb 22, 2023 05:54am
- “External environmental factors such as the spread of COVID-19 and the war between Ukraine and Russia have made domestic drug supply and demand abnormal. On January 15, Korea Rare Essential Medicines Center appointed Kim Jin-seok (58, Kyungsung University College of Medicine), former deputy director of the Ministry of Food and Drug Safety, as the 13th director. The KODC, which was established to provide various information on orphan drugs and national essential drugs, is currently managing 511 items of national essential drugs and 315 cases of orphan and essential drugs submitted to the on-site supply and demand monitoring center. A total of 179 items and 14,732 drugs were supplied by the KODC last year, worth 44.2 billion won. Nine free support programs that connect pharmaceutical companies and patients are also in operation, through which 969 new drugs in clinical trials were supplied. Director Kim met with reporters from the Ministry of Food and Drug Safety on the 21st and revealed his ambition to be appointed director of the KODC after 8 months of vacancy. The following is a Q&A from Director Kim. ▶ As the director was appointed after 8 months of vacancy, it seems that there was a setback in the project. "There was a long hiatus for eight months after the former director's resignation. During this period, there was a shortage of medicines around the world due to the outbreak of COVID-19 and monkeypox. Korea was no exception, and monitoring of essential national medicines and supply shortages of medicines occurred. We are aware of the need for a domestic supply of drugs, so this year we plan to focus our efforts on the stable supply of national essential medicines. As in the case of last year’s case where the center urgently imported from Australia to solve the domestic shortage of antipyretics and analgesics due to COVID-19, domestic We will develop our capacity so that the center can play a big role in the stable supply of medicines.” ▶ Please explain the promotion project in a little more detail. “As revealed in the name of the center, the primary goal is to supply medicines that have lost their market function, such as orphan drugs and national essential medicines, from state institutions. Whether it is an orphan drug, an essential drug, or a drug with usage monitoring, a situation in which supply and demand arise means that the function of the market appears in an abnormal situation. It depends on whether or not, but for orphan drugs, at least a network is built with data on suppliers and countries. This year, it plans to build an information network for essential medicines and medicines that require on-site supply and demand monitoring. The Ministry of Food and Drug Safety signed a contract for a consignment project to build an information network last week. Internally, a program is being developed to increase the accuracy of usage statistics for essential medicines. We will complete it within this year so that production and usage can be predicted based on statistical data. " ▶ Recently, there have been cases of drug price adjustments due to shortages, and we know that orphan essential drugs have the biggest concern about profitability. Are there separate studies in this regard? “Because the center is a non-profit corporation under the Ministry of Food and Drug Safety and does not operate a profit-making business, there is no need to adjust the price of medicines supplied by the center due to a shortage of medicines. There was a case that this center that had an impact on the drug price. Last year, the drug price of 'Natasin Eye Suspension' was adjusted due to the increase in the unit price of medicine." ▶Please explain the on-site drug supply and demand monitoring project. “The center is operating an on-site supply and demand monitoring center with 7 professional organizations, including the Korea Hospital Pharmacists Association, the Korean Medical Association, the Korean Pharmaceutical Association, the Korea Pharmaceutical and Biopharmaceutical Association, the Global Pharmaceutical Industry Association, the Korea Biopharmaceutical Association, and the Korea Pharmaceutical Distribution Association. Each organization When a request for medicines in need of supply is made through expert consultation, supply-related issues are informed and solutions are sought.” ▶The budget for the center increased from 3.3 billion won last year to 4.6 billion won this year. How will the increased budget be used? “The main items of the center’s increased budget this year are 490 million won for consignment manufacturing and 600 million won for office relocation, and isoproterenol hydrochloride injection will be introduced as a new consignment manufacturing item to address the need for a stable supply of medicines that have been continuously raised.” We plan to move the center to the Post Tower adjacent to Myeongdong Station in June. The building located along the main road will make it more convenient for users of the center." ▶At the plenary meeting of the Health and Welfare Committee of the National Assembly held on the 9th, it was pointed out that it is necessary to secure personnel exclusively responsible for monitoring the supply and demand situation of medicines in the Korea Rare Essential Drug Center and to establish a close cooperation system with medical and pharmaceutical organizations. "This year, we plan to strengthen the monitoring of discontinued medicines through the administrative network linked to the Ministry of Food and Drug Safety by further activating the operation of the on-site drug supply and demand monitoring network. In particular, actively promote two-way communication between supply and demand monitoring networks through real-time information sharing with 7 specialized organizations Through this, we intend to strengthen the monitoring of unstable supply together.”
- Policy
- Severe Cancer Drug Benefits, covered by the National Budget
- by Lee, Jeong-Hwan Feb 20, 2023 05:53am
- The legislation will be promoted in which the state is responsible for the cost of applying health insurance benefits for new drugs for the treatment of severe diseases and cancer. It also included a provision to include a new technology support project for cancer treatment in the scope of the National Health Insurance Service's work and to raise the funding rate used for new technologies for cancer treatment. On the 14th, Kang Sun-woo, a member of the Democratic Party of Korea, announced that he proposed three amendments to the Cancer Management Act, the National Health Insurance Act, and the National Health Promotion Act. Lawmaker Kang plans to name the three package bills proposed this time as the "Three Acts of State Responsibility for Severe Diseases" and push for legislation. The current law stipulates that cancer treatment and medical expenses should be subsidized according to income level to ease the economic burden of severely ill patients and cancer patients. However, it has been pointed out that in the current medical expenses support system, the limit of support is limited. Cancer patients are in financial difficulties and lose their lives due to the lack of rapid health insurance benefits after the approval of the Ministry of Food and Drug Safety. In response, Kang proposed a new support project to support new non-paid cancer treatment and new medical technology from the budget of the National Health Promotion Fund and included new cancer treatment technology support projects within the scope of the National Health Insurance Corporation's work. It also specified legal grounds for raising the National Health Insurance Service fund support rate (partial amendment to the National Health Promotion Act) used for related support projects such as new cancer treatment technologies. Lawmaker Kang said, "We proposed the bill in the sense that strengthening the coverage of drugs for severe diseases directly related to the lives of the people should be carried out more actively with government support."
- Policy
- The Minister's willingness to innovate regulations
- by Lee, Hye-Kyung Feb 20, 2023 05:53am
- A full view of Hanmi Pharmaceutical Oh Yoo-kyung, head of the Ministry of Food and Drug Safety, met with representatives of pharmaceutical companies and expressed his willingness to innovate regulations. At 2 p.m. today (15th), Director Oh met with representatives of pharmaceutical industries such as Hanmi Pharmaceutical, Dasan Pharmaceutical, Daewoong Pharmaceutical, Amgen Korea, Inist, Pfizer Korea, Huons, and Hugel at the Hanmi Pharmaceutical Research Center. The meeting was held in the name of the New Year's meeting, and the reason why Hanmi Pharmaceutical Research Center was selected as a venue is to encourage executives and employees of Hanmi Pharmaceutical, which has been approved for marketing by the U.S. FDA, for the first time in Korea. In September last year, Hanmi Pharmaceutical received FDA approval for the treatment of neutropenia, "Rolontis." "We are grateful for the hard work of the company officials who are striving to develop the domestic pharmaceutical industry and improve their international status," Oh said. "The Ministry of Food and Drug Safety will also do its best to improve the drug system and provide administrative support." It announced its plan to boldly change Korean drug regulations to global standards so that domestic companies can enter and compete in overseas markets. "The Ministry of Food and Drug Safety will work closely with the industry and related organizations to promote regulatory innovation so that Korean drug regulations can lead the international standards," Oh said. "Please continue to develop high-quality new drugs to open new treatment opportunities for our people." The meeting was held to introduce major policy directions and core brand businesses of the Ministry of Food and Drug Safety in 2023 and to discuss future development and regulatory innovation measures of the Ministry of Food and Drug Safety with related industry officials. The Global Leader, Partner, Supporter (GPS) project was introduced as a major policy in the pharmaceutical sector, which means accelerating entry into the international market through global leadership to strengthen export support, partners in pharmaceutical production using advanced digital technology, and customized support for global innovative products. The Ministry of Food and Drug Safety plans to support the virtuous cycle of the pharmaceutical industry by enhancing Korea's international status and becoming a leading regulatory country through international harmonization of pharmaceutical regulations. Previously, it operated a Global Innovative Products on Fast Track (GIFT) program to help global innovative medical products become quickly commercialized and dominate the global market. It said it would implement customized regulatory support projects to quickly enter the next-generation biopharmaceutical market. The plan is to establish a preemptive item classification system for new concept drugs as the development of new concept products that transcends the classification and concept of existing drugs is expanded. If a biopharmaceutical company applies for and discovers next-generation biopharmaceuticals, it will support regulations through internal communication, classification standards, customized regulatory support, internal review committee, external consultation, notification and objection, procedures, and information provision. To secure vaccine sovereignty, it also announced plans to operate a national cell bank, test and analysis of vaccines at an international level, comprehensive technology consulting from vaccine development to licensing, overseas licensing strategy consulting, and expand the foundation for future-oriented policy and system development. The Ministry of Food and Drug Safety said it will continue to play the role of a regulatory agency that protects public safety based on regulatory science expertise, push for export GPS strategies to enter the global market beyond global technical regulations, and play a role as a partner in organically communicating and cooperating with industries and organizations.
- Policy
- Will there be progress in introducing a checkup for Hep C?
- by Jung, Sae-Im Feb 20, 2023 05:52am
- Attention is focusing on whether the introduction of national screening for hepatitis C, which has been idle for eight years, will be able to make progress this year. At APASL 2023, which was held in Taipei, Taiwan for five days from the 15th, in-depth discussions were held on preparing national policies to combat hepatitis C. The forum examined the situation in Korea, where hepatitis C was still not included in the national examination. The WHO declared the eradication of hepatitis C by 2030 and called for international efforts. As hepatitis C has opened the era of cure due to the development of treatments, the most important goal is to find patients who have not been diagnosed. Several countries around the world, including Germany, Japan, and Taiwan, are reducing the number of patients through active diagnosis and treatment, including hepatitis C, in national checkups. Discussions on hepatitis C, which began in 2016, are still "in progress." Although cost-effectiveness has been consistently proven through feasibility studies and pilot projects centered on the Korean Liver Association, the government has not responded positively. Korean health officials who attended the forum made an optimistic prediction that "If positive results are obtained from this year's expert review, hepatitis C could be included in the national examination as early as next year." Kwak Jin, head of the infectious disease management department of the Korea Centers for Disease Control and Prevention, said, "The first expert review conducted in 2018 judged that there was not enough evidence to meet the qualifications for national screening." "If we pass the review successfully, we predict that national screening of hepatitis C could be possible next year or the year after next," he said. He also suggested other aspects to consider to combat hepatitis C. This means that a system from diagnosis to treatment and management, such as post-diagnosis treatment and high-risk group management, should be established organically. Manager Kwak said, "If a public or private examination confirms the infection, a system should be established that can be performed as treatment." It is also important to establish management and screening systems for high-risk groups of infection, such as correctional facility inmates, refugees, and injection drug users, and to establish a comprehensive public-private cooperation system including the hepatitis Policy Advisory Committee. Park Ji-min, a health promotion officer at the Ministry of Health and Welfare, said, "Since the Korean government is well aware of the importance of eradicating hepatitis C, two large-scale pilot studies have been conducted. However, Park took a cautious stance, saying, "Korea has a national health examination system, which is a program for all Korean citizens, and the inclusion of hepatitis C in the national examination has a great impact. Therefore, the careful and conservative application is needed according to the principles mentioned by Kwak." This is seen as a remark in consideration of whether it is right to include hepatitis C, which has a domestic prevalence of only 0.8%, in the screening system for all citizens. The prevalence of hepatitis C, which has met cost-effectiveness through various pilot projects, has been mentioned as the reason for failing to enter the national examination. The Korean Liver Association has reaffirmed the validity of the hepatitis C screening test through further research. According to the report on the study's final results on the feasibility analysis of hepatitis C screening and follow-up management of screening among the national health screening items released by the Korea Centers for Disease Control and Prevention, hepatitis C met all five conditions for introducing national screening items. The five conditions will be important health problems, diseases that can be detected and treated early, acceptable to the screening method, more profitable than loss, and effective against cost. The report relates to prevalence. In 2020, medical expenses due to hepatitis and related diseases were confirmed to be 11.5% of the total annual medical expenses," it stressed. At the forum, domestic specialists reiterated the need to introduce a rapid national screening of hepatitis C. Jang Jae-young, a professor of gastroenterology at Soonchunhyang University Seoul Hospital, said, "As a result of the study, the incidence of major liver diseases was significantly reduced when all people aged 40 to 65 were examined for hepatitis C through national checkups and was cost-effective at all ages. In particular, screening in the 60s is the most cost-effective, and when conducting hepatitis C screening tests at the age of 56 to 65, the savings have been greater than the input cost since 12 years ago. After 20 years, 20 billion won can be saved, and 30 billion won can be saved after 30 years."
- Policy
- Skyrizi benefit will be expanded from next month
- by Lee, Jeong-Hwan Feb 17, 2023 05:50am
- Expanded standards for oral hepatitis B drugs. From March 1, the scope of recognition of drug care benefits by Skyrizi PFS is expected to expand from existing psoriasis to active and progressive psoriatic arthritis. Reva-K and Reba-eye 2% are listed as new benefits, and medical benefits are recognized when administered to "improve corneal epithelial disorders in adult ocular anterior patients." The criteria for recognition of medical care benefits for oral chronic hepatitis B treatment will also be expanded compared to the previous one. The phrase of the Argatroban component injection is changed so that the detailed recognition criteria for medical care benefits are administered within the scope of permits for each drug. The hemostatic oxidative regenerative cellulose benefit item is changed from Equtamp to Surgicel. On the 15th, the Ministry of Health and Welfare will announce the administrative notice of "partial revision of the criteria and methods for applying for medical care benefits" and conduct a related opinion inquiry until the 24th. First, the standard of the AbbVie interleukin (IL)-23 inhibitor Skyrizi PFS will be expanded. Skyrizi, which is an indication of plate psoriasis and psoriatic arthritis, is currently only reimbursed for psoriasis. The Ministry of Health and Welfare adds 'active and progressive psoriatic arthritis' to the Skyrizi standard. Skyrich will also be added to the replacement pay standard for Tremfya, Taltz PFS, Cosentyx, and Stelara. 2% Reva-K and Reba-ye, are newly registered and a new standard will be established. Nursing benefits are recognized if administered within the scope of the permit, "Improvement of corneal epithelial disorders in adult dry eye patients." However, benefits are not recognized when administered in combination with mucin secretion promoters such as Diquasol Eye drops. Oral chronic hepatitis B drugs expand the liver enzyme (AST/ALT) numerical standard that recognizes drug benefits. The HBV-DNA numerical standard, which recognizes benefits even in chronic hepatitis B patients accompanied by targeted cirrhosis, is expanded. Specifically, "Patients with 40-80 units of AST or ALT and showing stages of liver biopsy or fibrosis of illiterate periphery" will be added to the initial treatment benefit standard. Patients with chronic active hepatitis B with cirrhosis and hepatocellular carcinoma are recognized for benefits if they are HBV-DNA positive. The standard item of Agastroban injection, an antithrombotic component used to treat chronic arterial obstruction, will be revised from "Argaron Inj" to "Argaron Inj, etc." Considering that each drug has different permits, the statement of the administration discussion will be changed within the scope of each drug. The standard item for hemostatic oxidatively regenerated cellulose is changed from Equtamp to Surgicel. This is to make it current as an item on the list of drug benefits.
- Policy
- NHIS President “will improve the PVA system"
- by Lee, Tak-Sun Feb 17, 2023 05:49am
- NHIS President Do-Tae Kang is explaining NHIS Do-Tae Kang, President of the National Health Insurance Service expressed plans to continue managing pharmaceutical expenditures by preparing a plan to improve the price-volume agreement (PVA) negotiation system within the year. Also, Kang added that the NHIS will be applying the refund type of the performance-based risk-sharing agreement (RSA) system that was applied to Kymriah and Zolgensma to high-priced drugs that cost over KRW 300 million and reduce the reimbursement negotiation period for new anticancer or severe and rare disease drugs. At a new year’s roundtable meeting with industry journalists that was held at a Korean-Chinese restaurant in Mapo-gu on the 16th, Kang explained that he would promote such policies this year as part of HIRA’s plan to manage drug expenditures. Kang said, “Our research service results showed that the PVA system has produced great outcomes in reducing NHIS’s drug expenditures and had a positive impact from a social and industrial aspect. Based on the results, we will work with pharmaceutical companies and the working group to prepare improvement plans to continue managing pharmaceutical expenditures this year by adjusting the maximum discount rate, improving the negotiation reference formula, and deriving a plan to expand the exclusion criteria, etc.” The refund type of the performance-based RSA system is expected to be mainly used as a measure to manage high-priced new drugs. Kang said, “Drug expenditures have been soaring every year in line with the rising social demand for high-priced new drugs. However, the mechanism for predicting and controlling drug expenditures is yet inadequate. We plan to apply the ‘expenditure cap type’ and ‘performance-based refund type’ RSA to new drugs with high prices that were recently developed and have unverified treatment efficacy and cost-effectiveness to consider both the accessibility to essential drugs and fiscal health of Korea’s national health insurance.” He added, “We introduced a ‘performance-based refund type’ of RSA where pharmaceutical companies bear a portion of the expenditures according to treatment performance to reimburse the ultra-high-priced drugs Kymriah and Zolgensma. This year, we plan to expand the performance-based refund type RSA to drugs that cost over KRW 300 million and shorten the negotiation period for anticancer drugs or new severe or rare disease drugs for prompt listing.” The NHIS also plans to prepare a plan to improve the fee negotiation system and find the right balance between the parties. Kang said, “Despite the difficult economic situation, Korea’s national health insurance finances are expected to see a surplus for the second year in a row, therefore fee negotiations are expected to be quite difficult this year. While the subscribers are expected to request a minimum raise in fees, the suppliers are expected to demand a bigger raise in fees as a compensatory measure in consideration of the companies’ management difficulties." He added, “As NHIS is in charge of managing NHI finances, we will comprehensively consider the fiscal soundness, essential medical reinforcement policies, and the subscribers’ insurance premium level to find a reasonable balance between parties. Based on the results of the research service, we will conduct a multilateral analysis and discuss with the ‘system development consultative body' that subscribers and suppliers are involved in to prepare an agreeable model and apply it to fee negotiations." NHIS will also continue to manage chronic diseases and promote the big data business this year. Kang said, “We have been promoting a 'Pilot project on primary care for chronic disease', which provides annual care plans and services for patients with hypertension and diabetes in neighborhood clinics and have advanced the chronic disease management model by managing service quality and improving the project participation process. This year, we will consult with stakeholders and the government to reach an agreement on the appropriate fee level and copayment rate, conduct a pilot project, and then promote its conversion to a main project." Regarding the big data business, the NHIS has been providing customized health information for individuals on their health status and life cycle through mobile apps and will develop a new personal health record (PHR) service to promote public health and manage the disease with a ‘QR Electronic Prescription System’ among others in the future. Also, as a data integration institution, the NHIS will develop a guideline for the provision of combined data and expand the analysis center to promptly provide data necessary for drug development and research. Kang said, “The health insurance finances are being stably operated so far. We expect a current account surplus that exceeds what was made in 2021 to occur in 2022." “However, fiscal expenditures are continuing to increase due to the aging population and the introduction of new health technologies. Therefore, we will do our best to responsibly carry out key tasks by independently operating the 'fiscal consolidation promotion team,’ and find new tasks to pursue in line with the mid-term fiscal consolidation plan.” On this, the NHIS opened a ‘Proposal and report center to protect the fiscal soundness of NHI finances’ in December last year to reinforce the management of financial leakage factors by directly collecting public opinion. After the operation of the report center, reports were filed on illegal medical institutions and unfair claims, for which an investigation is underway. Lastly, regarding the embezzlement of its employee last year, “Many people must have been shocked and disappointed by the disreputable incident. The NHIS announced comprehensive measures last November to fundamentally prevent the recurrence of such events, and consulting with external specialized institutions is currently underway for a more professional inspection. After the consultations are complete, we will prepare improvement plans for each work type and implement them immediately.” He added, "In addition, we plan to support insurance premiums for the low-income and the vulnerable class whose insurance premiums are significantly less likely to be collected, by using donations voluntarily collected from NHIS executives and staff.”
- Policy
- Rebamipide eye drops will be reimb next month
- by Lee, Tak-Sun Feb 16, 2023 05:51am
- Mucosta ophathalmic solution (Rebamipide) being currently sold in Japan Whether the reimbursement of Samil Pharmaceutical and Kukje Pharma’s rebamipide eye drop solutions that were developed as a treatment for dry eye will reorganize the artificial tears market is gaining attention. In particular, with reimbursement reevaluations set to be conducted for hyaluronic acid eye drops that occupy the largest share of the artificial tears market this year, the possibility of changes made in the market share and rank has also been raised. On the 15th, the Ministry of Health and Welfare issued an administrative notice of an amendment to newly establish a reimbursement standard for Rebamifide 0.1/5ml. The drugs subject to the amendment are Samil Phamraceutical’s ‘Reva-K Eye Drops’ and Kukje Pharma’s ‘Reba-eye Eye Drops 2%.’ The Health Insurance Review and Assessment Service decided to approve the drugs for reimbursement within its approved indication, for the ‘improvement of corneal and conjunctival epithelial damage in adult patients with dry eye syndrome.’ However, its combined administration with mucin secretagogue (diquafosol sodium) will not be allowed reimbursement. The reimbursement will be add a rebamipide option to the dry eye treatment market. Rebamipide eye drops have already been released in Japan in 2012 by Otsuka Pharmaceutical as 'Mucosta ophthalmic suspension UD 2%', but Samil and Kukje’s products are the first to be introduced to Korea. Rebamipide is known to stabilize the tear film by increasing ocular mucin secretion and contribute to the improvement of corneal and conjunctival epithelial damage to improve dry eye symptoms. Samil and Kukje demonstrated the drug's improved outcomes through a clinical trial. In a clinical trial that was conducted on a total of 220 patients with dry eye symptoms (74 patients in the 2% Rebamipide ophthalmic suspension arm, 74 patients in the placebo arm), patients were administered the drug or placebo in each eye four times (every 4 hours). At week 12, outcomes in the 2% Rebamipide ophthalmic suspension arm were superior to the placebo arm. With the drug demonstrating an effect in improving dry eye syndrome when administered just 4 times a day, Rebamipide has been evaluated to have an improved convenience compared to existing artificial tear products that require administration 5-6 times per day. Reimbursed eye drop options currently in use for dry eye include hyaluronic acid, diquafosol sodium, and cyclosporine. Among the options, hyaluronic acid boasts the largest share in the market, which is estimated to bring in an annual sales of KRW 230 billion. These hyaluronic acid eye drops will be receiving reevaluation on their adequacy of reimbursement this year. According to HIRA, as of January 2022, reimbursement is being applied to 427 items from 51 companies, and the average annual claims amount of the drugs for the past three years was estimated to be around KRW 231.5 billion. Controversy over the reimbursement adequacy of hyaluronic acid eye drops, which were reimbursed since 1997, has been raised for some time. In 2000, the National Evidence-based healthcare Collaborating Agency (NECA) argued for the need to improve the reimbursement standards for dry eye, saying that it was too early to conclude that hyaluronic acid ophthalmic solutions are clinically significantly different from other treatment alternatives. Hyaluronic acid eye drops are currently used both for specialized and general drugs in Korea, however, most are used with a doctor's prescription, putting pressure on Korea’s national insurance finances. On the other hand reimbursement for hyaluronic acid is not applied in major developed countries and is only reimbursed in Japan. If the reevaluation concludes that hyaluronic acid eye drops are not eligible for reimbursement, the artificial tears market will inevitably be reorganized. The analysis is that the existing diquafosol sodium and cyclosporine products will reap reflective benefit, and the rebamipide eye drops that are reimbursed this time may also serve as an alternative. Recently, Daewoo Pharm is also known to be preparing a same-ingredient drug with Samil Pharmaceutical and Kukje Pharma for approval. An industry official said, “Rebamipide eye drops that will be reimbursed this time, developed by Samil and Kukje, have improved marketability. It offers an improvement in the irritability experienced using the original Japanese product. Therefore, I believe the products will settle as new options in the dry eye syndrome treatment market upon release.
- Policy
- Paxlovid's expiration date has been extended
- by Lee, Hye-Kyung Feb 14, 2023 05:48am
- While the expiration date of Pfizer's COVID-19 treatment Paxlovid has been changed from 12 months to 18 months, experts said that a six-month extension is reasonable for the volume purchased after approval. According to the minutes of the Central Pharmaceutical Review Committee recently released by the Ministry of Food and Drug Safety, there was a feasibility consultation on the extension of the validity of Paxlovid, and all members agreed to increase the validity of medical field distribution. At the meeting, the Korea Centers for Disease Control and Prevention explained that 1.7 million COVID-19 treatments were introduced as of the end of October last year, leaving 500,000 people in stock, of which Paxlovid accounts for 400,000 to 450,000. Based on the stability test data in December 2021, Paxlovid has been recognized for 18 months as a previous submission data in August last year after initial approval with a validity period of 12 months. However, if the expiration date of the emergency use approved product is extended, the product imported before the change approval is not retroactively applied, so Celltrion submitted additional data on the amount that was suitable for up to 12 months at the time of Paxlovid import. The Korea Centers for Disease Control and Prevention said, "The amount purchased after the approval of the change has an expiration date of 18 months, but the previous purchase is applied to 12 months, so we need a six-month extension," adding, "As of the end of October last year, 380,000 people need to be extended." Currently, about 4,000 pharmacies and medical institutions are storing Paxlovid in a packaged state by tablet, and the Korea Centers for Disease Control and Prevention said it has conducted a full document survey and on-site inspection of pharmacies to see if it is properly stored and managed. When asked by the committee whether it is possible to purchase a new product with an 18-month validity period instead of extending the validity period of Paxlovid, the Korea Centers for Disease Control and Prevention said, "It is important to prevent budget waste with expensive drugs. If there is no safety problem, we will reduce disposal." The Korea Centers for Disease Control and Prevention said, "If a re-test is necessary to extend the validity period, we will proceed with the test as much as possible," adding, "However, there is a concern that the test will take a lot of time and cannot be extended." In response, a member of the committee said, "The key is what data to replace the appropriateness of the storage of on-site supplies," and stressed, "There should be sufficient explanation for the public afterward." The Korea Centers for Disease Control and Prevention said, "If it is extended, we will check the storage condition again, and if the storage is appropriate, we will label the expiration date and check whether it is working." The Commission agreed that the validity period of medical field distribution can be extended by applying the requirements for detailed submissions under the Pharmaceutical Affairs Act to extend the validity period of crisis-responsive medical products.
- Policy
- MFDS prepares a cost-sharing plan
- by Lee, Hye-Kyung Feb 10, 2023 05:53am
- The Ministry of Food and Drug Safety plans to prepare measures to disperse risk responsibility in preparation for the occurrence of drug safety accidents such as unintentional impurity generation and mixed drugs. According to the 4th plan for drug safety management recently released by the Ministry of Food and Drug Safety, related industries such as pharmaceutical organizations and user organizations will be discussed to compensate for costs incurred in exchanging drugs. This is to come up with social sharing measures for costs incurred due to the exchange of drugs that are feared to be harmful as unintentional impurity accidents may continue to occur in the future following NDMA detection accidents such as Valsartan and Ranitidine. In 2021, according to the re-prescription, re-prescription, or exchange procedure prepared by the Ministry of Health and Welfare and related associations, the remaining amount of impurities produced by consumers can be re-prescribed, re-prescribed, or exchanged for normal products of the same drug at hospitals, clinics, and pharmacies. Hospitals and clinics have been charging pharmaceutical companies for the cost of re-prescribing and re-preparing impurities-producing drugs as normal manufactured products through the Korea Appraisal Board and the Health Insurance Corporation. However, 36 companies are responding to a lawsuit to confirm the absence of debt when the National Health Insurance Service requested 69 companies to make up 2.03 billion won for the loss of health insurance related to valsartan. At the time of the Valsartan impurity accident, the Pharmaceutical Affairs Act was revised, and after consultation between ministries through the Legislative Policy Council of the Ministry of Government Legislation, the Pharmaceutical Affairs Act was revised. Accordingly, the Ministry of Food and Drug Safety plans to provide legal grounds by reflecting on the discussions of the consultative body and the results of research services this year. When revising the Pharmaceutical Affairs Act, the goal is to prepare and revise sub-laws that set details such as applications for compensation for the operation of the Deliberation Committee for the calculation and collection of the cost compensation charges. The Ministry of Food and Drug Safety said, "We plan to establish a social safety net to protect public health and create a safe use environment for drugs by preparing measures to disperse risk in case of drug safety accidents such as unintentional impurity generation."
