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- 2026-03-10 08:28:03
- Opinion
- [Reporter’s View] The key to the ‘PE Exemption’ issue
- by Eo, Yun-Ho Oct 17, 2022 10:52pm
- The cries that the improvement reduces rather than expand benefits have reached the National Assembly. The government’s improvement plan for the special pharmacoeconomic evaluation (PE) exemption system was brought onto the chopping block at the NA audit. During the NA audit for the Health Insurance Review and Assessment Service that was held on the 13th, Rep. Sun-Woo Kang of the Democratic Party of Korea raised an issue on the PE exemption system improvement plan that had been submitted by the Ministry of Health and Welfare and HIRA. The “Measure to improve patient access and reinforce reimbursement management for high-priced severe disease treatments” that was recently presented by the government includes a measure to improve the PE exemption standards. According to Rep. Kang, unlike the authorities’ explanation, the drugs subject to PE Exemptions will be rather reduced if the improvement plan is applied. The “small number of eligible patients” which had previously been an “OR” clause for PE exemptions became a prerequisite in the proposed amendment, reducing the scope of eligible drugs. This issue has been raised continuously across the industry, including by the Korean Research-based Pharmaceutical Industry Association (KRPIA), since the government announced the amendment. In other words, the concern is that all drugs that wish to take the PE exemption track will have to have a “small number of eligible patients (less than 200 patients)” if the amendment is applied. On this, HIRA President Sun-Min Kim replied that “The 200 people limit is not absolute. All drugs that do not have enough patients to prepare evidence for PE evaluations are applied the PE evaluation exemption track.” In other words, the authorities will show some flexibility in the “small number” standard. However, the impact of this amendment is not only due to the changed premise. If the amendment is applied in the current state, all drugs that wish to take the PE exemption track have to have a small number of patients (as defined as 200 in the current criteria) and receive recognition from the committee for its difficulty in producing evidence to satisfy Article 2.c of the regulation. In other words, the companies will not be able to know if their drugs are eligible for the PE exemption track until HIRA’s Drug Reimbursement Review and Assessment Committee make a decision. This will inevitably have a significant impact on the predictability of reimbursement listings for companies that wish to use the PE exemption system. Considering how the new administration promised rapid listing of anticancer and rare disease drugs immediately upon its inauguration and the non-reimbursed blind spots still remain for drugs that are applied special exemptions, the government needs to seriously consider whether this amendment is achieving its original purpose.
- Opinion
- [Reporter’s View] Real crisis will come after COVID-19
- by Kim, Jin-Gu Oct 05, 2022 06:11am
- Contrary to the hopes that peace will come with the end of the COVID-19 crisis so near, another crisis of the ‘three highs’ - high exchange rates, high interest rates, and high inflation – has now arrived. Experts are predicting shock waves at the level of the 1997 IMF crisis and the 2009 global financial crisis or severer. Externally, the exchange rate, trade balance, and current account are shaking at the same time. Internally, red lights are flaring in Korea’s growth rate, price level, and interest rates. The future outlook is also bleak. Negative prospects are pouring in, that the low growth will continue for the time being, resulting in fewer jobs and a contraction in investment. Some analysts believe we have already entered stagflation, in which high inflation and economic downturn occur at the same time. Obviously, the domestic biopharmaceutical industry cannot be immune to this macroeconomic trend. The high exchange rates, high interest rates, and high inflation constrain the pharma and bio companies from all directions. Anxiety is growing bigger and bigger, and with the growing anxiety, companies contract. Given that the long-term investments made by the industry are just beginning to bear fruit, concerns are being voiced that the potential of the K-pharmaceutical and bio industry will be nipped in the bud, without blooming to its full potential. The Korean pharmaceutical and bio industry is considered to have made good progress during the past 3 years in the COVID-19 crisis. Some companies have used the crisis as an opportunity to grow significantly or to attract large-scale investments. It is not that the industry has fared well, but it is difficult to say that the COVID-19 crisis has been overcome solely by the capabilities owned by Korea’s pharmaceutical and bio industry. Pharmaceuticals are consumer staples, therefore, the industry was not greatly affected by the surge of confirmed COVID-19 cases or strengthened social distancing measures, etc. Also, much of the cash released through the quantitative easing measures competitively carried out by countries had flowed into the industry. In such a sense, it is true COVID-19 did not greatly impact the pharmaceutical industry as much as other industries. The government believes that COVID-19 will turn into an endemic by early next year. The pandemic is finally coming to an end. With the declaration of an endemic so near in sight, the pharmaceutical and bio companies are now on the testing bed. How well the companies have built their foundation will be tested in the era of the ‘three highs.’ Experts have contrasting views on how long the factors of concern represented by the ‘three highs’ will last. However still, one thing certain is that the companies must now brace for the long-term recession that is certain to come. Executives would need to make cool-headed judgments about the situation and set the right direction. The real crisis has only just begun.
- Opinion
- [Reporter's view] Reimbursement of Zerbaxa
- by Eo, Yun-Ho Oct 04, 2022 06:07am
- Super antibiotic Zerbaxa will receive insurance benefits from this month. It is the first time in about five years that a domestic permit has been granted. The government's response to the application of the PE system to some of the national essential drugs, especially in the face of the seriousness of antibiotic resistance issues internationally, has made new antibiotic drugs. Even though it is not a "life-threatening disease," the need for important drugs has been recognized. Zerbaxa was approved in Korea in April 2017, but the prevailing view was that it was difficult to register under the system at the time. This is because new antibiotic drugs are not easy to prove cost-effectiveness compared to existing conventional drugs, and it is difficult to prove clinical superiority due to the nature of the drug. In fact, an application for Zerbaxa was submitted in the second half of 2018 and went through the procedure, but failed to pass the HIRA Drug Benefit Evaluation Committee in 2019. Since then, the government has implemented an improvement plan to include essential drugs such as antibiotics in PE targets as a way to expand coverage. The government designated antibiotics as PE targets, limiting the scope of antibiotics to antibacterial agents such as Zerbaxa. The medical concept of antibiotics refers to antimicrobial medics, which encompasses antimicrobial agents (treatment of bacterial infections), antimicrobial agents (treatment of fungal infections), and antiviral drugs (treatment of viral infections). This continuous increase in antimicrobial resistance is considered the most important public health agenda worldwide. The WHO defines the concept of AMR as 'a threat to the effective prevention and treatment of continuously increasing infections caused by bacteria, parasites, viruses and fungi'. AMR is not limited to the well-known superbacterial outbreak problem. Antibiotic resistance, also called Superbugs, refers to changes that occur when microorganisms (such as fungi, viruses, parasites, etc.) that cause infection, including bacteria, are exposed to antibiotics, antifungal drugs, and antibacterial drugs. In fact, the real liberation of antibiotics has not been achieved. As the benefits of step by step one goes a long way. Zerbaxa began, the medical environment in Korea has improved little by step. With a round of applause, it adds to the remaining concerns.
- Opinion
- [Reporter's view]Bio-Administrative Orders of the USA
- by Kim, Jin-Gu Sep 23, 2022 05:51am
- Korea's CDMO (consignment development production) industry, which has just begun in earnest, has a hurdle. U.S. President Joe Biden recently signed an executive order for the "National Biotechnology and Bio Manufacturing Initiative," which calls for the production of biopharmaceuticals in the country. The Biden administration is emphasizing "Made in USA" every day ahead of the upcoming midterm elections in November. Along with the automobile and semiconductor industries, CDMO, one of the pillars of the pharmaceutical bio industry, has become a target. The decision is based on political intentions, but the intention is expected to have a significant impact on the domestic industry anyway. In the pharmaceutical bio industry, Samsung BioLogics is expected to be affected the most. Samsung BioLogics has been investing generously for the past 10 years. Since two to three years ago, orders for consignment production of biopharmaceuticals have been pouring in from around the world, including the United States. When the fourth plant is completed next year, it will become the world's top production base. However, if the administrative order is materialized, Samsung BioLogics' plan to occupy more than 30% of global biopharmaceutical CMO production is also expected to be disrupted. Just last year alone, about 20% of the company's sales came from the United States. It is not just a problem for Samsung BioLogics. After Samsung BioLogics presented a successful model, many pharmaceutical companies in Korea have entered the CDMO business. As an industry, not a company of Samsung BioLogics, the seed of CDMO was sown. However, the crisis has hit even before it is properly sprouted. The bigger problem is the possibility of U.S. protectionism spreading around the world. Protectionism is highly contagious. This means that if the U.S. takes action first, the world, including Europe, will likely jump into protecting its industries. Concerns are raised about the K-CDMO industry in that most companies that have entered the CDMO business are limited to Korea. The government seems to be aware of these concerns. The Ministry of Health and Welfare and the Ministry of Trade, Industry and Energy plan to hold a joint meeting of government ministries in the near future and come up with countermeasures related to the U.S. executive order. It plans to summarize South Korea's position here and deliver it to the U.S. during the South Korea-U.S. ministerial meeting this week. A single diplomatic negotiation cannot solve all the problems. With all possibilities in mind, other additional measures should be prepared. It is time for the government, which said it will focus on fostering the pharmaceutical bio industry, to show its true will with diplomatic power.
- Opinion
- [Reporter's view] Reform of the innovative system
- by Lee, Jeong-Hwan Sep 19, 2022 05:56am
- Will the "innovative pharmaceutical company certification system," which has been operating unchanged for 10 years since its introduction in 2012, be able to pave the way for reform through the disclosure of the reorganization plan? The Ministry of Health and Welfare announced plans to announce the reform of the innovative pharmaceutical company certification system at the end of the year. It is a relatively large reorganization plan, including subdivision of certification types and customized support measures, and attention is being paid to whether it can be a turning point to remove the stigma of the certification system that is low in effectiveness. Strengthening support for innovative pharmaceutical companies has been an agenda that has been needed for years. The pharmaceutical industry demanded that actual drug treatment or tax support for innovative pharmaceutical companies should be greater to encourage innovative pharmaceutical companies to develop new drugs and encourage non-selected companies to select new drugs, but the government has not been able to provide enough budget or come up with innovative drug measures due to trade friction. The Ministry of Health and Welfare continued to make efforts to improve the certification system for innovative pharmaceutical companies to resolve such criticism, and the reorganization plan, which will be unveiled at the end of the year, will be the first result to determine whether it will improve. First of all, the reorganization plan is expected to discriminate against the actual support method as the certification screening criteria for each size and type of pharmaceutical companies are different. As the customized support plan for innovative pharmaceutical companies has been discussed several times, such contents are expected to be included in the reorganization plan to be unveiled at the end of the year. More important than improving the framework and extension of the certification system is the government's reinforcement of support for innovative pharmaceutical companies, which is the purpose of operating the certification system. If designated as an innovative pharmaceutical company, the government should provide benefits such as preferential drug prices, tax support, and R&D support, but the pharmaceutical industry has long complained that it is difficult to expect sufficient benefits. Innovative pharmaceutical companies are given symbolic titles, but they do not have significant benefits that directly benefit from the development of new drugs. Among the companies selected by innovative pharmaceutical companies, there is also a pessimistic response that they will not be hit much even if the certification is canceled because they do not enjoy any practical benefits. The National Assembly also urges the government to strengthen support for innovative pharmaceutical companies every year. It is pointed out that the overall fostering of the domestic pharmaceutical industry can be achieved only when both the quantity and quality of support measures for innovative pharmaceutical companies are improved. The Ministry of Health and Welfare, which is set to unveil the certification system, also agreed with the criticism that the budget and policy support in line with the reorganization plan should follow, so we hope that the reform will be repeated starting with the reorganization plan.
- Opinion
- [Reporter’s View] Evrysdi awaits reimb review for over 1 yr
- by Eo, Yun-Ho Sep 16, 2022 05:53am
- One year has passed since the company applied for insurance reimbursement but to no avail. No progress has been made on the matter, not even the frequent news of the agenda being rejected by the Drug Reimbursement Evaluation Committee has been heard on the matter. Although the reimbursement application for the spinal muscular atrophy (SMA) treatment ‘Evrysdi (risdiplam)’ had been submitted in July last year after its approval in November 2020, the agenda has not been listed for deliberation on any of the lists disclosed by the Health Insurance Review and Assessment Service. There is a deadline for each stage of HIRA’s reimbursement assessment. The current overall reimbursement review period is 150 days, and the government had announced a systemic reform to reduce the period to 120 days. However, this period is often not kept. This is why the industry was not so enthusiastic about the reform plan. In the case of Evrysdi, its review period had already exceeded 150 days earlier this year, as the company had once failed to pass the Drug Reimbursement Standard Subcommittee and reapplied for reimbursement after supplementing data. On this, the Solidarity Against Disability Discrimination issued a statement last month when Zolgensma started being reimbursed, asking HIRA to abolish the reimbursement discontinuation standards set for another SMA treatment, ‘Spinraza (nusinersen),’ and the prompt reimbursement discussion to be made for Evrysdi. SADD had pointed out that SMA patients are being left unattended in the blind spot because HIRA is postponing discussions on Evrysdi just to discuss it in line with the adjustment made for Spinraza’s reimbursement criteria. So Evrysdi, which has applied for and is awaiting review, is still waiting in line after a year without even a single discussion made for its reimbursement and remains a ‘pie in the sky' for the patients. The importance of providing a clear explanation of an administrative decision is essential in the process of handling administrative affairs. This becomes all the more important when an exception arises in the application of a system, which raises more questions than an introduction or abolition of a system. However, the government has never provided an explanation on drugs that were extended their drug pricing negotiation period after passing the set deadlines. And more and more drugs receiving reviews for reimbursement listing or standard extensions or are being left without news. In the current “high-priced drug era,” plenty of very effective but expensive drugs are being introduced to the market. Therefore, it can be difficult for the government and the pharmaceutical company to reach an agreement within the set ’60-day’ period. In particular, the area of SMA treatments had been an ongoing issue due to their high price. However still, the emphasis needs to be laid on the word, deadline. Deadline is a promise. Also, the NHIS has described the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new drugs. In other words, the period is set for the final negotiation period to speed up listing and allow others to estimate the time to listing or rejection. Also, the people need to know why the negotiation fell through so that they could criticize the faulty party and find a compromise.
- Opinion
- [Reporter's view] PVA market should be actively reflected
- by Lee, Tak-Sun Sep 13, 2022 05:51am
- The pharmaceutical industry is in accordance with PVA didn't like being drug price cut. Excessive government intervention in the law according to the principle of supply and demand markets. Other goods has increased the use of demand than supply shortages, needs to be raised prices. But people pay health insurance run to fund health insurance system for the integrity of the principles that are not in arms. The COVID cold medicines such as drug case is a typical example of the increased trend in use. In an emergency due to infectious disease, without reflecting the system would drugs is lowered to in the pharmaceutical industry is concerned. But, but not the government through the correction amount of disadvantage companies contained in the target group cut drug price just worried. Sudden reflex to stop sales profit is a drug containing impurities need medication to take a closer look at the situation. The drugs increased by the use of existing drugs often cheaper than the sales suspension is true, but rather believed to have to reduce the drug price. Whenever these situations unfold, the pharmaceutical industry suggests the Ministry of Health and Welfare or the NHIS to exclude PVA. Each time, the government fully collects opinions from the pharmaceutical industry, but does not reflect all of the industry's claims by citing the purpose or principles of PVA. Some vendors in the end product price to appeal the cut is an injustice to happen happens. The NHIS is currently conducting research services for PVA improvement plans. That are currently fixed up to 10% will raise new standards will increase direct deposits. Most of them are intended to seek expansion and operation of the system for fiscal reduction. But the system of acceptability of the participants to build a broader view of the principles and detailed criteria with the situation and the environment should be reflected in the same time is also necessary. As such, detailed proposals such as national emergency situations caused by infectious diseases and increased use of drugs with reduced finances compared to alternative drugs should not be made to prevent unfair cases. If the system is operated as it is now, consumers will discuss the effectiveness of drug reduction, and on the contrary, suppliers will only highlight unreasonable aspects. We hope that PVA will come up with a more elaborately designed improvement plan.
- Opinion
- [Reporter’s View] Novartis's restructuring path similar
- by Eo, Yun-Ho Aug 31, 2022 05:40am
- Mergers, split-off, purchases, and sales... Global biopharmaceutical companies are busy making transformations to their respective businesses. Among the various transformations being made, the spin-offs and sales of the multinational pharmaceutical companies’ divisions have received particular attention over the past few years. Although such transformations are made under the premise of adopting a "selection and concentration" strategy, the spin-offs and sales draw out various positive and negative responses from society. One thing to note is that this phenomenon is being serially observed in various Novartis, one of the leading Big Pharmas, is currently integrating and spinning off its business at the same time. The company had integrated its Oncology and Pharmaceuticals business units that had been virtually operated like separate entities and announced its decision to separate its generics and biosimilars division, Sandoz. Although Novartis's spin-off of Sandoz was not unexpected, the integration of its other business units may have seemed less usual at first. However, the goal of the company - in conducting the spinoff and merger – has always remained the same. Like the other companies, Novartis is making corporate transformations to “separate innovation with legacy” in its business. Although being in the same company, Novartis’s Pharmaceuticals and Oncology Business Units had been on quite different paths. Its Pharmaceutical Unit focused on sales of relatively low-cost drugs for chronic diseases such as diabetes and respiratory diseases, whereas the Oncology Unit focused on premium-priced oncology drugs like Gleevec. However, at some point, the Pharmaceutical Unit started deviating from its usual path. Including ‘Zolgensma,’ high-priced premium drugs have now become flagship products in non-cancer areas as well. This is why the company decided to integrate the units into one combined unit - Innovative Medicines. Did the company’s separation from Sandoz also affect the company’s internal integration? Of course. With the integration, Novartis is also preparing to create a business unit dedicated to off-patent drugs. Corporate spin-offs cause separation in corporate size and profit structure. In other words, the company is seeking rebirth by dividing its business by concept, into an investment-oriented unit and a legacy unit. Such spin-offs do not impose a financial burden on companies because no claims for stock purchases are made in the process. Since it becomes a legally independent company after the split, the separate company may immediately be listed on the stock market upon spin-off. Most multinational companies conduct split-offs prior to such measures, which then would serve as a stepping stone for improving financial soundness and support sales of companies. For example, Pfizer established three business units (BUs), including its Upjohn Business Unit (BU) that was dedicated to its legacy brands, before initiating the separation of Viatris. Afterward, news of its merger with Mylan had been reported in line with the spin-off. In this sense, Novartis’s separation of Sandoz and integration of its business units are consistent with the steps that had been taken by other multinational companies in the past.
- Opinion
- [Reporter's view] Reflecting opinions on cold medicine
- by Lee, Hye-Kyung Aug 31, 2022 05:39am
- The Ministry of Food and Drug Safety has been monitoring the supply and demand of cold medicines since March. The targets for monitoring are NSAIDs and Expectorants such as complex cold medicines, Acetaminophen, Ibuprofen, Dexibuprofen, Loxoprofen, and Erdosteine. When pharmaceutical companies computer-report the production (import), sales, and inventory of products to the Drug Safety Country's Weekly Production and Import Status Report system, they have identified cold drugs in circulation and encouraged them to produce insufficient or unproduced items. However, there was a big difference between the results of monitoring the supply and demand status and the distribution of cold medicines felt at the front-line pharmacy site. The Ministry of Food and Drug Safety said that if there are items that are producing and distributing even a little, they are not "out of stock." It is an opinion that pharmacies cannot have inventory of cold medicines with certain ingredients. In the end, officials from the Ministry of Food and Drug Safety said they wanted to resolve the supply and demand of cold medicines only with monitoring results, and the Ministry of Food and Drug Safety established a quick response system for cold medicines using a small-packed drug supply guide system. The Korean Pharmaceutical Association selects 10 items of cold medicines requested by pharmacies and reports them to the Ministry of Food and Drug Safety every week, and when the Ministry of Food and Drug Safety groups the items requested and provides them to the Pharmaceutical Association, the pharmaceutical company enters the system. Although the cold medicine supply and demand monitoring and rapid response system are operating at the same time, the front-line pharmacies still complain that supply and demand are disrupted even if they check inventory in the system and ask wholesalers to supply supplies. The Ministry of Food and Drug Safety is also asking for cooperation from individual pharmaceutical companies and wholesalers in connection with pharmaceutical and distribution associations and distributed prescriptions for cold medicine ingredients that are smooth in supply and demand, but they have no significant effect. The operation of such a system has not caused the cold medicine to be sold out, which occurred during the re-proliferation of COVID-19 earlier this year. It is necessary to solve practical problems about the fact that the supply of cold medicines for specific ingredient preparation is not smooth, and pharmacists who have to prepare prescribed Rx are burdened with difficulties. Just as the public mask system was introduced during the mask crisis, the government plans to establish a public supply management system to actively prevent cold medicine from being sold out in the future. It is commendable that the Ministry of Food and Drug Safety has been continuously checking the distribution status by monitoring the supply and demand status since March in the wake of the cold medicine sold out earlier this year. However, if they respond only with statistics entered into the system, they will have no choice but to file complaints at the front-line sites. In the future, we look forward to actively preparing countermeasures to prevent the second cold medicine from being sold out by steadily reflecting the opinions of the site.
- Opinion
- [Reporter’s View] Unresolved insulin cold chain issue
- by Aug 24, 2022 05:56am
- With no clear alternative found for insulin distribution in Korea, on how to set the regulations for cold chain transport of insulin remains unresolved and beleaguered. Unlike other biological agents that are mainly prescribed in hospitals, insulin is often dispensed at outside pharmacies. And the lives of patients with Type 1 diabetes, who cannot produce insulin in their own bodies, may be threatened if this insulin is not readily available. However, on the pharmaceutical distribution companies’ part, insulin is a ‘white elephant.’ Although it is not a favored item on the companies' part due to its low distribution fee, it is an essential item when considering the companies' business relationship with patients and customers. For this reason, distributors refer to insulin as "a drug that is being distributed as a service item with little or no distribution margin." In other words, although the companies are currently distributing insulin, there is no reason or benefit for the company to distribute it at a loss. When the transport regulations for vaccines were revised earlier last year, and then extended application to all biological products, the government did not consider the difficulty and complexity the revised regulations would bring to insulin distribution. The fact that insulin would be included as biologics may not have even crossed their minds during the revision process. There Ministry of Food and Drug Safety had newly enacted guidelines thereafter to reflect the voices of the industry after receiving countless complaints from the distribution companies but to no avail. Although the newly enacted guidelines showed some progress, such as allowing insulin to be contained in various transport containers and not taking issue with temperature fluctuations during delivery to pharmacies as long as the company can verify the validity of the cold chain process. However, even these changes were not worth the excessively increased workload and cost required to maintain the thorough cold chain requested by the government. In fact, as of July 17th, when the revised regulation was implemented, instability in insulin supply and demand arose at distribution sites. Also, with orders piling up due to fears of stock shortages, this instability in supply and demand continued to deepen. The reduced number of insulin deliveries and extended terms between deliveries to pharmacies further heightened the anxiety of the patients. And due to railing opposition from diabetes patient groups, the MFDS granted an additional 6-month guidance period specifically for insulin distributions. However, anxiety continues to sweep through the industry with the sentiment that this problem cannot be resolved without further consideration of the fundamentals of the revision itself. Officials from distribution companies jointly voiced that “the guidance period is virtually meaningless.” With no distribution, an increased amount of insulin stock would be useless. Also, with the government holding a close eye over the issue, insulin may be better distributed in the short term during the guidance period, but it is clear that the same problem would return as soon as the eye moves away. In other words, there is no other viable option without the additional review of the revised regulations. However, how the revisions should be re-revised remains a further issue, and concerns deepen due to lack of reasonable grounds required for additional revisions of regulations. It is not easy to make further revisions because the regulations were not made after collecting sufficient data and identifying realistic situations in the first place. The government is continuing discussions with the industry, patient organizations, and relevant organizations, and the proposal for holding a public hearing is only now being discussed. It is odd that a public hearing, which should have been conducted before the revision was finalized, is only being discussed now, 8 months after the enforcement of the regulation. It is understandable how frustrated the patients would feel about the unresolvable insulin distribution issue.
