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- 2025-12-20 04:52:23
- Opinion
- [Reporter's view] PVA improvement plan & domestic drugs
- by Lee, Tak-Sun Mar 21, 2023 05:58am
- There is also concern about the proposal for improving PVA through research service. Last year, researchers (Bae Seung -jin, Ewha Womans University, etc.), who studied PVA's performance evaluation and improvement plan, ordered the screening management of drugs with high financial impacts. As a result, the selection criteria for the usage type 'Ka' were proposed to expand by adding 5 billion won and a 10% increase in the existing claims. Drugs with low financial impacts, such as a plan to raise the exclusion of negotiations from 2 billion won to 3 billion to 5 billion won, are required to ease management. The proposal for improvement will be discussed in May and institutionalized from January next year. In summary, the system improvement is expected to be promoted in the direction of a high -financial reduction rate, low drug reduction rate, and lowering the cut-rate. In the industry, there are many voices in favor of the system improvement direction. It is efficient to differentiate the upper limit according to the number of claims. However, there is a concern that the type of new drug will be added to the 'negotiations', and the burden will be increased to multinational pharmaceutical companies or domestic new drug development companies. In particular, domestic new drugs have been concerned about the improvement plan as the pharmaceutical industry has insisted on easing the PVA in order to ease development and encouragement. As the government uses biotechnology as a next-generation growth engine and declines domestic new drugs, it is also necessary to support the drug price. Domestic new drugs enter the low price without preferential treatment from the time of listing, and if the drug price is increased due to active sales and marketing, the new drug development company, which spends large-scale costs, ' If it was, only regret will remain. Although the government cannot discriminate against domestic and overseas new drugs, the domestic new drug preferential policy is inevitable to protect and foster our industry. Therefore, from May, we should focus on preparing more sophisticated measures in consideration of concerns about the domestic pharmaceutical industry.
- Opinion
- [Reporter’s View] ‘The smart office system’s great, but…
- by Eo, Yun-Ho Mar 15, 2023 05:56am
- The smart office system has become an industry trend. The term, which originally refers to an IT-based office near a residential area that allows employees to work remotely from satellite offices rather than commute to an office downtown, is applied a bit differently in the pharmaceutical industry. Taking into account the characteristics of the industry, as employees often have to move from office to hospital or government office, the companies created workspaces fit for such mobile environment and implemented free seating systems. Due to the telecommuting culture that naturally settled during the pandemic, the number of resident workforce had also decreased. In their place, conference rooms with various concepts and phone booths for long-term calls were added like frosting to the cake. The transition to a smart office had let companies catch two birds with one stone. The reduced number of resident workforce allowed the company to save office expenses, while more space became available for those who came to work. In fact, many multinational pharmaceutical companies that have applied the smart office system moved their offices to relatively less expensive areas. The executive-level employees gave up their space as well. To embrace the horizontal organizational culture and make space for spacious conference rooms with a view, the executives left their rooms to work next to other employees. Even the ‘bosses’ gave up their office space. “I don’t have a room either. It was awkward at first, but the change has turned out for the better. Working next to the employees, we were able to become closer and communicate better." Some companies went on to further remove the honorific expressions altogether. These companies asked employees to call their bosses ‘Mr./Ms.OO’ or by their English names. Unlike in domestic companies, many multinational company employees are known to have a more candid relationship with their bosses. However, not everyone would agree that these changes are all for the good. For example, contrasting views exist on ‘owners that dine together at employee cafeterias.’ One employee confessed “You would naturally feel nervous and uncomfortable if your boss is sitting next to you. I understand the intention and my boss is a good person, but I can’t say I am all for the situation where I have to face the highest-ranking officer of my company continuously during work.” Just as in this employee's confession, although the changes are in the right direction and follow the trend of the times, the system may need to be somewhat adjusted to suit Korea. In the cutest sense, hold a friendly ear out to the complaint and let the ‘boss’ stay in his or her room.
- Opinion
- [Reporter's view]Is the Drug Price Reduction Act Good?
- by Kim, Jin-Gu Mar 06, 2023 05:56am
- The fate of the so-called drug price reduction/refund law will be decided sooner or later. It is expected that a decision will be made within this month at the earliest, whether it will be possible to limit the tricks of avoiding drug price cuts for original drugs for several years by applying for suspension of execution. The amendment to the National Health Insurance Act, which passed the Health and Welfare Committee of the National Assembly, was initially put on hold by the Legislation and Judiciary Committee and was likely to fail. However, it was revived as the Health and Welfare Committee decided to directly refer to the plenary session centering on the opposition party. As a result, this amendment is awaiting the final decision of the plenary session of the National Assembly. The plenary session was scheduled for the 23rd and 30th of this month. In the past, there has been a fierce debate over this amendment. The Ministry of Health and Welfare and the opposition party, which favored the bill, put forward the pharmacist's trick and the leakage of health insurance finances as justification. Opposing legal circles and judiciary committees fought back with the logic that the right to request a trial, a legitimate remedy for rights guaranteed by the Constitution, was violated. In the current situation where the opposition party is the majority, the amendment bill seems to be weighted toward passage. For a resolution at the plenary session, the presence of a majority of the current members and the consent of a majority of the members present is required. In other words, the possibility of passing the plenary session, tied to other agenda items, has increased. If the amendment is finally passed, pharmaceutical companies will have to vomit the health insurance finances invested during the drug price cut suspension period if they lose the prominent lawsuit in the future. The problem is that in the process, there is a risk of shrinking the lawsuit claims of pharmaceutical companies. Of course, the abuse of the judicial system will disappear, but it is pointed out that even if the drug price cut is felt to be unfair, even the opportunity to legitimately dispute it can be limited. In terms of the judicial system, there are also criticisms that it can undermine the essence of the suspension system. The bigger problem is then. If the amendment is passed, there is a possibility that the second and third legislations that reduce the right to request a trial will follow. Legislation that limits the right to appeal for a plausible cause is only difficult for the first time and relatively easy for the second and third. The argument in favor of the amendment can be reinterpreted as not a problem if the drug companies' right to file a lawsuit is slightly reduced if it is to root out the abuse of the suspension system and thereby prevent health insurance financial leaks. No matter how repugnant a pharmaceutical company is, it cannot violate even the fundamental rights of the Constitution. It is time to think about whether the drug price reduction method is the only way to prevent pharmaceutical companies from cheating.
- Opinion
- [Reporter's view] Implications of Lucentis biosimilar
- by Lee, Tak-Sun Feb 27, 2023 05:57am
- The domestic prescription drug market is not a market where prices can operate with competitiveness. This is because paying patients do not have the option to choose a product, and doctors who have the option do not have a margin on sales of insurance drugs, so there is little incentive to prescribe low-priced products. Because of this, even generics that sell products with the same ingredients want a higher insurance limit. However, in the product market where treatment costs are high and the number of products is small, price competition sometimes takes place. A good example is Lucentis biosimilar, a treatment for macular degeneration. Only two companies, Chong Kun Dang and Samsung Bioepis, entered the market for Lucentis biosimilars in January. Both companies put pressure on the original Lucentis by setting an upper limit that was less than the calculated amount. Chong Kun Dang's generic price is 300,000 won per bottle, which is only 36.6% of the original price limit of 820,636 won. Samsung Bioepis Amelivu was listed at 463,773 won, 56% of the original 828,166 won. In the case of biosimilars, you can receive an upper limit of 80% of the original amount, but the two companies were listed at a lower price than this in consideration of price competitiveness. Samsung Bioepis Amelivu will lower the price again in March. It will be reduced by about 24.5% from the existing 463,773 won to 350,000 won. Some analyze that they were conscious of the lowest price Chong Kun Dang products. Such voluntary cut competition is very welcome from the perspective of health insurance authorities. This is because companies can see the effect of reducing insurance financial expenditures as a result of voluntary cuts. Drugs that are cheaper than the calculated amount play a role in reducing finances, but there is no great benefit either. Products with scheduled sales prices that are lower than the calculated amount may also be subject to a drug price reduction by applying PVA. If the upper limit is not lowered during the PVA monitoring period, it will be subject to the same follow-up management as other products. There are also few government incentives to enhance the market competitiveness of low-cost drugs. Although there is a policy that provides incentives to pharmacists if they substitute cheaper drugs among the same-component drugs, it is not easy for pharmacists who do not have the right to choose prescription drugs. It is difficult for patients as well as medical staff to compete for low-cost drugs in a situation where the reliability of originals is much higher than that of latecomers such as generics or biosimilars. Therefore, low-price competition is entirely the responsibility of pharmaceutical companies. Doctors who have the right to choose products should be persuaded of the justification for choosing low-cost drugs. We hope that the low-price strategy of the two pharmaceutical companies will lead to success in the Lucentis biosimilar market. It is hoped that price cuts will be activated through the appearance of low-cost drugs that are rare and competitive in the domestic market, and that this will serve as an opportunity to increase the reliability of generics. The government should also promote the positive function of generics to the market by implementing more aggressive incentive policies for pharmaceutical companies that sell low-cost drugs.
- Opinion
- [Reporter’s View] Decide whether to offer free HCV testing
- by Jung, Sae-Im Feb 24, 2023 05:53am
- Eight years have passed since discussions began on adding hepatitis C (HCV) screening as a free item in Korea’s national health examination program. Despite various supporting evidence that was produced during the period, including the feasibility study that started in 2016, and an analysis that showed that it was cost-effective to include HCV as a national health examination item, as well as the results of the pilot project, the government's intentions are still unclear. Recently, more feasibility analyses and follow-up management measures have also been released on the matter. One of the major reasons why the government was reluctant to introduce HCV screening to the national health examination was its prevalence rate. The first principle among the five conditions that must be satisfied for items to be added to the system is for the disease to be a ‘serious health condition,’ which is evaluated by whether the prevalence rate is 5% or higher. However, the prevalence rate of HCV is around 1%, therefore being unable to satisfy the condition. Its highest prevalence rate is in the 1.7% range for those aged in their 70s. Although the global prevalence rate of HCV remains below 1%, the World Health Organization has a different view on the gravity of the situation. The WHO had set the goal of eradicating HCV by 2030 and urged governments to actively implement policies on their part to achieve this goal. This goal was set as HCV can be easily cured with early diagnosis with the development of treatments, but also carries an increased risk of developing severe diseases such as liver cirrhosis or liver cancer when left untreated. The direct-acting antiviral (DAA) medications that were introduced to the field led to the era of curing HCV. Also, a retreatment option exists for the 1% of patients who fail treatment. This is why the WHO defined HCV as the next disease that can be eradicated after the smallpox virus. Even so, Korea is still stuck on the prevalence rate. An official from the Ministry of Health and Welfare who had attended the ‘32nd Conference of the Asian Pacific Association for the Study of Liver 2023 (APASL 2023),’ mentioned the prevalence rate of HCV in Korea, saying “Korea has a national health examination system in place for all citizens. Therefore, adding HCV screening as an item to the system can have a serious impact, and items should be careful and conservatively added in strict compliance with the set principles.” The remark seems to have been made to imply the authorities' stance on whether HCV screening, which has a low prevalence rate, should be included in the health examination system that is for the entire Korean population. If the prevalence rate was going to be a barrier in the first place, the government wasted more than KRW 1.3 billion in research funds on a concluded issue. No matter how cost-effective the introduction of hepatitis C screening is, all discussions become meaningless if the government raises prevalence as an absolute requirement. But diseases with a prevalence rate of less than 5% are already included for screening in the national health examination system. Therefore, the prevalence rate cannot be an absolute criterion for introducing items in the national health examination system. The government will soon be reviewing the research results that were newly presented this year. If it mentions the prevalence rate again this time, it would be safe to interpret their stance as saying, “Actually, the prevalence is just an excuse and the government has no intention of investing money in HCV." After 8 years of false hope, now is the time to draw a conclusion already.
- Opinion
- [Reporter's view] An uncomfortable gift from the gov
- by Kim, Jin-Gu Feb 17, 2023 05:50am
- The Ministry of Trade, Industry and Energy is pushing to designate key technologies used in the development of biopharmaceuticals as "national high-tech strategic technologies." If bio-core technology is designated as a state-of-the-art strategic technology, various benefits will follow. They include support for the creation of specialized complexes, training professionals through the establishment of specialized graduate schools, and tax credits. In particular, it is known that tax credits can receive up to 40% of R&D costs and up to 16% of facility investment. In November last year, the Ministry of Industry selected 15 core technologies in semiconductor, display, and secondary battery fields as state-of-the-art strategic technologies. The Ministry of Industry's plan is to provide "semiconductor-level" treatment to the pharmaceutical bio-industry by adding biotechnology. However, the pharmaceutical bio-industry is not positive about this. Some are rather opposed to the Ministry of Industry's policy. It was prepared in good faith, but the person involved did not want it. The reason why the pharmaceutical bio-industry refuses the good faith of the Ministry of Industry is because of the "regulations" accompanying support measures. The biggest concern in the industry is to require companies with related technologies to obtain approval from the Ministry of Industry when they make overseas mergers and acquisitions or establish joint ventures. The global trend of the pharmaceutical bio-industry is open innovation, which is feared to disrupt close and prompt consultations with global companies if it is approved by the Ministry of Industry every time. Furthermore, some point out whether it is appropriate for the state to intervene in transactions between companies. Some say that the pharmaceutical bio-industry and the semiconductor and display industries are physically different. In the case of the semiconductor and display industries, it is necessary to prevent the outflow of core technologies from overseas in a position where Korea leads industries around the world. On the other hand, the pharmaceutical bio-industry is still chasing the global industry. It is pointed out that it will be a burden to have to wait for the approval of the Ministry of Industry every time it is time to narrow the technology gap with global leading companies. Considering these practical benefits, the pharmaceutical bio-industry believes that losses will eventually be greater than profits. Currently, the Ministry of Trade, Industry, and Energy is collecting industry opinions to designate the nation's state-of-the-art strategic technology for core biotechnologies. In this regard, related organizations such as the Korea Pharmaceutical Bio Association are reportedly planning to convey the opposite position. It is hard to say that the Ministry of Industry's intention to provide semiconductor-level treatment to the pharmaceutical bio-industry itself was bad. But there is no guarantee that a good start will necessarily produce good results. The starting point for fostering and supporting the pharmaceutical bio-industry may be to look at the industry from the perspective of the pharmaceutical bio industry.
- Opinion
- [Reporter's view]National Security & the Price Policy
- by Lee, Jeong-Hwan Feb 16, 2023 05:52am
- Second Vice Minister of Health and Welfare Park Min-soo reaffirmed that the pharmaceutical bio-industry is directly related to national security and expressed his belief to support the pharmaceutical bio-industry by reorganizing the drug price system. It said it will give some form of benefit to pharmaceutical companies that make medicines using domestic raw materials and pharmaceutical companies that are reluctant to make due to their low profitability, and actively operate a public-private consultative body to effectively work on new drug preferential laws developed by innovative pharmaceutical companies. Expectations from the domestic pharmaceutical industry have also swelled due to Vice Minister Park's clear willingness to improve the drug price system. The expressions of pharmaceutical companies, which have expressed the need to improve the reasonable drug price system toward the government every year, seem to be brightening due to Vice Minister Park's blueprint for drug price policy. In the end, among pharmaceutical raw materials and national essential medicines imported in large quantities from China and India, drug price measures are likely to become visible soon for items that require self-sufficiency through domestic production. It is time for raw material companies and essential drug manufacturers to read the needs of ingredients or items the government believes are urgently needed for self-sufficiency in Korea. The Ministry of Food and Drug Safety, KPBMA, KODC, and pharmaceutical experts have already started to list domestic self-sufficiency materials and items, and according to Vice Minister Park's policy, the policy to strengthen domestic self-sufficiency is expected to continue to expand in the future. The National Assembly's special law on the pharmaceutical industry, which has been pointed out for years, is likely to materialize the preferential treatment of new drug prices for innovative pharmaceutical companies soon. Attention is focusing on whether legislation that stipulates the national compensation system for innovative new drugs as the Pharmaceutical Affairs Act can be realized. At a meeting of the government-run public-private consultative body, pharmaceutical organizations such as KPBMA need to actively submit their opinions to create reasonable drug-friendly measures. The Ministry of Health and Welfare should drastically improve the supply of essential drugs or out of stock, and design a drug price policy that can speed up the development of new drugs in global blockbusters. "I don't even want a drug preference. We should think about improving the drug price system so that does not recur in frustration of some pharmaceutical circles, saying, "We hope that the government will actively introduce a policy to exempt or suspend the follow-up management mechanism for drugs that have contributed to reducing health insurance finances." As COVID-19 has been prolonged for more than three years, the pharmaceutical bio-industry has soon become a national security industry. These days, the COVID-19 virus, which has persistently plagued mankind, is finally slowing down. Advanced overseas countries such as the World Health Organization (WHO), the United States, and Japan are assessing whether they will be able to lift the international public health emergency caused by COVID-19 as of May. It is feared that the government's perception of national security and willingness to improve the drug price system, which has grown further due to COVID-19, will be shaken along with the downward revision of the crisis stage. Only when the Pandemic crisis caused by the new virus recurred in the near future should we not rush to supply and demand essential drugs to cope with infectious diseases necessary for national quarantine. It is hoped that the domestic pharmaceutical bio-industry and the government will agree to prepare a reasonable drug price environment to create a worry-free country for any type of national security crisis in the future.
- Opinion
- [Reporter’s View] Asthma drugs await reimb discussions
- by Eo, Yun-Ho Feb 14, 2023 05:48am
- The asthma drugs that had long remained unreimbursed since their approval has resurfaced at the table for discussions, but the situation has not improved much from before. The government and the companies are seemingly unable to reach a consensus on the appropriate drug price. Three asthma biological drugs that were developed at similar periods - Nucala (mepolizumab), Cinqair (reslizumab), Fasenra (benralizumab) – have finally started their reimbursement listing process 3 years after being approved in Korea, but had difficultly making progress ever since. As interleukin-5 antagonists, the drugs reduce levels of blood eosinophils, a type of white blood cell that is involved in the development of asthma exacerbation. At the time of their approval, the drugs received attention for being an effective treatment option that had not been available before. However, no other asthma biodrug has been reimbursed since the reimbursement approval of Novartis Korea’s ‘Xolair (omalizumab)’ in 2020. Although all the drugs were introduced for ‘asthma,’ the indication and other specifics for the three drugs differ from Xolair. However, as Xolair was considered the comparator of the 3 drugs from the government’s perspective, the government’s suggested price had been unacceptable on the biodrug companies’ part, which brought a halt to the reimbursement process. Xolair itself had also been reimbursed 13 years after approval. Although there had been controversy over the holdout tactic it may have implemented, the long time and turmoil that the company had undergone until its reimbursement should be adequately considered. Regardless of the right and wrongs on either part, the time has passed and discussions have now resumed. It is time for both sides to make the effort to push the discussions through. The pharmaceutical companies must have had a reason and a purpose for deciding to go through the reimbursement process for the items again. Even without reference to their launch status in other countries, it is evident that the companies would have made a consensus internally on an acceptable level. Although the government also has to consider the limited amount of resources, the government should also fully look into the history and value of the drugs before carrying on the dialogue. Also, attention will be focused on whether any of the three drugs show differing results.
- Opinion
- [Reporter’s View] Improving NHI-related legislation
- by Lee, Jeong-Hwan Feb 06, 2023 05:51am
- The bill to remove the administrative drug price cut and reimbursement suspension dispositions that were imposed on illegal drug rebates from the current National Health Insurance Act and raising the penalty surcharge system has drawn industry attention and rose as an issue of focus this year. The bill aims to minimize third-party damage inflicted on patients, prescribing doctors, and dispensing pharmacists by the administrative dispositions imposed on rebate drugs, and to strengthen control over illegal rebates. The controversy over the irrationality of the drug price cuts and reimbursement suspension dispositions imposed on rebate drugs had been an issue for quite some time. The law was revised to improve the irrationality of reimbursement suspensions, where doctors and patients were left with no choice but to use more expensive drugs or experience other disadvantages in treating their diseases due to the reimbursement suspension dispositions. After the reimbursement suspension system on rebate drugs was implemented in July 2014, the revised National Health Insurance Act that applies drug price cuts according to the number of rebates and suspends reimbursement or imposes fines after 3 violations took effect in March 2018. The bill that proposed the reform of the National Health Insurance Act was submitted by NA Rep. Min-Suk Kim of the Democratic Party of Korea as representative. The bill attempts to improve the institutional irrationality of the current reimbursement suspension system. For this, the proposed bill not only contains measures that remove the price cut and suspension of reimbursement dispositions on rebate drugs and improve the standard for fines, but provisions to resolve the issue of drugs that have received reimbursement suspensions in the past. The supplementary provision of the proposed bill allows the law to be applied to drugs that received drug price cuts or reimbursement suspension dispositions or are undergoing administrative litigation at the time Rep. Kim’s bill was implemented. If so, it will be possible to retroactively apply the new system to drugs that were fined when the previous reimbursement suspension system was applied, reducing the risk of unreasonable cases and improving patient rights. The National Health Insurance Service agreed with Kim’s proposed bill that replaces reimbursement suspensions with fines. The NHIS said, “The reimbursement suspensions may violate the health rights of patients in need of the drug, so the NHIS agrees on the purpose of the amendment to impose a fine instead,” acknowledging the harm caused by the reimbursement suspension disposition. Although Kim’s bill cannot be completely flawless., the bill shows traces of multifaceted considerations made to improve the issue of the reimbursement suspension system as rationally as possible while strengthening control over rebates. Lee’s bill to revise the National Health Insurance Act is soon set to be reviewed by the Ministry of Health and Welfare soon. It is hoped that the efforts of the pharmaceutical industry and the National Assembly, which have been struggling to address the issue of reimbursement suspension for a decade, will be thoroughly reflected in the legislation during the review. Also, the legislation, which can allow three birds - preventing unnecessary damage to patients, doctors, and pharmacists, minimizing waste of health insurance finances, and strengthening punitive fines for rebates on pharmaceutical companies - to be caught with one stone, will be successfully implemented.
- Opinion
- [Reporter’s View] CDDC continues to raise controversy
- by Eo, Yun-Ho Feb 01, 2023 05:54am
- The Cancer Disease Deliberation Committee has settled as the highest threshold in reimbursement for anticancer drugs in Korea. This expert committee, which is a mandatory step for reimbursement in Korea, has put many anticancer drugs through an ordeal, to the extent that it was coined the ‘wailing wall’ to reimbursement in Korea. The committee, which had originally been launched for the purpose of evaluating the clinical usefulness of anticancer drugs that applied for reimbursement listing, had become ridden with issues after additionally starting a review on each drug’s fiscal impact. Questions were raised on what grounds the CDDC had to analyze the drug’s fiscal impact, and the fairness and objectivity of the review results were also criticized. However, the Health Insurance Review and Assessment Service only disclosed the meeting results and made no other significant change in the operation of the committee. As a result, the CDDC’s power grew stronger, empowering the government with the justification that ‘the doctors that use the drugs said no,’ and the doctors that were selected as members have become priority targets for management by pharmaceutical companies. Recently, controversy arose over the composition of the committee itself. The criticism was that the blood cancer drugs were not properly evaluated due to the high proportion of solid cancer experts in the committee. In other words, it was pointed out that the large proportion of solid cancer specialists with low expertise in hematologic malignancies in the committee made the committee unfit for proper evaluation of blood cancer drugs. In fact, the Korean Society of Hematology and The Korean Society of Blood and Marrow Transplantation had asked HIRA to organize a separate deliberation committee to review blood cancer drugs, but HIRA has been conservative in their response. This is not the first time an issue was raised on the expertise of the committee’s review. The CDDC had excluded direct stakeholders from deliberations in last year’s committee. In other words, doctors who participated in the clinical study of the subject drug were not allowed to attend the committee on the day of the drug’s deliberation. In terms of the purpose itself, the measure was made to secure transparency. However, as the scope of “direct stakeholders” included doctors who participated in PMS – or Phase IV studies – the composition of the committee itself was at a point where the expertise on the drug could not be ensured. Doctors are not financial experts. They are word by word, a medical expert. This is why the government had to explain that financial experts and healthcare experts were added to the CDDC to support the legitimacy of CDDC in evaluating the financial impact made by anticancer drugs. If so, the key role of the doctor in CDDC is to inform the committee of the medical necessity of the drug and the significance of its clinical trial results. An expert committee can no longer function as an expert committee without expertise. CDDC deliberates not any drug, it evaluates long-awaited new drugs for cancer patients. Neither exclusion for transparency nor the proportion of hematological and solid cancer experts should lead to a lack of expertise. With so many voicing the need for change, when will the government continue to argue that there is “no problem?”
