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- 2025-12-19 22:27:10
- Opinion
- [Reporter's view] There's no instability in supply & demand
- by Lee, Tak-Sun Jan 26, 2023 06:06am
- Last-minute discussions between the NHIS and the pharmaceutical industry are underway regarding PVA of cold medicines, which increased their use due to COVID-19 last year. The consultation began when the government decided to correct the usage instead when the pharmaceutical industry suggested that cold medicines, which have increased their usage due to COVID-19, should be excluded from the PVA. The issue is how far we look at a specific time when usage increased due to COVID-19 last year. This is because the longer the correction time, the more advantageous it is for the pharmaceutical industry, and the shorter the correction effect. The PVA of cold medicines, which are mostly generic drugs, compares the usage of last year and the year before and negotiates the level of drug price reduction according to the increase. Therefore, there is a possibility that it will be excluded from the negotiation, except for a specific time last year when the usage increased due to COVID-19. Since it is difficult to confirm whether it was used for COVID-19 patients one by one, the advantages and disadvantages of the pharmaceutical industry are expected to vary depending on how the two sides consult. The important point is that this PVA should not negatively affect the supply and demand of cold medicines. This is because pharmaceutical companies could lose production power if they are subject to drug price cuts just because of increased usage. It is also a decision against interest rates to raise the upper limit of acetaminophen in December to increase production, and on the contrary, to cut the upper limit to PVA. Therefore, it is important to accurately calculate the level of correction based on actual data, but political calculations are also needed in consideration of the risk of supply and demand instability in the future. We hope that NHIS and the pharmaceutical industry will engage in reasonable consultations without threatening the public health of the people.
- Opinion
- [Reporter’s View] Our expectations for ADC technology
- by Jan 18, 2023 06:04am
- Professor Park Yeon-hee of the Hematology and Oncology department at Samsung Medical Center who recently spoke at the press conference held to celebrate the launch of ‘Enhertu’ in Korea said, “I have never seen such data in breast cancer.” This goes to show the superior efficacy of Enhertu in breast cancer. She added, “During the Enhertu clinical trial, I was inspected by the Ministry of Food and Drug Safety due to the large number of patients enrolling in the trial. And during inspections, my sole concern was, ‘what if a fault I didn’t know about is found that disallows patients from using the drug?’ This was how essential Enhertu is to the patients.” At the American Society of Clinical Oncology meeting last year, Enhertu received a standing ovation from the audience. ASCO is one of the three major global academic conferences in oncology. At the meeting, Enhertu became the first drug to demonstrate an effect in HER2-low breast cancer patients that account for half of all breast cancer patients but have difficulty seeing an effect with existing drugs. The drug lowered the risk of disease progression and death by over 50% compared with chemotherapy and emerged as the star of the ASCO meeting last year. Enhertu is an antibody-drug conjugate (ADC). ADCs are drugs made by connecting antibodies that bind to specific target antigens on the surface of tumor cells to cytotoxic payloads with a linker. Although various ADC drugs existed in the past, Enhertu gained particular interest as it improved the shortcomings of existing ADC drugs by applying next-generation technology. Contrary to concerns that ADCs are highly toxic, Enhertu did not produce dose-limiting toxicity (DLT), and the drug's high cell membrane permeability also affected surrounding tumor cells, producing a bystander antitumor effect. With the spotlight on Enhertu, many Korean pharma and bio companies have also joined in the competition to develop ADC drugs. Biotechnology companies generally develop key platform technology, and large-scale companies pursue equity investments or joint development. Major biopharmaceutical CDMO companies in Korea have also set out to build ADC manufacturing facilities. Various biotechs and mid to large-sized pharma and bio companies including Dong-A Socio Group, LegoChem Biosciences, Lotte Biologics, Samsung Biologics, Samjin Pharm, Celltrion, Ahn-Gook Pharmaceutical, Yuhan Corp, Pinot Bio, Hanmi Pharmacuetical have started developing of ADCs. As in any field, not all of them will see good results. In areas like ADC where cutting-edge technology is applied, and many tasks remain unresolved, fierce technology-based competition is required. There was a time when Big Pharma's interest in ADC wavered after clinical trials were discontinued due to serious side effects such as toxicity that arose due to technical limitations. If these drugs fail to prove the effect equivalent to high cost, marketability for these drugs that apply cutting-edge technology is low even with approval. For example, the new ADC drug ‘Trodelvy,’ which was introduced at the same time as Enhertu, was evaluated to have fallen short of expectations. As a drug, Enhertu established itself as a success case where its company, Daiichi Sankyo set up a future-oriented strategy in the midst of a crisis and fully utilized its technology specialized in the development of small molecule drugs. Dae-Jung Kim, President of Daiichi Sankyo Korea, mentioned in a contributory article he sent to a paper last year that " We will be able to accumulate success stories in Korea by being true to the basics of 'solving unmet medical needs based on science and technology,’ showing persistence, and devoting ourselves to new drug development in the long run..” In the growing field of ADC technology, there is still room for the technology to leap to the next level with steady development. As Kim said, it is the reporter’s wish that the current wave of developing ADCs in the industry will continue to become greater waves in the future.
- Opinion
- [Reporter's view] The Pharmaceutical Bio-Innovation Committe
- by Kim, Jin-Gu Jan 13, 2023 06:01am
- President Yoon Suk Yeol is in his second year in office. President Yoon made various pledges to foster the pharmaceutical bio-industry when he was a candidate. The first of them was to set up a pharmaceutical bio-innovation committee. The pharmaceutical bio-industry was excited by his pledge. Expectations were high for the organization in charge of fostering and supporting the fragmented pharmaceutical bio industry. Preparing a control tower to lead the industry was one of the long-cherished hopes of the pharmaceutical bio industry. However, now in its second year in office, the Pharmaceutical Bio-Innovation Committee was still a pledge. Expectations in the pharmaceutical bio industry for the installation of the control tower are gradually turning into skepticism. It is not a pledge that the interests of the ruling and opposition parties are sharply divided. During last year's parliamentary audit, Rep. Chung Chun-sook of the main opposition Minjoo Party of Korea called for the early establishment of the committee. Rep. Seo Jung-sook of the People's Power proposed a revision to the Special Act on the Promotion and Support of the Pharmaceutical Industry, which calls for the upgrade of the Pharmaceutical Bio Innovation Committee. However, as the National Assembly vacates, President Yoon's first pledge to foster the pharmaceutical bio-industry is also in vain. Minister of Health and Welfare Cho Kyu-hong said he would make efforts to quickly establish the Pharmaceutical Bio Innovation Committee, but the Ministry of Health and Welfare alone is not enough. It is expected that the pharmaceutical bio-industry development project, which has been fragmented into the Ministry of Health and Welfare, the Ministry of Trade, Industry and Energy, and the Ministry of Science and ICT, will be carried out this year. Other pledges are also disappointing. A typical example is the creation of a megafund. In August last year, President Yoon directly announced that he would create a mega fund worth 500 billion won to develop new drugs and vaccines in Korea. The plan calls for securing 300 billion won in private investment at home and abroad. On top of that, the company plans to create a mega fund worth a total of 1 trillion won by adding 500 billion won by the end of this year.
- Opinion
- [Reporter’s View] Can new drug listings really be accelerat
- by Eo, Yun-Ho Jan 11, 2023 05:59am
- The measures to accelerate reimbursement listing of new drugs is expected to be implemented in earnest this year. However, the practicality of the measure – on whether it will really accelerate drug listings – remains in question. The health authorities made a preannouncement on the amendment of the pharmacoeconomic evaluation exemption guidelines and drug pricing negotiations to expedite the listing of anticancer drugs and severe disease treatments as promised by the Yoon Suk-Yeol administration for implementation next year. Through this, the reimbursement listing of new drugs with no alternatives will be reduced by 60 days at most. Reducing the reimbursement listing period of drugs has been a regular agenda that had been discussed every year. With every discussion, the regulatory deadline was reduced incrementally. This applies to both the evaluation and negotiation process conducted by the Health Insurance Review and Assessment Service and National Health Insurance Service. However, this deadline is only the term set for the authorities to review reimbursement after someone (a pharmaceutical company) applies for reimbursement listing. The fault is on both parts. Quite a lot of pharmaceutical companies spend a considerable amount of time before applying for reimbursement after approval to discuss strategies with their headquarters. In other words, the companies take their time to thoroughly calculate their strategies and options. In the process, the companies weigh the timing of reimbursement to receive a higher price or forgo some indications in consideration of competition with other products. Companies really deliberately defer pricing negotiations waiting to be included in the government’s coverage reinforcement measure or decided to cancel the introduction of their drugs determining that Korea's marketability is poor. The decision to pass Korea, the ‘Korea passing’ phenomenon of “deciding to enter Korea after OO country” has become too common. The government's stance to “take discussions to the Drug Reimbursement Evacuation Committee after addressing most issues in the front end” has also played a role. When tracing back the listing process of drugs that have long exceeded the review deadline, applications for many of these drugs have been voluntarily withdrawn by the company after experiencing delays at the Drug Reimbursement Standard Subcommittee level. However, many companies have spoken out on how this voluntary withdrawal is not so ‘voluntary.” The deferral decision is very common during drug pricing negotiations between the NHIS and pharmaceutical companies. However, we need to remember that the 60-day deadline set for negotiations is a promise, and a deadline is a deadline. Also, the NHIS has referred to the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new drugs. The problem is that there is no transparency in the progress made in that 60-day period. Nothing is disclosed on what happened to the drugs that exceeded the listing review deadlines. As a result, only the patients are left to suffer in endless await. No answer nor explanation on the direction of progress is provided to those that wait in dire need. This new year, all the stakeholders involved should make collaborative efforts to reduce the period to actual reimbursement listing.
- Opinion
- [Reporter’s View] Decide whether to reimb diabetes combos
- by Lee, Tak-Sun Jan 09, 2023 06:11am
- Once again, discussions on expanding reimbursement to combination therapies to treat diabetes are at a standstill. The Ministry of Health and Welfare was unimpressed with the price reduction plans submitted by relevant companies under the assumption that reimbursements are expanded. This discussion, which had shown small progress only recently after being deliberated since 2016, has now again come to a standstill. Some have questioned whether the authorities intend to push back reimbursement of combination therapies for two more years until the patent expires for the original drugs. However, the issue cannot be ignored any longer. The combinations being discussed for reimbursement are triple-drug-combinations including metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, as well as some SGLT-2 inhbitors+sulfonylurea or insulin combinations. The voices are strong in the field on the urgent need for their reimbursement due to wide use. The health authorities will not be able to dismiss the doctors’ claim that the combination therapies above are the best options available for the treatment of 6 million diabetes patients in Korea. On the pharmaceutical companies' part, they have also waited enough. Many companies have received approval for their combination therapies in anticipation of reimbursement expansions. The first new combination drug that had been approved is subject to reevaluations this year and is on the verge of being canceled. Domestic companies have invested immensely in the development of combination therapies, and many have already received approvals for the drugs. If the discussions are delayed or come to a full stop, the companies may incur significant losses in their investment. The biggest issue is the fiscal scale. If reimbursement is extended to combination therapies, its fiscal expenditure is expected to reach nearly KRW 100 billion. Therefore, the MOHW is seeking to minimize fiscal expenditure by lowering the insurance price ceiling of listed diabetes treatments. Now is the time to come to a conclusion. If expanding reimbursement to the combination of all classes cannot be made, the authorities should now seriously consider applying reimbursement to at least some substances at a level that will minimally affect the state’s fiscal expenditures. There is no time left. To reduce patient burden and industry damage, this is now the time for the government to derive an optimal plan and come to a conclusion.
- Opinion
- [Reporter's view] Expectations for Revlimid
- by Eo, Yun-Ho Jan 03, 2023 05:41am
- The maintenance therapy of Revlimid, a treatment for multiple myeloma, has been on the insurance benefit list since the new year of 2023 after more than four years of waiting. Revlimid maintenance therapy has simply had a lot of ups and downs. Since 2019, BMS Pharmaceutical Korea has actively carried out the registration process, but there has been no progress in discussions. Revlimid was submitted to the deliberation committee, which attracted attention in September 2019, June 2020, and September last year due to the introduction of the CAR-T treatment Kimriah, but the result was a failure. The NCCN recommends Revlimid maintenance as the highest level of preferred treatment in both transplantable and impossible patients, and ESMO guidelines also recommend it as the only maintenance after autologous hematopoietic stem cell transplantation. Continuous administration of drugs for a kind of prevention is not a concept that was originally absent. In chronic diseases, drugs have already been taken with the concept of management rather than treatment, and in some cases, the reason for the existence of drugs, such as anticoagulants, is prevention. The problem comes from the emergence of adjuvant therapy and maintenance therapy in the field of chemotherapy. The reason why it is difficult to appear is the price. Everyone knows, but even if cancer is cured, it is scary to recur. There are also diseases with a recurrence rate of nearly 80%, depending on the cancer type. Since it is an era of high-priced drugs, prescribing anticancer drugs that are leading the trend for prevention and applying insurance benefits to them is bound to be a burden for health authorities. Existing anticancer drugs are steadily adding adjuvant and maintenance indications, and new anticancer drugs, which are the first indications of adjuvant therapy, are also being approved one after another. In this regard, the registration of benefits for Revlimid maintenance therapy has considerable meaning. Pharmaceutical companies are now able to put their expectations on adjuvant therapy and maintenance therapy indications, which have been only looking at distant mountains in their hands. Revlimid's voluntary drug reduction is already being discussed, but maintenance and adjuvant therapy here is a task to be solved. Since recurrence and metastasis increase the mortality rate of cancer, the specificity of each drug and patient situation should be considered. Of course, the government, pharmaceutical companies, and stakeholders should make efforts to find an agreement that takes into account the Korean health insurance system and the pharmaceutical industry ecosystem.
- Opinion
- [Reporter’s View] Preserve the industry's willpower
- by Dec 21, 2022 06:05am
- Even before the world was able to recover from the COVID-19 pandemic, a global economic recession has arrived to further the damage. With the rise in the price of raw materials, the price of every single consumable including food such as flour, sugar, and cooking oil, as well as fuel, utility bills, etc. have risen. Every day, you can see a flood of articles that report “the price of noodles has risen” or that “eggs cost a fortune these days.” In the age of rising prices, only the price of pharmaceuticals seems to be on the decline. In Korea, the price of pharmaceuticals is on a constant decline under strong state control. The only exception was the price of cold medicine. Their price was recently raised due to a surge in demand for cold medicine during the COVID-19 pandemic. This premium pricing was proposed by the government as a ‘joker card’ to incentivize companies that were reluctant to manufacture more cold medicine due to concerns over deficits. The increase, which was a mere KRW 40 raise from the previous KRW 50 to KRW 90, was a rare exception made under special circumstances. Looking at the government’s recent policy direction, the prospects for pharmaceuticals are even dimmer. More drugs will be subject to reimbursement reevaluations that had significantly affected domestic pharmaceutical companies. Choline alfoscerate drugs have already taken a blow, and other ingredients including streptokinase, almagate, and avocado-soya have been subject to reevaluations and received reductions in their scope of reimbursements or price cuts. These reevaluations are expected to continue on next year. New drugs are not much better off, either. The government recently announced plans to include Australia and Canada as drug price reference countries. Australia is known to have one of the lowest drug prices among developed countries. As the drug prices in Australia are similar to or lower than that of Korea, the industry had criticized how the government is seeking to add these countries to further lower the state’s pharmaceutical expenditures. Industry concerns are rising on how if Australia is included as a drug price reference country, drug prices in Korea, which are already on the lower side in the global market, will be set even lower. While manufacturing and distribution costs are all on the rise, it is clear that the price of end products, the medicines, will continue to fall in Korea. Even the development of new drugs is not easy to carry out. Biotechs specializing in new drug development have also been experiencing a series of hardships. Investments dried up due to concerns over a prolonged economic downturn, and the listing has also become increasingly difficult. CEOs of bio companies are worrying about their business in the coming year. Clinical results do not come out right away, and they need to hold on to the depleting investment funds no matter what. Most of them are in a position to worry about corporate survival. Has the government already forgotten its big talk on how the pharmaceutical and bio-industry is the next-generation growth engine amid concerns over an economic recession? With the government tightening up regulations on the industry contrary to its promise, the industry is grappling for survival in the narrowing market. Despite the hardship, the industry had produced 35th and 36th homegrown new drugs and presented new candidates in the largest Asian oncology society meeting this year. However, these achievements were only made by a select few large pharmaceutical companies, which goes to show how much more support will be needed to nurture the growth of the domestic pharmaceutical bio industry. The ‘Impossible is Nothing’ campaign that became so popular with the World Cup described the importance of willpower. However, in the case of the pharmaceutical and bio-industry, it is rather the government’s willingness to preserve the industry's willpower that’s so important.
- Opinion
- [Reporter’s View] Value of convenience in drug intake
- by Eo, Yun-Ho Dec 13, 2022 06:07am
- Taking the right medicine and taking the daily drug only once every month. This convenience in administration has become a competitivity in the pharmaceutical market. Although this had been more emphasized in the field of chronic diseases in the past, it is being emphasized in the field of anticancer drugs as well. The emergence of one-shot treatments played some role, but advanced new drugs are now showing off not only their efficacy but also their convenience. Convenience in administration. This means that the drug is easy to administer. Some may raise the question, “Why is convenience important when taking drugs? Since drugs are taken to treat illnesses, isn’t their efficacy what’s important?” However still, pharmaceutical companies seem to be obsessed with the concept. Some go as far as to use ‘convenience in administration' as the main slogan for the marketing and sales of their products. Why? The reason is simple. Efficacy alone does not cut it for newly introduced drugs. Of course, groundbreaking paradigm-shifting drugs are also sometimes introduced, but it is also true that it is becoming increasingly difficult to make drugs that are much better than existing drugs. This is why pharmaceutical companies do not conduct direct head-to-head trials with their previous competitors. Usually, head-to-head trials are conducted in comparison with the existing first-line drug (standard treatment) for the disease. Occasionally, when a competitor is a first-line drug, head-to-head trials are conducted, but such drugs rarely secure “superior” results over existing options. However, there are more chances for drugs to improve the convenience in administration while having the same efficacy as existing drugs. Of course, convenience is not of the utmost importance. Its importance varies by situation. Commonly, doctors would not change easily prescriptions for life-or-death conditions like cancer just because another drug has better convenience of intake. Therefore, anticancer drugs need to demonstrate a significant improvement in convenience or better efficacy, in addition to convenience. Due to the risk of unexpected side effects, no doctor will prescribe a new drug to a patient when the existing drug shows effect. Also, the benefit of convenience may falter due to the use of a drug as a combination therapy or related diseases. On the other hand, convenience is more important in chronic diseases that require daily intake of medications. This is the same reason why fixed-dose combinations are preferred for elderly patients who need to take a large number of drugs every day. In this sense, the growing expectations for drugs with longer dosing intervals that require monthly or annual administration reflects the need for improvement in the quality of life of patients in addition to efficacy. Convenience is a difficult value to blindly ignore or support. However, it is also necessary to acknowledge the value of convenience in diseases for which convenience is a major factor and develop drugs to address that clear need, as more and more drugs with improved convenience in administration are suffering in the reimbursement approval process due to non-recognition of their benefit.
- Opinion
- [Reporter's view] A plan to expand the reference country
- by Lee, Tak-Sun Dec 08, 2022 06:05am
- The pharmaceutical industry is strongly opposed to the government's plan to expand drug price reference countries. Although the Ministry of Health and Welfare says it has gone through a sufficient discussion process, the industry is strongly criticizing it as a one-sided push. The revision of the HIRA's administrative notice on the 21st of last month calls for expanding the comparative reference countries of PE drugs to two countries. It is to add Canada and Australia to the current reference countries such as the United States, Japan, the United Kingdom, Germany, France, Italy, and Switzerland. On the 5th, the KRPIA clarified its opposition that the amendment seriously undermines access to new drugs for patients with severe and rare diseases, as well as hinders the development of the domestic pharmaceutical industry. The KRPIA said, "There are cases where benefits are delayed or abandoned due to too low prices and difficulties in insurance registration in Korea, but this amendment will delay the introduction of new anticancer drugs and severe and rare diseases, seriously affecting patients' access to new drugs." Multinational pharmaceutical companies with many new drugs are expressing concerns that the expansion of reference countries could lower the price of related drugs. The domestic pharmaceutical industry, which focuses on generic business rather than new drugs, is also strongly opposed to the revision. This is due to concerns that the revision of the expansion of reference countries could be used to re-evaluate registered drugs in the future. Moreover, Australia argues that the price of generic drugs in Korea will inevitably be lowered further if the re-evaluation is carried out due to the low price of generic drugs. Based on the results of policy research conducted in 2019, the government claims that the revision has been sufficiently collected as it has been discussing the revision by forming a working-level association with the pharmaceutical industry for four months since May this year. However, as expected from the announcement of the implementation of the revision bill in January next year, which is opposed by the pharmaceutical industry as a whole, it cannot be said that the opinions of both sides have been well collected. The Korea RPIA also expressed regret that the government unilaterally pushed ahead with the announcement of policy results focused only on reducing drug costs without drawing a reasonable agreement with the industry. In order to push for a proposal that the parties are opposed to, there must be a good reason, but it is difficult to understand even if you look at the reasons for the Far from persuading the parties, it is questionable why this amendment is necessary to anyone who is a third party. The HIRA announced in advance that it has prepared the revision to enhance transparency and clarity and supplement validity due to the long and insufficient formula for calculating adjusted prices that convert drug prices from seven overseas countries. However, there is a lack of explanation as to why the existing calculation formula lacks evidence and whether additional inclusion of Australia and Canada complements transparency, clarity, and validity. The revision is known to be based on the "Measures to Improve Reference Standards for Foreign Pharmacists" conducted by Gachon University's Industry-Academic Cooperation Group in 2019. In this study, Taiwan as well as Canada and Australia were added to the existing seven countries. The reason for the addition is that Canada and Australia have similar economic levels as Korea, and HTA (medical technology evaluation) plays an important role in the process of determining drug benefits. In the case of Taiwan, it was added because the economic level and health insurance system were similar and geographically close. However, it is reported that Taiwan was excluded because it was conscious of China. However, this explanation seems to be insufficient as a justification for Canada and Australia to be added to the reference countries among many countries. In addition, it is not known why it is a problem to charge drug prices with the existing seven countries as reference countries. Although pharmaceutical companies strongly oppose the revision during the period of submitting their opinions on the revision, it is under the impression that the government is not properly explaining the legitimacy of the revision. In this way, even if the amendment is implemented, it is difficult to avoid criticism that it is a hasty push.
- Opinion
- [Reporter's view] Opinions surrounding the multinational ERP
- by Eo, Yun-Ho Nov 29, 2022 05:54am
- Every office worker has a fear of restructuring. Companies have no choice but to consider layoffs in terms of cost reduction when circumstances are difficult. This year, a number of multinational pharmaceutical companies have either cut their jobs or are in progress. In the case of these multinational pharmaceutical companies, the number of people is often reduced through a method called the Early Retirement Program (ERP). ERP literally takes the form of 'voluntary'. But it doesn't really go spontaneously. Since ERP is also restructuring, the media is also dealing with it somewhat negatively, and in severe cases, labor-management conflicts may occur. In particular, older sales workers may be implicit targets of ERP. However, domestic pharmaceutical companies are often envious of multinational companies' ERP because they often proceed with job cuts without specific compensation. In fact, some employees of multinational companies are seeking to raise a large amount of money through ERP. Industry workers can transfer to other companies as much as they want depending on the demand for each position. For them, ERP could be a form of luck. Under these circumstances, multinational corporations' ERP compensation packages are always at the top of the agenda. "How much more does it give you for two years' salary?", Stories such as "Company A is the best in package" become the subject of common industry drinking stories. The situation in which the company sends people out is not a laughing matter. The issue of coercion, which is exercised behind the word hope, is a problem that must be solved, and the scale of the reduction should not be matched like a puzzle. It is also true that if it is a restructuring that is going on anyway, it is better to have compensation. There will be no beautiful job cuts, but I hope ERP will be the next best.
