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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.
Opinion
[Reporter's view]There should be no recurrence of COVID kit
by
Lee, Hye-Kyung
Nov 28, 2022 05:50am
Demand for self-examination kits is increasing rapidly as Twindemic, where COVID-19 and seasonal flu are prevalent at the same time, becomes a reality. According to the pharmacy site data analysis service Care Insight (www.careinsight.co.kr), 12,629 self-kits were sold at 396 pharmacies in the 47th week of this year (11/13-19), with daily sales of about 4.56 pharmacies. As the average daily sales per pharmacy in the 43rd week of this year increased every week from 2.45 to 2.87 (44 weeks) → 3.28 (45 weeks) → 3.91 (46 weeks), some are concerned about the recurrence of the supply shortage of self-kits in the first half of this year. The Ministry of Food and Drug Safety said it is continuously monitoring domestic production and inventory, adding that it is not at a stage where it is concerned about the reproduction of supply shortages. The reason is that as of November 15, the inventory of self-kits is 70 million people, which can produce about 40 million people a week. Front-line pharmacies are concerned that if the number of people looking for self-kits increases due to the Twindemic, the supply shortage that occurred earlier this year could be reproduced if demand suddenly increases more than supply. In particular, as pharmacies were confused by the Ministry of Food and Drug Safety's management system, which changes every day at the time of the supply of self-kits, they have no choice but to worry about securing inventory of self-kits in preparation for Twindemic. When the shortage of self-kits occurred in February, the government's policy changed several times in just 10 days. On February 11, the Ministry of Food and Drug Safety announced a ban on online sales on February 10, followed by then Prime Minister Kim Boo-kyum's "consideration of introducing the highest price system," limiting sales to pharmacies and convenience stores, allowing small sales, and limiting purchases. Pharmacists could not trust the government as they announced the designation of 6,000 won for each sale on Feb. 14, announced the application of 50 quotas per seller, and changed their words to abolish the 50 quota system on Feb. 16. The problem occurred once more last August. Complaints from pharmacies have increased as convenience stores that have not reported medical device sales businesses have been allowed to sell their own kits from July 20 to September 30. It is said that the supply of self-kits is sufficient now, but if there is a shortage again, the Ministry of Food and Drug Safety is expected to actively intervene as in the cases in February and July. However, if another unprepared policy and plan to ignore the existing system are announced, trust will eventually be broken. The Ministry of Food and Drug Safety should predict demand with experts in advance and create natural solutions together, not urgent measures so that there is no confusion and dissatisfaction at the site.
Opinion
[Reporter's view] Godex benefit adequacy will be further di
by
Lee, Tak-Sun
Nov 25, 2022 06:05am
At the Health Insurance Policy Deliberation Committee held on the 23rd, it was decided to further discuss the appropriateness of the salaries of Godex and Imotun at the next deliberation committee. Although the HIRA Drug Benefit Evaluation Committee recognized the appropriateness of the benefit, the final organization, the Health Insurance Policy Review Committee, put the brakes on it. The review committee plans to revisit whether it is appropriate to recognize the appropriateness of benefits just because drugs with unclear clinical usefulness are cost-effective. The decision of the Health Insurance Policy Review Committee should serve as an opportunity to look back on whether the re-evaluation of drug benefits, which has been underway since last year, is proceeding correctly. First of all, it is necessary to check whether the basis for judging the clinical usefulness being evaluated is playing its role. The HIRA first evaluates clinical usefulness based on the basis of evidence such as textbooks, clinical care and guidelines. Items with ambiguous clinical usefulness and unclear items are emerging. Godex and Imotun were those kinds of drugs. If so, it is necessary to look back on whether the data on which the evaluation is based lack of reliability or the threshold of evidence is too low. Unlike the salary re-evaluation, the Ministry of Food and Drug Safety's re-evaluation of efficacy is much clearer. If the effectiveness of the drug is unclear, the basis is provided through clinical trials. The permission also varies depending on the success of the clinical trial. The evaluation of the clinical usefulness of the HIRA is supposed to be skipped if it is ambiguous. In other words, if the clinical usefulness is unclear, the appropriateness of the salary is evaluated by considering the cost effectiveness. Even if the clinical usefulness is not accurately proven, there is a way to maintain the salary. In some ways, I don't know if it's effective or not, but it's cheap, so it can be seen as maintaining benefit. The deliberation committee also points out this point and asks if it fits the purpose of re-evaluation of benefit adequacy for the purpose of optimizing drug expenditure. Even if Godex and Imotun are recognized for their appropriateness as determined by the committee at the next hearing, the existing clinical usefulness evaluation part should be revised. It is necessary to provide clues that make it clear whether it is clinical useful without intermediate or if the clinical usefulness is unclear. In that respect, the current evaluation of benefit adequacy is not clear. It may be a way to leave drugs with unclear clinical usefulness to the Ministry of Food and Drug Safety to conduct clinical re-evaluation. I would like to ask again whether it is efficient to undergo double verification because the efficacy verified by the Ministry of Food and Drug Safety and the clinical usefulness evaluated by the HIRA are different. The HIRA should not dismiss the review committee's decision as a kind of distinction, but should use it as an opportunity to double-check whether the re-evaluation of salaries has been carried out correctly.
Opinion
[Reporter's view] Poor COVID-19 vaccine inducement
by
Nov 22, 2022 06:04am
"Did you get the COVID-19 vaccine in winter? Mom and dad are the ones who should be vaccinated" The mother answered in a casual manner. "It's okay. I'm in my 60s, so I don't have to get it." "What are you talking about? You have hyperlipidemia. Get it right quickly." "It's okay. I think it'll pass lightly even if I get COVID-19." But will parents listen to the government's recommendations when she doesn't listen to their daughter easily? The government is trying to increase the vaccination rate for COVID-19. Understandably, a crisis is detected in recent COVID-19 statistics. As of the 21st, the number of critically ill patients hospitalized for COVID-19 was 465, up 14 from 451 the previous day. It is the highest level in two months since September 21 (494 people). The cumulative death toll from COVID-19 exceeded 30,000. As the number of deaths increased, the fatality rate also rose to 0.11%. As the number of confirmed cases increased due to the 7th re-pandemic, the average number of new confirmed cases per day over the past 7 days reached 52,002. In the end, it is necessary to protect the vulnerable group of COVID-19 with a vaccine, but the vaccination rates for booster shots in winter for the elderly aged 60 or older or those related to vulnerable facilities are only 17.3% and 17.6%, respectively. Eight out of 10 elderly people did not receive a divalent vaccine. The quarantine authorities set an additional vaccination period for winter from this week to the 18th of next month and started to encourage vaccinations centered on the elderly and vulnerable facilities. The goal is to complete the divalent vaccination of more than half of the elderly aged 60 or older within this period and achieve a 60% vaccination rate for vulnerable facilities. In contrast to these big goals, the incentives are fairly poor. Incentives given to individuals include temple stay discounts, cultural experience benefits such as free admission to palaces and Neungwon, and discounts when using local governments' facilities. From a child's point of view, it is unlikely that my parents will get a vaccine to go to Temple Stay or Palace. Even the old palaces and ridges are already open for free to those over 65. The public perception of COVID-19 has already changed too much. Even if you get COVID-19, you don't think it's a big deal, and rather, you're scared of the side effects of vaccines. They are not vaccinated for prevention but vaccinated for necessity. There are cases where you need to go on a trip, but you need booster shot certification, or if you don't get a vaccine, there are disadvantages. In this situation, it is hard to understand to offer incentives such as free admission to Temple Stay, which only worked last year. More effective incentives are needed. It is also necessary to promote in various ways so that the public can voluntarily seek vaccines for prevention. It is not useful to simply emphasize the justification of "vaccination." If the government's power is not enough, it can borrow the hands of pharmaceutical companies. As public advertisements are allowed for vaccines, COVID-19 vaccine developers can promote their own vaccines to increase the overall vaccination rate. The government encourages vaccination at daily briefings. It is time for an in-depth strategy to persuade the public not to end up with a cry in the air.
Opinion
[Reporter's view] Generic drugs can't be me-too drug
by
Kim, Jin-Gu
Nov 17, 2022 05:54am
Controversy is brewing over the government's push to replace the term "generic" with me-too-drug. The KPBMA and the Korean Pharmaceutical Association immediately objected. They stress that it is not enough to contain all the meanings of the term generic in the term copy drug. The backlash from the pharmaceutical industry seems reasonable. This is because there is a very large difference. The meaning of generic is the same as general. It is also defined in the dictionary as 'comprehensive', 'no characteristics', and 'no name'. The English dictionary describes it as "not sold or made under a specific brand name" as the second meaning. Me-too drug is defined as 'making or doing the same thing as the original'. The word 'Reproduction' or 'Copy' is more like the word 'Generic'. However, no generic drug is named Reproduced Medicine or Copy Drug anywhere in the UK. Even if you look at the process of generics development, it is different from a me-too-drug. The Ministry of Food and Drug Safety explains that generic drugs are "first developed (original) drugs and drugs that are made equal in the content of main ingredients, how to take them, efficacy, effectiveness, and quality." It goes through a process called a biological equivalence test to see if the original and generic are the same. Instead of simply copying the original, it is necessary to examine whether the efficacy and safety of the human body are the same, and then undergo a separate permission review. This is why the KPBMA expressed its opinion, saying, "It is not the result of reproduction created as if it were simply printed." If a generic is replaced with a generic drug, there is a high concern that it will be recognized differently from the essence of the general public. The Korean Pharmaceutical Association is concerned that "it may be sold under the name of 'fake medicine' or 'copy medicine' in the sense of the word cloning." Language is a vessel for thought. It's not just a symbol to express things. It acts like a kind of formwork that determines the scope of perception. If generic drugs are replaced by the term me-too drug, it is difficult to escape the range of recognition of 'replication'. The term generic may be a somewhat unfamiliar word from the perspective of the general public. Nevertheless, me-too-drug should not be a substitute for a generic. The word me-too drug does not seem appropriate to represent the nature of generic.
Opinion
[Reporter's view] APAP price increase should be quick
by
Lee, Tak-Sun
Nov 16, 2022 06:10am
The government is rushing to raise the upper limit of Acetaminophen which supply and demand are unstable due to COVID-19. The government's plan is to end the review and negotiations as early as this month to reflect the increase plan next month. As the supply and demand of cold medicine continue throughout the year and a large-scale COVID-19 epidemic is expected at the end of the year, we should hurry to raise the price of medicine to expand supply. If the existing procedure is followed, the weak price increase will not be realized until February next year at the earliest, but it is likely to be too late then. It is worrisome that a hasty agreement will be reached in accordance with the unreasonable rapid processing policy. The upper limit of Acetaminophen 650mg is listed at 43 won to 51 won. Some say that it should be more than 100 won, twice as much as this price. First of all, it is necessary to analyze the cost data of individual pharmaceutical companies and come up with a suitable increase plan. We can't just keep up with the position of pharmaceutical companies. Safety measures are also needed so that an increase in weak prices can lead to supply expansion. Therefore, as the price has risen, it is necessary to expand the supply in proportion to it. If the government emphasizes only expedited processing, the government will not be able to avoid criticism that it only raised prices without practical benefits. It is bound to be a burden for the HIRA and the NHIS, which hold the key to analysis and negotiation. As the increase in the weak price is for the people exposed to COVID-19, a wide agreement is urgently needed. If it is difficult to reach an agreement with only mutual interests, it seems that there is no need to stick to swift action. This is because, although this issue is special, equity for other drugs must also be considered.
Opinion
[Reporter’s View] Advanced new drugs, reimb, and patients
by
Eo, Yun-Ho
Nov 15, 2022 05:39am
Some drugs can be prescribed regardless of mutation or receptor status at certain stages of a disease. Other drugs can be prescribed regardless of disease if a certain gene mutation is identified in the patient. As such, the field of pharmaceuticals is evolving at a rapid pace. New drugs that are no longer attached to a specific disease are emerging, introduced as all-comers or disease-agnostic drugs. And the emergence of these drugs is heralding a paradigm shift. However, the new drugs are not easily granted reimbursement in Korea. Due to the broad application of the drugs, the government has to consider how their increased use volume may raise financial concern. For all-comer drugs, further concerns remain. Some raise doubts about their efficacy, on how they can be effective regardless of the gene targeted by their mechanism of action. However, although the efficacy may vary, these drugs have proven their effect as all-comer drugs and obtained approval from the Ministry of Food and Drug Safety. The case is not so different for disease-agnostic drugs that target gene mutations either. And the development of precision medicine is heralding the shift in the prescriptions from ‘disease’ to ‘gene,’ announcing the arrival of the era of personalized medicine. Existing targeted therapies, immunotherapies, as well as tumor-agnostic therapies that were listed this year have also suffered much in the course of expanding their scope of reimbursement. Not only because the drugs are expensive but because each drug needs to reconduct value assessments and estimate their increase in usage volume. This is the main framework that supports Korea's health insurance system. While prudence in financial spending is important, the government also needs to consider the demand of the patients and make some compromises. Times have changed. Patients and their families no longer solely depend on their doctors to make decisions. They search papers for new drugs in clinical trial databases like clinicaltrial.gov. Therefore the question remains, how should Korea embrace these advanced new drugs in the future?
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