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- 2025-12-20 04:52:23
- 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?
- Opinion
- [Reporter's view] COVID-19 demand has disappeared
- by Nov 10, 2022 05:45am
- The boom of pharmaceutical companies, which had benefited from COVID-19, has subsided since the third quarter. Representatively, Roche Group suffered a sharp drop in sales of diagnostic kits and treatments in the third quarter. Roche Group supplies Actemra and Ronapreve, a treatment for COVID-19, and Roche Diagnostics manufactures a COVID-19 diagnostic kit. In the third quarter of this year, Actemra fell 42% year-on-year. Ronapreve's sales also shrank by 36%. Sales of Roche Diagnostics' COVID-19 diagnostic kit, which introduced the first COVID-19 diagnostic kit at the time of the outbreak of COVID-19, also fell sharply. Roche believes that it is no longer possible to benefit from COVID-19 from the third quarter. Roche CEO Severin Schwan said, "COVID-19 demand completely disappeared in the third quarter." It was judged that sales related to COVID-19, which had been on a roll until the end of last year, would not continue this year. Pfizer and Moderna's COVID-19 vaccine sales have also peaked in the fourth quarter of last year and have been on the decline in the first quarter of this year. Although the two companies were the fastest to respond to the COVID-19 mutation among the developers of the COVID-19 vaccine, a drop in sales was inevitable. Overall, the need for vaccination was lowered as the fatigue level of vaccination increased and the severity rate decreased as the coronavirus mutated. The situation of domestic pharmaceutical companies, which benefited from the COVID-19 vaccine and diagnostic kits, is similar. SK Bioscience, which focused on the production of COVID-19 vaccines, saw its sales and operating profit fall 59% and 79% in the third quarter, respectively. The company gave up the flu vaccine, which was its main source of sales, to produce the COVID-19 vaccine. It has also succeeded in developing the first domestic COVID-19 vaccine but has not yet led to profits. Domestic diagnostic kit companies, which recorded all-time sales with COVID-19 diagnostic kits, are also expected to receive sluggish report cards in the second half of the year. The only companies that still benefit from COVID-19 are Pfizer and MSD, which have developed COVID-19 treatments, and pharmaceutical companies that manufacture cold medicines. They are mainly companies that supply treatments for patients with mild COVID-19. In fact, SK Bioscience is considering resuming the production of flu vaccines next year. This is a measure to prepare for a decrease in the production of COVID-19 vaccines. Pfizer is expanding its sales excluding COVID-19-related sales as its existing flagship products are on a roll. However, market concerns are increasing for diagnostic kit companies that have seen the COVID-19 vaccine as the only source of sales or have excessively expanded sales to COVID-19. Countries have supported COVID-19-related diagnosis, prevention, and treatment at the government level, but the situation is expected to change next year. The United States and Japan are already considering charging COVID-19 vaccines or treatments. The loss of government support means that related companies will find it difficult to generate as many sales as they do now. It remains to be seen whether pharmaceutical and bio companies, which have benefited from the COVID-19 special for about two years, will be able to quickly prepare new growth engines.
- Opinion
- [Reporter’s View] Reimb for SLGT-2i combo still in discussi
- by Eo, Yun-Ho Nov 04, 2022 05:39am
- The agenda has been in the last stages of review for 5 months. At this pace, discussions on expanding reimbursement of SGLT-2 inhibitors as combination therapy may again be passed on to the next year. The discussion on expanding reimbursement of SGLT-2 inhibitors as combination therapy has remained stagnant for a long time. After no progress being made for over 3 years, the industry saw hope in listing their fixed-dose combinations with the Health Insurance Reimbursement and Assessment Service’s diabetes expert committee agreeing on integrating and recognizing reimbursement for the combined use of DPP-4 inhibitors and SGLT-2 class drugs and three-drug combination therapies. However, the year has changed since then, and no news of reimbursing of SGLT-2 inhibitor combos, which are under formal review by HIRA, has been released until now. HIRA had announced that the agenda was "in the final stages of determining reimbursement standards" in June, but now it is November. Moreover, SGLT-2 inhibitors are now under further pressure with the imminent expiry of their post-marketing surveillance term. Most of the SGLT-2 inhibitor drugs are required to submit PMS results by 2023-2024. This means the companies have only 1 to 2 years until the deadline. For PMS, companies need to secure and register hundreds to thousands of patients in their study. However, due to the characteristic of Korea’s antidiabetic drug market, non-reimbursed drugs cannot attract and make prescriptions. Unless the reimbursement issue is resolved, it would be virtually impossible for companies to fulfill the number of patients for PMS as required by the Ministry of Food and Drug Safety. A conclusion has to be made one way or another. The academic society has found consensus and submitted its opinion statement recommending reimbursement to be expanded to combination therapy, and the MFDS had changed the labeling category for SGLT-2 inhibitors from by ingredient to ▲monotherapy or ▲combined therapy. The baton is now in HIRA’s hands, and the institution must now cross the finish line. Also, an institutional arrangement should also be made. SGLT-2 inhibitor combinations are also prescription drugs, and there is no harm in playing caution. Although the government had taken too long, such a cautious stance was also necessary. If the class effect of SGLT-2 inhibitors is to be recognized, guidelines on 'the amount of time required to obtain sufficient prescription experience or the amount of prescription' should also be soon prepared.
- Opinion
- [Reporter’s View]Raising price of cold medicines not enough
- by Lee, Tak-Sun Oct 28, 2022 05:56am
- With the shortage of cold medicines remaining unresolved, the government proposed a drug price increase as its final card. The government decided to first take price adjustment applications for dispensed drugs that contain acetaminophen, which is cheaper than other cold medicines. The government had been implementing support measures such as monitoring supply and demand and easing GMP inspections among others to increase the supply of cold medicines that have been lacking due to COVID-19. Also, the government will exclude the amount used for COVID-19 patients from the amount counted for the price-volume agreement system. However, the measures weren’t enough to resolve the shortage. This was why the MFDS Minister Yu-Kyung Oh brought up raising the drug price at the NA Audit as the final card, saying that no other cards were left. Given that this came from the head of the MFDS, not the Ministry of Health and Welfare which is in charge of the price increase, reflects the limitations and frustrations in the support measures for expanding the manufacture of cold medicines so far. However, just a superficial drug price increase will not be enough to resolve the issue, because the ceiling price set for dispensed acetaminophens is too low. Currently, the ceiling price of the dispensed acetaminophen is set at KRW 11-32 for the 0.5g, KRW 26 for the 0.16g, KRW 29 for the 0.325g, and KRW 43-51 for the 0.65g strength. Considering how the over-the-counter 0.65g strength is sold at KRW 200 per tablet, pharmaceutical companies have no choice but to be less active in selling their drug for dispensing purposes. From the companies’ perspective, putting more weight on the over-the-counter products sold at pharmacies or supplying more expensive prescription drugs instead of acetaminophen helps improve company profits. Therefore, the industry believes the government’s price increase will not make a significant impact in increasing the supply if the increased amount is in a superficial range. If the government is to raise the drug price, the rate should be at the extent that considers the suppliers' needs. Moreover, the price should be raised soon. Considering the development of the COVID-19 crisis, applying the price increase in February next year after undergoing all administrative procedures will be too late. Of course, strict screening and negotiations to facilitate smooth supply are required, but if the purpose of the measure is to immediately increase the supply, the procedure should be boldly omitted. Also, prompt action must be taken in advance, as suppliers are likely to stock up on products and defer sales until the price increase is applied. Therefore, the government should also require companies to commit to expanding their supply along with the price increase. The price increase of cold medicines this time is made largely for the public interest of allowing the timely provision of such drugs to patients and long-term care institutions by expanding supply. In consideration of this, the government and pharmaceutical companies should closely work together to achieve the desired effect with the price increase measure.
- Opinion
- [Reporter's view] Two plays in the parliamentary audit
- by Kim, Jin-Gu Oct 25, 2022 05:46am
- A Member of Parliament asks about the need to introduce a prescription for active ingredients. Then, whether it was the Minister of Health and Welfare or the Minister of Food and Drug Safety, he replied that he sympathized with the purpose. There is a strong backlash from medical groups. This concludes the play. The same is true this year. Seo Young-seok, a member of the Democratic Party of Korea, asked for the opinions of the Minister of Health and Welfare and the Minister of Food and Drug Safety on the introduction of a prescription for active recipients at a recently completed parliamentary audit of the National Assembly's Health and Welfare Committee. Oh Yoo-kyung, head of the Ministry of Food and Drug Safety, said, "I agree," and Minister Cho Kyu-hong avoided an immediate answer, saying, "I will discuss measures with the Ministry of Food and Drug Safety." The screenplay is much the same and only the actor changes every year. It is hard to find sincerity in both the National Assembly and the government that has raised questions and sympathized with the purpose. The introduction of the prescription of active ingredients is discussed only during the parliamentary audit season. This year's parliamentary audit also featured plays related to lowering generic drug prices. When Choi Jae-hyung, a member of the People's Power Party, pointed out that "the price of generic drugs is higher than that of advanced countries abroad," Minister Cho Kyu-hong replied, "We will find a way to lower them step by step." The authenticity doesn't feel much. There seems to be no fierce concern about the impact of the generic drug price cut on the domestic prescription market and the pharmaceutical industry. It seems to read the written script as it is, whether it is on the side of asking or answering. In 2012, the government implemented a package of weak cuts. At that time, the National Assembly pointed out that generic drugs were too expensive, and the government reorganized the drug price system under the pretext of financial reduction of health insurance. In the end, the damage caused by this was suffered by the domestic pharmaceutical industry. This is not to say that discussions on lowering generic drug prices should begin. It is repeated every season of the parliamentary audit. It is necessary to think more deeply about how much the shock is in the process of reading and answering the set script. As it is a huge topic that will shake up the pharmaceutical prescription market and the pharmaceutical industry, there should have been time to gather opinions, whether it is a debate or a public hearing, before simple questions and answers. The National Assembly and the government are expected to repeat the parliamentary audit next year similar to this year. The play with the obvious ending is not interesting. I hope that a more sincere and novel script will be written on the stage, where the theme of health insurance fiscal reduction is to be the theme.
