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- 2026-05-01 00:26:34
- Opinion
- [Reporter's view] Only 2% of patients
- by Eo, Yun-Ho Jun 23, 2022 05:50am
- #Will the new EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer treatment, which was useless for existing TKI, be able to receive insurance benefits? It's all the same cancer, but it's different. Cancer species such as liver cancer, stomach cancer, and lung cancer, which we call, are only a simple category, and in fact, they are classified in detail. Even if tumors originate from the same organ, the difficulty of treatment varies according to this detailed classification and the number of patients also varies. For example, EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer is so rare that only 2% of EGFR mutated non-small cell lung cancer patients in Korea are identified. Until now, there has been no suitable treatment for the treatment of this disease, and the NCCN guidelines have also recommended platinum-based anticancer therapy. Even this is subject to reduction in Korea. Lung cancer is not a rare disease, but EGFR Exon 20 Insertion–Mutated Non–Small-Cell Lung Cancer can be a rare cancer. EGFR Exon 20 Insertion–Mutated Non–Small-Cell Lung Cancer has a 75% higher risk of death compared to common EGFR mutated non-small cell lung cancer, a 5-year survival rate of 8% and patient life expectancy of less than 2 years. In this situation, the anticancer drug Rybrevant, which targets EGFR Exon 20 Insertion-Mutation, will be submitted to the HIRA Cancer Disease Review Committee on the 29th to register insurance benefits. This drug, well known as Leclaza's combination therapy partner, was approved in Korea in February this year as the first targeted treatment for EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer treatment. Rybrevant confirmed the overall response rate (ORR) of 40% through a CHRYSALIS clinical study, with 4% of patients achieving CR and 36% achieving PR. In recognition of its value as a treatment for rare carcinomas, it was quickly approved by the U.S. FDA in May last year with only the results of phase 1 clinical trials, and was designated as a subject for rapid review in Korea before obtaining permission. The question is whether or not value is recognized in the benefit evaluation. As it is a drug licensed as a single-Arm clinical data without a control group, the key is whether the value of Rybrevant, which should take the PE system, can be recognized as rare cancer, not just lung cancer. The new government, which was launched last month, promised to promote a rapid registration system for anticancer drugs and treatments for severe rare diseases without alternative drugs. It remains to be seen whether the speed of registration of rare disease and rare cancer drugs in Korea can be improved in the future.
- Opinion
- [Reporter's view]Will arbitrary manufacturing be eradicated?
- by Kim, Jin-Gu Jun 08, 2022 05:56am
- A revision to the Pharmaceutical Affairs Act, which allows the imposition of "punitive fines" on pharmaceutical companies that violate GMPs, passed the National Assembly. It also included canceling the judgment of suitability for the GMP if a violation is found, and allowing a prison term of up to five years or a fine of up to 50 million won, apart from the fine. It contains the will of the MFDS that there is no longer tolerance for deceiving the authorities of permission by false or fraudulent means. What is noteworthy in the revised Pharmaceutical Affairs Act is that a 'GMP exclusive investigator' was appointed. In order to increase the administrative efficiency of GMP investigation and evaluation work, GMP manufacturing and quality control investigators were appointed and pharmaceutical manufacturers were allowed to enter and investigate. It is interpreted that the GMP Special Planning and Inspection Team, which was temporarily operated after a series of GMP violations were detected last year, will be changed to a regular operating system. There has been a role in managing and supervising pharmaceutical companies' compliance with GMP. Article 36 of the current Pharmaceutical Affairs Act designates a "Manufacturing Manager" and manages and supervises the overall drug manufacturing work. But it's actually a private law. Many manufacturing managers have long acquiesced in the evil practice of the name. There are also many expedient ways to fill out related documents in double and then take a new pharmacist to sign them. Manufacturing managers were unable to make a proper opinion from the standpoint of receiving a salary from the company. Pharmaceutical companies forced them to be loyal, and the Ministry of Food and Drug Safety remained unaware. It means that there is no role in managing and supervising drug manufacturing, so GMP violations have not continued. It's just that the law hasn't been used properly. The MFDS has steadily detected GMP violations through the pharmacist monitoring system. According to data released at last year's parliamentary audit, the MFDS conducted 1,277 pharmacist monitoring (regular monitoring + special monitoring) for 5 years and 9 months from 2016 to September 2021. In the process, 485 violations of 189 companies were detected. It means that four (38%) of the pharmacist monitoring were caught 10 times. The problem is that 118 companies have been caught twice or more. There were 45 companies caught more than four times, and two companies were caught more than 10 times. This means that there was no appropriate follow-up by the MFDS even after detecting GMP violations. The main point of the new system is to strengthen surveillance and punishment. The plan is to strengthen surveillance through GMP investigators and impose strong penalties on companies caught to prevent recurrence. Strengthening surveillance and punishment in the new system require appropriate interaction. The focus should not only be on detecting GMP violations. Without proper follow-up measures to prevent recurrence, it is meaningless even if the number of GMP violations is doubled or tripled.
- Opinion
- [Reporter’s View] Differing indication and reimb standards
- by Eo, Yun-Ho Jun 02, 2022 05:58am
- There are some cases where the insurance reimbursement standards and the indication for a drug differs. This gap emerges as not all the uses of a drug approved by the regulatory authorities may be deemed appropriate by the insurance authorities to spend their limited insurance finances on. This is why voices of complaint often arise in the field. It is impossible for the authorities to address all the complaints, but there exist cases where the non-reimbursement measure seems unreasonable, no matter how ‘financial’ the reason may be. One representative example of this is the restrictions set on switching and the period of administration. Let us look at the reimbursement standards set for the acute myeloid leukemia (AML) treatment Xospata (gilteritinib) which was recently listed for insurance benefit. The reimbursement standards for Xospata state that patients who show partial remission or higher after 2 cycles of administration and have received prior approval to receive allogeneic hematopoietic stem cell transplantation (or have presented evidence equivalent to the condition above) are allowed to receive 2 additional cycles of treatment in consideration of the preparation period for allogeneic hematopoietic stem cell transplantation. In general, the restrictions on a drug’s dosing cycle are set based on the design of the drug’s clinical trial or guidelines set by overseas authorities. However, there is no reason to limit the period of administration for Xospata. The ADMIRAL study that was conducted on Xospata shows that the drug was designed without limitation in the administration period, and the NCCN guidelines also recommend the drug as ‘Category 1’ without restricting its period of administration. JAK inhibitors that receive attention as oral rheumatoid arthritis treatments are facing a switching issue. The JAK inhibitors approved in Korea are ' Xeljanz (tofacitinib)', ' Olumiant (baricitinib)', ' Rinvoq (upadacitinib),’ etc. However, if patients switch to a different drug while receiving another, the reimbursement for their first drug is not recognized, In other words, if the patient who had switched to a different drug expecting better treatment results wishes to reuse the previous drug after seeing poor results, they may not receive reimbursement. The anti-TNF agents that had first entered the autoimmune disease treatment market had also undergone the same process. With the issue continuously raised in the field, switching of drugs such as ‘Humira (adalimumab),’‘Remicade (infliximab),’ and ‘Enbrel (etanercept)’ were finally allowed reimbursement in 2013. In Korea, the reimbursement of drugs significantly affects prescription in the field. Most HCPs in Korea give up prescribing a drug even if it is deemed necessary for a patient if the drug is non-reimbursed. Restricting fiscal spending in areas where prescriptions are needed may be toxic. In this sense, a little more trust on the health authorities’ part in the judgment made in the field would be mutually beneficial.
- Opinion
- [Reporter’s view] What was gained and lost with COVID R&D
- by Kim, Jin-Gu May 25, 2022 05:47am
- Literally, the companies have played it out to the end. By the companies, this reporter is referring to the developers of COVID-19 treatments and vaccines. Just 2 years ago, the developers had received the investors’ utmost interest. Stock prices soared when news broke out that a company is developing COVID-19 treatments or vaccines. The domestic stock market had been in a boom then, and every day, press releases on related news poured in. Some companies had even made malicious attempts to ride the investment boom. Many new treatments and vaccines were released in the past 2 years, but many of the companies that attempted to develop COVID-19 treatments and vaccines have also waved the white flag. In the case of the other companies still continuing on their R&D journey, their motive and drive have weakened significantly. Skepticism prevails over how many of these companies will continue to carry out their COVID-19 R&Ds to the end. The investors’ interest has also dropped sharply. They are no longer interested in whether the companies applied to initiate clinical trials, completed patient enrollment, or saw positive interim results. The stock prices of the companies that dangerously soared 2 years ago are making their way back. The COVID-19 R&D companies have both gained and lost much during the past 2 years. One gain is that the companies were able to imprint their names into the investors’ minds amid fierce competition. Also, the companies accumulated practical experience deriving candidate substances and conducting clinical trials in an emergency situation like the pandemic. Some companies also secured considerable cashable assets by selling their shares when their stock prices rose. On the other hand, many of these companies are losing their investors' interest and trust in return. In particular, the declining investor trust seems to be adding weight to the bubble theory in the pharmaceutical and bio industry. KRXHLTH, which represents the stock price of the pharmaceutical and bio-industry in Korea, has returned exactly to the level it had been before the pandemic. KRXHLTH rose 89.3% from 2915.31 at the start of 2020 to 5517.31 at the end of 2020 but then has been steadily declining to return to the pre-COVID-19 level of 2916.62 (as of May 20th). Among the 17 industry sectors that make up the KRX sector, the decline compared to the end of 2020 has been the largest in Healthcare. Now, there is rising concern that KRXHLTH may become lower than even before the COVID-19 outbreak. It is not about applauding the companies that have succeeded and criticizing those that failed to develop COVID-19 treatments and vaccines. It is more about asking the conscience of the companies that have carried out massive promotions about their development of COVID-19 treatments and vaccines. What did you truly gain, and what have you lost?
- Opinion
- The Minister should be appointed to lead policy continuity
- by Lee, Hye-Kyung May 20, 2022 06:11am
- On the 13th, the Yoon Seok-yeol government announced the appointment of vice ministers, ministries, and commissioners. However, as the head of the Ministry of Food and Drug Safety was excluded from the list of appointments, many talks were exchanged about the background. The most credible argument was that the appointment of the head of the affiliated agency would not have been easy at a time when the appointment of the MOHW was not made. Candidate for Minister of Health and Welfare Chung Ho-young has yet to be appointed since the personnel hearing. Some say they are trying to trade for the confirmation of Prime Minister nominee Han Duck-soo and the resignation of Minister of Health and Welfare candidate Chung Ho-young. In this situation, attention is also being paid to who will become the head of the regulatory agency, the MFDS. Oh Yoo-kyung, dean of Seoul National University College of Pharmacy, Kim In-kyu, former head of Gyeongin Office, Yoon Hyung-joo, and Seo Kyung-won, head of safety evaluation, were mentioned as candidates for his successor. All candidates seem to have the advantage of being able to maintain policy continuity and consistency as internal personnel of the MFDS. It is unclear whether the head of the MFDS, who is first appointed by the Yoon Seok-yeol government, will also be able to exceed the average tenure. The MFDS is a regulatory agency for pharmaceutical and food safety management, and frequent replacement of the head of the MFDS does not seem desirable to maintain continuity and consistency. Yoon Seok-yeol, the first head of the government's MFDS, who will be appointed soon, should be empowered to lead policies such as rapid approval of medical products such as medicines and support the development of COVID-19 treatments.
- Opinion
- [Reporter’s View] New govnt signals expanded PE exemptions
- by Eo, Yun-Ho May 18, 2022 05:52am
- The inauguration of a new government brings hope and anticipation to each and every industry. The same goes for multinational pharmaceutical companies. In the pharmaceutical industry, hopes are rising for the expanded eligibility of the pharmacoeconomic evaluation exemption scheme. Although many agendas remain in need of resolution, such as improvement of drug prices for each indication and the pre-listing post-evaluation scheme, etc., the industry believes the improvement of the PE exemption system is most realistic. This seems plausible from the third person's perspective as well. In fact, Yoon Suk-Yeol’s administration plans to promote the accelerated listing of anticancer drugs and treatments for severe and rare diseases that have no alternatives to improve patient access to such treatments. However, due to the conservative stance held by the relevant ministries such as the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and the National Health Insurance Service in improving drug prices for each indication and the application of the pre-listing post-evaluation system, no drastic change may be possible even with the administration change. But there still lies hope for improvement in the PE exemption system, as this special system that was introduced as an exception by the Korean government is still being well utilized, and the request for its improvement has been continuously raised for some time. Strangely enough, new drugs with low profitability due to a small number of eligible patients and drugs that have difficulty demonstrating cost-effectiveness even after overcoming developmental difficulties are becoming a trend and being actively introduced to the market. It may be due on one part because drugs for almost all other diseases have already been released, but still, the addition of these new treatment options cannot be bad for mankind. The industry has been requesting expanding eligibility of the pharmacoeconomic evaluation exemption scheme. The industry requested a more flexible application of the system, under which the PE exemption system is applied to drugs with no alternatives that have been approved with placebo-controlled data or be applied the same eligibility standards for the patients, etc. However, from the government’s perspective, it is difficult to open up its pockets upon every request as it has to pay the expenses from a limited budget. This is why the rumor that the PE exempted drug’s price will be set at ‘80% of the lowest A7-adjusted price’ had turned the industry upside down last year. PE exemptions are the only option for necessary drugs deemed difficult to receive pharmacoeconomic evaluations. It contains various fiscal management devices and has incorporated the ‘expenditure cap’ design ever since its implementation to protect fiscal sustainability. It’s just that with more drugs introduced to the market, more flexible management of the system may now be required for the right treatment to be prescribed to patients at the right time. In this context, on what picture the new administration has prepared to address this issue remains a focus of attention.
- Opinion
- [Reporter’s View] Now is the time for drug reclassification
- by Lee, Tak-Sun May 06, 2022 05:46am
- 10 years have already passed since the heated discussion arose on the drug reclassification and sale of over-the-counter drugs in non-pharmacy venues. As the Korean saying goes, even nature can change in one decade. In that not-so-long but also an epoch of a period in terms of change, many drugs have established safety profiles and await better patient access. In other words, the time has now come for discussions on drug reclassifications, just as we have done in 2012 a decade ago. Above all, we need to make an opportunity to discuss reclassifications because no system that regularly reclassifies drugs exist in Korea. The Ministry of Food and Drug Safety announced that it would establish a regular system at the time of the reclassification in 2012, but the switchings based on overseas and safety data are not being performed smoothly. There are cases where the reclassification process itself is at a standstill despite rising social demand, such as in the case of the morning-after pill. This is mainly due to the absence of an applicant, but this doesn’t mean that the government should just let go of the matter. The government should actively come up with a plan and have applicants such as pharmaceutical companies, medical/pharmaceutical associations, and consumer groups fill out application forms. The environment and timing are also set for reclassifications, as 10 years have passed since the full reclassification and the people who led the reclassification at the time have returned with the administration change. Of course, opposition from medical and pharmaceutical groups such as the Korea Medical Association and the Korean Pharmaceutical Association is expected. KMA is opposed to the reclassification plan, and the KPA is also passive in reclassification to avoid increasing the number of over-the-counter drugs. Also, civic groups are much less interested in enabling reclassification than a decade ago. The pharmaceutical companies that rely on insurance prices are less likely to request reclassification on their part. However, it is negligence on the government's part to let go of the drug classification issue due to fear of conflict. The authorities must do what is needed despite the expected turmoil. Update the overseas cases and collect the new safety data to reform the outdated system. Just firmly withhold the set principles during the reform. Allow easier access for drugs with verified safety, if not, tighten access. Stop walking on eggshells in fear of the medical and pharmaceutical groups and gather the experts who are aware of the gravity of the situation and hear their opinions.
- Opinion
- [Reporter’s View] Use of maintenance and adjuvant therapies
- by Eo, Yun-Ho May 04, 2022 06:03am
- Continuous administration of a drug for ‘prevention.' This is not a new concept. Patients have been taking drugs to ‘manage’ their chronic condition for a long time, and drugs such as anticoagulants exist for the purpose of prevention. This only became an issue after the concept of maintenance and adjuvant therapies were introduced in cancer treatment. The introduction has been less welcomed undoubtedly because of its high price. Everyone fears the risk of recurrence after being cured of cancer. Depending on the type of cancer, some cancers have a recurrence rate of up to 80%. But in the era of high-priced drugs, prescribing the industry-leading high-priced anticancer drugs for preventive purposes, and providing insurance benefits for such can come as a burden for the health authorities. On the other hand, the introduction of such therapies has become the trend in the pharmaceutical industry. Existing therapies have been continuously adding maintenance and adjuvant therapy indications, and new anticancer drugs with their initial indication approved as adjuvant therapy are also being introduced into the field. This shows for sure that we now need to seriously consider the use of maintenance and adjuvant therapies. It is time for the authorities carefully examine the necessity of administering anticancer drugs as a preventive measure by each drug and consider the practicality rather than the indefinite ‘burden' they may bring. Paying out drug costs for the relapsed patients may be less cost-effective than reimbursing maintenance and adjuvant therapies. Recurrence and metastasis are fatal factors that increase the mortality rate of cancer. We now need to weigh the pros and cons of the drugs as the accumulating adjuvant and maintenance therapy drugs cannot be left unattended anymore, fully recognizing that there is no right answer. The drugs have to be considered not only by their profit and loss but also by the specificity of each drug and patient situation. All the interested parties including the health authorities and the pharmaceutical industry must make an effort to reach an agreement that takes into account Korea's health insurance system and the pharmaceutical industry’s ecosystem.
- Opinion
- [Reporter’s View]Recall the purpose of regulating biologics
- by Apr 27, 2022 06:04am
- The Ministry of Food and Drug Safety visited 3 pharmaceutical distributors on the 21st to prepare a new guideline that reflects voices in the field and the realistic difficulties of the industry in preparing to comply with regulations on the distribution of biological products. The government is resetting the guideline after the revised version of the ‘regulation on the Manufacture and Sales Management of Biological Products’ was implemented in January last year faced with strong opposition from the pharmaceutical distribution industry on the sudden rise in the distribution standards of biological products without considering the cost or preparation period. The raised standards increased the cost of transporting biologicals that already have low distribution fees to the extent that many companies decided rather not to distribute them. Also, the industry pointed out the difficulties in managing the temperature of biological products that have to be frequently shipped in small amounts to pharmacies like insulin. Under the revised regulations, it is necessary to maintain 2-8 degrees at all times using transport containers equipped with automatic temperature recording devices when delivering biological products, and the record must be kept for two years. Unlike the regulations that forbid even a single deviation from the designated temperature, there are times when the temperature may suddenly jump out of the reference range for unknown reasons in reality. Although this has no effect on the efficacy of the drug because the temperature does not deviate for a long period of time, they are subject to punishment under the regulations. This is why the distributors are struggling with the issue. A representative of a company has been testing various transportation containers every day, including custom-made containers, but has not been able to find a solution even now. It also depends on which and how many refrigerants are added. This is why the industry is making complaints and requesting that the MFDS should suggest the type and number of refrigerants and containers used that are not too heavy, not too expensive, and have good temperature control for 24 hours. This is the result of overlooking the fact that it takes a lot of money and a long preparation period to prepare a perfect cold chain. More than 90% of pharmaceutical distributors are small and medium-sized enterprises (SMEs) that cannot afford to spend a lot of money on the cold chain of biologics. However, the government implemented the revised regulations in just 6 months since it was announced, in a hurry to implement the regulations within the year. Faced with backlash from the industry, the authorities granted a 6-month guidance period, but the end of the guidance period is now less than three months away. The MFDS said it will include the details in the guidelines, but the problem is time. If the companies do not abide by the regulations, they will be subject to punishments starting on July 17th. There is not enough time for the authorities to rewrite and announce the guidelines and for the companies to complete preparations accordingly. The original purpose of strengthening the regulations for the transport of biological products was to enable the safe delivery of drugs that are directly related to the people's right to health. However, such hasty measures that are focused on administrative procedures and written deadlines leave much room for issues in the regulations that were made with good intentions. This is why the government should show patience and take the right steps step by step so as not to defeat the purpose of strengthening the regulations.
- Opinion
- [Reporter’s View] 1st oral abortion pill approval difficult
- by Lee, Hye-Kyung Apr 21, 2022 06:03am
- A year has passed since the decriminalization of the abortion ban has taken effect. The Korean Health and Medical Workers’ Union distributed a press release on the 11th on ‘ensuring safe abortion of the people 1 year after the decriminalization of abortion in Korea.’ The press release contained the request for marketing authorization of the oral abortion inducer Mifegymiso (Mifepristone·Misoprostol) and the preparation of an alternative legislation following the decriminalization of abortion under the criminal law in Korea. On April 11, 2019, the Constitutional Court made a constitutional discordance adjudication on the provision on abortion under the Criminal Act. The ruling took effect on January 1st, 2021, after which Hyundai Pharm applied for the marketing authorization of Mifegymiso in July of that year. Hyundai Pham has signed an exclusive marketing and distribution agreement for the supply of Mifegymiso in Korea with the UK-based Linepharma International. The drug is being used in 75 countries after the World Health Organization designated the drug as an essential medicine in 2005, The Ministry of Food and Drug Safety had assured expedited review of the drug to Hyundai Pham before the company applied for the marketing authorization of Mifegymiso. Since then, the drug went through a preliminary review process for 4 months from February last year, during which it was implied that the drug may be commercialized within the year with an expedited review. The Mifegymiso that Hyundai Pharm applied for is a combination pack that contains one 200mg Mifepristone tablet and four Misoprostol 200ug tablets. 10 months have passed since the marketing approval, but there is still no news of its approval in Korea, with the drug still under review. The MFDS is known to have requested supplementary data to Hyundai Pharm in the review process, but the company requested a postponement of the deadline for submitting supplementary data, which has rendered the approval schedule unpredictable. In addition, the need to create a legislative environment in which abortion drugs can be used stably was emphasized. As controversies continue to arise over the approval of the abortion drug, the MFDS is having trouble promptly proceeding with the approval of the product. In November last year, the MFDS and MOHW held an expert advisory meeting on the issue, but the meeting ended fruitlessly due to strong objections by obstetricians and gynecologists. While civic groups are urging for the prompt approval of Mifegymiso, the medical community, mainly the Korean Association of Obstetricians and Gynecologists, is pointing out the dangers of Mifegymiso and insisting that it must undergo a bridging study in accordance with the principle of drug introductions in Korea. In addition, it seems difficult for domestic pharmaceutical companies to expedite the marketing of abortion drugs in the absence of revisions to legislation such as the Criminal Act and Maternal and Child Health Act that would contain specific conditions and regulations for allowing abortions. Ultimately, it seems that the approval of the first abortion drug in Korea will not be granted until all controversies in legislation and safety are revised and resolved.
