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- 2025-12-19 22:53:54
- Opinion
- [Reporter’s View] On the best way to issue impurity recalls
- by Lee, Tak-Sun Nov 29, 2021 05:58am
- Once again, impurities were detected in the losartan ingredient of antihypertensive drugs that are being used by many patients. Some pharmaceutical companies have already started product recalls under orders from the Ministry of Food and Safety. With the results of the companies’ impurity investigations being released one after another, the number of items subject to recall will continue to increase. The problem is in recalling drugs that were already taken by the patients. The MFDS had held roundtable meetings with doctors’ and pharmacists’ associations that had prescribed and sold the affected drugs and their manufacturers in preparation of the consumer recall in plan. The purpose of the meetings was clear: Who will bear the burden of the cost incurred during consumer recalls? As the government, doctors’ and pharmacists’ associations have unanimously pointed to the manufacturer/seller, these companies are expected to bear most of the recall costs. But what about the consumers? No discussions have been made with consumers on the consumers' part. Of course, for the consumers to receive re-prescriptions and switch drugs, advance discussions with medical/ pharmaceutical associations and manufacturers are inevitable. However, with the risk that medicines containing the impurities may continue to be prescribed, a ban should first be issued on the release and prescription of drugs that had excess impurities. If it is difficult to issue bans on the release and prescriptions of individual drugs, ton how to address this problem should be first discussed. However, the MFDS had warned and forbade individual action on the companies’ part before it issues a compressive announcement, fearing confusion. The MFDS' priority seems to be on muddling the voice of confusion and dissatisfaction that may arise in the recall process rather than on the prompt ban of harmful drugs. If consumer recall measures are implemented, we need to put more consideration into how to recall even one more tablet that contains such impurities. Looking at the past measures made by the MFDS, the authority had prepared a manual for the recall and let the consumers handle the exchange for themselves. With such inadequate publicity and post-measures, it is questionable whether any statistics have been collected on how much was recalled during the last impurity-related drug recall. Maybe the consumer recall is just a publicity gimmick to arouse public opinion rather than a sincere measure. In fact, neither the pharmaceutical associations nor pharmaceutical companies welcome consumer recalls, as such measures give rise to many cumbersome tasks including re-prescription, redispensing, and reimbursement of costs, etc. If consumer recall is inevitable, the MFDS should first consider measures that would minimize its effect on the consumers rather than discussing recalls with medical/pharmacist associations and pharmaceutical companies. And as the consumer recall is already considered certain, we need to now ask whether we are missing the ‘golden time’ for the recalls busy making pre-arrangement discussions before full recalls.
- Opinion
- [Reporter’s View] On HIRA's price cuts for PE waiver drugs
- by Eo, Yun-Ho Nov 15, 2021 05:56am
- HIRA’s unilateral notice of its decision leaves a lingering question on whether this really was the best way to conclude the discussions. Couldn't the government have included its favorite words - "in discussion" or "in coordination" - that it uses best? The Health Insurance Review and Assessment Service responded that the criteria for evaluating the cost-effectiveness of drugs that are waived submission of pharmacoeconomic evaluation data was set at ‘80% of the lowest A7 adjusted price’ rather than the lowest A7 adjusted price to a written QA submitted by NA member Miae Kim of the People Power Party during the NA audit. This is a sort of forced conclusion and a line drawn to the persistent resistance and controversy raised by the industry. On the news, the Korean Research-based Pharma Industry Association immediately issued its criticism, expressing strong regrets. KRPIA said, “During discussions with HIRA, we have continuously expressed that the uncertainties caused by the application of the risk-sharing system in A8 countries should be flexibly evaluated according to characteristics of each drug. A blanket application of the 80% standard without clear grounds on its calculation will seriously undermine access to drugs that are subject to pharmacoeconomic evaluation exemptions that are being allowed limited use in rare and severe disease patients.” The association added that such a standard would invalidate the system in itself. Some may consider the industry’s sullen response as a natural course of making transitions. However, the response provided for the NA audit was a blow in the back from the industry’s view as the issue had not been discussed after the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits had said it will continue to collect stakeholder opinions following the serious concerns that were raised in the two meetings the HIRA held with the industry (industry roundtable in June and the private consultative body in July). The pharmacoeconomic evaluation exemption system is the only way for drugs that cannot undergo economic evaluations but is necessary to receive reimbursement. Various fiscal management systems are included in the scheme, and the ‘Expenditure Cap’ design has been embraced ever since the system was implemented. With the increasing number of drugs being eligible for the system, the government could have deemed some improvement is necessary. However, the way how they implemented the system is regrettable. “We will continue discussions with stakeholders. We will review the issue.” Why HIRA was unable to implement the caution and ambiguity that it had so often implemented in the written response to the NA remains in question.
- Opinion
- [Reporter’s View] Verify the oral COVID-19 treatments
- by Lee, Tak-Sun Nov 10, 2021 05:55am
- Following COVID-19 vaccines, oral COVID-19 treatments are also expected to enter the market soon as the government plans to phase in 404,000 courses of COVID-19 oral antivirals from next February. If oral treatments for COVID-19 are introduced, Korea will have laid the groundwork for managing the COVID-19 virus like influenza. Also, clinical results for COVID-19 treatment candidates are being announced one after another. MSD's 'molnupiravir' was found to reduce the risk of hospitalization and death by 50% if taken within 5 days of symptom onset. Pfizer also released clinical results showing that ‘Paxlovid’ reduces the risk of hospitalization and death by 89% if taken within 3 days of symptom onset, and by 85% if taken within 5 days of symptom onset. The movement to introduce the drugs has also been speeding up abroad. On the 4th, the UK became the world’s first country to approve molnupiravir. The US FDA also plans to review the use of molnupiravir at the end of this month. The treatment is also set to be introduced in Korea from February through an advance purchase agreement. The faster the treatments are introduced the better, considering how late we were in introducing and commercializing vaccines compared to other countries at the end of last year. With legislation such as the Emergency Use Authorization established for the prompt introduction of such treatments, we will need to thoroughly prepare so that the oral antivirals developed abroad can promptly be imported for use in Korea. In addition to such prompt introduction, we would also need to pay close attention to and verify the oral treatments in advance so that the drugs may be safely used in Korean patients. This is a task for the Ministry of Food and Drug Safety. As the government announced that it will introduce COVId-19 treatments in February, the MFDS does not have much time for review. Therefore, MFDS would need to independently conduct its review and thoroughly verify the safety of the treatment in the limited time provided rather than rely on news of approvals from agencies abroad to reassure the public. In other words, now is the time for the government to take initiative. The government should proactively search for and persuade pharmaceutical companies to promptly introduce their COVID-19 treatments to Korea even if they have no plan to introduce the drugs to Korea yet. The reality is that Korea will have to depend on COVID-19 treatments developed overseas, just like the case was for the vaccines. Rather than focus on the commercialization of domestic COVID-19 treatments, the government should fully mobilize its administrative power to promptly introduce new COVID-19 treatments developed overseas.
- Opinion
- [Reporter’s View] New drugs for Alzheimer’s in development
- by Nov 05, 2021 05:24am
- "I felt like it was all a dream. But I wasn't sure if I was young dreaming that I’m older, or I was old dreaming that I was younger. I have Alzheimer's." This is what Hye-Ja Kim, acting as a dementia patient in the “The Light in Your Eyes” TV drama two years ago, said as she revealed her condition to her friends. The drama gained much acclaim with the twist that the story depicted the world from an Alzheimer’s patient's view rather than being a common ‘time leap (time travel)’ story. The most common cause of dementia among the 840,000 dementia patients over the age of 65 in Korea is Alzheimer’s. The exact pathogenesis or cause of Alzheimer’s remains unknown, but it is being presumed that the condition is caused by Beta-amyloid and tau deposition. One of the reasons why Alzheimer’s was feared was because no drug could fundamentally treat the disease, and only drugs used to improve cognitive function were available. Countless global pharmaceutical companies had attempted to develop treatments to no avail. With no treatment available, prevention was considered as the only option for Alzheimer’s. However, the field has entered a new turning point this year with Biogen introducing a new treatment for Alzheimer's. Biogen's 'aducanumab (product name: Aduhelm),' was approved by the US Food and Drug Administration, and Eli Lilly is also preparing for the approval and review of its ‘donanemab.' When approved, two new treatment options will suddenly be available in the 'impregnable' field of Alzheimer's disease. Of course, many issues remain to be addressed despite the introduction of these new drugs. Both Biogen and Lilly’s new drugs target beta-amyloid plaques and reduce beta-amyloid to improve Alzheimer’s symptoms such as cognitive function, etc. However, the issue is that it is unclear whether beta-amyloid is the determining cause of Alzheimer’s. Recent studies have shown that the tau protein may be the main cause of Alzheimer’s, which raises mixed opinions on what needs to be targeted to treat Alzheimer’s. Also, the two new drugs will need to be further verified. The FDA had granted breakthrough therapy designation to both drugs and accelerated approval for aducanumab in consideration of the lack of treatment for Alzheimer's. Donanemab is also expected to go through the same accelerated approval process soon. Drugs that are approved with the accelerated approval system can receive faster approval than through traditional review processes but needs to demonstrate their clinical benefit through a confirmatory trial. Otherwise, their approval is revoked. In particular, Biogen’s aducanumab needs to justify its approval through further clinical trials as its two Phase III trials showed mixed results. On the positive side, the introduction of these new drugs has changed public perception. Alzheimer’s is no longer considered unconquerable. Pharmaceutical companies in Korea and abroad are eagerly racing to be the first to develop more and better drugs for Alzheimer's. Just earlier last year, the COVID-19 outbreak brought fear to the whole world. However, with the introduction of COVID-19 vaccines and the introduction of COVID-19 treatments soon to be expected, COVID-19 has now entered the realm of being 'manageable.' This is why countries are now gaining the courage to attempt to live ‘With COVID-19’ even if more than 2,000 patients are confirmed every day. Awaiting the second new Alzheimer’s drug to come, I have faith that Alzheimer's will soon become manageable, as with COVID-19 and the many other crises that we managed to overcome.
- Opinion
- [Desk's view] It should also prepare for "With Corona"
- by Chon, Seung-Hyun Oct 25, 2021 05:50am
- The government has announced that it will shift the COVID-19 quarantine system to a "step-by-step daily recovery" (with COVID-19) centered on the management of the number of critically ill patients or deaths. As the proportion of COVID-19 vaccination completion exceeds 70%, a relaxed quarantine system such as lifting restrictions on operating hours for multi-use facilities such as restaurants and cafes is expected to be implemented. The pharmaceutical industry is also gradually moving to prepare for "With Corona." Along with the COVID-19 pandemic, the number of people working at home seems to be reduced and the number of people working at the company is increasing. Some companies terminate the flexible working system implemented to avoid overlapping working hours of executives and employees as much as possible. In fact, the pharmaceutical industry has changed a lot in the COVID-19 situation that has been going on for more than a year and a half. The drug prescription market has changed significantly. Markets such as antibiotics and Jinhae girders have shrunk significantly as the number of flu and cold patients has plummeted due to strengthened personal hygiene management to prevent COVID-19. As the COVID-19 vaccination expanded, the pain reliever "Tylenol" jumped to the top in general drug sales. The market landscape has also changed as companies that have benefited from COVID-19 have emerged one after another. SK Bioscience's performance jumped sharply due to the consignment production of the COVID-19 vaccine. Samsung Biologics' performance has soared due to consignment production of COVID-19 antibody treatments, and it is also preparing to produce a Moder or COVID-19 vaccine. Diagnostic kit companies have exceeded 1 trillion won in sales. Pharmaceutical companies' R&D capabilities were also focused on conquering COVID-19. Many pharmaceutical bio companies have rushed to develop COVID-19 vaccines and treatments. Celltrion, which was focusing on biosimilars, developed its own COVID-19 treatment "Regkirona." On the other hand, in general, domestic companies' R&D performance has been lower in technology exports than before COVID-19. The spread of COVID-19 has reduced direct exchanges with global companies and focused on non-face-to-face promotion, so they have not been able to actively win technology exports. Even if the government gradually eases the quarantine system, it will not return to its daily life before COVID-19 in a short period of time, but pharmaceutical companies should gradually prepare for "With COVID-19." If R&D capabilities are actively appealed at large domestic and international academic conferences in the future, it is expected that technology exports, which have been stagnant, will also become active. The development of COVID-19 treatments and vaccines also requires strategies. It is necessary to reflect on whether the R&D efforts to conquer COVID-19 were simply a trick to boost stock prices. Many people in the pharmaceutical industry were also hurt by COVID-19. However, we hope that the COVID-19 crisis will serve as an opportunity for our pharmaceutical industry to become more mature.
- Opinion
- [Reporter's view] Disclosure of the results of the Committee
- by Eo, Yun-Ho Oct 25, 2021 05:49am
- The results of the Cancer Drugs Benefit Appraisal Committee were released from the 13th. The HIRA has accepted complaints continuously filed in the pharmaceutical industry. Some point out that they are not satisfied yet, but it can be said that it is encouraging in itself because the HIRA expressed its intention to deliver the exact reason for the success at the request of the company. In the pharmaceutical industry, discussions on expanding insurance benefits for new drugs have been focused on the Cancer Drugs Benefit Appraisal Committee along with the COVID-19 incident.The Cancer Drugs Benefit Appraisal Committee, which was discussing the clinical usefulness of drugs, began examining the financial burden last year. Since then, as more and more drugs are pending in the pharmaceutical industry due to the Cancer Drugs Benefit Appraisal Committee, even companies have submitted economic evaluation data to the subcommittee. Of course, there may have been many pharmaceutical companies that were greedy last year, and there may have been many drugs that were not clinically useful. So the industry's argument was focused on transparency. This was not a necessary procedure only for the pharmaceutical industry. This is because knowing which drugs have been judged to be unsuitable for what reason, greedy pharmaceutical companies can be criticized and make efforts to find a compromise. Of course, the disclosure of the details of the discussion is 'not yet', but the transparency of the committee has risen to the first level. Beyond the pharmaceutical industry, the healthcare industry is facing a new era. Patients, or their families, now search for surgical papers and search for new drug information in the clinical trial database clinic at clinicaltrial.gov. If domestic licensed drugs do not receive insurance benefits, complaints will pour out to the relevant ministries, the HIRA and the MOHW. The anger of patients and their families looking at "the medicine that exists but cannot be taken" is indescribable. The urgency that cannot be estimated unless it is a party, the level of knowledge of the people who have risen, and the administrative power resulting from the development of the Internet are amazing. Transparency in the process of listing or expanding insurance benefits for new drugs will gradually increase in the future. Both the government and pharmaceutical companies should now fear social views that include desperation. The disclosure of the results of the Cancer Drugs Benefit Appraisal Committee is welcome for now.
- Opinion
- [Reporter's view] A manual has been established
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- The recovery of hypertension treatments containing excess impurity Sartans is significant in that it has established a new manual for drug recovery. All items were banned and recovered, making it difficult for manufacturing, sellers, and medical institutions to do additional work due to collection. However, since only excess Sartan items have been recovered this time, the loss of pharmaceutical companies is expected to be minimized, and the inconvenience caused by the recovery of medical institutions such as pharmacies is expected to be reduced. All of these measures were not perfect. In particular, the MFDS explained that the risk of impurity-containing drugs is low, but that patients with health concerns can be exchanged for normal products. In order for consumers to exchange them for normal products, pharmacies must exchange medicines to open pt's medicine packet. The question was who should pay the additional fees and additional work costs incurred by this. The government wants pharmaceutical companies to pay health insurance premiums, saying it is difficult to pay. Pharmacies are also not willing to volunteer for free. In this situation, the MFDS mediated to discuss settlement issues between pharmaceutical companies and pharmacists. The consultation was satisfactory. Two pharmaceutical companies have agreed to pay 110% of the existing formulation, which has become a guideline for other pharmaceutical companies. As the recovery has been delayed for more than a week, there is no separate suspension of sales, so the response is too late. Another problem is that it is not easy for consumers to put it into practice. Since this recovery only applies to the product number in question, consumers need to know the product name and manufacturing number to request an exchange. However, most patients often do not know the name. It is not easy for many elderly people to know this through the internet. Most patients do not know about this recovery. Therefore, it is necessary to establish a system so that minimal information can be delivered, even if it is difficult to actively communicate the recall to consumers, as in the case of automobile recall. With this voluntary recovery, the government should create a manual and take measures to enable consumers to actually recover so that they do not suffer damage.
- Opinion
- Clear standards needed for direct purchase of drugs overseas
- by Kim JiEun Sep 08, 2021 06:06am
- The world’s leading online e-commerce platform Amazon joined forces with one of the top e-commerce companies in Korea to set foot into the Korean market. The entry of this global direct purchasing giant into Korea had raised industry concerns that it would increase the illegal direct purchase of pharmaceuticals overseas and void the government’s efforts to eradicate the expanding market for such items. Aware of such concerns, 11street had prepared a separate guide on ‘precautions for direct purchase of drugs and health functional foods overseas’ to its Amazon store website and blocked the transaction of pharmaceuticals and health functional foods that contain ingredients that are not permitted in Korea. While answering that they feel partially reassured by such measures, pharmacists stressed that a more fundamental standard and measures are necessary to regulate online transactions of pharmaceuticals at a time when the direct purchase of goods overseas is being established as a culture in the midst of the rise of the e-commerce. The Pharmaceutical Affairs Act in Korea completely prohibits the sale of pharmaceuticals online. However, the Customs Act recognizes overseas transactions of pharmaceuticals as legal to a limited extent, leading to a conflict between the two Acts. In addition, the standards for overseas transactions stipulated in the Customs Act are obscure. The law stipulates that up to 3 months' worth or 6 bottles of OTCs that do not contain specific products or ingredients may be brought into the country for self-use, which leaves much room for interpretation. Some pharmaceuticals contain 100 tablets or even 1,000 tablets per bottle. The ‘Pharmacists’ Community for Future Pharmacy’ pointed out that the customs regulations mentioned above are unclear and meaningless, as a consumer may abuse the regulation and purchase up to 6,000 tablets at most to bring into the country. The illegal direct purchase of pharmaceuticals overseas had been carried out openly in many e-commerce open markets in Korea. Leading e-commerce platforms in Korea have allowed transactions of pharmaceuticals through direct purchase from overseas, including many unauthorized drugs as well as prescription drugs that should not be traded between individuals. Times have changed. E-commerce has taken over the offline retail market, and the market for direct purchases from overseas is also growing at a rapid pace. With the growth, the direct purchase of illegal pharmaceuticals has also increased explosively. This is why the government can no longer hold back revising the related laws while weighing the different perspectives held by the ministries.
- Opinion
- [Reporter’s View]Reimbursement of antidiabetic combos
- by Eo, Yun-Ho Aug 27, 2021 05:59am
- After 3 long years, discussions on extending reimbursement of SGLT-2 inhibitor combos are expected to begin. In September, the Health Insurance Review and Assessment Service will hold an expert meeting to discuss approving reimbursement for combination use of the two classes of oral antidiabetics: DPP-4 inhibitors and SGLT-2inhibitors. ‘Recognizing the expected efficacy of two drugs with the same MOA.’ Acknowledging this class effect has been a long-discussed dilemma in the industry. The opinion has been divided among the HCPs, and the interest of individual pharmaceutical companies also differ. The conclusion was to take on the agenda ‘case by case.’ It is not necessarily a question that requires a fixed answer. The decision made by the prescribing doctor based on his or her experience and medical knowledge is, of course, most important. However, for the SGLT-2 inhibitor issue, the problem lay in the consistency of the decisions. For some classes, the class effect was recognized regardless of the drug’s indications and applied the same reimbursement standards, while reimbursement for other classes was approved for different scopes by each product. In 2013, the Korean Diabetes Association had played a leading role in extending reimbursement to cover the combined use of DPP-4 inhibitors and Thiazolidinedione (TZD) class drugs, insisting on the justification and necessity of its reimbursement. Clinical experience and expert judgment were emphasized rather than the fiscal impact, and the government accepted the reimbursement extension based on the disease characteristics and drug use experience. What has changed since then? In 2018, the academic community had mixed opinions regarding SGLT-2 inhibitors, which put discussions on reimbursing the combined use of the drug on hold. Many drugs were at stake, as this not only affected SGLT-2 inhibitors like ‘Jardiance(empagliflozin),’ ‘Forxiga(empagliflozin),’ ‘Suglat (ipragliflozin), ‘Steglatro (ertugliflozin),’ but also the many DPP-4 inhibitors including ‘Januvia (sitagliptin), ‘Galvus (vildagliptin),’ ‘Tradjenta (linagliptin),’ ‘Gemiglo(gemigliptin),’ etc. However, the changes that followed were encouraging. In April last year, the academic society saw consensus and submitted the opinion that expanding reimbursement is necessary. In August last year, the Ministry of Health and Welfare announced that it will simplify the indication listing method of antidiabetic drugs from by substance to ▲monotherapy or ▲combination therapy. Now the baton is in the hands of the insurance authorities. Time has already passed, and dissatisfaction still does exist around primary medical institutions. As it is a prescription drug, it is also true that the issue should be considered carefully, and a cautious approach is needed. However, if the class effect is to be finally acknowledged, this could be the perfect opportunity for the stakeholders to reach a consensus on ‘the time or amount of prescription required to accumulate sufficient prescription experience.’
- Opinion
- [Reporter's view] Controversy over α-GPC
- by Lee, Hye-Kyung Aug 25, 2021 05:57am
- Negotiations on the return of benefits of the 'Choline alfoscerate' legislation, which was the subject of the revaluation project of the listed drugs, have been concluded. However, the controversy over the return rate has not ended. The NHIS negotiated with 58 pharmaceutical companies that owned 123 Choline alfoscerate on August 10. It announced that it has agreed with 44 pharmaceutical companies on a 20% return rate. Chong Kun Dang, which had been conducting PVA in the third quarter of this year, also finished negotiations. There are about 10 pharmaceutical companies that have not agreed. Negotiations on the repatriation of Choline alfoscerate lasted about eight months from December 14 to August 10. In the process, the timing of recovery was changed from "the day of submission of a clinical trial to the MFDS" to "the day when the MFDS approved the clinical trial," and the amount of recovery also fell from "full 100%" to "20%." The controversy erupted when three pharmaceutical companies that had already signed a 100% return rate in PVA negotiations before the benefit revaluation Choline alfoscerate filed complaints with the Anti-Corruption and Civil Rights Commission for equity reasons. Negotiation about Choline alfoscerate is the first conditional recovery negotiation in conjunction with the MFDS' clinical reassessment. However, all the NHIS negotiations in accordance with the safety and validity verification and quality control requirements have a redemption clause related to revaluation. This is a revised guideline after the 2019 Lipiodol crisis. In the second quarter of last year's PVA negotiations, Arlico, Hana and Kyongbo agreed that if the authorization for revaluation is dropped, the pharmaceutical company should return the full claim from the date of clinical testing to the NHIS. Anti‑Corruption and Civil Rights Commission has conveyed to health authorities that the NHIS and the three pharmaceutical companies should maintain a contract following a clinical trial revaluation, but set a 100% return rate equal to 20%. Anti‑Corruption and Civil Rights Commission's recommendations are not compulsory. However, it is unlikely to raise the rate again, as the rate of return of Choline alfoscerate, which is undergoing simultaneous re-evaluation and clinical re-evaluation, has been agreed to 20% with an eight-month negotiation process. The NHIS should set out what guidelines to maintain in future drug price negotiations in accordance with AAnti‑Corruption and Civil Rights Commission's recommendations. Through revaluation, it is necessary to clarify whether there is a possibility of maintaining the existing "health insurance claim in full" or changing it to 20% agreed with pharmaceutical companies.
