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- 2026-07-22 11:58:23
- Opinion
- [Reporter’s View] Ahead Kymriah’s NHIS negotiations
- by Eo, Yun-Ho Jan 28, 2022 05:57am
- Only the National Health Insurance Service left to go, the ultra-high-priced novel CAR-T therapy ‘Kymriah (tisagenlecleucel)’ passed all the steps necessary for insurance benefit. In other words, the fate of Kymriah’s reimbursement now lies The fate of Kymriah’s reimbursement, a drug that costs around ₩500 million for a single shot, now lay at the hand of the NHIS negotiations. However, the prevailing view is that the road to reimbursement would not run so smoothly. The drug is indicated for: ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲ patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse The reimbursement standards set for Kymriah that is taking the PE exemption pathway differ by indication. Only the expenditure cap was applied to the B-ALL indication, but for DLBLC, the performance-based type of restriction was added to the expenditure cap. This means that the company would have to share a certain proportion of the cost used by DLBLC patients according to treatment performance. The problem is that unlike the mass-produced general drugs, a single batch of Kymriah is produced with the cells extracted for each patient, which brings the manufacturing cost to be astronomically high. In such cases, when the number of patients exceeds the expenditure cap set by the government, the exceeding cost directly becomes the burden for the company. Of course, Novartis Korea’s ‘efforts’ are essential to bring the ‘drug pricing negotiations’ through and reach an agreement, whether the efforts will definitively bring positive results remains unknown. Other drugs that are mass-produced and generally have a low manufacturing cost are not greatly affected in their profit structure when exceeding the expenditure cap set for the drugs. However, as Kymriah has a high manufacturing cost, just a few patients exceeding the expenditure cap can bring a significant burden. Also, reimbursement in the DLBLC indication has the added limitation of being performance-based. From the NHIS’s perspective, the authorities will be determined to protect the sustainability of its NHI finances by setting the right first step with Kymriah in preparation of the high-priced cell and gene therapies that are expected to pour in in the near future. With negotiations soon to engage, the wish is that those sitting at the negotiation table overcome the compulsion of deriving a certain result and consider the specificity of the manufacturing process as well as the limited number of patients subject to its care, and that the pharmaceutical company’s sincere ‘patient-focused’ mind shine through.
- Opinion
- [Desk] The task of reimbursement for ultra-high-priced drugs
- by Kim, Jung-Ju Jan 18, 2022 06:05am
- The evaluation of the adequacy of the super-high-priced Kymriah's benefit is approaching insurance coverage. This is because the agenda to expand the health insurance standards for Kymriah, a treatment for acute lymphocytic leukemia and lymphoma CAR-T, and Keytruda, a non-small cell lung cancer immuno-cancer drug, passed side by side at the HIRA meeting on the 13th. Until now, the biggest obstacle when it was decisively blocked by cost-effectiveness in the process of reimbursement for high-priced drugs was the discussion process of the Pharmacist Evaluation Committee or the Cancer Disease Review Committee. Whenever the reimbursement priority and adequacy were discussed, the effect and necessity were recognized, but the cost was too high, so Kymriah's registration was delayed for 11 months, and Keytruda was also in progress for 4 years and 4 months. Patients' struggles to ensure these drugs were also tearful. Patients and their families who need immediate medication as life-related drugs have protested in front of the company to urge rational fiscal sharing, issued press conferences and statements, and filed petitions against the government, so the committee's passage will be impressive. Drug price negotiation procedures are still needed, and considering the period required for deliberation and resolution by the Health Insurance Policy Deliberation Committee, two to three more months must be waited. As such, it is a drug that is essential to patients, but it is an innovative drug that the general public cannot afford, and as technology continues to develop, similar cases like this are expected to continue to appear in the future. In fact, the government is aware of this and has prepared various mechanisms such as positive list system to strengthen the coverage of not only drugs but also medical technology, but it cannot cover all innovations with limited finances. Patients argue that a rapid health insurance registration system should be introduced for new drugs directly related to life to protect their lives at the national level, but the difficulty of accepting them from the government's point of view may be due to predictability and financial problems. As mentioned earlier, ultra-high-priced drugs such as Kymriah and Keytruda will be released every time, and the speed will increase as technology develops. Currently, in the face of such a problem, the authorities demand a rational fiscal sharing plan between the company and the government (insurer) from the developing company. There are already many cases empirically that such an agreement is not premised in the drug price negotiation process, which is another major obstacle. The government sought to strengthen the coverage and accessibility of ultra-high-priced drugs, but has repeatedly expressed its intention to use the existing negotiation mechanism under the positive list system. It is necessary to effectively establish a reasonable and predictable finance, that is, a voting structure and procedures to share mutual risks, and a mechanism to prevent delays in discussions without damaging the screening registration system, the central axis of drug registration. Academia should actively and actively conduct related research to present evidence and solutions to patients, the government, and companies, and the government and the National Assembly should consider them in practice to find solutions that our society can accept.
- Opinion
- [Reporter’s View] Can companies get EUAs as they promised?
- by Lee, Tak-Sun Jan 12, 2022 06:04am
- The Emergency Use Authorization (EUA) system was first introduced to Korea in March last year. AstraZeneca’s COVID-19 vaccine manufactured in Italy, Moderna’s COVID-19 vaccine manufactured by Samsung Biologics, Pfizer’s oral COVID-19 treatment Paxlovid, and the COVID-19 injection Remdesivir for use in patients under 15 were approved using Korea's EUA system. All of the drugs above were introduced to Korea through EUA before receiving marketing authorization through an official process. Among these, AstraZeneca’s vaccine that was manufactured overseas and Samsung Biologics’ Moderna vaccine are now officially approved in Korea. As such, the EUA system had gained attention as the new way to introduce COVID-19 drugs before applying for marketing authorization. Using this as momentum, companies have even set out goals to introduce their drugs to Korea using the EUA system. Rather than applying for marketing authorization that requires a long time for review, the companies made the plan to quickly introduce their drugs using the EUA track after completing domestic clinical trials. However, some have criticized that the companies are setting impractical goals and making hollow promises to raise their stock price. The idea that the companies that completed clinical trials may voluntarily apply for EUA is in itself a false logic. The EUA is granted only after a request from a head of a relevant agency such as the KDCA, and when the MFDS deems the drug is necessary for responding to a public health crisis. Therefore, the pharmaceutical company cannot first ask authorities to grant EUA to its drugs. The only way this is possible is when the MFDS issues a public notice on the scope of medical products in need. Of course, there is a possibility that the companies may actively appeal the need for their drugs to the MFDS to receive EUA. However, this is also quite impractical. The government is in charge of introducing and purchasing COVID-19 drugs. Therefore, it would be very unlikely for the MFDS to grant EUA to drugs that are not included in the purchasing agreement. Therefore, the only realistic way for a drug to receive EUA is if the drug was already approved in other countries and has made a purchasing agreement with our government. The 4 products that were previously granted EUA had also been first approved overseas and signed advance agreements with the Korean government. Therefore, the claim of pharmaceutical companies that it will promptly introduce its drug through EUA can be considered an overstatement, deceiving investors who invested in the companies after reading promotional materials that contain such contents. Pharmaceutical companies must provide accurate information about their respective companies to fulfill their ethical responsibilities. They should state the feasibility and risks involved in addition to their goals. If not so, their intent pursuit to raise their stock price in this COVID-19 crisis will adversely result in the loss of what should matter the most - the consumer’s trust.
- Opinion
- [Reporter’s View]Year of regulations, principle vs practice
- by Kim, Jin-Gu Jan 05, 2022 05:57am
- As in every other year, regulations imposed on the pharmaceutical and biopharmaceutical industry are again expected to be further reinforced this year. In particular, GMP-related regulations will be strengthened even further. Starting this month, the government may impose punitive fines on the arbitrary manufacture of pharmaceuticals by companies. In addition, the government and the National Assembly are pushing to amend the law so that an assigned GMP investigator could conduct on-site investigations on drug manufacturing plants. Also, a bill to revise the law to allow business suspension dispositions up to one year and license revocations in case of GMP violations is pending at the National Assembly. Some may complain that such excessive regulations hinder the development of the pharmaceutical and biopharmaceutical industry. However, the regulations did not appear out of nowhere. There were always events that triggered the tightening of regulations. The GMP regulations were reinforced due to the series of arbitrary manufacturing events that occurred last year. The arbitrary manufacturing of pharmaceuticals that were once considered rare incidents conducted by one or two companies was identified in several companies last year. The industry thus lost the public’s trust. In depth, the ruling may indeed have felt unfair for some pharmaceutical companies. However, their protests failed to gain public sympathy as their argument, in essence, is an excuse that they did not follow the 'principle' in the name of customs and practice. And this is not an issue that just arose last year. The license of Kolon’s ‘Invossa’ was canceled in 2018, Medytox’s botulinum toxin in 2019 because they were found to have manufactured their product differently from their approved specifications. This would not have happened if the companies stuck to the basic principles. This new year, the industry should look back on itself. Companies should look back and examine whether they have chosen practice rather than principle in other areas of their business as well. If so, they must remedy their ways immediately as these small incidents are what intensify to become serious issues. The MFDS should also review its ways to become an institution that is faithful to principles. This does not mean that the ministry should adhere to principles on every issue that arises. Punishing pharmaceutical companies based on pure principle is not a fundamental solution. If deviations of front-line pharmaceutical companies have become a practice, the ministry should more deeply look into the background on why it became so. As the regulatory authority, the MFDS’s role is to establish principles in the direction that can protect the public’s health and further develop the industry. In other words, if the regulations are causing the issue, it is the MFDS’ role to establish “new principles.”
- Opinion
- [Reporter’s View] Have we secured enough COVID-19 pills?
- by Dec 20, 2021 06:12am
- The world is in preparations to use oral COVID-19 treatments to end the pandemic. Following the UK, Demark became the second country to authorize the use of MSD’s (US Merck’s) ‘molnupiravir,’ with the EU and the US also reviewing approval of the said drug. Pfizer’s oral treatment ‘Paxlovid’ is also under regulatory review. Korea has also joined in the preparations and started the review process for ‘molnupiravir,’ and signed an advance purchase agreement with MSD and Pfizer for 312,000 courses of their treatments (242,000 courses from MSD and 70,000 courses from Pfizer). The authorities also significantly increased the budget for such purchases. Although 36.2 billion won was first allocated for COVID-19 treatments, the National Assembly had passed 192 billion won as reserve funds for additional purchases of such treatments on the 14th. As a result, a total of 228.2 billion won is being invested for oral COVID-19 treatments in Korea. Considering the total purchase volume alone, it may seem that Korea has secured a sufficient amount of oral treatments. However, with the pros and cons of the two treatments taking shape, it is questionable whether the amount and ratio of the two were a wise purchase. The government believes that there is a sufficient supply of oral treatments to prescribe to non-hospitalized COVID-19 patients who will be at high risk of progressing to severe disease. The weekday daily confirmed COVID-19 cases as of December 19th was 6,834 per day, with an average of 755 hospitalizations per day. The drug will be used on COVID-19 patients with comorbidities such as old age, obesity, diabetes, heart condition, etc among the daily 6,079 non-hospitalized cases. Although the molnupiravir that Korea purchased the most is, in theory, effective against all COVID-19 variants, the most recent clinical trial left lingering questions regarding its efficacy against the more recent variants. Although interim analysis of patients that were confirmed with COVID-19 between May and August showed that molnupiravir reduced the risk of hospitalization and death by half compared to placebo, the same drug had much less effect, a 30% efficacy in reducing risk on those who were confirmed with COVID-19 between August and October. The reduced efficacy in the second half of the period when the delta mutation was dominant has been raising concern that molnupiravir may not be so effective against the delta variant. Also, a long-term safety concern has been raised on molnupiravir as a ribonucleoside analogue that enters the COVID-19 virus’s RNA. The concerns raised had deepened the authorities’ concerns over how to set the target patient group for the oral treatment. In other words, the number of patients that may be authorized to recieve molnupiravir may be partially restricted or limited. Pfizer had announced clinical trial results of Paxlovid demonstrating an 89% efficacy in high-risk patients. ALso, ongoing clinical trials indicate that there is a higher likelihood that a broader range of patients will be allowed to use Paxlovid. Pfizer is conducting trials on non-hospitalized patients at low risk of hospitalization or death (EPIC-SR) and as post-exposure prophylaxis on patients exposed to COVID-19 (EPIC-PEP). According to Pfizer’s announcement on the 14th, Paxlovid may reduce the risk of progression to moderate-to-severe disease by 70% in standard-risk patients such as healthy non-elderly adults or those who have risk factors but have received vaccinations. Based on such observations, the 242,000 courses of molnupiravir may not be used as much as expected and the 70,000 courses of Paxlovid may not be enough. Also, the price of Paxlovid may increase if molnupiravir has a lower-than-expected effect. Pfizer had raised the price of its COVID-19 vaccines in August for similar reasons. This is why we cannot rest assured with the 310,000 courses that we secured in advance.
- Opinion
- [Reporter’s View] Moderna needs to learn the Korean way
- by Dec 14, 2021 05:57am
- “We expect the establishment of the Korean subsidiary will aid the smooth supply of mRNA vaccines and allow for a more active engagement and communication with the Korean government, media, and academia.” This was what Moderna had said on the 2nd to the invited media at a press conference. Moderna’s establishment of the Korean subsidiary had been the focus of all interest, that a US biotech that had gained nationwide fame in the COVID-19 pandemic will be establishing a subsidiary in Korea. Their establishment of a branch indicates that their plans do not end at selling COVID-19 vaccines in the area. It had also signed CMO agreements with Samsung Biologics for the fill&finish manufacturing of its vaccine. In addition, there were rumors that the company may also CMO the drug substance as well or build a plant of its own to manufacture the drug substance. It was the same day that the company announced the appointment of Ji-Young Sohn as the new general manager of Moderna Korea. This official announcement was seen as the start of the company’s official activity in Korea and was why many had anticipated the press conference that was held that day. There were many questions to be asked on how the Korean subsidiary will be organized, its activities, the company’s plans in Korea, and collaboration with local companies, among others. However, the active engagement in communication that the company had signified was not up to par or two-way. The press conference that day was rather disappointing. Only two Moderna officials – the VP of Global Medical Affairs at Moderna HQ and the VP of Medical Affairs from the Korean subsidiary had attended the conference. The newly appointed GM was also not at the meeting, and the attendees refrained from answering any questions related to the company’s business activities as they are medical officials. The reporters were only able to get little insight into how the company’s workforce will be organized. The only response provided to questions unrelated to vaccines, such as those regarding the company, was that we should refer to the company’s PR agency for answers. Moderna only provided detailed information on its ‘plans to develop booster shots,’ and the ‘myocarditis side effect’ of vaccines that it had planned to deliver at the conference. Of course, such vaccine-related news is important information. But the company should have also been more open in sharing information about the activities and collaborations that will be made by the Korean branch that the media and the public were also curious about. From Moderna’s point of view, the actives of its Korean branch may not be such a big issue. But still, true communication entails the faithful exchange of questions and answers on both sides. The response and non-participation of relevant personnel required to answer questions are more of a non-communication. The miscommunications on Moderna's part this time left much to be desired.
- Opinion
- [Reporter's view] Despite ↑reimbursed drugs for rare dz
- by Eo, Yun-Ho Dec 10, 2021 05:52am
- The need for improvement emerges every year, but patients with rare diseases are still struggling. In particular, even if there are drugs, the number of patients is so small that it is difficult to prove the cost effectiveness and predict financial consumption, making it difficult to register insurance benefits. There were many opinions this year. Kang Sun-woo, a member of the National Assembly Health and Welfare Committee, began holding a parliamentary debate in May to strengthen access to new drugs for rare genetic diseases, and in August, Kang Byeongwon, Kim Won-i, Seo Young-seok, and Shin Hyun-young held a public hearing to discuss ways to improve the treatment environment for rare diseases. But the HIRA reported that the average benefit rate for treatments for rare diseases was 85.3% (2016-2020) and 100% in 2020. At this rate, it is thought that the patient's access to the treatment for rare diseases was perfect. Then, why were there still many opinions on expanding benefits for treatments for rare diseases? The results announced by the HIRA differed from the benefit rate of drugs with rare diseases actually licensed as the benefit rate for drugs that went through the screening and evaluation process. Various factors such as dropout and voluntary withdrawal were excluded. According to data surveyed by the KRPIA and the KPBMA, only about 50% of the items designated as rare drugs over the past decade have been listed on the insurance benefit list for rare diseases. In order for the benefit rate of treatments for rare diseases to rise, the use of RSA and PE systems must eventually increase. Rare diseases are diseases in which the number of patients is less than 20,000 or difficult to diagnose, making it difficult to know the number of patients. In many cases, clinical trials themselves are difficult due to the small number of patients. Due to the small number of patients, it is difficult to actively develop new drugs because it is difficult to expect profitability in the market, and even if new drugs are developed with difficulty, it is difficult to prove cost effectiveness through PE. As a solution to this, the industry has insisted on expanding the PE exemption system. If there is no alternative drug, the PE exemption system should be applied even if it is approved for placebo control data, or the number of patients should be applied in accordance with the special calculation criteria. However, drug price adjustment for drugs subject to PE exemption has recently been predicted. The figure of 80% of the lowest A7 adjustment price has made the industry difficult for a while. In this regard, it is said that the HIRA and KRPIA meetings have recently clarified that they are at the "reference" level. The point is that PE exemption drugs increased and the government thought additional management measures were needed. The point is that PE exemption drugs increased and the government thought additional management measures were needed. If the government has reduced the risk factors, it should look at blind spots.This is because it is an area with few patients and no medicine.
- Opinion
- [Reporter's view] Improving guidelines excluding PVA
- by Lee, Hye-Kyung Dec 09, 2021 05:58am
- The NHIS announced the revision of Article 6 (1) and (2) of the Price-Volume Agreement (PVA) detailed operation guidelines for "Article 6 (Drugs Excluding Negotiations)." According to the policy, The NHIS guidelines will be implemented immediately after the revision is made, but this time, they will be applied from January 1 next year after inquiring opinions as opposition from the pharmaceutical industry is expected. The revision calls for expanding the "same product group with an annual claim of less than 1.5 billion won" to "less than 2 billion won" in Paragraph 1, Paragraph 2, "items with an upper limit of less than the arithmetic average of the main component code." The NHIS unveiled a plan to improve the PVA (excluding) system at the 10th public-private consultative body held on the 2nd. The reason is that PVA has been reserved for drugs with small insurance financial savings in consideration of the burden of the pharmaceutical industry and administrative costs required to conduct drug price negotiations, but guidelines have been improved due to various problems. When the health authorities made the guidelines in 2014, the standard for making the exclusion clause for PVA was a drug with a small effect on insurance financial savings. While operating PVA for 7 years and 4 months, drugs with a large effect of reducing insurance finances were often excluded from negotiations for reasons below the arithmetic average, or they voluntarily cut drug prices to avoid PVA. These drugs included blockbuster drugs with an annual claim of more than 80 billion won, which went against the PVA system. As a result of the NHIS' analysis of drugs that have avoided PVA negotiations with voluntary cuts within the past two years, a total of 39 drugs have been cut by 1 won, and some of them have exceeded the arithmetic average price. If the NHIS suddenly lowers its arithmetic average exclusion standard from 100% to 90%, the pharmaceutical industry will face a backlash. The NHIS said it has set the PVA negotiations to be omitted if it accepts a 10% drop in drug prices according to the "weighted average of alternative drugs 90%" of the new drug negotiations criteria. Like new drugs, it means to voluntarily cut 10% of the usage, or otherwise proceed with the NHIS and PVA. PVA will be able to proceed smoothly if it is a pharmaceutical company that makes a trick at the arithmetic average price, but it is also understandable that the pharmaceutical industry will protest if the arithmetic average price is reduced by 1%. There is no reason for the pharmaceutical industry to oppose the expansion of claims for the same product group under paragraph (1) 1. If the NHIS' simulation results raise the billing amount from 1.5 billion won to 2 billion won, 23 out of 59 items under the same regulation that completed PVA negotiations this year will be excluded from the list. The NHIS will receive opinions from the pharmaceutical industry on the PVA guidelines containing such information. KPBMA, KRPIA, and KOBIA, which have already participated in public-private consultations, have opposed the revision of the guidelines. There are two main contents of this amendment. The pharmaceutical industry may want only the criteria for expanding the amount of claims to be reflected and the criteria for reducing the arithmetic average to be not reflected. However, the NHIS may not be meaningful in improving the PVA guidelines with just one thing. The association's opinion is important during the opinion inquiry period, but it is also important to reflect the opinions of individual pharmaceutical companies according to their size. This is why it is important for pharmaceutical companies to express their opinions on improving PVA guidelines during this period.
- 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.
