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- 2026-04-30 19:05:33
- Opinion
- [Reporter's view]National Security & the Price Policy
- by Lee, Jeong-Hwan Feb 16, 2023 05:52am
- Second Vice Minister of Health and Welfare Park Min-soo reaffirmed that the pharmaceutical bio-industry is directly related to national security and expressed his belief to support the pharmaceutical bio-industry by reorganizing the drug price system. It said it will give some form of benefit to pharmaceutical companies that make medicines using domestic raw materials and pharmaceutical companies that are reluctant to make due to their low profitability, and actively operate a public-private consultative body to effectively work on new drug preferential laws developed by innovative pharmaceutical companies. Expectations from the domestic pharmaceutical industry have also swelled due to Vice Minister Park's clear willingness to improve the drug price system. The expressions of pharmaceutical companies, which have expressed the need to improve the reasonable drug price system toward the government every year, seem to be brightening due to Vice Minister Park's blueprint for drug price policy. In the end, among pharmaceutical raw materials and national essential medicines imported in large quantities from China and India, drug price measures are likely to become visible soon for items that require self-sufficiency through domestic production. It is time for raw material companies and essential drug manufacturers to read the needs of ingredients or items the government believes are urgently needed for self-sufficiency in Korea. The Ministry of Food and Drug Safety, KPBMA, KODC, and pharmaceutical experts have already started to list domestic self-sufficiency materials and items, and according to Vice Minister Park's policy, the policy to strengthen domestic self-sufficiency is expected to continue to expand in the future. The National Assembly's special law on the pharmaceutical industry, which has been pointed out for years, is likely to materialize the preferential treatment of new drug prices for innovative pharmaceutical companies soon. Attention is focusing on whether legislation that stipulates the national compensation system for innovative new drugs as the Pharmaceutical Affairs Act can be realized. At a meeting of the government-run public-private consultative body, pharmaceutical organizations such as KPBMA need to actively submit their opinions to create reasonable drug-friendly measures. The Ministry of Health and Welfare should drastically improve the supply of essential drugs or out of stock, and design a drug price policy that can speed up the development of new drugs in global blockbusters. "I don't even want a drug preference. We should think about improving the drug price system so that does not recur in frustration of some pharmaceutical circles, saying, "We hope that the government will actively introduce a policy to exempt or suspend the follow-up management mechanism for drugs that have contributed to reducing health insurance finances." As COVID-19 has been prolonged for more than three years, the pharmaceutical bio-industry has soon become a national security industry. These days, the COVID-19 virus, which has persistently plagued mankind, is finally slowing down. Advanced overseas countries such as the World Health Organization (WHO), the United States, and Japan are assessing whether they will be able to lift the international public health emergency caused by COVID-19 as of May. It is feared that the government's perception of national security and willingness to improve the drug price system, which has grown further due to COVID-19, will be shaken along with the downward revision of the crisis stage. Only when the Pandemic crisis caused by the new virus recurred in the near future should we not rush to supply and demand essential drugs to cope with infectious diseases necessary for national quarantine. It is hoped that the domestic pharmaceutical bio-industry and the government will agree to prepare a reasonable drug price environment to create a worry-free country for any type of national security crisis in the future.
- Opinion
- [Reporter’s View] Asthma drugs await reimb discussions
- by Eo, Yun-Ho Feb 14, 2023 05:48am
- The asthma drugs that had long remained unreimbursed since their approval has resurfaced at the table for discussions, but the situation has not improved much from before. The government and the companies are seemingly unable to reach a consensus on the appropriate drug price. Three asthma biological drugs that were developed at similar periods - Nucala (mepolizumab), Cinqair (reslizumab), Fasenra (benralizumab) – have finally started their reimbursement listing process 3 years after being approved in Korea, but had difficultly making progress ever since. As interleukin-5 antagonists, the drugs reduce levels of blood eosinophils, a type of white blood cell that is involved in the development of asthma exacerbation. At the time of their approval, the drugs received attention for being an effective treatment option that had not been available before. However, no other asthma biodrug has been reimbursed since the reimbursement approval of Novartis Korea’s ‘Xolair (omalizumab)’ in 2020. Although all the drugs were introduced for ‘asthma,’ the indication and other specifics for the three drugs differ from Xolair. However, as Xolair was considered the comparator of the 3 drugs from the government’s perspective, the government’s suggested price had been unacceptable on the biodrug companies’ part, which brought a halt to the reimbursement process. Xolair itself had also been reimbursed 13 years after approval. Although there had been controversy over the holdout tactic it may have implemented, the long time and turmoil that the company had undergone until its reimbursement should be adequately considered. Regardless of the right and wrongs on either part, the time has passed and discussions have now resumed. It is time for both sides to make the effort to push the discussions through. The pharmaceutical companies must have had a reason and a purpose for deciding to go through the reimbursement process for the items again. Even without reference to their launch status in other countries, it is evident that the companies would have made a consensus internally on an acceptable level. Although the government also has to consider the limited amount of resources, the government should also fully look into the history and value of the drugs before carrying on the dialogue. Also, attention will be focused on whether any of the three drugs show differing results.
- Opinion
- [Reporter’s View] Improving NHI-related legislation
- by Lee, Jeong-Hwan Feb 06, 2023 05:51am
- The bill to remove the administrative drug price cut and reimbursement suspension dispositions that were imposed on illegal drug rebates from the current National Health Insurance Act and raising the penalty surcharge system has drawn industry attention and rose as an issue of focus this year. The bill aims to minimize third-party damage inflicted on patients, prescribing doctors, and dispensing pharmacists by the administrative dispositions imposed on rebate drugs, and to strengthen control over illegal rebates. The controversy over the irrationality of the drug price cuts and reimbursement suspension dispositions imposed on rebate drugs had been an issue for quite some time. The law was revised to improve the irrationality of reimbursement suspensions, where doctors and patients were left with no choice but to use more expensive drugs or experience other disadvantages in treating their diseases due to the reimbursement suspension dispositions. After the reimbursement suspension system on rebate drugs was implemented in July 2014, the revised National Health Insurance Act that applies drug price cuts according to the number of rebates and suspends reimbursement or imposes fines after 3 violations took effect in March 2018. The bill that proposed the reform of the National Health Insurance Act was submitted by NA Rep. Min-Suk Kim of the Democratic Party of Korea as representative. The bill attempts to improve the institutional irrationality of the current reimbursement suspension system. For this, the proposed bill not only contains measures that remove the price cut and suspension of reimbursement dispositions on rebate drugs and improve the standard for fines, but provisions to resolve the issue of drugs that have received reimbursement suspensions in the past. The supplementary provision of the proposed bill allows the law to be applied to drugs that received drug price cuts or reimbursement suspension dispositions or are undergoing administrative litigation at the time Rep. Kim’s bill was implemented. If so, it will be possible to retroactively apply the new system to drugs that were fined when the previous reimbursement suspension system was applied, reducing the risk of unreasonable cases and improving patient rights. The National Health Insurance Service agreed with Kim’s proposed bill that replaces reimbursement suspensions with fines. The NHIS said, “The reimbursement suspensions may violate the health rights of patients in need of the drug, so the NHIS agrees on the purpose of the amendment to impose a fine instead,” acknowledging the harm caused by the reimbursement suspension disposition. Although Kim’s bill cannot be completely flawless., the bill shows traces of multifaceted considerations made to improve the issue of the reimbursement suspension system as rationally as possible while strengthening control over rebates. Lee’s bill to revise the National Health Insurance Act is soon set to be reviewed by the Ministry of Health and Welfare soon. It is hoped that the efforts of the pharmaceutical industry and the National Assembly, which have been struggling to address the issue of reimbursement suspension for a decade, will be thoroughly reflected in the legislation during the review. Also, the legislation, which can allow three birds - preventing unnecessary damage to patients, doctors, and pharmacists, minimizing waste of health insurance finances, and strengthening punitive fines for rebates on pharmaceutical companies - to be caught with one stone, will be successfully implemented.
- Opinion
- [Reporter’s View] CDDC continues to raise controversy
- by Eo, Yun-Ho Feb 01, 2023 05:54am
- The Cancer Disease Deliberation Committee has settled as the highest threshold in reimbursement for anticancer drugs in Korea. This expert committee, which is a mandatory step for reimbursement in Korea, has put many anticancer drugs through an ordeal, to the extent that it was coined the ‘wailing wall’ to reimbursement in Korea. The committee, which had originally been launched for the purpose of evaluating the clinical usefulness of anticancer drugs that applied for reimbursement listing, had become ridden with issues after additionally starting a review on each drug’s fiscal impact. Questions were raised on what grounds the CDDC had to analyze the drug’s fiscal impact, and the fairness and objectivity of the review results were also criticized. However, the Health Insurance Review and Assessment Service only disclosed the meeting results and made no other significant change in the operation of the committee. As a result, the CDDC’s power grew stronger, empowering the government with the justification that ‘the doctors that use the drugs said no,’ and the doctors that were selected as members have become priority targets for management by pharmaceutical companies. Recently, controversy arose over the composition of the committee itself. The criticism was that the blood cancer drugs were not properly evaluated due to the high proportion of solid cancer experts in the committee. In other words, it was pointed out that the large proportion of solid cancer specialists with low expertise in hematologic malignancies in the committee made the committee unfit for proper evaluation of blood cancer drugs. In fact, the Korean Society of Hematology and The Korean Society of Blood and Marrow Transplantation had asked HIRA to organize a separate deliberation committee to review blood cancer drugs, but HIRA has been conservative in their response. This is not the first time an issue was raised on the expertise of the committee’s review. The CDDC had excluded direct stakeholders from deliberations in last year’s committee. In other words, doctors who participated in the clinical study of the subject drug were not allowed to attend the committee on the day of the drug’s deliberation. In terms of the purpose itself, the measure was made to secure transparency. However, as the scope of “direct stakeholders” included doctors who participated in PMS – or Phase IV studies – the composition of the committee itself was at a point where the expertise on the drug could not be ensured. Doctors are not financial experts. They are word by word, a medical expert. This is why the government had to explain that financial experts and healthcare experts were added to the CDDC to support the legitimacy of CDDC in evaluating the financial impact made by anticancer drugs. If so, the key role of the doctor in CDDC is to inform the committee of the medical necessity of the drug and the significance of its clinical trial results. An expert committee can no longer function as an expert committee without expertise. CDDC deliberates not any drug, it evaluates long-awaited new drugs for cancer patients. Neither exclusion for transparency nor the proportion of hematological and solid cancer experts should lead to a lack of expertise. With so many voicing the need for change, when will the government continue to argue that there is “no problem?”
- Opinion
- [Reporter's view] There's no instability in supply & demand
- by Lee, Tak-Sun Jan 26, 2023 06:06am
- Last-minute discussions between the NHIS and the pharmaceutical industry are underway regarding PVA of cold medicines, which increased their use due to COVID-19 last year. The consultation began when the government decided to correct the usage instead when the pharmaceutical industry suggested that cold medicines, which have increased their usage due to COVID-19, should be excluded from the PVA. The issue is how far we look at a specific time when usage increased due to COVID-19 last year. This is because the longer the correction time, the more advantageous it is for the pharmaceutical industry, and the shorter the correction effect. The PVA of cold medicines, which are mostly generic drugs, compares the usage of last year and the year before and negotiates the level of drug price reduction according to the increase. Therefore, there is a possibility that it will be excluded from the negotiation, except for a specific time last year when the usage increased due to COVID-19. Since it is difficult to confirm whether it was used for COVID-19 patients one by one, the advantages and disadvantages of the pharmaceutical industry are expected to vary depending on how the two sides consult. The important point is that this PVA should not negatively affect the supply and demand of cold medicines. This is because pharmaceutical companies could lose production power if they are subject to drug price cuts just because of increased usage. It is also a decision against interest rates to raise the upper limit of acetaminophen in December to increase production, and on the contrary, to cut the upper limit to PVA. Therefore, it is important to accurately calculate the level of correction based on actual data, but political calculations are also needed in consideration of the risk of supply and demand instability in the future. We hope that NHIS and the pharmaceutical industry will engage in reasonable consultations without threatening the public health of the people.
- Opinion
- [Reporter’s View] Our expectations for ADC technology
- by Jan 18, 2023 06:04am
- Professor Park Yeon-hee of the Hematology and Oncology department at Samsung Medical Center who recently spoke at the press conference held to celebrate the launch of ‘Enhertu’ in Korea said, “I have never seen such data in breast cancer.” This goes to show the superior efficacy of Enhertu in breast cancer. She added, “During the Enhertu clinical trial, I was inspected by the Ministry of Food and Drug Safety due to the large number of patients enrolling in the trial. And during inspections, my sole concern was, ‘what if a fault I didn’t know about is found that disallows patients from using the drug?’ This was how essential Enhertu is to the patients.” At the American Society of Clinical Oncology meeting last year, Enhertu received a standing ovation from the audience. ASCO is one of the three major global academic conferences in oncology. At the meeting, Enhertu became the first drug to demonstrate an effect in HER2-low breast cancer patients that account for half of all breast cancer patients but have difficulty seeing an effect with existing drugs. The drug lowered the risk of disease progression and death by over 50% compared with chemotherapy and emerged as the star of the ASCO meeting last year. Enhertu is an antibody-drug conjugate (ADC). ADCs are drugs made by connecting antibodies that bind to specific target antigens on the surface of tumor cells to cytotoxic payloads with a linker. Although various ADC drugs existed in the past, Enhertu gained particular interest as it improved the shortcomings of existing ADC drugs by applying next-generation technology. Contrary to concerns that ADCs are highly toxic, Enhertu did not produce dose-limiting toxicity (DLT), and the drug's high cell membrane permeability also affected surrounding tumor cells, producing a bystander antitumor effect. With the spotlight on Enhertu, many Korean pharma and bio companies have also joined in the competition to develop ADC drugs. Biotechnology companies generally develop key platform technology, and large-scale companies pursue equity investments or joint development. Major biopharmaceutical CDMO companies in Korea have also set out to build ADC manufacturing facilities. Various biotechs and mid to large-sized pharma and bio companies including Dong-A Socio Group, LegoChem Biosciences, Lotte Biologics, Samsung Biologics, Samjin Pharm, Celltrion, Ahn-Gook Pharmaceutical, Yuhan Corp, Pinot Bio, Hanmi Pharmacuetical have started developing of ADCs. As in any field, not all of them will see good results. In areas like ADC where cutting-edge technology is applied, and many tasks remain unresolved, fierce technology-based competition is required. There was a time when Big Pharma's interest in ADC wavered after clinical trials were discontinued due to serious side effects such as toxicity that arose due to technical limitations. If these drugs fail to prove the effect equivalent to high cost, marketability for these drugs that apply cutting-edge technology is low even with approval. For example, the new ADC drug ‘Trodelvy,’ which was introduced at the same time as Enhertu, was evaluated to have fallen short of expectations. As a drug, Enhertu established itself as a success case where its company, Daiichi Sankyo set up a future-oriented strategy in the midst of a crisis and fully utilized its technology specialized in the development of small molecule drugs. Dae-Jung Kim, President of Daiichi Sankyo Korea, mentioned in a contributory article he sent to a paper last year that " We will be able to accumulate success stories in Korea by being true to the basics of 'solving unmet medical needs based on science and technology,’ showing persistence, and devoting ourselves to new drug development in the long run..” In the growing field of ADC technology, there is still room for the technology to leap to the next level with steady development. As Kim said, it is the reporter’s wish that the current wave of developing ADCs in the industry will continue to become greater waves in the future.
- Opinion
- [Reporter's view] The Pharmaceutical Bio-Innovation Committe
- by Kim, Jin-Gu Jan 13, 2023 06:01am
- President Yoon Suk Yeol is in his second year in office. President Yoon made various pledges to foster the pharmaceutical bio-industry when he was a candidate. The first of them was to set up a pharmaceutical bio-innovation committee. The pharmaceutical bio-industry was excited by his pledge. Expectations were high for the organization in charge of fostering and supporting the fragmented pharmaceutical bio industry. Preparing a control tower to lead the industry was one of the long-cherished hopes of the pharmaceutical bio industry. However, now in its second year in office, the Pharmaceutical Bio-Innovation Committee was still a pledge. Expectations in the pharmaceutical bio industry for the installation of the control tower are gradually turning into skepticism. It is not a pledge that the interests of the ruling and opposition parties are sharply divided. During last year's parliamentary audit, Rep. Chung Chun-sook of the main opposition Minjoo Party of Korea called for the early establishment of the committee. Rep. Seo Jung-sook of the People's Power proposed a revision to the Special Act on the Promotion and Support of the Pharmaceutical Industry, which calls for the upgrade of the Pharmaceutical Bio Innovation Committee. However, as the National Assembly vacates, President Yoon's first pledge to foster the pharmaceutical bio-industry is also in vain. Minister of Health and Welfare Cho Kyu-hong said he would make efforts to quickly establish the Pharmaceutical Bio Innovation Committee, but the Ministry of Health and Welfare alone is not enough. It is expected that the pharmaceutical bio-industry development project, which has been fragmented into the Ministry of Health and Welfare, the Ministry of Trade, Industry and Energy, and the Ministry of Science and ICT, will be carried out this year. Other pledges are also disappointing. A typical example is the creation of a megafund. In August last year, President Yoon directly announced that he would create a mega fund worth 500 billion won to develop new drugs and vaccines in Korea. The plan calls for securing 300 billion won in private investment at home and abroad. On top of that, the company plans to create a mega fund worth a total of 1 trillion won by adding 500 billion won by the end of this year.
- Opinion
- [Reporter’s View] Can new drug listings really be accelerat
- by Eo, Yun-Ho Jan 11, 2023 05:59am
- The measures to accelerate reimbursement listing of new drugs is expected to be implemented in earnest this year. However, the practicality of the measure – on whether it will really accelerate drug listings – remains in question. The health authorities made a preannouncement on the amendment of the pharmacoeconomic evaluation exemption guidelines and drug pricing negotiations to expedite the listing of anticancer drugs and severe disease treatments as promised by the Yoon Suk-Yeol administration for implementation next year. Through this, the reimbursement listing of new drugs with no alternatives will be reduced by 60 days at most. Reducing the reimbursement listing period of drugs has been a regular agenda that had been discussed every year. With every discussion, the regulatory deadline was reduced incrementally. This applies to both the evaluation and negotiation process conducted by the Health Insurance Review and Assessment Service and National Health Insurance Service. However, this deadline is only the term set for the authorities to review reimbursement after someone (a pharmaceutical company) applies for reimbursement listing. The fault is on both parts. Quite a lot of pharmaceutical companies spend a considerable amount of time before applying for reimbursement after approval to discuss strategies with their headquarters. In other words, the companies take their time to thoroughly calculate their strategies and options. In the process, the companies weigh the timing of reimbursement to receive a higher price or forgo some indications in consideration of competition with other products. Companies really deliberately defer pricing negotiations waiting to be included in the government’s coverage reinforcement measure or decided to cancel the introduction of their drugs determining that Korea's marketability is poor. The decision to pass Korea, the ‘Korea passing’ phenomenon of “deciding to enter Korea after OO country” has become too common. The government's stance to “take discussions to the Drug Reimbursement Evacuation Committee after addressing most issues in the front end” has also played a role. When tracing back the listing process of drugs that have long exceeded the review deadline, applications for many of these drugs have been voluntarily withdrawn by the company after experiencing delays at the Drug Reimbursement Standard Subcommittee level. However, many companies have spoken out on how this voluntary withdrawal is not so ‘voluntary.” The deferral decision is very common during drug pricing negotiations between the NHIS and pharmaceutical companies. However, we need to remember that the 60-day deadline set for negotiations is a promise, and a deadline is a deadline. Also, the NHIS has referred to the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new drugs. The problem is that there is no transparency in the progress made in that 60-day period. Nothing is disclosed on what happened to the drugs that exceeded the listing review deadlines. As a result, only the patients are left to suffer in endless await. No answer nor explanation on the direction of progress is provided to those that wait in dire need. This new year, all the stakeholders involved should make collaborative efforts to reduce the period to actual reimbursement listing.
- Opinion
- [Reporter’s View] Decide whether to reimb diabetes combos
- by Lee, Tak-Sun Jan 09, 2023 06:11am
- Once again, discussions on expanding reimbursement to combination therapies to treat diabetes are at a standstill. The Ministry of Health and Welfare was unimpressed with the price reduction plans submitted by relevant companies under the assumption that reimbursements are expanded. This discussion, which had shown small progress only recently after being deliberated since 2016, has now again come to a standstill. Some have questioned whether the authorities intend to push back reimbursement of combination therapies for two more years until the patent expires for the original drugs. However, the issue cannot be ignored any longer. The combinations being discussed for reimbursement are triple-drug-combinations including metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, as well as some SGLT-2 inhbitors+sulfonylurea or insulin combinations. The voices are strong in the field on the urgent need for their reimbursement due to wide use. The health authorities will not be able to dismiss the doctors’ claim that the combination therapies above are the best options available for the treatment of 6 million diabetes patients in Korea. On the pharmaceutical companies' part, they have also waited enough. Many companies have received approval for their combination therapies in anticipation of reimbursement expansions. The first new combination drug that had been approved is subject to reevaluations this year and is on the verge of being canceled. Domestic companies have invested immensely in the development of combination therapies, and many have already received approvals for the drugs. If the discussions are delayed or come to a full stop, the companies may incur significant losses in their investment. The biggest issue is the fiscal scale. If reimbursement is extended to combination therapies, its fiscal expenditure is expected to reach nearly KRW 100 billion. Therefore, the MOHW is seeking to minimize fiscal expenditure by lowering the insurance price ceiling of listed diabetes treatments. Now is the time to come to a conclusion. If expanding reimbursement to the combination of all classes cannot be made, the authorities should now seriously consider applying reimbursement to at least some substances at a level that will minimally affect the state’s fiscal expenditures. There is no time left. To reduce patient burden and industry damage, this is now the time for the government to derive an optimal plan and come to a conclusion.
- Opinion
- [Reporter's view] Expectations for Revlimid
- by Eo, Yun-Ho Jan 03, 2023 05:41am
- The maintenance therapy of Revlimid, a treatment for multiple myeloma, has been on the insurance benefit list since the new year of 2023 after more than four years of waiting. Revlimid maintenance therapy has simply had a lot of ups and downs. Since 2019, BMS Pharmaceutical Korea has actively carried out the registration process, but there has been no progress in discussions. Revlimid was submitted to the deliberation committee, which attracted attention in September 2019, June 2020, and September last year due to the introduction of the CAR-T treatment Kimriah, but the result was a failure. The NCCN recommends Revlimid maintenance as the highest level of preferred treatment in both transplantable and impossible patients, and ESMO guidelines also recommend it as the only maintenance after autologous hematopoietic stem cell transplantation. Continuous administration of drugs for a kind of prevention is not a concept that was originally absent. In chronic diseases, drugs have already been taken with the concept of management rather than treatment, and in some cases, the reason for the existence of drugs, such as anticoagulants, is prevention. The problem comes from the emergence of adjuvant therapy and maintenance therapy in the field of chemotherapy. The reason why it is difficult to appear is the price. Everyone knows, but even if cancer is cured, it is scary to recur. There are also diseases with a recurrence rate of nearly 80%, depending on the cancer type. Since it is an era of high-priced drugs, prescribing anticancer drugs that are leading the trend for prevention and applying insurance benefits to them is bound to be a burden for health authorities. Existing anticancer drugs are steadily adding adjuvant and maintenance indications, and new anticancer drugs, which are the first indications of adjuvant therapy, are also being approved one after another. In this regard, the registration of benefits for Revlimid maintenance therapy has considerable meaning. Pharmaceutical companies are now able to put their expectations on adjuvant therapy and maintenance therapy indications, which have been only looking at distant mountains in their hands. Revlimid's voluntary drug reduction is already being discussed, but maintenance and adjuvant therapy here is a task to be solved. Since recurrence and metastasis increase the mortality rate of cancer, the specificity of each drug and patient situation should be considered. Of course, the government, pharmaceutical companies, and stakeholders should make efforts to find an agreement that takes into account the Korean health insurance system and the pharmaceutical industry ecosystem.
