- LOGIN
- MemberShip
- 2025-12-20 04:07:28
- Opinion
- [Reporter's view] AI drug development, should face reality
- by Hwang, Jin-joon May 16, 2023 05:39am
- "Artificial intelligence (AI) drug development will be useful, but there is a problem with only talking too much hope. Domestic AI drug development is still at an early stage, so more R&D is needed." These are the words the representative of an AI drug development company attending a recently held event related to digital healthcare threw to the debaters in the audience. It seems to point out that although new drug development using AI is being carried out in various parts of the world, companies that have achieved tangible results in Korea have yet to be seen. According to the Ministry of Science and ICT, new drug development is one of the projects that take an average of 10 years or more for a new drug to come to the market. It takes about 5 years to discover 5,000 to 10,000 promising candidates. Among the discovered candidate substances, 10 to 25 substances are entering preclinical trials. Of these, nine substances are approved for phase 1 clinical trial plans. The success rate is so low that there are only 5 in Phase 2, 2 in Phase 3, and only 1 in the market. In order to overcome the low success rate of new drug development and entry barriers that require long-term and high costs, a plan to utilize AI in the early R&D stage has been proposed. For traditional new drug development, a method of selecting a target disease and searching for a candidate substance by a research team reviewing about 400 to 500 related papers is used. AI is expected to have the advantage of being able to search for more than 1 million papers and hundreds of thousands of chemicals so that dozens of researchers can do the work that they have to do for 1 to 5 years more quickly. The AI drug development market is estimated to have high growth potential. The AI drug development market is expected to grow from 636.2 billion won in 2019 to 4.7693 trillion won by 2027, growing at an average annual rate of 28.63%. Global pharmaceutical companies such as AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, GSK, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sanofi, and Roche have also actively collaborated with AI drug developers to discover candidate substances. In 2021, a candidate substance for the treatment of pulmonary fibrosis discovered and designed through AI by Insilico Medicine in Hong Kong entered clinical trials. In October of last year, Verge Genomics, a US AI drug developer, started clinical trials of candidate materials for amyotrophic lateral sclerosis (ALS, Lou Gehrig), which were secured using AI's new drug discovery platform Converge. Verge Genomics is a biotech company that has received investments from Eli Lilly, MSD, WuXi AppTec, and BlackRock. In Korea, the Ministry of Science and ICT invested 25.8 billion won for three years from 2019 to 2021 to develop new AI drugs. The main goal was to build a customized AI platform for each stage of new drug development. It aimed to lead the development of three areas: candidate substance discovery, drug re-creation, and smart pharmacovigilance. Through a three-year support project in the field of AI new drug development, it developed an AI model that can be applied to neurodegenerative diseases and new anticancer drugs. The developed AI model is loaded into the public platform KAIDD and is openly operated so that researchers from industry, academia, and research institutes can utilize it. As a follow-up project that started in September of last year, the company plans to improve the data sharing and utilization environment by advancing the AI new drug development model by 2026. We plan to develop new drug candidates that can be applied for a clinical trial plan. There are several areas that need improvement in clinical prediction and targeting of clinical patient groups. It is also an important issue to establish social consensus and specific action plans that can utilize personal medical data classified as sensitive information. It is problematic that the AI drug development industry is not securing tangible results such as sales while talking only about the ideal use of technology, overseas cases, and the growth potential of the global AI market. It is necessary to face reality and solidify internal stability to be competitive.
- Opinion
- [Reporter’s View] MSD Korea ‘Calm before the storm’
- by Jung, Sae-Im May 11, 2023 05:46am
- “There were rumors from a month ago, but they proved true. I am at a loss for words at the announcement that the department will be closed down." With the news that MSD Korea’s blockbuster antidiabetic treatment ‘Januvia Series’ will be handed over to Chong Kun Dang, the employees at MSD Korea received the crushing news that the company’s General Medicine Business Unit that used to sell Januvia will be shut down. Blinded by the unexpected blow, the employees are currently at a loss for words. Although the company refrained from directly using the term, ‘closure of a department,’ the notice included phrases such as ‘we are deeply grateful to MSD Korea’s GM employees who have shown dedication and worked hard to fulfill their responsibilities’ and that the company is ‘preparing a competitive voluntary retirement and external career support programs,’ indicates the imminent abolishment of the business unit. No more drugs are left for the GM unit to sell. When MSD spun off Organon 3 years ago, it handed over a large number of its off-patent drugs to Organon including Atozet, Cozaar, and Singulair. Only the Januvia series whose patent term remained and the company’s new SGLT-2 inhibitor drug ‘Steglatro’ had survived the spinoff. From July, all rights to Januvia will be transferred to Chong Kun Dang, and Steglatro and its combination therapy Steglujan will also be sold independently by Chong Kun Dang. No follow-up drugs await release either. The reduction of the GM unit had been expected to some extent due to the company’s shift in focus to anticancer and personalized vaccines. However, no one would have imagined that a department with about 100 employees would disappear so suddenly. Moreover, MSD Korea currently does not have a leader to oversee the company's business affairs. MSD Korea's Managing Director’s spot has remained vacant ever since Kevin Peters, who had actively engaged in communication with the labor union, took office as the Managing Director of the German branch in January. David Peacock, president of the Asia-Pacific region, is temporarily serving as the manager of MSD Korea as well. This is why concerns are rising on whether the voices of Korean employees will be well conveyed amid the change with no head in place to lead the company. The company had always chosen to go with the most profitable decision for the company so far. At the time of the Organon spin-off, the company did not hand over Januvia as it was bringing in profit then and then chose to hand it over now because the patent is scheduled to expire this year. By keeping Januvia, the company had earned more than KRW 200 billion in sales over the past 2 years from June 2021. Employees in the GM unit who will now be eligible for voluntary retirement would also want to make the most profitable decision for themselves. Therefore, the key question is, how well will the company compensate the employees? For employees who may wish to remain, the company should also actively consider ways to relocate personnel. The livelihood of as many as 100 employees and their families is at stake. Employees are not products that can be handed over when it’s of no use to other companies at an appropriate price. MSD Korea said, “The company will use all its available resources to help employees adapt to the new circumstances and prepare for another opportunity for growth. We will have individual meetings with each employee to sincerely discuss their career plans and concerns." It is our sincere hope that the company will hold true to its statement and that it is not just a brief excuse to calm the confusion.
- Opinion
- [Reporter's View] Suspension of drug price cut
- by Kim, Jin-Gu May 08, 2023 05:41am
- The price of Forxiga, an SGLT-2 diabetes drug, remains unchanged despite the release of a generic version. AstraZeneca applied for suspension of drug price cut execution along with an administrative lawsuit, and the court accepted it. AstraZeneca cited the reason that Forxiga's indications include not only diabetes but also heart failure and kidney disease. A generic Forxiga was released as a treatment for diabetes, and the government's price cuts that affect other indications are unreasonable. Unlike the US, Switzerland, and Australia, Korea does not differentiate drug prices by indication. In other words, unless the current drug pricing system changes in a broader framework, it is very likely that the administrative lawsuit filed by AstraZeneca will not be accepted by the courts. There is no way that AstraZeneca did not know about this situation. Nevertheless, AstraZeneca applied for a suspension of execution of Forxiga's drug price cut. It is a very clever decision from AstraZeneca's point of view. Considering that it usually takes more than three years for the Supreme Court to make a final decision, it can prevent expected losses of tens of billions of won every year for more than three years. However, at the same time, it cannot be free from criticism that it abused the suspension system. Coincidentally, the day Forxiga's drug price cut enforcement suspension was cited was the day the 'Drug Price Cut Refund and Refund Act' passed the National Assembly. This law is about the collection and refund of pharmaceutical expenses paid or unpaid during the period of suspension or execution of drug price cuts. The government has emphasized the necessity of this bill. Biopharmaceutical companies complained that the judiciary's decision to suspend the execution of drug price cuts caused a loss in health insurance finances. The biopharmaceutical industry criticized that it was concerned about violating the constitutional right to sue. Regarding the government's claim that the pharmaceutical industry abuses the judiciary's suspension of execution, he protested that it was only a "partial problem." The face of the biopharmaceutical industry, claiming the injustice of the drug price reduction/refund law, has become meaningless. Rather, it has strengthened the government's argument that has emphasized the necessity of the bill. According to the government's logic, health insurance financial losses of tens of billions of won are expected over the next few years. Neither the government nor the biopharmaceutical industry can view this positively. On the day the bill to correct the problem was passed, he did that very problematic act. Criticism comes from the pharmaceutical industry that the degree of cleverness is too much. The bill will come into effect six months after promulgation. After 6 months, such an application for suspension of execution is burdensome. If the Forxiga drug price cut had been six months later, would AstraZeneca have made the same decision as it is now?
- Opinion
- [Reporter's View] Patent expired original
- by Lee, Tak-Sun May 03, 2023 05:38am
- For original drug patents that have expired, the upper limit is adjusted under the authority of the Ministry of Health and Welfare when a generic drug with the same product appears. Original drugs will be reduced to 70% of the previous price for one year, and from the second year onwards, the price will drop to the same 53.55% level as generic drugs. If the price drops by half, sales are likely to drop in proportion to him. That's what we call performance cut in half. Therefore, from the company's point of view, it is necessary to devise a strategy to prevent generics from being produced. First, it is to delay the expiration of the patent. In order to further guarantee the validity of a 20-year substance patent, the patent period can be extended by requesting an extension of the duration. In Korea, there is no limit on the extension of the duration. Therefore, pharmaceutical companies have been delaying the expiration of patents by extending the duration in consideration of the drug registration period. Another is to register subsequent patents. Commonly referred to as an evergreening strategy, it is to delay the release of generics by additionally registering salt patents, formulation patents, composition patents, and use patents. Domestic pharmaceutical companies sometimes make salt-modified drugs to avoid extending the duration or subsequent patents. However, as the Supreme Court disallowed it as a means of avoiding extending the duration, it is now widely used to neutralize subsequent patents. However, the salt-modified drug is not the same drug as the original drug because the salt is different. Therefore, even if a salt-altering drug comes out, the upper limit of the original drug does not fall. Maybe the original drug's evergreening strategy worked. Last year, generics were also released for diabetes treatment Tenelia, but the price ceiling did not fall because they were all salt-modifying drugs. Despite this patent strategy, generics are bound to come out. Last month, generics of Forxiga, a diabetes treatment, were poured out in heaps. Therefore, the original drug price was scheduled to be adjusted ex officio this month. The drug price cut was temporarily postponed because AstraZeneca, a pharmaceutical company, applied for suspension of execution to the court, and this was tentatively quoted. AstraZeneca applied for suspension of execution to the court because Forxiga, unlike generics, has indications other than diabetes. The company claims that it is unreasonable to cut drug prices that affect all other indications for which benefits have been applied, such as heart failure and kidney disease. It is interpreted that AstraZeneca pulled out a suspension card as a last resort when generics came out and drug price cuts became a reality. If the company suffers huge property damage, the possibility of suspension of collection increases. As mentioned earlier, the original drug's original drug price cut is halved, so property loss is inevitable. As a result, the rate of suspension of execution is also high. Once a suspension of execution is cited, price adjustments are not made until the outcome of the trial on the merits, so pharmaceutical companies can buy time for a long time. The longer the drug price adjustment period is, the more it will inevitably lead to financial losses for health insurance. As this problem has emerged, there is a movement to crack down on the door through revision of the law. The amendment to the Health Insurance Act, which provides for the recovery and refund of drug expenses paid or unpaid during the period of suspension of enforcement following the outcome of administrative litigation to cancel drug price cuts by pharmaceutical companies, passed the National Assembly on the 27th of last month. It is expected that if this law goes into effect six months after the government promulgation, the number of indiscriminate applications for suspension of enforcement by dissatisfaction with drug price cuts will decrease. A partial amendment to the Patent Act was proposed to limit the extension of the patent term to 14 years after approval and limit the number of patent rights that can be extended. If this law is passed, it is expected that generics will be more likely to be released earlier than before. I would like to think about introducing a more active reduction strategy, such as applying the ex officio adjustment condition limited to generics of the same product to late-release drugs with the same active ingredient after the expiration of the substance patent. There may be many things to consider, such as resistance from the pharmaceutical industry, laws and principles, and equity, but if the mechanism for adjusting authority is narrowly designed as it is now, strategies or tricks that abuse it will inevitably continue.
- Opinion
- [Reporter's View] Rise of patients and concerns
- by Eo, Yun-Ho Apr 18, 2023 05:37am
- Medicine is a product with strong public goods characteristics. It is a means of curing human diseases and maintaining health. In Korea, national health insurance is also applied. Another fact is that it is the company that makes and sells it. The purpose is to make a profit. Pharmaceuticals are high-value-added products that can make a lot of money. In this situation, the awakening of patients now exerts its power again, raising the popularity of prescription drugs. Their actions are influencing the decision-making itself for entitlement to benefits. These days, new drug development trends are anticancer drugs and rare incurable diseases. Innovative new drugs are emerging one after another in various cancer areas directly related to human life. There is also hope for patients with rare incurable diseases who have been suffering without proper treatment because only a small number of patients suffer from them. But those drugs are expensive. Most of these drugs are super-expensive. It's been a long time since it was approved by the Ministry of Food and Drug Safety, but prescriptions have not been made and the process for listing benefits has not been completed. The HIRA and the NHIS are bombarded with complaints from patients. Complaints even reach the National Assembly. The Ministry of Health and Welfare and its affiliated agencies are inundated with questions and criticism. Even without determining whether or not to receive reimbursement itself, cases, where the patient's power was clearly demonstrated in the speed of registration, are gradually accumulating. Pharmaceutical companies say that when they promote a drug, it is for the sake of patients. That is true, but there are times when there is no inspiration. It is thanks to companies that are inclined towards 'products' without a dilemma. That's why we hope that the industry's approach to patients will be accompanied by rigorous prudence.
- Opinion
- [Reporter's View] Preferential price for innovative drugs
- by Lee, Jeong-Hwan Apr 06, 2023 05:54am
- Second Vice Minister of Health and Welfare Park Min-soo promised the National Assembly that he would make a rule that gives preferential prices to medicines made by innovative pharmaceutical companies over other medicines. This is in the same context as Vice Minister Park Min-soo clearly expressed his will to improve the drug pricing system, which includes specific drug price preferential treatment for innovative new drugs and essential drugs, at a meeting of the Ministry of Health and Welfare's press conference in February. Last month, at the Health and Welfare Committee of the National Assembly, Vice Minister Park asked that the preferential treatment policy for innovative drugs be made clear so that the mandatory drug price preferential legislation proposed by Rep. Seo Jeong-sook of the People’s Power of Innovative pharmaceutical companies should not be passed and the review suspended. To borrow the expression at the time, Vice Minister Park said, "(Within the Pharmaceutical Industry Promotion and Support Special Act), we will materialize the presidential decree and prepare a policy plan to improve the health insurance drug price system. Please keep an eye on it. Legislation of compulsory regulations is burdensome." When inquiries from Rep. Seo Jeong-sook, who proposed a bill to enforce preferential drug pricing in the 21st National Assembly, and Democratic Party lawmaker Nam In-soon, who first proposed a bill for voluntary drug price preferential treatment in the 20th National Assembly, Vice Minister Park stopped the legislation and confirmed the implementation of the policy. am. It is noteworthy that Vice Minister Park's promise to enact lower-level laws is in stark contrast to the Ministry of Health and Welfare's passive attitude in making lower-level laws, citing trade frictions. However, it is regrettable that Vice-Minister Park did not suggest a specific timing for establishing a preferential drug price policy. Even now, it should have set the exact time when the policy will be made and released so that it can be free from criticism that the enactment of the lower statute is very slow. In November 2018, the government promulgated legislation on preferential drug prices, including the addition of the upper limit on drugs manufactured by innovative pharmaceutical companies, after passing the plenary session of the National Assembly. However, even after four years, it is evaluated that the work of enacting sub-laws to support the effectiveness of drug price preferential treatment has not progressed forward. This is the background of Congressman Seo, who sympathized with the long wait and frustration of the pharmaceutical industry and introduced a bill to change the voluntary drug price preferential regulation into a compulsory regulation. The expert committee of the Welfare Committee also supported Congressman Seo's bill with the intention that the legislation was not unreasonable and the necessity and legitimacy were recognized. There was a movement for a sub-decree. In October 2021, the Ministry of Health and Welfare through the Korea Health Industry Development Institute ordered a 'research on drug price support policies for innovative pharmaceutical companies that conform to the international trade order'. However, even in this study, the original plan to announce the research results in May 2022 was not properly followed, and the vacuum in the lower statute has been walking in place so far. This is the reason why Rep. Seo and Rep. Nam did not hide their suspicious suspicions from Vice Minister Park, who revealed his will to legislate the rule of preferential drug pricing without fail. Fortunately, this time, along with the expression of Vice Minister Park's will, the Ministry of Health and Welfare's movement to enact substantive sub-statutes is accompanied by an atmosphere. The Ministry of Health and Welfare, along with NHIS, HIRA, and three pharmaceutical organizations, supervised a public-private consultative body to improve the drug price system. Vice Minister Park said, “Even if the law is changed to a mandatory regulation to prepare a preferential drug price clause, there is no problem when the Ministry of Health and Welfare does not comply with it, so it is ineffective.” It was explained that if the government's will and policy direction were firm, it could create a preferential treatment plan without amending the law. As the Ministry of Health and Welfare has virtually ended the work of collecting opinions from domestic and foreign pharmaceutical companies and bio companies, Vice Minister Park believes that he must directly roll up his sleeves and take the lead so that specific drug price preferential regulations can be completely unveiled at least within the first half of this year. If the enactment of sub-statutes is postponed again without a promise in the face of the temporary suspension of the National Assembly legislation, it will be difficult to be free from criticism that the Ministry of Health and Welfare is taking the legislative branch lightly. It is hoped that the enactment of the sub-statute by the Ministry of Health and Welfare will eliminate the need for review by the National Assembly for the enforcement of preferential drug price regulations ahead of the midsummer heat wave that will be approaching this year without fail. In addition, it is hoped that the sub-laws to be enacted will be filled with effective content to quench the thirst of the pharmaceutical industry, which has been waiting for five years and repeatedly complaining. It is important to carefully reflect on the preferential provisions that the industry really wants, not the formal administration of the National Assembly in preparing a plan for preferential drug prices. In order to nurture the biopharmaceutical industry and realize the creation of global blockbuster domestically produced new drugs, it is possible to achieve economic effects as well as realize policy goals by establishing sincere preferential measures by listening to the opinions of the industry.
- Opinion
- [Reporter’s View] Accepting drugs used by very few patients
- by Eo, Yun-Ho Mar 30, 2023 05:41am
- It's the same 'cancer', but different. So how should we regard these new anticancer drugs that target only a very few among all patients that have the same type of cancer? The cancer types that we commonly refer to, such as liver cancer, stomach cancer, and lung cancer are just major categories used, and the specific condition of each patient is classified in more detail. According to the specific class of cancer, the difficulty of treatment may vary even for tumors that originate from the same organ and affect a varying number of patients. The development of precision medicine is already heralding a shift in the prescription standards from organs to genes. In other words, the era of personalized healthcare has now arrived but is still regarded as an unfamiliar concept by many. Korea is still having difficulty accepting cutting-edge targeted anticancer therapies that show an effect regardless of cancer type according to each patient’s identified gene mutation. In this sense, targeted anticancer therapies and cancer immunotherapies that have previously been listed are experiencing considerable difficulties in the process of extending their reimbursement. This is due not only to the high price of the drugs but also because the drugs need to undergo value assessments again and reestimate their amount of use. This is the key framework that sustains Korea's national health insurance system. However, one of the characteristics of the recently developed new drugs is that the number of subject patients, that is, the number of patients confirmed with the specific genetic mutations that allow the use of such new drugs is very small. In other words, there are not many people who are eligible to use the new drugs. Less than 1% of all solid cancer patients have a rare type of solid cancer, and in terms of diagnosis, around 200 are diagnosed with such rare conditions in Korea. The typical standard-of-care therapies (existing drugs) do not work well in these patients. This was why industry voices have been on the need to redefine rare diseases. In other words, the number of patients corresponding to each treatment option should be reflected rather than the number of patients that are affected by the same disease. Of course, such redefinition would require systematic and detailed discussions. However, the time has now come for Korea to consider how to reimburse the new targeted anticancer drugs whose use has increased and targets reduced. Korea's current system is not the issue. Korea just need to consider how to solve the problem regarding the increasing number of anticancer drugs difficult to reimburse through the current system.
- Opinion
- [Reporter's view] The goal of global new drug development
- by Hwang, Jin-joon Mar 28, 2023 05:54am
- When the government announced the 'Third Five-Year Comprehensive Plan to Foster and Support the Pharmaceutical Bio Industry', it was emphasized that it would create three new blockbuster drugs that record global sales of more than 1 trillion won by 2030. For this purpose, strategic R&D investment was selected as a key task. In the development of new drugs, it is planned to significantly increase public and private R&D investment. Looking at the detailed support measures, the government plans to promote R&D investment of a total of 25 trillion won jointly with the private sector for 5 years with 10 global new drug development goals. The government also expects to invest 4 trillion won in government R&D and 21 trillion won in private R&D from this year to 2027. Based on the national new drug development project that inherited the results of the pan-governmental new drug development project from 2011 to 2020, a joint public-private investment of 2.2 trillion won was invested to develop one new blockbuster drug and three new drugs by 2035. A plan for development was also established. The government's will to foster the industry is positive, but the problem with new drug development is that speed is not important. As of last year, there were zero blockbuster new drugs recognized by the government. The government expects to secure two by 2027. Under the current circumstances, only Yuhan's non-small cell lung cancer drug Leclaza and SK Biopharmaceuticals' epilepsy drug Xcopri appear to be the only drugs developed by domestic biopharmaceutical companies by 2027 that have the potential to become global blockbusters. Leclaza was transferred from Genosco/Oscotec to Yuhan Corporation in July 2015 when preclinical development was underway. In November 2018, the technology was transferred from Yuhan to Janssen, a subsidiary of J&J, a global pharmaceutical company. Yuhan received conditional approval for Leclaza as a treatment for secondary mutations in non-small cell lung cancer in Korea in 2021. In other words, it took five and a half years from preclinical trials to conditional approval. It seems that it will take more time for Leclaza to rise to prominence as a global blockbuster. Janssen, which holds the global copyright, is conducting a phase 3 trial of Leclaza alone and Rybrevant as an indication for non-small cell lung cancer. Cenobamate started with basic research in 2001, went through clinical trials and licensing, and was approved by the U.S. Food and Drug Administration (FDA) in 2019. It took 18 years from the first research to enter the large-scale US pharmaceutical market. Last year, US sales of Cenobamate more than doubled from the previous year to 169.2 billion won, but it will take more time to get on the list of global blockbuster new drugs. Moderna's Corona 19 mRNA vaccine, which recorded $18.4 billion in sales last year, was praised for succeeding in developing it in about a year, but the actual situation is different. Moderna's COVID-19 mRNA vaccine is the product of 30 years of RNA research, 20 years of LNP development that protects mRNA, and 10 years of Moderna's own research and development. The government recognized the biopharmaceutical industry as a 'future food in a low-growth period', a 'key field for securing jobs', and an 'essential national strategic industry for overcoming infectious diseases and other diseases and guaranteeing public health'. In order to realize this, not only R&D support measures such as active support for global clinical trials but also support measures for basic research fields such as chemistry and biotechnology from a long-term perspective must be prepared.
- Opinion
- [Reporter's view] Tagrisso's first benefit
- by Mar 27, 2023 05:56am
- AstraZeneca's lung cancer drug Tagrisso has begun receiving benefits for first-line treatment. After 5 challenges, he passed the HIRA Cancer Disease Review Board. After adding the first treatment indication in December 2018, Tagrisso actively tried to expand benefits but was rejected by the review committee every time. The reason was that looking at the data of the phase 3 sub-analysis, the effect of improving overall survival in Asians could not be confirmed. The controversy over the efficacy of Tagrisso was started by Japan and ended by Japan. In the phase 3 FLAURA clinical trial, Japan had the greatest impact in making the OS values of Asians insignificantly different from those of the control group. The medical environment where drug switching is free is a crazy aftermath. The real damage was seen by Korean patients. In Japan, the first benefit is applied regardless of the results of the sub-analysis, but in Korea, because of this data, they had to receive treatment without benefit for more than 4 years. It is also Japan that has quelled OS doubts in Asia. Last year, Japan's large-scale real-world data came out. Real-world data is not clinical in a controlled environment, so it is generally less effective than data from clinical practice. However, Tagrisso showed a longer progression-free survival period and an overall survival period of more than 3 years compared to the phase 3 trial in the Japanese real world. There is no longer any need to argue over phase 3 sub-data. Already, the first-line Tagrisso therapy has fully established itself as a global trend for EGFR-mutated non-small cell lung cancer. A German professor of hemato-oncology whom I met in an interview last year expressed some disapproval at the reporter's question, "What do you think of the sequential treatment that uses the first and second generations first and then the third generation?" This is because I had never thought about sequential therapy after Tagrisso. His answer was, "I heard that even in Germany, a small number of hospitals choose sequential treatment. However, since Tagrisso has already become the clear first-line standard treatment, to be honest, I have never thought about sequential treatment. I'm sorry I couldn't give you an answer. it was" It will take a little longer for Tagrisso to become the standard first-line therapy in Korea. Concern about cancer is just the beginning of reimbursement for anticancer drugs, and in the future, drug price negotiations with the HIRA and the NHIS, and the Ministry of Health and Welfare must all pass. Now it's a speed battle. Depending on how long it stays on the drug rating, the Tagrisso benefit expansion could be over the year or within the year. First of all, AstraZeneca has a very high will to cooperate with the government as much as possible and expedite the process. The HIRA also has many new drugs to review for reimbursement adequacy. But it's only 4 years. The fact that the first petition for Tagrisso's salary exceeded 50,000 people can be said to have reached its maximum level of desperation. I hope that their wait will not exceed 5 years.
- Opinion
- [Reporter's view]Vaccine self-sufficiency rate to 80%
- by Kim, Jin-Gu Mar 23, 2023 04:45am
- In 2013, 10 years ago, the Ministry of Health and Welfare distributed a press release. The plan is to foster the domestic vaccine industry and raise the self-sufficiency rate of the National Immunization Vaccine to 80% by 2020. At the time, among the 28 types of National Immunization Vaccines, only 8 types of vaccines were self-sufficient, but the government's plan was to expand this to 22 types within 7 years. Only two years later, the plan to achieve 80% vaccine self-sufficiency was partially modified. The Ministry of Food and Drug Safety secretly delayed the target achievement from 2020 to 2022 at the Biopharmaceutical Global Growth Policy Forum. Four years later, the plan changed once more. The Ministry of Food and Drug Safety has delayed the goal of achieving the goal by one more year, to 2023. At the same time, the self-sufficiency rate target was lowered from 80% to 75%. Then what about the current situation? According to the KPBMA, the domestic National Immunization Vaccine self-sufficiency rate is only 50% as of 2021. This means that only 14 out of 28 types can be produced domestically. This is because many of the vaccine stocks are dependent on foreign imports. There are only six vaccines that domestic pharmaceutical companies can manufacture and supply from raw solutions to finished products, including hepatitis B, influenza, chickenpox, and tetanus/diphtheria. The self-sufficiency rate is less than 30%. Vaccine self-sufficiency is a very old issue. However, progress toward resolving the problem has been slow. The order that the vaccine self-sufficiency rate should be increased is only repeated as an empty cry every year around the state audit. Over the past three years, while the corona crisis has been prolonged, we have realized how desperate it is to secure vaccine sovereignty. As SK Bioscience succeeded in developing its own COVID-19 vaccine, it also confirmed its development capabilities. All that remains now is the motivation to drive the development and production of the National Immunization Vaccine by private companies. The solution of affordable pricing for the National Immunization Vaccine has been around for a long time. However, the slogan of securing vaccine sovereignty burns for a very short time and then goes out. While more than 10 years have passed, the plan to achieve 80% self-sufficiency in essential vaccines remains only a lofty goal. The corona crisis is turning into an endemic. In other words, great momentum is passing by to achieve the ambitious goal of securing vaccine sovereignty. We must act now. It is difficult to achieve this goal with only the pure will and efforts of private companies. It is difficult to attract participation from private companies through indirect means such as supporting vaccine R&D or improving licensing and regulation. There is a quick and sure solution called 'reasonable compensation'. Unless this solution is introduced, it is clear that the lofty goal will be revised once again before the year is out.
