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- 2026-04-10 02:22:16
- Opinion
- [Reporter’s View] Closer look into Korea’s new drug access
- by Eo, Yun-Ho Jun 21, 2023 05:53am
- “Korea has low new drug access. It needs to be improved.” As much as the phrase comes to heart, we need to look more closely into the matter to correctly assess the situation. Recently, the Korean Research-based Pharmaceutical Industry Association (KRPIA) recently published a report on Korea’s current new drug release status based on the ‘Global Access to New Medicines Report.’ The Global Access to New Medicines Report was published by the ‘Pharmaceutical Research and Manufacturers of America (PhRMA)’ in April. The report investigated new drug release and health insurance reimbursement status in a total of 72 countries including Korea, and subdivided the investigation results by G20, OECD status, and region. The results were based on a survey of a total of 460 new drugs approved for marketing in the US, Europe, and Japan over the past 10 years from 2012 to 2021. According to the report, it takes longer than the Organisation for Economic Co-operation and Development (OECD) country average for new drugs to be introduced to Korea since their global launch, and Korea’s release rate and reimbursement rate were also below the OECD country average. In its report, KRPIA stressed how Korea's release rate of non-reimbursed new drugs was only 5%, which is much lower than the average of 18% found in OECD countries. Non-reimbursed release means the release of drugs without government support. However, one can wonder how significant the comparative advantage in non-reimbursed releases is in this era of high-priced drugs. The rate can be significant for patients who have the financial means to receive prescription drugs without reimbursement, but they are certainly a minority. Moreover, it is also worth noting that it is individual pharmaceutical companies, not the state, that decide whether to release drugs without reimbursement. The reimbursement-related numbers were also interesting. According to KRPIA's data, it took a total of 46 months from the first global launch of a new drug to its reimbursement in Korea. The average in other OECD countries was not that different, at 45 months. However, KRPIA pointed out that compared to Japan (17 months) and France (34 months), it took 10 months to twice as long in Korea for drugs to be reimbursed in Korea. Also, KRPIA stressed that the proportion of new drugs covered by health insurance in Korea was 22%, which was below the OECD average (29%). This is only half that of Japan (48%) and the UK (48%). In fact, my first impression of the data was that ‘the numbers are higher than expected.’ I believed that the time taken to list new drugs in Korea and the reimbursement rate would be much less than that of OECD countries. However, the data showed that there was no difference in the average number of years taken to reimburse new drugs. Although the report compared Korea’s numbers with Japan, unlike Korea, Japan adopts a negative list system rather than a positive list system. Under the negative list system, new drugs that are approved are granted reimbursement after only conducting domestic clinical trials. In addition, we should also bear the characteristics and advantages of Korea’s universal health coverage insurance system in mind. The same goes for the reimbursement rate. It is doubtful whether a 7% difference in reimbursement rates should be considered a significant gap considering the specificity of each country. However, it is noteworthy that the reimbursement rate in the UK, whose health insurance system is most similar to Korea, is 48%. Although the UK is also a reference country for many countries like Korea, its reimbursement rate was fairly high. It stings a little to think that the difference in market size and the influence of NICE in the UK would have contributed to this difference, as a similar system has served as a reason for ‘passing’ Korea. Korea’s reimbursement system has many advantages, but there are definitely areas for improvement. There is also a clear concern that listing new drugs in the future will become increasingly difficult under the current system. Therefore, it remains a regret that the association’s points were not supported by more meaningfully organized data. For example, it could have been possible to elicit stronger awareness if the data presented more detailed indicators that reflect Korea’s reality, such as the listing rate of additional indications rather than the registration of a single drug itself.
- ‘Botulinum resistance lasts for at least 4 years’
- by Jung, Sae-Im Jun 21, 2023 05:52am
- Reporter Sae-Im Jung (Reporter Jung): Some say that 'unnecessary proteins can increase immunogenicity, but they do not lead to the formation of neutralizing antibodies.’ Can we say that this opinion lack grounds based on actual clinical data? Dr. Michael Martin: Well, it is not only weak, but it is also wrong. Because we have clear publications. I can name your three independent clinical publications that document quite clearly that there are no neutralizing antibodies, no immune-resistance if you treat your patients exclusively with a pure botulinum toxin. And in the same studies, other patients were treated with other preparations that contain complexing proteins, and they develop neutralizing antibodies, depending on the concentration, the dose up to 13, 14%. These are therapeutic patients with neurological disorders. So, this is very high. It's not that high in aesthetics yet. But as I said, the doses that are used in aesthetics in the APAC region is easily now comparable to the dose that neurologists used in these clinical studies. So, claiming that immunogenicity has nothing to do...I don't understand the arguments. You know immunogenicity tells whether the immune system makes antibodies or not. And if you accept that there is the risk of immunogenicity, and you link it to the presence of impurities, then it's quite clear that more impurities mean more antibody, and less impurities mean less antibodies. It's quite simple. Reporter Jung: . In fact, more types of botulinum toxin products are offered in Korea than in other countries. When choosing for aesthetic purposes, we also look at the brand, but sometimes our choices can change depending on the price or promotions. Are there things we should pay attention to when choosing a botulinum toxin? Dr. Martin: Of course, you're absolutely correct. I think Korea is the country in the world with the most products available on the market, especially for aesthetics. So, you're very active. And many of these products are in fact Korean products. So, I know, in the world, 3 products including Xeomin at the moment available, that contain only the pure toxin. But they differ; they differ in how they are produced, and which type of excipients are in there, how they are prepared. So, they're not the same, although they are all 3 pure. But what should a patient a lay-person consider? I think we have to make the physician, the person who's treating this adult person…... aesthetics is always adult person grown up persons, never children. And it's always an elective treatment, you want to be treated, because you want to be more beautiful, you want to feel more satisfied with yourself. But it's not like a neurology, where you have a severe disorder that relieves your life quality. You know, it's different. So, it's an adult person that chooses to be treated with botulinum neurotoxin. And I think it's very difficult for the layperson, alone, to make this decision. She or he needs help. And I think the person who injects, the physician or the healthcare professional, is really the person that should inform the patient of possible risks, possible implications, if treated with a not-so-pure – let me say not-so-pure – maybe, cheaper product, right? Because that, of course goes hand in hand. Because producing a high-quality product does not only mean that you will get rid of the dirt, but you have to get rid of the dirt of the bacterial impurities in a clearly documented process, under so-called GMP production, good manufacturing procedures. This is controlled by authorities. In Korea, you have an authority, Korean FDA, like in United States, like in Europe. So, it's not surprising that very well purified and well characterized products are a little bit more expensive than some that may have not undergone such a stringent and reliable process. So yes, they may be cheaper products. I agree. But I think safety and security also has a price. But the patient needs to be informed by the person that injects. I think this is mandatory. And therefore, it's mandatory that the person who injects herself or himself is aware of the problem, and accepts that there are risks if one injects an impure neurotoxin preparation, be it from Korea or some other place that has nothing to do with the country where it's used or where it's produced. It's clearly international problem. I think the person that decides to have an aesthetic treatment with botulinum neurotoxin, must be aware that it is a medical treatment. It's not like a massage. It's not like putting a cream on the face that you can remove immediately. You are being injected with a pharmaceutical. It's a medical treatment. It's no fun, and medical treatment comes with risks. We accept that medical treatment comes with risks. And I think people have to know these risks. And they have to be aware of possible consequences for their future life, especially when you consider that people are younger and younger, now. They are treated, for example, for aesthetic purposes with let's say, an impure petroleum toxin, and they are developing resistance. This resistance lasts for a long period of time. There are studies that claim you have to wait years, 4 to 6 years before they decline. That's a long time. In that time, this person may have a disorder that would require therapeutic use of botulinum neurotoxin; neurological disorder. There are many, many indications nowadays for botulinum neurotoxin. But you cannot treat this person with botulinum neurotoxin in that period, as long as the neutralizing antibodies are high. And this is very important, that somebody who decides to be treated is made aware of these risks. And I think if you know what could happen, you may also be more willing to pay a little bit more for quality. And a little bit more for safety. Documented safety. Reporter Jung: What if a patient already has used products that contain many complexing proteins and have developed a resistance to them? What should these patients do? Dr. Martin: Maybe one point to this…... In aesthetics, it's a little bit different than therapeutics. Because patients that go for botulinum neurotoxin treatment for neurological disorders, they go to hospital. And they're very well documented. And they don't tend to change their doctors. They stick to their clinic, to that hospital to the neurological unit, where they are being successfully treated. So even if they develop antibodies, they will stick to that doctor. In aesthetics, it's a little bit different. Because, of course, people can say, oh, it does not work as good as it worked before. The doctor‘s doing something wrong, he or she is injecting wrong, the material is not so good, maybe I get better results, and they have to pay for it. Maybe I get better results if I go somewhere else, and have another brand with more dose. So, it's a bit different in therapeutics and aesthetics. And therefore, I think it is absolutely necessary to make the people who use the toxin for aesthetic purposes, to make them aware that it's not a good idea to hop from one doctor, from one brand to the other. Because that can increase immunogenicity and not reduce it. And if they do that, they're completely free in that decision, of course, where they go and what they want as treatment, they should tell the new physician that they had an injection or more injections with a certain brand before so that they can judge what to do. Is it riskier now to change the brand, is it riskier to increase the dose in terms of immunogenicity? But it's always the patient together with the physician. And they have to be made aware of the problem. I don't think it's fair to live leave it all up to the consumer, to the one that is being treated. It is the duty of the physician to inform the future patient of what she or he can expect for the money he or she pays, and what the risks are, and what options there may be, that may be a bit more expensive, but maybe less riskier. And I think you should not underestimate the role you, the press, can play in informing the end-user. Maybe the companies are not so interested, but you can force the end-user to seek for information, and you can force the companies to provide information. And I think this is very important. And you can participate in this. Reporter Jung: Yes. I will do my part to provide more accurate information in the future. Thank you for the interview. Dr. Martin: It was my pleasure. Thank you very much.
- Policy
- 85% of the public requests more coverage for severe diseases
- by Lee, Jeong-Hwan Jun 21, 2023 05:52am
- A survey found that more than 8 of 10 Koreans are in favor of increasing health insurance spending on new health technologies and new drugs to treat severe diseases such as cancer and rare diseases. Also, over 80% of the respondents agreed that the proportion of new drugs in total health insurance pharmaceutical spending should be increased and that health insurance should promptly cover new drugs. On the 19th, the Future Health Network (representative Ok-Ryun Moon, Professor Emeritus at Seoul National University), a think tank in the field of healthcare, unveiled the survey results that contained the results above at a ‘Policy Debate for Health Insurance Reform that the People Want’ that was hosted by Rep. Lee Jong-Seong of People Power Party. The survey, which was commissioned to Gallup Korea, researched 5,039 people aged 19 to 65 across the country last April. In the survey, 85% of the respondents agreed (21% strongly agree, 21% strongly agree, 64% agreed) that ‘expanding the coverage of essential healthcare from now on, should focus on severe diseases rather than mild diseases.’ On which requires priority coverage – essential healthcare for severe diseases or frequently occurring mild diseases, 73% responded in favor of severe diseases, which was more than four times higher than the 17% that choose mild diseases. To the question that how a (presumable) KRW 10 million of Korea’s health insurance finances should be allocated, respondents allocated KRW 6,615,000 to severe diseases and KRW 3,385,000 won to mild diseases. When asked would be better to preferentially spend the funds secured by reducing health insurance drug expenses on covering severe disease or mild disease, 72% chose severe diseases, which was 54%p higher than the proportion of those who chose mild disease. Also, 81% agreed with the plan to increase expenditures on new drugs or new health technologies out of the total health insurance budget. 83.8% agreed on the need to increase the proportion of new drugs in Korea’s total health insurance pharmaceutical expenditures. On the reason why the government should strengthen coverage of new drugs and new health technologies, respondents showed a strong agreement of 91.2% to the reason that ‘Those can save the people's lives or guarantee their quality of life.’ Also, 87.1% agreed to the claim that it was 'because it can prevent losses that may arise from non-coverage, such as other medical expenses, care expenses, and social and economic burdens.’ 87.9% of the respondents agreed that the government should promptly apply health insurance coverage when new drugs for severe diseases such as cancer and rare diseases are developed in Korea and abroad. As its measure, 80.0% of the respondents agreed that a pre-listing post-evaluation system should be applied to new drugs and new health technologies that have been approved for their efficacy and safety by overseas health authorities. As for the reason for consent, 45.3% said 'because this will allow timely coverage of new drugs and new health technologies for the patients’, and 25.5 said 'because patients cannot receive sufficient treatment with private insurance alone for severe or rare diseases.' 80.5% of the respondents agreed that the government should further expand its financial support for the national health insurance finances and create a separate medical expense fund. 82.4% of respondents agreed on the need to create a separate medical expense fund for those with severe or rare diseases and the vulnerable with government subsidies. 83.2% of respondents agreed that the pharmaceutical companies' health insurance contributions should fund the catastrophic medical expense support project to support the use of new drugs and new health technologies. Based on the results above, Professor Jin-Hyoung Kang, who was in charge of the presentation, suggested a policy that shifts the principle of health insurance coverage to give priority to severe diseases and essential healthcare, and that it is necessary to create and operate a medical safety net fund. Pressor Kang also suggested promoting a pilot project in the form of a pre-listing and post-evaluation system to promptly apply coverage to new drugs and new health technologies, and devise ways to expedite review such as integrated operation of the HIRA-NHIS committees or parallel review. In addition, Professor Kang out the need to comply with the government's statutory support rate for health insurance to ease the public burden of national insurance premiums. His argument was that the government should take measures such as increasing the government subsidization rate from the current 14% of the expected revenue of health insurance to 20%, in compliance with the legal rate. Meanwhile, the government plans to establish and announce the 2nd Comprehensive National Health Insurance Plan, which will contain the health insurance policy direction for the next 5 years (2024-2028) in the second half of the year.
- Company
- Camzyos, which prevents sudden cardiac death in young people
- by Jung, Sae-Im Jun 21, 2023 05:51am
- Korea BMS Pharmaceuticals (CEO Lee Hye-young) announced on the 20th that it held a domestic approval meeting for Camzyos, a treatment for 'obstructive hypertrophic cardiomyopathy (oHCM)', on the 19th and introduced its clinical value. Obstructive hypertrophic cardiomyopathy is a severe and rare heart disease in which thickened left ventricular muscle blocks blood flow to the whole body, causing shortness of breath, heart failure, fainting, and sudden cardiac death. Camzyos, developed by Korea BMS Pharmaceuticals, selectively inhibits excessive cross-linking of cardiac myosin and actin, which is the cause of obstructive hypertrophic cardiomyopathy. On May 23, it received approval from the Ministry of Food and Drug Safety as a treatment for improving motor function and symptoms in patients with symptomatic (mild and moderate) obstructive hypertrophic cardiomyopathy. In the first presentation, Professor Kim Hyung-gwan of Seoul National University Hospital's Department of Cardiovascular Medicine mentioned the overall overview of hypertrophic cardiomyopathy in Korea, the treatment environment, and unmet needs in the current treatment strategy. Professor Kim explained, "In the myocardium, two proteins, actin, and myosin, are connected to each other to contract the heart, and then separate again to relax the myocardium, acting as a pump, which is the function of the heart." "In patients with hypertrophic cardiomyopathy, actin, and myosin are excessively connected to each other, causing excessive contraction of the myocardium, and this excessive connection makes it difficult for the myocardium to relax," he explained. According to Professor Kim, hypertrophic cardiomyopathy is one of the main causes of sudden cardiac death in young people, and its prevalence is gradually increasing in Korea along with the expansion of echocardiography. This disease is divided into two types, obstructive and non-obstructive, and 15-20% of all patients are classified as obstructive hypertrophic cardiomyopathy. Treatment of obstructive hypertrophic cardiomyopathy is very limited, focusing on symptom relief and prevention of complications. He added that some beta-blockers and calcium channel blockers, which are representatively used drugs, are difficult to expect long-term improvement in symptoms and the effect is not as good as expected, so there is a high unmet demand. If drug treatment does not work, surgical myocardial resection or alcoholic septal resection is considered, but the explanation is that the risks of surgery are not small. Camzyos is a new class of treatment that directly acts on the excessive binding of actin-myosin, which is the root cause of obstructive hypertrophic cardiomyopathy. Kamgios improves left ventricular outflow tract obstruction and normalizes excessive cardiac contractility by reducing the number of excessive cross-links of actin and myosin. This restores left ventricular diastolic function, reduces ventricular filling pressure, and improves myocardial energy overconsumption. The clinical trial that served as the basis for Camzyos approval is the EXPLORER-HCM study. In this clinical trial, Camzyos improved the primary endpoints, patient symptoms (NYHA grade), and exercise capacity (maximum oxygen intake, pVO2) more than twice as compared to the placebo. Twenty percent of the Camzyos group achieved both NYHA ratings and pVO2 improvements. After exercise, the index of left ventricular outflow tract obstruction also decreased more than 4-fold. Seven out of 10 patients treated with Camzyos improved their index to such an extent that they did not consider surgery, and maintained consistent effects for 30 weeks. “Obstructive hypertrophic cardiomyopathy is a rare and serious disease that can cause sudden cardiac death without warning in young people,” said Lee Hye-young, CEO of BMS Korea Pharmaceutical Korea. “We are delighted to be able to present a new treatment paradigm for oHCM with the approval of Camzyos.”
- Company
- [two thousandth]Toxins accumulated in Soyul's body every day
- by Jung, Sae-Im Jun 21, 2023 05:50am
- Soyul, who turned 5 this year, stopped growing at 80cm and is no longer growing. Her arms and legs are not straight and straight. If you try to forcefully stretch it, you could break a bone. This is because Soyul's bone density is low enough to be found in an elderly person in his 80s. Soyul also has carpal tunnel syndrome, which affects 7 out of 10 people in their 70s. Born in 2019 at 2.8kg, Soyul met the world with a dislocated hip joint. When she was about six months old, she also suffered an inguinal hernia where her intestines protruded into her groin. Soyul's small vertebrae seemed to be slightly bent. Her parents, who were worried that their child was not growing well from the inside out, thought that Soyul might be ill and went to the local hospital. The parents were a little relieved when the doctor said, "If it's not for a 0.01% rare disease, it will grow well." However, Soyul was diagnosed with a 0.01% rare disease. It was a disease called 'mucolipidosis type 2', which has one of the highest numbers of patients worldwide. Low growth, hip dislocation, scoliosis, umbilical/inguinal hernia, and many other symptoms that Soyul had to experience before she turned one year old were all due to this disease. There is no cure for this disease, so it is an incurable disease that gradually worsens and leads to death before entering adolescence. Soyul is a condition in which a large number of acidic polysaccharides and glycolipids accumulate in the body due to a lack of enzymes due to abnormalities in certain genes. Broadly speaking, it belongs to one of the lysosomal storage diseases. The complications that arise from this are so diverse that it is difficult for doctors to clearly define which symptoms will appear. Some children may develop abnormalities in their heart valves, severe middle ear infections, or cloudy corneas. Like Soyul, you may have frequent high fevers or problems with your joints. Main symptoms of mucolipidosis type 2 (source: Korea Centers for Disease Control and Prevention) “Symptoms appear differently depending on where the toxin called mucolipid accumulates. Even looking at children with the same disease as Soyul, the main symptoms are very different. Soyul’s joints are the most severe. "I can't stretch my arms straight out. I can't live, I can't touch my ears with my hands. I also bent my fingers and toes inward, but it got better as I rehabilitated. I have no choice but to keep rehabilitating so that it doesn't get worse." Due to a rare disease, Soyul lives with frequent high fevers and the risk of pneumonia. (Photo: courtesy of the patient Thanks to hard rehabilitation last year and last year, Soyul even walked on two legs with the help of a walker. My height, which was said to be no longer growing, has grown a little. Her mother's thrill at seeing her like that did not last long. Because Soyul's illness is still ongoing. Soyul practicing walking. (Photo: courtesy of the patient "I told the doctor, and I heard that it was only that a child with mucolipidosis was able to walk, and that the disease did not disappear. In the end, there was no medicine, so the symptoms reappeared and worsened. Oh, I really shouldn't have hope. That's it... I wanted to." Reality sometimes does not allow for even the slightest hope. Seeing the children with the same disease as So-yul leave one by one, So-yul's mother swallows her sadness every time. She is terrified of what may happen to So-yul when and where. According to a thesis examining the clinical characteristics of children diagnosed with this disease in Korea ('Analysis of clinical characteristics of mucosteatosis patients in Korea, including one case of mucosteatosis type 2 diagnosed with a new GNPTAB gene mutation'), Most are diagnosed in infancy, around age 2, and die within 10 years of age. Respiratory problems were also cited as the leading cause of death. "There is a group chat room for parents suffering from the same disease as Soyul to share information. There were 9 children... 2 of them left us. One child who recently left turned 11 and told us It was like a pillar. That's why when Soyul is struggling with rehabilitation and cries sadly, I suddenly think, 'Is it true that I'm doing well right now?' I couldn't give up hope when I saw that I could walk, learn how to use a straw, and understand almost everything my mom and dad say because my cognitive abilities improved." Soyul is a 5-year-old girl who likes to play on the playground with her friends the most. Seeing Soyul's smiling face, her mother finds hope in her again. Soyul can feel more joy in the world, her mother informs her of So-yul's illness through SNS and begs him to make a cure for her. And not too long ago, Soyul's mother said she got a really miraculous phone call from her. She was informed that Soyul was going to develop a cure for her illness at Samsung Seoul Hospital, so she asked to participate. "Somehow, the story of Samsung Electronics Chairman Lee Jae-yong's impersonation account became a lot of articles, but in fact, I didn't know that the account was an impersonation account (laughs). It's just that Samsung Seoul Hospital made a mucopolysaccharidosis treatment that is related to mucolipidosis, so Samsung Seoul I think a hospital could make a cure for my child, because, as you know, this disease is so rare that there are less than 100 patients worldwide, and I wonder who would spend their time and money on this cheap bottle. I almost gave up and sent a DM (direct message) to Chairman Lee Jae-yong's (impersonated) account every day, but I was so surprised to hear this." Soyul will undergo various tests to develop a treatment at Samsung Seoul Hospital next month. You will also receive an injection to protect your weakened bones. She plans to travel to Jeju Island with her family after the 5 days and 4 nights of examination and treatment. For Soyul, whose respiratory system is particularly weak, and her winter is dangerous, her family diligently goes on a trip to remember her in the summer. "I'm going to play hard with Soyul this summer. And I'll work harder on Instagram and YouTube so that I can publicize Soyul's illness and take classes that Soyul finds interesting. If anyone has to do something, Soyul and I will I think it should be done. It would be great if more people came to know about this disease and progressed in a good direction.” So that Soyul and her children with mucolipidosis can welcome healthy teenagers. So that we can see Soyul's smiling face every year. Her mom gives her strength even today. Soyul smiles at her mother (photo: courtesy of the patient
- Policy
- Mandatory benefit for Erleada impact?
- by Lee, Tak-Sun Jun 20, 2023 05:36am
- As Erleada, a prostate cancer treatment, has received mandatory reimbursement since last April, attention is focusing on whether the co-payment ratio for Xtandi and Zytiga in the same class will be reduced. Currently, Erleada receives mandatory benefits with a co-payment of 5%, and Xtandi·Zytiga receives 30% screening benefits. The Cancer Disease Review Committee of the Health Insurance Review and Assessment Service held the 4th meeting in 2023 on the 14th and decided to reduce the co-payment rate for Xtandi and Zytiga. Earlier in April, Janssen Korea's Erleada was listed as a mandatory benefit with a co-payment rate of 5% for the first time in the Androgen receptor targeted agent series. Accordingly, the same family of drugs, such as Xtandi and Zytiga, which receive screening benefits of 30% of the co-payment rate, applied for the expansion of mandatory coverage. The review committee recommends androgen deprivation therapy (ADT) in combination with Xtandi for the treatment of patients with hormone-responsive metastatic prostate cancer (mHSPC) and Zytiga for the treatment of patients with hormone-responsive high-risk metastatic prostate cancer (mHSPC). ) and combination therapy (combination with prednisolone), it was decided to change the rate of co-payment. On the same day, the review committee also set the reimbursement standards for the new reimbursement application drugs, Jemperli for endometrial cancer treatment and Xpovio for multiple myeloma treatment. On the other hand, Gavreto and Vyxeos Liposomal failed to set reimbursement standards.
- Policy
- Negotiations between Verquvo and Retevmo begin
- by Lee, Tak-Sun Jun 20, 2023 05:36am
- Retevmo, an anticancer drug with mutations in RET, and Verquvo, a treatment for chronic heart failure, have entered into drug price negotiations with the NHIS. It is said that negotiations are still underway for Cibinqo, which started negotiations on drug prices in March, and Onureg, which started negotiations with the company last month. The NHIS recently updated its new drug price negotiation target through its website. The newly updated information is that Verquvo 2.5, 5, and 10mg and Retevmo 40, 80mg were included in the drug price negotiations in June. The two drugs were recognized for their reimbursement adequacy at the 2023 5th Pharmaceutical Reimbursement Evaluation Committee held on the 4th of last month. Verquvo is effective for chronic heart failure, and Retevmo is effective for RET fusion-positive non-small cell lung cancer, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer. Verquvo is the world's first sGC accelerator to be approved for the treatment of chronic heart failure, and clinical trials have shown that it reduces deaths or hospitalizations due to heart failure by 10% compared to the placebo group. Retevmo was the first RET gene mutation anticancer drug to pass the evaluation committee in Korea. It has become official that drug price negotiations are underway for Onureg 200 and 300mg, which passed the committee last April. This drug is approved for maintenance therapy after induction therapy in adult patients with acute myeloid leukemia. It is understood that the atopic dermatitis treatment Cibinqo 50, 100, and 200mg, which passed the committee in February, is still under negotiation even after 60 days of negotiations. In particular, it was analyzed that this drug would shorten the time until it was listed as reimbursement, as it was known to have accepted the drug price suggested by the committee, but the NHIS negotiations are sluggish.
- ‘Risk of resistance to BoNT-A may rise in the next 1-2 yrs'
- by Jung, Sae-Im Jun 20, 2023 05:35am
- Dr. Michael Martin Reporter Sae-Im Jung (Reporter Jung): Hello. Welcome to DP Interview. Today’s topic is botulinum toxin, a procedure that men and women both consider an easy option for wrinkles. Due to the popularity of the procedure, awareness of the side effects that can occur from its use, especially resistance, has also been rising. This is not just a problem in Korea, and an international expert committee has been established to study its use without resistance. Dr. Michael Martin, who is a member of the committee and one of the world's leading immunologists, is with us today for the interview. Doctor, I heard that you held a seminar lecture during your visit to Korea. Could you briefly tell us about your presentation? Dr. Michael Martin: BoNT-A is a very valuable pharmaceutical, in aesthetics, here, especially in Korea, it's very important. But it's also a very valuable drug in therapeutics. So, you can help, with this drug, people with neurological disorders. And the problem that can arise when people in aesthetics or therapeutics are treated with botulinum neurotoxin type-A or BoNT-A for a long period of time is that, they can develop a non-response, which sometimes is also called immune resistance. I like the phrase antibody-mediated non-response better, because that already points to the reason why the problem arises; because these people generate antibodies against the pharmaceutical. And we can discuss what happens then. And I explained this morning, how the immune system responds to this pharmaceutical and why it makes antibodies. As I'm an immunologist, I can try to explain. Reporter Jung: So you mentioned the issue of antibody-mediated non-response that can arise from BoNT-A. Is this emerging as an important issue worldwide? Dr. Martin: Well, clearly it is an emerging global issue. Because the number of reports that are dealing with the problem that patients do not respond as well to botulinum neurotoxin treatments after repeated injections – at a weaker response or no response at all – these reports are increasing. We have had these reports before in therapeutics. And there are many clinical studies, very good clinical studies, published in very good journals for therapeutics, that show that this problem exists. And in aesthetics, for a long time, physicians or healthcare practitioners (HCPs) did not realize that this would also be a problem in aesthetics. But it is becoming a problem and people are aware of this now, and that is why I'm trying to explain how this happens, that antibodies can arise. May I add one more sentence? Consider, even if the frequency that is reported for esthetics is relatively low at the moment, please consider there are millions of injections of botulinum neurotoxin performed in the world per year; millions, many millions. And the number of indications where this pharma-protein is used is continuously increasing. In addition, the age of the persons that become treated with botulinum neurotoxin for aesthetic reasons, they become younger and younger and younger, especially in the Asian Pacific area. It's not so much in Europe, but here in Korea and other countries in this area, they become younger and younger. And therefore, I think it's necessary that we are aware of this problem, and we have to accept that immune resistance exists, and we have to react appropriately. Reporter Jung: Some may think ‘I will be fine since I only receive local procedures infrequently.’ But as an expert member of the Aesthetic Council for Ethical Use of Neurotoxin Delivery (ASCEND), where a multidisciplinary body of experts from around the world work for the safe use of botulinum toxin, could you correct some of the common misconceptions that we may have? Dr. Martin: This is a vaccination. It's nothing else than a vaccination. And the vaccination, how well the vaccination works, is depending on several parameters. One is the doses of course of the vaccine. And one more important is how the vaccine is composed; what is in the vaccine. We understand that better now. So, I think it's easier nowadays after the pandemic, to explain what vaccination is about, and why it can happen, that if you inject repeatedly, a bacterial protein, which is foreign to us, why our immune system response. It's not surprising, it's normal. And therefore, people should not dispute that they exist. We should ask why is there a difference between therapeutic indications in reported frequencies and in aesthetic indications in reported frequencies. And that can be explained why there is a difference at the moment. Reporter Jung: So resistance is inevitable, but you are studying why it occurs less frequently in aesthetics than therapeutics. Dr. Martin: Well, it's absolutely correct, what you're saying, there is a difference. And we know where there is a difference. We don't have to really conduct scientific research. We just have to watch, watch what is going on in the world. We have to watch what is going on in the Asian Pacific area, and especially also in Korea. And there are different reasons why there are, at the moment, these great differences between therapeutics and aesthetics. Why is that? Because in the recent years, the doses of botulinum neurotoxin used in therapeutics were much higher than the doses used in aesthetics. This is a few years ago, and it's still true in Europe. But it's not true anymore in the Asian Pacific area; it's not true in Korea. Nowadays, the doses that are injected into young people in aesthetics easily, easily, reach the level that is used in neurological disorders in therapeutics. So, the doses are slowly approaching to be the same, almost. And we can expect that the frequency of neutralizing antibodies of immune-resistance is continuously increasing. And it will take a few more months and years till all of these reports come to our knowledge. I'm absolutely sure that we will see increasing numbers in the next year or two to come. And Korean federal administration is aware of his problem. They warned that immuno-resistance can be a problem when treating patients with botulinum toxin type A. And maybe I can add one more word. The immune system does not know why the physician injects the botulinum neurotoxin. The immune system does not know if it is for an aesthetic purpose or to treat a neurologic problem. The immune system doesn't care. It senses, how high is the dose. And very important, it also senses the purity of what you inject. This is a very important aspect we will discuss, I think, later Reporter Jung: So I would like to how resistance affects the patients. Could you explain the immunological issues that patients might experience? Dr. Martin: It's very easy to understand, when you know how the botulinum neurotoxin works. It is a molecule that physicians inject, and then the molecule has to be taken up into the nerve terminal into the cell. And then it works inside of the nerve cell. Okay? So, this is important to know. If a patient... it doesn't matter whether it's in aesthetics or therapeutics...develops, during treatment, neutralizing antibodies to this botulinum neurotoxin type A, and you inject now into this patients, these antibodies will bind to the toxin, and then it cannot interact with the nerve terminal, with his target, anymore. So, it's not taken up into the nerve terminal, and it does not perform its function. So, you inject botulinum neurotoxin, but it never reaches the target, the nerve cell, so there is no effect. And it depends on the level, how high the level of antibodies are. If there are not enough neutralizing antibodies to catch all BoNT-A molecules, then you still have a partial response. If you have a very high titer, very high level of antibodies… It's like a vaccination, similar to vaccination. If you’re a good responder to vaccination, you have a high level of antibodies, then you don't get sick. And it's the same here. If you have a high level of antibodies to BoNT-A that neutralize the injected BoNT-A, it does not work at all. And this is a problem. It’s a problem in therapeutics, especially for people with severe neurological disorders. But it's also a problem in aesthetics because the patients are not satisfied with the result of the treatment. Reporter Jung: I heard that there are various BoNT-A products available in the market and that the incidence of neutralizing antibodies may vary depending on the purity of the product. How is it related? Dr. Martin: As you say correctly, there are different products on the market. We don't have to name names, we don't have to name these products, but the products differ. They differ in how they are produced. They don't differ in the active substance. The neuromodulator itself is the same active substances, but it differs how they're produced. And they differ to what extent the companies purify the toxin. So, we have toxin preparations, where there's only the neuromodulator, the core toxin if you like, and then we have a lot of products on the market that contain additional bacterial proteins that are not necessary for the pharmacological activity, but they remain in the product during the purification process. All of the products that are produced are produced in bacteria, by bacteria. And all of the companies take efforts to remove these contaminating proteins. And some companies stop earlier than others. Some companies invest a lot of time, a lot of money to have the pure substance, that is sufficient for the job. And other companies stopped purifying earlier. And these bacterial components that play no role in the neuromodulation, they can activate the immune system.
- Policy
- Rationalization of expedited review of new pharmaceuticals
- by Lee, Hye-Kyung Jun 20, 2023 05:35am
- In the case of a new drug developed by a first-in-class pharmaceutical company, a priority review request can be made to the rapid review division of the Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety recently prepared detailed procedures, such as the method of requesting designation from the Minister of Health and Welfare, when prioritizing new drugs developed by innovative pharmaceutical companies. According to Article 35, Paragraph 4 of the Pharmaceutical Affairs Act, which was revised in July 2021, 'drugs for which the Minister of Health and Welfare has requested designation among new drugs developed by innovative pharmaceutical companies pursuant to Article 2, Subparagraph 3 of the Special Act on the Promotion and Support of the Pharmaceutical Industry' may be designated for priority review. This means that even for a new drug developed by a first-in-class company, the Ministry of Health and Welfare must request designation before the Ministry of Food and Drug Safety can proceed with an expedited review. If this continues, innovative pharmaceutical companies will have to request a request for support from the Ministry of Health and Welfare, and after that, the Ministry of Health and Welfare will request designation, and the Ministry of Food and Drug Safety will have to go through the process of reviewing the rapid review. The Ministry of Food and Drug Safety said, "In order to quickly resolve the difficulties of first-in-class companies, we have prepared a procedure so that an official letter requesting designation can be sent from the Ministry of Health and Welfare's Health Industry Promotion Division to the Ministry of Food and Drug Safety's Rapid Review Division without establishing a separate procedure." When an innovative pharmaceutical company proceeds with a request for review of priority review designation to the Ministry of Food and Drug Safety's rapid review department, the rapid review department requests confirmation of the innovative pharmaceutical company's certification from the Ministry of Health and Welfare and receives a reply and a request for priority review designation directly from the Ministry of Health and Welfare. Therefore, first-in-class companies only need to contact the Ministry of Food and Drug Safety to apply for expedited review, and then apply for product approval. Meanwhile, not only new drugs developed by innovative pharmaceutical companies but also drugs prescribed by the Prime Minister Ordinance that is used for the purpose of treating serious severe diseases or rare diseases under Article 2, Subparagraph 1 of the Rare Disease Management Act are subject to expedited review. The Ministry of Food and Drug Safety shall decide whether to designate the drug within 30 days of receiving the application for priority review and notify the applicant of the result.
- Company
- ALS drug Teglutik may be prescribed at general hospitals
- by Eo, Yun-Ho Jun 20, 2023 05:35am
- SK Chemical’s Lou Gehrig's disease treatment ‘Teglutik’ can now be prescribed at general hospitals in Korea. According to industry sources, Teglutik (riluzole) passed the drug committees (DCs) of tertiary hospitals including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, as well as medical institutions such as Pusan National University Hospital The drug, which was released this year, was approved by the Ministry of Food and Drug Safety in May last year to extend the survival period or delay tracheostomy in patients with amyotrophic lateral sclerosis (ALS) ALS, which is also commonly referred to as Lou Gehrig's disease, is a neurodegenerative disorder that results in the progressive loss of motor neurons, leading to paralysis in the limbs and breathing. So far, there is no cure for Lou Gehrig's disease itself, however, symptomatic treatments such as Teglutik are available to slow down symptoms. Teglutik comes in a suspension formulation that allows an easier oral intake for patients suffering from swallowing disorders. The company explained that Teglutik offers an improved convenience in intake compared to existing treatments. Meanwhile, other riluzole treatments available in the market are Rilutek (Sanofi) and Yooritek Tab. Based on IQVIA, Rilutek sold KRW 3.7 billion and Yooritek KRW 2.5 billion in 2021. Teglutik, the only riluzole suspension formulation available, was listed for insurance reimbursement in January last year. The ceiling insurance price is KRW 133,970 per vial for 15-day use. Therefore, the price is the same as the price of existing tablet formulations (KRW 4,499 per day) in terms of daily dosage. Therefore, what changes will occur with SK Chemicals' entry into the riluzole market that had been shared by Sanofi and Yoo Young Pharmaceutical remains to be seen.
