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- 2026-05-07 20:36:41
- Policy
- Imfinzi recieves RSA reevals and seeks to extend reimb
- by Lee, Tak-Sun Sep 15, 2023 05:32am
- The Risk-Sharing Agreement (RSA) reevaluations for term renewal are underway for Imfinzi Inj (durvalumab, AZ), which applied for reimbursement extensions to its biliary tract cancer indication. The reevaluations are being conducted in preparation for the RSA contract renewal set for March next year. According to industry sources on the 14th, AstraZeneca Korea recently submitted the pharmacoeconomic evaluation data for Imfinzi to the Health Insurance Review and Assessment Service for RSA renewals. Korea's RSA system requires companies to submit PE evaluation data for reevaluation within 1 year of RSA term expiry. The company signed an RSA for Imfinzi, and the drug was listed for reimbursement in April 2020 for patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based concurrent chemoradiation therapy (CRT). The drug was reimbursed through two types of RSA: Refund-type and Expenditure cap-type RSA. The RSA term expires on March 31st. The company refunds a certain proportion of the claims amount back to NHIS, and if the claims amount exceeds the expected amount, a certain proportion of the exceeded amount is also returned to the NHIS. The expected claims amount at the time was KRW 22 billion. Imfinzi’s sales last year, based on IQVIA, amounted to KRW 52.4 billion. The company has recently been working to extend reimbursement to biliary tract cancer. Imfinzi’s biliary tract cancer indication was approved by the Ministry of Food and Drug Safety in November last year, as a first-line treatment for locally advanced or metastatic biliary tract cancer in combination with gemcitabine and cisplatin. With the approval, Imfinzi became the first new standard therapy introduced to the field of biliary tract cancer in 12 years. Imfinzi’s effect as a combination therapy was demonstrated through Phase III TOPAZ-1 which was conducted on 685 treatment-naïve patients with unresectable locally advanced or metastatic biliary tract cancer. Results showed that the Imfinzi arm (Imfinzi+gemcitabine+cisplatin) showed a 20% improvement in overall survival (OS) versus the placebo arm (placebo+gemcitabine+cisplatin). At 2 years, the survival rate in the Imfinzi arm was 24.9% compared with the 10.4% in the placebo arm. The median progression-free survival (PFS) was 7.2 months for the Imfinzi arm, which was a 25% improvement compared to. the 5.7 months in the placebo arm. Whether AstraZeneca will be able to kill two birds with one stone and renew its RSA and extend reimbursement to the biliary tract cancer indications remain the focus of industry interest.
- Policy
- Reevaluation difficult for Ildong and Abbott’s Lypsta
- by Lee, Tak-Sun Sep 14, 2023 06:40am
- There are slightly ambiguous aspects to Abbott Korea's ‘Lypsta Plus Tab,’ whose drug price was lowered on the 5th after the insurance price ceiling reevaluations. This drug was jointly developed between Abbott Kore and Ildong Pharmaceutical, and the bioequivalence test data among the clinical trial data was submitted by Abbott. Perhaps for this reason, Abbott opposed the price cut and filed for a stay of execution, due to which the drug price will be maintained as is the 28th. According to industry sources on the 13th, The price of Lypsta Plus Tab’s 10/5mg formulation had been lowered from KRW 895 to KRW 761; the 10/10mg formulation from KRW 1,251 to KRW 1,063; and the 10/20mg formulation from KRW 1,263 to KRW 1,074. However, the execution of the price cut is set to be suspended until the 28th due to Abbott’s application for a stay of execution. The drug is a combination drug for hyperlipidemia that combines rosuvastatin and ezetimibe. Lypsta and 'Droptop Tab’ were jointly developed by Ildong and Abbott. During the reevaluations conducted this time, a price reduction could only be avoided if the company proves that it has conducted its own bioequivalence test or clinical trial, even for jointly developed products, In a Q&A session before the reevaluation, HIRA said, “Even for drugs that were developed through joint clinical trials, in-house bioequivalence test or an in-house clinical trial must be conducted, and data of such proof be submitted to meet the standard requirements. In the case of products approved through clinical trials, the clinical trial has to be conducted under the supervision of the marketing authorization holder (pharmaceutical company).’ However, HIRA added that the standard requirements do not apply if the product that was approved through joint clinical trials is the first product to be listed for reimbursement in Korea. However, Lypsta is not the first product reimbursed in its class. Rosuzet is the first product that was ever listed, and Lypsta was released two years after Rosuzet’s reimbursement. However, HIRA’s self-bioequivalence test verification requirements are a little ambiguous. This is because the two companies divided the clinical trials and shared the results with each other. For example, Ildong Pharmaceutical submitted drug interaction test and therapeutic confirmatory clinical trial data among quality assessment data, non-clinical trial data, and clinical trial data, and Abbott submitted the biopharmaceutics test data among clinical trial data. Excerpt from Lypsta In other words, Abbott conducted the Phase I bioequivalence test, and Ildong conducted the Phase III therapeutic confirmation trial. The two items were shared between the companies and the drug was approved in December 2017. This aspect is indicated in the approval report disclosed by the Ministry of Food and Drug Safety. It is understood that health authorities concluded that although there was a bioequivalence test submitted by Abbott, the core clinical trial was conducted by Ildong Pharmaceutical, its joint development partner, therefore the data did not meet the standard requirements. During reevaluations, Ildong Pharmaceutical's 'Droptop’ was excluded from receiving drug price cuts for meeting the standard requirements. With an administrative suit in place, whether Lypsta Plus Tab meets the standard requirements is expected to depend on the court's judgment in the future.
- Company
- Wellysis receives FDA approval for electrocardiograph
- by Nho, Byung Chul Sep 14, 2023 06:40am
- Access Bio (CEO Choi Young-ho), a global in vitro diagnostic company, announced on the 13th that Wellysis' patch-type electrocardiograph S-Patch Ex, with which it formed a strategic partnership last year, has received approval from the U.S. Food and Drug Administration (FDA). Access Bio previously made an investment by acquiring redeemable convertible preferred stock issued by Wellysis through Mason Healthcare New Technology Investment Association No. 2. The market expects that the solid global distribution network of Access Bio, headquartered in the United States, will play a significant role in Wellysis' entry into the United States through this approval. In the future, Access Bio plans to expand its business model to enable real-time monitoring, analysis, tracking, and remote patient management by combining Wellysis' platform technology with its diagnostic products. Through this, we plan to leap forward as a digital healthcare platform service company by maximizing IT convergence synergy in ‘field-centered diagnosis’. An Access Bio official said, “Many domestic healthcare startups are trying to enter the United States, the largest market, but in reality, it is not easy due to the high entry barrier,” adding, “On the other hand, Access Bio, headquartered in the United States, has advanced technology and global supply capabilities during the COVID-19 pandemic. “It has already been recognized through the pandemic,” he said confidently. Wellysis is a digital healthcare company that spun off from Samsung SDS in 2019 and currently provides S-Patch-EX to 14 countries. S-Patch, which weighs only 9g, is a small and lightweight cable-shaped patch design that collects accurate ECG waveforms while minimizing noise. Continuous measurement is possible for up to 100 hours without battery replacement, so the arrhythmia detection rate is high. Inside the device, Samsung Semiconductor's Bio-Processor, a chip specializing in biosignal collection, is installed, allowing the electrocardiogram to be collected and processed effectively. The global wearable electrocardiogram test market is estimated to be worth more than 1.5 trillion won by 2022, of which the US market accounts for about 55%. Access Bio has also recently invested in CuraPatient, a US digital healthcare company, and is looking forward to further accelerating its digital healthcare business with Access Bio's US FDA approval. Access Bio is a KOSDAQ-listed American company in which PharmGen Science acquired the majority stake and has been recognized for its high technology, including being recently selected as a research company for the development of next-generation diagnostic kits by the National Institutes of Health.
- Policy
- [Reporter's view] Focus on non-face-to-face contraceptives
- by Lee, Jeong-Hwan Sep 14, 2023 06:37am
- The Ministry of Health and Welfare will hold a public hearing to prepare a reform plan for the non-face-to-face medical treatment pilot project from 2 p.m. today (14th). After disclosing the status of the pilot project, the plan is to hold a panel discussion to hear opinions from the medical community, pharmaceutical industry, platform app industry, and patient and consumer groups. The Ministry of Health and Welfare has not officially commented on the direction of the pilot project reform. Some media outlets only 'leaked' a statement that they are considering a reform plan to expand the scope of non-face-to-face first visitation. For this reason, some criticize that “the Ministry of Health and Welfare is busy using the media to gauge public opinion in order to expand the implementation of the non-face-to-face medical treatment pilot project.” Some even point out that rather than starting administration based on specific policy implementation grounds, they are belatedly formulating policies that suit their tastes after being conscious of public opinion. Non-face-to-face medical treatment is a policy that Minister of Health and Welfare Cho Gyu-hong and Second Vice Minister Park Min-soo have repeatedly emphasized over the years as to the need for institutionalization, but I wonder why they are so unsure about it. First of all, the Ministry of Health and Welfare plans to prepare a reform plan after holding a public hearing on the non-face-to-face medical treatment pilot project, but there are already media reports that there is a strong direction to expand the permitted time zone for the non-face-to-face first treatment to nights, late at nights and public holidays, and to expand the permitted area to areas with a shortage of medical institutions. The purpose is to enable residents in vulnerable areas who are not guaranteed access to medical care in the current pilot project to benefit from non-face-to-face medical treatment. There is some criticism of the direction of the Ministry of Health and Welfare's reorganization that it is trying to allow unlimited non-face-to-face first visits by modifying the 'time zone' regulations, but if evidence is presented that the truly unreasonable reality of pilot projects can be improved, there is some sympathy with the direction of the Ministry of Health and Welfare's reorganization. It can be expressed. This means that the Ministry of Health and Welfare should specifically present cases where non-face-to-face treatment is not available due to a lack of medical institutions nearby, even though the area is not remote, such as islands or mountainous regions. The Ministry of Health and Welfare has not made a single comment on how to manage the side effects that are concentrated in non-covered high-risk prescription drugs such as morning-after contraceptives, isotretinoin-based acne treatments, and finasteride-based hair loss treatments, which have been pointed out several times as representative side effects of non-face-to-face therapy. The Ministry of Health and Welfare only reiterated its position that it would discuss expanding the scope of prescription-restricted drugs through a pilot project advisory group meeting but did not present any measures or blueprints on how to manage the concentration of prescriptions for high-risk medications. Even after the implementation of the pilot project, non-face-to-face treatment prescription patterns or statistics are not disclosed. Due to this situation, pharmacist professional organizations such as the Seoul Pharmaceutical Association and the Korean Pharmaceutical Association are individually calculating and publicizing their own statistics. The justification for implementing and institutionalizing the non-face-to-face medical treatment pilot project announced by the Ministry of Health and Welfare is ‘strengthening medical access for medically vulnerable groups and residents.’ It is questionable whether the concentration of non-covered prescriptions for morning-after contraceptives, acne medicines, and hair loss medicines is in line with the Ministry of Health and Welfare's goal of strengthening the medical rights of the medically vulnerable. Even in this situation, the Ministry of Health and Welfare is considering improvement measures to expand the scope of initial and repeat visits for non-face-to-face medical treatment, and it is highly likely that the Ministry of Health and Welfare will continue to mention the need to expand the scope at the public hearing to be held today. The fact that the Ministry of Health and Welfare has not made any comments regarding regulatory measures for non-covered prescription drugs influenced Democratic Party lawmaker Jeon Hye-sook to come to the conclusion that she suspected 'collusion between platform operators and the government.' The National Assembly and medical groups have been calling for several years since the COVID-19 pandemic to address the side effects of unnecessary medications being excessively prescribed through non-face-to-face treatment and platforms, but the Ministry of Health and Welfare has not made any specific comments. Vice Minister Park Min-soo strongly opposed Rep. Jeon Hye-sook's point that the Ministry of Health and Welfare is pushing for non-face-to-face medical treatment to save the platform. Rather than protesting, the first priority is to create an alternative that can solve the problem of wasting health insurance funds through excessive treatment and overprescription and increasing the risk of side effects from medicines for patients. Platforms have gained too much power and have grown into 'super apps', standing over medical institutions and pharmacies to gather opinions on how to address side effects that could damage the healthcare delivery system. The public hearing for the non-face-to-face medical treatment pilot project should be held in a format where the Ministry of Health and Welfare directly discloses the prescription statistics and patterns that occurred during the guidance period over the past three months, while also collecting opinions on solutions that will erode concerns about the concentration of prescriptions for high-risk non-reimbursed drugs and concerns about platform side effects. It should not just be a formality and a basis-building effort to expand the scope of non-face-to-face first and return visits. The slogan that face-to-face treatment is the principle and non-face-to-face treatment is an auxiliary means was put forward every time the Ministry of Health and Welfare insisted on the need to implement pilot projects and legislate. The Ministry of Health and Welfare is breaking the principles of face-to-face treatment by discussing a pilot project reform plan that blindly expands the scope of first and repeat visits without any valid basis.
- Company
- Hanmi will focus on anti-obesity drugs... from GLP-1 to DTx
- by Kim, Jin-Gu Sep 14, 2023 06:37am
- Hanmi Pharm Hanmi Science has pointed to obesity management as a future growth engine for the Hanmi Group. Hanmi Science plans to select 5 types of pipelines, including a new GLP-1 obesity treatment, and operate the project under the name, 'H.O.P (Hanmi Obesity Pipeline)'. The H.O.P project includes 5 types of treatment that include ▲'efpeglenatide', which is being developed as an economical GLP-1 obesity treatment customized for Koreans, and ▲ a 'next-generation triple agonist (LA-GLP/GIP/GCG)' that simultaneously activates GLP-1, glucagon, and GIP. In particular, Hanmi’s LA-GLP/GIP/GCG is a candidate substance that uses the company’s next-generation independent platform technology rather than the existing biodrug platform ‘LAPSCOVERY,’ Hanmi Science explained that it is a different substance from the ‘efocipegtrutide (LAPSTripleagonist)’ that is currently undergoing global Phase IIB clinical trials as a treatment for NASH. Based on the effects confirmed through preclinical studies, Hanmi Science expects that its LA-GLP/GIP/GCG substance will be able to demonstrate strong efficacy comparable to the weight loss effect (about 25%) of surgical therapy. In addition, the company is also developing a new biodrug that can prevent the loss of muscle mass that may occur from the use of GLP-1 agents, improving the quality of weight loss, while helping to suppress the weight rebound. In addition, the company has also identified candidate substances that can improve eating disorders like binge eating. In addition, the company has started to develop oral peptide platform technology plans and saw its potential for commercialization and will start development of an oral GLP-1 agent as soon as possible. Hanmi Science also added that it plans to start working on developing digital therapeutics. Hanmi Science believes that digital therapeutics can further increase the weight loss effect of the treatments administered and taken by patients, strengthen the safety of drugs, and help correct the patients' lifestyles. Furthermore, the company plans to sequentially introduce a series of ‘personalized treatments' that can support the patient’s obesity treatment cycle that covers the whole range of treatments from obesity treatment to weight gain prevention and post-weight-loss management. Hanmi Science explained that a large number of researchers from Hanmi Pharmaceutical’s R&D Center, New Product Development Headquarters, Strategic Marketing Team, Pyeongtaek Bio Plant, Paltan Pharmaceutical Research Center, and Hanmi Fine Chemical (raw material company), are all participating in this H.O.P project. In particular, the company emphasized that company-wide efforts are underway to establish the H.O.P. project as Hanmi’s next-generation core growth engine based on the leadership of the recently appointed Director of Strategic Planning, Ju-Hyun Lim. An official from Hanmi Science said, “We expect the H.O.P project to become a new growth engine for Hanmi as it prepares to make another leap forward in celebration of its 50th anniversary.”
- Company
- SMA drugs Spinraza and Evrysdi complete pricing negotiations
- by Eo, Yun-Ho Sep 14, 2023 06:36am
- The spinal muscular atrophy (SMA) treatment ‘Evrysdi (risdiplam)’ finally passed the final hurdle to its reimbursement in Korea According to industry sources, both SMA treatments, Biogen Korea’s ‘Spinraza (nusinersen)’ and Roche Korea’s treatment ‘Evrysdi (risdiplam),’ reached a final agreement with the National Health Insurance Service after drug pricing negotiation. The discussions were being made for Spinraza's reimbursement extension and the new listing of Evrysdi. As a result, the two drugs are expected to be listed for reimbursement starting next month (October) if no unexpected events arise. The current reimbursement standard for Spinraza is 5q which satisfies all of the following criteria: ▲genetic diagnosis of deletion or mutation of the 5q SMN-1 gene ▲appearance of SMA-related clinical symptoms and signs at age 3 or younger ▲case not using a permanent ventilator He is a patient with spinal muscular atrophy. Spinraza is currently reimbursed for the treatment of 5q Spinal Muscular Atrophy in patients that satisfy all of the following conditions: ▲received genetic diagnosis of 5q SMN-1 deficiency or mutation; ▲had onset of SMA-related clinical symptoms and signs at the age of 3 or less; and ▲ are not using permanent ventilators. In other words, only patients whose symptoms have been found before the age of 3 were allowed reimbursement until now. The reimbursement extensions discussed this time aimed to expand that age limit to ‘the age of 18 or less.’ In the case of the oral SMA drug Evrysdi, the drug will be also listed for reimbursement under the same reimbursement standards set for Spinraza. Discussions on the reimbursement and reimbursement extension of SMA treatments had seemingly started to make rapid progress due to rising demand for the abolition of Spinraza’s treatment discontinuation standards, however, the discussions became prolonged as the requested range of reimbursement was broader than what the government and pharmaceutical companies had expected. At the time, the government had planned to proceed with discussions on the reimbursement listing of Evrysdi after making an agreement on the scope of extended reimbursement for Spinraza, but both drugs have entered the final negotiations stage. The decision for the two drugs had been delayed once.
- Policy
- Monterizine generics prepare for release in Oct
- by Lee, Tak-Sun Sep 13, 2023 05:28am
- Hanmi Pharm’s asthma and rhinitis combination drug Companies are preparing to release their generic versions of Hanmi Pharm’s Monterizine (Montelukast+Levocetirizin) in October at the earliest. The generic drugs that were approved in August obtained first generic exclusivity and were able to move up their reimbursement listing date. According to the industry sources on the 8th, the price calculation process for Monterizine generics has been completed and it is expected to be listed with reimbursement next month. HIRA is known to have been conducting pricing calculations for Monterizine generics that applied for reimbursement after being approved in August. The generics, which received generic exclusivity, are expected to be released in October. Unlike general drugs that take 3 months to reimbursement listing, it only takes 2 months for drugs that are granted generic exclusivity to reimbursement listing. 10 Monterizine generics that were granted generic exclusivity by HIRA are owned by Genupharma, Huons, Daehwa Pharmaceutical, DongKoo Bio&Pharma, Binex, Boryung Pharmaceutical, Daewon Pharmaceutical, Daewoong Pharmaceutical, Medica Korea, and Jeil Pharmaceutical. The difference between the generics and the original Monterizine Capsule is that the to-be-released generics are tablet formulations. The pharmaceutical companies succeeded in avoiding Monterizine’s formulation patents with that difference. The MFDS therefore granted them exclusive rights so other companies may not sell the same drug until May 2024. Monterizine is Hanmi’s incrementally modified drug that it received approval in May 2017. It is the world’s first combination of montelukast, which blocks the action of leukotriene that causes tightening of airway muscles, breathing difficulties, and runny nose, and levocetirizin hydrochloride, an antihistamine used to treat allergic rhinitis. Hanmi demonstrated its combination’s superior efficacy compared to a single agent in a Phase III trial targeting domestic patients. Monterizine exceeded the blockbuster drug threshold of KRW 10 billion for the first time last year. Based on UBIST, the amount of its outpatient prescriptions was KRW 11.5 billion last year, up 24% points from the KRW 9.3 billion it had posted in the previous year. Supported by its marketability, the generic companies are expected to make efforts to market their drugs early into their release. An official from a related company said, "Because it is effective in relieving allergic rhinitis symptoms in patients with asthma and perennial allergic rhinitis, we expect to achieve high performance if we focus on marketing our product to HCPs in Korea." The current insurance ceiling price of Monterizine Cap is KRW 886/capsule. Hanmi also owns a chewable tablet formulation of the same drug at the same price.
- Opinion
- [Reporter’s View] MFDS makes changes ahead PIC/S reeval
- by Lee, Hye-Kyung Sep 13, 2023 05:28am
- The Ministry of Food and Drug Safety will be amending the ‘Regulations for Good Manufacturing Practices for Medicinal Products’ as preannounced ahead of PIC/S re-evaluations. The main point of the amendment is to amend the GMP for sterile medicinal products to align with those of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This includes the establishment of a contamination control strategy through quality risk management and the establishment of management standards for the latest aseptic manufacturing equipment and technology. The main purpose of the amendment is for the MFDS to prepare for the PIC/S reevaluations that will be held next year. This is because member countries are obligated to implement the PIC/S’s GMP regulations to maintain their member status. PIC/S is the only organization worldwide that promotes the international harmonization of GMP and inspection procedures. Since its establishment in 1995, 56 regulatory agencies from 53 countries, including the US FDA, the UK, France, Germany, and Japan, have joined as members. Korea became the 42nd country to join in 2014 but will be subject to reevaluation of its PIC/S member state requirements starting in H2 of this year. As part of the reevaluation process, the PIC/S will visit Korea in H1 next year. In order to receive a good evaluation, the latest revisions to PIC/S GMP regulations must be reflected in Korea’s regulations as well. This is why the MFDS prepared ‘Regulations for Good Manufacturing Practices for Medicinal Products (Plan) that reflect the latest PIC/S GMP regulations that include improvements to the GMP for sterile medicinal products. PIC/S member countries can receive benefits such as the waiver of some procedures including on-site GMP inspections when exporting pharmaceutical products to other member countries. Therefore, the membership status can strengthen the competitiveness of domestic pharmaceutical companies seeking to export products to other countries. Therefore, the MFDS has been preparing to amend the regulations since 2021 ahead of the PIC/S reevaluations. The Ministry of Food and Drug Safety expects that there will be no difficulties in implementing the amended regulations, as it has set a sufficient grace period for its enforcement in consideration of industry opinion on their need for ample time to prepare for regulatory implementation. However, there are bound to be difficulties following the introduction of new systems, due to the addition of new personnel or new facilities such as lyophilizers and sterilization equipment. At the information session MFDS will be holding for managers of domestic sterile medicinal product manufacturing plants from the 19th to the 20th, the reporter hopes that the authorities will hold an ear out to the voices in the industry and make efforts to reflect the opinions into the system.
- Policy
- BT public-private council will soon resume operations
- by Lee, Jeong-Hwan Sep 13, 2023 05:28am
- The Ministry of Health and Welfare is expected to soon resume the operation of the 'BT (breakthrough therapy) Public-Private Council', a pharmaceutical industry discussion body necessary for establishing and implementing BT price preference policies. The Ministry of Health and Welfare is expected to establish standards for preferential drug prices based on the results of discussions at the BT public-private consultative body held from February to April, and then finalize them after gathering opinions from the pharmaceutical industry at the public-private consultative body, which is scheduled to resume as early as this month. In the case of the public-private consultative body to reform the generic drug price system, there has been no concrete movement yet, and as the Ministry of Health and Welfare has begun research on the form of private contracts, the atmosphere is waiting until the research is completed and the analysis of the results is completed. According to the pharmaceutical industry on the 11th, the Ministry of Health and Welfare recently met with three pharmaceutical organizations along with NHIS and HIRA and held a public-private consultative body to discuss pending issues of reforming the drug price system. At this meeting, the Ministry of Health and Welfare reportedly announced plans to resume the public-private consultative body in the near future and confirm the BT preferential treatment standards in response to inquiries from the three pharmaceutical organizations regarding the BT preferential drug price policy. It has been reported that the Ministry of Health and Welfare's position is to partially accept the demands of the three pharmaceutical groups not to announce preferential policies without prior discussion or to immediately submit them to the Health Insurance Policy Deliberation Committee agenda. Pharmaceutical industry officials are observing that the Ministry of Health and Welfare has already reached the stage of completing the internal establishment of BT preferential standards and measures. It is explained that the Innovative New Drug Public-Private Consultative Body, which will be launched in September at the earliest or early October at the latest, will decide on what criteria and how to give preferential treatment to the prices of drugs made by innovative pharmaceutical companies. The Ministry of Health and Welfare and NHIS have announced plans to announce BT preferential measures within September at a National Assembly debate and press conference. The public-private consultative body that will discuss the generic drug price system, including comprehensive generic drug price cuts, is showing no significant movement. Previously, in July, the Ministry of Health and Welfare signed a private contract with Professor Kim Dong-sook of Kongju University's research team for a research project to 'prepare a plan to improve the generic drug price system', so the pharmaceutical industry predicts that the implementation of the system related to generic drug price reduction will be delayed until the study is completed and the results are analyzed. This is the consensus of experts. Last April, under the direction of Second Vice Minister Park Min-soo, the Generic Drug Price System TFT was formed and the reform of the drug price system was initiated. Compared to the time when the pharmaceutical industry expressed concern that the government might immediately move to reduce generic drug prices in batches, some portion of the system has not been implemented. It has been delayed. An official in the domestic pharmaceutical industry explained, “We requested the Ministry of Health and Welfare to publicly announce the drug price preferential treatment plan after going through the BT public-private consultative body and go through a sound review process, and they responded that they would accept it.” He explained, “Research on the generic drug price system reform plan, including generic drug price cuts, is scheduled to be studied until this year, and discussions are expected to begin only after next year.” This official said, “Fear or backlash over the wholesale price cut for generics has been delayed until the end of the study, but just reevaluating the comparison of overseas drug prices right now is a significant burden on pharmaceutical companies.” He added, “I hope that the Ministry of Health and Welfare will create the system together rather than unilaterally establish the system and then go through a formal opinion-gathering process.”
- Opinion
- [Reporter's view] What is the solution
- by Eo, Yun-Ho Sep 13, 2023 05:28am
- A drug is so effective that it is difficult to discuss listing it for insurance benefits. Although it has proven a very large improvement in survival rate compared to existing drugs, this actually increases uncertainty in health insurance, making it difficult to estimate cost-effectiveness. Since no patients die in clinical trials, costs increase. The important point is effect estimation. OS can only be counted when the patient dies, but since no one dies, calculating OS becomes difficult. Paradoxically, if the effect of the drug is too good, the cost will definitely increase, but the problem of not knowing how much the effect will increase arises. However, the clinical results are excellent. Drugs that are truly the best of all time are emerging right now. So what is the solution to these drugs? Currently, the government is requesting a financial sharing plan, but this is not a regular regulation. I think it is time to consider establishing a fundamental evaluation system for the value of social requirements themselves. Decisions related to healthcare are a process of compromise between many complex and conflicting factors. Multiple-criteria decision analysis (MCDA) is a type of decision analysis designed to transparently integrate multiple considerations in decision-making situations where multiple criteria act simultaneously. Using such a structured and explicit approach can improve the quality of decision-making, and its application in the medical field has recently been increasing. There is an increasing discussion on the introduction of MCDA as a decision-making support tool related to pharmaceutical reimbursement in countries other than these countries. In Spain, MCDA is referred to as a method of systematic evaluation procedure that helps consistent decision-making and ensures equity in access to medicines when evaluating early access to medicines and indications before approval and reimbursement. MCDA faced opposition domestically. However, on the other hand, it is already being used domestically. In accordance with the National Health Insurance Comprehensive Plan, the Ministry of Health and Welfare is conducting a reevaluation of drug coverage adequacy every year, starting with Choline alfoscerate, a brain function improvement drug, in 2020. At this time, clinical usefulness, cost-effectiveness, and social needs are used as criteria to evaluate the adequacy of benefits. Comprehensive evaluations such as MCDA may have interpretation difficulties depending on the weights and methodology, but the reality is that the current new drug registration method relies too much on cost-effectiveness and does not reflect the characteristics of each drug. Now is the time to take action.
