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- 2025-12-22 01:05:02
- Policy
- Dual punishment for CSO rebates passes NA committee
- by Lee, Jeong-Hwan Mar 24, 2023 05:48am
- A provision that stipulates the prohibition of doctors from receiving rebates offered by contract sales organizations (CSOs) and a plan to amend the Medical Service Act to advance regulations on medical advertisements and allow the Ministry of Health and Welfare to intervene in the Medical Advertisement Deliberation Committee passed the plenary meeting of National Assembly’s Health and Welfare Committee. Also, a proposal to amend the Pharmaceutical Affairs Act, which includes a clause prohibiting illegal hospital subsidies in exchange for prescriptions between hospitals and pharmacies that are preparing to open, and a clause that allows pharmacists to refuse to dispense poor or counterfeit narcotics prescriptions was passed in the same the plenary meeting. Also, the bill to manage the harm from cigarettes, which was merged as an alternative by the NA Chair after the bill was separately presented by NA Rep. Hye-Young Choi of the Democratic Party of Korea and Ki-Yoon Kang of the People Power Party, also crossed the threshold set by the Health and Welfare Committee. On the 23rd, the NA Health and Welfare Committee. held a plenary session and voted on the bills that were reviewed by the 1st and 2nd legislation subcommittees. A bill that adds drug CSOs to the scope of rebates such as money and valuables that doctors should not receive and obligates the medical device CSOs to report to the government and local governments passed the Health and Welfare Committee deliberations. Therefore, these agendas will go through legislative procedures with the drug CSO reporting system that had been pending at the Legislation and Judiciary Committee level. Changes are expected in the review of medical advertisement deliberations in the future as the Medical Advertisement Deliberation Committee, which consists of functional groups of medical professionals such as those from the Korean Medical Association, passed the bill to improve MDAC deliberations and allows the Ministry of Health and Welfare the right to intervene. Also, the Pharmaceutical Affairs Act, which prohibits prospective hospitals and pharmacies from exchanging hospital subsidies for prescriptions, is subject to review by the NA’s Legislation and Judiciary Committee. Furthermore, legislation of the Tobacco Hazard Control Act, which includes disclosure of the types and amounts of harmful substances contained in e-cigarettes as well as leaf tobacco is expected to accelerate progress. Also, an amendment to the Narcotics Control Act that stipulates that pharmacists at pharmacies may refuse to dispense drug prescriptions issued by medical institutions that poorly entered patient information or are suspected a forgery also passed the Health and Welfare Committee. Whether to present the bills at the plenary session will be determined by the Legislation and Judiciary Committee after considering the agenda seriatim.
- Policy
- Rinvoq also succeeded in expanding youth atopy benefits
- by Lee, Tak-Sun Mar 24, 2023 05:48am
- Rinvoq 15mg will be covered from April as an adolescent atopy treatment. On the same day as the biologic drug Dupixent, the youth atopic treatment benefit is applied. It is the first among JAK inhibitors to obtain reimbursement for the youth indication before Cibinqo, a competitor drug. According to the industry on the 22nd, Rinvoq SR 15mg will be reduced by 5.1% from 21,085 won to 20,100 won by voluntarily lowering the upper limit of the salary. In addition to the reduction in the upper limit, benefits are also applied to the treatment of atopic dermatitis in adolescents. This drug was covered only for the treatment of moderate to severe atopic dermatitis in adults. As a result, it is expected that the treatment accessibility of adolescent atopic dermatitis patients will be improved. It is known that Rinvoq SR 15mg sought to lower the drug price according to the expansion of the range of use for the application of youth benefits. Although the upper limit of the range of use is adjusted within 5%, it is interpreted that the drug price cut was widened voluntarily, and the youth benefit was applied earlier than Cibinqo, a competing drug. From April, Dupixent will also be covered for atopic dermatitis in children and adolescents. The insurance authorities decided to apply Dupixent PFS 200mg and Dupixent PFS 300mg not only to adults with severe atopic dermatitis but also to children and adolescents aged 6 years or older through refund-type, total-limit, and initial treatment cost-reimbursement contracts. Pfizer's Cibinqo, a similar drug to Rinvoq, is currently negotiating with the NHIS to receive coverage as a treatment for atopic dermatitis in adults and adolescents. As the pediatric and adolescent atopic dermatitis treatment market expands, competition among related drugs is expected to intensify.
- Policy
- Pharma industry makes a request to MOTIE and MOEF
- by Nho, Byung Chul Mar 23, 2023 04:45am
- Public opinion has been rising for the government to revoke the designation of botulinum toxin as a national core technology. The rise of this public opinion brings more meaning as the request was made by Korea Pharmaceutical and Bio-Pharma Manufacturers Association, which represents the industry. Breaking away from lesser movements that had been made by individual companies or internally within the Ministry of Trade, Industry, and Energy, KPBMA has taken entitative and requested the above for industry development and the future. According to industry sources, KPBMA sent an opinion statement last week requesting the MOTIE to revoke the national core technology designation it had set for the manufacturing technology of botulinum toxin strain and products. In addition, within this week, the association plans to deliver an improvement proposal to the Ministry of Economy and Finance’s Economic Regulatory Innovation TF that requests the revocation of the designation of the national core technology on toxins. KPBMA submitted the petition to MOEF to revoke the toxin national core technology destination request to MOEF because the ministry had organized an 'Economic Regulation Innovation TF' to foster and support the industry, which team listens to the voices of the field, and reflects them in actual policy and institutional improvement. The TF consists of 13 private members and 12 government members and is jointly led by the Deputy Prime Minister of Economy and Finance and a private expert. An industry official said, “Since a written opinion has already been submitted to MOEF, the agenda will be discussed at MOEF’s TF meeting. After setting the direction, official discussions will be made between the two ministries on the withdrawal of the national core technology designation to toxins.” The designation, maintenance, and cancellation of toxin as a national core technology is regarded a sensitive issue for which considerable debate has taken place even within MOEF. The MOTIE Minister can designate or drop the designation of a certain technology after deliberation with the Industrial Technology Protection Committee (which consists of less than 25 members including the chair) under Article 9 ① and ③ of relevant laws. However, the agenda is busy being discussed due to the strong difference in opinion among the 25 committee members, which is why the committee is having trouble setting the specific direction of modifications, and the technology is far from originality and lacks progressive superiority. The representative key core technology designations in Korea include the following technologies: ▲Semiconductor (DDI design technology for OLED to operate driving display panels); ▲Electricity and electronics (design, process, manufacturing, and evaluation technology of ultra-high-performance electrodes or solid electrolyte-based lithium secondary batteries); ▲Display (AMOLED panel design, process, manufacturing, and operating technology). The technologies above are widely accepted as advanced technologies, however, the prevailing opinion is that toxins do not require advanced technology as the toxin strains are more discovered and purchased than developed. As the safety of these toxins can be ensured with the existing management and supervision of the health authorities, the industry has been voicing that it is time for the government to actively prepare a blueprint (revocation of national core technology) on toxins to increase domestic demand and exports. In the absence of general knowledge and information, concerns about the threat of terrorism due to the chemical weaponization of toxins could be raised, but it is a consistent opinion in academia that it is virtually impossible to weaponize the toxins in general pharmaceutical/bio-pharmaceutical research institutes or the private sector. In this regard, another industry official said, "The national core technology designations are made to strengthen the competitiveness of domestic companies by preventing and protecting illegal leakage of industry technology and to contribute to national security and national economic development. However, such toxins are already being approved, manufactured, and sold in a consigned CDMO format among domestic biopharmaceutical companies after they sign joint sales contracts. Therefore, its value as a national core technology is lessening in value.” Meanwhile, KPBMA is taking active steps to revitalize the industry through cooperative governance, therefore, the specific direction on whether to maintain and revoke toxins as national core technology may be determined as early as this year.
- Policy
- Legislation requiring submission of botulinum strains
- by Lee, Jeong-Hwan Mar 23, 2023 04:45am
- A bill that makes it mandatory to submit genetic information of bioterrorism infectious diseases such as botulinum toxin to domestic quarantine authorities and cancels the possession permit if not submitted did not pass the Health and Welfare Committee of the National Assembly held on the 22nd. If the bill is passed, it may lead to excessive regulation of trade secrets and property values of pharmaceutical companies with botulinum toxin strains, and retroactive application of the submission obligation to pharmaceutical companies prior to the enforcement of the law may be intrusive or cause trust protection problems. This is the result of reflecting the opinion of the expert member's office of the Welfare Committee that a policy judgment on legislation is necessary. The members of the subcommittee on the bill sympathized with the expert's point out that corporate trade secrets and property values could be excessively regulated while acknowledging the necessity of the bill. The bill has emerged as a controversial bill in the pharmaceutical industry as it contains a retrospective application clause that imposes the obligation to submit genetic information such as strains and base sequences to licensees and pharmaceutical companies that have obtained domestic marketing permission and have botulinum toxin before implementation after passing the National Assembly. Pharmaceutical companies with botulinum toxin have mixed opinions about the passage of the bill, but the opposing pharmaceutical companies are in the position that the legislation, such as the source of the strain and the submission of the base sequence, is ineffective given that the botulinum toxin strain is a natural substance. It is pointed out that Medytox and Daewoong Pharmaceutical are in a dispute over whether to steal botulinum strains in Korea, so if the bill is passed, disputes between pharmaceutical companies may escalate. The amendment to the Infectious Disease Prevention and Management Act, proposed by Choi Jong-yoon, a member of the Democratic Party, requires those who possess a total of eight types of bioterrorism infectious disease pathogens, including botulinum bacillus, to submit the pathogens to the Director of the Korea Centers for Disease Control and Prevention within 30 days from the date of possession. It also contains a provision allowing the director of the Korea Centers for Disease Control and Prevention to cancel the permit to possess the pathogen of an infectious disease of bioterrorism, even though it must be submitted within 60 days from the date of request for resubmission. The Director of the Korea Centers for Disease Control and Prevention checked whether the submitted bioterror infectious disease pathogens and the bioterror infectious disease pathogens approved for possession matched and made it possible to build a database. The purpose is to strengthen the safety management system for bioterror infectious disease pathogens. While acknowledging the necessity of the bill, the expert pointed out that it is necessary to judge whether there is room for excessive regulation on companies and research activities if the state management of pathogens, which are corporate trade secrets and property values, is strengthened. In particular, it was considered that it was necessary to review whether there is room for less invasive means to be applied and whether there is a possibility of specifying a legitimate reason for the content that allows the cancellation of the possession permit rather than an administrative fine as a sanction in the case of non-submission of pathogens of biological infectious diseases. Regarding the clause imposing the obligation to submit bioterror infectious disease pathogens of previous holders, the expert committee's office believed that there should be a policy judgment on whether the database establishment would pose an additional burden or protection of trust in the related industry. “The bioterrorism database, in which the state analyzes and builds genetic information for the submitted pathogens, is planned to be used for the purpose of preparing for and responding to bioterrorism, which requires strict security management", the director stated. As the legislative subcommittees decided to continue the review, the bill requiring the submission of botulinum strains was a chance for future legislative review.
- Policy
- Janssen's CAR-T treatment Carvykti was approved
- by Lee, Hye-Kyung Mar 21, 2023 05:57am
- The Ministry of Food and Drug Safety (Director Oh Yu-kyung) announced that it has granted CARVYKTI, a CAR-T treatment agent, a rare drug of Jansen, a rare drug. CAR-T cells are called chimera because they modify the surface receptor to better recognize and attack cancer cells. Carvykti is an anticancer drug that injects the T cell into the patient's body after putting genetic information that can recognize the B cell mature antigen (BCMA) into the patient's immune cells (T cells). B-cell maturity antigen (BCMA) is an ideal target for transplanted cell carcinoma (multiple myeloma) because it is selectively expressed during transformed cell differentiation and is not expressed in other major organs. Carvykti has previously provided new treatment opportunities for patients with recurrence or dissatisfaction with at least four treatments, including Proteaums, immunomodulatory preparations, and anti-CD38 antibodies. The MFDS scientifically reviewed and evaluated the quality, safety and effectiveness, manufacturing, and quality control criteria of the drug in accordance with the screening criteria prescribed in the Act on the Safety and Support Act of Advanced Regenerative Medical and Advanced Bio. Carvykti is a long-term tracking survey under Article 30 of the Advanced Regeneration Bio Act and must be tracked over the case of more than 15 years from the date of administration. The MFDS said, "We will do our best to ensure that the therapeutic drugs that are fully confirmed with safety and effectiveness based on regulatory science are quickly supplied."
- Policy
- Which Vemlidy IMD among the 5 will rise to the top?
- by Lee, Tak-Sun Mar 21, 2023 05:57am
- Although failing to receive reimbursement in advance, many Vemlidy IMDs are awaiting entry into the Korean market. All the drugs are incrementally modified drugs that were developed with different salt formations. According to industry sources on the 20th, 5 more companies are waiting to enter the market with Vemlidy latecomers. These companies follow the earlier entrants, such as Dong-A ST, which received reimbursement approval in January, and Chong Kun Dang and Daewoong Pharmaceuticals, which received reimbursement approvals in February. Vemlidy (tenofovir ala fenamide) is an upgraded version of Gilead Science’s previous chronic hepatitis B treatment, ‘Viread (tenofovir).’ Vemlidy has been evaluated to have improved tolerance and nephrotoxicity over Viread. Same-ingredient Vemlidy generics are unable to enter the market because the drug’s hemi-fumarate patent is set to last until August 15, 2032, However, domestic companies have succeeded in releasing drugs in the market by avoiding the patent by changing the sodium ingredient of the drug. Starting with Dong-A ST’s release of ‘Vemlia (tenofovir alafenamide citrate)’ with reimbursement, Chong Kun Dang followed in February by releasing Tenofobell-A (tenofovir alafenamide succinate) with reimbursement and Daewoong Pharmaceutical also released Vemliver (tenofovir alafenamide hemitartrate) with reimbursement. Their ingredients show that all use different salts with Vemlidy. Donga ST, Chong Kun Dang, and Daewoong Pharmaceutical each developed their own salt-modified drugs. 2 more types of salt-modified drugs are set to follow. Jeil Pharmaceutical Tecavir-D (tenofovir alafenamide) was approved in the same month as those by Chong Kun Dang and Daewoong Pharmaceutical but was not granted reimbursement. On its reason, a company official said, “reimbursement had been delayed due to disruptions in the supply of the drug’s API,” he explained. With the normalization of the supply, it is highly likely that our product will also be released with reimbursement.” Also, 4 tenofovir alafenamide hemimalte products were approved on March 15th and are set to be released with reimbursement in June. The drugs are manufactured and supplied by Samjin Pharm but will be marketed by Bukwang Pharm, which has strong marketing strengths in the hepatitis B treatment market. Also, Dongkook Pharmaceutical, Hutecs Korea Pharmaceutical, and Samil Pharm will also receive products from Samjin and enter the market with individually approved products. As of now, a total of 5 salt-modified Vemlidy IMDs have been released to the market. The fact that so many salt-modified drugs were developed and released for one product shows the interest large companies have in this market. Large companies tend to develop and sell their own products rather than receive drugs upon consignment from other companies. This is why, large pharmaceutical companies that gross large sales, such as Donga ST, Chong Kun Dang, Daewoong Pharmaceutical, and Jeil Pharmaceutical, dedicated and developed their own salt-modified drugs to preoccupy the market. On the other hand, since it is difficult for small and medium-sized companies to develop drugs independently due to development costs, Samjin is known to have addressed the problem through joint development with other companies under the 1+3 regulation set for consigned bioequivalence tests. Therefore, which salt-modified product will be leading the market is gaining attention.
- Policy
- Erleada applied for health insurance in April
- by Lee, Tak-Sun Mar 20, 2023 05:51am
- As this drug is an upgraded version of prostate cancer treatment, which is increasing every year, many patients are expected to benefit if health insurance benefits are applied. On the 16th, the HIRA foretold the reimbursement standards for anticancer drugs, which include the establishment of new reimbursements for ADT and combination therapy for Erleada's hormone-responsive metastatic prostate cancer (mHSPC) patients. The effective date is the 1st of the following month. According to the announced reimbursement criteria, Erleada is covered as first-line therapy, block therapy (ADT), and combination therapy for mHSPC patients. ADT is an androgen deprivation therapy, limited to orchiectomy, LHRH agonist + 1st generation anti-androgen, and LHRH antagonist. In addition, LHRH agonist + 1st generation anti-androgen among ADT therapy will not be recognized when administered in combination with new hormone therapy drugs. The HIRA is a drug that Erleada has approved for use in combination with ADT for the treatment of patients with hormone-responsive metastatic prostate cancer (mHSPC). As a result of reviewing with reference to textbooks, guidelines, and clinical papers, the therapy is mentioned in textbooks, and the NCCN Guide It is stated that it is recommended as category 1 in the line, [Ⅰ, A] in the ESMO guidelines, and ESMO-MCBS score 4. In phase 3 clinical trial (TITAN study) for patients with hormone-responsive metastatic prostate cancer (mHSPC), as a result of comparing the therapy with the control ADT monotherapy, median overall survival (mOS) NR vs. mPFS2 NR vs. 52.2 months, confirmed by PSA progression, etc. He explained the justification for reimbursement, saying that clinical usefulness was confirmed at 44 months. Erleada passed the HIRA in February last year and the committee in December and has been negotiating with the NHIS since January.
- Policy
- Lansoprazole+antacid combo awaits entry into market
- by Lee, Tak-Sun Mar 20, 2023 05:51am
- A new combination is awaiting entry into the Proton pump inhibitor (PPI)+ antacids combination market. This time, the new entrant is a combination of lansoprazole and precipitated calcium carbonate. Ever since Chong Kun Dang achieved outstanding results in the market, new combinations have been pouring out every year in the market. With already over 70 products in the market, whether the newly released product may settle in the market is gaining attention. According to industry sources on the 19th, the lansoprazole 30mg + precipitated calcium carbonate 600mg combination that was approved in Korea in January is expected to be listed for reimbursement in April. 6 companies including Guju Pharm, Myungmoon Pharm, Yu & Life Science, Hana Pharm, and Union Korea Pharm had received approval for related products. The drugs are being manufactured by Yu & Life Science. Four PPI ingredients are now available for use in combination with antacids - omeprazole, esomeprazole, rabeprazole, and lansoprazole. The antacids used with the PPIs are sodium hydrogen carbonate, precipitated calcium carbonate, and magnesium hydroxide. PPI+antacids are characterized by the shorter time required to take effect. The drugs combine antacids with PPI, which is weak against stomach acid, to complement the shortcoming and provide a rapid effect. Chong Kun Dang’s Eso Duo is a representative product in the market. Based on UBIST, Eso Duo recorded outpatient prescription sales of KRW 16.3 billion last year, which was a 10% YoY decrease from the previous year. This is analyzed to be due to the immense inflow of PPI+antacids in the market. 25 esomeprazole+ sodium hydrogen carbonate products are currently available in the market, and over 70 PPI+antacids are approved in the market. In this context, attention is focused on whether the latecomer lansoprazole+precipitated calcium carbonate will be able to overcome the fierce competition and settle in the market. However, in terms of price, the new entrant is expected to have competitivity over previous combination drugs due to its relatively cheaper price. The combination drug awaiting entry contains the high-strength lansoprazole (30mg, ceiling price KRW 877), and the ingredient’s price is relatively lower than the high-strength esomeprazole (40mg, ceiling price KRW 1,078), or the high-strength rabeprazole (20mg, ceiling price KRW 1,069). The price of the combination drugs is calculated based on the price of the single ingredient, the ceiling price for lansoprazole+precipitated calcium carbonate is expected to be lower than those set for other high-strength PPI combination drugs. However, whether a lower price will lead to an increase in market prescriptions remain unknown. There is also an analysis that the low price may instead become a burden on the profitability of the pharmaceutical companies.
- Policy
- Marketing authorization imminent for Obizur in Korea
- by Lee, Hye-Kyung Mar 17, 2023 05:46am
- Marketing authorization for Takeda Pharmaceuticals Korea’s ‘Obizur Inj (susoctocog alfa)’ is imminent in Korea. Obizur Inj is a treatment for bleeding episodes in adults with acquired hemophilia A. The drug has been used as a treatment for hemophilia A in Korea after receiving an orphan drug designation in July 2021. According to the industry on the 16th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Obizur. If the MFDS completed the safety and efficacy review without issues, the drug’s marketing authorization is expected to be underway soon. Hemophilia is a congenital bleeding disorder caused by a congenital deficiency of a blood clotting factor and is estimated to have an incidence of 1 per 10,000 births. Depending on the deficient blood clotting factor, hemophilia is divided into two types – hemophilia A and hemophilia B – and hemophilia A accounts for 80% of all hemophilia and hemophilia B for the other 20%. Unlike general hemophilia, acquired hemophilia A is a very rare condition caused by the development of autoantibodies directed against factor VIII, which leads to bleeding episodes like those experienced by hemophilia patients. According to domestic research, 55 patients are reported to have acquired hemophilia in Korea, and the prevalence rate is 0.2-1.48 per 1,000,000 people. Unlike congenital hemophilia, which almost always occurs in boys, acquired hemophilia mostly affects men and women over the age of 65. Orphan drugs are treatments used for diseases that affect 20,000 or fewer patients (prevalence population) in Korea, and are used for diseases for which no appropriate treatment method or drug has been developed, or drugs whose safety or efficacy have been significantly improved compared to existing alternatives.
- Policy
- Upper limit re-evaluation of drugs in the negotiation stage
- by Lee, Tak-Sun Mar 16, 2023 05:45am
- The re-evaluation of the drug cap amount according to the standard requirement has now moved to the negotiation stage with the NHIS. Pharmaceutical companies that submitted their primary drugs to the HIRA by last February will proceed with prior consultation with the NHIS in March. After that, the main negotiations will be completed and the final drug price adjustment results will be announced in July. The NHIS announced on the 15th that it will hold prior consultations with pharmaceutical companies from this month in accordance with the re-evaluation of the standard requirements for the maximum amount of drugs. Accordingly, the NHIS plans to hold a briefing on the reevaluation negotiations on the 27th. An official from the corporation said, "We recently shared matters related to negotiations on standard requirements through a meeting with pharmaceutical organizations." About 15,000 drugs will be targeted for the first round, and prior consultations will be held until May. During the preliminary consultation period, the items to be negotiated will be checked and an agreement will be sought, so it is expected that the agreement will be concluded during the main negotiations in June. Based on this, the contents of the final drug price adjustment will be announced in July after going through the review committee in June. Negotiations are underway for the second target drug. The secondary target drugs are about 5,000, and if data are submitted to the HIRA by July, negotiations will proceed with the NHIS again. Negotiations will be conducted by the NHIS Pharmaceutical Control Office's Generic Management Division. An official from the generic management department explained, "Based on our experience over the past two years, we are thoroughly preparing to complete the negotiations within the deadline." The re-evaluation of the upper limit amount is being carried out by maintaining or lowering the upper limit amount depending on whether the company's own BA test and DMF registration criteria are met. If both of the BA and DMF requirements are met, the upper limit is maintained, and if one is met, the price is reduced to 85% of the adjusted standard price, and if both are not met, the price is reduced to 72.25%.
