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- 2026-05-13 22:00:59
- Policy
- We will continue to strengthen cooperation with the HIRA
- by Kim, Jung-Ju Nov 07, 2022 06:05am
- The HIRA (Director Kim Sun-min) announced on the 4th that Rudi Eggers, director of the World Health Organization (WHO) Integrated Health Services (IHS), visited the HIRA to discuss international cooperation measures. Under the agreement with the WHO, the HIRA has been sending screening and evaluation experts to the WHO Integrated Health Service Bureau since 2016, and in December last year, it was designated as the WHO Cooperation Center in Strategic Purchasing and has strengthened practical cooperation such as holding joint training courses. The visit came within today from the 31st of last month when Director Rudy Eggs asked Director Kim Sun-min to discuss ways to cooperate with the two organizations. Director Rudi Eggers began discussing ways to cooperate by introducing the work of the healthcare system and the HIRA. He admired the HIRA's achievements in improving medical quality and efforts to collect and utilize health and medical big data, and suggested that "the WHO and the HIRA work together to expand health security in the international community and improve medical quality." Director Kim Sun-min said, "We will continue to expand the role of the HIRA in the international community to ensure universal medical care and strengthen the sustainable healthcare purchase system."
- Policy
- No budget set to compensate increasing Paxlovid AE reports
- by Lee, Jeong-Hwan Nov 07, 2022 06:05am
- It has been found that no government budget has been set to compensate for the adverse events that may occur after receiving COVID-19 treatments granted emergency use authorizations in Korea. Therefore, a claim has been raised that a supplementary budget needs to be set to review and provide damage relief from the use of EUA drugs that did not receive official approval like Paxlovid, Lagevrio, and Evusheld when patients apply for compensation to the government. In other words, a separate budget needs to be set to compensate for adverse drug reactions from EUA drugs as Korea’s current relief system for adverse drug reactions only applied to drugs that received official marketing authorization under the Pharmaceutical Affairs Act. Senior expert member SunHee Jin of the National Assembly’s Health and Welfare Committee made such a statement in the 4th in the review report for the Ministry of Food and Drug Safety's 2023 budget plan. In March 2021, the ‘Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis’ was enacted to respond to public health crises such as COVID-19. The Act allows manufacturers and importers to supply drugs that have not been granted marketing authorization or have been reported to respond to public health crises through EUA. Based on the Act, one item last year – Paxlovid, and 2 items this year – Lagevrio Cap and Evusheld, have been granted EUA in Korea. As of September of this year, 614 cases of dysgeusia, dizziness, and high blood pressure were reported and 3 cases of adverse event damage relief applications were submitted to the government from the use of EUA drugs. However, the problem is that it is unclear whether adverse events that arise from EUA drugs can be compensated through the existing relief system. The adverse drug reaction relief program, which is supported by the Korea Institute of Drug Safety & Risk Management, provides relief from adverse events of drugs approved under the Pharmaceutical Affairs Act. Therefore, the grounds are unclear as to whether it can provide compensation for adverse reactions from EUA drugs that were approved under the Public Health Crisis Response Act. The compensation for relief provided under the Pharmaceutical Affairs Act is not financed by the state but is financed by contributions paid by drug manufacturers, marketing authorization holders, and importers. Expert member Jin Seon-hee judged that adverse events from drugs that were approved under the Public Health Crisis Response Act cannot be provided compensation for damages under the Pharmaceutical Affairs Act. Therefore, Jin pointed out that such compensations for EUA drugs including Paxlovid should be made using national finances, however, this has not been reflected in the budget. Jin said, “A partial amendment to the Public Health Crisis Response Act has been presented to provide legal grounds to compensate for adverse events from EUA drugs with national finances. Rep. Hye-Young Choi and Miae Kim submitted the bill that is under review by the Health and Welfare committee, therefore, additional budget considerations are needed.”
- Policy
- Strepto formulations negotiated at a rate of 20%
- by Lee, Tak-Sun Nov 04, 2022 05:39am
- The pharmaceutical industry has low drug prices, so if the recovery rate is more than 20%, there is no margin left Based on the results of the clinical re-evaluation of the anti-inflammatory enzyme drugs Streptokinase and Streptodornase, the NHIS and pharmaceutical companies, which have started negotiations to recover their salaries, are reportedly showing differences in their positions over the recovery rate. While the NHIS requires more than 20% of the recovery rate, pharmaceutical companies say they can never agree on more than 20%. The return rate of 20% is the rate agreed upon in the negotiation for the return of the brain function improvement drug Choline alfoscerate. According to the industry on the 3rd, the NHIS began negotiations with pharmaceutical companies until the 14th as the HIRA decided to suspend the re-evaluation of benefit adequacy for one year only for items that agreed to be recovered according to the results of clinical re-evaluation. It is said that data has already come and gone along with face-to-face negotiations. The key to negotiations is the rate of return and the period of return. However, it is known that it is not easy to reach an agreement due to significant differences in the recovery rate. The NHIS is said to have offered a higher amount as a baseline for the 20% return rate agreed with Choline alfoscerate pharmaceutical companies in 2021. However, pharmaceutical companies say they can never accept more than 20%. An industry official said, "Streptokinase and Streptodornase have nothing left from the cost if the return rate exceeds 20% because the upper limit is cheap." The upper limit of Streptokinase and Streptodornase is 58 to 70 won, which is not comparable to the 500 won Choline Alfocerate. However, the NHIS is said to be unable to lower the recovery rate as the recovery period is expected to be short as the results of the clinical re-evaluation of the drug are scheduled for next year. In fact, the clinical re-evaluation of Choline alfoscerate was launched last year, and considerable time is left until 2025. In comparison, Streptokinase and Streptodornase are likely not to have a long recovery period like Choline alfoscerate as they have been confirmed to be submitted as a result of clinical re-evaluation next year. However, the recovery period may vary depending on how the NHIS and the pharmaceutical company agree on the timing of the recovery. It is unclear whether an agreement will be reached by the end of the negotiations on the 14th because the gap between the two sides is significant in the recovery rate. If the agreement fails, the Ministry of Health and Welfare is expected to consider whether to order renegotiation or reflect it in the results of salary adequacy. For now, the Ministry of Health and Welfare plans to reflect the results of the re-evaluation of benefit adequacy in the list.
- Opinion
- [Reporter’s View] Reimb for SLGT-2i combo still in discussi
- by Eo, Yun-Ho Nov 04, 2022 05:39am
- The agenda has been in the last stages of review for 5 months. At this pace, discussions on expanding reimbursement of SGLT-2 inhibitors as combination therapy may again be passed on to the next year. The discussion on expanding reimbursement of SGLT-2 inhibitors as combination therapy has remained stagnant for a long time. After no progress being made for over 3 years, the industry saw hope in listing their fixed-dose combinations with the Health Insurance Reimbursement and Assessment Service’s diabetes expert committee agreeing on integrating and recognizing reimbursement for the combined use of DPP-4 inhibitors and SGLT-2 class drugs and three-drug combination therapies. However, the year has changed since then, and no news of reimbursing of SGLT-2 inhibitor combos, which are under formal review by HIRA, has been released until now. HIRA had announced that the agenda was "in the final stages of determining reimbursement standards" in June, but now it is November. Moreover, SGLT-2 inhibitors are now under further pressure with the imminent expiry of their post-marketing surveillance term. Most of the SGLT-2 inhibitor drugs are required to submit PMS results by 2023-2024. This means the companies have only 1 to 2 years until the deadline. For PMS, companies need to secure and register hundreds to thousands of patients in their study. However, due to the characteristic of Korea’s antidiabetic drug market, non-reimbursed drugs cannot attract and make prescriptions. Unless the reimbursement issue is resolved, it would be virtually impossible for companies to fulfill the number of patients for PMS as required by the Ministry of Food and Drug Safety. A conclusion has to be made one way or another. The academic society has found consensus and submitted its opinion statement recommending reimbursement to be expanded to combination therapy, and the MFDS had changed the labeling category for SGLT-2 inhibitors from by ingredient to ▲monotherapy or ▲combined therapy. The baton is now in HIRA’s hands, and the institution must now cross the finish line. Also, an institutional arrangement should also be made. SGLT-2 inhibitor combinations are also prescription drugs, and there is no harm in playing caution. Although the government had taken too long, such a cautious stance was also necessary. If the class effect of SGLT-2 inhibitors is to be recognized, guidelines on 'the amount of time required to obtain sufficient prescription experience or the amount of prescription' should also be soon prepared.
- Policy
- Government-Pharmaceutical Consultation on Acetaminophen
- by Lee, Jeong-Hwan Nov 04, 2022 05:39am
- Second Vice Minister Park Min-sooThe Ministry of Health and Welfare met with domestic and foreign pharmaceutical companies to cooperate to increase production and facilitate distribution of cold medicine Acetaminophen 650 mg, and actively promote necessary institutional support such as raising the price of drugs. Park Min-soo, the second vice minister of the Ministry of Health and Welfare, held a meeting with officials from six major pharmaceutical companies that produce cold medicine (acetaminophen ingredients for preparation) at 2 p.m. on the 3rd at Seoul City Tower (based in Jung-gu, Seoul). Chong Kun Dang, Korea Johnson & Johnson, Kolon Pharmaceutical, Hanmi Pharmaceutical, Bukwang Pharmaceutical, Genuonescience officials, and Jang Byung-won, vice chairman of the Korea Pharmaceutical Bio Association, attended the meeting. Second Vice Minister Park Min-soo thanked the pharmaceutical bio industry for its efforts and cooperation in producing and developing medicines, including cold medicines, in the process of responding to COVID-19. In addition, considering the recent increase in COVID-19-confirmed patients and flu patients, we listened to the current status and difficulties of cold medicine and collected opinions on the ongoing process of adjusting health insurance drug prices at the request of pharmaceutical companies. The Ministry of Health and Welfare and the pharmaceutical industry decided to cooperate to increase production and facilitate distribution in order to ensure that people do not suffer inconvenience due to a lack of cold medicine in winter. It decided to actively promote necessary institutional support such as raising drug prices for this purpose. Second Vice Minister Park Min-soo said, "The government and the pharmaceutical industry's efforts are important to prevent disruptions in the production and supply of medicines needed for people's lives and health," adding, "We will continue to listen to the opinions of the field and actively promote practical and diverse support." Meanwhile, along with Vice Minister Park, Oh Chang-hyun, director of insurance and pharmaceutical affairs, Jeong Hae-min, director of the NHIS, and Yoo Mi-young, director of the HIRA's drug management office, also attended.
- Policy
- Reimb standards set for first RET-targeted Retevmo
- by Lee, Tak-Sun Nov 04, 2022 05:39am
- Reimbursement listing for Lilly’s ‘Retevmo cap(selpercatinib),’ the first RET-targeted anticancer therapy in Korea, is gaining speed after successfully setting reimbursement standards. As the drug is eligible for expedited listing in Korea as a treatment used for life-threatening conditions, its time to reimbursement listing is expected to be further shortened. The Health Insurance Review and Assessment Service announced that it had held the 9th Cancer Disease Deliberation Committee meeting and made the decision on the 2nd. At the meeting, CDDC set new reimbursement standards for Retevmo Cap as a treatment for ‘advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy’ and ‘advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy with prior sorafenib and/or lenvatinib treatment history.’ In addition, the CDDC further set reimbursement standards for Retevmo in non-small-cell lung cancer as well. RET is a kinase that can cause cancer. When mutated or bound with other genes, RET is known to promote cancer cell proliferation. Retevmo targets this RET gene mutation. In Korea, Retevmo is the first drug in its class to receive approval and set reimbursement standards. At the last NA Audit, HIRA mentioned that the reimbursement period for Retevmo can be reduced as it is a treatment used for a life-threatening condition. HIRA and NHIS are currently working to reduce the reimbursement listing period by 30 days for the applicable drugs. The plan is to shorten the listing period by negotiating with HIRA 30 days prior to the commencement of the Drug Reimbursement Evaluation Committee (DREC) meeting. As Retevmo’s reimbursement passed CDDC review and will be deliberated by DREC soon, the company may benefit from the government’s implementation of the expedited listing measure. Meanwhile, reimbursement standards failed to be set for TS-1 Cap+Eloxatin inj combination therapy and Kyprolis Inj+Darzalex Inj+Dexamethasone combination therapy that had been deliberated with Retevmo at the CDDC meeting.
- Policy
- The self-sufficiency of national essential drugs has begun
- by Lee, Hye-Kyung Nov 04, 2022 05:38am
- The selection of 11 candidate medicines that require the development of domestic manufacturing and quality evaluation technologies has been completed. The Ministry of Food and Drug Safety recently selected a total of 11 items (5 raw materials & 6 finished products) as the first stage of development candidates after deliberation by the Product Selection Committee and is announcing the recruitment of developers through the website of research institutes such as the Korea Rare Essential Drug Center and the KPBMA. The Ministry of Food and Drug Safety has selected items that are highly dependent on imports and unstable supply and demand to the self-sufficiency of national essential drugs and is promoting the "National Essential Drug Stabilization Management Research Project" from this year to 2026. The project aims to establish a stable supply system for products that are feared to be unstable in supply and demand among the national essential drugs used in public health crises, and aims to develop raw material and finished drug production technologies for domestic production. A total of 5 billion won will be spent on development for 5 years, with more than 40% of the drugs selected and targeted for development in the first stage, and the rest of the drug technology development and comprehensive evaluation in the second stage (year 3 to 5). There are six drugs that have completed support for the stable supply of the first phase of the project, including the candidate group, Amiodarone inj., Melphalan, Stiripentol Cap, Dantrolene inj., Amiodarone HCl, and Bromcriptine. The raw material drugs are five items: Amiodarone, 2% Lidocaine, Ibuprofen, Ketoconazole, and Benserazide. According to the opinion of the advisory committee, two items of complete pharmaceutical and two items of raw material will be selected in consideration of priorities, and additional items can be selected within the scope of the first-stage project research cost. The Ministry of Food and Drug Safety said, "We will expand the recognition of multiple standards of raw materials to diversify the supply chain as well as develop technologies to localize raw materials and realize self-sufficiency." The issue of self-sufficiency in medicines was also one of the points pointed out by this year's parliamentary audit. As the national crisis caused by the global supply chain, such as the Ukraine-Russia war and the Urea solution crisis, as well as COVID-19, has become a reality, it has been pointed out that the domestic drug supply situation cannot be relieved. Of the 567 finished drugs reported to have been suspended from production, import, and supply from 2017 to June 2022, 31 were suspended due to the supply and demand of raw materials, and 17 of them were found to be national essential drugs. The self-sufficiency rate of finished drugs, which was 77.6% in 2017, gradually decreased to 60.1% in 2021.
- Company
- Recobell can be prescribed at infertility centers
- by Eo, Yun-Ho Nov 03, 2022 05:54am
- The infertility treatment Recobell is available in general hospitals. According to related industries, Ferring Pharmaceutical's Recobell passed the Drug Committee of medical institutions with infertility centers such as Sinchon Severance Hospital, Bundang Seoul National University Hospital, and Bundang Cha Hospital. Along with the expansion of insurance benefit standards in May, the benefit is also expanding. Originally, the drug, which was only administered alone, is covered by Controlled Ovarian Stimulation to mature a number of oocytes in women undergoing auxiliary reproduction such as IVF or ICSI with hMG combination therapy. The expansion of Recobell's benefit criteria was based on the MARCS study, a multi-agency, open-label, and single-cohort clinical trial, which evaluated the efficacy and safety profile of Recobell's hMG combination therapy in 110 infertile patients with IVF/ICSI. According to the Gardner classification system, 3BB or higher is defined as a qualitative good-quality blastocyst. As a result of the MARCS study, it was confirmed that Recobell increased the possibility of collecting qualitatively good vesicles in combination therapy with hMG. The average number of qualitatively good distributions available on Day 5 or Day 6 of treatment, which is the primary evaluation variable, was 4.9, and the results were significantly higher than 2.0 in the ESTHER-1 study conducted with Recobell alone therapy. The number of mature oocyte collections, a major secondary evaluation variable, was also reported to be 11.3 on average, significantly higher than the ESTHER-1 study, which showed 7.4. In particular, it was confirmed that the proportion of appropriate oocyte (8-14 oocyte) collection was higher in patients aged 35 or older than those under 35, proving that combination therapy is more effective than single administration in elderly patients with relatively low pregnancy rates. Lee Won-don, director of Maria Hospital, said, "We expect that the use of Recobell and hMG combination therapy will be possible, greatly reducing the economic burden of patients who needed more effective treatment, and leading to a more improved pregnancy success rate."
- Downsizing underway at Sanofi... conducts voluntary ERP
- by Nov 03, 2022 05:54am
- Sanofi’s Korean subsidiaries Sanofi Aventis and Sanofi Pasteur are offering early retirement programs (ERPs) for their employees. It has been 2 years since the company offered the last ERP with the spin-off of its Sanofi Consumer Healthcare (CHC) business. According to industry sources on the 3rd, Sanofi-Aventis will accept voluntary retirements from sales personnel in its GenMed business division, which excludes the Specialty Care BU. The company will be holding a townhall meeting this day to announce the ERP. The GenMed BU is in charge of prescription drugs such as those for chronic diseases such as cardiovascular and diabetes drugs. The sales personnel in the department is estimated to be around 200, and the company plans to reduce the workforce by about 10%. The compensations for voluntary ERP are currently being discussed between labor and management. A company-wide reorganization will also be carried out after the downsizing measure. The plan is to reassign elite personnel strategically around key focus products in each region rather than by the size of hospitals. Sanofi Pasteur also announced that it will be conducting voluntary ERP for all its employees. The ERP will be offered regardless of internal or sales positions. Like Sanofi Aventis, Sanofi Pasteur is also planning to reduce the total number of employees by 10% and is negotiating compensation conditions between labor and management. Sanofi had previously offered a voluntary ERP in 2020. At the time, the company had conducted the first voluntary ERP in 10 years with the spin-off of its Consumer Healthcare BU. The ERP at the time was for the Consumer Healthcare and General Medicine BU. The spin-off and the ERP had been in line with Sanofi's new strategy to reduce its over-the-counter drugs and chronic disease businesses and focus on rare diseases, cancer, and neurological diseases. This another voluntary ERP conducted in just 2 years, further reflects the company's will to reduce its General Medicine BU. Sanofi’s union is concentrating on systematizing the voluntary ERP for its transparent operation so as to ensure that it does not pressure specific personnel or departments. A union official said, "We are continuously discussing measures to prevent the company from conducting individual interviews without receiving the employee's application first and to raise the average conditions of compensation. There may be a gap between the ERP goal desired by the company and the goal of employees. This is why we need to implement a transparent voluntary retirement system to find a balance between the two.”
- Product
- Imported Tylenol is sold at half the domestic price
- by Kim JiEun Nov 03, 2022 05:54am
- Tylenol is being sold on Online and SNS, has given up selling it because they could not get it at pharmacies. It is sold illegally through overseas direct purchases and parallel imports, and there is a need for the government to strengthen its crackdown. On the 1st, an informant informed Dailypharm that drugs such as Australian Tylenol are being sold in the form of joint purchases on certain SNS accounts and online sites. "OTC such as Tylenol is sold on SNS and online, and it is questionable whether it has been officially approved for import and sale." "If online sales of imported drugs in this way are subject to reporting, measures will be needed to prevent reckless overseas purchase agencies or parallel imports," he said. The SNS account, which was informed by the informant, was selling 100 tablets of Australian Tylenol 500mg through a joint purchase method, and it was purchased by going to the site listed on the SNS account. 100 tablets of Australian Tylenol 500mg were sold for 18,900 won on the site linked to SNS. The existing price is 35,000 won, but it also states that it will be sold at a 46% discount by applying a time sale. The seller said, "I tried to buy Tylenol at the pharmacy, but it was difficult to get it because it was all sold out, and they gave me other products of a similar line," adding, "The pharmacy and convenience store couldn't get it because Tylenol was sold out, and the price was up to 3,500 won." "The pharmacy is based on 10 tablets of Tylenol and the convenience store is based on 8 tablets, and 100 tablets are from 27,000 won to 35,000 won," he added. "As it is about half the price, buy it quickly." In addition to Australian Tylenol, it has been confirmed that a number of illegal overseas direct purchase products are being sold in Korea, including OTCs such as Bepanhen and Fabron Gold A. It is strictly illegal to sell drugs online, including overseas direct purchases and parallel imports. The Ministry of Food and Drug Safety is also conducting self-monitoring on overseas direct purchases and online sales of drugs, but it continues to point out that it is insufficient. Pharmacists said the government needs to tighten crackdowns and sanctions as illegal distribution and online sales of drugs that are feared to be misused and abused continue due to the increase in overseas direct purchases. An official from the Pharmaceutical Association explained, "As overseas direct purchases are related to the Ministry of Food and Drug Safety and the Korea Customs Service, there seems to be no strong crackdown and sanctions." He stressed, "Even if individuals are allowed to purchase and take overseas drugs within a certain limit, clear sanctions are needed for the behavior of purchasing in large quantities and selling them through SNS or online through joint purchases."
