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- 2026-05-04 03:19:43
- Policy
- Will expedited listing be possible within the year?
- by Lee, Tak-Sun Nov 10, 2022 05:46am
- The implementation of the measure that allows expedited listing for serious disease treatments is expected to be deferred somewhat. Although the government started the opinion collection process with the goal of implementing the measure in November, government officials see the measure to be implemented at the end of December at the earliest. According to industry sources on the 9th, the Health Insurance Review and Assessment Service and the National Health Insurance Service made a preannouncement on the proposed amendment to regulations that reduce the listing period of drugs related to life-threatening conditions and started the opinion collection process. The amendment contains plans to reduce the reimbursement review period of treatments for life-threatening conditions by 60 days through concurrent operation of reimbursement evaluation and pricing negotiations. Under the amendment, HIRA’s drug reimbursement evaluation period is set to be reduced from 150 days to 120 days, and the NHIS’s drug pricing negotiation period from 60 days to 30 days. Severe and rare disease treatments and PE exemption drugs are eligible for the expedited listing. The NHIS and HIRA will share data during HIRA’s review process and prepare a prior consultation process so as to establish a financial sharing plan. For this, HIRA decided to amend the ‘Regulation on the standards and procedures to evaluate the eligibility of reimbursement of drugs’ and the ‘Detailed evaluation standards for drugs subject to negotiations such as new drugs, etc,’ and the NHIS to revise the drug pricing negotiation guideline, with the common goal of implementing the measures in November. However, it is now November and the opinion collection process is now complete, but the amended regulations have not been announced yet. The industry believes that the implementation is being delayed due to a delay in the review of HIRA's regulations, and preparations for revision of drug price negotiation guidelines on NHIS's part are complete. HIRA’s proposed amendments to its regulations are now being discussed with the MOHW after completing the opinion collection process. Some are speculating that HIRA's delay may be due to amendments being made to address the criticism that arose regarding drugs eligible for pharmacoeconomic evaluation exemptions. In the proposed amendment to the regulations that are under review, the government added a clause allowing PE exemption for ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option and demonstrates improvement in quality of life or is otherwise approved by the committee.’ The industry has been voicing opposition to the system, saying that the amendment narrows the pathway for PE exemptions rather than expanding it. The Korean Research-based Pharmaceutical Industry Association had issued a statement, pointing out that “Drugs that fall under Item 2(a) and 2(b) that have difficulty generating evidence were eligible for PE exemptions even if they were not used to treat a ‘small number of’ patients. However, the amended regulation mandates the ‘small number’ condition to be met. This will only reduce the scope of eligible subjects. This rather reduced the scope of eligibility.” The same had been raised as an issue at the NA Audit. Rep. Sun-Woo Kang of the Democratic Party of Korea pointed out that the proposed system rather reduces the scope of eligible drugs by changing the standard of 'a small number of patients' that had been an ‘OR’ clause for PE exemptions into a requirement.” However, HIRA explained through a written response that “The ‘small number of patients’ standard is not absolute and drugs are evaluated for PE exemption through committee deliberations in consideration of the severity of disease, etc.” HIRA added that the ‘drugs used by pediatric patients’ mean drugs whose main indication is applied to pediatric patients, and recommended that companies prove the ‘meaningful improvement in quality of life’ through the use of Multi-Attribute Utility Instrument (MAUI) and that the drugs will be evaluated through committee deliberations in consideration of the characteristic of each disease. As such, there is an opinion that the implementation of the system is being delayed in order to revise the relevant regulations due to constant issues raised by the pharmaceutical industry and the National Assembly. An industry official said, “As the measure needs to be concurrently applied by HIRA and NHIS, implementation of the expedited listing system will inevitably be delayed if either side is less prepared. Therefore, it seems unlikely that the amendment will be implemented in November, and most are expecting the amendment to be applied at the end of December at the earliest.”
- Policy
- We will do our best to compensate for Paxlovid side effects
- by Lee, Jeong-Hwan Nov 10, 2022 05:45am
- Director Oh Yoo-kyung (Photo = Provided by the National Assembly Professional JournalistsOh Yoo-kyung, head of the Ministry of Food and Drug Safety, said she would focus on budget and legislation to compensate for side effects and damage relief for drugs approved for emergency use for the treatment of COVID-19. Oh Yoo-kyung said she will immediately process the patient's compensation as soon as the results of the side effect review of the emergency use approved drug are released. This is an answer to the question of pending issues of Choi Hye-young, a member of the Democratic Party of Korea, at the plenary session of the National Assembly's Health and Welfare Committee on the 7th. Representative Choi Hye-young pointed out that there is no national damage compensation track for side effects that occurred after the administration of oral treatments for COVID-19 such as Paxlovid and emergency use approved drugs. In fact, the side effect damage relief system is currently in operation only for drugs that have obtained official marketing permission based on the Pharmaceutical Affairs Act. Representative Choi said, "The administration rate of oral medicine for COVID-19 tripled from February to August. As the administration rate increases, the number of abnormal cases caused by the treatment taken increases, she said. "The drug has no legal basis for compensation for damage." Representative Choi said, "There are two screening procedures for emergency approval drugs, and even if the compensation is decided, there are no financial resources," adding, "We have submitted a bill to solve this problem." She said, "Please try to pass the bill and show your initiative in explaining the need for the bill and budget at each office of lawmakers." She responded to Choi's criticism that she would speed up budget and bill work. Director Oh said, "We are currently actively trying to revise related laws quickly. We are also trying to secure the budget, she said. "The Korea Pharmaceutical Safety Management Agency is receiving counseling for victims' damage compensation so that damage compensation can be paid as soon as the budget is secured." "We will push ahead with it quickly," she said.
- Policy
- Drug prices should be raised if RWD show high effect
- by Lee, Tak-Sun Nov 09, 2022 05:47am
- Jin Yong Lee, Director of HIRA Research Institute, is answering questions at the press briefing held on the 8t Jin Yong Lee, Director of the Health Insurance Review and Assessment Research Institute, expressed his personal view that the government should raise the prices of high-priced drugs that confirm improved outcomes with real-world data (RWD). Currently, the Health Insurance Review and Assessment Service conducts performance analysis for some high-priced drugs with RWD to manage NHI reimbursement expenditures. However, the purpose of the system is mostly in retrieving the reimbursed expenditures, and there is no mechanism established to allow drug price increases for better-performing drugs. However, Director Lee strongly expressed the need for a mechanism to increase the drug price as well as one to secure mutual trust with the pharmaceutical companies. Director Lee said so at the press conference that was held at The National Health Insurance Service’s Wonju headquarters with its press corps on the 8th. Director Lee is a former professor at Seoul National University Hospital who took office in August 2020 through an open position system, and his three-year term is set to be completed in August next year. HIRA’s reimbursement management model based on RWD has also been developed after Director Lee took office. The model allows for the government to apply reimbursement to high-priced drugs such as Kymriah and Zolgensma based on RWD. Therefore, the system contains a clause that regulates the companies to refund the reimbursed amount to patients that see no treatment effect. The RWD for the system is collected through data from actual claims and those used for prior approval of the drugs. However, Director Lee explained that a drug price increase is also necessary for high-priced drugs that show a high treatment effect. Lee had made the same claim at the 2021 Innovation Research Symposium,’ which was held under the theme of ‘Measures for establishing an RWD collection system to manage drug reimbursements.’ Lee said, “I still hold the same view (as the one I made at last year’s Innovation Research Symposium). It's my personal opinion, but I think that’s a kind of 'rule' to ensure mutual trust with pharmaceutical companies." He added, “From my experience, although it is difficult for drugs to receive a price increase through reevaluations, the possibility should be left open." However, Lee reiterated that it is just his personal opinion and that there is a high possibility that his claim will be agreed upon by only a few people. HIRA Research Institute has recently confirmed the difference in treatment effect according to the age of the patient through RWD analysis. In addition, the institute is conducting cost calculations after designing a pharmacoeconomic evaluation model to confirm the appropriateness of the listed drug prices. Lee said, “Use of RWD in analyzing drug effect and pharmacoeconomic evaluations will increase to improve access to high-priced drugs and for the management of NHI finances. Therefore, it is necessary to collect and continuously accumulate analysis results of various pharmaceuticals to derive more meaningful results.” The definition of high-priced drugs and measures for their reimbursement that was reported to the Health Insurance Policy Deliberation Committee in July was also one of HIRA Research Institute’s major achievements this year. Although there is no international consensus on the definition of high-priced drugs, the Institute defined the drugs as those that require price management and long-term effect confirmation due to high prices and uncertainty in effect. Also, to manage reimbursements, the institute planned to improve access by shortening the registration period, strengthening monitoring of treatment effects and safety, and securing the sustainability of NHI finances by strengthening financial management. Drugs subject to the measure were defined as drugs that are expected to bring long-term effects after a single treatment (one-shot treatment), drugs with annual financial spending exceeding KRW 300 million per person, and drugs with annual health insurance claims that exceed KRW 30 billion. Director Lee also expressed high expectations for the new administration’s plan to support treatments for pediatric patients and severe and rare diseases.
- Policy
- Ex officio adjustment reduces prices of Faslodex and Acelex
- by Kim, Jung-Ju Nov 08, 2022 05:43am
- AstraZeneca Faslodex and Crystal Genomics Acelex will receive a 30% discount due to the government's authority adjustment. They are expected to fall 23.5% each in the second half of next year when the addition ends. Roflumilast formulations such as Sama Roflu 500μg and AstraZeneca Daxas 500μg of Korea, which has been receiving additional assets, will maintain their added value for two more years. According to the industry on the 24th, the Ministry of Health and Welfare plans to revise the "Amendment to the Drug Benefit List and the benefit limit table" and is pushing for application as of the 1st of next month. First of all, there are three items for authority adjustment. When the same product is registered, the government is ex officio adjusting the insurance drug price of products with the same administration route, ingredients, and formulations as the first registered product. In the case of synthetic drugs, if the same drug is first registered, it will be added at 53.55%, which will be added at 70% for one year, and if the additional conditions are satisfied, it will be added at 80% for one year. Looking at the items, Faslodex is 30% and Acelex is 30.1% ex officio adjusted. Here, the addition of Faslodex will end on August 1 next year and Acelex on October 1 next year, which will fall 23.5% further. Despite the additional period of more than one year, the government maintains family wealth if the number of companies with the same product is less than three. However, if pharmaceutical companies want to extend the additional period due to a stable supply of products after two years, they can adjust the additional ratio and extend the period within the two-year limit after deliberation by the Pharmaceutical Benefit Evaluation Committee every year. Looking at the items, Sama Roflu 500μg maintains a drug price addition rate of 11.1%, and Daxas 500μg maintains 30.7%. Two years later, on November 1, 2024, these drugs ended their addiction and prices fell. The reduction rate is 10% for Sama Roflu and 23.5% for Daxas.
- Policy
- It has been four years since Eucept was released
- by Lee, Hye-Kyung Nov 07, 2022 06:06am
- The permission of LG Chem's rheumatoid arthritis treatment Eucept (Etanercept) will be changed. The MFDS will prepare an order (proposal) to change the permission items based on the results of the re-examination of Eucept Prefilled Syringe and Eucept Auto Injector and inquire about opinions until the 17th. Eucept is LG Chem's first antibody-drug and was approved in Korea in March 2018 as a treatment for rheumatoid arthritis, psoriatic arthritis, axial spinal arthritis, and psoriasis. LG Chem started developing Eucept in 2010 and launched it in Japan and Korea, even before the biosimilar market was formed. Eucept was selected as a national project for the Daedeok Special Zone Strategic Industry R&D Project hosted by the Ministry of Science and ICT in 2010 and the Health and Medical Technology R&D Project hosted by the MOHW in 2015, and conducted a 52-week long-term clinical trial for 370 rheumatoid arthritis patients in Korea and Japan. In particular, the Auto Injector type was also released to make it more convenient for patients with rheumatoid arthritis who have difficulty with their hands due to the nature of the product that patients inject themselves. LG Chem has been approved for two products, Auto-Injector and PFS formulation, which are automatic injection methods for pen formulations. For re-examination in Korea, a post-marketing survey of 351 people has been conducted over the past four years. As a result, the expression rate of abnormal cases was reported as 35.33% (124/351 people, a total of 187 cases) regardless of the causal relationship. Significant drug adverse reactions that cannot exclude causality were 0.57% (2 patients/351 patients, 2 cases), showing bacterial pneumonia, increased eosinophils, and drug reactions accompanied by systemic symptoms. Unexpected drug abnormalities were 3.99% (14/351, 14 cases), with pus blisters, insomnia, breast inflammation, abnormal sensation in the eyes, palpitations, wet cough, liver lipoma, joint swelling, rheumatoid nodules, fever, and based on this, abnormal cases will be added in the precautions for use of the permit.
- 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.
- 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.
