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- 2026-04-11 08:01:13
- 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.
- Fenofibrate 145mg available for an empty stomach
- by Lee, Tak-Sun Nov 07, 2022 06:06am
- Attention is focusing on whether GC Pharma, which has 145mg of non-reimbursement, will be involved in selling Abbott products. Unlike conventional Fenofibrate 160mg tablets, the 145mg tablet market, which can be taken regardless of meals, is gradually heating up. This is because Abbott products are also about to be listed after Yuhan Corporation listed related products for the first time in July. In particular, Abbott is the original developer of Lipidil Supra, currently the No. 1 Fenofibrate, and attention is being paid to how Abbott's appearance will affect the market. According to the industry on the 6th, Abbott received permission for "Lipidil NT" from the Ministry of Food and Drug Safety in June and is undergoing a registration process. This product is a Fenofibrate 145mg tablet that can be taken regardless of diet. Existing identical products include Fenowell 145mg and Neofeno 145mg of Yuhan Corporation, both of which are manufactured by Yuhan. Fenowell 145mg was the only one on the list in July. Fenofibrate, which is used to treat primary hyperlipidemia, is a 160mg tablet as the main formulation. In particular, Lipidil Supra sold by GC Pharma is a blockbuster product that steadily generates more than 10 billion won every year, recording 16.5 billion won in out-patient prescriptions last year. However, 160mg tablets have the inconvenience of having to be administered orally immediately after meals due to the problem of absorption in the stomach. 145mg has the advantage of being able to be taken regardless of food intake due to fast absorption in the gastrointestinal tract through improved formulation. 145mg has been released overseas before, but there was no limited product in Korea before the registration. Abbott's Lipidil NT, which was approved this time, was licensed later than Yuhan and GC Pharma and classified as generic, but it is similar to the original product. Abbott developed and supported the 145mg tablet itself, and Lipidil Supra, the original 160mg tablet, is also Abbott's original developer. In the market, attention is being paid to the role of GC Pharma following the release of Lipidil NT. This is because Abbott's original developer, Lippidil Supra, is sold by GC Pharma in Korea. GC Pharma also co-sold Cholib, a 145mg compound of Fenofibrate & Micronized-Simvastatin, with Abbott in 2015. The calculation of drug prices is also noteworthy. The upper limit of the limited Fenowell 145mg, which was first registered in July, is 339 won. This is because generic companies are also expected to feel burdened because they are relatively cheaper than existing 160mg tablets.
- Company
- 2 new myelofibrosis drugs fail to extend coverage
- by Eo, Yun-Ho Nov 07, 2022 06:06am
- New drugs for the rare disease myelofibrosis are having difficulty expanding coverage in Korea. According to industry sources, after ‘Jakabi (ruxolitinib)’ failed to expand reimbursement in Korea in May, ‘Inrebic (pedratinib),’ the first new drug to be introduced to the field in one decade, also failed to pass the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review in June this year. At the meeting, expanding reimbursement for Jakabi as a treatment for intermediate- or high-risk patients with myelofibrosis had been discussed. However, the applicant that applied for the reimbursement extension was the Korean Society of Hematology, not its supplier Novartis. Therefore, resuming or advancing discussions on its reimbursement may be unlikely. The case was more disappointing for Inrebic as it was the first new drug to be introduced to the field since Jakabi. Discussions had been made to extend the drug’s reimbursement as a treatment for patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis, but the reimbursement standards had not been set. In the U.K., Inrebic is covered by the Cancer Drugs Fund (CDF). Although the drug’s reimbursement was rejected by the National Institute for Health and Care Excellence last year, this alternative has been prepared due to a consensus made on its need. Therefore, both the pharmaceutical company and the government needs to be willing to receive and grant reimbursement for Inrebic in Korea. Meanwhile, the once-daily oral treatment Inrebic has been for a broader indication that includes patients who have no treatment experience with Jakabi, but BMS had proposed a more limited patient population during the NICE evaluation process. As a JAK-2 inhibitor, Inrebic is receiving another level of expectations from the JAK1/2 inhibitor Jakabi. Inrebic was the first drug to obtain approval in Korea as a once-a-day oral medication that greatly reduces the burden from spleen volume and symptoms in treatment-naive patients with myelofibrosis.
- 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.
- 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.
