- LOGIN
- MemberShip
- 2025-12-24 07:46:18
- Policy
- The patient died due to the delay in Kymriah benefits
- by Lee, Jeong-Hwan Oct 06, 2021 06:06am
- Ko Eun-chan Korea leukemia patients organization launched a one-man protest, urging the first C-ART treatment Kymriah (Tisagencleucel)'s fast track. The Korea Leukemia Association held a press conference in front of the National Human Rights Commission of Korea at 10 a.m. on the 1st and announced that it submitted a petition to the National Human Rights Commission of Korea demanding Kymriah's health insurance registration and fast track for new drugs. Kymriah is the world's first chimera antigen receptor T-cell treatment that is effective in treating patients with recurrent or refractory B-cell acute lymphocytic leukemia and refractory giant B-cell lymphoma. Although patients are expected to have an effect of 82% cure rate even with one dose, the cost of one dose amounts to about 460 million won. Novartis applied for health insurance registration with the HIRA in March, but failed to pass the Cancer Drugs Benefit Application Committee. Lee Eun-young said, "Kymriah was not presented as an agenda at the 5th Cancer Drugs Benefit Appeal Committee in July and was not passed by the 6th Committee in September." She said, "If pts don't receive Kymriah treatment, they may die within three to six months." Lee Bo-yeon, the mother of Ko Eun-chan, who died in June while battling acute lymphocytic leukemia, also urged the introduction of fast track, saying that the government approved drugs to treat the disease, but they were useless due to the price of 500 million won. Mr. Lee said, "The government has not prepared a plan to allow high-priced drugs such as Kymriah and pay for them by dividing the amount or support the loan system for the use of new drugs." "This forced us to use loans from the second financial sector to raise drug prices," she said. "It's been nearly four months since my child died. "I thought health insurance would be applied soon because the effectiveness of the drug has already been proven and the number of people needed is limited, but I'm angry that the children are dying without any change," she said. "A malignant lymphocyte tumor progresses quickly. Through Kymriah's fast track, we need to make sure that there are no people in Korea who are dying because of lack of money like Eun-chan,"she said. Ahn Ki-jong, CEO of the Patient Association, said, "The Constitution prohibits the right to life and discrimination. Even though Korea is a citizen who pays taxes and health insurance premiums equally, people's lives should not be at stake depending on their economic capabilities." He then said, "After obtaining approval from the MFDS among the expensive new drugs, I only waited for health insurance registration. Eventually, this situation of death has been repeated over the past 15 years, at least patients who need new drugs directly related to life should temporarily apply health insurance at the same time as the MFDS approves to treat patients." Ahn also said, "Starting with Kymriah, we will not let any patients who cannot be treated because they do not have money at least in Korea." The patient association will hold a one-man relay protest in front of Novartis Korea's headquarters from the 1st to urge them to come up with active financial sharing measures. A national petition will be posted on Cheongwadae to convey the position of the patient association to the government and demand improvement.
- Policy
- Boryung's Dukarb Plus is about to be commercialized
- by Lee, Tak-Sun Oct 05, 2021 05:58am
- Dukarb, Tuvero, and Kanarb It was found that commercialization of the high blood pressure combination drugs including Boryung's Fimasartan is imminent. If this product is approved, a total of four products will form treatment options in the hypertension treatment lineup leading to Kanarb-Kanarb Plus-Dukarb. Through this, it is expected that the diversity of patient prescriptions can be secured. According to the industry on the 4th, Boryung recently submitted an application for permission for the tentatively named Dukarb Plus to the MFDS. Dukarb Plus is a complex in which a diuretic component, HCTZ, is bonded to Dukarb (Fimasartan-Amlodipine), a second complex. Already, Boryung has conducted phase 3 clinical trials in 250 hypertensive patients at 32 hospitals in Korea since May 2019 under the name of FAH. FAH is the first alphabet of Fimasartan, Amlodipine, and HCTZ. If Dukarb Plus is approved, it will be the seventh product containing Fimasartan since the launch of Kanarb in 2011. It is the fourth product to treat hypertension only after Kanarb (Fimasartan), Kanarb Plus (Fimasartan+HCTZ), and Dukarb (Fimasartan+Amlodipine). Patients who are not well controlled by Dukarb will be able to choose Dukarb Plus with diuretics added. Including Tuvero (Fimasartan + Rosuvastatin), Dukaro (Fimasartan + Rosuvastatin + Amlodipine), and Akarb (Fimasartan + Atorvastatin), it will be released up to the 7th drug. With Kanarb showing an annual performance of 49.2 billion won (as of UBIST 2020), combination drugs are also successfully settling in the market. Sales of Dukarb recorded 35.1 billion won last year, and Dukaro is also expected to become a blockbuster with 10 billion won this year. Dukarb Plus is expected to be released amid the imminent expiration of Kanarb patents. Material patent of Kanarb expires on February 1, 2023. Accordingly, pharmaceutical companies have started developing generics for Kanarb and Dukarb. The two drugs are so popular that many pharmaceutical companies are expected to release generics. In this situation, if complex with exclusive rights comes out, it is expected to boost the competitiveness of original products. This is because if Dukarb Plus is approved, it is likely that a six-year PMS (reexamination) will be granted.
- Policy
- Rate of reimbursement expansions is falling?
- by Lee, Hye-Kyung Oct 05, 2021 05:56am
- To the criticism that the rate of reimbursement extensions for anticancer drugs have been falling, the Health Insurance Review and Assessment Service had pointed to the increased number of high-priced drugs that are being covered with the RSA system. HIRA had explained that the increased number of drugs covered through the RSA system since 2017, such as immuno-oncology drugs and targeted drugs, have increased the need to consider the cost-effectiveness and fiscal impact of drugs that require reimbursement extensions. Ahead of the NA audit scheduled for the 15th, HIRA submitted a ‘Report on the results of the requested corrections and processes from the 2020 NA audit’ that contains the matters stated above. Last year, the NA requested the authorities to realign the reimbursement priorities due to the declining rate of NHI reimbursement extensions for anticancer drugs. On this, HIRA has convened a consultative body that consists of clinical experts, government, HIRA, NHIS, etc., to discuss measures to increase the reimbursement coverage of immuno-oncology agents. HIRA said, “We will continue our best efforts to collect opinions from various stakeholders in order to enhance coverage of anticancer drugs." Regarding the request to establish a specific standard for determining reimbursement priorities for high-priced drugs and a systematic follow-up management plan, the report explained that the body “plans to review the measures for listing high-price drugs by collecting opinions from various stakeholders and consultation with the government” The institution has been utilizing the approval-assessment linkage system, PE exemption system, and the rapid assessment of treatment for rare diseases in need of an urgent and prompt introduction to reimburse high-priced rare disease treatments, and also explained that it has been continuing efforts to enhance coverage (accessibility) for patients with rare diseases by expanding the RSA scheme.
- Policy
- Kymriah's fast track is needed
- by Kim, Jung-Ju Oct 05, 2021 05:56am
- Patient groups objected to the decision of the Cancer Drugs Benefit Appeal Committee on hold against Kymriah (Tisagenleclecel), which drew attention to insurance benefits as a cell therapy and a "one-shot treatment." This is because it is a new drug that is directly related to life for leukemia patients, and even though they have to be paid in a hurry through the fast track system, the progress is slow and causes pain. Korea Leukemia patients organization said it will submit a petition to the National Human Rights Commission of Korea on October 1. Kymriah is the world's first CAR-T treatment licensed as efficacy and effect indication for treatment of recurrent or refractory B cell acute lymphocytic leukemia patients and recurrent or refractory giant B cell lymphoma adult patients. Novartis Korea was approved by the MFDS on March 5 and applied with the HIRA on the 3rd, two days ago. However, at the 6th Cancer Drugs Benefit Appeal Committee held on September 1, the progress was blocked. At that time, members of the Cancer Drugs Benefit Appeal Committee decided to quickly re-discuss the amendments mentioned. It costs about 500 million won per dose, which is an ultra-high-priced drug. The patient group expressed regret over the slow progress, saying, "If the patients do not receive Kymriah treatment, most patients with end-stage acute lymphocytic leukemia and lymphoma can die within 3 to 6 months." In fact, the drug was previously expected to be discussed at the Cancer Drugs Benefit Application Committee in July, but the patient group's demand grew even greater because it was not even proposed and was suspended in the September discussion. What the patient organization requires is to include Kymriah in the fast track system. Insurance authorities are paying for drugs that are directly related to life by stepping on a track that can make fast tracks. Korea Leukemia patients organization plans to submit a petition to the Minister of Health and Welfare in the name of not introducing a "quick registration system for new drug health insurance directly related to life" to Korea. In addition, considering that the drug is an ultra-high-priced drug, the patient association will hold a press conference at the same time urging the preparation of active financial sharing measures for fast track.
- Policy
- Botulinum toxin by fraudulent means can be revoked
- by Lee, Jeong-Hwan Oct 01, 2021 06:08am
- Regulations on handling and management, such as reporting high-risk pathogens such as botulinum toxin and anthrax, will be strengthened, and permission for bioterrorism infectious disease pathogens licensed by fraudulent methods will be revoked. On the 28th, Baek Jong-heon (Busan Geumjeong-gu), a member of the National Assembly's Health and Welfare Committee, said that the "Partial Amendment to the Infectious Disease Prevention Act" has passed the plenary session of the National Assembly. The current law regulates those who want to install and operate high-risk pathogen handling facilities to obtain or report permission from the head of the KDCA by safety management level. If permission is obtained or reported by deception or fraudulent means, permission is revoked or the facility is ordered to be closed. In order for a person who has obtained permission to bring a high-risk pathogen into Korea to take over and move the high-risk pathogen, the movement plan must be reported in advance to the head of the KDCA. Rep. Baek Jong-heon pointed out that it is necessary to consider using facilities handling high-risk pathogens so that civilians or private businesses can diagnose and conduct academic research on infectious diseases. In particular, he pointed out the problem that there is no basis for processing high-risk pathogens when canceling permission for high-risk pathogens or ordering closure, and that there is no basis for canceling permission if they are not acquired for a long time after approval. In response, Rep. Baek proposed a bill that allows individuals and private businesses to use high-risk pathogen handling facilities for the purpose of diagnosing infectious diseases and academic research. In addition, it allows domestic entrants of high-risk pathogens to cancel if they have not taken over or reported, and also provides a basis for handling high-risk pathogens in case of cancellation or closure of handling facilities. He said, "With the passage of today's plenary session, safety management for high-risk pathogens will be further strengthened to protect the health of the people. In the future, we plan to come up with laws that can strongly punish high-risk pathogens such as botulinum toxin."
- Policy
- Domestic new drugs shouldn't be discriminated against
- by Lee, Jeong-Hwan Oct 01, 2021 06:08am
- Problems with the PVA system are expected to be discussed during this year's parliamentary audit of the National Assembly's Health and Welfare Committee. The domestic pharmaceutical community criticized that it is too harsh for the government to unilaterally decide on a drug price cut without acknowledging the innovation of new domestic drugs in the process of operating PVA. Accordingly, the National Assembly's welfare committee members agreed on this. On the 28th, the National Assembly's Health and Welfare Committee members plan to inquire about the current PVA system operation status, problems claimed by the pharmaceutical industry, and directions for improvement to government agencies such as the MOHW. Domestic pharmaceutical companies argue that a system should be introduced to exclude new domestic drugs developed by investing steady R&D costs from PVA targets or limit the number of drug cuts after negotiations. They say that PVA negotiations that do not consider structural and environmental differences between new drugs and domestic new drugs by overseas global big pharma are dampening domestic pharmaceutical companies' willingness to develop new drugs or invest in R&D. The National Assembly's welfare committee members also agree with the criticism of the pharmaceutical industry and try to raise the need to overhaul and advance the post-evaluation system for drug prices such as the PVA system. Due to the insufficient PVA system, domestic new drugs will be reversely discriminated against by global new drugs in the prescription market and inquire about the government's position. It is expected that inquiries will be made in a way that vaguely checks the problems of the system itself rather than preferential treatment of new domestic drugs over new global drugs. An official from belonging to the Welfare Committee said, "The PVA system is a post-drug price policy that realizes fiscal efficiency by improving the soundness of health insurance finances. However, some pharmaceutical companies with new domestic development drugs are complaining that the PVA system is unreasonable. "We plan to examine the operation status of the system itself and analyze whether there is a need for maintenance or improvement," he said. He added, "In this process, the government and the pharmaceutical industry will be able to improve their understanding of the PVA system," adding, "If the PVA system is insufficient as the pharmaceutical industry claims, we expect it to be improved through a parliamentary audit."
- Policy
- Pts can participate in Phase III tx for terminal cancer
- by Lee, Tak-Sun Sep 30, 2021 05:57am
- The MFDS announced on the 29th that it has revised and distributed the "Guidelines for applying rapid screening of medicines" so that even early cancer patients can participate in clinical trials, considering the difficulty of recruiting large-scale phase 3 clinical trials for terminal cancer patients. However, even in the early stages of the disease, cancer, which can confirm clinical effects and safety at the end of the disease, is allowed, and domestic and foreign screening cases will be comprehensively reviewed and strictly applied after sufficient advice from experts. The MFDS permits patients who do not have a cure or who need a new treatment due to failure to comply with the effect or rapid progression on the condition of submitting data after completion of the test. The revision was made to give flexibility to phase 3 clinical trials of conditionally licensed anticancer drugs and expand treatment opportunities for patients by reflecting the screening criteria of overseas regulators such as the U.S. FDA and the EMA. The MFDS said it expects the revision to help carry out phase 3 clinical trials of conditionally licensed anticancer drugs and have a positive effect on rapid development of anticancer drugs and expansion of treatment opportunities for terminal cancer patients. The MFDS added that it will continue to communicate with the pharmaceutical industry and actively support drug development. Details can be found on the MFDS' website (www.mfds.go.kr) > statutes/data > statute information > civil service guidelines / civil petition guides.
- Policy
- 24 new drugs receive ₩177.9 billion benefit this year
- by Kim, Jung-Ju Sep 30, 2021 05:56am
- A total of 24 new drugs were newly listed or expanded reimbursement standards by this month, improving patient accessibility. Among new drugs that were already listed, reimbursement standards for 4 products were extended, improving coverage. Although only 10,000 patients in Korea will benefiting from the extension, the result could be interpreted as a result of Korean society’s effort to flexibly expand accessibility to drugs in recognition of the social importance of each drug. The government estimates around 104,849 patients will be benefiting from the new drugs. By fiscal scale, this will roughly translate to ₩177.9 billion’s worth of coverage reinforcement every year. First, 20 new drugs were newly listed on the reimbursement list or were already listed but their reimbursement standards (indication, administration criteria) were enhanced (based on the drug’s representative strength, etc.) from January to September this year. Newly listed drugs as of the 1st this month were Somavert (acromegaly), Atctrua and Enerzair Breezhaler capsules(asthma), and Yervoy inj (renal cell carcinoma). The expected number of patients using new drugs that were listed or expanded reimbursement is also diverse. For example, the number of patients expected to be applied reimbursement was 90, however, those for ), Atctrua and Enerzair Breezhaler capsules were 13,000 and 12,000, respectively. For Yervoy, the number is expected to be around 300. The two items that are newly expanded reimbursement are the cancer immunotherapy Opdivo inj. and the breast cancer treatment Kisquali tab. Reimbursement for Opdivo will be applied to 490 new patients, increasing finances invested by ₩14.5 billion, and for Kisquali, ₩5.1 billion will be invested to benefit 270 new patients. Such a large difference in the expected number of patients is interpreted as the result of the government’s policy to flexibly expand coverage for high-priced drugs that are used for a small number of rare diseases, and social maturity that can accommodate such policies. For the new listings and expanded reimbursement standards, the government and payer will spend around ₩177.9 billion annually to provide access to new drugs to around 104,849 patients.
- Policy
- Will a treatment for resistant hypertension be released?
- by Lee, Tak-Sun Sep 29, 2021 05:54am
- Attention is focused on whether a treatment for resistant hypertension that cannot be controlled with existing drugs, that is in the final stages of its clinical trial, will succeed in commercialization. The drug is firibastat, that is developed by Quantum Genomics. Dong Wha Pharmaceuticals owns exclusive commercialization rights to supply the drug in Korea. The Ministry of Food and Drug Safety approved the multinational Phase III trial for firibastat on the 24th. The clinical trial will verify the efficacy and long-term safety of once-daily oral administration of firibastat for a maximum of 48 weeks in difficult-to-treat resistant hypertension patients. A total of 750 patients will participate in the clinical trial, among which 75 are from Korea. The clinical trial will be conducted in 12 large hospitals in Korea including the Seoul National University Hospital. Resistant hypertension is high blood pressure that is not well controlled even with the use of three or more blood pressure medications. It accounts for 10% to 20% of all hypertension patients Such patients usually also have other accompanying diseases and take over 4 types of hypertension drugs or are considered for surgical options such as renal denervation. Firibastat is a promising new treatment option for resistant hypertension. It is a Brain Aminopeptidase A inhibitor (BAPA) that blocks the generation of angiotensin III in the brain’s RAS (Renin Angiotensin System) to bring a triple action of lowering blood pressure, diuretic effect, and heart rate control. In the clinical trial, the drug’s efficacy will be verified through the systolic blood pressure after 12 weeks of treatment. It seems that the company will immediately apply for marketing authorization if the drug’s efficacy is verified in the Phase III trial, In April, Dong Wha Pharmaceuticals has signed an exclusive license to supply firibastat in Korea with Quantum Genomics in France. Under the agreement, Dong Wha Pharmaceuticals owns an exclusive license to develop and sell the drug in Korea. Dong Wha Pharmaceuticals sees the commercialization of firibastat as an opportunity to rise to a new leader in the 1.4 trillion won hypertension market. The drug is currently under global Phase II trial in patients with heart failure.
- Policy
- DUR check for more than 28 days of Zolpidem combined Rx
- by Lee, Hye-Kyung Sep 29, 2021 05:54am
- In the future, 49 drug ingredients, such as "Zolpidem," that should be careful during the administration period, will also be checked for drugs that exceed the maximum administration period by adding up the number of prescription days. The HIRA announced that it will apply "improvement of DUR inspection standards" to 345 items (213 reimubrsed drugs and 132 non reimbursed drugs) of 49 medicines that need to be careful of the administration period from November. Currently, DUR inspections on drugs that are subject to the period of administration are conducted only on drugs that exceed the maximum administration period per Rx. If 20 days' worth of Zolpidem-based drug A and 20 days' worth of B-based drug are prescribed in one prescription, the maximum administration period of 28 days. However, if a patient visits two medical institutions and receives 20 days' worth of prescriptions for Zolpidem-based drug at medical institution A and 20 days' worth of Zolpidem-based B drug at medical institution B, it is excluded from the DUR inspection as a separate prescription. As a result, out of the 102 million outpatient DUR information provided by the HIRA last year, 1.6 million cases, or 1.6%, were provided with medication information for the period of administration. Therefore, it was decided to check all prescriptions prescribed, induce proper use of medicines, and strengthen patient safety.
