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- 2025-12-22 02:42:34
- Policy
- PVA, the higher the bill, the greater the discount rate
- by Lee, Tak-Sun Mar 08, 2023 05:52am
- Lee Sang-il, executive director of NHIS, held a meeting with the Korea Special Press Association on the 7thThe NHIS plans to increase the reduction rate of the upper limit for drugs with high claims in the PVA, and lower the reduction rate or exclude drugs with low claims. This is based on research conducted last year. The results of the research service (performance evaluation and improvement plan of PVA (researcher: Bae Seung-jin, Ewha Womans University)) has not yet been disclosed, but will be disclosed at the end of this month and discussed at the Workie Group, which will be held from May. At the Korea Special Press Association meeting held on the 7th with Lee Sang-il, executive director of the NHIS, this PVA improvement plan was revealed for the first time. Director Lee said, "In order to improve the effectiveness of drug cost management, we conducted a research service last year to evaluate the performance of the PVA system and improve it." As a way to improve the system, we suggested selective management of drugs with high fiscal impact and efficient system operation.” Accordingly, a plan was devised to expand the selection criteria for usage type 'Ka' by adding 5 billion won and 10% increase conditions from the existing 30% increase condition for the selective management of drugs with high financial impact. The reference formula is differentiated by dividing it into three sections according to the size of the bill, and a plan to increase the maximum reduction rate in consideration of the coefficient of the reference formula was proposed. As a result, the plan is to increase financial efficiency by increasing the reduction rate for drugs with high claims. Currently, the maximum reduction rate is limited to 10%, but the maximum reduction rate is expected to exceed 10% for drugs with high claims through improvement measures. Conversely, a plan was proposed to further include drugs with low claims, which have a small reduction rate and are excluded from negotiations. For efficient operation of the system, the exclusion criteria will be raised from 2 billion to 3 to 5 billion, and a temporary refund system will be introduced. In addition, a plan to lower the maximum reduction rate for small-amount drugs was also proposed. The temporary refund system refers to a one-time refund to the NHIS by a pharmaceutical company for a price cut instead of a price cut for a drug whose usage has temporarily increased due to a pandemic or other reasons. The target and materialization plan will be discussed in the working group to be held in May, but this plan is not expected to be promoted immediately as a mid-term task. Jeong Hae-min, head of the NHIS Pharmaceutical Management Office, said, “The rest of the parts except for the temporary refund system are short-term tasks, and we plan to promote system improvement through a working group that will be held from May.” We plan to operate according to the schedule of, and based on the matters discussed through this, we will come up with an improvement plan, revise the relevant regulations in the second half of the year, and implement them from next year.” A plan to correct the number of drugs related to COVID-19 has also been outlined to some extent. The target drugs are cold medicines and antibiotics that are encouraged to be produced by the Ministry of Food and Drug Safety, and it is explained that they correspond to about 2,600 items based on the 2022 benefit list. As for the correction method, a method of correcting the usage amount was proposed, excluding the period (month) when usage increased sharply during the pandemic, and the director Lee explained that they are currently in final coordination with the pharmaceutical industry. The NHIS plans to finalize the correction plan this month when discussions with the pharmaceutical industry are completed and to apply to monitor for negotiations in April.
- Policy
- Free vaccination of Rotarix·RotaTeq is available
- by Lee, Jeong-Hwan Mar 07, 2023 05:39am
- The Korea Centers for Disease Control and Prevention (KCDC) will start a national vaccination project for Rotavirus vaccines Rotarix and RotaTeq, which are distributed in Korea, from the 6th. From this day, infants aged 2 to 6 months who are subject to vaccination will be able to receive one of the two vaccines free of charge at nationally consigned medical institutions or public health centers. Rotavirus is easily spread through the hands and mouths of infants from contaminants in diapers or toys. Infection can cause vomiting, high fever, and severe diarrhea, leading to dehydration and requiring hospitalization. Even if the 1st rotavirus vaccine was charged for 6 days before the implementation date of the national vaccination program, free vaccination is possible from the remaining 2nd or 3rd vaccination for complete vaccination. Rota vaccination requires 2 or 3 doses depending on the type of vaccine used to obtain the sufficient preventive effect. Rotarix requires a total of 2 doses and RotaTeq requires a total of 3 doses. The current status of the nearest vaccination institution can be checked on the vaccination helper website. Rotarix and RotaTeq are classified into monovalent and pentavalent depending on the number of serotypes included in the vaccine, but both vaccines showed similar efficacy and safety in terms of preventing rotavirus infection and severe disease in Korea. Since cross-inoculation is not allowed, it should be noted that after the first vaccination, all rounds must be completed only with the same manufacturer's vaccine. Director Ji Young-mi of the Agency for Disease Control and Prevention said, “The introduction of this national rotavirus vaccination will lower the cost burden for parents who needed about 200,000 to 300,000 won for vaccination,” and “the incidence of rotavirus infection, which causes acute diarrhea and high fever in infants, will also decrease. I expect that," he said.
- Policy
- ‘Improve rare disease designations standards for equity'
- by Lee, Jeong-Hwan Mar 07, 2023 05:38am
- The claim that Korea’s rare disease designation standards should be improved and expanded to ease the disease burden borne by patients from drug costs, etc. The request arose with the rising need to address the irrationalities in the current rare disease designation system, such as those from the unclear diagnostic criteria set due to the extremely small number of patients or irrational standards set for acquired (secondary) rather than congenital diseases. On the 6th, Professor Hyun-Young Kim of Pediatric Surgery at Seoul National University Hospital claimed so during her presentation at the ‘Discussions for a national measure to manage life-threatening rare diseases’ that was held at the Members' Office Building of the National Assembly. The meeting was hosted by Rep. Sun-Woo Kang of the Democratic Party of Korea. Professor Kim's presentation was about ‘Limitations in the designation of rare diseases and application of special calculations.’ The Rare Disease Management Act defines a rare disease as a ‘disease that affects fewer than 20,000 people, or whose number of carriers is unknown because diagnosis of the disease is difficult, which is determined according to the procedures and standards prescribed by Ordinance of the Ministry of Health and Welfare.’ Most treatments for diseases that are designated as rare diseases can be applied the special calculation system, which allows the patient’s coinsurance rate to be reduced to 10% of all medical expenses. Due to this, the burden of treatment and drug expense among rare disease patients whose condition has not been designated as a rare disease increases significantly and is excluded from legal support Regarding the limitations in rare disease designations, Kim pointed out that there is a gap between the definition and designation of a rare disease, and the problem of equity in designation and non-designation exists even in the same disease depending on whether the condition is congenital or acquired. Also, she raised the issue of how patients with secondary conditions that suffer the same symptoms, disease burden, and pain as the congenital condition are not allowed designation as a rare disease. Professor Kim said, “It is necessary to designate rare diseases after comprehensive consideration of the characteristic of the disease, the pain suffered by the patients, and its effect on the quality of life. The authorities should provide ample opportunity for relevant academic societies and patient groups to submit opinions and actively review the designations.” As an example, Professor Kim pointed to short bowel syndrome to point out the issues that exist in Korea’s rare disease designation system. Short bowel syndrome is not designated as a rare disease as it affects over 20,000 patients and is an infectious and transient condition with a low socioeconomic cost. Also, the fact that it is a secondary disease and has unclear diagnostic criteria and diagnosis was also a reason for its non-designation as a rare disease. In other words, patients with congenital short bowel syndrome can receive special calculation benefits for their treatment expense with a rare disease designation, but patients with acquired short bowel syndrome are deprived of the same benefit. This non-designation of rare diseases has led to the non-application of reimbursement for a short bowel syndrome treatment. In Korea, teduglutide was approved to treat short bowel syndrome in 2018. However, the drug is unavailable for use due to its non-reimbursement. Without reimbursement, the drug costs KRW 50 million with 3-6 month administration, and KRW 100 million with 1-year administration. Professor Kim stressed, “In Korea, if the doctors work hard and save the patients, the patients cannot receive the benefit as they exceed the rare diseases designations standards. The standards need to be improved to provide benefit to these rare disease patients who are left unattended in the blind spot."
- Policy
- ‘RSA may be applied to non-rare innovative new drugs'
- by Lee, Jeong-Hwan Mar 07, 2023 05:38am
- Chang-Hyun Oh, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare The Ministry of Health and Welfare announced it will improve its policy to allow innovative new drugs to be listed for reimbursement through the risk-sharing assessment (RSA) track even if they are not anticancer or rare disease treatments if they demonstrate a clinical effect. If allowed, it is expected that the scope of drugs that are applied RSA will increase, and more drugs that are not designated as rare disease may be promptly listed for reimbursement as long as they have a good effect. Chang-Hyun Oh, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare, said so at the ‘Discussions for the national measure to manage life-threatening rare diseases’ that was held at the National Assembly on the 6th. Director Oh said, “Only anticancer drugs and rare disease drugs are currently applied RSA, however, we plan to pave the way to take the innovativeness of drugs into account and apply RSA to those drugs. We are discussing how to apply RSA to drugs that clinically demonstrate an improvement in quality of life by determining the scope of recognizing innovation for drugs.” Director Oh reiterated the need to set an appropriate drug price compensation policy for innovative new drugs that the ministry had announced as an improvement task this year. Although the ministry had been flexible in applying the reimbursement listing system to life-threatening diseases until now, Director Oh said that the ministry will introduce a system that can improve patient access to drugs that were not designated as rare disease drugs in the future. Director Oh said, “We will discuss measures to allow the application of RSA to treatments that are not designated as rare diseases to allow compensation of their appropriate drug price as long as the treatments have verified their efficacy. For example, diseases such as generalized pustular psoriasis and short bowel syndrome have not been designated as rare diseases, but we will set a standard that can recognize the innovativeness of these treatments as well.” He added, “Although pharmaceutical companies would need to share a part of the burden, we will contemplate ways to open up opportunities for new reimbursement listings this year. We haven’t decided on to what extent we will be recognizing the innovativeness, but will make more efforts under the policy goal of expanding access to new drugs.”
- Policy
- Tecentriq fails urothelial carcinoma trial but beneficial
- by Lee, Hye-Kyung Mar 06, 2023 05:56am
- Although the conditional clinical trial failed for Roche’s cancer immunotherapy ‘Tecentriq,’ experts in Korea decided to recognize Tecentriq’s benefit for ‘patients with locally advanced or metastatic urothelial carcinoma who are not eligible for platinum-based chemotherapy’ and maintain the indication as it is unethical to reorder clinical trials when these patients have no other alternatives. According to the minutes of the Central Pharmaceutical Affairs Council meeting that was held on November 28th last year which was recently disclosed by the Ministry of Food and Drug Safety, the CPAC members decided to recognize the benefit of the therapeutic confirmatory clinical trial results on Tecentriq. At the time, Roche’s subsidiary Genentech had voluntarily withdrawn Tecentriq’s indication in the US for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. In the US, Roche had first acquired Tecentriq’s bladder cancer indication through the Accelerated Approval Program under the condition of conducting a confirmatory trial, then conducted a Phase III IMvigor130 trial to evaluate Tecentriq plus platinum-based chemotherapy for the first-line treatment of people with previously untreated advanced bladder cancer. However, as the designated postmarketing requirement (PMR) did not meet the primary endpoint of overall survival (OS) for Tecentriq plus chemotherapy compared with chemotherapy alone, the company had withdrawn the indication. In 2017, Tecentriq was conditionally approved for the ‘treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 tumor proportion score of at least 5%,’ under the condition that it conducts a therapeutic confirmatory trial to demonstrate superiority over chemotherapy in urothelial carcinoma. The MFDS asked the CPAC to “determine whether the indication should be maintained despite the recent results in the current situation where treatment options have not changed much for urothelial carcinoma since 2017.” To the request, one CPAC member said, “Tecentiq showed an improvement over chemotherapy in some of the efficacy endpoints such as DOR in ITT or PD-L1 positive patients. Therefore, we need to maintain the approval status to offer options to such patients.” The member's opinion was that not many options exist for patients who cannot use platinum-based chemotherapy and that it is better to maintain approval, even if it is a conditional one if the results show a similar level of effect to chemotherapy. Another member said, “Based on the trial, Tecentriq’s combined use with chemotherapy should be excluded, and the indication for patients who are not eligible for platinum-based chemotherapy should be maintained as they have no other options. Therefore, what we need to decide is whether to maintain the indication for patients that can use carboplatin.” The committee chair added the opinion that the company should reconduct the clinical trial in principle. The CPAC chair said, “In principle, the company should conduct the trial again. What matters most is the therapeutic efficacy, so we need to decide whether it is appropriate to allow Tecentriq’s use in all situations and options.” Also, an opinion that it would be better to maintain the indication for patients without options was raised, pointing to how it would not be appropriate to create a situation where the committee's conclusion deprives patients of the only option they may have. The chair concluded, “Although Tecentriq failed the confirmatory trial in urothelial carcinoma, we conclude that we acknowledge the benefits of the drug as it is unethical to order the company to reconduct a clinical trial when patients with locally advanced or metastatic urothelial carcinoma who are not eligible for platinum-based chemotherapy have no other alternatives.” Meanwhile, Roche Korea is known to be discussing whether to maintain Tecentriq’s urothelial carcinoma indication in Korea, with regards to the voluntary withdrawal of the urothelial carcinoma indication in the US.
- Policy
- Full-fledged competition in the ultra-large market
- by Lee, Tak-Sun Mar 06, 2023 05:56am
- Competition among domestic pharmaceutical companies surrounding the ultra-large market is expected to intensify from April. About 20 companies are expected to receive benefits in the late-breaking drug market for Dukarb, a high blood pressure complex drug of Boryung, which four companies first entered in March, and AstraZeneca's diabetes drug Forxiga's generics have been poured in in droves since April 7, when the patent expired. because it is highly probable. Last year's outpatient prescriptions were 46 billion won for Dukarb, 48.5 billion won for Forxiga, and 42.9 billion won for Xigduo XR, a combination of Forxiga and Metformina. According to the industry on the 1st, domestic pharmaceutical companies are warming up ahead of entering the large market in April. First, a large number of products licensed in January are expected to be listed in Dukarb's generic market. In March, four companies (Arlico, Hana, Hutecs, and Shin Poong), which were licensed in December, entered the market first. However, most companies were approved in January. Only 23 companies were licensed in January. Unlike the original amlodipine, they used S-amlodipine. Since the patent for Kanarb's active ingredient Fimasartan expired on February 1st, there are no barriers to market entry. However, there is no approved item for Kanarb's generic, which is a single agent. Regarding this, an official from a generic company explained, "I understand that they prefer Dukarb's generic, a combination drug, rather than Kanarb, considering the low price of a single drug and its status as a domestic new drug." Given that many generic companies are small and medium-sized enterprises, it is interpreted that they are establishing market strategies considering costs. Forxiga and Xigduo, which use Dapagliflozin as an active ingredient, the entry barrier has been virtually removed after the first substance patent expired on April 7 as the Supreme Court ruled that the second substance patent was invalid in early February. Regardless of the size of sales, most domestic pharmaceutical companies are expected to jump into the generic market. Only 89 companies have licensed Forxiga and Xigduo generics. However, among these, if the deadline for applying for reimbursement was missed in January, if the same ingredient as the applied combination drug is not on the reimbursement list, or if the drug is the same as generic for exclusivity, it will be difficult to enter the market on April 8. In most cases, registration is expected on May 1st, and in the case of the same drug as the generic for exclusivity item, market entry is only possible after January 7th next year when the validity of the generic for exclusivity expires. It seems that many items other than these products will be paid for at once on April 8th. It is known that a number of companies applied for reimbursement in January, and the HIRA conducted a drug price calculation last month. There is also a concern that the market will become complicated, such as illegal rebate competition, if generics are rushed at once.
- Policy
- GC Biopharma’s Livmarli approved as first ALGS Tx in KOR
- by Lee, Hye-Kyung Mar 02, 2023 05:53am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) announced that the ministry approved GC Biopharma’s ‘Livmarli (maralixibat chloride)’ on the 28th. Livmarli is an imported rare disease drug used to treat cholestatic pruritus in patients with Alagille syndrome who are 1 year of age and older. Alagille syndrome is a rare genetic disorder in which bile builds up in the liver and does not flow out due to reduced number of bile ducts inside the liver. It can also cause cardiovascular, skeletal, ocular, and dermatological complications. According to the Health Insurance Review and Assessment Service data, there were currently 136 patients diagnosed with Alagille syndrome in Korea in 2021. The newly approved Livmarli interrupts bile acid recirculation through inhibition of the apical sodium-dependent bile acid transporter, increasing fecal excretion and reducing the amount of bile acids in the body. As the first treatment available for use to treat cholestatic pruritus in patients with Alagille syndrome, the drug is expected to be of great help to patients who have previously suffered from itchy skin due to this condition. Minister Oh said, “The MFDS will continue to promptly review the safety and efficacy of rare disease drugs and seek innovation in safety to expand and ensure treatment opportunities for people with rare or intractable diseases. This effort will also contribute to realizing the government’s national goal of ‘accompanying the people to realize a happy society.’ The MFDS said it will continue to make the best effort to expand treatment opportunities to patients by promptly supplying treatments with verified safety and efficacy based on its expertise in regulatory science.
- Policy
- Negotiations on the Brukinsa price have begun
- by Lee, Tak-Sun Feb 28, 2023 05:52am
- Crysvita and Dupixent are also negotiating drug prices. It has been found that Chinese pharmaceutical company BeiGene Korea has entered into drug price negotiations with the NHIS for Brukinsa capsules 80mg sold domestically. When the NHIS drug price negotiation is completed, the drug will be covered through a report to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare. According to the industry on the 27th, The NHIS recently disclosed this fact on its website. Since April 2019, The NHIS has been disclosing the drugs ordered by the Ministry of Health and Welfare to NHIS for drug price negotiations on its website for the public's right to know. According to the Ministry of Health and Welfare's negotiation order, the drug price negotiations will be carried out within 60 days between the NHIS and pharmaceutical companies. At the HIRA held on the 9th, this drug was judged to be eligible for reimbursement for WM. WM is a rare blood cancer in which the bone marrow produces many abnormal white blood cells that crowd out healthy blood cells. Previously, the US FDA approved Brukinsa as a WM treatment in September 2021. Meanwhile, the NHIS said Crysvita 10, 20, and 30mg were also included in the drug price negotiations. This drug also passed the committee on the 9th, and the negotiation period was shortened from 60 days to 30 days after prior consultation with The NHIS as a drug to improve the quality of life for children. Crysvita is used for 'FGF23-associated hypophosphatemic rickets and osteomalacia'. The NHIS also said that drug price negotiations are underway for Dupixent, which passed the committee in January. Dupixent, which is currently receiving reimbursement for adult atopic dermatitis, is undergoing reimbursement procedures for pediatric atopic dermatitis.
- Policy
- The value of pharmaceutical bio innovation is reflected
- by Lee, Jeong-Hwan Feb 24, 2023 05:53am
- Second Vice Minister Park Min-sooSecond Vice Minister of Health and Welfare Park Min-soo promised to support the biopharmaceutical sector by implementing drug pricing policies that reflect innovative values and improving the certification system for innovative pharmaceutical companies. Vice Minister Park also asked biopharmaceutical companies to make efforts to create blockbuster new drugs and jobs through bold technology development investment and open innovation. Vice Minister Park made this announcement at the '78th KPBMA regular general meeting' held at the KPBMA on the 21st. Vice Minister Park said, “The biopharmaceutical industry is at a very important juncture in leaping into the global market by having the capacity to develop innovative new drugs and to produce and export high-quality, large-scale medicines.” “We will support our biopharmaceutical industry to grow to the level of sixth in the global market through the establishment of mid- to long-term strategies such as a roadmap for regulatory innovation in the health sector and manpower training plans,” he said. Vice Minister Park said, "We will strive to improve related systems such as drug prices and innovative pharmaceutical company certification systems to appropriately compensate for the value of corporate innovation and ensure a stable supply of essential medicines." Please create blockbuster-level new drugs and create more jobs." Afterward, Vice Minister Park presented the Minister of Health and Welfare Commendation to five people of merit and expressed gratitude for their hard work in the pharmaceutical bio industry.
- Policy
- Expansion of insurance coverage for diabetes drugs
- by Lee, Tak-Sun Feb 24, 2023 05:52am
- SGLT-2 inhibitory antidiabetic drugs (from left: Forxiga, Jardiance, Xigduo XR, Jardiance Duo)While the combination benefit between SGLT-2 diabetes treatment and other treatments is expected to be applied from April, the two-drug regimen between SGLT2 and DPP4, which was omitted from the current discussion, is also expected to be reviewed. It is expected that if the SGLT2+DDP4 complex is applied for reimbursement, it will naturally be sorted out through discussion. According to the industry on the 23rd, some SGLT2+DPP4 combinations have applied for reimbursement to the HIRA. It is known that AstraZeneca's 'Qtern', Boehringer Ingelheim's Esglito, and LG Chem's SGLT-2 inhibitory antidiabetic drugs (from left: Forxiga, Jardiance, Xigduo XR, Jardiance Duo) applied for benefits. MSD's Steglujan is also expected to apply for benefits sooner or later. These items are being promoted to be registered as a benefit in time for April when the benefit is expanded. This is because they are products developed by the original developer of original ingredients, so they can be registered as products regardless of patents. However, 82 products of Dapagliflozin + Sitagliptin approved by domestic pharmaceutical companies are scheduled to be registered after September 1, when the substance patent for Sitagliptin (Januvia) expires. While pharmaceutical companies with combination drugs welcome the news of an increase in reimbursement, attention is focused on whether reimbursement for two-drug combination therapy is also applied. The concomitant benefit drugs currently being discussed for benefit expansion are triple therapy such as metformin + SGLT-2 + DPP-4, metformin + SGLT-2 + TZD, and some SGLT-2 items + sulfonylurea or insulin combination therapy. This is because the 2+DPP-4 two-drug regimen is missing. If the benefit expansion plan is applied as planned, the two-drug combination of SGLT2 + DPP4 should be used as a three-drug regimen with Metformin. As SGLT2 or DPP4 drugs are currently used alone, the pharmaceutical industry insists that these two-drug therapies should also be covered. The HIRA believes that if the SGLT2+DPP4 complex is applied, it is highly likely that the second drug will also be reviewed. An official from The HIRA said, “If a two-drug combination drug is applied for, we will not organize traffic regarding whether or not the second drug will be covered.” There is," he explained. If the review of whether or not to pay for the second system is prolonged, it cannot be ruled out that the third system will be started first, and whether or not the second system will be covered will be discussed later. Judging from the discussion so far, the three-drug combination of metformin + SGLT2 + DPP4 is advantageous in terms of ease of administration, but there are currently no domestically approved drugs.
