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- 2025-12-23 09:18:19
- Policy
- The method of writing for HBP combination is improved
- by Lee, Tak-Sun Dec 10, 2021 05:51am
- The method of writing permission for HBP and dyslipidemia combinations is improved more efficiently. Previously, information on individual ingredients was simply listed, but in the future, it will be prepared based on a comprehensive evaluation of combinations. According to the pharmaceutical industry on the 6th, the MFDS prepared a plan to improve the method of writing permission for high blood pressure and dyslipidemia combination drugs and guided them through pharmaceutical organizations. According to the improvement plan, the efficacy of the high blood pressure and dyslipidemia combination will be described in consideration of the purpose of administration, clinical trial results, and primary and secondary therapy. In particular, precautions related to the treatment of individual ingredients for dyslipidemia should not be described. However, in the case of a composite containing Ezetimibe, the matters related to diet, administered drugs, and lipid tests described in the "effect" can be stated in the "Precautions for Use." The precautions for use include prohibition of administration of each main ingredient, careful administration, and general caution related to administration as a complex agent. As for the adverse reaction, the contents of the clinical trial conducted as a composite agent may be first described, and then the adverse reaction may be additionally described as a single agent. However, adverse reactions of unlicensed ingredients can be omitted. For example, in the case of the fourth composite, the adverse reactions of the second to third composite agents should not be described. As the existing permission for high blood pressure and dyslipidemia complex drugs lists information on individual components, it is difficult for the general public to recognize the product characteristics of the combination drugs, and only the attached documents are prolonged. In this improvement plan, the MFDS said, "The permission for complex drugs should provide information so that experts and patients can use the drug safely and effectively." The MFDS explained, "It should be mainly prepared based on information obtained from combination or combined administration, and information obtained when individual ingredients are administered alone can be additionally presented if appropriate." An official from the MFDS said, "There was an opinion that it was difficult to read the existing description method because it lists individual ingredients." The MFDS distributed a revision to the "Guidelines for Clinical Trial of Combination Drugs" along with this improvement plan to guide efficacy, effectiveness, and approval of primary therapy. According to the guidelines, if an unlicensed single agent is developed as a combination agent, in principle, it is possible to obtain permission only for the efficacy of the combination drug through clinical trials (therapeutic confirmation clinical trials, etc.). In order to be approved as a primary therapy, the feasibility of development as a primary therapy must first be proven in consideration of the mechanism of action of individual main components of the complex and clinically recommended treatments. In particular, it is possible when a therapeutic confirmation clinical trial is conducted on patients who need to administer complex drugs from the beginning to reach the target treatment effect, and safety and effectiveness are proven.
- Policy
- The ruling party shouted to review the Judiciary Committee
- by Lee, Jeong-Hwan Dec 09, 2021 05:58am
- Democratic Party of KoreaThe ruling party members of the Health and Welfare Committee issued a statement and strongly protested when the revision to the National Health Insurance Act, which included strict regulations on doctor licenses, and the bill to return and refund drug prices, were put on hold at the stage of the Legislation and Judiciary Committee. Members of the Democratic Party of Korea and of the Welfare Committee, urged the bill to be immediately proposed, saying that the leak of national health insurance finances is intensifying due to the brakes of the agenda of the Legislation and Judiciary Committee. On the 7th, the ruling party's welfare committee members adopted and published a statement. The ruling party's welfare committee members asked the People Power Party to withdraw its opposition to the revision of the Health Insurance Act and immediately cooperate with the Legislation and Judiciary Committee on the agenda.This is the second time that ruling party members have issued a statement after the bill on health medicine has been canceled. Earlier on February 26 this year, the ruling party's welfare committee held a press conference and issued a statement after the revision to the medical law, including the cancellation of a serious crime doctor's license, failed to be reviewed during the extraordinary National Assembly in February. In addition, the Democratic Party of Korea's welfare committee criticized the People Power Party for blocking the review of the revision to the Health Insurance Act. Democratic welfare committee members say that despite the administrative litigation of pharmaceutical companies' suspension of execution over the past five years, the People Power Party has prevented the bill from being proposed only with opposition from some pharmaceutical companies. In addition, members of the Democratic Party of Korea pointed out that the Health Insurance Act also included a bill to recover all unfair profits from illegal health insurance recipients such as illegal secretariat hospitals, and that the process was delayed due to opposition from the People Power Party. In addition, the Democratic Party of Korea's welfare committee members said, "An alternative to the Health Insurance Act passed by the ruling and opposition parties at the plenary session of the Welfare Committee was not presented on the agenda of the Legislation and Judiciary Committee on December 8th." They pointed out, "People Power Party argues that the Moon Jae In government's strengthening of health insurance coverage is at stake, but opposes legislation that leaks health insurance finances due to indiscriminate overuse of lawsuits by pharmaceutical companies." He then said, "Alternatives to the Health Insurance Act also included provisions to block illegal supply and demand by collecting all unfair profits from illegal hospitals run by the office manager." They emphasized, "It is a betrayal of interest to leave the office manager's hospital, which gnaws away insurance finances, and insist on protecting health insurance premiums while leaving the health insurance leak intact due to indiscriminate administrative litigation by pharmaceutical companies."
- Policy
- 6 cases of Ultomiris & 1 case of Spinraza were pre-approved
- by Lee, Hye-Kyung Dec 09, 2021 05:58am
- Benefits for pre-approval of six new PNH patients for Ultomiris administration were approved and four cases were rejected. There were no applications for new salary administration for Soliris, but two applications for pre-approval for new aHUS patients were not accepted. In the case of Spinraza, a treatment for Spinal Muscular Atrophy (SMA), one application for new patient benefits and two data supplementations were decided. Of the 25 monitoring reports, 23 were approved and 2 were disapproved. The HIRA conducted deliberation on six items, including Soliris and Ultomiris, and whether hospitalization fees were recognized. According to the results of the deliberation on the 2nd, Soliris decided to approve 33 PNH monitoring applications, to disapprove 2 new aHUS cases, to disapprove 1 retrial, to approve 2 monitoring cases, and to disapprove 1 case. Ultomiris has approved 6 out of 10 new patient approval applications for PNH, 4 disapproval, 3 re-deliberation, and 1 monitoring approval. Soliris is 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price per year alone is 400 million won. Ultomiris was listed at 5,598,942 won per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris and Ultomiris are ultra-high-priced new drugs, so they implement a pre-approval system to determine whether they are eligible for medical care benefits, and the agency must administer Soliris or Ultomiris within 60 days from the date of notification of the results of the deliberation. If it is intended to be administered after 60 days, it must be re-applied. In one case, data supplementation was requested, and in the other case, data supplementation was required as it was necessary to confirm whether the patient could receive spinal canal injection stably due to the long course of the disease. Spinraza is an ultra-high-priced new drug of 92.35 million won per bottle of 5ml, and medical institutions that want to take it must apply for pre-approval and submit a monitoring report every four months after approval of salary. Details of the deliberation can be found in the case of www.hira.or.kr or biz.hira.or.kr > Comprehensive Review Standards Service> Criteria> Review Standards> Public Deliberation.
- Policy
- Patients fume over non-deliberation of Kymriah·Keytruda
- by Lee, Jeong-Hwan Dec 09, 2021 05:58am
- Patients have set out to demand PBAC's prompt deliberation of the new reimbursement listing for Novartis Korea’s cancer immunotherapy Kymriah in acute lymphoblastic leukemia and diffuse large B-cell lymphoma and reimbursement expansion for MSD Korea’s non-small cell lung cancer treatment Keytruda to first-line in NSCLC. The patients expressed strong regrets after it was found that the agenda related to the reimbursement of Kymriah and Keytruda was not put up for deliberation by the Pharmaceutical Benefit Assessment Committee on the 2nd, the last meeting set for this year. On the 1st, the Korea Alliance of Patient Organizations (KAPO) said, “The non-deliberation of the agenda at the PBAC meeting reduces the will to fight the disease and threatens the lives of leukemia, lymphoma, and NSCLC patients in Korea." Novartis had applied for the reimbursement of its leukemia and lymphoma treatment, the CART-T therapy Kymriah, on March 3rd this year through the ‘approval-reimbursement review linkage system,’ and received a conditional nod from the Cancer Disease Deliberation Committee deliberation 7 months later on October 13th. Keytruda, which was listed for reimbursement as a second-line treatment, applied to extend its reimbursement to first-line monotherapy in NSCLC in September 2017 but failed 9 times. After 4 years and numerous attempts, the agenda had finally received a conditional nod at the CDDC meeting on July 14th, 2021. The life expectancy of recurrent·refractory leukemia and lymphoma patients that need treatment with Kymriah is only 3 to 6 months. In other words, patients who cannot bear the non-reimbursed 460 million won cost of the drug are dying waiting for the reimbursement listing. Also, Stage 4 NSCLC patients had borne the 70 million to 100 million won drug cost of Keytruda for the past 4 years to receive treatment or received partial support with their indemnity medical insurance or MSD's non-reimbursement drug cost support program. Others received treatments from hospitals that have been pilot operating the new DRG system or received treatment with another anticancer drug then used Keytruda as second-line with disease progression. KAPO said, “Deliberations on Kymriah and Keytruda have barely passed the CDDC on condition and are being delayed, but this is not due to the clinical efficacy of the drugs. Kymriah and Keytruda are representative drugs that are directly related to life, and there is little controversy about their therapeutic effect. It is just that the drugs’ prices are very expensive and patients so many. The concern over the increased burden on NHI finances, the drug price, and fiscal concerns are what has been delaying the listing of these drugs.” The patient organization stressed that the access to treatments that are directly related to life should not be obstructed due to administrative procedures for reimbursement listing. It said, “Patients who meet the MFDS indication can even now receive non-reimbursed treatment with Kymriah or Keytruda. The harsh reality is that the late-stage patient’s life or death, and extension of life depends on their economic ability, on whether they have the ability to pay for the high priced non-reimbursement cost for their treatments. For new drugs directly related to life such as Kymriah and Keytruda, the government should spend NHI finances to save the patients’ lives first, then decide on how to list and set their drug price through formal procedures as they are doing now.” Currently, no system in Korea allows for the priority use of NHI finances even if the new drugs are directly related to life. Therefore, KAPO demanded that the government and the National Assembly introduce a constitutionally guaranteed 'rapid NHI listing system for new drugs directly related to life'. The organization also plans to propose the introduction of this system as a presidential campaign to presidential candidates. It added, "Pharmaceutical companies develop and market new drugs to save the lives of patients. Also, the nation operates a NHI system to ensure that no citizen is left untreated due to reasons of cost if there are drugs available. To fulfill this objective, we need to quickly complete Kymriah’s reimbursement listing process that has been ongoing for 9 months and Keytruda’s first-line reimbursement that is being discussed for over 4 years.”
- Policy
- Impurity detected Cozaar is excluded from recovery
- by Lee, Tak-Sun Dec 08, 2021 06:01am
- In the case of a single drug in Losartan formulation where impurities were detected, it is interpreted that only the original drug was excluded from recovery, exposing the risk of domestic generics again. It is analyzed that the reason why the original drug was excluded from the collection list is because the raw material process is different. The MFDS announced on the 7th that it will recover 295 items (98 companies) of Losartan drugs that have been excessively detected with Azido-based impurities. The majority of the 306 (99 companies) items in circulation are included. As impurities were confirmed to be within the daily intake allowance, 11 items were excluded from the collection, 5 items from foreign pharmaceutical companies and 6 domestic pharmaceutical companies. In particular, in the case of Losartan potasium, only "Cozaar" and "Cozaar 100mg" of Organon, Korea were excluded from the recovery list. All of the remaining identical generic drugs were included in the recovery list. An official from the MFDS explained, "We estimate that this impurity was caused by unintended residue from the use of Azide during the raw material process," adding, "However, we know that the original did not use Azide." However, the official explained that there are products that are currently shipped below the standard by improving the raw material synthesis process for generic drugs. The original and generic materials are the same ingredients, but there was a difference in the synthesis process. Finished drugs were included in the collection list one after another due to consignment. There are 16 factories in Korea that produce Losartan single 5-mg finished products. These 16 places are connected by consignment and consignment structures supplied to 88 pharmaceutical companies. As a result, if a problem occurs in one finished product factory, products from various companies will also be recovered. This consignment structure has also been problematic in the Valsartan formulation, where the NDMA impurity crisis first occurred. Accordingly, the government has been implementing a policy since last year to discriminate against generic items entrusted with biological equivalence tests for consignment production when registering drug prices. In addition, from July this year, a revision to the Pharmaceutical Affairs Act was implemented to require one trustee to supply products to only three consignment companies to restrict consignment production through sharing of biological equivalence tests. As a result, it can be seen that the Losartan impurity incident also showed generic risks. However, experts say that it is dangerous to interpret that there is a difference in quality between the original and generic in that the generic raw material process was initially approved by the MFDS.
- Policy
- No recall crisis expected to arise from losartan impurities
- by Lee, Tak-Sun Dec 08, 2021 06:00am
- Although 295 antihypertensive treatments that were found with impurities were ordered recalled, due to the low risk and specificity of the targeted items, no disruption is expected from the exchange, re-prescriptions, or re-dispensing of such drugs. The Ministry of Food and Drug Safety announced on the 7th that 295 losartan items that were found to contain azido impurities that exceed the allowed daily intake of 1.5㎍/day (1.7~88.7㎍/day) will be recalled. However, the ministry emphasized that the risk of its harm to the human body is very low and that the patients should not discontinue taking the drugs. The azido impurities that were detected this time occur specifically in the losartan ingredient, and although the properties of genetic mutations have been confirmed in the ingredient carcinogenicity has not been yet identified. In particular, an assessment of its health effect on the majority of patients who took losartan that had an excess amount of impurities than the allowed daily intake showed that the added risk of cancer from the impurities was 0.54 out of 100,000, which was a very low and negligible level. An MFDS official said, “The evaluation was based on the representative value (median value) that was set with losartan drugs that had impurities exceeding the amount allowed for daily intake. We also took into account the possibility that the drugs that had a higher amount of impurities will be taken for life (70 years).” As a result, the MFDS emphasized that even if one takes losartan drugs that contain an excess amount of impurities, it has little effect on one’s health, and that patients who were prescribed the product should not arbitrarily discontinue taking the drugs. However, the exchange, re-prescriptions, or re-dispensing measures were prepared to resolve anxiety for patients with health concerns. The exchange, re-prescriptions, or re-dispensing of the drugs can be done at no out-of-pocket cost on the patient’s part. However still, the number of re-prescriptions or re-dispensing is not expected to be high. Although all lot numbers of 241 items will be fully recalled, only some lot numbers of 54 items and none from 11 items are recalled, and identifying the drugs that are subject to recall is also a complicated process. Also, some of the items for which full recalls are being conducted for all lot numbers, some are being re-released as normal items, and may only be exchanged at hospitals rather than be re-prescribed or re-dispensed at hospitals. In fact, only 4 cases of consumer exchanges arose for sartan drugs that were recalled due to excess impurities in September. Due to this, there had been some criticism that the authorities had wasted too much time on the consumer exchange process that did not have many actual cases, delaying the recall period for the harmful drugs in business.
- Policy
- Detailed screening for α -GPC begins in earnest next year
- by Moon, sung-ho Dec 07, 2021 05:57am
- Tensions are rising as the government announces the review of the revised supplementary budget bill starting next year amid deepening concerns among pharmaceutical companies over the issue of Choline Alfoscerate. According to the pharmaceutical industry and the medical community on the 1st, it has been confirmed that the MOHW has decided to strengthen the screening of prescriptions for hospitals and clinics starting next year in accordance with the clinical re-evaluation policy for Choline Alfoscerates. Over the past two years, the MOHW has set the first target of strengthening screening according to the drug clinical re-evaluation policy as the Choline Alfoscerate formulation. In fact, the Choline Alfoscerate drug is recognized as a drug in Italy, while it is sometimes used as a health functional food in other countries, so controversy over its efficacy has continued. The MFDS ordered a "clinical re-evaluation" last year to re-evaluate the Choline Alfoscerate formulation on its own, and 57 companies, including Daewoong Bio and Chong Kun Dang, have begun clinical re-evaluation. At the same time, the MOHW reduced the benefit of Choline Alfoscerate. Since August last year, patients who have not been diagnosed with dementia have raised the drug price burden rate from 30% to 80% when using Choline Alfoscerate. Then, pharmaceutical companies actively took legal action and began to defend their sales. However, unlike the pharmaceutical industry, which is preparing such a defense strategy, some say that the actual medical field has little impact on the reduction of benefits. It was expected to have a big impact as the government decided to reduce benefits, but the actual feeling at the medical field is quite low. "In fact, the HIRA is currently not cutting according to the reduced benefit policy," said a professor at University Hospital A belonging to Korean Dementia Association, who requested anonymity. "There is no big problem with maintaining similar billing guidelines," he said. In the end, the MOHW and the MFDS have strengthened their guidelines following the reduction in benefits, but they are actually prescribing them without paying much attention to them in the actual clinical field. This is why The HIRA has announced cuts through specific screening starting next year. An official from the HIRA said, "Strengthening the screening is a situation in which we have to go through the Central Review and Coordination Committee, an organization within the institution. He said, "It is not easy to apply a specific examination yet, but we will proceed quickly and strengthen the examination of prescriptions by medical institutions from next year."
- Policy
- The original patent's negotiation period will be reduced
- by Kim, Jung-Ju Dec 07, 2021 05:57am
- The period of ex officio adjustment drug price negotiations for the original drug that expires patents collectively cut drug prices will be reduced to one-third. It is aimed at improving cases of health insurance financial leaks by abusing the prescribed negotiation period as much as possible when the legal drug price cut rate is set. The MOHW announced that it held a Health Insurance Policy Deliberation Committee this afternoon (25th) and reported on the "improvement of the drug negotiation system." The government is currently negotiating all reimbursed drugs. This is in accordance with the policy to expand the negotiated drugs from the application of new drug insurance to the entire drug from October 2020 to strengthen the quality control and stable supply management of insurance drugs after detecting Valsartan impurities in 2018. For example, in the past, negotiations between the government and companies were conducted to register new drugs, adjust drug prices, and expand the scope of use. However, since the reorganization, negotiations have been underway to adjust the original drug price (100 → 70%) and re-evaluate according to the first generic insurance application. Although the negotiation system has been expanded in this way, the problem of confusion in the operation of the system has been exposed due to insufficient detailed procedural regulations. In the case of supply and quality management contracts, unnecessary overlapping negotiations were held, such as drug price adjustments, and some pharmaceutical companies delayed the negotiation deadline of 60 days to delay the timing of drug prices falling. Some also pointed out that there are no renegotiation and procedural regulations when negotiations break down. It was pointed out that the drug negotiation procedure under the narrow law was unclear about the regulations on follow-up measures, such as exclusion of benefits, in the event of a final breakdown. The improvement plan largely sets ▲ the target to be omitted when negotiating drugs, ▲ to adjust part of the negotiation period of , ▲ to prepare renegotiation procedures in the event of a breakdown of negotiations, and ▲ to clarify that benefits are excluded in the event of a final breakdown of. Specifically, the negotiations will be omitted if there is a contract between the corporation and pharmaceutical companies. In the case of ex officio adjustment negotiations due to the application of a package reduction in drug prices, it will be shortened from the current maximum of 60 days to 20 days. This is a measure designed to reasonably shorten the negotiation period in the case of original ex officio adjustment. When negotiations broke down, renegotiation procedures were also in place. In order to prevent confusion in the clinical field, the government asked to renegotiate the drug characteristics and the progress of negotiations after deliberation by the Drug Benefit Evaluation Committee. In addition, in the case of drugs whose final negotiations have broken down, grounds have been established to exclude benefits. The government has decided to push for the standard rules for medical care benefits and the individuality of notification sometime next month. Considering administrative procedures such as legislative notices, the implementation of the amendment is expected to be possible in the first half of next year.
- Policy
- KB Pharm's generic for Vildagliptin nitrate will be approved
- by Lee, Tak-Sun Dec 06, 2021 05:54am
- The post-inflammatory drugs of the diabetes treatment Galvusmet (Vildaglipin-Metformin Hydrochloride), which the Supreme Court ruled invalidating part of its extended duration, are appearing one after another. These items will be able to be released early in January next year if some of their duration is confirmed to be invalid. On the 30th of last month, three dosage products of Vildagliptin-Metformin HCl, a compound of KB Pharm, were approved. It is the seventh company to launch generic for Galvusmet. However, this is the first salt-changing drug containing Vildagliptin nitrate. Pharmaceutical companies participated in the development one after another. At first, only An-gook and Hanmi Pharm, which claimed invalidation of their duration, were developed, but when the Patent Tribunal achieved results, KOREA UNITED PHARM and KB Pharm also participated in the development. The lawsuit for invalidation of the extension of the duration ended on October 28 when the Supreme Court recognized 55 of the 1,068 extended days as invalid. If some of the invalidity of the duration is finalized, material patent of Galvusment will expire on January 9 next year. In this case, other pharmaceutical companies that have not participated in the lawsuit can also launch products on the market as their substance patents are terminated. Currently, generics for Galvusmet have been approved by Hanmi Pharm, KOREA UNITED PHARM, Ahn-gook, Ahn-gook Newpharm, Shinpoong, Samjin, and KB Pharm. However, Hanmi Pharmaceutical and KB Pharm are the only pharmaceutical companies that have been approved for three doses. The rest of the pharmaceutical companies were granted only 50/500 mg. In the case of generic for Galvusmet, there are no restrictions on selling products because there are no products that have received general for inclusion. In the case of single-drug Vildagliptin, Ahn-gook Newpharm has acquired generic for exclusivity, and the same drug will be banned from selling until May 29, 2022. Last year, Galvusmet recorded 36.4 billion won in outpatient prescriptions, continuing its popularity in the diabetes treatment market. Competition is expected to intensify when the generic market opens next year.
- Policy
- Asciminib's domestic approval is at a quick step
- by Lee, Tak-Sun Dec 06, 2021 05:53am
- Novartis' Asciminib, which is attracting attention as a fourth-generation targeted anticancer drug in the chronic leukemia treatment market, is also speeding up domestic permits. The drug, which was approved by the U.S. FDA last month, has recently been approved for four clinical plans in Korea alone, boosting the analysis that it is accelerating its entry into the Korean market. According to the MFDS on the 26th, Asciminib has been approved for four clinical plans since August. Asciminib is a TKI (tyrosine kinase inhibitor) family fourth-generation targeted anticancer, and is attracting attention in that it attacks targets different from those of the first to third generations. This is because different targets reduce interference between anticancer drugs. Chronic myelogenous leukemia treatment continued to evolve in 2001 when the world's first targeted anticancer drug, Glivec, was launched. The second generation was developed into Sprycel, Tasigna, and the third generation Iclusig. The survival rate of patients is also on the rise with the release of third-generation targeted anticancer drugs, but the rate of treatment failure due to resistance is known to increase as the treatment stage goes up. As a result, expectations for fourth-generation treatments are also growing. Asiminib is set to be officially released on October 29 as the FDA decided to approve. In Korea, the MFDS designated it as a rare drug for the "chronic Philadelphia chromosome-positive chronic myeloid leukemia" disease in May and opened the way for it to be used before official approval. If it is designated as a rare drug, it will be reviewed more quickly, so the speed of domestic approval is expected to accelerate. It is interpreted that it has considered expanding indications and bridging tests after a series of clinical approval permits. In August, a phase 3b test plan was approved to evaluate long-term safety in patients who completed the Asciminib clinical trial and judged that the tester would benefit from continued administration. In addition, in September, phase 1/2 was approved to determine the dose and safety of oral Asciminib in pediatric patients with chronic Philadelphia chromosome-positive chronic myeloid leukemia previously administered one or more tyrosine kinase inhibitors. On the 4th of this month, a phase 3b plan of oral Asciminib was approved in patients with chronic myelogenous leukemia in the chronic phase who had previously been administered two or more tyrosine kinase inhibitors. And on the 22nd, a phase 3 test of oral Asciminib versus TKI was approved in patients with newly diagnosed chronic myeloid leukemia positive for Philadelphia chromosomes. Industry sources say Asciminib is expected to speed up its approval in Korea with FDA approval, adding that approval is also possible as early as next year. The U.S. FDA has fully approved accelerated approval and chronic CML patients with T315I mutations for cases where two or more of Asciminib has been treated with Philadelphia chromosome CML patients, and it is known that the same indication is being reviewed in Korea.
