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- 2025-12-24 02:58:39
- Policy
- New reimbursement standards on Rinvoq and Remicade
- by Kim, Jung-Ju Nov 04, 2020 06:09am
- Starting this month, the drug reimbursement would be granted on AbbVie Korea's rheumatoid arthritis treatment Rinvoq Sustained-release Tablet (upadacitinib) 15mg. As a result, the reimbursement standards have been changed for drugs with other various substances available for a treatment switch, and the combination therapy with the drug would be included in the reimbursement standards. Janssen Korea's Remicade (infliximab) injection, an immunosuppressant drug used in adult patients with Crohn's disease, has been newly indicated to treat intestinal Behçet's disease and received expanded coverage. South Korea's Ministry of Health and Welfare's (MOHW) partially revised standards of the healthcare reimbursement (pharmaceuticals) has come in effect from Nov. 1. ◆New and revised standards on pharmaceuticals: As Rinvoq is newly listed from this month, a new reimbursement standard for upadacitinibs, including Rinvoq, was added. An additional six months of reimbursed use would be permitted, if DAS28 score is decreases by 1.2 or more after six months of the use. From then on, the score would be evaluated every six months and the continuous administration would be approved if the evaluation results from the first six months are maintained. Due to the new reimbursement standard on the injection, the standards for other substance drugs eligible for switching have been added and changed. Following are the drugs, including upadacitinib, to be applied with modified standards; Janssen Korea's rheumatoid arthritis treatment Simponi (golimumab) Prefilled Syringe Injection 50 mg, JW Pharmaceutical's Actemra (tocilizumab) Injection and Actemra Subcutaneous Injection 162 mg, Korea BMS' Orencia (abatacept) 250 mg and Orencia SubQ-Prefilled Syringe 125 mg, AbbVie Korea's Humira (adalimumab) Injection, Pfizer Pharmaceuticals Korea's Enbrel (etanercept) Injection, and Roche Korea's lymphoma treatment Mabthera (rituximab). ◆Newly listed Pencivir Cream: A new reimbursement standard was established to list a herpes simplex virus infection treatment Pencivir (penciclovir) Cream by Kolmar Korea. According to the detailed criteria of the reimbursement, the healthcare benefit would be limited to the use within the approved indication of the drug (herpes simplex virus infection (herpes labialis)). ◆Additional changes on Remicade Injection: Among all infliximab drugs, immunosuppressant Remicade Injection by Janssen Korea was able to expand indication to treat intestinal Behcet's disease. The coverage would be limited to the drugs with the indication. As orally taken upadacitinib is newly listed, the reimbursement standard for the drug would add the name of the ingredient for a prescription switch. The healthcare benefit on treating intestinal Behçet's disease is granted on patients older than 19 years of age, diagnosed with Behçet's disease, confirmed an intestinal ulcer via endoscopy, and not responsive to standard of care (SOC) (two or more drugs) or discontinued treatment due to adverse reaction. Further sustained administration would be approved when the Behcet Disease Activity Score for Intestinal Behcet's Disease (DAIBD) is decreased by over 20 points within 14 weeks after the initial administration (administered three times).
- Policy
- Hanmi’s generic for Nexavar has been approved
- by Lee, Tak-Sun Nov 04, 2020 06:08am
- Hanmi's generic for Nexavar (Sorafenib, Bayer) was first approved in the liver cancer treatment market. In addition, it acquired exclusive rights in the generic market for nine months after its launch. On the 29th, the MFDS approved Hanmi's Soranib 200mg. Soranib is generic for Nexavar. It is used for hepatocellular carcinoma, advanced renal cell carcinoma, refractory to radioactive iodine, locally recurrent or metastatic advanced differentiated thyroid cancer, which has failed previous cytokine therapy, or for which this treatment regimen is not appropriate. Nexavar is the only oral drug for the first-line treatment of liver cancer since it obtained a domestic product license in 2008. Last year, when Eisai's Lenvima (Lenvatinib) was approved as the first-line treatment for liver cancer. Last year's IQVIA sales of Nexavar was about ₩25 billion. Hanmi will participate as the only generic competitor in this market. Hanmi won Nexavar's lawsuit for invalidation of patents for formulation and use. If it was lost, it could only be released after February 22, 2026, when the patent expires. Hanmi also obtained a generic for exclusivity license, which grants exclusive rights to the generics market. Accordingly, the ban on the sale of same active ingredient drugs is for 9 months from today (October 30) to July 29 next year. Considering the time it takes to acquire drug prices, the generic for exclusivity can be extended within the range of two months, so Hanmi is expected to enjoy exclusive rights without entering other generics for nine months after the release of benefits. Currently, other generic companies such as Kwang Dong are preparing to commercialize generic for Nexavar. The success or failure of the market depends on how much Hanmi's share of the original Nexavar during the generic for exclusivity period. Although it is the only generic drug, it is expected that it will be a difficult challenge as most of the liver cancer treatments are used in large hospitals and original product (Nexavar) are mainly prescribed.
- Policy
- Daewoong's DWP16001 targets synergistic effect with Zemiglo
- by Lee, Tak-Sun Nov 03, 2020 05:58am
- Daewoong Daewoong's new SGLT-2 inhibitory diabetes drug candidate is aiming for synergy with another domestic drug. The drug, first designated for expedited review, has been approved for three phase III clinical trials. The MFDS approved a phase III clinical trial protocol for Daewoong Pharmaceutical's new diabetes drug candidate 'DWP16001 (Enavogliflozin)' on the 30th of last month. This clinical trial is a Phase III therapeutic confirmation clinical trial conducted to evaluate the efficacy and safety of DWP16001 in patients with type 2 diabetes who have insufficient blood sugar control with Metformin and Gemigliptin. The clinical trial hospital is Bucheon ST. Mary’s Hospital. It is already the third phase III approval. In September, it received approval for Phase III clinical trials for both monotherapy and combination therapy with Metformin. In addition, validation of the combination therapy with Metformin-Gemigliptin is in progress. Gemigliptin is the active ingredient for Zemiglo, a new DPP-4 inhibitory diabetes drug developed by LG Chem. Daewoong has been selling Zemiglo since 2016. It also recently agreed to extend the joint sales until 2030. As Daewoong started selling the single drug Zemiglo and the combination drug Zemimet, last year, it achieved sales of ₩100 billion for the first among Korean new drugs. It is very interesting that Daewoong's SGLT-2 drug combination therapy selected a new domestic drug among DPP-4 drugs. In the case of the SGLT-2 series drugs mentioned above, most of the combined DPP-4 drugs are imported new drugs. Januvia (sitagliptin) and Onglyza (Saxagliptin) for Forxiga, Januvia (sitagliptin) for Suglat, Trajenta (linagliptin) for Jardiance and Januvia (sitagliptin) for Steglatro was validated through combination therapy. In addition, if Daewoong sells Zemiglo for the next 10 years and a new drug SGLT-2 is released in the middle, the combination therapy is expected to produce synergies in terms of profitability. The medical community argues that even if the SGLT-2 drug is administered in combination therapy clinical trials with one DPP-4 drug, the benefit should be made even if it is used in combination with another DPP-4 drug. Daewoong's Enavogliflozin is expected to be used in combination with other DPP-4 drugs even if it is used in combination clinical trials with Gemigliptin. Enavogliflozin is a drug that was selected for the first rapid review by the MFDS. It has been operating an expedited screening system based on corporate application since September. For drugs designated for expedited review, the approval review period is shortened by about 30 days (120 days → 90 days), and advance consultation is possible, so the supplementation rate is also lower. The MFDS said that Daewoong was designated as an innovative pharmaceutical company and that Enavogliflozin was designated as a subject for rapid review because it was a Korean drug.
- Policy
- Merck green lit to test novel COVID-19 antiviral in Korea
- by Lee, Tak-Sun Nov 03, 2020 05:58am
- A novel COVID-19 antiviral candidate, currently in development by a U.S.-based pharmaceutical company Merck, is to conduct a clinical trial in South Korea. Previously, Bloomberg covered the novel candidate as a ‘potential game-changer in the COVID-19 therapeutic scene. On Oct. 29, the Ministry of Food and Drug Safety (MFDS) has approved of a Phase 2/3 trial on Merck’s novel COVID-19 treatment candidate 'MK-4482.' The trial would test efficacy, safety and pharmacokinetics of MK-4482 in 60 adult patients in South Korea confirmed positive with COVID-19. The multinational company is enrolling total 1,300 patients around the world to test the novel antiviral candidate. The primary outcome measures are the time-to-sustained recovery, adverse event and adverse event to halt the test. The secondary outcome measures are all-cause mortality, pulmonary score on a scale, the U.K. National Early Warning Score on a scale and the World Health Organization (WHO) 11-point outcome score on a scale. MK-4482 is an antiviral candidate developed to treat patients with influenza. First discovered by the researchers at Emory University in the U.S., the candidate medicine is under development with a partner company Ridgeback Biotherapeutics. The treatment in tablet form, taken orally unlike remdesivir, has been under the public’s spotlight with an anticipation to significantly improve administration convenience, when its efficacy is confirmed.
- Policy
- 1 out of 4 claims for unltra priced Spinraza were approved
- by Lee, Hye-Kyung Nov 03, 2020 05:58am
- Only one out of four applications for pre-approval for salary medication 'Spinraza (Nusinersen)', a treatment for Spinal Muscular Atropy (SMA), was approved last month. The remaining one can be approved conditionally, and two have to be supplemented with data. A monitoring report must be submitted before administration of maintenance dose every 4 months after approval of benefits, and all 34 cases of administration monitoring were approved. The HIRA (President Kim Sun-min) unveiled cases of review by the Medical Review and Evaluation Committee in September. Spinraza is an ultra-high-priced new drug with upper limit price of ₩92.3 million per 5ml bottle, and medical institutions that want to take it must apply for prior approval. According to the details of the standards and methods for applying medical care benefits, in the case of Spinraza, a patient with 5q spinal muscular dystrophy, who was genetically diagnosed with a 5q SMN-1 gene defect or mutation, developed SMA-related clinical symptoms and signs at the age of 3 years or younger, and should not be using a permanent ventilator in order to receive benefits. Soliris (Eculizumab), which was the subject of pre-approval application prior to Spinraza, was approved in only one out of five applications for pre-approval. Last month, there were no reports of paroxysmal nocturnal hemoglobinuria (PNH), and only one out of five new applications for Soliris benefits for atypical hemolytic uremic syndrome (aHUS) were approved. Medical institutions which have received pre-approval of Spinraza and Soliris must administer it within 60 days from the date of notification of the review result, and reapply if they intend to administer it after 60 days. On the other hand, detailed deliberations deliberated by the Medical Review Evaluation Committee in September can be found on the HIRA’s website.
- Policy
- Hyundai is preparing for domestic approval of Mifegyne
- by Lee, Jeong-Hwan Nov 02, 2020 06:13am
- Hyundai Pharm, which maintains the No. 1 market share in the emergency (post) contraceptives market, is preparing for the domestic market approval of the artificial abortion drug Mifegyne. Mifegyne was ruled by the Constitutional Court for an abortion inconsistency in April last year, and the need to legalize domestic use and interest in domestic pharmaceutical companies also increased significantly. On the 1st, it was confirmed that Hyundai Pharm had inquired in advance with the MFDS about the requirements for submitting data on safety and efficacy in order to apply for Mifgene for artificial saving during pregnancy. So far, no pharmaceutical company has applied for approval or consulted in advance for spontaneous abortion-inducing drugs. Hyundai Pharm’s Mifegyne is the only drug that has inquired in advance on the data submission requirements. The MFDS believes that it is possible to apply for Mifegyne's product permission in the future based on the fact that the revision of the Criminal Law, the Maternal and Child Health Law, and the Pharmaceutical Affairs Law were announced. Under the current law, artificial abortion is possible only by surgery. After the constitutional abortion crime was determined to be inconsistent with the constitution, amendments to the related law are announced, and artificial abortion through medicines is expected to be allowed. Mifegyne is a prescription drug approved in 1998 by the French pharmaceutical company Exelgyn. Mifegyne (Mifepristone) induces abortion by blocking the progesterone receptor. Approved in France in 1998, the prescription drug was developed by Russel Uclaf SA, one of Sanofi's predecessors. Currently, All rights reserved outside the United States by Exelgyn. If Hyundai Pharm acquires the copyright of Mifegyne and succeeds in licensing, it becomes the first pharmaceutical company to market artificial abortion drugs in Korea. In addition, Hyundai Pharm is expected to enjoy the effect of further strengthening its obstetrics and gynecology pipeline. Hyundai Pharm currently holds the No. 1 market share in the domestic emergency contraceptives market with Ellaone and Norebwon. A company official briefly replied that it is difficult to respond to the related details as there is currently no specific knowledge of the plan to introduce Mifegyne in Korea.
- Policy
- Special agreement for re-evaluation of α-GPC is urgent
- by Lee, Jeong-Hwan Nov 02, 2020 06:12am
- Nam In-soon a member of Democratic Party of Korea Nam In-soon, a member of Democratic Party of Korea, stressed that there is a need for a 'special contract to return the reimbursement price' between the NHIS and pharmaceutical companis that applied for the clinical re-evaluation of Choline alfoscerate. In clinical reevaluation, a pharmaceutical company that failed to prove the usefulness of Choline alfoscerate for indications other than dementia should sign a special contract to return the entire reimbursement price paid during the reevaluation period to prevent unfair pharmaceutical companies from applying for reevaluation for the purpose of deleting the indication or avoiding damage. She raised the need for a special contract for returning Choline alfoscerate reimbursement, and furthermore, the Health Insurance Act, which reimburses pharmaceutical companies unfair benefits according to the results of winning or losing administrative litigations such as drug price cuts and positive list system, or compensating for damages to pharmaceutical companies caused by the government's incorrect disposition. The revised bill is also planned. On the 28th, she said that the deadline for submitting the application for clinical reevaluation of Choline alfoscerate is less than two months, so it is urgent to issue an executive order for the special contract to return the reimbursement of the MOHW. The MFDS announced December 23 as the deadline for submission of clinical reevaluation plan for Choline alfoscerate. Accordingly, 134 pharmaceutical companies with Choline alfoscerate are preparing to submit re-evaluation plans for 255 items. She believes that prior to reevaluation, Pharmaceuticals with Choline Alfoscerate and the NHIS should sign a special agreement to return all reimbursement prices paid by the pharmaceutical company within the reevaluation period in case of clinical failure, so that pharmaceutical companies which apply for reevaluation will be able to delay the duration of indication maintenance. In particular, she pointed out that it would be difficult to prevent unnecessary damage of health insurance finances because there is no basis for returning the reimbursement price of Choline alfoscerate sold by pharmaceutical companies during the clinical reevaluation period, which takes more than 3 years if the drug efficacy fails to prove unless a special contract is signed. In addition, for a special agreement between Choline alfoscerate pharmaceutical company and the HIRA, the procedure for issuing an administrative order is required by the MOHW, but it is not enough time because the administrative order procedure must be followed before the deadline for the application for reevaluation. Beyond clinical re-evaluation of Choline alfoscerate, she was also contemplating a revised bill of the Health Insurance Act related to the administrative disposition of pharmaceutical reimbursement such as drug price reduction and positive list system. In this year's National Audit of the Health and Welfare Committee, as pharmaceutical companies' administrative lawsuits for cancellation of notifications and provisional disposition for suspension of execution became issues, the necessity to advance lawsuits related to the drug price of Choline alfoscerate as well as all medicines emerged. As a single example, there is no legal regulation that allows the government to return the amount of prescriptions and benefits for indications other than dementia paid during the period following the first trial, a trial on an appeal case, and a trial at the Supreme Court when the pharmaceutical companies in the Colin Alpo lawsuit finally lose. This is why there are criticisms that it is highly likely that pharmaceutical companies will abuse the lawsuit to neutralize the effect of drug price cuts or delay the effective time to pursue unfair drug prescription profits. Assuming the actions the MOHW can take if Choline alfoscerate pharmaceutical company loses under the current legal system, it is about the disposition of government loss payment notice and reimbursement claim against the unpaid pharmaceutical company. This means that the reimbursement redemption is not legalized, so separate administrative orders and additional lawsuits are carried out. In response, she plans to make an amendment to the Health Insurance Act to compensate for the unfair repayment of pharmaceutical companies' unfair benefits according to the results of a drug price reduction lawsuit between the pharmaceutical company and the government, or to compensate for the damages in sales of drugs that pharmaceutical companies unfairly suffered due to government administrative measures. In a drug price cut lawsuit, it is a two-way bill that establishes a law to recover unfair benefits incurred during the lawsuit if a pharmaceutical company loses, and calculates and compensates the damage caused by the disposition by the government, such as drug price cuts. She plans to collect opinions from the MOHW, the MFDS, the NHIS, and the HIRA, as well as domestic and foreign pharmaceutical companies, civic groups, and related academic societies. Since the impact on the government administration and pharmaceutical industry is great, the goal is to collect opinions from various fields and reflect them in the legislation. She said the immediate urgent thing is that the MOHW issues an executive order to sign reimbursement return contract between the pharmaceutical company and the NHIS before the MFDS conducts clinical reevaluation of Choline alfoscerate. She also explained that the contract could eliminate the cases of pharmaceutical companies applying for unfair re-evaluation and prevent possible financial damage to health insurance during the re-evaluation period. In addition, she said that she plans to promote legislation to supplement and improve problems arising from administrative disposition lawsuits related to drug prices, including lawsuits for canceling Choline alfoscerate’s positive list system and temporary disposition for suspension of execution. In addition, she emphasized that the major framework of the current legislation is to redeem the treasury for unfair benefits when a pharmaceutical company loses and to compensate for unnecessary sales damage suffered by pharmaceutical companies when the government loses.
- Policy
- Vildagliptin generic preferential sales date may get delayed
- by Lee, Tak-Sun Oct 30, 2020 05:55am
- A diabetic treatment ‘Galvus’ by Novartis The preferential sales rights Ahn-gook Pharmaceutical has earned for the Galvus (vildagliptin) generic could be cut as a higher court trial has overturned the patent litigation decision. Accordingly, the South Korea’s Ministry of Food and Drug Safety (MFDS) is internally reviewing the matter. On Oct. 29, the Patent Court has partially ruled in favor of Novartis that filed litigation against Ahn-gook Pharmaceutical and Hanmi Pharmaceutical to cancel the decision made to nullify the extended term of Galvus substance patent term. Previously, the Intellectual Property Trial and Appeal Board stated 187 days out of 26 months and 23 days of the extended Galvus patent term would be nullified. The deducted number of days (MFDS approval review supplementary evidence submission period) delayed the patent term coming in effect due to the patentee’s liability. Hence the Board stated the extended term was unjust. Based on the Board’s decision, Ahn-gook Pharmaceutical was able to nab the preferential sales rights over the Galvus generic ‘Ahngook Vildagliptin tablet.’ The preferential sales rights would be effective from Aug. 30 2021 through May 29 2022, or from 187 days prior to the patent expiration (Mar. 4, 2022). Regardless, the Patent Court said otherwise and stood on the side of Novartis unlike the Board. Although the specifics were not disclosed as the full decision is not yet opened to the public, the sources report the nullified period would be significantly less than 187 days. Now that the higher court has overturned the decision, some claim the effective term of the preferential sales rights Ahn-gook Pharmaceutical won should be shortened in accordance to the Patent Court’s decision. An industry insider commented, “For a precedent of the court accepting the litigation against the extended patent term nullification, there was an interpretation that the preferential sales rights was only effective for the period deducted due to the partially nullified extended patent term. So it would make sense to deduct the number of effective days as well.” Another industry insider said, “They just need to change the effective dates of preferential sales rights stated on the indication. Nevertheless, the change in number of effective days would not impact the industry greatly, as only Ahn-gook Pharmaceutical’s subsidiary Ahngook Newpharm won the preferential sales rights, and the number of deducted days was insignificant.” However, MFDS is contemplating about the situation; so far, since the system was implemented from 2015, the number of effective preferential sales rights days has never been changed. But if the number of days is changed, the same substance sales ban period would also get affected and create an inevitable ripple effect on the follow-on drug market. A MFDS official said, “When either one of the patentee or the preferential sales right holder reports the final outcome to MFDS, the ministry would need to have an extensive internal discussion. We cannot provide any clear answer immediately.” Depending on Ahn-gook Pharmaceutical’s preferential sales rights period, the fate of other companies with the follow-on drugs would be decided as well. Hanmi Pharmaceutical, although it did not win the preferential sales rights, can release its incrementally modified drug (IMD) along with Ahn-gook Pharmacetuical as the IMD has a different salt base.
- Policy
- Roche approved to release a new drug treating lymphoma
- by Lee, Tak-Sun Oct 30, 2020 05:55am
- A new drug by Roche, Polivy injection (polatuzumab vedotin), is released to the South Korean market to treat patients with lymphoma, a type of blood cancer. The injection, used in combination with bendamustine and rituximab, is expected to be a new option for patients not responsive to the existing treatment. On Oct. 27, the Ministry of Food and Drug Safety (MFDS) green lit Roche Korea’s Polivy injection for the Korean market. The injection, in combination with bendamustine and rituximab, is indicated to treat adult patients, who are not suitable to take a hematopoietic stem cell transplant, but have relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after at least two prior therapies. Eisai’s Symbenda injection is the original bendamustine, and Roche’s Mabthera injection is the original rituximab. Both injections are prevalently used as first-line treatments in patients with DLBCL. Apparently, however, 30 percent of the patients who have used the drugs did not demonstrate satisfying response rate. Polivy injection is an antibody-drug conjugate (ADC) that targets CD79b, a surface immunoglobulin of B lymphocyte antigen receptor. Its clinical studies have confirmed the efficacy in combination with bendamustine and rituximab. The polatuzumab vedotin plus bendamustine plus rituximab combination therapy and bendamustine plus rituximab combination therapy as a reference drug, were administered to 40 patients each to observe their results for 42 months. The Polivy group showed a significantly better complete reaction (CR) of 42.5 percent than the reference drug group reaching 15 percent. The new drug is highly anticipated by a group of patients who could not respond to the existing option of bendamustine plus rituximab combination therapy. Polivy injection has been approved by the U.S. Food and Drug Administration (FDS) in June last year. As the injection was approved as a biological drug that has to submit evidences in-development, MFDS plans to manage the drug with the risk management plan (RMP) even after its market launch.
- Policy
- Can the ICER value increase the range of GDP?
- by Kim, Jung-Ju Oct 30, 2020 05:55am
- The National Assembly is calling for an increase in the incremental cost effectiveness ratio (ICER), which is used as the basis for price determination, for reimbursement of expensive drugs, which is the key to strengthening the coverage of Moon Jae In Care pharmaceutical sector. This is because the price of breakthrough new drugs used for serious diseases is getting higher and higher, and it seems difficult for insurers who manage finances to diagnose as the cause of excessive spending and exceed the current maximum of ICER. The NHIS and The HIRA's recent written responses to the National Assembly's Health and Welfare Committee are summarized, and the position on this is consistent. As of 2018, Korea's health insurance coverage rate was 63.8%, the highest level since 2010. Although it appears to be in the early 60% of the figures, it is interpreted that the driving effect of'Moon Jae-in Care' is significant when considering the rapid change in population diseases, the expansion of expensive drug reimbursement, the increase in natural increase and the balloon effect. The NHIS (left) and The HIRA Severe treatments, anticancer drugs, and drugs for treating rare diseases are the key to strengthening the coverage of the drug sector. As these new drugs become more expensive, the ICER range, which determines the benefit price (insurance ceiling) of these drugs, is also required to be expanded. In fact, on the 22nd, at the general government audit of the Welfare Committee, Minister of Health and Welfare Park Neung-hoo was struggling with a question from Rep. Lee Yong-ho, who raised the need for an upward adjustment of the first-line treatment for the new lung cancer drug Tagriso. At the time, Minister Park explained, "Tagriso's drug price is not a very expensive drug, because new drugs are released every day and there are a lot of very expensive drugs. There are some super expensive drugs that cost 100 million won per administration." Kim Yong-ik, chairman of the NHIS, also said at the NHIS·the HIRA on the 20th, "The listing of new drugs is inevitable. If negotiated, the NHIS or the government, which has to set the drug price, will be in a difficult position." "If this is set up, it can be difficult for patients." Kim Sun-min, Chief of the HIRA was in the same position. He said, "The value of ISR should be effective when you inject additional costs. Recently listed anticancer drugs require as much as 1 billion won or more to extend the average one-year lifespan." also he added, "We need to consider patients with other diseases and discuss with social consensus." Accordingly, Rep. Kang Ki-yoon of the Welfare Committee made a written inquiry to the HIRA, saying that GDP applied to the ICER value should be realized. ICER is a key tool that compares the effects and costs of life extension after one year of taking drugs belonging to the comparative group when evaluating the economics of drugs for which insurance benefits are applied. Korea has dualized drug reimbursement work, and the HIRA is conducting economic evaluation and the NHIS is conducting drug price negotiations. Most of the world's advanced insurance countries that are evaluating the economic feasibility of new drug benefits use the ICER tool to evaluate and deliberate just before drug price negotiations. Usually, the country's GDP level is the reference range. It is threatening the reinforcement of guarantees as there is a growing tendency to derive a price range that is far beyond. Regarding this, the HIRA said, "There is no explicit ICER threshold for determining whether to pay benefits. GDP per capita is based on the 2013 level of 25 million won (1ICER)." We are considering it and evaluating it.” In order to overcome these difficulties and strengthen the security of new drugs, Korea has already established the ICER threshold for new drugs for treatment of severe and rare diseases in the case of new drugs for the treatment of severe and rare diseases, which is 50 million won (2ICER) in GDP. It is applying elasticity to the level. Accordingly, there is a need to further increase the ICER threshold with'Moon Jae-in Care' pursuing a breakthrough strengthening of security. However, it is difficult for the insurer. This is because Moon Jae In Care is being continuously promoted by taking steps as a long-term plan at the government level, so enormous finances are being invested, and in particular, it is self-determining that financial overspending has resulted in increased access to new drugs. The NHIS responded to a written inquiry from Rep. Nam In-soon asking for a reinforcement explanation of Moon Jae-in Care. "The area that needs to be improved" answered. It is said that the ICER threshold expansion is not realistic given the fact that an increase in the ICER threshold will lead to an increase in fiscal expenditure. The HIRA also said, "The ISR threshold adjustment can contribute to strengthening accessibility to new drugs, but it is necessary to collect sufficient social opinions as it is accompanied by additional financial requirements such as an increase in drug prices.
