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- 2026-05-18 18:57:15
- Company
- Ipsen established a union led by MZ generation
- by Jul 05, 2021 05:54am
- A labor union led by MZ generation (1980-2000s) is also being established in the pharmaceutical industry. According to the pharmaceutical industry on the 2nd, a labor union consisting of Ipsen sales workers officially launched on the 2nd after reporting on the 29th of last month. The union leader is Choi Chang-woo (35 years old), a young employee who has been employed for three years. "It was established to improve the unreasonable and closed company policy implemented by senior managers," he explained. "Ipsen Korea is using sexual harassment, harassment at work, violations of the Labor Standards Act, power abuse, and disadvantages to certain employees," the union said in a statement. "We are creating working conditions and corporate culture that are inconsistent with Ipsen Global." The labor union set the goal of ▲ establishing labor's three primary rights ▲ democratization of corporate management and establishing fairness and transparency in performance distribution ▲ improving working conditions equivalent to multinational pharmaceutical companies. "The top priority is to normalize Ipsen Korea, which is operating abnormally," Chairman Choi said. "We will gradually increase the number of union members to form a majority union."
- Policy
- The price of 7 Seretide products will be reduced
- by Kim, Jung-Ju Jul 05, 2021 05:53am
- The government won the suit. But there is a possibility of change depending on the company's decision. Insurance prices for 7 items of asthma treatment Seretide by GSK will be lowered from the 2nd of next month. The government won the lawsuit against the company to cancel the reduction of the price. If the company disagrees with the ruling, there may be another change in drug prices. The sixth part of the Seoul Administrative Court sided with the MOHW in a lawsuit filed by the company. Therefore, suspension of execution, which had maintained the previous price without lowering the drug price during the lawsuit period, was lifted. The lawsuit was taken by the Ministry of Health and Welfare on June 1, 2019, in line with the end of the additional period of these products, on May 28, 2019. The company filed a suspension with the court and applied for a suspension of execution to keep the drug price intact during the lawsuit period, but it was lifted with the ruling. These drugs include Seretide 125 Evohaler(120 doses), Seretide 100 Diskus(60 doses), Seretide 250 Diskus(60 doses), Seretide Evohaler 250(120 doses), Seretide 250 Diskus(28 doses), Seretide 500 Diskus, Seretide 50 Evohaler(120 doses) . The MOHW said it would apply the reduction as of July 2 in accordance with suspension of execution. However, there is a possibility of change if the company disagrees. In response, the MOHW has decided to provide additional guidance if there is any change in the future.
- Company
- Metformin with excess NDMA was removed from the market
- by An, Kyung-Jin Jul 03, 2021 05:56am
- Most of the prescriptions for 31 types of Metformin, which had been suspended for detection of excess impurities a year ago, have disappeared. Sales of drugs, including Metformin, rose, but some companies were virtually kicked out from the market. There are many opinions that the government should take a more careful suspension of sales. According to the drug research agency UBIST on the 1st, JW Pharm's Guardmet had no outpatient prescription until May this year. It posted ₩4.2 billion in prescription performance during the same period last year, but has not sold since June. Guardmet is a combination of JW Pharma's DPP-4 inhibitor Guardlet(Anagliptin) and Metformin. Although it emerged as JW Pharma's main product as prescription performance rose sharply to ₩5.6 billion in 2017, ₩8.2 billion in 2018, and ₩9.7 billion in 2019, all three doses, including "Guardmet" 100/500mg, 100/850mg, and 100/1000mg, disappeared from the prescription market in May last year. Sales amounting to ₩10 billion a year have been lost due to unexpected detection of impurities. In the case of Hanall's Glucodaun OR, the company posted a cumulative sales of ₩3.3 billion from January to May last year, but no sales this year. Glucodaun OR has been temporarily suspended. It recorded ₩8 billion in accumulated prescriptions in 2019. The MFDS said on May 26 last year that it has temporarily suspended manufacturing and sales and imposed prescription restrictions as 31 items were found to contain excess carcinogenic N-nitrosodimethylamine (NDMA). It has been about six months since the risk of impurities erupted in Singapore. Singapore's Health and Science Administration (HSA) recalled three products in December 2019 on the grounds that more than NDMA was detected as a result of investigating 46 items of Metformin on sale locally. The MFDS is applying the maximum daily allowance of based on NDMA 96ng provisional management standards. 31 items from 22 companies, which were suspended from sale at the time, accumulated ₩10.3 billion in five months from January to May last year, but only ₩800 million this year. It is down 91.8% year-on-year. There were no sales of 25 items except for Jeil's Lipito-M, HKinno.N's Atomet SR and Daewoong Bio's Diformin XR. Products from 19 companies, including JW Pharm, Hanall and Jinyang, have virtually left the market after the impurity measures. Several companies have induced prescription changes to other drugs or similar products of their own that have not been suspended from sale. For example, Daewoong Bio's "Diaformin" made a prescription record of ₩25 million for five months this year. Although the three capacities, Diformin XR 500 mg, Diformin XR 750 mg and Diformin XR 1000 mg, were suspended for NDMA provisional over-detection, Diformin 250 mg, Diformin 500 mg and Diformin 1000 mg products were available for sale. However, compared to ₩546 million in the same period last year, the amount of prescriptions decreased 62.5% in a year. In the case of Lipito-M and Atomet, only some of them were suspended, recording prescription results of more than ₩300 million and ₩100 million, respectively, this year. Except for JW Pharma and Hanall, of course, the rest of the companies are not losing much. Of the 31 items, Hutecs' Gluless-M and Nelson's Glutamin, which were among the top prescriptions, managed to exceed ₩200 million in cumulative prescriptions by May last year. During the same period, Hanmi's Grimefol SR, Shin Poong's Dybis and Unimaryl M have less than ₩200 million in prescriptions. The prescription loss is only less than ₩1 billion. Metformin had little influence on the entire pharmaceutical market. Last year, the prescription amount of a single metformin drug was ₩77.3 billion, up 4.1% from the previous year. Considering that it increased 2.9% year-on-year in 2019, the increase was even greater. Last year, the amount of prescriptions for Metformin combined with DPP-4 inhibitors was ₩458.4 billion, up 10.5% from the previous year. Similarly, it rose 8.2% year-on-year. Despite the spread of COVID-19 infections and the detection of impurities, there was little damage to the prescription market. The reason is that discontinued products account for a small percentage of the product and that there is no drug to replace Metformin that can be prescribed for type 2 diabetics. It is diagnosed that some of the learning effects of the high blood pressure treatment Valsartan, Ranitidine, and Nizatidine have been shown to have minimal harmful effects. However, some say that the MFDS should be more careful in taking measures related to impurities. The MFDS suspended the sale of the entire product if even one lot number of NDMA excess raw material was found for Metformin agents. They say they will allow sales if the problematic product is recovered and proven suitable for carcinogens by lot numbers. However, it has been a year since the temporary suspension of sales, but it is confirmed that no companies have attempted to sell them. Due to the characteristics of generics, it is recognized that it will be kicked out of the market once it is suspended. They say that the unexpected detection of impurities and suspension of sales during manufacturing process are damaging pharmaceutical companies. An official from the pharmaceutical industry said, "In the U.S., in the case of Valsartan and Ranitidine, only the lot numbers that used impurities detection raw materials were recovered. they did not suspend sales of the entire item," He said. "We need to be more careful about temporary sales suspension measures due to the detection of impurities."
- Company
- Lilly applies for listing of its fast-acting insulin Lyumjev
- by Eo, Yun-Ho Jul 03, 2021 05:56am
- The reimbursement benefit listing process for Lilly’s fast-acting insulin ‘Lyumjev’ will begin. According to industry sources, Lilly Korea had recently applied for the reimbursement of Lyumjev (insulin lispro). The drug, which has been approved in Korea on the 28th of last month, is attempting quicker market entry using the Drug Approval – Benefit Evaluation Linkage System. Lyumjev is a mealtime insulin that contains the fast-acting active ingredient, ‘insulin lispro’ which helps patients with Type 1 and Type 2 diabetes control their high blood sugar levels after meals or maintain their blood sugar in the target range. The domestic approval of Lyumjev was based on the results of the PRONTO clinical trial program that was conducted on adult patients with Type 1 and Type 2 diabetes. The PRONTO-T1D and PRONTO-T2D trials evaluated the safety and efficacy of Lyumjev compared to Humalog in people with type 1 and type 2 diabetes, respectively. The studies were designed as treat-to-target trials in which each arm was treated to achieve the same level of blood glucose control and evaluated for other important treatment effects, such as rates of hypoglycemia and post-meal glucose control, as well as maintenance of appropriate blood sugar levels. Results from both studies showed that Lyumjev was found to be non-inferior to Lilly’s existing fast-acting insulin ‘Humalog (insulin lispro) with regard to HbA1c reduction from baseline to week 26 (primary endpoint) when administered after meals. Also, Lyumjev demonstrated a superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog. Results of Phase 1 clinical trial on Type 1 diabetes patients had also shown that Lyumjev is absorbed faster than ‘Humalog,’ ‘insulin aspart’ and ‘fast-acting insulin aspart.’ Also, blood glucose excursions over the first 3 hours after administration of Lyumjev were comparable to those in participants without diabetes.
- Company
- Takeda's Susoctocog alfa has been designated as a rare drug
- by Jul 03, 2021 05:56am
- Korea Takeda's "Susoctocog alfa," a bleeding treatment for patients with acquired haemophilia A, was designated as a rare drug by the MFDS on the 1st. Hemophilia is a major hemorrhagic disease caused by a lack of clotting factors in the blood due to mutations in genes located on the X chromosome. Hemophilia A, caused by lack of coagulation factors, accounts for about 70% of all hemophilia patients. Among them, acquired hemophilia A is an autoimmune antibody to coagulation factor VIII, which is a very rare condition in which coagulation factor VIII in the blood is suppressed and depleted, resulting in bleeding-related complications. It is reported that 0.2 to 1.48 out of 1 million people occur per year. Unlike congenital haemophilia, which usually occurs in boys, most of them appear at a similar rate for both men and women aged 65 and older. Kim Na-kyung, general manager of Takeda's Hematology BU, said, "We are pleased that the designation of rare drugs will help patients with acquired hematology A more stable treatment of the disease.""We will not only research and develop innovative treatments to positively change the lives of patients with rare hematopoietic diseases, including patients with acquired hemophilia A, but also do our best to improve the treatment environment." Rare drugs are treatments used for diseases with a population of less than 20,000 patients in Korea, meaning drugs that are used for diseases without proper treatment methods and medicines, or that have significantly improved safety or effectiveness than existing alternative drugs.
- Company
- Martín Corcoll, Boehringer Ingelheim Korea's new GM
- by Jul 03, 2021 05:56am
- Boehringer Ingelheim Korea announced the appointment of Martín Corcoll as the company’s new GM and Head of Human Pharm as of July 1st. Since joining Boehringer Ingelheim in 2006, the new GM Corcoll had accumulated extensive experience and expertise in the industry, serving in various positions and divisions for over 15 years. After graduating from the University of San Andrés in Argentina with a Bachelor’s degree in Business Administration, he obtained an MBA from ESADE Ramon Business & Law School in Barcelona, Spain. In 2006, Corcoll joined Boehringer Ingelheim Mexico as a central nervous system (CNS) and urology brand manager. After establishing a solid foothold as a cardiovascular marketing leader until February 2010, Corcoll moved on to the Boehringer Ingelheim's headquarters in Germany as a global brand manager of the company’s diabetes division. During his time in Germany, Corcoll was recognized for his expertise and successful contribution to the company’s growth in establishing international alliances for its diabetes division and leading the global launch of the company’s diabetes products. Until 2018, Corcoll served as the Marketing Head of Human Pharma at Boehringer Ingelheim Spain and oversaw the primary care and specialty care brands, after which he moved to the Austrian branch to serve as the Regional Business Manager and as became the Head of Human Pharma and GM of Boehringer Ingelheim Austria in 2019. “I am pleased to be joining Boehringer Ingelheim Korea. I had a great interest in our Korean branch as I often heard of the performance and growth it has made during my time in Boehringer Ingelheim.” said Corcoll. “Based on the company’s corporate vision, ‘create value through innovation,’ the company will strive to improve the health of our patients and animals in Korea by providing effective new drugs and healthcare solutions for diseases with a high unmet need.”
- Policy
- The reasons why Hemlibra's benefit was not recognized?
- by Lee, Hye-Kyung Jul 03, 2021 05:56am
- The HIRA's Central Review and Coordination Committee revealed specific reasons for not recognising benefit of JW Pharma's Hemlibra (Emicizumab). The HIRA released a June review of the Review and Assessment Committee on its portal on Thursday. There are five cases of deliberation, including Hemlibra, Soliris, ventricular assistive therapy, Spinraza, and hematopoietic stem cell transplantation. In the case of Hemlibra, the HIRA unusually disclosed the results on the 8th due to controversy over the standards. Based on the data submitted by the medical institution, the central group said that cases A, B, and C lacked objective data to prove that it was difficult to secure venous blood vessels and to insert and maintain central vein tubes. ▲For pediatric administration, patients with failed Immune Tolerance Induction,▲ If there is a doctor's statement that it meets the requirements subject to Immune Tolerance Induction but is not possible to carry out it,▲ If antibodies are regenerated after the success of Immune Tolerance Induction, the patient must pay the full copayment of Hemlibra. According to the case of disapproval, which was specifically disclosed to the medical institution's business portal, A case was diagnosed with hereditary 8th factor deficiency syndrome in June 2019 and antibodies were found in December 2019 and started administering Hemlibra through clinical trials in March 2020. In February this year, the patient met the criteria for Immune Tolerance Induction benefits, but claimed Hemlibra because it was very difficult to secure venous blood vessels and difficult to insert and maintain central venous tubes as antibodies to factor VIII. However, the HIRA did not acknowledge the benefit, saying that "submitted medical records show insufficient objective data to determine that Hemlibra administration in February 2021 is difficult to secure venous blood vessels and to insert and maintain central venous ducts." Case B is a male (22 months), diagnosed with factor VIII disease in August 2019 and antibody was found in June 2020. The patient also applied for Hemlibra benefits because of the very difficulty in securing venous blood vessels, difficulty in inserting and maintaining central venous tubes due to antibodies to factor VIII, and psychological problems such as fear of intravenous injections, but was not recognized for the same reason as case A. There was also a lack of medical explanation for "stress from a vein injection". Case C was a 4-year-old boy, diagnosed with factor VIII disease in June 2016 and discovered antibodies in July 2016, but had a history of treatment in intensive care due to subgaleal hemorrhage and epidural hemorrhage at birth. The HIRA judged that "the past history of severe bleeding is not the case when immunotherapy cannot be attempted." Case D is a 3-year-old (40 months)-old male diagnosed with factor VIII disease in September 2017 and antibody was discovered in November 2017. In November 2018, chemoport was approved, but three days later, intestinal bleeding failed, and Hemlibra was charged for failing to be administered due to severe intestinal bleeding in February 2021. However, the HIRA ruled that "Immune Tolerance Induction could not be performed due to intestinal bleeding in November 2018, but medical records confirm the application for IImmune Tolerance Inductionagain in January 2019." Meanwhile, the MOHW announced that it would review the benefit standard in consultation with the HIRA as problems with the Hemlibra standard were pointed out at a plenary session of the National Assembly on the 16th.
- Company
- Opdivo+Yervoy's negotiations failed to reach an agreement
- by Jul 01, 2021 05:56am
- Drugs for the combination of the immuno-cancer drugs Opidivo (Nivolumab) and Yervoy (Ipilimumab) in primary treatment for kidney cancer were not negotiated within days. In the end, it is expected to take longer to apply the benefit. According to related industries on the 1st, Ono Pharmaceutical and BMS have extended drug price negotiations with the NHIS for Opdivo and Yervoy kidney cancer primary treatment benefits. Earlier, Opdivo and Yervoy combination therapy was recognized for their benefit adequacy and began drug negotiations with the NHIS for "median or high-risk progressive neocyte cancer treatment" at the HIRA. Pharmaceutical price negotiations run for up to 60 days, and the recent period has expired. The NHIS and pharmaceutical companies never reached an agreement. However, they decided to extend it because they believed that additional negotiations were needed. PD-1 inhibitor immuno-cancer drugs Opdivo and CTLA-4 inhibitor immuno-cancer drugs Yervoy demonstrated excellent effectiveness in primary treatment of kidney cancer. In June 2020, and it passed the HIRA's Cancer Drugs Benefit Appraisal Committee. Later, it took about nine more months for the HIRA's Pharmaceutical Benefits Advisory Committee to recognize the benefit adequacy. In clinical trials of CheckMate-214 compared to the standard treatment of Sutene (Sunitinib Malate) in intermediate and high risk groups, Opdivo and Yervoy combined therapy showed a significant effect compared to the median (mOS) of 48.1 months, compared to 26.6 months. The objective response rate was also significantly higher at 41.9% to 26.8% and the rate of patients maintaining it was higher (65.2% to 49.6%). In particular, 10.4% of patients treated with combination therapy reached full response and received attention. Professor Park Soo-hyung of Kaist GMSE said, "In immune mechanism, CTLA-4 activates priming, which is the first antigen-specific immune response, to induce T-cell reactions, and anti-PD-1 prevents degradation of T-cells, which can create synergies." If Opdivo and Yervoy therapy are listed, the use of immunocancer drugs in kidney cancer is expected to become more active. This is also the first case in which immuno-cancer drug combination therapy is applied in chemotherapy. Both companies are also seeking to expand insurance coverage for Opdivo and Yervoy combined therapy in primary care for non-small cell lung cancer.
- Company
- Yuhan’s Leclaza reimb. held back by companion diagnostics
- by Eo, Yun-Ho Jul 01, 2021 05:56am
- Reimbursement of the novel domestic drug ‘Leclaza’ that was due today (July 1st) was postponed. The listing process of Yuhan Corporation’s new drug which had been progressing at an unprecedented pace came to a full stop due to ‘companion diagnostics.’ Dailypharm found that the Ministry of Health and Welfare had pulled a temporary stop on the enforcement of the notice related to Leclaza (lazertinib). Leclaza was supposed to be listed from July after passing the Health Insurance Policy Deliberative Committee’s review on the 25th of last month. The brakes were pulled by an objection that was registered during the pre-announcement of administration period regarding the lack of a companion diagnostics device Delayed listing of a drug that has already passed the HIPDC deliberations is rare. Since 2018, the Ministry of Food and Drug Safety had regularized a sort of ‘customized use’ of in-vitro companion diagnostics devices through the ‘Guideline on the Review & Approval of companion diagnostic medical devices,’ under which a drug and the companion diagnostics device used as the basis for medications and prescriptions are reflected together in the license. The measure was implemented to precisely screen patients eligible for each prescribed drug target. The problem was that no MFDS-approved diagnostic device existed for the purpose of prescribing Leclaza even though the drug already passed the HIPDC review. Under the current regulations, 3rd generation EGFR TKIs like ‘Tagrisso (Osimertinib)’ and Leclaza may only be prescribed to ‘patients whose EGFR T790M mutation status has been confirmed with an in-vitro diagnostic medical device approved by MFDS.’ In-vitro diagnostic medical devices that are approved and used to identify the EGFR T790M mutation status in Korea include the blood-based ‘Cobas EGFR Mutation Test,’ and ‘PANAMutyper EGFR Kit,’ among others. However, these devices are only approved to be used to screen patients for Tagrisso. In other words, the objection was that Leclaza prescriptions, if made, are all off-label prescriptions, and therefore unfit for reimbursement. As the health authorities have been limiting reimbursement of anticancer therapies with targets such as Tagrisso, the immunotherapy ‘Keytruda (pembrolizumab).’ ‘Tecentriq (atezolizumab),’ the ALK-inhibitor ‘Xalkori (crizotinib), and 'Alubrig (brigatinib)' to those that have used approved diagnostic devices to prescribe the therapies, it was difficult for the government to overlook the objections made regarding this matter. Accordingly, the MFDS had requested the Ministry of Food and Drug Safety to deliberate on whether the in-vitro diagnostic device needed for the prescription of Leclaza should be regarded as a 'companion diagnostics device.' To add an in-vitro companion diagnostic device to a drug's license, additional data that demonstrates that the diagnostic device used in the clinical trial and the device the company wishes to register is equivalent in identifying EGFR T790M mutations need to be submitted. Generally, it takes around 3 to 4 months for the tests to be conducted and the MFDS license to be updated.
- Policy
- Rationalizing ICER threshold requires various considerations
- by Kim, Jung-Ju Jul 01, 2021 05:56am
- Yoon-Seok Yang, Director of MOHW’s Division of Pharmaceutical Benefits Insurance authorities expect the evaluation results of the listed drugs that underwent quality reassessment on the reasonableness of their medical care benefit (re-evaluation of medical benefits of listed drugs) will be applied as early as October this year. This means that the results will pass the Health Insurance Policy Deliberative Committee’s review and be notified in October. Also, regarding the issue of Keytruda’s reimbursement expansion that has been making little progress, the government has pressed for a clear financial sharing scheme with measures such as initial refunds. On lowering the drug price in the detailed evaluation criteria of drugs up for drug pricing negotiations to 80% of the lowest A7 adjusted price, the government plans to continue to hold an ear out to the industry and accept acceptable opinions. This was what Yoon-Seok Yang, Director of Ministry of Health and Welfare’s Division of Pharmaceutical Benefits said in response to the Korea Special Press Association’s questions on pending issues. Director Yang candidly shared the authorities’ positions and concerns over various pharmaceutical policies in his division ranging from reimbursement entry, expansion, improving reimbursement accessibility of ultra-expensive drugs, to ICER thresholds and other various reevaluation issues related to new drug listings. The following is a QA of an interview with Director Yang New drug listings – regarding ICER and PE exemption, RSA, and detailed criteria for drug pricing negations ▶The industry has been requesting rationalization of the ICER threshold in line with the $30,000 GDP per capita era. The ICER threshold is already being flexibly applied on severe and rare diseases, but the industry seems to believe that the threshold should be set at least 3 GDP. “The issue has come up in the NA audit and has also been requested by the industry. As far as I know, HIRA is currently reviewing the issue. Accessibility to new drugs is directly related to drug price, and from the government’s perspective, directly related to NHI finances, so this issue needs to be approached with caution. The fact that you use the term ‘rationalize’ seems to imply that the current ICER threshold is unrealistic. However, there are others who believe that the current threshold is reasonable. We need to gather opinions from various sides before implementing any measures because the drug price also affects reimbursement expenditures. Many drugs have been receiving reimbursement benefits through the PE exemption system without ICER evaluations, so when the government collectively considers its finances, these drugs also need to be taken into account in this discussion. As I said, we need to first gather various opinions. We also need to bear in mind that not many countries use ICER thresholds directly connected to GDP.” ▶There was also talks in the industry that HIRA would lower the PE exemption criteria to 80% of the lowest A7 adjusted price while revising some phrases in HIRA’s evaluation criteria for negotiated drugs. In detail, the criteria would, in principle, set the rate at 80%, and some at 100% according to each drug’s characteristic. Multinational pharmaceutical companies have been greatly opposed to this change, and the question of whether the system and mechanism would become a ‘dead letter’ is also being raised. Is there any room for adjustment on this matter? “We will listen, review, and accept reasonable arguments to the extent possible. The government and HIRA are both aware that the ‘visible’ price listed for most RSA drugs is not the ‘actual price.’ Our focus is on whether the price should be accepted as is, or be adjusted to reflect the real price. The industry will not be able to deny that this is a serious issue. But we will keep an ear out for suggestions from the industry.” ▶Considering that over half of the high-price drugs receive reimbursement through the PE exemption scheme, did the ministry lower the PE exemption criteria to 80% of the lowest adjusted price because the PE exemption scheme is being used more actively than expected?. “Drugs need to be evaluated and given a price according to their value. We know that it is very difficult for rare disease drugs to prepare data for such evaluations, and that’s why we have the existing tools that strengthen post-management measures. HIRA wishes to find measures to strengthen the criteria through discusstions with the industry, but the industry is pushing their opinion. They need to discuss this together. The PE exemption scheme increases payment on HIRA’s part, so HIRA believes in the need to strengthen its management.” Tecentriq and Keytruda ▶Tecentriq applied for reimbursement separately and is up for deliberation by the Cancer Drug Review Committee. I heard that the two drugs will be now discussed together, and the key to Keytruda’s issue is that it lacks a cost-sharing scheme. As the government’s signal would play an important role in the decision, the question that remains is - is the initial refund is crucial?. "Under the premise that the clinical efficacy has been demonstrated, in general, the payer and the pharmaceutical company’s actions are what makes or breaks reimbursement expansions. In other words, the discussion and negotiations on how to share the financial burden are what take up the longest time. A slow progress like Keytruda's is a first for us in our history as well. I cannot disclose specific numbers, but even after CDRC's recommendation to take up the financial sharing request, pre-negotiations fell through. The government's request for a financial sharing scheme similar to those made for other drugs also broke down. The company just increased the scope of its indications and reapplied for reimbursement. This financial-sharing issue is still being discussed, and I hope the company would take a more forward-looking stance regarding this matter. The reason why the authorities emphasize the initial sharing plan is because it allows for a clearer sharing of cost during the initial period where the increase in reimbursement expenses from the expansion is unclear. Initial sharing of cost eliminates financial uncertainty on the government’s part. I know that the company is also seriously considering this matter, and hope that an agreement can be reached in the near future. ▶When will the agenda be introduced?. “The agenda will be introduced sequentially according to HIRA’s order of placement. I believe it will be introduced around July or August.” Premium pricing reevaluation ▶The issue at hand is the premium pricing of single-brand drugs. As brought up during the last pharmaceutical-HIRA roundtable, even when after applying for adjustments, the possibility of accepting the adjusted price is low and it is realistically difficult to reach an agreement, which eventually leads to discussions of taking legal actions. Wouldn't it be resolved by adjusting the timing, by allowing for adjustment applications to be submitted during the 60-day negotiation period set for the stable supply obligation so that they can reach an agreement earlier? “We are reviewing various options. We are trying to adjust the price according to our system, but if the companies say the price is unsuitable for supplying the drug, I think it is right to adjust it to a reasonable price. Some parts of the current standard seem to be strict, and there are other parts where HIRA is not properly carrying out its assessment, and we are determined to address and improve these parts. However, as addressing these issues will increase the drug price, it is natural for the government to be precautious of implementing such price-increasing mechanisms because it will increase the burden on NHI finances, so we are seriously reviewing options with HIRA. Receiving applications during the negotiation period is not being reviewed under current circumstances. However the re-evaluation of premium pricing is being implemented due to a change in the law and system, and I hope the industry would accept this. After the grounds are fully justified, we will seek measures to adjust the price of the drugs.”
