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- Zejula for ovarian cancer gets close to 4th-line coverage
- by Eo, Yun-Ho Nov 19, 2020 06:14am
- An anticancer therapy for ovarian cancer Zejula is at the last threshold to win the reimbursement expansion. According to pharmaceutical industry sources, Takeda Pharmaceutical has recently initiated the drug pricing negotiation with the National Health Insurance Service (NHIS) on a poly ADP-ribose polymerase (PPARP) inhibitor Zejula’s (niraparib) expanded indication to treat patients with relapsed ovarian cancer, who have received more than four chemotherapies, as a single therapy. A first PARP inhibitor to be used, regardless of BRCA mutation, Zejula was approved in South Korea in March last year as a monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to second or later-line platinum-based chemotherapy. Although it was listed for reimbursement last December, the first reimbursement standard was limited to patients with gBRCA mutation. In last June, the Cancer Deliberation Committee reviewed using the drug as a single-agent maintenance therapy in patients with gBRCA-negative high-grade serous relapsed ovarian cancer who showed complete or partial response in platinum-based chemotherapy, and as a monotherapy in patients with relapsed ovarian cancer who previously received fourth-line or later chemotherapy. Ultimately, only the fourth-line monotherapy indication was approved, while the gBRCA-negative indication failed. But in August, Takeda immediately submitted an application for reimbursement on Zejula as a monotherapy for the patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first-line platinum-based chemotherapy, regardless of BRCA mutation. Currently, the company awaits the decision by Cancer Deliberation Committee. The fourth or later-line indication, currently in negotiation with NHIS, has been approved based on multicenter, open-label QUADRA study in adult patients with ovarian cancer, who have been treated with third or later-line therapy. During the clinical study, Zejula reached its primary efficacy endpoint and demonstrated clinical efficacy with an object response rate (ORR). The patient group with platinum-sensitive homologous repair deficiency (HRD) demonstrated ORR of 24 percent, where as BRCA-positive platinum-sensitive group, BRCA-positive platinum-resistant group and BRCA-positive platinum-refractory group recorded ORR of 39 percent, 29 percent and 19 percent, respectively. And the median duration of response (mDOR), a secondary efficacy endpoint of the trial, in the HRD group was confirmed at 8.3 months. The drug’s safety profile seems it could be under control by adjusting the dose. Originally, Zejula’s reimbursed price was set at 76,400 won per capsule. Compared to the alternative option, Lynparza (olaparib) by AstraZeneca, Takeda’s option was evaluated as more cost-effective. But because Lynparza was listed with a pharmacoeconomic-analysis exemption through the risk sharing agreement (RSA), Zejula was also applied with the expenditure cap type RSA.
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- SGLT-2 inhibitor, effective for patients with kidney disease
- by Nov 19, 2020 06:10am
- SGLT-2 inhibitors, developed as a treatment for diabetes, are further expanding their indications. It has proven its protective effect beyond simple cardiovascular safety, and recently, data proving the benefit of kidney disease is accumulating. In patients with type 2 diabetes, SGLT-2 inhibitors prevented the deterioration of renal function, and in recent large-scale clinical trials, it was also effective in patients with renal impairment regardless of diabetes. This rationale is not limited to Randomized Controlled Trials (RCT). Various RWE studies (CVD-REAL) conducted by AstraZeneca confirm the usefulness of SGLT-2 in the field. In a recent large-scale RWE study conducted on Koreans, CVD-REAL 2, which included 340,000 Koreans, confirmed the cardiovascular benefits in type 2 diabetes patients. However, this CVD-REAL 3 KOREA conducted a study exclusively for Koreans. Also, it has proven effective in diabetic patients with kidney disease. Dailypharm met with Professor Koh Eun-sil, Nephrology of Yeouido St. Mary's Hospital and Professor Hyuk-Sang Kwon, Endocrinology, who participated in the CVD-REAL 3 KOREA study, and heard about the significance of this study and the prospects of SGLT-2 inhibitors. Professor Koh was the first author and Professor Kwon was the corresponding author. From the left, Professor Koh Eun-sil and Professor Hyuk-Sang Kwon The CVD-REAL 3 KOREA study is an RWE study conducted to confirm whether the renal function protection effect of SGLT-2 inhibitors, which was confirmed in previous RCT studies, appears even in the real world containing confounding factors. The study analyzed 90,000 patients with type 2 diabetes in Korea using a propensity score matching technique to analyze patients who started taking SGLT-2 inhibitors and those who started taking other hypoglycemic drugs at a one-to-one ratio of 45016 patients each. It is characterized by the fact that it is the same method as CVD-REAL 3 previously conducted in countries around the world, and that it is only for Koreans. In the SGLT-2 inhibitor group, Forxiga (Dapagliflozin) was the most common with 73.3%, followed by Jariance (Empagliflozin) 20.8%, and Suglat (Ipragliflozin) 6%. As a result, patients taking SGLT-2 had a 53% lower risk of developing end-stage renal failure than those taking hypoglycemic drugs. In particular, patients with glomerular filtration rate (eGFR) of 60-90 and patients with 60 or less showed greater benefits. In this group, SGLT-2 inhibitors had a lower risk of developing end-stage renal failure than taking hypoglycemic drugs by 61%, with or without proteinuria. In addition, taking SGLT-2 inhibitors reduced death from all causes by 18% compared to taking hypoglycemic drugs. Prof. Koh Eun-sil said, "The follow-up period is somewhat short, but this study clearly confirmed the kidney protection effect of SGLT-2 inhibitors." "We participated and the rate was only about 11%, and this time, even a study only observed by Koreans came out in the same way as the global study." Professor Koh expected that this study will play a major role in resolving questions about racial differences. In addition, the RWE study was thought to be helpful in predicting the effect of drugs in actual clinical practice. Corresponding author Professor Kwon Hyuk-Sang also said, "Most of the SGLT-2 inhibitor studies have an average percentage of Asian applicants of 10%, so even if the results are good, it is questionable whether it will be effective in domestic patients." In addition, he added, "This study is meaningful in that it has proven its effectiveness in 100% Korean patients." He then explained, "I think this renal protective effect is a series of effects of the entire SGLT-2 inhibitor rather than a specific drug." He added, "However, since the guidelines are based on evidence, the recommendations will be given priority to drugs that have demonstrated cardiovascular or kidney benefits and have demonstrated cardiovascular or renal benefits." The DECLARE-TIMI58 study confirmed the benefits of kidney in diabetics, and the DAPA-CKD study proved its effectiveness as a treatment for chronic kidney disease with or without diabetes. Currently, AstraZeneca is trying to acquire indications for treatment of chronic kidney disease based on the clinical results of DAPA-CKD. The guidelines of international conferences are also rapidly reflecting the paradigm shift caused by SGLT-2 inhibitors. Recently, Kidney Disease Improving Global Outcomes (KDIGO) recommended a combination therapy of metformin and an SGLT-2 inhibitor as the first-line treatment for chronic kidney disease patients with diabetes based on Forxiga's clinical trial. Although there are possibilities in various areas, it is evaluated that more follow-up observations should be made to determine whether the benefits can be safely maintained in the long term. Nevertheless, Professor Koh looked forward to SGLT-2 inhibitors because there is no suitable treatment for chronic kidney disease. Prof. Koh said clinical studies of drugs that were expected in the field of chronic kidney disease as well as heart failure failed. It has emerged as a hot issue in renal medicine as studies related to SGLT-2 inhibitors are actively conducted. Of course, more analysis through long-term observation is needed, but she said she expects a lot of good data to come out in the future.
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- Game changer Spravato first novel antidepressant in 30 years
- by Nov 19, 2020 06:10am
- Spravato Nasal Spray by Janssen Korea For the first time in three decades, a novel antidepressant has been released in South Korea. Although the drug would be able to provide new treatment opportunity to patients with severe depression through a new mechanism of action, the patients may face high barrier in convenience and pricing. On Nov. 17, Janssen Korea convened a press conference for the launch of Spravato Nasal Spray (esketamine hydrochloride). Spravato is used to treat patients with treatment-resistant depression (TRD), who do not appropriately respond on at least two or more antidepressants. Not only is it the first new antidepressant to be launched in 30 years, but also it is a first option for TRD. Spravato’s main substance esketamine controls the activity of the N-methyl-D-aspartate (NMDA) receptor—an ionotropic glutamate receptor—to improve synaptic transmission and treat the symptoms of depression. Janssen has conducted about 28 studies and clinical trials to test the drug’s efficacy in patients with severe depression, whom do not respond to at least two or more antidepressants, and won the U.S. Food and Drug Administration (FDA) approval in March last year. The South Korean health authority green lit the drug in last June. The biggest benefit of Spravato is a rapid reduction of depression symptoms. While the effect of existing antidepressant options start demonstrating a few weeks after the administration, Spravato’s effect is apparent from the first day of administration. President Lee Sang-yeol (Department of Psychiatry at Wonkwang University School of Medicine) of Korean College of Neuropsychopharmacology (KCNP) explained, “Since 2008, the demand for a novel mechanism of action to display treatment response or remission in a few hours or days was getting bigger. And many of the specialists were most impressed with Spravato’s rapid reduction of symptoms. In fact, many patients repeatedly commit suicide due to depression. I think Spravato would be a big help for these patients.” President Lee Sang-yeol of Korean College of Neuropsychopharmacology Spravato is expected to contribute in raising the complete remission rate and lessening the residual symptoms with its new mechanism of action. In a clinical trial, Spravato showed 52 percent of patients were in remission, and the Spravato group was 51 percent less likely to relapse compared to the reference group only using an oral drug. Regardless of the significant benefit, the realistic barrier still exists. The administration can be done only in hospital to prevent adverse reaction like dissociation. Also it requires a healthcare provider’s monitoring for two hours after the administration. The twice-weekly administration and monitoring at hospital would make patients rather inconvenient. Even President Lee Sang-yeol agreed, “It would be difficult to use Spravato in clinics, as it requires the two-hour monitoring. The drug would be used more frequently in tertiary hospitals with plenty of healthcare providers and emergency patients.” Also its non-reimbursed cost has to be entirely covered by patients. Janssen Korea has not disclosed the official supply price in Korea, but the monthly cost can be estimated based on cases in foreign countries. At a Spravato clinic in Canada, four doses in two weeks would cost approximately CAD 3,000 (approximately KRW 3.57 million). Considering other oral antidepressants cost around a few hundred won and injection around 1,600 won, the patients would be heavily burdened to cover the cost of the nasal spray drug. Although Janssen Korea is seeking for healthcare reimbursement on Spravato, the company is likely to face challenges. It is highly questionable that the current reimbursement system in South Korea would appropriately recognize the drug’s value as other reference drugs’ prices are extremely low. President Lee Sang-yeol stressed the high demand on the Spravato coverage and noted, “New drugs for other diseases can receive coverage regardless of the high price, but a novel psychopharmaceutical struggles to get coverage as they are compared to exceptionally low-priced drugs. As there are tens of thousands of patients with depression in Korea, I desperately hope Spravato would get listed for reimbursement.”
- Company
- Reorganization of multinational companies & plans
- by Nov 19, 2020 06:10am
- A meeting is held to discuss ways to improve workers' environment related to reorganization of multinational pharmaceutical companies. Yoon Joonbyeong, a member of the National Assembly's Environment and Labor Committee, announced that the meeting will be held on the 18th at 10:00 am in the 2nd conference room of the Seoul Metropolitan Council on the way to 'improving the working environment and securing the right to live for workers of multinational pharmaceutical companies' with Seoul City Council member Chu Seung-woo. The conference, hosted by Daesang Labor Law Firm, will be presented by Oh-sung Kwon, professor of law at Sungshin Women's University, and Sang-nam Shim, chairman of the Korean MSD labor union, on whether to succeed in labor relations due to corporate division. The debate was followed by Choi Young-woo, professor at Korea Employment and Labor Educational Institute. And, Seon-mi Jin, Vice Chairman of Korea Certified Public Labor Attorneys Association, Jong-Hwan Shin, advisor to MSD Korea's labor union, Kyung-rak Kim, representative laborer at Daesang Labor Law Firm, and Man-mok Han, representative laborer at A1 Labor Corporation, and Kang Seung-wook, chairman of Pfizer Pharmaceutical Korea's union, attend as a panel to discuss ways to secure workers' right to live.
- Company
- Sanofi to stand alone Consumer Healthcare and offer ERP
- by Nov 18, 2020 12:19pm
- Sanofi is reportedly planning to spin off the Consumer Healthcare (CHC) businesses and offer early retirement program (ERP) to employees under CHC and General Medicine (GenMed). On Nov. 13, Sanofi-Aventis Korea notified all employees the global Sanofi CHC stand alone plan that would also affect the South Korean branch as well. Sanofi official stated, “From early this year, the Sanofi group has been preparing the CHLOE project to consolidate competitiveness within the worldwide organization. The restructuring would be executed to improve business efficiency and sustainable competitiveness. And the key objective is to establish an independent consumer healthcare subsidiary.” Sanofi aims to spin off the CHC and shift the OTC drug sales tactics from direct sales to third-party sales. Also the company is to actively implement the online business model. As a part of the spin off, scheduled to get finalized September next year, the company officially initiated the ERP. The program would be offered to two departments CHC and GenMed The internal change signifies Sanofi’s new R&D strategy to halt researches on diabetes and cardiovascular disease treatment and focus on rare disease, cancer and neurological disorder. Accordingly, the company has disclosed the plan to reduce the size of GenMed businesses, centering on diabetics and cardiovascular treatment currently, based on the headquarters’ new strategy. Sanofi official explained, “As a new product launch from GenMed is unlikely to take place anymore, the demand for necessary human resources would get limited.” The compensation for the ERP would be doubled the number of consecutive working years plus eight months, a standard for multinational pharmaceutical company. However, the company insiders are concerned the number of ERP applicants from CHC would not meet the management’s expectation. Unlike GenMed with over 200 employees and a half of the sales executives having over a decade of experience, CHC has only about 60 employees, who have short consecutive working years ranging from four to five years. Relatively, the ratio of ERP applicants would have to be greater than GenMed. Regarding the issue, Sanofi labor union has requested the management to seek measures to reassign CHC employees to other departments, when the number of applicants is low, conduct ERP only to those who voluntarily applied for, and clarify offer application due date. The union representative said, “CHC is our biggest concern for the ERP. Out of 23 sales executives, at least 18 would have to apply for the ERP, except for the four the management has decided to keep. Because most of them are young, many of them are apparently not planning to apply for the program. We would like for the management to propose other reassignment plan.” Answering to the union’s request, the management official said, “We do not have any other reassignment plan, yet. However, the company does also offer employment referral, training, consulting and other various programs to facilitate employees to transfer.” In 2016, Sanofi and Boehringer Ingelheim have signed a deal to swap CHC businesses. Its major line-ups include the laxative Dulcolax and multivitamin supplements Cenovis.
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- All bets are off for patent dispute of Galvus
- by Kim, Jin-Gu Nov 18, 2020 06:36am
- 가브스 제품사진. The patent dispute over the DPP-4 inhibitor-based diabetes treatment'Galvus (Vildagliptin)' turns around and ends at the KIPO. The Patent Court of Korea sided with Novartis, and Ahn-gook, who lost, gave up the Supreme Court appeal, and the KIPO finally took over the case again. According to the pharmaceutical industry on the 17th, Ahn-gook abandoned its appeal to the Supreme Court after losing the second trial in patent dispute of Galvus with Novartis. With Ahn-gook giving up his appeal, the stage of the dispute is expected to shift back to the KIPO. ◆Conflicting 1st and 2nd Judgment... Material patent invalidation period 187 days → 55 days Ahn-gook and Novartis have been in dispute for more than three years. The issue is how much of the'extended duration' of Galvus material patent of Galvus is invalid. When Novartis first registered the material patent of Galvus, it requested that the patent duration be extended by the time it took to supplement the data required by the MFDS. The request was accepted by the Patent Court of Korea, and the duration was extended by two years and two months. In short, the material patent expiration has been delayed from January 2020 to March 2022. In July 2017, Ahn-gook argued that some of this extended substance patent duration was invalid. The KIPO sided with Ahn-gook. Out of a total of two years and two months, it was decided that '187 days' was invalid. ◆Novartis objected. The KIPO filed a lawsuit in the Patent Court to cancel the trial decision. After the patent court of Korea ruling, Ahn-gook had two options. Through appeal, the Supreme Court had to more actively insist the period of invalidity, or whether to renounce the appeal and return to the Patent Court of Korea to be tried again. Consequently, Ahn-gook chose to abandon the appeal. To choose to go to the Supreme Court, an appeal must be filed within 14 days of the date the decision was reached (October 30), but Ahn-gook did not file an appeal within the deadline. It is said that Ahn-gook was deeply concerned about the decision to abandon the appeal. The reason Ahn-gook struggled was that the second trial ruling was unclear. Ahn-gook benefited from the court's ruling in some of Novartis' prevailing decisions. Although the period of invalidation of Ahn-gook was reduced from 187 days to 55 days, it is still evaluated that it is not practically bad in that some were recognized as invalid. Moreover, considering that there has been no case of overcoming the duration of an original material patent by invalidity even for a single day, it is worth just 55 days. With Ahn-gook's renunciation of appeal, the dispute is expected to continue at the KIPO again. It has a similar shape to the case that the superior judge canceled and returned the lower court in the general court. ◆Will the KIPO accept the judgment of “55 days” The key is whether The KIPO will accept the opinion of the Patent Court of Korea's '55 days of validity'. In the usual remand after reversal case, the lower judge mostly cites the opinion of the higher one. However, in this case, Novartis is strongly opposed to acknowledging the period of invalidity, and the dispute is expected to develop fiercely again. If the KIPO accepts the opinion of the Patent Court of Korea, the release date of Ahn-gook's Galvus generic is likely to be delayed by 130 days from mid-August 2021 to early January 2022. A pharmaceutical industry patent official said, "Novatis, who won the second trial as Ahn-gook gave up the appeal, has legally lost its appeal status. Patent dispute of Galvus is automatically resumed at the KIPO." "The dispute between Novartis and Ahn-gook will be fierce again over how much invalidity will be," he said.
- Company
- General hospitals pass antifungal Cresemba for prescription
- by Eo, Yun-Ho Nov 18, 2020 06:35am
- South Korean general hospitals have started registering Pfizer’s novel antifungal Cresemba for prescription. According to pharmaceutical industry sources, the Drug Committee (DC) at the Big Five general hospitals and other healthcare institutes in South Korea, including Seoul Asan Medical Center and Severance Hospital, have cleared Cresemba (isavuconazonium). In last January, the Ministry of Food and Drug Safety (MFDS) has approved Cresemba, indicated to treat adult patients in age of 18 and older with invasive aspergillosis, and adult patients in age of 18 and older with mucormycosis for whom amphotericin B is inappropriate. With a wide variety targeted antifungal spectrum, Cresemba can treat both invasive aspergillosis and invasive mucormycosis. The drug is currently the only azole antifungal in South Korea indicated for invasive mucormycosis. However, the drug faces an issue with the healthcare reimbursement. In last month, the Health Insurance Review and Assessment Service (HIRA) internally revised the regulation on the pharmaceutical reimbursement subject evaluation standard and procedure. HIRA narrowed the scope of prospective subject for pharmacoeconomic (PE) analysis exemption, initially suggested as ‘antibiotics,’ to ‘antibacterials.’ Both the industry and academic scholars supported the government’s plan to expand the subject scope of the PE analysis exemption. But their definition of antibiotics was controversial. Medically speaking, an antibiotic means antimicrobial medicines that cover antibacterial, antifungal and antiviral. And the constant increase of antimicrobial resistance (AMR) is considered as the most critical public health risk around the world. Due to the major public health risk, some were disputing over unifying the definition of the new PE exemption subject—antibiotics—as ‘antibacterial’ based on the variant definitions of antibiotics. And the government sealed the deal by ‘limiting the exemption to ‘antibacterial’.’ Cresemba, categorized as an antifungal, is in shock of the government’s decision. President Choi Jung-hyun (Catholic University of Korea Eunpyeong St. Mary's Hospital) of Korean Society for Antimicrobial Therapy (KSAT) said, “The risk of secondary nosocomial infection increases higher, when a patient with COVID-19-like severe disease is hospitalized for a long term or uses respirator for a long term. While the demand for securing sufficient amount of infectious disease drug is becoming ever more important to respond against novel infectious disease and secondary nosocomial infection, it is regretful that the government had to neglect the academic society’s advice and narrow down the definition of antibiotics.” Including South Korea, the number of fungal infection cases around the world has been surging as more than one million people reportedly die annually from fungal infection. However, the number of developed antifungal is limited. Among all fungal infection, the invasive aspergillosis is considered as one of three most dangerous invasive fungus to the human race. Even in Korea, the infection is counted as one of most frequent causes of death in patients with immune deficiency, due to increased number of patients receiving anticancer therapy and fighting against AIDS.
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- How can the domestic drug price system be improved?
- by Nov 17, 2020 06:28am
- As drugs that target specific genes or activate the immune system to treat diseases have been released, the use of one drug for various types of cancer has become more frequent. As of 2018, 75% of target anticancer drugs are multiple indications, and in the case of immune anticancer drugs, thousands of single and combined clinical trials for various carcinomas are reached. There are many opinions that the current drug price system needs to be changed. This is because, as indications are added, only the factors that lower the drug price increase, reducing the patient's access to new drugs. How can the domestic drug price system be improved? To find the clues, Dailypharm held the 40th Future Forum on the 11th at the Moonjeong-dong office building under the theme of 'prerequisites for introducing drug prices by indications'. From left, Professor Dongcheol Seo (Chair), Professor Mihye Park, Secretary Kyungho Choi, Manager Younghee Lee, and Chiyoung Ryu The forum was attended by Professor Seo Dong-cheol of the College of Pharmacy at Chung-Ang University. Park Mi-hye, professor of the College of Pharmacy at Sungkyunkwan University, Choi Kyung-ho, secretary of the Department of Health and Welfare Insurance and Pharmaceutical Affairs Department, Lee Young-hee, head of the Drug Price System Improvement Department of the Health Insurance Corporation, and Ryu Chi-young, director of the Korea Global Pharmaceutical Industry Association (KRPIA), attended. Prof. Mi-Hye Park, who came out as a speaker on this day, analyzed the drug price system for each foreign indications under the theme of 'A measure of valuation when expanding indications of new drugs-Focusing on immune anti-cancer drugs and targeted anti-cancer drugs', and suggested the most suitable method for the domestic environment. Currently, Korea is maintaining or lowering drug prices in consideration of the additional usage (additional financial requirements) of already approved drugs. This is a method that recognizes only the first value assigned at the time of listing of the first salary and not the value of other indications. For this reason, as the standard is expanded, the drug price gradually decreases. Based on the standard anticancer drug, as the number of supplementary extensions increased, the tendency of drug price cuts was more pronounced, and as indications increased, the dropping rate was found to be greater. Professor Park Mi-hye Prof. Park pointed out that the current method, which does not recognize the value of additional indications, is also contrary to the 'value-based evaluation system', which determines whether or not to pay benefits based on relative clinical usefulness and cost-effectiveness when listing new drugs. .This is because even if an unlicensed drug proves high value in a new indication, it is excluded .There are also concerns about this .Professor Park Mi-hye explained, "If the value of the additional indication is higher and it is not recognized as a drug price, there is a possibility that pharmaceutical companies will not promote the expansion of the standard." In the light of research by Cole et al., "If the value of each indication is recognized, high-value indications can receive high drug prices .Therefore, pharmaceutical companies will be more active in research and development on new indications, so that patients' treatment options can be wider .Therefore, social welfare can be further increased.” Differential structure of drug prices by actual indication, such as Australia and Italy How to determine reimbursement of multiple indication drugs abroad ?As a result of an analysis of the survey published this year by Professor Park by the OECD, it was found that there are no countries that explicitly operate the drug price system by indication, but some countries are implementing a structure in which the price of drugs by indications is substantially different for certain drugs .As a result of the OECD survey, Australia, France, Greece, and Italy said that when an indication is added, they concluded a new RSA and the drug price was substantially different Norway and the UK charge all indications at that price when cost-effective .Australia and Germany calculate single-weighted pricing for each indication, reflecting the cost-effectiveness of the patient group for each indication when determining drug prices for multiple indications .In addition, Italy, Belgium, France, Switzerland, etc .negotiate a risk-sharing system (RSA) for each indication, so that the drug price is substantially different .Professor Park said, "Typically, Australia is making changes by calculating a single weighted average price by referring to the Medicare data collected during the prescription period." "Also, Italy has established a registry very well for nearly 20 years, so that which drug is suitable for any indication of a patient .It is possible to track how much it has been used .Based on this, different types of risk-sharing drugs are implemented for each indication even for the same drug." In addition, Italy, Belgium, France, Switzerland, etc .negotiate a risk-sharing system (RSA) for each indication, so that the drug price is substantially different With the increasing number of anticancer drugs with multiple indications, what is the most appropriate drug price system considering the domestic environment ?Prof .Park disclosed the results of the survey to practitioners related to drug prices of pharmaceutical companies registered with the Korea Global Pharmaceutical Industry Association (KRPIA), the Korea Biopharmaceutical Association (KoBIA), and the Korea Pharmaceutical Bio Association (KPBMA) .System 3 is the most supported from▲ Calculation of a single weighted average price according to the value of each indication (system 1), ▲ application of a different risk-sharing system for each indication (system 2), and ▲ different drug prices for each indication (system 3) .Professor Park said, "The majority of respondents evaluated the current system as negative in terms of improving access to new drugs and reflecting appropriate values, and more than 90% agreed with System 2, which received an overall positive evaluation in the direction of system improvement." He said that the way to give different drug prices is practically limited .Based on this, Professor Park proposed to introduce a method that practically differentiates drug prices by applying different types of risk-sharing system for each indication, as in Italy .Professor Park said, "In Korea, RSA is already being implemented, and since 2018, selective benefits have been introduced to medicines, and a system that differentiates the level of reimbursement for each patient has been established, so it seems to be a sufficiently accessible policy." Even when considering harmony, it is considered the most feasible solution." He added, "Currently, the RSA application is operated on a relatively strict basis, so it is difficult to apply it to all drugs for which indications are expanded .This part requires coordination." Professor Park said, "In the future, the possibility of expansion of the indications for anticancer drugs is very high, but the potential risk is left alone .If this situation is repeated, the damage will eventually be suffered by the patients .It is time for a future-oriented policy alternative."
- Company
- A heated panel discussion on indication-basis drug pricing
- by Eo, Yun-Ho Nov 17, 2020 06:27am
- In this day and age of a single drug offering a variety of indications, the problem now lies on the drug pricing. The negotiation between the South Korean government and pharmaceutical company is slowing down and the patients have to wait longer as the country’s drug pricing system cuts the pricing when a drug expands its uses. From left: Professor Suh Dong-churl as speaker, Professor Park Mi Hye, Deputy Director Choi Kyung-ho, Director Lee Young-hee and Senior Manager Ryu Chiyoung On Nov. 11, Daily Pharm convened the 40th Future Forum on the topic of priorities in introducing the drug pricing system by indication. The pharmaceutical industry, government and academic society representatives gathered to find the answer of unending question of treatment access and appropriate pricing. Professor Suh Dong-churl of Chung-ang University College of Pharmacy led the forum as a speaker, where Professor Park Mi Hye gave a keynote speech on ‘Introducing Indication-basis Drug Pricing to Improve Patient Access,’ followed by a heated discussion among panelists like Deputy Director Choi Kyung-ho of the Ministry of Health and Welfare (MOHW) Pharmaceutical Benefits Division, Director Lee Young-hee of National Health Insurance Service (NHIS) Drug Pricing System Improvement Division and Senior Manager Ryu Chiyoung of Korean Research-based Pharmaceutical Industry Association (KRPIA). Senior Manager Ryu Chiyoung ◆The need of introducing the indication-basis drug pricing system: The indication-basis drug pricing system decides the price of a drug by each indication and its innovativeness. Last month, the industry finally solved the problem of applying risk sharing agreement on follow-on drugs that have treatment level on par with a first-in-class drug and favorable cost-effectiveness. However, the government has added another condition; while allowing follow-on drugs to sign RSA, any drug seeking to expand reimbursement, regardless of being the RSA subject, would have to prove cost-effectiveness (administration cost comparison or pharmacoeconomic (PE) analysis). In other words, when the Health Insurance Review and Assessment Service (HIRA) requires cost-effectiveness evaluation, a drug would be priced at lowest level compared to either PE or clinical evidence with reference drug, and have the price reduced according to the same standard as the first-in-class drug. Senior Manager Ryu Chiyoung stated, “These days, a single drug now gains 15 to 20 indications through various researches. But if their pricing drops as they expand indications, then which company would voluntarily take an additional action to actually expand the indication? KRPIA proposes the government to apply weighted average pricing by indication or to adjust refund rate, if it looks for cost-effectiveness when approving additional indication.” Deputy Director Choi Kyung-ho He added, “Besides the system revision, many of market access managers in multinational companies are struggling to negotiate with the headquarters on supplying new drugs in South Korea. Increasing number of other countries using the international reference pricing (IRP) is worsening the risk of the ‘Korea Passing’ phenomenon.” ◆The unavoidable issue of ‘financial burden’: When the reimbursement scope of a drug is extended, patients receive the benefit, but at the same time the financial burden also gets bigger. Under the National Health Insurance (NHI) system, the government has to contemplate on cost-effectiveness whenever it lists a new drug. The controversial premise of ‘reducing drug pricing when use is expanded’ is also a result of the contemplation. Deputy Director Choi Kyung-ho said, “Taking a look at immunotherapy, the indication expansion of the drug in South Korea has been sluggish compared to the company’s expectation. Two to three indications are added a year. If the talks on reimbursement are delayed, more and more indications would be left non-reimbursed.” But the deputy director also explained, “The additional expenditure for the expanded reimbursement is through the roof and the indication-basis pricing is unprecedented. The government does see the issue, and it would try to find the point of agreement through thorough discussion.” Regardless, the academic scholars highlighted another means of approaching the issue. Director Lee Young-hee Professor Park Mi Hye advised, “The NHI finance is both about drug pricing and the use. But the country heavily relies on the drug pricing that it is losing flexibility in the financial management, which is also why the industry and the government are in a deadlock for a longer period of time. It may be better to shift the paradigm away from reducing the expenditure simply through drug pricing.” However, the government is also highly concerned of the drug pricing increase due to the indication-basis pricing. Director Lee Young-hee claimed, “The drug pricing could be increased when a number of indications receive weighted average pricing or differentiated refund rate on a single labeled pricing. NHIS can only pay when it has money. The agency has no choice but to be careful about the indication-basis pricing as it is directly related to the sustainability of NHI.” The industry representative gave a clear answer on the government’s concern. Senior Manager Ryu disputed, “No company would demand for pricing increase, when adding an indication with the revised system. But, what we are saying now is that we need to adjust the current pricing reduction measure.” ◆The realistic difficulties and hastiness: The change in administration could only be cumbersome. Giving different pricing for each indication would have to input two to three codes for a single drug. Accordingly, the billing system HIRA and NHIS operate would have to undergo a significant change, and even the healthcare institute could get confused by inputting the major and minor disease codes. Professor Park Mi Hye Director Lee noted, “When applying differentiated refund rate, various side effects, such as erroneous claim, claim omission and the system abuse by the healthcare institute, could break out. Generally considering the detailed execution plan, the indication-basis pricing requires comprehensive revision on the system and other supplementary actions.” Some argue introducing the indication-basis drug pricing to the South Korean market could be a hasty decision at the moment. Director Lee elaborated, “From 2013 through 2017, total 45 novel anticancer treatments were released in the Korean market, and the number indications surged from 265 to 935. So far, only six countries have adopted the indication-basis pricing, although all countries are experiencing the same issue with indications and pricing. It testifies how the system is difficult for everyone accept.” KRPIA official rebutted the claim straight on. Senior Manager Ryu said, “The current billing system in South Korea allows input up to top ten. I beg to differ that the disease code monitoring could get difficult and cause confusion. South Korea is one of the few countries that have successfully unified and systematized the billing system. Only because other countries are not adopting the system, it would not make sense for Korea to be hesitant to take the lead and revise the system.”
- Company
- Korus Pharm is in charge of Russian COVID-19 vaccine
- by Kim, Jin-Gu Nov 17, 2020 06:27am
- COVID-19 vaccine Sputnik V product photo developed by Russia (Photo by BBC) It was confirmed that Korus Pharm, a small and medium-sized pharmaceutical company, is in charge of the Korean production of the Corona 19 vaccine developed by Russia. According to the pharmaceutical industry on the 13th, GL Rapha signed a three-party contract with the Russian Direct Investment Fund (RFID) and Yas Pharmaceuticals of the United Arab Emirates (UAE) for the production and supply of Sputnik V in September. Korus Pharm, a subsidiary of GL Rapha, is responsible for the production and supply of this vaccine. All vaccines produced by Korus Pharm are supplied to the Middle East through Das Holdings, known as a UAE pharmaceutical company. The supply is estimated to be 150 million doses per year. Korus Pharm's main business is the overseas export of antibiotics and generic drugs. The unlisted company's sales last year were about ₩38 billion. Although there is no history of directly developing and producing vaccines, it is reported that the company recently expanded its business to biopharmaceutical research and development and built related facilities. The specific contract amount related to this production and supply contract is not known, but it is estimated to be tens of billions of dollars. Vaccine production is handled by two factories located in Chuncheon and Andong. Although it has not entered full-scale production yet, it is expected that initial shipments will be possible in the first half of next year. However, Korus Pharm explained that there are no plans to sell this vaccine in Korea. An official from Korus Pharm said, "It is a plan to supply all vaccines to the Middle East according to the contract." Earlier, in August, Russia approved the world's first Sputnik V as a vaccine for COVID-19. Since then, Tthe CEO revealed the possibility of Korean production, and attention was focused on where the company was in the domestic pharmaceutical industry. However, domestic vaccine companies and CMO companies denied consignment production of Russian vaccines. GC Pharma, SK Bioscience, Ilyang, Eu Biologics, Celltrion, and Samsung Biologics. Russia chose Korus Pharm, a small and medium-sized pharmaceutical company, over Korean vaccine companies and CMO companies. Russia chose Korus Pharm because the UAE's Yas Pharmaceuticals brokered it. Korus Pharm had exported medicines to the Middle East even before the corona vaccine supply contract.
