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- 2026-04-14 23:24:31
- Company
- Novartis Korea surpassed ₩500 billion in annual sales
- by An, Kyung-Jin Apr 19, 2021 05:55am
- Novartis Korea has surpassed ₩500 billion in annual sales for the first time since entering Korea. Despite the confusion of COVID-19, representative medicines and new products generated synergy, which led to the highest sales ever. According to the Financial Supervisory Service on the 15th, Novartis Korea last year recorded ₩532 billion. With a 7.8% increase in sales compared to the previous year, it achieved the most sales among multinational pharmaceutical companies that entered Korea for the second consecutive year following 2019. This is the first time Novartis Korea has exceeded the annual sales of ₩500 billion since the inauguration of Novartis Korea in 1997. Operating profit was aggregated to ₩5.3 billion, down 12.4% from the previous year. Novartis Korea Novartis Korea is a foreign-invested company established in September 1984 under a joint venture agreement between Dongwha and Swiss pharmaceutical company Sandoz (now Novartis AG). In April 1997, the company changed its name from Sandoz Korea to Novartis Korea. Novartis AG and Novartis Pharma AG own 98.3% of the shares, while Dongwha owns the remaining 1.7%. Among the bad news for Corona 19, new products that were recently released showed high growth, generating the largest sales ever. According to IQVIA, a drug market research organization, the sales of Entresto, a chronic heart failure treatment, were ₩21.7 billion last year, up 64.7% from the previous year. Entresto is a combination drug consisting of two ingredients: Valsartan, an angiotensin receptor blocker (ARB) family, and Sacubitril, a neprilysin inhibitor (NEPI). It is prescribed to reduce the risk of death from cardiovascular disease and hospitalization due to heart failure for chronic heart patients with decreased left ventricular contractile function (NYHA class II-IV). In Korea, since October 2017, it has been receiving benefits as a treatment for chronic heart failure patients whose left ventricular ejection rate has decreased to 40% or less. Psoriasis treatment Cosentyx (Secukinumab) has established itself as a blockbuster product with annual sales of ₩20 billion by introducing a self-injectable pen in addition to the existing PFS. The two types of Cosentyx and Cosentyx Sensoready Pen made a joint venture of ₩20.9 billion, with a 51.5% increase in sales from the previous year. The metastatic breast cancer drug Kisqali (Ribociclib), launched at the end of last year, made the first sales of ₩1.7 billion. Existing representative products are also performing well. ARB-based hypertension combination drug Exforge (Amlodipine Besylate/Valsartan) sold ₩71.4 billion last year. Novartis has the largest sales volume among products sold in Korea. In July 2018, the impurity isuue gave a reflective profit. Macular degeneration treatment Lucentis (Ranibizumab) is also on the rise in sales with the release of PFS type. Last year's sales of Lucentis were ₩37 billion, up 23.0% from the previous year. The DPP-4 inhibitor-based diabetes combination drug Galvusmet (Metformin HCl/Vildagliptin) sold worth ₩31.5 billion last year. Glivec, a leukemia drug, posted sales of ₩41.2 billion. In the process of launching new products, expenditures increased and profitability decreased slightly, but it is evaluated that the sales of existing products and new products harmonized, resulting in stable performance. Novartis Korea is focusing on improving earnings by sorting out some items with relatively low profitability. It handed over the domestic copyright of the anti-epileptic drug Trileptal and the Alzheimer-type dementia treatment Exelon to Handok, and also stopped investing in sales marketing for the rest of the items, including the anti-epileptic drug Tegretol and Parkinson's disease treatment Stalevo and Comtan. It is expected to focus on introducing biologics known as ultra-high-priced drugs such as Zolgensma, a treatment for spinal muscular atrophy (SMA), starting with Kymriah, the first licensed CAR-T treatment in Korea.
- Policy
- Leclaza’s clinical trial targeting Tagrisso is launched
- by Lee, Tak-Sun Apr 19, 2021 05:55am
- 'Leclaza (Lazertinib)', a Korean anticancer drug developed by Yuhan, is conducting a Sponsor Initiated Clinical Trial for patients with non-small cell lung cancer Leptomeningeal metastasis. Since the competitive drug Tagrisso (Osimertinib, AZ) has proven effective in metastasis to the central nervous system such as brain and soft meninges, if this test of Leclaza is successful, it is expected to be competitive in the 3rd generation EGFR-TKI market. The MFDS approved Leclaza's Sponsor Initiated Clinical Trial plan submitted by Seoul National University Hospital on the 5th. This trial is a phase II clinical trial in which Lazertinib and Pemetrexed Disodium Heptahydrate (Alimta) are used in combination in EGFR mutation-positive non-small cell lung cancer with leptomeningeal. Bum-seok Kim, a professor of hematology and oncology at Seoul National University Hospital, applied for approval for a clinical trial. Leclaza was approved as a treatment for patients with EGFR T790M mutation-positive local advanced or metastatic non-small cell lung cancer who had been treated with EGFR-TKI before last January, subject to the submission of Phase III clinical trial. On the 8th, it passed the HIRA's Pharmaceutical Benefits Advisory Committee, the first step in the reimbursement. The final drug price is announced after a drug price negotiation with the NHIS. When the drug price is announced, it is used in earnest for patients. Leclaza is expected to be Tagrisso's competitor. In particular, a fierce fight is expected to unfold in patients who are resistant to second-generation ERFR-TKI treatments such as Iressa, Tarceva, and Alimta. Tagrisso is expanding the market by advocating that it is effective for patients with central nervous system metastasis such as brain and leptomeningeal. As a result of confirming the status of cancer cells through MRI in the BLOOM phase I study, Tagrisso was found to reduce progressive lesions of the central nervous system regardless of the patient's T790M mutation. In particular, it was found to reduce the degree of EGFR mutations in the cerebrospinal fluid (leptomeningeal). In the AURA3 clinical trial using Tagrisso as a second-line treatment, the response rate to brain metastasis was 40%. Therefore, it is analyzed that Tagrisso lowered the risk of death due to metastasis to the central nervous system. In order for Leclaza to compete with Tagrisso, data showing that it is effective in patients with central nervous system metastasis is needed. Therefore, the results of this Sponsor Initiated Clinical Trial are drawing attention. This test was named LAZARUS. It also means 'Lazaros' resurrected by Jesus, and it is expected that Leclaza will become a valuable remedy that can restore life like this.
- Company
- Will ‘Keytruda’ be reviewed for reimbursement in May?
- by Eo, Yun-Ho Apr 16, 2021 06:03am
- MSD Korea threw a game-changer for the reimbursement expansion of the immunotherapy drug ‘Keytruda.’ According to industry sources, the company has once again submitted a revised cost-sharing proposal to the Health Insurance Review & Assessment Service (HIRA) to expand the reimbursement of ‘Keytruda (pembrolizumab)’ to cover first-line treatment of non-small cell lung cancer (NSCLC). With the submission, the industry’s eyes are on whether the issue will put on the agenda for deliberation by the Cancer Drug Review Committee in May. If selected, this will be the 8th discussion held by the Committee for Keytruda. The decision for the drug was put on hold at the committee meeting in August last year as the committee determined that MSD Korea’s proposal lacked compromise on the company’s part. In September of the same year, HIRA handed the proposal back to MSD Korea and requested a 're-revision.' A month later, MSD Korea submitted a re-revised proposal, which was discussed by the Reimbursement Standard Sub-committee meeting but to no avail. The agenda of Keytruda’s reimbursement was not discussed by the Cancer Drug Review Committee. So, once again, MSD Korea submitted a cost-sharing plan to HIRA this year. The proposal submitted by MDS this time contains an offer equivalent to the company ‘covering the initial 3 cycles’ worth of administration cost’ through measures including adjusting the reimbursement rate. If the new cost-sharing proposal is reviewed and, again, rejected by the Cancer Drug Review Committee, expanded reimbursement for Keytruda will likely be difficult to achieve. An MSD official said, “Although we cannot share details as discussions with the government are still ongoing, we will do our best so that our patients in Korea can promptly receive the global standard-of-care treatment.” Meanwhile, MSD Korea has submitted additional applications to expand the indication of its PD-1 inhibitor Keytruda (pembrolizumab) ▲ as first-line treatment in patients with microsatellite instability-high (MSI-h) or mismatch repair deficient (dMMR) advanced colorectal cancer; and ▲ as first-line treatment in combination with platinum-based chemotherapy for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that is not amenable to surgical resection
- Policy
- Korean CMO will produce MNC's COVID-19 vaccine from August
- by Kim, Jung-Ju Apr 16, 2021 06:03am
- A COVID-19 vaccine developed by a multinational pharmaceutical company will be produced by a Korean pharmaceutical company under a CMO deal. The government plans to officially announce the specific company and manufacturing plan in the near future. Young-Ha Baek, head of vaccine procurement at the pan-government vaccine procurement task force, announced the news today (15th) during the morning briefing. In a press gaggle, Baek said, “A Korean pharmaceutical company is currently working out the details on a contract manufacturing organization (CMO) deal to produce a COVID-19 vaccine that has been developed abroad. Under the CMO deal, the vaccine will be manufactured in Korea from August.” However, Baek did not disclose specifics on which company will manufacture how much for distribution, as the talks between the two companies are still in progress. Emphasizing how the deal will increase Korea’s manufacturing capacity, Baek added, “We will promptly organize the details in writing for an official announcement. Also, we will continue to promptly inform the public on matters related to vaccine procurement whenever they arise.”
- Policy
- Nicobreak ODF was approved for the first time in Korea
- by Lee, Tak-Sun Apr 16, 2021 06:02am
- CTC Bio's'Nicobreak ODF', a smoking cessation treatment that melts and eats, was approved for the first time in Korea. this. This product has been confirmed to be equivalent to the existing Champix (Varenicline, Pfizer), which is the same ingredient product. The Ministry of Food and Drug Safety approved two items of Nicobreak ODF1mg/0.5mg of CTCBIO on the 13th. This product is a varenicline, such as Pfizer's Champix, and is used as an adjuvant therapy for smoking cessation. In particular, this drug is the first ODF formulation in Korea that can be dissolved with the tongue without water. Conventional Varenicline tablets should be swallowed with water. Patients with difficulty swallowing or refusal to rehydration feel uncomfortable with the tablets. ODF formulations are expected to increase ease of use by covering the disadvantages of these tablets. After a smoking cessation date is set, this drug should be administered one week before the designated date. Smoking can be started within 35 days from the 8th day after the drug administration. For 1~3 days, 0.5mg once a day, 4~7 days 0.5mg twice a day, 1mg twice a day until the end of the administration after the 8th day. Champix ▲ Pfizer's anti-smoking treatment This drug has been compared to Champix to confirm its equivalence. As a result of measuring the plasma concentration of varenicline in 28 healthy adults taking THIS DRUG and Champix, it was demonstrated that the 90% confidence interval of the mean difference was bioequivalent from log 0.8 to log 1.25. Nicobrec's oral melting film is also different from Champix' salt. This drug differs from Champix's tartrate because it has salicylate. Champix's sales based on IQVIA last year were 20.7 billion won, and it is 10 billion blockbuster drugs despite the decrease in the number of nationally supported smoking cessation. Equivalence check with Champix CTCBIO Nicobreak ODF, a dissolving smoking cessation treatment, succeeded in obtaining approval for the first time in Korea. This product has been confirmed to be equivalent to the existing Champix (Varenicline, Pfizer), which is the same ingredient product. On the 13th, the Ministry of Food and Drug Safety approved two items of Nicobreak ODF 1mg/0.5mg of CTCBIO. This product is a varenicline, such as Pfizer's Champix, and is used as an adjuvant therapy for smoking cessation. In particular, this drug is the first ODF formulation in Korea that can be dissolved with the tongue without water. Conventional Varenicline tablets should be swallowed with water. Patients with difficulty swallowing or refusal to rehydration feel uncomfortable with the tablets. ODF formulations are expected to increase ease of use by covering the disadvantages of these tablets. After a smoking cessation date is set, this drug should be administered one week before the designated date. Smoking can be started within 35 days from the 8th day after the drug administration. For 1~3 days, 0.5mg once a day, 4~7 days 0.5mg twice a day, 1mg twice a day until the end of the administration after the 8th day. This drug has been compared to Champix to confirm its equivalence. As a result of measuring the plasma varenicline concentration of 28 healthy adults taking THIS DRUG and Champix, a 90% confidence interval of the mean difference was within log 0.8 to log 1.25, demonstrating bioequivalence. Nicobreak ODF is also different from Champix' salt. This drug differs from Champix's tartrate because it has salicylate. Champix's sales based on IQVIA last year was 20.7 billion won, which is a 10 billion blockbuster drug despite the decrease in the number of nationally supported cessation cessation applicants.
- Opinion
- [Reporter's view]Controversy over Novavax vaccine
- by Lee, Tak-Sun Apr 16, 2021 06:02am
- The government explained that the Novavax COVID-19 vaccine, which had signed a technology transfer contract with SK Bioscience on the 12th, could be supplied as soon as possible in June. The release of this announcement raised controversy over the introduction of the Novavax vaccine, which has not yet been licensed abroad. Eventually, the conservative opposition party criticized using the people as clinical maruta. As the controversy continued, the government was controversial over the introduction of the ax vaccine before approval the day after the announcement. The government explained that the Novavax COVID-19 vaccine, which had signed a technology transfer contract with SK Bioscience on the 12th, could be supplied as soon as possible in June. The release of this announcement raised controversy over the introduction of the Novavax vaccine, which has not yet been licensed abroad. Eventually, the conservative opposition party criticized using the people as clinical subject of experiment. As the controversy continued, the government refuted the day after the announcement that it had never considered pre-licensing the Novavax vaccine. After reading this controversial article, I couldn't help but laugh. It is not possible at all for Korea to introduce a vaccine developed abroad first. There has not been a case of using overseas drugs developed first under the approval of Korean health authorities. All drugs can be sold only after obtaining approval from the MFDS. The same goes for vaccines. However, the MFDS has so far required to attach a certificate of manufacture and sale of the exporting country when applying for a new drug for import. This is to refer to the case of approval of the exporting country. In early April, the MFDS revised the regulations so that the approval results from exporting countries are not attached when applying for a permit for biological products such as vaccines. The reason is that the MFDS can also be independently screened. According to the regulations, domestic permits were possible without the need for overseas approval. However, there is no possibility that an overseas development company such as Novavax will first apply for a license in Korea instead of in large markets such as the US or Europe. SK Bioscience, which has transferred the technology, can also be approved if it has data from a clinical trial conducted by Novavax. Prior to application for overseas approval, clinical trial results are not shared with other companies in which the technology has been transferred. Among the COVID-19 vaccines, the only basis for the special import of Pfizer vaccine was the case of overseas approval such as the United States and Europe. In order for Novavax vaccine to be introduced in Korea before overseas approval, Novavax should prioritize the small market in Korea, and health authorities or experts must approve the introduction of the vaccine without referencing overseas approval. It is unlikely that this will happen. Health authorities are conservative. If safety or effectiveness is uncertain, it will not be introduced. The safest way is to consult foreign cases, especially FDA or EMA. Pfizer and AstraZeneca vaccines will be the same, and will be introduced in the future. Through this controversy, I feel that the media and politics are too concentrated on the success or failure of the government vaccine introduction. Anyway, in a situation where vaccine development with our technology has not been made, it is inevitable to be attracted to foreign companies. Japan, which has a lot of Big Pharma, does not have a vaccine developed in-house, so it is the same situation as Korea. Accordingly, the timing of the introduction and the overall supply and demand issue are uncertain. It seems pointless to question whether the policy is successful or not. The government should also be honest about the current situation and demand patience from the people. The media should also not criticize the government's policy of introducing vaccines. And we have to reflect on why we didn't make the vaccine on time.
- Company
- Celltrion-Icure applied for permission for Donepezil patch
- by Chon, Seung-Hyun Apr 16, 2021 06:02am
- Celltrion announced on the 13th that it has applied to the MFDS for an item license for the “Donerion patch” for the treatment of Alzheimer's dementia jointly developed with Icure. Donerion patch (Donepezil) is a product jointly developed by bio-venture Icure and Celltrion. In June 2017, after Icure developed and completed the non-clinical and phase 1 clinical trials, it signed a joint domestic copyright contract with Celltrion. Together with Icure, we conducted phase 3 clinical trials in about 400 patients with mild and moderate dementia in 4 countries including Korea, Taiwan, Australia, and Malaysia. Donerion patch is an IMD developed by attaching the oral Donepezil once a day twice a week. Compared to oral drugs, it is evaluated as a product that improves medication compliance and improves convenience. Donepezil is the original medicine by Eisai's Aricept. Celltrion said, "Donepezil is currently only commercialized for oral administration due to the difficulty in formulation development. If the Donerion patch is approved by the Ministry of Food and Drug Safety, it will become the world's first Donepezil patch." Both companies are aiming to commercialize next year after acquiring an item license. The clinical phase 3 of the Donerion patch was conducted for a total of 24 weeks in patients with mild and moderate Alzheimer's dementia. Oral Donepezil or Donerion patch was administered by dividing into a group taking oral Donepezil 5 mg or 10 mg and a group who had never taken Donepezil. Donepezil for oral administration by setting the Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS-cog), a representative standard tool for dealing with memory, language, reconstruction, behavior, and mentality, as a primary efficacy endpoint in mild and moderate Alzheimer's Contrast the Donerion patch proved its non-inferiority. The non-inferiority of the Donerion patch compared to the oral Donepezil was also confirmed in the secondary efficacy endpoints CIBIC-plus, MMSE, CDR-SB, and NPI, which were additionally set to comprehensively evaluate the drug effect in terms of both cognitive and functional improvement. did. Donepezil is the most commonly prescribed ingredient in Alzheimer's dementia treatments. According to UBIST, a drug market research organization, Donepezil accounts for about 30 billion won, 80% of the domestic sales of Alzheimer's dementia treatments in 2020, of about 290 billion won. A Celltrion official said, "As Donerion was developed as the world's first Donepezil patch, it is expected to enter the market quickly with competitiveness differentiated from existing formulations if it obtains approval from the MFDS by improving patient convenience."
- Company
- Vyndamax tries RSA after failing essential drug designation
- by Eo, Yun-Ho Apr 15, 2021 05:56am
- Once again, attempts are in progress to receive reimbursement for 'Vyndamax,' a new drug for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Industry sources said that Pfizer Korea had recently submitted an application for the reimbursement of its new ATTR-CM drug, Vyndamax (tafamidis 61mg). This time, the company conducted the PE assessment and aims to receive reimbursement through the risk-sharing agreement (RSA) scheme. After failing to receive designation as an essential drug earlier this year, the company has quickly supplemented the data to try for reimbursement once again, which shows the company’s determination to be listed for reimbursement. So once again, the industry is keenly eyeing whether Vyndamax, virtually the only ATTR-CM treatment option available in Korea, may finally list its name on the benefits list. Compared to Vyndaqel (tafamidis 20mg), which was listed in October 2018 for the treatment of the hereditary transthyretin amyloid polyneuropathy (ATTR-PN) and therefore targets a very small number of patients, Vyndamax’s indication for the treatment of ATTR-CM includes patients with both hereditary and the wild-type form associated with aging and therefore has a high prevalence. So, these many patients, who have this fatal disease that has a survival period of 2 to 3.5 years without treatment, are currently left unattended as ATTR-CM is known as a disease with a poor treatment performance due to the lack of available treatment options and is commonly mistaken for simple heart failure. However, the efficacy of Vyndamax was demonstrated through the Phase III ATTR-ACT study by reducing the number of cardiovascular events in patients and improving functional athletic ability in the six-minute walk test. Based on the findings, healthcare professionals in Korea are stressing the need to prescribe Vyndamex. As it is a fairly expensive drug, the determination and will of the government and the pharmaceutical company may play a crucial role in the listing. As Pfizer showed the effort to conduct the PE assessment despite its difficult situation demonstrating the drug’s cost-effectiveness, expectations are rising that the two sides will be able to reach an agreement. In the ATTR-ACT study, 441 patients were randomly assigned in a 2:1:2 ratio to receive 80 mg of tafamidis, 20 mg of tafamidis, or placebo. The primary endpoint of the study was hierarchically assessed all-cause mortality, followed by frequency of cardiovascular-related hospitalizations. The secondary endpoint of the study was a change in the 6-minute walk test from baseline to month 30 and the score on the 'Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS),' in which higher scores indicate better health status. Study results showed that all-cause mortality and cardiovascular-related hospitalizations rates were statistically significantly lower in patients who received tafamidis than those who received placebo.
- Policy
- SK's Cosca 25mg was first approved
- by Lee, Tak-Sun Apr 15, 2021 05:56am
- SK Chemical introduces generic for Losartan 25mg earlier than the original. At one time, SK Chemicals had the experience of selling delegated generics of the original Cozaar, so it is drawing attention. On the 14th, the MFDS approved SK Chemical's Cosca25mg (Losartan potassium). Losartan potassium 25mg has been widely used, but it has not been approved so far. Originally, only Cozaar (MSD) 50mg and Cozaar (MSD) 100mg, which are representative products, are available. However, Cozaar (MSD) 25mg is used a lot in certain age groups as an initial dose. For example, Cozaar 25mg is recommended as an initial dose for the elderly over 75 years, dialysis patients, children and adolescents over 6 years old, and patients with excessive blood pressure reduction. Until now, Cozaar 25mg was not available, so Cozaar 50mg had to be split in half for the first dose prescription for that age group. This is uncomfortable for pharmacists when dispensing them, and there is a risk of contamination. The reason why this product is attracting attention is also that SK Chemicals sold entrusted generics through co-marketing with MSD in the past. SK chemicals received products from MSD Korea from 2008 to 2012 and sold them under Cosca. It was delegated generic for Cozaar. However, the partnership was ended in 2012, and after that, through a change of license, the company's factory is producing generics that have been verified to be equivalent to the original. It became a competitor to MSD. Cozaar and Cosca are long-established drugs among ARB-based hypertension drugs. Since many new drugs of the same series have been released so far, sales have decreased significantly compared to the initial release. Based on UBIST last year, Cozaar recorded ₩27.9 billion and Cosca recorded ₩3.4 billion. Before the release of generics, Cozaar exceeded ₩70 billion, and Cosca was the only generic over ₩10 billion. It is noteworthy whether SK Chemicals will recover Losartan's past sales through this product.
- Company
- Measures for the reimbursement of advanced therapies
- by Apr 15, 2021 05:56am
- The release of the CAR-T treatment ‘Kymriah (tisagenlecleucel)’ in Korea was met with both anticipation and concerns. The drug itself is undeniably an innovative drug that can offer new opportunities to blood cancer patients with short life expectancy. However, the challenge lies in how this innovative new drug that costs 500 million won per dose should be listed for reimbursement in Korea’s healthcare system. Clearly, these advanced drugs cannot be evaluated under the same standards as existing drugs. The development trend of new drugs has already shifted towards the treatment of severe or rare diseases, and gene and cell therapies that combine new science and technology occupy a large proportion of development. Therefore, a new model that may reasonably evaluate the price of ultra-expensive drugs is necessary to accommodate the changing environment. Then, what limitations and changes has the industry seen and desired in Korea’s reimbursement environment? To hear the voices in the field, Dailypharm held its 41st Pharmaceutical Industry Future Forum, "Finding the correct solution for the ultra-expensive drug listing system," at its Moonjeong-dong office. Dr. Hyung-Ki Lee, Professor of Clinical Pharmacology and Therapeutics at the Seoul National University Hospital, chaired the event. Also, various industry and government officials including Kyung-Ho Choi, Deputy Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare; Min-Young Kim, Director at Korean Research-based Pharma Industry Association (KRPIA); Hyeon-Seok Na, Senior Manager at JW Pharmaceutical Corp.; and Jae-Ho Jeong, Department Head at Novartis Korea attended the event to share their views on the matter. (from the left) Dr. Hyung-Ki Lee, Professor of Clinical Pharmacology and Therapeutics at the Seoul National University Hospital; Kyung-Ho Choi, Deputy Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare; Min-Young Kim, Director at Korean Research-based Pharma Industry Association (KRPIA); Hyeon-Seok Na, Senior Manager at JW Pharmaceutical Corp.; and Jae-Ho Jeong, Department Head at Novartis Korea attended Dailypharm’s 42nd Future Forum. ◆'Advanced therapies that cost hundreds of millions of won may deliver value beyond their cost = Kymriah was tagged as an ‘ultra-expensive' drug as its single injection costs 500 million won. However, Jae-Ho Jeong, Department Head at Novartis Korea, expressed his opposition to the view. Unlike conventional drugs that should be taken annually or on a regular cycle, one can expect a full cure with a single injection of Kymriah, which ultimately would reduce the total cost invested in treatment. “We need to consider whether Kymriah is really an ultra-expensive drug from the financial aspect,“ said Department Head Jae-Ho Jeong. “Other orphan drugs that cost 400–500 million won per year are also listed as reimbursement. The only difference is, with Kymriah, one can expect to reach complete remission with a single injection.” He added, “The value of Kymriah lies in that it can provide the return to daily lives for patients who were non-responsive to existing treatments and therefore left with only several months of to live at most. We need to reconsider drawing the line just because a drug is expensive.” In fact, Kymriah achieved complete remission (CR) in 82% of the young adult and pediatric patients with acute lymphoblastic leukemia (pALL) within 3 months of its administration. The patients were relapsed and refractory patients with a life expectancy of only 6 months. Emily, a pediatric patient who participated in the first trial of Kymriah, is currently living a normal life after receiving Kymriah 9 years ago. Like Kymriah, advanced therapies such as CAR-T cell therapies and gene replacement therapies allow patients to dream of the long-awaited ‘cure.’ ‘Zolgensma,’ a gene replacement therapy, can cure the rare disease spinal muscular atrophy (SMA) with a single dose. ◆The need for a personalized reimbursement system = Rather than introducing a completely new system, industry experts have suggested implementing measures that may allow for more flexible use of the existing system, in other words, a personalized reimbursement system. KRPIA director Min-Young Kim referred to the U.K. as an example. For rare diseases that are chronic, severely disabling, and require life-long treatment, the U.K.’s Highly Specialised Technologies (HST) evaluation system weighs the quality-adjusted life-year (QALY) gain and allows a QALY index of 3 if the gain is 30 QALY or more. Also, the Patient Access Scheme (PAS) and Confidential Commercial Arrangement (CCA) implements a kind of risk-sharing system for drugs that have not been able to receive an ultimate value judgment from NICE or drugs with a large difference in ICER due to different health benefits per drug or indication. Also, a Cancer Drug Fund (CDF) system provides funding for oncology drugs that are not recommended by NICE for reasons of clinical uncertainty during the drug's data collection period “Like the U.K., Korea also needs segmentized, personalized policies so as to provide the opportunity for a full cure to patients with severe rare and incurable diseases,” said Kim. He continued, “In terms of patient accessibility, we may consider using systems like the ‘pre-listing post-evaluation' system. Financial uncertainty can be resolved by collecting information on the use amount based on real-world data during the pre-listed period, and then evaluating once the period is over. Also, customized systems that price drugs by indication or the trade-off system may also be used.”
