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- 2026-06-24 09:41:47
- Company
- SK Life Science’s sales rise tenfold in 5 years in the US
- by Chon, Seung-Hyun Mar 20, 2024 05:44am
- SK Biopharmaceuticals' U.S.-based subsidiary posted sales of nearly KRW 500 billion last year. The sales of its epilepsy drug cenobamate increased in the U.S., increasing the company’s sales by over tenfold in 5 years. According to the Financial Supervisory Service on Tuesday, SK Life Science’s sales totaled KRW 49.9 billion last year, up 26.5% from the previous year. SK Life Science is a wholly-owned subsidiary of SK Biopharmaceuticals. It is in charge of the U.S. sales of cenobamate, a new drug developed by SK Biopharmaceuticals. Annual sales of SK Life Science (Unit: KRW 100 million, Data: FSS) SK Life Science’s sales have been showing strong growth, up 83.7% in 2 years since posting KRW 267.2 billion in 2021. Its sales have expanded more than tenfold in five years from a mere KRW 47.5 billion it generated in sales in 2018. This is in part due to the surge in sales of its new epilepsy drug cenobamate in the United States. Xcopri, which contains cenobamate, is an epilepsy drug independently developed by SK Biopharmaceuticals and sold in the United States. It is prescribed for the treatment of partial-onset seizures in adults in the U.S. Its mechanism of action relieves seizure symptoms by simultaneously regulating two targets related to excitatory and inhibitory signaling, which are causes of epilepsy. SK Biopharmaceuticals had independently performed the whole course of Xcopri’s development and commercialization from early development to U.S. Food and Drug Administration (FDA) approval. The company received approval for its cenobamate under the brand name ‘Xcopri’ in November 2019, and has been selling the drug through SK Life Science since May 2020. Last year, cenobamate’s U.S. sales reached KRW 270.8 billion, up 60.1% YoY. In 2021, cenobamate posted sales of KRW 78.2 billion, more than tripling in 2 years. SK Life Science has about 150 medical representatives. Epilepsy is a condition that is treated by a small number of focus specialists in the United States. Due to the small number of target physicians, the company was able to sell the drug directly in the U.S. with such a small sales force. SK Life Science’s marketing center, which consists of sales and marketing personnel, has experts with more than 20 years of experience in successfully launching and selling epilepsy treatments and major central nervous system drugs at Johnson & Johnson, UCB, and other leading companies in the U.S. CNS market. Quarterly sales of Xcopri in the US (Unit: KRW 100 million, Data: FSS) With the rise in cenobamate’s sales, SK Life Science’s parent company has also increased its operating expense support. Last year, SK Life Science's revenue included KRW 220 billion in operating expenses paid by its parent company SK Biopharmaceuticals. SK Biopharmaceuticals earned revenue by supplying SK Life Science with cenobamate. The company pays SK Life Science a certain amount of operating expenses each year, which are reflected in SK Life Science's revenue, according to the company. The company said, "The number of prescriptions in December last year, the 44th month of cenobamate’s launch, was about 26,000, which is about 2.2 times the number of prescriptions made in the 44th month by its competitors. We will work to accelerate growth by increasing the number of monthly prescriptions to over 30,000 this year.”
- Company
- Sales of Tagrisso stay strong, Leclaza rises in lung cancer
- by Mar 20, 2024 05:44am
- In the EGFR-positive non-small cell lung cancer (NSCLC) treatment market, Leclaza’s sales growth stood out amid strong sales of Tagrisso. Tagrisso and Leclaza are both third-generation targeted therapies, and the two were approved as a first-line treatment for lung cancer this year and were given the green light to expand sales. Among first- and second-generation targeted therapies, all drugs other than Giotrif posted sluggish sales last year. According to the market research institution IQVIA on the 20th, Tagrisso generated sales of KRW 111 billion last year, up 4.2% YoY. Tagrisso is a third-generation tyrosine kinase inhibitor (TKI) that was developed by AstraZeneca. EGFR-positive lung cancer treatments are categorized into four types: first-generation EGFR TKIs like AstraZeneca's Iressa (gefitinib) and Roche's Tarceva (erlotinib); second-generation EGFR TKIs like Boheringer Ingelheim's Giotrif and Pfizer's Vizimpro (dacomitinib); and third-generation EGFR TKIs like Leclaza (lasertinib) and AstraZeneca's Tagrisso (osimertinib). Sales of Tagrisso, which exceeded the KRW 100 billion mark in sales in 2020, have remained stagnant for 2 years. After reaching KRW 106.5 billion in 2020, the drug posted similar sales in 2021 and 2022. After working to receive reimbursement for the drug as a first-line treatment for years, AstraZeneca received the reimbursement approval this year as a first-line treatment for EGFR-positive lung cancer, and this is also expected to expand sales. Moreover, Tagrisso is also the only third-generation TKI to be approved for use in early-stage lung cancer. In December last year, Tagrisso was approved as an adjuvant therapy for patients with EGFR exon 19 and exon 21 mutated NSCLC after complete resection. In the phase III ADAURA study, Tagrisso was shown to reduce the risk of death by 51% compared to conventional therapy. Powered by the advantages, Tagrisso’s sales are expected to increase further in the coming years. Leclaza posted sales of KRW 22.6 billion last year, up 40.3% YoY. Leclaza, which was approved in Korea in January 2021, was also granted reimbursement the same year. After posting KRW 4.1 billion in sales in Q2, it posted sales of KRW 16 billion the following year, then surpassed KRW 20 billion last year. Leclaza’s approval as a first-line treatment for EGFR-positive NSCLC in July last year is analyzed to have contributed to the rise in sales. Before the approval, patients had to be confirmed to be T790M-positive through an additional tissue test after using a first- or second-generation EGFR TKI to be eligible to use Leclaza with reimbursement. With all 3 TKIs, including Leclaza and Tagrisso, now covered as first-line treatments, physicians and patients will have a full range of first- and third-generation targeted therapies to choose from. Another benefit of Leclaza is its potential for use in combination with Rybrevant. Combination therapies, including Tagrisso plus platinum-based chemotherapy and Rybrevant plus platinum-based chemotherapy, are currently approved by regulatory authorities abroad for the first-line treatment of lung cancer. Combining the use of Leclaza, which targets EGFR-mutated exon 19 and exon 21 deletion, with Rybrevant, which targets exon 20 deletion, has been attracting attention as a viable targeted therapy combination. Currently, the Leclaza + Rybrevant combination is being reviewed for approval in the US as a first-line treatment for lung cancer. Sales of all first-generation EGFR TKIS other than Giotrif decline During the same period, first- and second-generation TKIs saw sluggish growth. Only Giotrif’s sales showed growth, while all others declined. Giotrif generated KRW 27.2 billion in sales last year, up 5.8% from 2022. Since its launch in Korea in 2014, Giotrif has seen a gradual but steady increase in sales. After surpassing the KRW 10 billion mark in sales for the first time in 2017, Giotrif posted sales of KRW 16.6 billion in 2019, KRW 22 billion in 2021, and KRW 25.7 billion in 2022. Giotrif benefited how third-generation TKIs not being used as first-line treatments. On the other hand, Vizimpro’s sales had been sluggish. Vizimpro, which had been released later in 2020, had increased slightly to KRW 1.4 billion in 2021 and KRW 2.8 billion in 2022, but stagnated at KRW 2.7 billion last year. The weakness of Vizympro is in its side effects. In the ARCHER 1050 study, the Phase III trial that became the grounds for its approval, Vizympro showed better efficacy compared to first-generation TKIs, but also a higher rate of adverse events. 60% of patients in the Vizympro arm required dose adjustments due to adverse events. In general, first-generation TKIs are continuing to show declining sales. First, Iressa posted sales of KRW 12.7 billion last year, down 9.2% YoY. Sales have been on a steady decline since 2020 when sales fell below KRW 20 billion (USD 19.6 billion). Iressa posted KRW 16.7 billion in sales in 2021 and KRW 14 billion in 2022. Iressa is known to be a milder cancer drug with fewer side effects among targeted therapy options. As such, it has been used as a priority in patients with relatively poor health. However, sales have been declining with more treatment options becoming available, with latecomers confirming their efficacy over Iressa. Tarceva’s sales fell 13.8% YoY to KRW 3.1 billion last year. This is the fifth consecutive year the drug saw declining sales after posting KRW 8.2 billion in 2019. Compared to the KRW 17.3 billion it had earned in 2016, Tarceva’s sales have more than halved. Tarceva’s sales are also on a decline due to the emergence of more effective second and third-generation targeted therapies. Tarceva also suffered a setback in 2016 when its maintenance therapy indication was removed for patients with stage IIIA or higher NSCLC. Also, Tarceva was not proven effective in retrospective clinical studies. Therefore, its sales are expected to continue to decline when combined targeted therapies are approved for use in the first line.
- Company
- Professor Yoo discovers specific protein expression in HCC
- by Lee, Tak-Sun Mar 19, 2024 05:45am
- Professor Changhoon Yoo, Department of Oncology, Asan Medical Center On the 15th, CMIC Korea, a contract research organization (CRO), announced that the results of the RENOBATE (IIT, Phase II) trial led by Professor Changhoon Yoo (Department of Oncology, Asan Medical Center) were recently published in the international academic journal, Nature Medicine (IF=82.9). This is the first time the results of a clinical study conducted by a Korean researcher have been published in Nature Medicine. In the RENOBATE 42 patients with hepatocellular carcinoma were administered the immunoconology drug regorafenib in combination with the targeted anticancer drug nivolumab. The study used circulation tumor DNA and single-cell RNA sequencing analysis to identify the characteristics of immune cells expressed in patients who did not respond to the combination therapy. The recent development of immuno-oncology drugs, also known as 3rd generation anticancer drugs, that offer better anticancer effects with less toxicity and side effects, has raised hopes for many cancer patients. However, 3 out of 10 patients with HCC were either not responding to or getting worse with the use of targeted anticancer drug+immune-oncology drug combination therapy. The RENOBATE study found that these patients had more than 2 times more expression of a specific protein called TMEM176A/B. This is very promising news for HCC patients who were unable to see much effect with the use of existing anticancer therapies and raises expectations for further developments. The study, which has raised the profile of Korea’s anti-cancer research, was initiated by Professor Changhoon Yoo in 2019 with his collaborators and was completed 3 and a half years later in late 2022. Even though the study was an investigator-initiated trial, which usually has a small amount of research funding, CMIC Korea, the first clinical contract research organization (CRO) in Korea, took charge of monitoring, data management, and clinical analysis to ensure and collect accurate and ethical clinical research data. According to Professor Yoo, this has helped improve the credibility of his research, which has been recognized by peer review and Nature Medicine. This has also been mentioned in the methodology part of the paper as well. Professor Yoo said, "We will continue on our efforts to support patients suffering from incurable diseases through reliable clinical research."
- Company
- Celltrion rolls out Zymfentra in the U.S.…its 1st new drug
- by Chon, Seung-Hyun Mar 19, 2024 05:44am
- On the 18th, Celltrion announced that it had launched Zymfentra, a subcutaneous (SC) formulation of infliximab, in the United States. Pic of Zymfentra Zymfentra is a subcutaneous injection formulation of Celltrion's infliximab. The company received approval from the U.S. Food and Drug Administration last year for its use as a treatment for patients with ulcerative colitis or Crohn's disease. Zymfentra is currently approved and marketed in Europe under the brand name Remsima SS. The original infliximab product is Remicade. Zymfentra’s wholesale price has been set at $6,181 (for 2 doses, 4 weeks). A Celltrion official said, “Based on Zymfentra’s new drug status, the price of competitors in inflammatory bowel disease, and the characteristics of the U.S. pharma-biotech market, we have set an optimal price for us to carry out an effective sales strategy.” If the company’s patent applications for Zymfentra’s SC formulation and method of administration are granted and registered, the drug will receive patent protection by up to 2040. According to the market research institution IQVIA, the U.S. market for TNF-α inhibitors, which includes infliximab, has been valued at approximately KRW 62.06 trillion in 2022. The IBD market, which is the company’s area of focus for Zymfentra, had been valued at KRW 12.8 trillion. Celltrion aims to raise the prescription rate of Zymfentra to reach at least 10% of its target patient population by the second year, 2025, and establish Zymfentra as a global blockbuster that brings in over KRW 1 trillion in annual sales. Celltrion plans to sell Zymfentra directly through its U.S. subsidiary. A Celltrion official said, “Already, several small and mid-sized payers have recognized Zymfentra’s competitivity and have added the product to their formularies without negotiation, laying the groundwork to expand prescriptions.”
- Opinion
- [Reporter’s View] Let Enhertu’s case guide new listings
- by Eo, Yun-Ho Mar 19, 2024 05:44am
- The reimbursement listing of the advanced ADC anti-cancer drug Enhertu is imminent. The company completed drug pricing negotiations with the National Health Insurance Service at a ‘superfast’ speed when considering the slow progress it had made during previous procedures. At this pace, Enhertu is likely to be reimbursed in April this year. After passing HITA’s Cancer Disease Deliberation Committee last year, Enhertu’s reimbursement agenda was rejected by the Drug Reimbursement Evaluation Committee 8 times and was unable to cross the threshold until February this year. But its pricing negotiation took less than one month. This is both encouraging and unusual. Adding on to the wonder, the ICER threshold that the government had set for Enhertu is likely above KRW 50 million. Due to its superior efficacy, the company had difficulty calculating Enhertu’s cost-effectiveness. This is also the reason why it took a long time for the drug’s reimbursement agenda to be submitted to DREC, because the Economic Evaluation Subcommittee was unable to conclude on cost-effectiveness for a long time. The fact that this good drug with a high threshold passed the DREC review signifies that the government set an ICER threshold to pass the drug. Although there is no documented figure, it is generally accepted that the maximum ICER granted for reimbursement in Korea is KRW 50 million. And even the KRW 50 million threshold is known to have been granted very few times. Raising the ICER threshold has been a long-standing desire of the pharmaceutical industry. In a study published last year in the online edition of the medical journal Springer, "An Industry Survey on Unmet Needs in South Korea's New Drug Listing System," the ICER threshold was the No.1 improvement desired by market access managers in the industry. 93% of the respondents chose so. Improving the ICER threshold also topped the list of benefits the government promised to provide as preferential drug pricing measures for innovative new drugs last year. Enhertu’s case rose to attention amid such a trend. Other factors did take part in the incredibly rapid progress made in its drug price negotiations. When considering the given conditions, the pricing negotiation for Enhertu could not have gone so easily. This is why some analysts have been suggesting that the political pressure had played a role ahead of the general elections. However, regardless of the pace, Enhertu has set a promising example for other companies that need to pass pharmacoeconomic evaluations. Enhertu’s case should not end as a one-time event; rather, it should serve as a milestone for other cases to come.
- Policy
- Liver cancer therapy, ‘Stivarga’ set for 2nd RSA renewal
- by Lee, Tak-Sun Mar 19, 2024 05:44am
- Stivarga. It has been reported that a risk sharing agreement (RSA) has been renewed for the second time for Stivarga (regorafenib; Bayer Korea), a second-line treatment for liver cancer. The news comes two months before the reimbursable RSA contract for Stivarga is set to expire on May 31st. According to industry sources on the 18th, the National Health Insurance Service (NHIS) agreed to renew a RSA with Bayer for Stivarga. Under the RSA, Stivarga is expected to receive reimbursement for five years until May 2029. Stivarga was first listed In June 2016 as reimbursable under RSA for the first time for treating gastrointestinal stromal tumor (GIST). Then, since May 2018, it has been reimbursable through RSA for a second-line treatment for hepatoma. In May 2020, Stivarga successfully received the first contract renewal. The contract duration is four years until May 31st, 2024. At the time of the first renewal, Stivarga’s list price was reduced by 7%. After the price cut in January 2022, the current maximum list price is KRW 303,868. It has not been confirmed whether it will receive a price cut in the list price in this contract renewal. However, it is anticipated that there will be a change in the actual price. Stivarga is a second-line treatment for liver cancer, used after Nexavar, the first-line treatment. Its out-patient prescription amount was KRW 9.3 billion won, down 24% from the previous year. Overall sales of existing targeted anticancer therapies are slowing down as immunotherapy with reimbursement emerged. According to Real World Data, which involved 182 Asian patients (Korea, China, and Taiwan), median Overall Survival (OS) with Stivarga was 16.3 months, an improvement of about 54% compared to the previous Phase 3 clinical study, ‘RESORCE.’
- Company
- New CKD drug Kerendia is reimbursed in Korea
- by Son, Hyung-Min Mar 18, 2024 05:50am
- Sunggyun Kim, Professor at Hallym University Sacred Heart Hospital (Secretary-General, The Korean Society of Nephrology) Whether the reimbursement coverage of Bayer’s Kerendia will help address the unmet needs of patients with chronic kidney disease with type 2 diabetes, is gaining attention. Until now, blood pressure medications and diabetes drugs have been used to treat chronic kidney disease, but the introduction of Kerendia has expanded the treatment options. Supported by its proven clinical efficacy, the drug is expected to be more widely used by patients with chronic kidney disease. On the 15th, Bayer Korea held a press conference to celebrate the launch of Kerendia (finerenone) for chronic kidney disease with type 2 diabetes in Korea. Kerendia is a first-in-class, selective, non-steroidal mineralocorticoid receptor antagonist(MRA) that has a novel mechanism of action that inhibits the overactivation of mineralocorticoid receptors, which can cause inflammation and fibrosis in the kidneys and blood vessels. Overactivation of mineralocorticoid receptors causes inflammation and fibrosis in the kidneys, which can lead to deterioration of kidney function and cardiovascular disease. The drug was granted reimbursement in combination with ACE inhibitors and ARBs for adult patients with type 2 diabetes who have been taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) for at least 4 weeks but ▲have an albumin-to-creatinine ratio (uACR) >300 mg/g or a positive urine dipstick test (1+), or ▲have an estimated glomerular filtration rate (eGFR) of at least 25 but less than 75. Kerendia’s reimbursement approval was based on the reduction in kidney disease progression, cardiovascular benefit, and safety that was demonstrated through the Phase III trials FIDELIO-DKD and FIGARO-DKD. The FIDELIO-DKD study evaluated the safety and efficacy of Kerendia compared with placebo in 13,171 adult patients with type 2 diabetes in 48 countries. Over a median follow-up of 3 years, Kerendia reduced the composite cardiovascular endpoint (cardiovascular death, nonfatal myocardial infarction, and stroke, etc) by 14%, and the renal composite endpoint (occurrence of a sustained decline in eGFR below 15 Ml for at least 4 weeks, chronic dialysis, and kidney transplantation) by 23%. Results were consistent with and without treatment with GLP-1 receptor agonists and SGLT-2 inhibitors at baseline. Kerendia also demonstrated significant risk reduction in the cardiovascular composite endpoint in the FIGARO-DKD study, which included patients with Stage I and II chronic kidney disease. Yong-Ho Lee, Professor of Endocrinology and Metabolism at Severance Hospital (Secretary General, Korean Diabetes Association), said, “We have been using GLP-1 receptor agonists, SGLT-2 inhibitors, and blood pressure medications on chronic disease patients with diabetes, but there always remained a residual risk of chronic kidney disease in the patients. SGLT-2 inhibitors do not completely reduce proteinuria, but Kerendia's efficacy, which was demonstrated through multiple clinical trials, makes the drug an important treatment option for patients with chronic kidney disease.” Sunggyun Kim, Professor at Hallym University Sacred Heart Hospital (Secretary-General, The Korean Society of Nephrology), said, “ The American Diabetes Association guidelines recommend a reduction in uACR of at least 30%, and Kerendia reduced the average uACR by 32% compared to placebo in the first 4 months of treatment. Therefore, the drug can be considered in priority for patients with kidney disease."
- Company
- NMOSD drug Enspryng can be prescribed at general hospitals
- by Eo, Yun-Ho Mar 18, 2024 05:50am
- Enspryng, a new drug for neuromyelitis optica spectrum disorder (NMOSD) is landing in general hospitals in Korea. According to industry sources, Roche Korea's Neuromyelitis Optica Spectrum Disorder (NMOSD) drug Enspryng (satralizumab) has passed the drug committees (DCs) of tertiary hospitals including Seoul National University Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, as well as medical institutions including the National Cancer Center, Chonnam National University Hospital, and Chungnam National University Hospital. In addition, the drug can be prescribed in an increasing number of medical institutions that inserted the drug code through emergency DC meetings to prescribe Enspryng. As such, the drug’s prescriptions have been increasing steadily after being granted reimbursement in December last year. Enspryng was approved in Korea in the first half of 2021, after which the company submitted an application for its reimbursement in the second half of 2022. However, due to its high price, the company faced considerable difficulties in setting its reimbursement standards and financial sharing plans. The company had first adopted the strategy of accepting the weighted average price (WAP) of its alternative, AstraZeneca’s ‘Soliris (eculizumab),’ but due to a delay in Soliris’s reimbursement listing process for NMOSD, the company turned to the pharmacoeconomic evaluation exemption track for its reimbursement. After switching to the PE exemption track, the agenda passed HIRA’s Drug Reimbursement Evaluation Committee in August and completed pricing negotiations with the NHIS in November of the same year. However, its reimbursement is currently limited to its use as a ‘fourth-line or later’ therapy. Currently, the immunosuppressant azathioprine is used as first-line maintenance therapy for NMOSD. If a patient fails treatment with azathioprine, mycophenolate, or rituximab is prescribed with reimbursement as second-line therapy. Both mycophenolate and rituximab are off-label drugs that do not have NMOSD indications. In other words, Enspryng can only be used as fourth or later-line therapy in patients who fail treatment with rituximab in the third-line. Therefore, it remains to be seen whether the company will seek to extend reimbursement for Enspryng after listing. Meanwhile, Enspryng’s efficacy was demonstrated through SAkuraStar and SAkuraSky clinical trials that were conducted on adult patients with anti-aquaporin(AQP4) antibody-positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody-positive subgroup, 76.5% of Enspryng-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with standard immunotherapy, 91.1% of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.
- Policy
- Sotyktu, Adtralza set for reimbursement listing
- by Lee, Tak-Sun Mar 18, 2024 05:49am
- Sotyktu. Two drugs, plaque psoriasis drug 'Sotyktu (deucravacitinib)' and atopic dermatitis drug 'Adtralza (tralokinumab)' have completed the negotiation with the National Health Insurance Service (NHIS) and may soon be listed for reimbursement. Additionally, the upper price limit of Soliris (eculizumab) is expected to be reduced following the expansion of reimbursement for neuromyelitis optica. According to industry sources on the 15th, Sotyktu and Adtralza concluded negotiations with the NHIS to receive reimbursement. Sotyktu is the first TYK2 inhibitor to be approved in South Korea for treating adult patients with moderate to severe plaque psoriasis. It is administered orally once a day for convenience. The drug was approved by the Ministry of Food and Drug Safety (MFDS) last August and cleared the review by the Drug Reimbursement Committee of the Health Insurance Review and Assessment Service (HIRA) in December. BMS Pharmaceutical, the company for Sotyktu, agreed to the evaluation price suggested by the Drug Reimbursement Committee. Notably, the company accepted an amount below the standard for negotiation exemption, solely negotiating for the anticipated claim amount. BMS Pharmaceutical and Yuhan recently made a joint promotion agreement for Sotyktu. When the drug gets listed on reimbursement next month, Sotyktu will likely be distributed through the marketing network of Yuhan-BMS. Adtralza. LEO Pharma’s 'Adtralza' is a treatment for atopic dermatitis with an underlying mechanism of neutralizing interleukin-13 (IL-13). Adtralza approval is expected to expand the treatment options for atopic dermatitis as Dupixent (dupilumab) is the only biologic available for treating the disease. Like Sotyktu, Adtralza is expected to be listed for reimbursement after one year of approval. It was approved last August and cleared for review by the Drug Reimbursement Committee in November Adtralza began negotiations with the NHIS in last November and it has recently come to an agreement. Currently reimbursed for atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH), Soliris is expected to receive approval for additional reimbursement for neuromyelitis optica spectrum disorder (NMOSD). Soliris is under pre-review by the HIRA. It is reported to be a high-priced new drug, valued at approximately KRW 500 million. Since 2015, the financial burden of the drug has been mitigated through Risk Sharing Agreements (RSA) but transitioned to regular listing in October 2019. Soliris. The company submitted the request for expanding Soliris’ reimbursement to neuromyelitis optica in 2021, but it took some time to be listed for reimbursement. After concluding negotiations with the NHIS, the coverage by reimbursement is expected to begin next month. With the reimbursement expansion, the current upper price limit of KRW 5,130,000 is expected to be reduced.
- Opinion
- [Reporter’s View] 'Tylenol,' no longer produced,
- by Lee, Hye-Kyung Mar 18, 2024 05:49am
- Twelve years have passed since the government desginated over-the-counter emergency medicines. On November 15, 2012, the government implemented 13 over-the-counter (OTC) emergency medicines, including antipyretic analgesics, gastrointestinal medicine, and patches. When designating 13 OTC emergency medicines, the government based its evaluation primarily on consumer ‘brand awareness,’ meaning medicines with high name recognigtion and a long history of use, allowing consumers to choose the brand. The current list of OTC emergency medicines includes Tylenol Tab 500 mg, Tylenol Tab 600 mg, Children's Tylenol Suspension, Brufen Syrup for Children, Pancol A Sol, Panpyrin-T Tab, Bearse Tab, Dr. Bearse Tab, Festal Gold Tab, Festal Plus Tab, Jeil Cool Pap, and Sinsin Pas Arex. Since the initial designation of OTC emergency medicine, the list has not been updated once. In July 2012, the Ministry of Health and Welfare (MOHW) stated they would make an interim evaluation after six months and re-organize the pharmaceutical items after a year. Additionally, if necessary, there can be a withdrawal of designation or additional designations according to the Pharmaceutical Affairs Act, which states that OTC emergency medicine can include ‘less than 20 items, not fixed to 13 items. However, the list still includes the drugs that can no longer be manufactured in South Korea as the manufacturing plant shutdown, and the government is reviewing on the withdrawal of those OTC emergency medicines for eight months. The Ministry of Food and Drug Safety (MFDS) approved discontinuances of ‘Children's Tylenol Tab 80 mg’ and ‘Tylenol Tab 160 mg’ on March 21, 2022. The reason for discontinuance is the manufacturing plant shutdwon due to relocation to overseas. Previously, the MOHW stated that despite the MFDS’s approval of withdrawal, they can not decide to withdraw OTC emergency medicines because the stocks are still in the market. As the stocks ran out in convenience stores last October, the MOHW has organized an expert advisory group. Two years have passed since two OTC Tylenol emergency medicines were voluntarily withdrawn. We hope that the expert advisory group will discuss not only the withdrawal of Tylenol from the list but also the designation of alternative medicines and the reorganization of the OTC emergency medicines list.
