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- 2026-04-06 23:29:23
- Policy
- Reevaluation of foreign drug price comparisons
- by Lee, Tak-Sun Aug 21, 2024 05:47am
- HIRA President Jung-Gu Kang The Health Insurance Review and Assessment Service (HIRA) announced that drug prices will be adjusted in the second half of next year by reevaluating foreign drug price comparisons. This year, an announcement about reevaluation will be made, and the HIRA will conduct the evaluation in the first half of next year. On August 20th, President of the HIRA Jung-Gu Kang announced this during a meeting with journalists. Kang said, "We have had ten meetings so far to discuss about detailed criteria related to the reevaluation of foreign drug price comparisons with the pharmaceutical industry." Kang explained, "Based on discussions, the final plan for reevaluation will be shared with the industry when prepared." The plan for reevaluation of foreign drug price comparisons is under review after the tenth meeting on August 5th. The products to be compared in the first year include 6467 items, including gastrointestinal medications, hypertension medications, and antibiotics. The average adjusted price, excluding the highest and the lowest, from A8 countries (U.S., U.K., France, Germany, Japan, Italy, Switzerland, and Canada) will be used as the reference price. The pharmaceutical company has suggested taking a 50% reduction from the drug price reduction portion and excluding Germany and Canada, which employ reference-pricing systems. Whether the final plan would reflect the industry's opinion garners attention. Kang said, "There will be a reevalutation this year." Kang added, "After the final evaluation, drug price adjustments will be implemented in the second half of next year." He drew a line to further delays in reevaluating foreign drug price comparisons. Kang explained the new drug innovative value revisions reflected in the recent Drug Reimbursement Evaluation Committee (DREC) review on August 8th. He stated, "The risk-sharing agreement (RSA) scope has been expanded to include drugs used for severe, difficult-to-treat diseases. Additionally, when expanding the reimbursement criteria for RSA-designated drugs, if the additional claim amount is less than KRW 1.5 billion, the evaluation by the DREC can be waived, allowing for faster reimbursement processing." Additionally, "The scope and criteria for assessing 'innovativeness,' which is one of the ICER value evaluation factors, will be specified for drugs that 'cannot be substituted or have no therapeutic equivalent products or treatments available. We have also clarified the process for evaluating the clinical value of drugs receiving RSA of outcome-based and reimbursable type." In answering the maximum ICER value to be applied, Kang said, "We will consider the individual drug's nature, and the maximum price has not been set." Regarding the second round of the pilot project for concurrent approval-reimbursement evaluation-drug price negotiations, Kang explained that the selection of drugs for the second round of the pilot project would be based on careful consideration of disease severity, the availability of alternative treatments, and treatment efficacy. This process will involve discussions with the government agencies (Health Insurance Review & Assessment Service (HIRA), the Ministry of Health and Welfare (MOHW), the Ministry of Food and Drug Safety (MFDS), and the National Health Insurance Service (NHIS)), as well as consultations with experts. The first round of the pilot project included Bilberry capsule and Qarziba, which are under review for reimbursement evaluation. However, the drug price listing of Qarziba has been delayed due to receiving the non-reimbursement decision from the DREC review in August. Kang explained, "There have been achievements such as reduced supplementary periods," and added, "Although there had been variables, we will make efforts to expedite the timing of reimbursement listings through concurrent evaluations by the MFDS, the HIRA, and the NHIS." Meanwhile, the HIRA plans to strengthen the DUR service for the safe use of narcotic drugs. Information on 471 narcotic drugs has been provided already, and the HIRA has expanded the assessment of the use of propofol overuse and antidepressants beyond the specified period. Kang said, "To solve issues related to long-term administration and overdose of narcotic drugs, we plan to improve the system by asking for the reasons for prescribing and dispensing that exceed the maximum dosage or duration limits," and explained, "The DUR should be mandatory for narcotic and antidepressant drugs, and we will continue to manage these drugs to resolve drug safety issue." This implies that the HIRA will make efforts to ensure that the mandatory DUR legislation passes the National Assembly."
- Policy
- MFDS reviews COVID-19 drugs Xocova and Lagevrio
- by Lee, Hye-Kyung Aug 21, 2024 05:47am
- Amid the resurgence of the COVID-19 pandemic, The food and drug authorities in Korea have been taking steps to approve COVID-19 treatments. According to the Ministry of Food and Drug Safety (MFDS) on the 19th, the agency began reviewing Ildong Pharmaceutical's ‘Xocova’ and MSD Korea’s ‘Lagevrio,' which the companies have submitted applications for approval in Korea. “Currently, three drugs are licensed or approved for emergency use in Korea - the oral drugs 'Paxlovid' and ‘Lagevrio’ and the injectable drug ‘Veklury.’” said an MFDS official, ”and we are reviewing the applications of additional products that have applied for marketing authorization thereafter.” Paxlovid and Veklury are officially approved in Korea, while Lagevrio, which was used under the Emergency Use Authorization, is undergoing a formal approval process. In the case of Xocova, the company hasn't even been approved for emergency use, according to an MFDS official, who added, “Emergency use approval requires close communication with the Korea Disease Control and Prevention Agency due to regulations.” Xocova is an oral COVID-19 treatment co-developed by Ildong Pharmaceutical and Japan's Shionogi Pharma. The companies applied for Xocova’s domestic marketing authorization in December last year, but the application is still stuck in the review stage. In Japan, it was granted emergency approval in November 2022 and received full approval from the Ministry of Health, Labor and Welfare in March this year. Xocova is regarded to have provided improved convenience for patients as patients only need to take Xocova once daily for 5 days as a single tablet compared to other conventional treatments that are administered twice a day. Ildong Pharmaceutical completed the technology transfer and trial production of Xocova last year and will be able to proceed with production and supply once the authorities grant domestic approval. Meanwhile, the number of hospitalized COVID-19 patients increased 5.1 times from 91 in the first week of July to 465 in the fourth week, according to data submitted by KDCA to the office of Representative Ye-ji Kim of the People's Power Party. Also, the weekly usage of COVID-19 drugs increased about 32 times from 1,272 doses in the fourth week of June to over 42,000 doses in the fifth week of July. However, as of the 9th, only 70,557 doses of COVID-19 treatments - 41,790 doses of Lagevrio and 28,767 doses of Paxlovid - were available in stock in Korea.
- Company
- Celltrion Pharm announces vision to become ‘Top 5'
- by Kim, Jin-Gu Aug 20, 2024 06:34am
- On the 19th, Celltrion Pharm announced its 'Vision 2030,’ which outlines the company’s vision to become one of the top five pharmaceutical companies in Korea by 2030. Until recently, Celltrion Pharm was promoting a merger with Celltrion, but the plan was reviewed again due to shareholder opposition, upon which the final decision was made not to merge on the 16th. Vision 2030 is the first mid- to long-term established for Celltrion Pharm since the cancellation of the merger. In Vision 2030, Celltrion Pharm presented detailed projects for each of the following sectors: ▲manufacturing, ▲R&D, and ▲sales as a comprehensive pharmaceutical company that manufactures and sells chemical and biological drugs. In manufacturing, the company will expand its production capacity around its core facility, its Cheongju Plant. The Cheongju plant is the company’s core production base for chemical drugs and has obtained GMP certification from international organizations including the United States, Europe, Japan, and Brazil. It also has an annual production capacity of 16 million prefilled syringes (PFS). The company plans to accelerate its growth by gradually increasing the proportion of PFS-type biopharmaceuticals that the company has started full-scale commercial production this year. To preemptively respond to the rapidly growing demand for PFS formulations, the company plans to build an additional production line utilizing its 13,500㎡ spare lands at its Cheongju plant. Upon completion of the expansion, the company’s production capacity will increase up to threefold. The company is also planning to expand its global CMO business. In the R&D sector, Celltrion Pharm plans to strengthen its capabilities by adding specialized personnel and developing ADC (antibody-drug conjugate) anticancer drugs and new drug platform technologies in earnest. To this end, Celltrion Pharm raised the status of its R&D organization in Cheongju last year to report directly to the CEO. It also expanded and reorganized the organization and relocated it to the Songdo Global Biotech Research Center in Songdo, Incheon. Through the reorganizations, Celltrion Pharm plans to become a drug development company that develops not only new drug platform technologies but also innovative new drugs to increase sales by licensing out technologies. In sales, the company will actively expand the range of its chemical and biological drug products. It plans to significantly expand the production of its biosimilar products, from the 6 it currently produces, including Celltrion's 'Remsima' and ‘Yuflyma,’ to a total of 22 products by 2030. The launch of its autoimmune disease treatment 'Stekima', eye disease treatment ‘Eydenzelt,’ and allergic asthma treatment ‘Omlyclo,’ which have received domestic approval, is also imminent. In the case of chemical drugs, the company's strategy is to secure additional high-value-added products through in-house development and active licensing-in activities and to expand its product portfolio to gain differentiated competitiveness. An official from Celltrion Pharm said, “We have achieved about twofold growth in sales over the past 5 years with even growth across all our business segments. As a comprehensive pharmaceutical company with a diversified portfolio and sales structure, we aim to continue this growth trend and do our best to achieve our goal of becoming one of the top five domestic companies by 2030.”
- Company
- 'Trodelvy' approved for prescription at general hospitals
- by Eo, Yun-Ho Aug 20, 2024 06:34am
- Product photo of Gilead Science Korea 'Trodelvy,' still not covered by reimbursement, has now been quickly approved for prescription in general hospitals. Sources said that Gilead Science Korea's Trodelvy (sacituzumab govitecan), a treatment for triple-negative breast cancer (TNBC), has cleared drug committees (DC) of 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Severance Hospital in Sinchon, and 34 medical centers nationwide. Although not covered by reimbursement, it has been approved for prescription at all medical centers with a prescription code issued. More prescriptions are anticipated if it succeeds in listing for insurance reimbursement. However, the reimbursement process for Trodelvy has not progressed since clearing the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) in November last year. It was expected that Trodelvy would be considered for the Drug Reimbursement Evaluation Committee (DREC) review this month, but it was not. The upcoming DREC review is scheduled to be on September 5th. It is to be watched whether the first Trop-2 targeting Antibody-Drug Conjugate (ADC), Trodelvy, is to be considered for reimbursement listing. Triple-negative breast cancer is an aggressive form among breast cancer types that is more likely to recur and metastasize. Patients with triple-negative breast cancer who have progressed metastasis despite undergoing chemotherapy have a life expectancy of several months. However, chemotherapy has been used as the standard therapy for a long time because an effective method to target cancer cells has not been discovered. The current guidelines in the United States and Europe recommend Trodelvy as a priority treatment for patients with metastatic triple-negative breast cancer who have a treatment history. According to the Phase 3 study, patients treated with Trodelvy had an overall survival of 11.8 months, close to a year, whereas patients undergoing chemotherapy had 6.9 months. Furthermore, Trodelvy has been shown to be effective in regulating symptoms and pains associated with cancer and improving overall well-being, thereby improving patients' quality of life. Trodelvy received the highest score of 5 on the ESMO-MCBS, a value-evaluation tool for anticancer medicines rated by the European Society for Medical Oncology (ESMO). Drugs with Score of 5 are indicated to not only extend patient survival but also be effective in improving quality of life. Trodelvy is the only drug to receive a Score of 5 among triple-negative breast cancer treatments. In South Korea, several petitions requesting reimbursement listing of Trodelvy were posted on the website, and over 100,000 people agreed to the petition. However, despite these efforts by patients and caretakers, the petition was ended due to the session ending of the 21st National Assembly. Accordingly, the Korea Alliance of Patients Organization has submitted a statement to the Ministry of Health and Welfare (MOHW) requesting reimbursement review to be made quickly for drugs with high patient demand, such as Trodelvy, in May. Meanwhile, in the United Kingdom, Trodelvy was granted a preferential status on a cost-effectiveness analysis based on extending survival of the patient group, a population less than rare disease, who have a life expectancy of less than two years. As a result, it was approved for reimbursement after receiving a twofold higher incremental cost-effectiveness ratio (ICER) than other drugs.
- Company
- Reimb remains an issue despite broadened options for UC
- by Moon, sung-ho Aug 20, 2024 06:34am
- Urothelial carcinoma, which is a type of bladder cancer, accounts for 90% of all bladder cancers and is considered a typical cancer type in the field. However, unlike other cancers like lung and breast cancer, where the standard of care changes quickly with the introduction of new drugs, UC has remained a barren area for decades, leaving a large unmet need for first-line treatment options. For the past 30 years, platinum-based chemotherapy has remained the first-line standard of care for UC. # Recently, new drugs, including immuno-oncology drugs and antibody-drug conjugates (ADCs), have been introduced for UC in Korea, shifting the treatment paradigm. However, until the health insurance reimbursement issue is resolved, their active use on-site seems unlikely. According to the medical and pharmaceutical industries on the 16th, platinum-based chemotherapy using gemcitabine, cisplatin, carboplatin, etc. had been used as a first-line treatment for UC. However, the median overall survival (OS) was only 12-15 months with their use due to toxicity, with patients often having to take a drug holiday from chemotherapy after 3-4 months of treatment, and disease progressing around 6-9 months after initiation. However, in the past year or two, the treatment paradigm for UC has been rapidly shifted with global pharmaceutical companies introducing treatments based on clinical research to Korea. One of the first treatments to receive attention is Merck's immuno-oncology drug Bavencio (avelumab). Bavencio is a fully human monoclonal antibody specific for PD-L1 and has demonstrated prolonged survival as a first-line maintenance therapy for UC. Since August last year, its use as first-line monotherapy has been reimbursed by Korea’s health insurance and is being used in practice. Bavencio’s efficacy was confirmed through the long-term follow-up Phase III JAVELIN Bladder 100 trial, which involved 700 patients with locally advanced or metastatic urothelial cancer in 29 countries, including Korea, for over 38 months. The trial results showed a median OS of 29.7 months with Bavencio+maintenance therapy. This is over 9 months longer than the 20.5 months found in the maintenance monotherapy arm. In July this year, the combination of the ADC cancer drug Padcev (enfortumab vedotin, Astellas) and the immuno-oncology drug Keytruda (pembrolizumab, MSD) was approved in Korea, marking another shift in the first-line UC treatment paradigm. The Phase III EV-302/KEYNOTE-A39 trial, which became the basis of its approval, showed a median OS of 31.5 months in the Padcev+Keytruda arm compared to 16.1 months in the control arm, which was a significant difference. Median progression-free survival (PFS) was 12.5 months in the Padcev+Keytruda arm versus 6.3 months in the control arm Around the same time the Padcev+Keytruda combination was approved, BMS and Ono Pharmaceutical’s immuno-oncology drug Opdivo (nivolumab) received approval in Korea as the first-line treatment for UC as well. The approval was based on results from the CheckMate 901 trial, which evaluated Opdivo versus the standard of care gemcitabine+cisplatin (GemCis) in 608 patients with metastatic UC. Results showed that at a median follow-up of 36 months, the primary endpoint, median OS, was 21.7 months with the addition of Opdivo versus 18.9 months in the control arm, resulting in improved treatment outcomes. The treatment paradigm for UC, which had remained unchanged for 30 years, has changed dramatically in the past 1-2 years after 30 years of unchanged treatment. Based on the results of the study, Padcev+Keytruda is expected to rise to the forefront among first-line treatment options on-site. “Based on the efficacy seen in the studies, the Padcev+Keytruda combination would be my first choice,” said In-Keun Park, Professor of Medical Oncology at Asan Medical Center in Seoul. ”The Opdivo+GemCis combination that has been approved at a similar period, has proven to be less effective. Also, we need to consider the availability of the cisplatin option and utilize drugs with caution, so I would consider using the Opdivo+GemCis option for patients with uncontrolled diabetes.” “The currently reimbursed Bavencio has fewer side effects and proven efficacy, but is indicated for patients who have not progressed after receiving platinum-based chemotherapy as a first-line treatment,” explained Professor Park. ”If Padcev+Keytruda or Opdivo+GemCis becomes a common first-line treatment option, Bavencio may lose more ground.” Now that the first-line treatment options for UC have been approved in Korea, attention is now focused on how quickly they will be available on-site. As Bavencio is covered as a maintenance therapy for first-line urothelial cancer, the industry is eyeing whether the Padcev+Keytruda combination will also be granted reimbursement. However, the Padcev+Keytruda combination presents a dilemma for pharmaceutical companies. This is because 2 different companies - Astellas and MSD - own the drugs that are included in the combination. In order for a combination therapy to be reimbursed, both companies must apply for reimbursement and participate in the process for the agenda to be discussed with the government. However, it is currently difficult for such discussions to take place due to the headquarters policies of global pharmaceutical companies and the possibility that discussions with other pharmaceutical companies may be judged as 'collusion' under domestic and international fair trade laws. In other words, both pharmaceutical companies must separately apply for reimbursement. If one of the companies is not interested in applying for reimbursement, reimbursement of the combination therapy is effectively off the table. This is the case for Padcev+Keytruda, and Astellas and MSD are known to be separately reviewing the need for reimbursement. However, the 2 companies are doing so at their discretion, as discussions between them could be regarded as collusion. As a result, the pharmaceutical industry has recently called for the need to establish regulations in the health insurance reimbursement process to address the combination therapy research being conducted between pharmaceutical companies. In other words, the industry has pointed out that a system needs to be established so that if one of the combination therapy developers applies for reimbursement, government agencies such as HIRA can notify the other companies so that the other companies can decide whether to participate in the reimbursement application process. A pharmaceutical industry official said, “If the developers of drugs used as combination therapies are different companies, the Fair Trade Act forbids the companies from discussing insurance reimbursement and insurance prices on their own. It is difficult for the government to proceed with the reimbursement process if one of the drug developers applies for health insurance benefits and the other does not show any willingness for its drug’s reimbursement.” This is why the industry sees it difficult for combination therapies to be applied reimbursement benefits. “Even though the number of first-line treatment options for UC has increased, it is difficult to actively utilize them on-site unless the cost issue is resolved,” said a professor of oncology at a tertiary hospital. ”It takes longer for combination therapies to be reimbursed. It may even be impossible if two separate pharmaceutical companies need to receive reimbursement together for one combination therapy regimen.”
- Company
- K-Pharma focuses on developing CAR-NK cell therapies
- by Son, Hyung-Min Aug 20, 2024 06:34am
- Korean biopharmaceutical industry speeds up the development of chimeric antigen receptor (CAR)-NK cell therapy. GC Cell has recently entered the Phase 1 clinical trial in South Korea. Companies are collaborating on developing CAR-NK therapies through joint-research agreements: GI Cell and Y-Biologics and TS Bio and Maru Therapeutics. NKMAX has confirmed the potential of its candidate in a preclinical study. According to industry sources on August 19th, GC Cell received approval of Investigational New Drug (IND) application from the Ministry of Food and Drug Safety (MFDS) for a Phase 1 clinical trial of its CAR-NK therapy 'GCC2005' on August 14th. GCC2005, an allogeneic cell therapy utilizing NK cells derived from umbilical cord blood, targets CD5, which is highly expressed in T-cell lymphoma. CD5 is a biomarker highly expressed in many T-cell lymphoma subtypes. GCC2005 is a CAR-NK cell therapy designed to co-express CAR and interleukin (IL)-15, improving the short persistence of existing NK cells and enhancing efficacy. GC cell developed a technology to mass culture high-purity and highly active NK cells from a small quantity of umbilical cord. CAR-NK, an allogeneic therapy, has the advantage of improving side effects compared to existing CAR-T therapies. CAR-T induces cytokines, such as interleukins associated with neurotoxicity, whereas activated NK cells generally produce interferon-gamma (IFN-γ) and granulocyte-macrophage colony stimulating factor (GM-CSF). Accordingly, CAR-NK is less likely to cause cytokine release syndrome (CRS) or neurotoxicity. GC2005 demonstrated anticancer effects in various in vivo CD5+ T-ALL models (RPMI-8402, CCRF-CEM). GCC2005 showed a higher survival rate and tumor-suppressive efficacy than a vehicle. Additionally, GC Cell is developing the CAR-NK cell therapy 'AB-201' with the U.S. affiliate company Artiva. AB-201 targets solid cancers, including HER2-overexpressed breast cancer and gastric cancer. In 2022, Artiva received IND approval from the U.S. Food and Drug Administration (FDA) for Phase 1/2 trials of its AB-201. Then, in December last year, GC Cell received IND approval from the MFDS and Australia's Human Research Ethics Committees (HREC) for a Phase 1 trial of AB-201. GC Cell and its U.S. affiliate company Artiva is developing CAR-NK therapies (photo source=Artiva). NKMAX is developing a CAR-NK candidate product, HER2 CAR-SNK02. NKMAX's HER2 CAR-SNK02 comprises HER2 gene targeting CAR and a cytokine that prolongs survival and activation of NK cells in the body, which is then stored by cryo freezing. Based on a preclinical study recently disclosed by NKMAX, HER2 CAR-SNK02 was confirmed to survive in vivo and exert anticancer effects in a mouse model engrafted with human gastric cancer cells. Collaborative research to co-develop CAR-NK therapies Korean biopharmaceutical companies are conducting collaborative research to develop CAR-NK therapies. GI Cell, an affiliate of GI Innovation, and Y-Biologics have signed a collaborate research agreement last year, commencing the new CAR-NK anticancer drug development. These companies plan to develop new anticancer drugs utilizing GI Cell's CAR-NK cell development and mass cell culture technology and Y-Biologics' nanobody-based antibody discovery platform technology. GI Cell has previously completed the domestic Phase 1 trial of the NK cell therapy 'T.O.P. NK' in patients with solid cancer and blood cancer. Since GI Cell proved T.O.P. NK's tolerability and safety, it began conducting a Phase 2a trial last month. Additionally, GI Cell is conducting collaborative research with HK inno.N for CAR-NK. HK inno.N and GI Cell are jointly conducting a basic research on CAR-NK targeting seven targets. In addition to this joint research, HK inno.N is also conducting two basic research cases on its own. TiCRos has entered into a license-based collaborative research agreement with Catherics, an Australian company focusing on developing iPSC-derived CAR-NK cell therapy. Based on the agreement, the companies are developing CAR-NK therapy with improved tumor-killing effects by incorporating TiCRos' 'CLIP-CAR' on Catherics' CAR-NK therapy. TiCRos will manufacture a CLIP-CAR targeting an antigen designated by Catherics. Catherics will incorporate this into iPSC-derived NK cells and evaluate the function in vitro and in vivo. TS Bio has been conducting joint research with Maru Therapeutics for CAR-NK cell therapy since last year. Both companies plan to actively develop CAR-NK cell therapy targeting blood cancers and solid cancers through the agreement.
- Policy
- New criteria set for flexible ICER threshold evaluations
- by Lee, Tak-Sun Aug 20, 2024 06:34am
- The National Health Insurance Review and Assessment Service (HIRA) established new criteria for drugs that apply flexible ICER (incremental cost-effectiveness ratio) thresholds during the Drug Reimbursement Evaluation Committee (DREC) meeting that was held on the 8th. The previous criteria only stipulated that a flexible ICER threshold could be applied, but specifics were established. this time. In February, DREC recognized reimbursement adequate for the breast and stomach cancer drug Enhertu (trastuzumab deruxtecan, Daiichi Sankyo Korea) by flexibly applying the ICER threshold. On the 8th, HIRA disclosed the "Criteria for detailed evaluation of drugs subject to negotiation, such as new drugs" which was newly amended based on DREC deliberations. The amendments include ▲ New criteria for flexible ICER threshold evaluation; ▲ Addition of severe diseases to the risk-sharing agreement scheme; ▲ Omission of the Drug Evaluation Committee review when expanding the reimbursement range of RSA drugs that claim less than KRW 1.5 billion; ▲ New conditions that require submission of clinical evidence such as RWD and RWE when renewing RSA schemes. ◆ New criteria for flexible ICER threshold evaluation=The existing regulations only stipulated that the ICER threshold “need not be explicit, and can be flexibly applied with regards to the results of previous deliberations in consideration of the severity of the disease, the burden of disease on society, the impact on quality of life, and innovativeness.” In the amendment, the 'innovativeness' requirement has been specifically established for the flexible evaluation of new drugs. A new drug is regarded as ‘innovative’ when it satisfies all of the following criteria: ▲ there is no substitutable or therapeutically equivalent product or treatment ▲ has shown significant clinical improvement, such as prolonged survival, is recognized in the final outcome, ▲is a new drug is approved by the MFDS under Article 35(4)(2) of the Pharmaceutical Affairs Act through expedited review or is recognized as equivalent by the committee. ◆ Addition of severe diseases to the risk-sharing agreement scheme = In principle, anti-cancer drugs or rare disease drugs were subject to RSA. However, the previous regulation had allowed drugs that are not necessarily anti-cancer or rare disease drugs to be applied to RSA if the committee recognizes the drugs as equivalent. However, the amended regulations clarified the ‘equivalent disease’ condition. The amendment stipulates that an ‘equivalent disease’ to a severe disease does not qualify for the currently recognized special calculations, but is difficult to cure, causes irreversible disability or organ damage due to the progression of the disease, and has a significant burden of disease. DREC had already recognized reimbursement of severe atopic dermatitis drugs like Dupixent and severe asthma drugs as reimbursable using RSA. ◆ Omission of the Drug Evaluation Committee review when expanding the reimbursement range of RSA drugs that claim less than KRW 1.5 billion = The new amendment allows RSA drugs to skip DREC review if the expanded claims amount amounts to less than KRW 1.5 billion. Specifically, if the expected additional claims of refund-type RSA drugs, excluding the mixed-type RSA drugs, is less than KRW 1.5 billion, DREC’s evaluation can be skipped and the insurance ceiling price and refund rate be re-negotiated through NHIS negotiations. ◆RWD, RWE, etc. to be submitted when RSA is renewed =The new amendment also requires drugs with a certain condition to submit RWD, RWE, etc. when renewing their RSA contract. This is in line with how Ilaris (canakinumab, Novartis Korea) was recently approved for reimbursement based on the condition of submitting prospective clinical trial data. As such, the amendment specifies that drugs that are listed under the condition of collecting clinical evidence, such as RWD and RWE, should collect and submit clinical evidence when renewing their RSA contract. On the other hand, the new amendment does not include terms for the preferential treatment of homegrown new drugs. The pharmaceutical industry had expected that the preferential treatment for domestic new drugs would be included by revising the ‘1.7. Cases where necessary in consideration of the impact on healthcare' clause of the ‘Criteria for detailed evaluation of drugs subject to negotiation, such as new drugs.’ The industry expected that preferential treatment of non-inferior new drugs and domestically developed new drugs utilizing natural products would be added in the amendment, but were not included. However, there are opinions that the condition for preferential treatment for domestic drugs may be included in other regulations.
- Policy
- KDCA apologizes for COVID-19 drug shortages
- by Lee, Hye-Kyung Aug 19, 2024 05:47am
- The Korea Disease Control and Prevention Agency (KDCA) apologizes for the COVID-19 medication shortages due to the increased volume of usage than expected. The KDCA stated that after acknowledging the need for medication supply, it had secured medication for 260,000 people after discussing it with the office for national finance. Additional distribution will be made in part starting this week. During the 'COVID-19 Status Report and Measures' briefing on August 16th, KDCA's Assistant Director of Reserve Material Park Jee-yeong stated, "The KDCA is considerably acknowledging the current medication shortage, and we are deeply sorry about the issue." Park said, "We will strive to stabilize the supply." According to the KDCA, pharmacies running out of stock of COVID-19 medications, such as 'Paxlovid,' are due to difficulty in predicting demand as the volume of usage surges compared to last year's summer. Park said, "Currently, more medications are being used than before. Once we were aware of the situation, we were closely in contact with global pharmaceutical companies and have been supplying a portion of the stock starting this week. Park added, "Unlike oral treatments, injectables are being provided as requested. We will also provide additional supplies to tertiary general hospitals."
- Company
- Will Handok’s Empaveli be reimbursed in 1H in KOR?
- by Eo, Yun-Ho Aug 19, 2024 05:47am
- Empaveli, a treatment for paroxysmal nocturnal hemoglobinuria imported by Handok Pharmaceuticals, has entered the final gateway to insurance reimbursement in Korea. According to industry sources, Handok will enter into drug price negotiations with the National Health Insurance Service for its new drug Empaveli (pegcetacoplan). Empaveli is a treatment for paroxysmal nocturnal hemoglobinuria (PNH) developed by the U.S. company Sobi. It is the first C3 protein-targeted therapy for the treatment of adult patients with PNH. Gaining attention as the first PNH drug that can prevent intravascular and extravascular hemolysis, Empaveli is approved for use in many countries, including the United States, Europe, Australia, and Japan. The drug was approved by the U.S. Food and Drug Administration (FDA) in May 2021 and the European Medicines Agency (EMA) in December 2021, and has completed two Phase III trials. According to the results of the Phase III PEGASUS trial that was published in the NEJM, Empaveli demonstrated superiority to eculizumab in changing hemoglobin concentration over 16 weeks. In an extension study, LDH levels, a marker of intravascular hemolysis, remained below 1.5 times the upper normal limit for 48 weeks in the Empaveli treatment arm. The percentage of patients who remained transfusion-free for 16 weeks was also higher in the Empaveli arm, at 85%, compared to 15% in the eculizumab arm. Empaveli also showed a 9.2-point improvement in the FACIT-fatigue score, a quality-of-life measure. A2-point or over change from the baseline of the FACIT-fatigue score is considered clinically significant. The efficacy of Empaveli was also confirmed in the PRINCE trial in complement inhibitor-naïve PNH patients. After 26 weeks of follow-up, 85.7% of patients in the Empaveli arm showed stabilized hemoglobin levels, and LDH levels were well controlled to below normal levels in the Empaveli arm. Meanwhile, Handok has entered into a strategic partnership with Sobi to introduce the rare disease drugs Empaveli and Doptelet (avatrombopag) to Korea. In April, the company officially launched its joint venture, Sobi-Handok, to strengthen its rare disease pipeline.
- Company
- Will Astellas’ gastric cancer drug Vyloy be approved in 2H?
- by Eo, Yun-Ho Aug 19, 2024 05:47am
- Zolbetuximab, a new targeted cancer therapy with a new mechanism of action for gastric cancer, may be commercialized in Korea in the second half of the year. According to industry sources, the Ministry of Food and Drug Safety (MFDS) is currently reviewing Vyloy (zolbetuximab), a treatment for patients with CLDN18.2 positive, unresectable, advanced, or recurrent gastric cancer. The drug was approved in Japan in March. Vyloy is an immunoglobulin (IgG)1 monoclonal antibody that targets Claudin 18.2, a cell surface protein expressed by gastric cancer cells. It binds to the claudin 18.2 protein expressed on the surface of cancer cells in gastric epithelial cells. However, unfavorable conditions to its approval also do exist. In January, Vyloy was denied approval by the U.S. FDA. The rejection was not based on any efficacy issues, including the drug's clinical data, but rather because of questions raised during the manufacturer's review. Astellas resubmitted its application to the FDA in June and the application is on track for Vyloy’s approval. Meanwhile, Vyloy has demonstrated efficacy in the Phase III SPOTLIGHT and GLOW studies. The POTLIGHT study evaluated the efficacy and safety of zolbetuximab+FOLFOX (fluorouracil, leucovorin, oxaliplatin) versus placebo+FOLFOX in 557 adult patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. In the trial, the zolbetuximab arm achieved a primary endpoint, progression-free survival (PFS), of 10.6 months, compared with the 8.7 months in the control arm. Additional study results showed that the zolbetuximab combination arm achieved an overall survival (OS) of 18.2 months, a 2.7-month improvement over the control arm. The zolbetuximab combination arm also showed an improvement in PFS and OS in the GLOW study. The study compared zolbetuximab+CAPOX therapy (capecitabine, oxaliplatin) with placebo+CAPOX therapy. Study results showed that the zolbetuximab arm had a PFS of 8.2 months, 1.4 months longer than that of the control arm. OS was 14.4 months in the zolbetuximab combination arm and 12.2 months in the control arm. In terms of safety, the most commonly reported adverse events were nausea and vomiting.
