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- 2025-12-19 14:03:29
- Policy
- Innovative Pharmaceutical Company certification to change
- by Lee, Jeong-Hwan Jan 17, 2025 05:53am
- The Ministry of Health and Welfare will improve the certification system for innovative pharmaceutical companies to a 'certification evaluation score system' that will increase the proportion of new drug research and development (R&D) and change the disqualification criteria to a point-based score system. The MOHW plans to issue an administrative notice next month after deliberations by the Pharmaceutical Industry Fostering and Support Committee. It will be interesting to see if the final notice will reflect the pharmaceutical industry's opinion that it is too harsh or unreasonable to cancel the certification of innovative pharmaceutical companies that encourage the creation of homegrown drugs and the development of the pharmaceutical industry based on illegal rebates in the past, etc. An MOHW official who requested anonymity made such remarks on the 15th, during a meeting with reporters from the Korea Special Press Association on Friday. While announcing its major work plan for 2025, the MOHW announced it would improve the core regulations for each industry to make the global leap. The improvement measures include overhauling the certification criteria for innovative pharmaceutical companies. The key is to add criteria for granting extra points for items such as a pharmaceutical company's R&D investment efforts and to allocate points for the disqualifying criteria, such as revoking the certification of innovative pharmaceutical companies based on the number of administrative penalties or the amount of illegal rebates. The industry has claimed that despite investing in R&D to create new drugs and its ethical management efforts, the revocation or decertification as an innovative pharmaceutical company due to rebate cases detected in the past dampens the companies’ will to develop new drugs. The current innovative pharmaceutical company certification system excludes innovative pharmaceutical companies based on the illegal rebate disqualification clause if they have received two or more administrative penalties for violating the Pharmaceutical Affairs Act in the past three years, or if the total amount of rebates exceeds KRW 5 million. A MOHW official said, “Under the current system if a company violates the standards, its innovative pharmaceutical company certification is revoked. We plan to introduce quantitative indicators to the disqualification criteria and add a premium for R&D efforts to allow companies to make up for the lost score” The MOHW is also considering the typification of the certification criteria for multinational pharmaceutical companies. The Korean Research-based Pharmaceutical Industry Association (KRPIA) has previously argued that open innovation collaboration with domestic research centers and companies, in addition to conventional clinical research, plays an important role in building global-level R&D capabilities. Therefore, the KRPIA has been requesting standards that can recognize and promote such activities. The MOHW has been preparing measures to reflect this. One of the improvements under consideration is to specify the reasons for rejection when notifying pharmaceutical companies of their innovative pharmaceutical company certification results. On the 10th, the 2nd Vice Minister of MOHW, Minsoo Park, said in a Q&A session on the 2025 Major Work Plan, “The most important criterion for selecting innovative pharmacuetical companies will be the R&D criteria, but we are looking at the specific condition and status of the current industry and trying to adjust the criteria accordingly.” He added, “We are considering expanding various quantitative evaluation criteria, creating customized criteria for each type of pharmaceutical company, and rationally improving the disqualification criteria,” he said. Such improvements must be reviewed by the Pharmaceutical Industry Fostering and Support Committee under the ‘Special Act on Fostering and Support of the Pharmaceutical Industry.’ The MOHW is currently preparing committee deliberations and plans to issue an administrative notice in February. Meanwhile, the benefits of being certified as an innovative pharmaceutical company include: (1) points for participating in government R&D; (2) corporate tax deduction for R&D expenses and tax deduction for investment in facilities to improve drug quality control; (3) When building research facilities, they are exempted from local regulations and levies on location; (4) companies that enter the KOSDAQ under the technology special exception or growth special exception are exempted from KOSDAQ listing requirements; and (5) drug prices are preferentially reduced for generic drugs, incrementally modified new drugs, and biosimilars, and reduce the actual transaction price reduction rate.
- Policy
- Boryung’s Pomalyst generic soon to be released
- by Lee, Tak-Sun Jan 14, 2025 05:57am
- Boryung's multiple myeloma drug Pomalikin Cap may soon be released in Korea’s market. The drug is the first generic version of Pomalyst Cap (pomalidomide, BMS). The risk-sharing agreement (RSA) applied to the original drug, Pomalyst Cap, ended this month, and the insurance price cap of the drug had been adjusted following the reimbursement application of its generic drug, Pomalikin Cap. According to industry sources, four dosage forms (1mg, 2mg, 3mg, and 4mg) of Pomalikin Cap, which were approved in August last year, are expected to be listed for reimbursement and be released to the market soon. The insurance price ceiling of the original drug has already been adjusted upon the generic drug’s reimbursement application. According to Article 13, Paragraph 4, Item 5 of the Standard for Medical Care of National Health Insurance, if a drug with the same route of administration, ingredients, and formulation applies for reimbursement approval, the risk-sharing agreement signed by the NHIS for the original drug will be terminated after NHIS evaluations. After Health Insurance Review and Assessment evaluations, BMS underwent negotiations with NHIS for Pomalyst Cap and decided to terminate the RSA and adjust the drug’s upper price limit. The drug was applied the refund type RSA, so there was a difference between the list price and the actual price due to the dual drug pricing system. Upon the termination of the RSA, the actual price was revealed. Before the price adjustment, the upper limit of the 1mg product was KRW 356,691, and the adjusted price was KRW 194,389, a 44.6% price cut. The fact that Boryung’s Pomalikin Cap is the only drug approved with the same route of administration, ingredients, and formulation as Pomalyst Cap indirectly implies that Boryung had applied for the reimbursement of Pomalikin Cap. Boryung succeeded in circumventing the original’s patent last year by filing a trial to confirm the passive scope of the original drug's patent to enter the generic market. Pomalyst Cap is a multiple myeloma treatment that posted sales of KRW 22.8 billion as of 2023, according to IQVIA. It is indicated ▲ in combination with bortezomib and dexamethasone in patients with multiple myeloma who have received at least one prior therapy, including lenalidomide; and ▲in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and bortezomib. Boryung has been focusing on the multiple myeloma market, recently introducing the lowest-priced lenalidomide to the market. As the only company that has released a pomalidomide generic, it will be interesting to see how Boryung will fare in the market established by the original.
- Policy
- Will 'Lorviqua' secure a deal on drug price negotiations?
- by Lee, Tak-Sun Jan 13, 2025 05:53am
- Product photo of LorviquaThe reimbursement expansion case for Lorviqua (lorlatinib, Pfizer), which was stalled during the drug price negotiation last year, has passed the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) under a conditional term. It draws attention to whether it will succeed this round. Pfizer wants the termination of the Risk Sharing Agreement (RSA) and the reimbursement expansion for this drug, so the focus is on whether the company will reach an agreement with the insurance authority. The DREC meeting on January 9 ruled that Lorviqua would be appropriate for expanded reimbursement scope if the company accepted the drug price below the evaluated amount. Consequently, if Pfizer agrees with the drug price below the evaluated amount, it will proceed with the negotiation phase with the NHIS. Lorviqua is under consideration for reimbursement expansion as a first-line treatment for patients with anaplastic Lymphoma Kinase (ALK)-positive and metastatic non-small cell lung cancer. The drug passed the DREC last year, but it failed after negotiating with the National Health Insurance Service (NHIS). It has been reported that the company differed in opinion regarding adjusting the cap for reimbursement ceiling type during the negotiation process. Pfizer wanted to terminate the RSA and switch to general medicine reimbursement. When it was initially approved for reimbursement, Lorviqua was categorized as a reimbursement ceiling type under the cost-effectiveness evaluation waiver system. However, it was approved for being cost-effective after receiving the economic evaluation by the HIRA. However, the company failed to reach an agreement at the drug pricing negotiation because RSA was not terminated. Following the announcement of failed negotiations, doctors and patients called for immediate reimbursement listings. During the parliamentary audit held in October, Rep. Han Ji-ah, a member of the People Power Party, stressed the importance of reimbursement expansion while introducing a male patient's case. Regarding this, Lee Joongkyu, Director of the National Health Policy at the Ministry of Health and Welfare (MOHW), said, "We will help patients receive benefits by quickly reaching an agreement as soon as possible." The NHIS recently revised the RSA guidelines regarding the termination clause. Cost-effectiveness-evaluated drugs like Lorviqua that have demonstrated cost-effectiveness through the DREC review, companies and NHIS can renegotiate to adjust reimbursement ceilings, reset expected claim amounts, or modify·terminate total expenditure-capped RSAs. This opens the possibility of terminating total expenditure-capped RSAs through the renewal of the agreement. Drugs categorized as a basic refund type RSA can be terminated early when a pharmaceutical company wishes to terminate. In the case of Lorviqua, the company applied for RSA termination before the revision, early termination may be possible, even if it is not for renewing contract negotiations. Prior to the revision, drugs were not categorized into specific types that could be terminated early. Consequently, when the company begins negotiation with the NHIS, there will be a discussion about RSA termination and reimbursement expansion. The remaining issue is whether both parties could agree on the drug price without financial burden while allowing RSA termination. In the CROWN trial, Lorviqua reduced the disease progression and death risk by 81% compared to crizotinib, and 60% of treated patients were alive without disease progression after five years. The results indicate that reimbursement of the drug is necessary. The industry draws attention to whether the discussion for expanding Lorviqua's reimbursement, which previously failed in drug pricing negotiations, will lead to an agreement this year.
- Policy
- New criteria set for unstable supply and demand drugs
- by Lee, Tak-Sun Jan 13, 2025 05:53am
- The Health Insurance Review and Assessment Service has decided to clarify the criteria for evaluating adjustment applications for drugs with unstable supply and demand and strengthen preliminary management of high-priced anticancer drugs. HIRA announced so on the 9th while issuing a prenotification of the “Partial Amendments to the Evaluation Criteria and Procedures for Whether a Drug is Eligible for Medical Benefits” and the “Partial Amendments to the Operating Regulations of the Severe Disease Deliberation Committee.” The deadline for submitting opinions on the criteria is the 15th. First, in the prenotification of the “Partial Amendments to the Evaluation Criteria and Procedures for Whether a Drug is Eligible for Medical Benefits,” drugs with unstable supply and demand were newly added as evaluation criteria for adjustment applications. “In order to support the stabilization of drug supply in the context of health security, HIRA has established criteria for the evaluation of adjustment applications to be eligible for negotiations in cases where there is a request for cooperation from central administrative agencies regarding the supply of drugs due to an infectious disease crisis or an urgent shortage of supply, and in cases where an increase in drug price is necessary due to diversification of raw material supply as a national essential medicine.” Accordingly, the following items will be added to the evaluation criteria for adjustment applications: ▲ if there is a request for cooperation from central administrative agencies related to the supply of drugs due to an infectious disease crisis or urgent shortage of supply ▲ if a national essential medicine has diversified its supply of raw materials. The amendment to the regulation is a follow-up to the government's “Plan to Reflect the Innovative Value of New Drugs and Improve the Drug Price System for Health Security.” In particular, the evaluation criteria for adjustment applications to grant drug pricing premiums for national essential medicines that use domestically produced raw materials seems to have been established. The price of drugs with unstable supply and demand is already being raised through adjustment applications upon the council's recommendation. The amendment to the Operating Regulations of the Serious (Cancer) Disease Deliberation Committee also added a provision for the Head of the department in charge of drug post-management to attend the CDDC meeting. On this, HIRA explained, “The recent increase in the number of new drugs that are expensive and have great uncertainty in terms of efficacy has increased the importance of performance management after reimbursement and expansion. Therefore, the amendment was made to strengthen the practicality of drug management by allowing the head of the department that collects and evaluates the actual effectiveness of drugs to participate in the deliberation stage.” HIRA has recently been promoting the introduction of post-management of high-priced drugs through RWD. It has also established a drug performance evaluation division under the Health Insurance Review and Assessment Policy Research Institute. Prior to the full-scale implementation of the system, it is understood that the amendment was made to preemptively prepare a post-management plan by having the heads of relevant departments participate in the cancer review, the first gateway to the review of anticancer drugs.
- Policy
- Chinese pharma targeting KOR, BeiGene gets greenlight
- by Lee, Hye-Kyung Jan 10, 2025 05:52am
- Product photo of BrukinsaBeiGene Korea expands market dominance by conducting clinical trials to achieve competitiveness in the Korean market. Based on this year's Ministry of Food and Drug Safety (MFDS)'s clinical trial approval report, two out of ten approved clinical trial applications were BeiGene Korea's Phase 1 clinical trials. BeiGene has been strengthening its pipeline of solid cancers, focusing on the PD-1 inhibitor, 'Tevimbra (tislelizumab).' The company was approved to conduct Phase 1 clinical trials for its new drug candidates, 'BGB-58067' and 'BG-C137.' BGB-58067 is a new drug candidate designed to avoid the hematological toxicity typically associated with PRMT5 inhibitors. It is recognized for its high efficacy and brain-penetrating capability. Domestic clinical trials are conducted in 'Big 4' hospitals, Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center, and Severance Hospital, enrolling patients with advanced solid tumors patients. BG-C137 is an antibody-drug conjugate (ADC) targeting FGFR2b in patients with advanced solid tumors. A Phase 2 trial is conducted in Severance Hospital, Seoul National University Hospital, Seoul National University Bundang Hospital, and Seoul Asan Medical Center. Meanwhile, BeiGene had prepared to enter the Korean market early, establishing a Korean subsidiary in October 2019. The company began conducting clinical trials in 2022. A total of 17 clinical trials were approved in South Korea. The company has new anticancer drugs, such as 'Tevimbra' and 'Brukinsa,' that received approvals from global regulatory institutes, including the US FDA. The second-generation BTK inhibitor 'Brukinsa (zanubrutinib)' and an immunotherapy 'Tevimbra' are new drugs designated as Korea's No.1 and No.2 new drugs, respectively. Brukinsa was approved by the MFDS in 2022 for demonstrated efficacy·effectiveness in ▲Monotherapy in adult patients with mantle cell lymphoma (MCL) who had one or more prior therapy ▲Monotherapy in adult patients with Waldenstrom macroglobulinemia (WM) who have had one or more prior therapy. Tevimbra, a PD-1 inhibitor immunotherapy cancer, received domestic approval in 2023 as a monotherapy for the treatment of adult patients with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma who are unable to continue platinum-based chemotherapy or have experienced recurrence or progression following such treatment.
- Policy
- AML treatment Mylotarg stalled at the DREC review
- by Lee, Tak-Sun Jan 09, 2025 05:56am
- Product photo of MylotargThe high price was found to be the reason Pfizer Korea's new drug Mylotarg (gemtuzumab ozogamicin), a treatment for acute myeloid leukemia (AML), did not pass the Health Insurance Review and Assessment Service (HIRA) stage. HIRA acknowledged the drug's improvement in clinical utility but did not approve its cost-effectiveness. According to industry sources on January 7, HIRA recently disclosed a report from the Drug Reimbursement Evaluation Committee (DREC) held in November 2024 on the non-reimbursement assessment review for Mylotarg inj 4.5mg. Mylotarg is an antibody-drug conjugate (ADC) that can be used for the first-line treatment of newly diagnosed adult patients with CD33-positive AML. It binds to cells involved in leukemia and releases calicheamicin upon internalization, causing DNA double helix breaks and inducing cell death. It was approved on November 18, 2021, in South Korea and has been considered for national health insurance reimbursement listing. In May 2022, it was considered for the Cancer Disease Review Committee (CDRC) of the HIRA review but failed to establish reimbursement criteria. In October 2023, its reimbursement criteria were successfully established at the CDRC. Then, it was considered for the DREC review, the final stage for determining reimbursement appropriateness; however, it was acknowledged for reimbursement appropriateness. According to the DREC assessment report, Mylotarg is an anticancer drug approved for the 'treatment of patients with newly diagnosed CD33-positive AML.' It was acknowledged for improving clinical utility, including event-free survival (EFS), compared to an alternative drug. However, the DREC determined to maintain non-reimbursement status due to not having cost-effectiveness based on the economic assessment. In the cost-effectiveness assessment, Mylotarg's price was found to be higher than that of alternative drugs, 'cytarabine + daunorubicin, cytarabine + idarubicin combination therapies.' Additionally, the economic assessment result did not sufficiently persuade DREC committee members. Meanwhile, its clinical utility was acknowledged. The Korean Society of Hematology showed that Mylotarg improved the EFS than the standard therapy (7+3). Regarding the safety profile, bleeding and veno-occlusive disease (VOD) occurrence slightly increased, but it was determined safe because it was not significantly different from the side effect frequencies. Since Mylotarg is a standard therapy for cytogenetically favorable-intermediate patient groups based on treatment guidelines of the United States and Europe, the assessment suggested it should be provided to patients in South Korea. In the ALFA-0701 Phase 3 trial, the drug significantly improved the primary endpoint, demonstrating a median EFS of 17.3 months compared to 9.5 months in the control group. Currently, this drug is listed in the prescription price list of the US, UK, Germany, Italy, and Japan. Meanwhile, the prevalence of domestic AML is 2.5 cases per 100,000 population annually. The prevalence of the disease increases with age, and the median age of AML patients is between 65 and 69. As life expectancy increases, more AML patients are older. Patients with AML experience fatigue, weakness, loss of appetite, anemia, and thrombocytopenia due to bone marrow failure and extended infiltration of leukemia cells. It has been reported that young patient survival rate is below 20% with poor prognosis.
- Policy
- Dong-A ST first to pay the raised new drug approval fee?
- by Lee, Hye-Kyung Jan 07, 2025 06:05am
- With the new drug approval fee raised to KRW 410 million on Jan. 1 this year, the industry is eyeing whether Dong-A ST will become the first to apply for marketing authorization and pay the raised new drug approval fee. According to industry sources on the 7th, Dong-A ST applied for a prior consultation before applying for marketing authorization for its new drug cenobamate for epilepsy at the end of last year. Cenobamate is known under the brand name ‘Xcopri’ in the U.S. The prior consultation is a procedure introduced when the fee was increased as an ‘innovative measure for new drug approval,’ and is only available once for new drugs that are scheduled to apply for marketing authorization within 3 months. SK Biopharm and Dong-A ST signed an agreement in January for cenobamate Cenobamate is a new drug independently developed by SK Biopharm, which was approved by the U.S. Food and Drug Administration (FDA) in November 2019 and launched in the U.S. in May 2020. In Europe, the drug was granted marketing authorization through the company’s partner Angelini Pharma in March 2021 and has been launched sequentially since then, showing strong growth in the global market. Since licensing out cenobamate to the European market for the first time in 2019, the cumulative upfront payment for the drug is currently about KRW 600 billion, and the total amount of technology exports, including milestone payments, is reportedly 1.6 trillion. In the U.S. market, SK Biopharm has a direct sales system. Domestic marketing authorization, production, and sales are handled by Dong-A ST. In January last year, SK Biopharm signed a licensing agreement with Dong-A ST for its cenobamate. Under the agreement, Dong-A ST will receive cenobamate’s finished drug manufacturing technology from SK Biopharm and will be in charge of marketing authorization, production, and sales of the drug in 30 countries including Korea, Southeast Asia, Southwest Asia, Russia, Australia, New Zealand, and Turkey. Dong-A ST plans to launch the product in 2026 after completing preparations for cenobmate’s approval and reimbursement. With the increase in new drug approval fees this year, the company will receive benefits such as a dedicated review team and prioritized GMP surveys, so the company expects to be able to launch the product in 2026 as planned. Meanwhile, SK Biopharm is currently conducting Phase III clinical trials in Asia, including Korea, for adult partial-onset epilepsy. The trial is expected to be finalized around 2025. According to SK Biopharm, there are about 190,000 patients with epilepsy in Korea. Its relevant market is estimated to be worth KRW 130 billion.
- Policy
- Zolgensma shows 94% effect during post-evaluations
- by Lee, Tak-Sun Jan 06, 2025 05:56am
- The spinal muscular atrophy (SMA) treatment Zolgensma (onasemnogene abeparvovec) showed promising results suited to its high price. The use of the once-daily, one-shot treatment, which has an insurance cap set at KRW 2, requires a post-marketing evaluation to measure its cost-effectiveness. According to industry sources on the 5th, Zolgensma Inj was approved for reimbursement in August 2022 and was administered to 21 patients by November last year, 18 of whom have received outcome evaluations. 17 of the 18 patients showed significant improvement, with 1 patient failing to receive the drug due to death. The Health Reviews and Assessment Service recently released the results of the Zolgensma Inj performance evaluation that contained the results above. The performance evaluations for Zolgensma Inj are conducted before dosing and every 6 months following administration for up to five years. Failure was defined as: a) permanent ventilation or death; b) CHOP-INTEND score not improving by at least 4 points from pre-dose baseline; or c) a decrease in CHOP-INTEND of at least 4 points or HFMSE of at least 3 points on two consecutive response assessments, even if the b) improvement was achieved. However, a significant improvement after treatment was considered to have occurred if there was an increase in motor function test scores, even if the patient’s outcome falls within the criteria for treatment failure. Spinal muscular atrophy is a genetic disorder caused by problems in the part of the nervous system that controls the movement of the voluntary muscles. Zolgensma is designed to deliver a functional copy of the SMN1 (survival motor neuron 1) gene into cells via transfection. It promotes the survival and function of the transgenic motor neurons by alternatively expressing the SMN protein in the motor neurons. The majority of patients receiving Zolgensma are infants less than 24 months old. The 9 additional outcomes reported by the panel were also all infants at 24 months of age. Eight of these patients showed significant improvement from 12 to 24 months. One patient showed a decrease in HFMSE of more than 3 points at the 24-month evaluation and was required to confirm motor function via HFMSE at the next review, and if necessary, submit video evidence to confirm the HFMSE score. A total of 21 patients had received Zolgensma Inj by November of last year when the post-evaluation was conducted, the agency said. Of these, the results of 18 patients were disclosed because 3 are yet to receive the 6-month post-evaluations. One of the 18 patients showed treatment failure with death, and 17 showed significant improvement, rendering the effectiveness rate to 94.4%. As high as the drug’s price is, with an insurance price ceiling set at KRW19.817,269, the drug has been showing a clear effect. The patient’s out-of-pocket cost for the drug is KRW 5.98 million (10% coinsurance rate) for a single dose with health insurance.
- Policy
- MFDS’s 2nd GIFT drug Nefecon applies for reimbursement
- by Lee, Tak-Sun Jan 06, 2025 05:56am
- Nefecon (micronized budesonide), the only drug approved by the U.S. FDA to treat lgA (immunoglobulin A) nephropathy, has applied for domestic health insurance reimbursement coverage in Korea. The drug was approved in November last year as its 2nd GIFT (Global Innovative Drug Fast Track) drug, MFDS’s fast track program. According to industry sources on the 3rd, the application for reimbursement determination of Nefecon enteric capsules 4 mg was recently submitted to the Health Insurance Review and Assessment Service. Nefecon is a drug used to treat primary IgA nephropathy in adults with a urinary protein-to-creatinine ratio of 1.5 or greater who are at risk of rapid progression. The drug was approved by the US FDA last year under the brand name Tarpeyo in December 2021 as the first and only IgA nephropathy treatment. The drug was developed by Calliditas Therapeutics AB based in Sweden. Everest Medicines has exclusive rights for the drug’s sale in Korea and China, Hong Kong, Macau, Taiwan, and Singapore through an exclusive license agreement with the original developer. Budesonide, the active ingredient, is commercially available in Korea. It is used for asthma, chronic obstructive pulmonary disease, and allergic rhinitis under the trade names Pulmicort and others. The original developer repurposed the ingredients and developed it for the first time as a treatment for IgA nephropathy. IgA nephropathy is a disease that occurs when immune complexes including IgA are deposited in the glomeruli of the kidneys, causing an inflammatory response, and is said to affect more than 9,000 patients in Korea. Symptoms can range from asymptomatic microscopic hematuria to rapidly progressive kidney failure. Treatment for lgA nephropathy is generally conservative and includes blood pressure control, the use of renin-angiotensin system blockers to reduce proteinuria, and lifestyle modification. Immunosuppressive drugs may then be used if the condition worsens. There is no fundamental cure that targets the disease. Nefecon is an expensive drug; it costs nearly KRW 20 million per month in the U.S., therefore, its financial sharing is expected to be a key issue during reimbursement reviews. However, the absence of a cure for IgA nephropathy may affect the reimbursement review.
- Policy
- 'Pivlaz Inj' makes another attempt to be reimb in KOR
- by Lee, Tak-Sun Jan 03, 2025 06:27am
- 'Pivlaz Inj,' which is supplied·distributed in South Korea by Handok, has been submitted for another attempt at reimbursement. The marketing authorization for Pivlaz was approved in South Korea in December 2023. Then, the company applied for reimbursement but voluntarily withdrew the reimbursement application in June 2024. According to industry sources on January 2, the reimbursement application for Pivlaz Inj (clazosentan disodium) was submitted to the Health Insurance Review and Assessment Service (HIRA). Pivlaz Inj, a selective endothelin receptor antagonist, received Korean marketing authorization on December 7, 2023, for the indication to prevent cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms in adults who had undergone clipping or coiling treatment for aneurysmal subarachnoid hemorrhage. Cerebral vasospasm after aneurysmal subarachnoid hemorrhage increases the risk of death in patients by twofold. Prevention and treatment are crucial because they accompany serious complications, such as local paralysis, language impairment, and decreased cognition. However, treatment for the disease has been difficult because there has been no medication available for it. In Phase 3 clinical trial (AC-054-305), involving patients who had undergone coiling treatment for aneurysmal subarachnoid hemorrhage, Pivlaz showed a statistically significant reduction in the percentage of mortality due to delayed ischemic neurologic deficit or all-cause associated with cerebral vasospasm in the 10mg/h treatment. The percentage for the placebo group was 28.8% (32/111 cases), and that of the 10mg/h treatment group was 13.6% (14/103 cases). Before the approval in South Korea, the Central Pharmaceutical Affairs Advisory Committee (CPAC) determined that the drug's concurrent use with nimodipine lacked a basis for the drug's benefit and, unlike in Japan, a trial result comparing the drug to nimodipine, which is a standard therapy in South Korea, is needed. However, during reconsideration by the CPAC, a comprehensive result from an additionally submitted document demonstrating a comparison with nimodipine and the company's plan to secure documents in Korean was evaluated. The CPAC has concluded that clazosentan monotherapy (excluding its concurrent use with nimodipine) will be approved based on Japan's Phase 3 clinical trial results. The company applied to HIRA for reimbursement after obtaining approval. However, it withdrew the approval in June. Recently, it was reported that the company attempted reimbursement again with strengthened documents. Nxera Pharma Korea obtained the domestic approval for Pivlaz. Nxera Pharma Korea is a Japanese multinational company that acquired the Pivlaz developer, Swedish pharmaceutical company Idorsia Pharmaceuticals. In April 2024, the company changed its name from Sosei Group to Nxera Pharma. On April 12, 2024, Handok signed an agreement with Nxera Pharma Korea for the domestic supply and marketing of 'Pivlaz.' Handok plans to launch Pivlaz this year. To achieve this goal, the company must pass the reimbursement review. It draws attention to whether Handok, which has been focusing on strengthening new drug competitiveness in the rare diseases field, will achieve business goals by potentially obtaining reimbursement for Pivlaz.
