- LOGIN
- MemberShip
- 2025-12-20 20:01:51
- Policy
- Handok paces its efforts to reimburse Pivlaz in KOR
- by Lee, Tak-Sun Jun 11, 2024 05:47am
- Handok is taking a break from its pursuit of reimbursement for ‘Pivlaz,’ a new drug used to prevent cerebral vasospasm in patients with subarachnoid hemorrhage that the company is supplying and distributing in Korea. The company immediately applied for Pivlaz’s reimbursement to the Health Insurance Review and Assessment Service after receiving approval in December last year, but was found to have voluntarily withdrawn the application recently. The company is expected to realign its strategy and then pursue reimbursement again. According to industry sources on the 10th, Handok submitted a letter requesting the withdrawal of the application for the drug determination (reimbursement) of Pivlaz Inj (clazosentan). The drug was granted marketing authorization last year on December 7. It is a selective endothelin A receptor antagonist indicated for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic events in adults who have undergone clipping surgery or coiling treatment for aneurysmal subarachnoid hemorrhage. Pivlaz is the first drug approved in Korea to prevent both cerebral vasospasm and its complications. Cerebral vasospasm, which occurs after aneurysmal subarachnoid hemorrhage, has been shown to double the risk of death in patients. It is also accompanied by serious complications such as localized paralysis, speech impairment, and decreased consciousness. Active prevention and treatment are crucial, but the field has been experiencing difficulties due to the lack of appropriate drugs. This is why Pivlaz is rising as a promising treatment option. Nxera Pharma Korea owns the sales rights for Pivlaz in Korea. The Japanese multinational company, former Sosei Heptares, changed its name to Nxera in April last year after acquiring the Swiss pharmaceutical company Idorsia, which developed Pivlaz. On April 12, Handok announced that it signed an exclusive domestic supply and distribution agreement with Nxera Pharma Korea for Pivlaz. Handok has been collaborating with Nxera Pharma Korea Korea since 2008 to conduct domestic clinical trials and obtain marketing authorization for Pivlaz. Handok and Nxera Pharma Korea are seeking to launch Pivlaz early next year. There is still time to receive reimbursement within the timeline. The industry’s attention is focused on whether the two companies will be able to realign their strategy and speed up the reimbursement process for Pivlaz.
- Policy
- Roche applies for Ocrevus' reimbursement in KOR
- by Lee, Tak-Sun Jun 10, 2024 05:41am
- Roche Korea applied for reimbursement of 'Ocrevus Inj. (ocrelizumab, Roche Korea),’ its multiple sclerosis treatment that was approved last month, to the Health Insurance Review and Assessment Service. The drug is administered twice a year, which is considered to have dramatically improved the dosing convenience for MS patients. The drug is a megablockbuster drug with global sales of about KRW 9 trillion in 2022. Celltrion is developing a biosimilar version of the drug. According to industry sources, Roche Korea submitted a drug determination application to HIRA for Ocrevus Inj on the 5th. Ocrevus Inj is a recombinant humanized monoclonal antibody (mAb, IgG1) that selectively targets CD20-expressing B cells, reducing the number and function of B cells to inhibit MS. MS is a disease of the central nervous system, which consists of the brain, spinal cord, and optic nerve, and is an autoimmune disease characterized by the patient's immune system attacking healthy cells and tissues. It is estimated that there are about 1,800 MS patients in Korea. The initial symptom is usually unilateral visual neuritis and is often accompanied by other various symptoms depending on the part of the central nervous system affected. Most patients complain of fatigue. Although there is no cure, various medications are being used to alleviate the symptoms. Beta interferon injections are the most commonly used, but the regimen requires receiving an injection from every other day to at least once a week. Ocrevus Inj offers greater dosing convenience with an initial dose of 600 mg administered in 2 intravenous infusions, followed by a single dose of 600 mg injection every 6 months. Ocrevus was approved by the U.S. FDA in March 2017 for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis. In Korea, the Ministry of Food and Drug Safety approved the drug as a treatment for ▲ relapsing forms of multiple sclerosis (RMS) in adults, including clinically independent syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis, and ▲ primary progressive multiple sclerosis (PPMS) in adults. In the U.S., the annual cost of the drug is USD 71,087, which is equivalent to KRW 97.73 million in Korea. Due to its high cost, how the company and government will share the reimbursement cost is likely to be an issue during reimbursement review. Ocrevus Inj generated global sales of KRW 9 trillion by 2022, leading Roche's growth. It is the No. 1 product in the multiple sclerosis treatment market. Celltrion submitted a Phase III IND for an Ocrevus Inj biosimilar to the European Medicines Agency (EMA) in May last year. Recently, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association named Roche as the pharmaceutical company that will generate top global sales in 2028, citing data from global pharmaceutical market research institution Evaluate. Its products, the immuno-oncology drug Tecentriq, macular degeneration drug Vabysmo, and Ocrevus are expected to contribute to the high sales.
- Policy
- Latuda·Dupixent enter negotiations with the NHIS
- by Lee, Tak-Sun Jun 07, 2024 05:50am
- (from the top) 'Latuda (lurasidone),' a medication used to treat schizophrenia and imported and distributed by Bukwang Pharmaceutical, and 'Dupixent (dupilumab),' which aims to expand reimbursement for young children, have entered negotiations with the National Health Insurance Service (NHIS). When an agreement with the National Health Insurance Service (NHIS) is completed, reimbursement coverage is possible following reporting to the Health Insurance Policy Review Committee According to the NHIS on June 5, Latuda 20, 40, 60, 80, 120mg and Dupixent Prefilled Inj 200 mg and 300 mg entered negotiations this month. These two drugs have cleared the review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) held in May. At the time, Latuda received a decision that it could receive reimbursement if accepted below-evaluated amount. It appears that Bukwang Pharmaceutical accepted the DREC’s suggested below-evaluated amount. When a company agrees with an amount below the standard to be exempted from the drug pricing negotiations, it will only negotiate the expected claim amount. Latuda, developed by Japan's Sumitomo Pharma, is an atypical antipsychotic medication used in the treatment of schizophrenia and type 1 bipolar disorder. It works by binding to dopamine and serotonin receptors in the central nervous system, blocking the action of neurotransmitters in the brain. Bukwang Pharmaceutical acquired the exclusive development·license of Latuda for South Korea in 2017. Latuda is reported to have generated US$1.465 billion (about KRW 1 trillion) in sales in the United States in 2022. Dupixent has applied for expanded reimbursement for treating patients with severe atopic dermatitis in children aged 6 months to younger than 6 years. In May, the DREC decided that the expanded reimbursement criteria were appropriate. When the negotiations for expanded usage are completed, Dupixent will be reimbursed for patients with severe atopic dermatitis from 6 months to adulthood. In the LIBERTY AD PRESCHOOL Phase 3 trial, Dupixent showed significant improvement in skin lesions in young children. At 16 weeks, 28% of patients treated with Dupixent in combination with topical corticosteroids (TCS) showed a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S), demonstrating a significant improvement in atopic dermatitis compared to 4% of the placebo group. Consequently, it met the primary efficacy endpoint. Its indication for young children was approved in South Korea in November 2022.
- Policy
- Gov’t will maintain criteria for KIPC recertifications
- by Lee, Jeong-Hwan Jun 05, 2024 05:47am
- The government has decided to maintain the recertification process and criteria for Korea Innovative Pharmaceutical Companies. Therefore, the government decided not to accept the demands of some in the pharmaceutical industry on easing the decertification regulations, ‘2 or more rebate detections and administrative disposition’, and the 'total rebate amount that exceeds KRW 5 million’ regulations. Based on the maintained regulations, pharmaceutical companies that fall under the current disqualification criteria for innovative pharmaceutical companies, such as the rebate detection regulation, are expected to fail recertifications. On the 3rd, an official from the Ministry of Health and Welfare explained, "We will proceed according to the current regulations, and will not accept complaints from the pharmaceutical industry about easing the decertification criteria." This month, the recertification process will be carried out for Korea Innovative Pharmaceutical Companies certified on June 20, 2021, based on the Special Act on Fostering and Supporting the Pharmaceutical Industry. Currently, the 28 companies include ▲GC Biopharma, ▲Daewoong Pharmaceutical, ▲Daewon Pharm, ▲Daehwa Pharm, ▲Medytox, ▲Helixmith, ▲Boryung Pharmaceutical, ▲Bukwang Pharmaceutical, ▲BC World Pharm, ▲Samyang Holdings, ▲Celltrion, ▲Shin Poong Pharmaceutical, ▲ST Pharm, ▲Yuhan Corp, ▲Isu Absix, ▲Chong Kun Dang, ▲Crystal Genomics, ▲Taejoon Pharm, ▲Korea Otsuka Pharmaceutical, ▲Korea United Pharm, ▲Genuone Sciences, ▲Handok, ▲Hanlim Pharm, ▲Hanmi Pharmacuetical, ▲Hyundai Pharm, ▲HK Inno.N, ▲LG Chem, and▲SK Chemical. The companies reportedly submitted the written evaluation materials required for the recertification last month and completed an interview evaluation. Specifically, the written evaluation consists of 25 criteria, including excellence in R&D resource input, innovation in R&D activities, excellence in technological and economic performance, and corporate social responsibility, ethics, and management transparency. The interview evaluation consists of 5 criteria on innovation in R&D activities such as R&D vision, mid- to long-term promotion strategy, and the company’s social responsibility and ethics. Several pharmaceutical companies that submitted documents to extend their certification claimed that it was unfair to revoke the innovative pharmaceutical company status, which is certified based on the percentage of investment in R&D for new drugs, for illegal drug rebates, which is an individual deviant behavior. They also raised the need to ease the rebate criteria for decertifying innovative pharmaceutical companies. They requested that the 2 two administrative dispositions on rebates and the total amount of rebates paid that exceed KRW 5 million thresholds should be eased. However, the MOHW has decided not to accept these complaints from the pharmaceutical industry this time. The reasoning is that there are already companies that have been decertified under the current regulations, so it would be unfair to change the criteria, and there is no consensus within or outside the MOHW on the feasibility of easing the rebate criteria. A MOHW official said, "If any of the 28 pharmaceutical companies whose innovative pharmaceutical company certification period expires apply for recertification, they will be judged according to the current criteria without changing the criteria such as disqualification reasons. We are not considering the pharmaceutical industry's request to ease the criteria for decertification.” As such, the 28 pharmaceutical companies whose certification was extended in 2021 and expires in June this year will be evaluated on whether to be granted recertification as innovative pharmaceutical companies based on the current criteria, including whether or not they are subject to administrative dispositions for illegal rebates. The MOHW plans to confirm and notify the recertification decision within this month after deliberations by the Pharmaceutical Industry Development and Support Committee earlier this month.
- Policy
- Lorviqua fails to receive reimb as first-line therapy
- by Lee, Tak-Sun Jun 04, 2024 05:47am
- The reimbursement extension application for Lorviqua, a treatment for anaplastic lymphoma kinase (ALK)-positive non-small-cell cancer, has failed to go beyond the negotiation stage with the National Health Insurance Service. With the breakdown of the negotiations, the company will have to start over from the application stage for Lorviqua’s reimbursement According to industry sources, Pfizer Korea’s recent negotiations with the National Health Insurance Service for Lorviqua’s reimbursement(NHIS) fell through. Lorviqua is a treatment for ALK (anaplastic lymphoma kinase) positive non-small cell lung cancer, that was listed for reimbursement in September 2022. The drug is currently reimbursed to treat patients with advanced or metastatic ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib (brand name: Alecensa) or ceritinib (Zykadia) or Xalkori (crizotinib) as first-line ALK tyrosine kinase inhibitor (TKI) therapy, However, patients who received crizotinib (Xalkori) as a first-line ALK inhibitor may also have received alectinib, ceritinib, or brigatinib as a second-line ALK inhibitor and can use Lorviqua with reimbursement. In other words, the drug is covered as second-line or later therapy in patients who have not responded to prior first-line or first- or second-line agents. Lorviqua has become a blockbuster drug since its reimbursement, posting sales of KRW 11.7 billion last year, according to IQVIA. Pfizer has been pushing to extend Lorviqua’s reimbursement to first-line based on clinical data. In January, the Drug Reimbursement Review Committee deemed the drug's reimbursement extension adequate if the company is willing to accept a price lower than the assessed value. Since then, Pfizer has been conducting drug pricing negotiations with the National Health Insurance Service, accepting the committee's opinion. However, the negotiations fell through after the company and the government failed to reach an agreement on the terms of the risk-sharing agreement scheme, etc. As a result, the company will have to start all over again from the reimbursement application stage. At the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024), which kicked off last month in Chicago, Pfizer unveiled the 5-year follow-up data on Lorviqua showing a progression-free survival rate of 60%, which is significantly higher than the 8% in the Xalkori arm. The data showed Lorviqua’s advantage in the first-line treatment environment. However, due to its failure to receive reimbursement extensions, existing first and second-line therapies will continue to dominate Korea’s ALK-positive targeted therapy market. Pfizer is reportedly planning to reapply for reimbursement as soon as possible.
- Policy
- Takeda’s Zejula Tab receives marketing authorization in KOR
- by Lee, Hye-Kyung Jun 03, 2024 05:49am
- Takeda Pharmaceuticals’ poly ADP-ribose polymerase Inhibitor ‘Zejual (niraparib)’ has been granted marketing authorization in Korea in its tablet form. The Ministry of Food and Drug Safety (MFDS) approved Zejula Tab 100 mg on the 31st. Like its capsule formulation, Zejula Tab is indicated ▲as monotherapy for adult patients with ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have shown response (partial or complete response) to first-line platinum-based chemotherapy; ▲ as monotherapy for adult patients with platinum-sensitive recurrent high-grade serous ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have responded (partial or complete response) to two or more lines of platinum-based chemotherapy. Its capsule formulation, Zejula Cap had been approved in Korea in 2019 as the first PARP inhibitor for use in patients regardless of BRCA mutations. Patients only need to take two 100 mg tablets once daily, making it the only once-daily treatment available for ovarian cancer. In a pivotal clinical study, Zejula demonstrated a significant improvement in median progression-free survival (mPFS) compared to placebo in patients with and without BRCA mutations. Among patients with ovarian cancer who have BRCA mutations, patients treated with Zejula had a mPFS of 21.0 months, which was 4 times longer than the 5.5 months confirmed in the placebo arm. In patients without BRCA mutations, mPFS with Zejula was 9.3 months, compared with the 3.9 months in the placebo arm, a clinically significant difference. In the U.S., Zejula is an "all-comer" that is reimbursable for all ovarian cancer patients, but in Korea, it is only available as first- and second-line maintenance therapy for patients who showed response to platinum-based chemotherapy. In April, a proposal to extend Zejula’s reimbursement as first-line maintenance therapy cancer to cover HRD-positive patients in addition to the current BRCA mutation-positive patients for unresectable ovarian cancer was submitted to the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee, but rejected due to its unclear reimbursement adequacy. Meanwhile, Zejula and Lynparza (olaparib) are the only PARP inhibitors in Korea with an indication for maintenance therapy for ovarian cancer.
- Policy
- Qarziba’s reimb standard has been set before approval
- by Lee, Tak-Sun May 31, 2024 05:51am
- The reimbursement standard has been set for Qarziba (dinutuximab, Recordati Korea), which was designated as the 1st drug for a “Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,” even though it has not yet received approval from the Ministry of Food and Drug Safety (MFDS). Qarziba is used for treating neuroblastoma in young children over 12 months. The Health Insurance Review and Assessment Service (HIRA) held the 4th Cancer Disease Review Committee (CDRC) meeting 2024 on May 29 and announced this review result. Qarziba was considered for a review as a novel drug. It has been assigned to a “Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations.” The process for product approvals, reimbursement coverage reviews, and drug price negotiations are being conducted concurrently. The MFDS has completed the safety and efficacy review and is currently processing the product approval. Even though the drug has not yet received product approval, a reimbursement standard has been set because it was designated as part of a pilot project. The CDRC set the reimbursement standard for this drug for young children over 12 months with ▲ A high-risk neuroblastoma who had received bone marrrow removal therapy and a stem cell transplantation therapy after showing partial adverse reactions following chemostheray ▲Recurrent and refractory neuroblastma. The CDRC review results for Qarziba, nexatin inj plus Loicosodium inj plus FU inj Choongwae, nexatin inj plus Xeloda tab, and Trisenox Inj plus Vesanoid Soft Cap. At the meeting, CDRC also approved a reimbursement expansion proposal for nexatin inj plus Loicosodium inj plus FU inj Choongwae or nexatin inj plus Xeloda tab. Additionally, the CDRC passed a reimbursement expansion proposal for Trisenox Inj plus Vesanoid Soft Cap. The committee also considered opinions by the Korean Academy of Medical Sciences and drafted a reimbursement standard improvement proposal reflecting current clinical settings. The reimbursement standards have been set for anticancer therapies for treating gynecologic cancer (2 items), breast cancer (1 item), esophageal cancer (1 item), and urological cancer (2 items). The HIRA stated that it has considered the opinions of the Korean Medical Association and the Korean Academy of Medical Sciences regarding reimbursement standards and is proactively pursuing a review to improve pharmaceuticals, activities, and treatment materials through communication with the medical industry and academics. For anticancer therapy, the CDRC’s task force team reviewed 6 items. As a result, reimbursement standards have been set for anticancer therapies for treating gynecologic cancer (2 items), breast cancer (1 item), esophageal cancer (1 item), and urological cancer (2 items). The CDRC delivered partial approval of Lutathera inj use coverage, limiting to application by clinics. Additionally, the CDRC approved reimbursement for the use of Lutathera inj use, limited to application by clinics, exceeding the standard approval.
- Policy
- MFDS approves the orphan drug 'Pluvicto' for prostate cancer
- by Lee, Hye-Kyung May 31, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS) approved The Ministry of Food and Drug Safety (MFDS) stated that on May 29th, it has granted approval of the orphan drug 'Pluvicto inj (Lutetium(177Lu) Vipivotide Tetraxetan)' for the treatment of prostate cancer. Pluvicto is imported by Novartis Korea. It is a radioligand therapy comprised of radioisotope Lutetium(177Lu), which binds to prostate-specific membrane antigen (PSMA), commonly expressed in prostate cancer, delivering therapeutic radiation to prostate cancer, leading to cell death of cancer cells. Pluvicto inj has been approved for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and ‘taxane‘-based chemotherapy. The MFDS stated that in June last year, it has designated Pluvicto inj as the '6th Global Innovative products on Fast Track (GIFT)' and expects to provide a new treatment opportunity for prostate cancer patients who cannot receive conventional therapies. The MFDS said, "We will continue to make efforts to expand treatment opportunities for rare and refractory diseases by ensuring the expedited distribution of medications with proven safety and effectiveness based on our expertise in regulatory science.”
- Policy
- Korea-US gov't pledge to strengthen biohealth cooperation
- by Lee, Jeong-Hwan May 31, 2024 05:51am
- The Korean government has decided to strengthen cooperation with the U.S. Department of Commerce in the field of telemedicine and digital health, including non-face-to-face medical treatment. CareLabs and Lulu Medic, Korea’s leading healthcare platforms including domestic non-face-to-face treatment applications, Teladoc, the No. 1 telemedicine provider in the U.S., and Baxter, a global healthcare company, had the opportunity to present their major business achievements to the two governments. At 8 a.m. (KST) on the 30th, the Ministry of Trade, Industry and Energy (MOTIE) announced that it held the 'Korea-US Telemedicine Showcase' with the U.S. Department of Commerce via video. The showcase was held to enhance mutual understanding of the digital health and telemedicine industries in the two countries and explore ways for cooperation. The MOTIE assessed that the digital health industry is expected to continue to grow due to the rapidly aging population and improved quality of life. In particular, the ministry said that mobile app-based non-face-to-face medical treatment is gaining commercial results. The showcase was jointly organized by MOTIE, the U.S. Department of Commerce, digital health associations from both countries and 30 promising digital health companies from both countries. Among associations, the Korea Digital Health Industry Association (KoDHIA) from Korea and the American Telemedicine Association (ATA) from the U.S. attended the event. By company, CareLabs and Lulu Medic, Korea’s leading healthcare platforms including domestic non-face-to-face treatment applications, and Teladoc, the No. 1 telemedicine provider in the U.S., and Baxter, a global healthcare company, presented their major business results and future plans. The MOTIE plans to strengthen all-around cooperation in the bio industry, including pharmaceuticals, medical devices, and materials, parts, and equipment industries, through 'Bio USA 2024,' which will be held from the 3rd to the 4th of next month. A MOTIE official said, "We are promoting policies such as supporting the commercialization of products and services and fostering human resources to create a digital health industry ecosystem. Building on the telemedicine showcase we held this time, we plan to continue our bilateral digital health cooperation.”
- Policy
- Research on reforming post-management of pharmaceuticals
- by Lee, Tak-Sun May 30, 2024 05:50am
- The government has initiated research on developing a comprehensive reform of post-insurance management of pharmaceuticals. This research was part of the 2nd Comprehensive NHI Plan, announced earlier this year. According to industry sources on May 29th, a policy initiative reporting session was held to announce the start of the research on post-insurance management of pharmaceuticals. As part of the 2024 initiative plan for the 2nd Comprehensive NHI plan, which was announced last month, policy initiative research will be conducted to develop a comprehensive reform of post-insurance management of pharmaceuticals. This plan aims to effectively manage the cost of pharmaceuticals as part of a mid-to-long-term strategy. The research will include the current state of the post-insurance management program, accomplishments, comparisons to foreign countries, and suggestions for improving the program to suit South Korean settings. The MOHW announced that the research will start in May and be completed by December. The Korea Institute for Health and Social Affairs (KIHASA) will conduct the research under a contract with the MOHW. "The research aims to develop a comprehensive reform of the post-insurance management of pharmaceuticals, including the Health Insurance Review and Assessment Service (HIRA)’s reevaluation of reimbursement appropriateness and the National Health Insurance Service (NHIS)’s Price-Volume Agreement (PVA) program," a government official explained. “Therefore, the MOHW, the HIRA, and the NHIS officials have joined the reporting session.” Earlier this year, there were talks of a possible reevaluation of comparisons to foreign pharmaceutical pricing following the research on the comprehensive measures for post-insurance management of pharmaceuticals. However, it appears that there are plans to separately pursue the reevaluation of comparisons to foreign pharmaceutical pricing this year. When the research report is available at the end of this year, there will be a discussion on systemization next year.
