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- 2026-05-11 12:01:48
- Company
- BeigeneKR's hematologic cancer drug Brukinsa, covered from M
- by Jung, Sae-Im May 04, 2023 05:50am
- BeigeneKR announced on the 2nd that Brukinsa, a treatment for Waldenstrom's macroglobulinemia (WM), will be covered from this month. Brukinsa reimbursement applies to monotherapy in adult patients with Waldenstrom's macroglobulinemia who have received one or more prior therapies. Brukinsa is a second-generation BTK inhibitor that targets BTK. Existing patients with Waldenstrom's macroglobulinemia were treated with chemotherapy that damages normal cells as well as cancer cells. Brukinsa improved both efficacy and side effects by targeting the BTK protein through the malignant B-cell receptor (BCR). Waldenstrom's macroglobulinemia is a rare type of non-Hodgkin's lymphoma. It mainly occurs in the elderly. The main pathogenesis is the infiltration of lymphoid plasma cells secreting monoclonal immunoglobulin M (IgM) into the bone marrow. Increased IgM causes blood viscosity to rise, resulting in symptoms such as blood flow disorders, headaches, nosebleeds, retinal hemorrhages, and cerebral hemorrhages. Anemia, thrombocytopenia, and neutropenia due to bone marrow involvement are also common. Some patients experience fever, night sweats, or unexplained weight loss. Brukinsa reduced median IgM levels by 79% in a phase 3 trial in patients with WM. The event-free rate at 18 months for patients who achieved a complete response (CR) or very good partial response (VGPR) was 93%. Brukinsa also has indications for ▲MCL and ▲MZL. However, the two indications failed to pass the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service.
- Company
- Erleada can be prescribed at general hospitals in Korea
- by Eo, Yun-Ho May 04, 2023 05:50am
- The new prostate cancer drug ‘Erleada’ can now be prescribed at general hospitals in Korea According to industry sources Janssen Korea’s metastatic hormone-sensitive prostate cancer (mHSPC) treatment Erleada (apalutamide) passed the drug committees (DCs) of tertiary hospitals in Korea including the Seoul National University Hospital and Asan Medical Center, including emergency DC meetings, a total of 60 medical institutions generated a prescription code for Enhertu. With the drug’s reimbursement listing last month, the approval is expected to quickly lead to actual Erleada prescriptions in the field. Erleada is an androgen receptor targeted agent and a latecomer that belongs to the same class of drugs as Zytiga (abiraterone)’ and ‘Xtandi (enzalutamide).’ The drug safety and efficacy in the Phase III TITAN trial in 1,052 patients with mHSPC. Despite the fact that about 40% of the patients assigned to the placebo group continued treatment with Erleada during treatment, the risk of death in the Erleada group was 35% lower than that of the placebo group. Overall survival (OS) at 48 months was 65% in the Erleada group and 52% in the placebo group. Also, when excluding the effect of patients who switched medication from the placebo group to Erleada, the risk of death in the Erleada group was 48% lower than that of the placebo group. Meanwhile, according to the National Cancer Registration Statistics Program, the number of patients diagnosed with prostate cancer in 2020 was 16,815, ranking third in men following lung cancer (19,657) and stomach cancer (17,869). The number surpassed that of colorectal cancer (16,485). In addition, among the 5 major male cancers (lung cancer, stomach cancer, prostate cancer, colorectal cancer, and liver cancer), only the rate of prostate cancer has been increasing, and at an annual average rate of over 5%.
- Company
- Daewoong is accelerating its global expansion
- by Kim, Jin-Gu May 04, 2023 05:50am
- A view of Daewoong Pharmaceutical’s Hyangnam factory (above) and Daewoong Bio’s Hyangnam factoryDaewoong Pharmaceutical Group is speeding up CAPA expansion. In order to speed up its global expansion, it decided to invest 250 billion won in establishing two new factories this year alone. Daewoong Pharmaceutical plans to expand its botulinum toxin production capacity to 3.6 times the previous level by constructing a third plant for Nabota. Daewoong Bio will expand its scope from the production and sales of raw materials and finished pharmaceuticals to the global CDMO business by establishing a new microorganism-only plant. ◆Production capacity increased 3.6 times with the establishment of the 3rd factory in Nabota, Will the utilization rate decrease to 150%? According to the pharmaceutical industry on the 4th, Daewoong Pharmaceutical has begun construction of a third plant exclusively for producing Nabota, a botulinum toxin. Daewoong Pharmaceutical plans to complete the construction by 2024 at a cost of 103.6 billion won. The third factory located in Hyangnam-eup, Hwaseong-si, Gyeonggi-do has an annual production capacity of 13 million vials. The production capacity of the existing Nabota Plants 1 and 2 was 5 million vials. This means that after 2024, Nabota production capacity will expand to 3.6 times the current level. Daewoong Pharmaceutical explained that it is setting out to establish a new plant to respond to the expanding global demand for Nabota. Daewoong Pharmaceutical achieved sales of 142.1 billion won with Nabota last year. It increased by 79% compared to 79.6 billion won in 2021. In particular, exports of Nabota increased 2.3 times in one year to 109.8 billion won. The production capacity of Daewoong Pharmaceutical's Hyangnam plant, including Nabota, has steadily expanded since 2018. It more than doubled in four years from 5.8 billion won in 2018 to 6.2 billion won in 2019, 9.3 billion won in 2020, 10 billion won in 2021, and 14.4 billion won last year. The utilization rate has already exceeded 100%. 159% in 2018, 156% in 2019, 149% in 2020, 143% in 2021, and 165% last year. The utilization rate of the entire Hyangnam plant is also steadily maintained at 150-160%. This means that even though factories are operating beyond their limits, the situation continues to be difficult to meet demand. In particular, in February 2021, Daewoong Pharmaceutical's US partner, Evolus, signed a three-way agreement with Medytox and AbbVie to eliminate risks associated with local sales of 'Jubo (Nabota's US product name)', and exports are rapidly increasing. Daewoong Pharmaceutical launched Nabota in the UK in September of last year, aiming to enter the European market in earnest. Daewoong Pharmaceutical obtained product approval from the EC in October 2019. It has been registered in 62 countries around the world so far and plans to release products in 9 European countries, China, Egypt, Chile, Australia, New Zealand, Singapore, and Malaysia. Daewoong Bio, entering the global CDMO business with the construction of a new plant, expects synergy with Daewoong Pharmaceutical. Daewoong Bio also announced an expansion of its production capacity recently. Daewoong Bio announced in January that it would build a microbe-based plant. At the same time, it announced that it would enter the global CDMO business. It plans to expand its business area from the production of existing raw materials and finished drugs. Daewoong Bio is operating its Hyangnam and Anseong factories in Korea. The production capacity of the Hyangnam plant is 200,000 liters per year. It has production lines dedicated to raw materials, UDCA, and Fexuclue, which are raw materials for Ursa. The Anseong plant has an annual production capacity of 400 million tablets and produces Gliatamine, Atorvastatin, and Clopidogrel. The new plant, with an investment of 146 billion won, is expected to serve as an outpost for the global CDMO business. In the pharmaceutical industry, there is a prospect that the CDMO business structure from Daewoong Pharmaceutical to Daewoong Bio will be completed. Daewoong Pharmaceutical obtained permission for an advanced regenerative medicine cell processing facility from the Ministry of Food and Drug Safety in July last year. Daewoong Pharmaceutical has been able to speed up the development of cell and gene therapy products by obtaining permission for cell processing facilities in addition to the existing high-tech biopharmaceutical manufacturing and management businesses such as human tax cells. If Daewoong Pharmaceutical's Yongin Bio Center provides services such as the development and quality testing of cell and gene therapy products, it is expected that Daewoong Bio's new plant will be able to complete the CDMO business structure in charge of the production of related products. It is analyzed that both Daewoong Pharmaceutical and Daewoong Bio made a bold investment decision at the group company level in the construction of a new plant. The 103.6 billion won invested in Daewoong Pharmaceutical's new plant construction amounts to 14% of its equity capital (741.2 billion won) at the end of last year. Daewoong Bio plans to invest 40% of its equity capital (365.1 billion won) in the construction of a new plant at the end of last year.
- Company
- Rare diseases still left neglected in Korea’s healthcare
- by Eo, Yun-Ho May 04, 2023 05:49am
- Patients with rare diseases suffer due to the rarity of their disease. Even when treatments are available, the drugs have difficulty receiving reimbursement as it is difficult to prove cost-effectiveness and predict financial expenditures for the drugs due to the small number of patients. The government is well aware of such difficulties. This is why it has attempted to improve access to rare disease treatments through various systemic improvements. However, the situation has not improved much. Among the 6,000 to 7,000 rare diseases known worldwide, only about 6% have available treatments developed. This is because it is difficult to secure statistical significance of the data due to the small number of patients and limited clinical data. This is why even the small number of rare diseases for which treatments have been developed is a pie in the sky in terms of reimbursement. In this sense, the ‘Study on the current status of access to rare disease treatments in Korea and measures to strengthen their coverage' that was recently announced by Professor Jong-Hyeok Lee of Chung-Ang University College of Pharmacy is attracting attention. Results of the study suggest that there are still many blind spots that remain unattended for rare disease treatments. Reimbursement rate remains at 33% for orphan drugs ineligible for special calculation exemptions First, when analyzing the reimbursement status of the total of 136 orphan drugs that were approved over the past 10 years (2012-2021), the reimbursement rate for anticancer drugs rose to 58% after measures were implemented to strengthen coverage for 4 major severe diseases that began in 2013. In the case of rare disease treatments, the rate is only 51%. In particular, the rate for orphan drugs that are not subject to special calculation exemptions is only 33.3%, indicating the existence of the neglected areas, or blind spots that remain, in the area of rare diseases. In addition, the period required for reimbursement was about 22 months for drugs subject to special calculation exemptions, while it was 34 months for those ineligible for special calculation exemptions, showing the significant difference. Such results show that Korean patients' access to rare disease drugs is still limited, and the process is time-consuming. ◆Lacks application of RSA and PE exemptions The RSA (Risk Sharing Agreement) and the pharmacoeconomic evaluation exemption (PE exemption) system, which are special systems established for the reimbursement of new drugs, were also found to be rarely applied to rare diseases. Reimbursement evaluation results of the drugs analyzed in the study showed that the special systems were mainly applied to anticancer drugs. The RSA and PE exemptions were only applied to 30% and 22% of the rare disease drugs, respectively. All in all, the limited scope of application of the special systems was affecting access to treatments for patients with rare diseases. Supported by such study results, the industry has been requesting that the government allow individual deliberations to be made for drugs that are not subject to the special calculation exemption but are chronically debilitating diseases as orphan drugs not subject to the special calculation exemption system cannot receive the systemic benefits for reimbursement (only 2 products have received benefits from the system). Meanwhile, the Ministry of Health and Welfare held public-private consultative body meetings to improve the drug pricing system with the National Health Insurance Service, Health Insurance Review and Assessment Service, and three pharmaceutical organizations. After 5 meetings, the MOHW is known to be preparing to announce the final measure to improve the drug pricing system. The ultimate purpose of preparing the 'Innovative New Drug Compensation Plan' by the 2nd Vice Minister Min-soo Park of the MOHW for the implementation of ‘Yoon Administration’s National Policy Tasts’ is not on increasing the value of drugs that are already reimbursed, but to fulfilling the fundamental purpose of allowing drugs that have not yet entered the system (received reimbursement benefits) to enter the system. Therefore, to expand access to rare disease treatment as listed as a national task by the Yoon administration, it is hoped that a practical and effective systemic improvement will be made rather than superficial attempts.
- Opinion
- [Reporter's View] Patent expired original
- by Lee, Tak-Sun May 03, 2023 05:38am
- For original drug patents that have expired, the upper limit is adjusted under the authority of the Ministry of Health and Welfare when a generic drug with the same product appears. Original drugs will be reduced to 70% of the previous price for one year, and from the second year onwards, the price will drop to the same 53.55% level as generic drugs. If the price drops by half, sales are likely to drop in proportion to him. That's what we call performance cut in half. Therefore, from the company's point of view, it is necessary to devise a strategy to prevent generics from being produced. First, it is to delay the expiration of the patent. In order to further guarantee the validity of a 20-year substance patent, the patent period can be extended by requesting an extension of the duration. In Korea, there is no limit on the extension of the duration. Therefore, pharmaceutical companies have been delaying the expiration of patents by extending the duration in consideration of the drug registration period. Another is to register subsequent patents. Commonly referred to as an evergreening strategy, it is to delay the release of generics by additionally registering salt patents, formulation patents, composition patents, and use patents. Domestic pharmaceutical companies sometimes make salt-modified drugs to avoid extending the duration or subsequent patents. However, as the Supreme Court disallowed it as a means of avoiding extending the duration, it is now widely used to neutralize subsequent patents. However, the salt-modified drug is not the same drug as the original drug because the salt is different. Therefore, even if a salt-altering drug comes out, the upper limit of the original drug does not fall. Maybe the original drug's evergreening strategy worked. Last year, generics were also released for diabetes treatment Tenelia, but the price ceiling did not fall because they were all salt-modifying drugs. Despite this patent strategy, generics are bound to come out. Last month, generics of Forxiga, a diabetes treatment, were poured out in heaps. Therefore, the original drug price was scheduled to be adjusted ex officio this month. The drug price cut was temporarily postponed because AstraZeneca, a pharmaceutical company, applied for suspension of execution to the court, and this was tentatively quoted. AstraZeneca applied for suspension of execution to the court because Forxiga, unlike generics, has indications other than diabetes. The company claims that it is unreasonable to cut drug prices that affect all other indications for which benefits have been applied, such as heart failure and kidney disease. It is interpreted that AstraZeneca pulled out a suspension card as a last resort when generics came out and drug price cuts became a reality. If the company suffers huge property damage, the possibility of suspension of collection increases. As mentioned earlier, the original drug's original drug price cut is halved, so property loss is inevitable. As a result, the rate of suspension of execution is also high. Once a suspension of execution is cited, price adjustments are not made until the outcome of the trial on the merits, so pharmaceutical companies can buy time for a long time. The longer the drug price adjustment period is, the more it will inevitably lead to financial losses for health insurance. As this problem has emerged, there is a movement to crack down on the door through revision of the law. The amendment to the Health Insurance Act, which provides for the recovery and refund of drug expenses paid or unpaid during the period of suspension of enforcement following the outcome of administrative litigation to cancel drug price cuts by pharmaceutical companies, passed the National Assembly on the 27th of last month. It is expected that if this law goes into effect six months after the government promulgation, the number of indiscriminate applications for suspension of enforcement by dissatisfaction with drug price cuts will decrease. A partial amendment to the Patent Act was proposed to limit the extension of the patent term to 14 years after approval and limit the number of patent rights that can be extended. If this law is passed, it is expected that generics will be more likely to be released earlier than before. I would like to think about introducing a more active reduction strategy, such as applying the ex officio adjustment condition limited to generics of the same product to late-release drugs with the same active ingredient after the expiration of the substance patent. There may be many things to consider, such as resistance from the pharmaceutical industry, laws and principles, and equity, but if the mechanism for adjusting authority is narrowly designed as it is now, strategies or tricks that abuse it will inevitably continue.
- Company
- Will Verzenio succeed in expanding benefits
- by Eo, Yun-Ho May 03, 2023 05:38am
- Attention is focusing on whether Verzenio will succeed in expanding early breast cancer insurance benefits. According to the related industry, the agenda to expand reimbursement for early breast cancer with a high recurrence risk of Verzenio, a breast cancer treatment with CDK4/6 inhibitory mechanism of Lilly Korea, is expected to be presented to the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service next month. Verzenio was approved by the Ministry of Food and Drug Safety in November last year as an adjunctive treatment for early breast cancer patients at high risk of recurrence of positive HR+/HER2- type lymph nodes, as an indication for combined administration with endocrine therapy. The clinical efficacy of this drug was confirmed through the monarchE study, a clinical study conducted on patients with HR+/HER- lymph node-positive early breast cancer who had a high risk of recurrence. In this clinical trial, Verzenio was conducted on patients with a low survival rate due to a high risk of recurrence among early breast cancer patients. Specifically, a very limited group of patients with ▲ four or more lymph node metastases, ▲ one to three lymph node metastases with a tumor size of 5 cm or more, and ▲ a grade 3 histological grade participated in the study. MonarchE 4-year follow-up data was announced at the San Antonio Breast Cancer Symposium Annual Conference in December last year. As a result of the study, Verzenio + endocrine therapy reduced the risk of recurrence and death by about 34% compared to endocrine therapy alone, and the risk of distant recurrence and death was also reduced. reduced by about 34%. Early breast cancer has a high risk of recurrence in the first 1 to 2 years after surgery. Therefore, unlike metastatic breast cancer, which requires continuous treatment, active treatment early after surgery minimizes the risk of recurrence and improves long-term prognosis. Verzenio is also administered only 2 years after surgery. The reason why the 4-year follow-up data announced in December of last year drew attention is that the IDFS and DRFS improvement results of Verzenio in the 4th year compared to the 2nd and 3rd years were more strengthened. Professor Joo-Hyeok Son of the Department of Oncology at Severance Hospital said, "The gap in invasive disease-free survival rate and remote recurrence-free survival rate between Verzenio + endocrine therapy and endocrine therapy alone continued to widen until the 4-year follow-up period, which was consistent with Verzenio even after completing adjuvant therapy after surgery for 2 years. "This suggests that Neo's treatment benefits may continue." Verzenio's benefit is recognized in HTA countries such as the UK and Canada.
- Policy
- The expansion of MPOX vaccination
- by Lee, Jeong-Hwan May 03, 2023 05:38am
- 17 million adult males aged 20 to 64, 170,000, about 1%, the high-risk group estimated As the number of MPOX cumulative confirmed cases in Korea increased to 49, concerns about community infection grew, and domestic quarantine authorities decided to expand the target of third-generation MPOX vaccine to 'high-risk subjects of infection', drawing attention. Currently, the quarantine authorities are implementing the MPOX 3rd generation vaccine by dividing it into 'pre-exposure vaccination' for medical staff and 'post-exposure vaccination' for contacts. The plan is to add people at high risk of infection among the general public. The high-risk target for infection is estimated to be 17 million adult male sexual minorities between the ages of 20 and 64, and the quarantine authorities plan to more actively recommend and publicize the third-generation vaccine for them. On the 2nd, the Korea Centers for Disease Control and Prevention (KCDC) responded to a written inquiry related to the MPOX epidemic in the community by In-soon Nam, a member of the Democratic Party of Korea. Rep. Nam In-soon closely inquired about the possibility of an outbreak in the MPOX community, the vaccination of medical staff, the current status of high-risk groups, and plans for siege vaccination. According to the Agency for Disease Control and Prevention, as of the 27th of last month, 109 people have been vaccinated, including medical staff in treatment beds to treat MPOX patients, and 165 people have received the first vaccination. The second dose of Jynneos, a third-generation MPOX vaccine, should be administered 28 days after the first dose. The Agency for Disease Control and Prevention announced through an official document the implementation of vaccination for those who wish to be pre-vaccinated with the Mpox 3rd generation vaccine in 17 cities and provinces to improve vaccination, such as treatment bed medical staff, diagnostic test laboratory personnel, and epidemiological investigators. The hospital for the confirmed patient was informed by phone to the hospital and actively encouraged vaccination in advance. Going further here, the Agency for Disease Control and Prevention plans to implement the 3rd generation vaccination administration. This is to prevent infection in the MPOX community in advance. Specifically, the target of third-generation vaccination before MPOX exposure is not limited to medical staff, but is expanded to 'high-risk subjects of infection'. The Agency for Disease Control and Prevention estimated that about 170,000 LGBT people are the high-risk group, based on UNAIDS, an AIDS task force under the United Nations, at about 1% of the 17 million adult male population aged 20 to 64 in Korea. MPOX 3rd generation vaccine The Agency for Disease Control and Prevention said, “We are currently conducting pre-exposure vaccination for medical staff and post-exposure vaccination for contacts.” We will expand it to those at high risk of infection.” The Agency for Disease Control and Prevention predicted that sporadic MPOX infections would continue for the time being, but diagnosed that it was not at a level to worry about a pandemic at the level of Corona-19. Unlike respiratory infectious diseases such as COVID-19 and MERS, where droplets are the main route of infection, MPOX is mainly spread through the skin and sexual contact with symptomatic infected people, and it was presented on the basis that the risk of transmission is low on the general population other than the high-risk group. The Agency for Disease Control and Prevention said, "Recently, MPOX patients have been steadily occurring in the region, and are not limited to a specific region and are distributed across the country, so sporadic cases in the community will continue." The prevailing opinion is that it is not at the level of concern about the same pandemic.” The Agency for Disease Control and Prevention added, “MPOX, which is transmitted through skin and sexual contact, has a relatively low risk of transmission in the general population of Korea, not in the high-risk group.” Meanwhile, on August 11 last year, the Korean government introduced 10,000 doses for 5,000 Jynneos, the third-generation Mpox vaccine produced by Bavarian Nordic A/S, a foreign pharmaceutical company. The third-generation smallpox vaccine, Jynneos, has been approved by the FDA and EMA for being effective against both human and monkeypox.
- Company
- Boryung fails 3 of 5 patent challenges
- by Kim, Jin-Gu May 03, 2023 05:38am
- Boryung's omnidirectional patent challenge strategy on orignial anticancer drugs has been making slow progress. Since the end of 2021, Boryung filed patent challenges on 5 anticancer drugs, and lost or voluntarily withdrew 3 of those claims. Despite the strong drive it has been making for its anticancer drug business with plans to launch generics earlier by avoiding or invalidating patents, industry analysis is that the company would inevitably have to change its plans as it failed to cross the threshold of the first trial for several of its challenges already. ◆ Boryung fails first trial for Cabometyx but succeeds in deleting the original company’s patent paragraphs #iAccoridng to industry sources on the 13th, the Korea Property Trial and Appeals Board decided to dismiss the claims Boryung filed to invalidate the substance patent of Ipsen’s liver cancer treatment ‘Cabometyx (cabozantinib).’ Although it was Boryung’s loss on the surface, the analysis is that this is not the case in reality. This is because Ipsen, the original company, voluntarily deleted all of the paragraphs that were subject to the IPTAB’s review. Boryung initially sought to invalidate Cabometyx’s formulation patent paragraphs 1 to 25. Amid the ongoing dispute, Ipsen corrected the patent. Among paragraphs 1 to 27 in its patent, Ipsen voluntarily deleted paragraphs 1 to 25, which Boryung claimed were invalid. Due to the deletion, the subject to rule upon disappeared and the related disputes came to an end. Externally, the trial ended with IPTAB dismissing Boryung's request for trial as the subject itself to claim invalidity has disappeared and the company’s request did not meet the formal requirements. Industry analysis is that although Boryung lost on the surface, it succeeded in removing the risk factor for patent infringement. This means that even if a generic is released before the patent expires in February 2032, Boryung will not be infringing on the original drug’s patent. However, from Boryung's point of view, it is regrettable as the company cannot receive the generic exclusivity rights by winning the patent trial. To make up for this, Boryung is known to be considering requesting an additional trial to challenge Cabometyx’s two remaining patents. The remaining two crystalline patents expire in January and April 2030, respectively. If the company succeeds in invalidating or avoiding either patent, it will obtain one of the requirements for generic exclusivity. ◆Boryung loses first patent trial over Ibrance and appeals... voluntarily withdraws claims for Tasigna Since 2021, Boryung has filed patent trials for five anticancer drugs including Cabometyx. The other 4 include Eisai's liver cancer treatment 'Lenvima (lenvatinib)', BMS' acute lymphocytic leukemia treatment 'Sprycel (dasatinib)', Novartis' leukemia treatment 'Tasigna (nilotinib)', and Pfizer's breast cancer treatment 'Ibrance (palbociclib).’ Among the trials, the company failed the first trial after challenging Ibrance's crystalline patent. Boryung originally planned to release the generic early after avoiding Ibrance's crystalline patent, which expires in February 2034, but the plan was put to a stop with the failed trial. This is why Boryung appealed the decision of the first trial and dragged the case on to receive a second trial. The patent challenge to Tasigna ended with Boryung's voluntary withdrawal of its claims. In April last year, Boryung requested an omnidirectional trial on Tasigna’s four patents. However, in March, Boryeong voluntarily withdrew its trial. The pharmaceutical industry pointed to the company’s discontinuation of Tasigna’s generic drug development as the cause. On the other hand, the company won the challenge for the patent for the crystalline form of Sprycel. In June last year, Boryung ruled in favor of its trial to confirm the passive scope of rights for the patent. With the ruling, Boryung became one step closer to the early release of its Sprycel generic. In addition, the company had challenged Lenvima's patent but has not received results. As a result, the company has failed 3 of 5 the patent challenges it had filed against original anticancer drugs.
- Company
- ‘Korea’s low reimb of orphan drugs needs to be improved’
- by Eo, Yun-Ho May 03, 2023 05:38am
- Study results have shown that Korea has low access to rare disease treatments. The Korean Research-based Pharmaceutical Industry Association (KRPIA) recently announced study results that stress Korea’s need to improve its reimbursement system in consideration of the characteristics held by rare diseases and rare disease treatments based on the ‘Study on the current status of access to rare disease treatments in Korea and measures to strengthen their coverage'. The results were derived from the research Professor Jong-Hyuk Lee from Chung-Ang University’s College of Pharmacy conducted as a principal investigator last year on the present status of access to rare disease treatments in Korea and measures to strengthen their coverage. The research analyzed the drugs in terms of usability –designation and marketing authorization of orphan drugs, and accessibility – reimbursement listing and medical expense support. The study pointed out how Korea defines orphan drugs and rare disease drugs separately and gives them different statuses and benefits, and that this disparity leads to the irrational result of drugs that are already approved as orphan drugs being unable to benefit from the system during the reimbursement evaluation process. In Korea, the reimbursement rate for orphan drugs (136) approved during the last decade (2012-2021) was 52.9%. When compared with similar research results overseas, this is a considerably lower level than that in Germany (93%) or France (81.1%). Also, it was noted that the average time required for orphan drugs or anticancer drugs to receive approval in Korea was 27.4 months, compared to 19.5 months in France and 18.6 months in Italy. Also, by analyzing the reimbursement rates of 136 orphan drugs approved in Korea according to special calculation exemption classification status, the study found that rare disease treatments(51.1%) and items ineligible for the special calculation exception (33.3%) showed lower reimbursement rates than anticancer drugs (57.6%). In other words, although the special calculation exemption system reduces the patient's burden for orphan drugs of rare diseases that are designated for special calculations, the system rather acts as an obstacle for diseases that are not subject to the special calculation exemption system that seeks to receive reimbursement. Korea's expenditures on orphan drugs is also 3.6%, which is lower than the OECD median of 6.8%, which is at the lower end among OECD countries. This shows the need for Korea to spend more on orphan drugs.
- Policy
- Pemazyre received domestic product approval
- by Lee, Hye-Kyung May 02, 2023 03:40pm
- Handok's locally advanced or metastatic cholangiocarcinoma treatment Pemazyre received domestic product approval on the 25th. The Ministry of Food and Drug Safety (Minister Oh Yoo-kyung) announced that it had approved three doses (4.5mg, 9mg, 13.5mg) of Pemazyre, an orphan drug. Pemazyre is an oral FGFR inhibitor that inhibits the proliferation of cancer cells caused by the fusion or rearrangement of fibroblast growth factor receptor 2 (FGFR2), which is involved in cell growth and differentiation. It is expected to provide a new treatment opportunity for adult patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement who have received one or more systemic treatments. Pemazyre is approved in the United States, Europe, and Japan for the treatment of adult patients diagnosed with locally advanced or metastatic cholangiocarcinoma with a fusion or rearrangement of the FGFR2 gene who have received at least one prior systemic therapy. In Korea, after being designated as an orphan drug in November 2021, it has been designated as a treatment for life-threatening or serious diseases since December. Previously, the US FDA designated Pemazyre as a breakthrough therapy for the treatment of previously treated patients with advanced, metastatic, or unresectable FGFR2 translocation cholangiocarcinoma, and designated it as an orphan drug, conducting an expedited review through a priority review program. Cholangiocarcinoma is a rare type of cancer and is classified according to its anatomical origin as iCCA and extrahepatic cholangiocarcinoma arising from the bile duct outside the liver. Cholangiocarcinoma is often diagnosed at an advanced or advanced stage with a poor prognosis. FGFR2 fusions or rearrangements are found in 10-16% of patients with intrahepatic cholangiocarcinoma. FGFRs play important roles in the proliferation, survival, migration, and angiogenesis of tumor cells. FGFR fusion, rearrangement, translocation, and gene amplification activities are closely related to the development of various cancers. Pemazyre is an oral FGFR inhibitor and is the first and only treatment approved by the FDA for this indication.
