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- 2026-04-12 18:23:58
- Policy
- Kymriah's price negotiation has rarely been concluded
- by Lee, Jeong-Hwan Mar 17, 2022 05:58am
- Two months after passing the Drug Benefit Evaluation Committee, negotiations on drug prices for acute lymphocytic leukemia and lymphoma CAR-T treatments have rarely been concluded. Leukemia patients are urging the NHIS and Novartis Korea to strengthen Kymriah's access to patients with rapid drug price negotiations. On the 15th, Korea Leukemia Patients Organization pointed out, "Kymriah, which received marketing approval from the MFDS, passed the committee on January 13, but patients are suffering because drug price negotiations have not been concluded." Kymriah's price negotiations will begin on January 27 this year, with the deadline of March 28, considering the 60 days of negotiations. The problem is that even if negotiations have been completed so far, it is difficult to propose the Health Insurance Policy Deliberation Committee in March, and health insurance treatment of Kymriah is only possible in May when it is proposed in April. Patients who need Kymriah treatment are patients with recurrent or refractory acute lymphocytic leukemia and lymphoma without treatment, and the life expectancy is less than six months. With one treatment, Kymriah demonstrated long-term survival in 8 out of 10 patients with acute lymphocytic leukemia and 4 out of 10 patients with lymphoma. Kymriah's one-time non-reimbursed costs about 460 million won, with health insurance authorities and Novartis unable to reach a deal. After passing the Cancer Disease Review Committee and the Pharmacist Evaluation Committee, patients are appealing for a negotiation through mutual efforts between the NHIS and pharmaceutical companies. Patients suffered a lot of chemotherapy and hematopoietic stem cell transplants due to recurrence several times, the association said. "The reason why they are waiting for the one-shot treatment Kymriah is that they can no longer handle the pain." The association said, Kymriah has been registered for registration for one year, he said. "If the registration is delayed because the drug price is expensive and the number of patients is small, it is the same as denying the existence of health insurance." He then said, "We should not restrict access to Kymriah, which is much more effective than existing treatments, because it is an advanced bio-new drug." "Over the past year, about 200 leukemia and lymphoma patients have given up on Kymriah treatment and most have died. If health insurance is not applied from April after concluding drug price negotiations, a free system should be implemented."
- Company
- Drug-resistant TB drug Dovprela applies for reimbursement
- by Eo, Yun-Ho Mar 16, 2022 05:57am
- ‘Dovprela,’ the first new drug introduced in the field of tuberculosis in 50 years, is attempting reimbursement listing in Korea. According to industry sources, Viatris Korea has submitted an application for the reimbursement listing of its multi-drug resistant tuberculosis treatment, Dovprela (pretomanid). Dovprela, which was first approved in September in the US and in October in Korea, is indicated in combination with bedaquiline and linezolid to treat adult patients with extensively drug-resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) pulmonary tuberculosis (TB). Pretomanid is the first new drug introduced in the field in 50 years. The field of TB has been neglected by front-line pharmaceutical companies due to its lack of economic feasibility. Pretomanid was also developed by a non-profit organization, ‘TB Alliance,’ rather than by general pharmaceutical companies. The drug demonstrated its efficacy in the Phase III Nix-TB trial. Dovprela in combination with bedaquiline and linezolid (BPaL) demonstrated 92% effect in patients with treatment-intolerant or nonresponsive multidrug-resistant TB and an 89% effect in patients with extensively drug-resistant TB within 6 months and identified its potential as a new short-term combination therapy in the field. Also, it reduced the treatment period from 18-24 months to 6 months, and almost all patients with treatment-intolerant or nonresponsive multidrug-resistant TB and extensively drug-resistant TB were found to be sputum culture-negative within 16 weeks. As the first ready-to-use combination that consists solely of oral treatments, the BPaL regimen reported a 90% cure rate in patients with extensively drug-resistant tuberculosis when used for 6 months compared to the standard treatment that recommends the use of at least 4 drugs in the initial intensive phase. Meanwhile, multi-drug resistant tuberculosis is a type of tuberculosis that cannot be treated with two or more TB treatments including isoniazid and rifampicin, the two most effective anti-TB treatments due to intolerance. Its cause can be divided into primary resistance and acquired resistance. Primary resistance develops when a patient is infected with drug-resistant MTB or during the course of treatment due to arbitrary discontinuation of treatment or irregular administration, etc. The treatment success rate of multi-drug resistant tuberculosis is around 50%. In addition to this low treatment efficiency, more side effects arise with the use of second-line drugs than first-line drugs. Moreover, due to its longer treatment period of 18 to 24 months, the cost burden is high, and may even require surgical operations.
- Policy
- Expectations on Yoon Seok Yeol's government
- by Lee, Jeong-Hwan Mar 16, 2022 05:57am
- Expectations are growing for the Yoon Seok-yeol administration's policy to quickly register and expand benefits for ultra-high-priced medicines such as anticancer drugs and rare incurable disease drugs. This is the effect of Yoon Seok-yeol, the elected president of the People's Power, making a pledge to quickly register severe diseases and rare cancers and expand health insurance to reduce the burden on patients and insurers. On the 15th, pharmaceutical companies and patient groups are paying attention to the trend of changes in health insurance policies for rare and intractable diseases that have obtained domestic marketing permits. Attention is focusing on whether cases in which health insurance registration and drug price negotiations have been relatively delayed within the Moon Jae In government period can be resolved with the inauguration of the new government. Yoon has put the rapid registration of rare and intractable disease drugs and the expansion of health insurance at the forefront of the campaign. Specifically, Yoon criticized the current government for being too slow to register new drugs for cancer and rare incurable diseases. It was pointed out that the Health Insurance Review and Assessment Service should register health insurance within 180 days, with 120 days for drug adequacy evaluation and 60 days for the National Health Insurance Service. It also said that although the RSA was introduced in December 2013, it was applied only to 41 drugs, and 32 were focused on cancer diseases as anticancer drugs. At the same time, Yoon announced that he would shorten the health insurance registration process for anticancer drugs and severe disease treatments without alternative drugs. It said it will significantly reduce the number of days listed by allowing post-evaluation and drug price negotiations to be conducted at the same time when conditions are met after pre-evaluation by the Korea Appraisal Board, and increase the drug price negotiation rate by using RSA of rapid registration. Pharmaceutical companies and patient groups are predicting a paradigm shift in the new government's policy to register new drug health insurance. The KRPIA, which met with party leader Lee Joon-seok just before the presidential election, also urged the establishment of a new health insurance and drug price system that can revitalize the use of innovative new drugs that are effective but expensive. The KRPIA criticized the narrow coverage of the current RSA and demanded that RSA be applied to drugs that are recognized for insurance fiscal neutrality and therapeutic needs, as well as drugs other than anticancer drugs and rare diseases. The patient group also delivered the "introduction of a rapid registration system for new drug health insurance directly related to life" as the top policy proposal in the four patient policies desired for the presidential candidate for the new year. Attention is focusing on how much the Yoon Seok-yeol administration can realize such demands for improvement in health insurance policies by the pharmaceutical industry and patients. An official in charge of drug prices belonging to a global pharmaceutical company said, "It is natural to expect the introduction or conversion of a new new drug health registration policy because the regime has been replaced. We hope that a different track from the current government or a more flexible health insurance and drug price system will be introduced. We need to actively come up with new tools to evaluate the value at a time when ultra-high-priced new drugs are pouring out."
- Policy
- Price of desvenlafaxine IMDs to be discounted up to 10%
- by Lee, Tak-Sun Mar 16, 2022 05:57am
- Pic of the anti-depressant ‘desvenlafaxine’ The price of the follow-on drugs of the anti-depressant ‘desvenlafaxine’ that had been listed at 90% of the price of its original by avoiding the original’s patent through salt alterations have fallen greatly after a year and a half due to the adjustment of the price cap that was conducted following an investigation into their actual transaction price. In other words, the companies’ efforts to develop formulations to receive a higher drug price were all in vain. Four companies including Hanlim Pharm, Myung-In Pharm, Nexpharm, and Whan In Pharm had first received approvals for their incrementally modified desvenlafaxine drugs on April 7th, 2020. The four drugs were all listed for reimbursement on June 1st, 2020. The original desvenlafaxine product is Pfizer Korea’s ‘Pristiq ER (desvenlafaxine succinate monohydrate).’ The patent for Pristiq ER will expire on October 7th this year, but the 4 companies had developed a salt-modified version that differs from the original and succeeded in avoiding the original’s patent. This allowed the companies to release their products before the patient's expiry term. In addition, the companies received a price that was set at 90% of the original based on the formula for calculating the drug price of a salt-modified drug before the expiration of the original’s patent. Based on June 1st, 2020, Pfizer’s Pristiq ER 100mg was priced at ₩1,257, while other salt-modified products were set at ₩1,129. The price difference between the two is only ₩128. However, due to the aftermath of the investigation into the drugs’ actual transaction price and the price cap adjustments that followed, the price gap had increased by 10% to 20% at the most. Myung-In’s Esven SR that was priced at ₩1,129 per 100mg fell to ₩1,016, Hanlim’s Prinexor ER to ₩1,050, and Whan In’s Defaxine SR to ₩1,016. Nexpharm Korea’s Desvela was the only drug that was able to maintain its original price of ₩1,129. Myung-In, Hanlim, and Whan In’s drug prices fell 7.0%, 10.0%, 10.0% respectively after the price cap adjustments that were applied following an investigation into their actual transaction price. The actual transaction price of Pfizer Korea’s Pristiq ER 100mg had also been adjusted following investigations, but its price drop was a mere 0.3% and was set ₩4 lower at ₩1,250. In other words, the price of salt-modified drugs has fallen 7-10% in just a year and a half. As their higher drug price was set as compensation for developing ingredients that can avoid the original's patent, the disappointment on the companies’ part is expected to be large. On the other hand, the question of why the drug prices were set at a higher level than the actual transaction price in the first place may also arise.
- Company
- Whether companies give up developing COVID-19 vaccines
- by Kim, Jin-Gu Mar 16, 2022 05:57am
- Domestic pharmaceutical companies are divided over the development of the COVID-19 vaccine. After the introduction of Pfizer, Moderna Vaccine, some companies stopped developing due to reduced commerciality and difficulties in recruiting clinical participants. Companies that are newly developing in preparation of the coronavirus are steadily appearing, creating conflicting scenes. ◆ Three new clinical trials after approval of Pfizer vaccine According to the pharmaceutical industry on the 14th, Genematrix applied for a patent for a candidate substance for the next-generation COVID-19 vaccine. The company confirmed its effectiveness on various mutations such as delta and omikron, and explained that it is expected to be used universally. In addition to Genematrix, at least three companies are believed to have challenged themselves to develop a new coronavirus vaccine in the past year. Quratis and HK inno.N were approved for phase I clinical trials in Korea in July last year. In August last year, Aijin was approved for the 1/2a clinical trial. They have entered clinical trials or began development in earnest since the domestic approval of the Pfizer vaccine (March 2021). ◆Genexine discontinued clinical trials, delaying Cellid's subsequent clinical approval Some of the companies that had previously conducted clinical trials stopped clinical trials. Genexine announced on the 11th that it will stop developing 'GX-19N'. Genexine plans to withdraw its Phase 2 and Phase 3 clinical trials approved in Indonesia. Genexine received approval for Phase 1/2a in Korea in June 2020 and began developing a coronavirus vaccine using a DNA platform. However, with the release of the Pfizer and Moderna vaccines first, the vaccination rate at home and abroad increased, and it was difficult to recruit patients and eventually gave up development. It is the same for other companies that have started to develop COVID-19 vaccines. In the case of Cellid, phase 1/2a, which began in December 2020, has been completed, but approval of phase 2b/3 is being delayed. Cellid applied to the Ministry of Food and Drug Safety for a phase 2b/3 in November last year. Geneone also went on phase 1/2a in December 2020, but it is confirmed that patients are still being recruited. ◆SK Bioscience and EuBiologics entered phase 3, and what they have in common is that they are synthetic antigen platforms It is understood that only SK Bioscience and EuBiologics are in progress among domestic coronavirus vaccine developers. SK Bioscience is conducting phase 3 of GBP510. SK Bioscience plans to commercialize its products within the first half of this year. EuBiologics also entered the final stage with the approval of Phase III clinical trials in January this year. SK Bioscience and EuBiologics have something in common that they have adopted a synthetic antigen platform. The pharmaceutical industry analyzes that synthetic antigen platforms, a traditional vaccine manufacturing method, have advantages in measuring safety and efficacy.
- Policy
- HPV vaccine, which costs 600,000 won, free of charge ?
- by Lee, Jeong-Hwan Mar 16, 2022 05:57am
- Human papilloma virus (HPV) vaccine, which costs about 200,000 won per inoculation and 600,000 won per inoculation, is expected to do well in the health insurance coverage of room 9. It is the gate that President-elect Yoon Seok-yeol promised to expand the insurance of Gadasil 9 as a life-friendly pledge. Looking at the 13th "59-second shorts" pledge posted on Yoon's YouTube channel on the 10th, the cost of vaccination for MSD Gadasil 9 in Korea, called cervical cancer vaccine, is expected to increase. Gadasil 9 currently has a much wider range of prevention of related diseases than Cervarix and Gardasil, the national HPV vaccines. This is because Cervarix is a divalent and Gardasil is a tetravalent vaccine, which has fewer target viruses than the 9-valent Gardasil 9. As Gardasil 9 targets a wider range of disease-causing viruses, inoculation costs are also high. Currently, the price of vaccinations for Gardasil 9 at front-line medical institutions is between 450,000 won and 600,000 won. In the 59-second shorts pledge, Yoon promised to apply insurance to both the recommended age and gender of Gardasil 9 licensed in Korea. Specifically, Gardasil 9 inoculation age is 9 to 45 years old for women and 9 to 26 years old for men, and Yoon pledged to pay all of them for inoculation. Women can prevent cervical cancer, vulva cancer, vaginal cancer, anal cancer, genital warts, etc. caused by HPV infection through Gardasil vaccination, and men can prevent anal cancer and genital warts caused by HPV infection. HPV is a virus that spreads to women through men and requires vaccination for both men and women, but the male vaccination rate has been significantly lower than that of women. Gardasil 9 is inoculated three times, and the price is known to be approximately 500,000 won to 700,000 won. As a result, the possibility of Gardasil9's health insurance benefits is expected to increase significantly after Yoon took office as president. It is explained that the People's Power Party fully considered the budget for Gardasil 9 health insurance benefits at the time of designing the pledge. "Gardasil 9 is inoculated to both women and men and must be inoculated three times in total," said an official at the People's Power Election Headquarters. "The pledge is to support the cost of inoculating 200,000 won per session three times."
- Company
- Exon 20 insertion targeting Exkivity comes to Korea
- by Eo, Yun-Ho Mar 15, 2022 05:58am
- Takeda’s new lung cancer drug ‘Exkivity’ is coming to Korea. According to industry sources, Takeda Pharmaceuticals Korea recently submitted an application for the marketing authorization of ‘Exkivity (mobocertinib).’ The drug is expected to be approved within the year at the earliest. Exkivity was approved in the US in September last year as a non-small cell lung cancer (NSCLC) treatment that targets EGFR Exon20 insertion mutations like Janssen’s ‘Ryvrevant (amivantamab)’ that was approved last month. Unlike Exkivity, Ryvrevant has the strength of being an oral tablet. Exkivity was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation by the FDA. EGFR Exon20 insertion mutation is a new biomarker that is newly receiving attention in the field of NSCLC. Targeted anticancer therapies that are currently available for prescriptions include those that target the Exon19 deletion or Exon21 L858R substitution mutations that are commonly found in EGFR mutations, but an unmet need existed for EGFR Exon20 insertion mutations. In this context, the introduction of targeted therapies like Exkivity is expected to play an important role in managing NSCLC in the future. Meanwhile, Exkivity demonstrated its efficacy through the Phase I/II trial. In the study, Exkivity demonstrated an ORR of 35% as well as a median progression-free survival (PFS) of 7.3 months. The Phase 1/2 trial of EXKIVITY consisted of 114 patients with EGFR Exon20 insertion-positive NSCLC who received prior platinum-based therapy and were treated with a 160 mg dose of Exkivity. The most common adverse reactions were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain.
- Policy
- The government will begin to establish an Asian vaccine fund
- by Lee, Jeong-Hwan Mar 15, 2022 05:58am
- The government will review the need for joint vaccine purchase funds in Asia and start working on creating grounds for establishment. The move is aimed at preventing repeated cases of global difficulties in supplying vaccines with COVID-19 Pandemic and bridging the gap in accessibility to public vaccines and biopharmaceuticals by country. On the 14th, the Ministry of Health and Welfare's Global Vaccine Hub Promotion Team announced that it will start researching a joint vaccine purchase fund to ensure access to vaccines in mid- to low-income countries in Asia. According to the MOHW, GAVI had difficulty in supplying vaccines in Asia as it implemented a vaccine supply policy that utilizes a differentiated pricing system according to income by country. Accordingly, the background of this study is that it is necessary to prepare to become a global vaccine hub by promoting vaccine cooperation in Asia. The Ministry of Health and Welfare predicted that through research, large-scale vaccine demand will be discovered, Korean vaccine production companies will pioneer markets and lay the foundation for vaccine exports by the authority to adjust the fund's contribution. It also analyzed that it will secure equity by bridging the gap in accessibility between countries to global health crisis management such as Pandemic and essential public vaccines and biopharmaceuticals. The Ministry of Health and Welfare will review the need for a joint Asian vaccine purchase fund and conduct literature surveys and interviews to lay the groundwork for its establishment. Considering the national mandatory vaccination by country and the status of infectious diseases, the status and demand of inconsistency in supply and demand of vaccines will be identified. Specifically, the current system to strengthen vaccine accessibility in middle and low-income countries is analyzed, and the necessity of introducing a vaccine accessibility enhancement program for countries excluding GAVI is reviewed. It will also come up with a plan to establish a vaccine joint purchase fund. Starting with the analysis of the impact of GAVI vaccine supply mechanisms and changes in target countries on vaccination by country, the need for Asian vaccine accessibility programs such as joint Asian vaccine purchase funds will also be reviewed. Along with basic designs such as vaccine joint purchase fund operators, joint purchase items, and operating systems, it will also investigate whether it can function as a basis for Korean vaccine exports by utilizing coordination rights based on fund establishment such as specific company priorities. The MOHW said, "It takes time to establish a vaccine joint purchase fund and it will estimate the budget and set the scope of participating countries, regions, and private foundations. The MOHW will visit the SAEAN to exchange information and ask for cooperation." The MOHW said, "We will be able to establish policies based on empirical data through accurate diagnosis and analysis related to the establishment of the Asian Vaccine Joint Fund." The Ministry of Health and Welfare added, "We will present the direction of fund establishment according to the demand and supply of vaccines for major infectious diseases by country and design effective operation plans."
- Company
- Samsung·Celltrion speeds up dev of follow-on similars
- by Ji Yong Jun Mar 15, 2022 05:58am
- (Pic of Samsung Bioepis and Celltrion) Celltrion and Samsung Bioepis’s follow-on biosimilars are gaining momentum in the global market. A total of 11 biosimilars from the two companies are being prepared for their launch into the global market. According to the industry on the 14th, Celltrion’s Avastin biosimilar is awaiting approval in the US and European market this year. Also, Samsung Bioepis’s Lucentis biosimilar eye drug, ‘Byooviz’ is preparing its release in the US market. Also, 9 other biosimilars from the two companies that target trillion-won market items such as the psoriasis treatment ‘Stelara,’ macular degeneration treatment ‘Eylea,’ SKE treatment ‘Prolia’ are awaiting release into the global market. Both companies are working to create new growth engines in addition to their existing flagship biosimilars. Celltrion’s pipeline as of December 31st last year (Data=Celltrion)◆CT-P16 expected to be approved this year… clinical trials for 5 of biosimilars to start this year In the case of Celltrion, its 6th biosimilar following Remsima, Remsima SC, Truxima, Herzuma, and Yuflyma, CT-P16, is expected to be approved within the year. Celltrion applied for the approval of CT-P16 in September and October in the US and Europe. In general, since the approval process takes around a year in the two regions, T-P16 is likely to be approved this year. Also, since Avastin’s patent has already expired in the US and Europe, CT-P16 can be released immediately upon approval. Avastin was developed by Roche for the treatment of metastatic colorectal cancer, metastatic breast cancer, NSCLC, and glioblastoma. According to IQVIA, Avastin’s global market size is around 8 trillion won. As CT-P16 has the same indication as Avastin, the company plans to grow the drug into its next flagship biosimilar. Pfizer’s Zirabev, Amgen’s Mvasi, Samsung Bioepis’s Aybintio are currently competing in the Avastin market. Celltrion is also working to expand its biosimilar portfolio. Celltrion is currently conducting global Phase III trials for its Stelara biosimilar ‘CT-P43,’ Xolair biosimilar ‘CT-P39,’ Eylea biosimilar ‘CT-P42,’ and Prolia biosimilar ‘CT-P41,’ among others. Celltrion started the development of its Actemra biosimilar ‘CT-P47’ in December last year. Also, the company may enjoy a market preoccupation effect if it succeeds in commercializing its Zolair and Stelara biosimilars, as the two products are being developed at a faster pace than the biosimilars of competitors. Samsung Bioepis’s pipeline as of December 31st last year (Data=Samsung)◆ Byooviz to be released in the US in the first half of the year … 4 Phase III trials underway Samsung Bioepis’s ‘Byooviz’ is awaiting entry into the US market. Byooviz respectively received marketing approval in the EU and the US in July and September last year. Its release in Europe is being coordinated with the company’s partner, Biogen, and is set to be released in the US in the first half of this year. With the release, a total of 6 biosimilars including its 5 existing biosimilars Benepali, Flixabi, Ontruzant, Imraldi, Aybintio will be penetrating the global market. Lucentis, which was developed by Genentech, is used to treat ophthalmologic diseases such as macular degeneration and macular edema. Its annual sales have recorded approximately 4 trillion won. As the first Lucentis biosimilar, Byooviz is expected to greatly enjoy a market preoccupation effect when released in the US. Samsung Bioepis is diversifying its pipeline from eye diseases to rare diseases. The company has completed Phase III trials for its Soliris biosimilar ‘SB12.’ With the completion, it is expected that the company may apply for the approval of SB12 in Europe and the US within the year. Also, Phase III trials for its 3 other pipelines - Eylea biosimilar ‘SB15,’ Prolia biosimilar ‘SB16,’ Stelara biosimilar ‘SB17’ – are underway.
- Policy
- RET mutant target anticancer drug has been approved
- by Lee, Tak-Sun Mar 15, 2022 05:57am
- For the first time in Korea, a new anticancer drug targeting a REarranged during Transfection (RET) mutation has been approved. RET is a phosphorylation enzyme that can cause cancer and is known to promote the proliferation of cancer cells when mutated or combined with other genes. The MFDS approved "Retevmo Capsule 40·80mg (Selpercatinib)" in Lilly, Korea, on the 11th. This drug is used for metastatic RET fusion non-small cell lung cancer, progressive or metastatic RET-variable thyroid cancer requiring systemic therapy, and RET fusion-positive thyroid cancer requiring systemic therapy with previous Sorafenib or Lenvatinib treatment experience. This is the first time in Korea that a drug targeting RET gene mutations has been approved. Retevmo was effective in inhibiting RET mutations that promote tumor cell proliferation. In a clinical trial (LIBRET-001) in 105 patients with metastatic RET fusion-positive non-small cell carcinoma who had previously undergone platinum chemotherapy, the overall response rate was 64%, of which 1.9% were complete and 62% were partial. The reaction period was 17.5 months, and the reaction rate over 6 months was 81% of the subjects. It is known that RET mutations are found in about 2% of non-small cell carcinoma patients. Accordingly, it is expected to be a new treatment option for non-small cell carcinoma patients with RET mutations. With the approval of Retevmo, more RET mutant target anticancer drugs are expected in the domestic market. Currently, Roche's Gavreto is also being introduced in Korea. Among domestic pharmaceutical companies, HK inno.N introduced the RET target anticancer drug "VRN061782" from Voronoi in February last year and is conducting commercialization development.
