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- 2026-04-11 18:25:00
- Policy
- Lipiodol’s price reduced from 25th... 2-year suit dismissed
- by Kim, Jung-Ju Sep 26, 2022 06:07am
- The price of Guerbet Korea’s liver cancer contrast medium, Lipiodol Ultra-Fluid (iodized oil, 12.8g/10mL), which had been under legal dispute for the past 2 years after the government decided to remove the drug from the reimbursement list, will be reduced from the 25th this month. This is because the pricing discount that had been originally made by the government was reapplied upon the court’s dismissal of the lawsuit and the automatic termination of suspension of execution that followed. On the 19th, the Seoul High Court’s Administrative Court Department 6-1 decided to dismiss the administrative lawsuit filed by Guerbet Korea and notified the company and the MOHW of the termination of the suspension of execution. Accordingly, the MOHW announced that it would reduce the drug price as of the 25th as it had decided in 2020. Earlier in July 2020, the MOHW decided to lower the price of Lipiodol through ex officio adjustment upon the listing of its generic, Dongkook Pharmaceutical’s Fattiodol. Under the government’s pricing formula, the upper limit of the first product can be lowered by the government through ex officio adjustments when a generic with the same route of administration, ingredient, and formulation as the original listed. Guerbet Korea immediately filed a suit against the government, and the dispute continued until recently. The Seoul High Court’s Administrative Court Department 7 had previously decided to extend the suspension of execution that had been ordered by Administrative Court Department 12 so that the company could keep its original price. The suit was then passed on to Department 6-1, where it was dismissed. The scope of its reimbursement had also expanded in the long course of the continued litigations. As of July 6th, Lipiodol is reimbursed for lymphography, hysterosalpingography, and transarterial chemoembolization (TACE) in liver cancer. However, the price cut that will be made this time is irrelevant to the reimbursement extension, and the final price of KRW 133,000 will be applied per ample as it was originally reduced in July 2020.
- Company
- Half of pts with macular degeneration have ↓ effect
- by Sep 26, 2022 06:07am
- Researchers expect the new VEGF inhibitor Beovu to address unmet demand. Patients with neovascular age-related macular degeneration in Korea had more than half of retinal exudates at the time of one year of treatment, indicating that the vision improvement effect was not significant. It was found in PROOF, which evaluated the retinal exudate regulation effect of the first year of existing VEGF inhibitor treatment in age-related macular degeneration patients. The results of the PROOF study, in which 12 domestic ophthalmic medical staff, including Kim Jae-hwi, a specialist at Kim's eye clinc, participated as the author, were published in the Scientific Reports on August 19. According to the study, more than half of the age-related macular degeneration patients in Korea treated with existing VEGF inhibitors such as Lucentis and Eylea remained retinal exudates until the first year of treatment, and their vision improvement effects were relatively poor. The PROOF study is a retrospective study based on the medical records of 600 age-related macular degeneration patients who visited ophthalmology hospitals in Korea from January 2017 to March 2019. The primary evaluation index is the proportion of patients with retinal exudations such as intra-retinal fluid/retinal subcutaneous fluid in the first year of treatment. In the early stages of treatment, 97.2% of patients had retinal exudate, and the rate after one year was 58.1%. The intra-retinal fluid, sub-retinal fluid, and retinal pigment epithelial fluid remained in 24.7%, 37.6%, and 21.2%, respectively. The proportion of patients with retinal exudate in the second year (24 months) of treatment reached 66.0%. In the first year of treatment, patients who did not have retinal effusions adjusted showed better eyesight improvement compared to those who did not. Patients with continuous retinal exudation control for a long period of time until the first year of treatment also showed better vision improvement effects. Whether retinal exudates remain is a major factor affecting vision improvement. Retinal exudates are frequently observed through optical tomography in age-related macular degeneration patients. Some studies have shown that if a new retinal exudate occurs during treatment, vision is likely to decrease by more than five characters. Retinal exudation is considered a sign of disease activity and requires additional VEGF inhibitor treatment. The researchers explained, "In actual clinical sites, there is a burden of treatment of existing VEGF inhibitors due to problems such as frequent administration and frequent hospital visits, and patients are not seeing the optimal treatment effect from a long-term perspective." Accordingly, it is expected that new anti-VEGF treatment therapy will be expected to help solve the unmet demand by reducing the burden of treatment with a prolonged mechanism of action. The researchers mentioned Beovu as a new anti-VEGF treatment. Brolusizumab is an antibody fragment drug that inhibits all VEGF-A isomorphic proteins. In phase 3 clinical trials, the Blucizumab 6mg dose group showed better disease control effects, including superior retinal exudation control effects compared to the Aflibercept 2mg group. After administration of loading dose, the Aflibercept group was administered every 8 weeks, while more than 50% of the Brolucizumab group was administered every 12 weeks. Kang Se-woong, an ophthalmologist at Samsung Medical Center at Sungkyunkwan University, said, "The emergence of anti-VEGF treatments has lowered the rate of blind or vision-damaged patients, but there is still an unmet demand for retinal exudation." He said, "We welcome the introduction of new and diverse treatment options to clinical sites and hope that this will help address unmet demand and ultimately prevent patients from impaired vision."
- Policy
- HCV treatment Epclusa·Vosevi start pricing negotiations
- by Lee, Tak-Sun Sep 23, 2022 05:52am
- The National Health Insurance Service is known to be conducting pricing negotiations with Gilead Science Korea for the company’s new Hepatitis C treatments, ‘Vosevi (sofosbuvir/velpatasvir/voxilaprevir)’ and ‘Epclusa (sofosbuvir/velpatasvir).’ The two drugs received conditional approval from the Drug Reimbursement Evaluation Committee in July this year. According to industry sources on the 22nd, the NHIS disclosed the negotiation status above while updating the list of new drugs subject to drug pricing negotiations on the NHIS webpage. Epclusa is a new drug that was approved in February, and Vosevi in March by the Ministry of Food and Safety. Gilead, which used to dominate the Hepatitis C treatment market with ‘Sovaldi,’ had been pushed down to second place due to Abbive’s ‘Mavyret.’ In an attempt to take back its throne, Gilead has released two new drugs – Epclusa and Vosevi. Like Mavyret, Epclusa can be used in all HCV genotypes 1 to 6, this is why Gilead believes that it has a winning shot against Abbvie. Gilead is planning to fuel its drive by adding another product, Vosevi, which contains an additional ingredient. Based on IQVIA, Mavyret recorded KRW 46.6 billion in sales last year. On the other hand, Gilead’s Sovaldi made KRW 0.2 billion, and Harvoni KRW 11.7 billion. Ironically, as HCV treatments have a high cure rate if the treatments are taken within the recommended treatment period, the sales performance of these drugs tends to decline over time. Therefore, pharmaceutical companies need to attract new patients to raise sales. Currently, the new influx of patients is concentrated around Mavyret due to its low price and its broad use in all genotypes. Mavyret’s insurance ceiling price is KRW 65,014 per tablet. Compared with the KRW 126,186 of Sovalidi and KRW 130,011 of Harvoni, this is around twice the difference. Therefore, if Gilead attempts to turn around the market, the industry sees that the company would need to set the price of Epclusa and Vosevi at the same level as Mavyret. When DREC announced the results of its deliberation in June, it said it would recognize the appropriateness of the drugs’ reimbursement if the two drugs will accept a lower price than the evaluated price. As the drugs have passed the reimbursement adequacy review by the Health Insurance Review and Assessment Service and are in pricing negotiations with the NHIS, Gilead would have had to accept a price lower than DREC’s evaluated price. Although DREC’s evaluated price was not disclosed, if Mavyret was used as the alternative drug in evaluations, Epclusa and Vosevi may likely be listed at a lower price than expected.
- Company
- Nubeqa can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 23, 2022 05:52am
- Nubeqa, a prostate cancer treatment, can be prescribed at general hospitals. According to related industries, Bayer Korea's oral androgen receptor inhibitor (ARi) Nubeqa for nmCRPC treatment passed the DC of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Nubeqa has not yet been covered by insurance benefits, so it is expected to take time to lead to actual prescription activation. The drug has not been registered since the HIRA Cancer Disease Review Committee ruled it failed in February 2021. Nubeqa is an androgen receptor inhibitor with a unique chemical structure that binds to androgen receptors to inhibit the growth of prostate pressure cells through strong antagonism. It was approved based on ARAMIS, a phase 3 clinical study that compared and evaluated the efficacy and safety of Nubeqa and placebo controls in combination with ADT. The main evaluation item of the study, MFS, was 40.4 months in the Nubeqa and ADT combinations, demonstrating significant improvement over 18.4 months in the placebo and ADT combinations. It was confirmed that the risk of death decreased by 31%. In addition, the Overall Survival data derived from the final analysis results pre-specified in a recent ARAMIS study was published in the New England of Medicine (NEJM) on the 9th. As a result of the study, the combined survival period of the Nubeqa and ADT groups was statistically significantly improved compared to the combined placebo and ADT groups, and the risk of death decreased by 31%. This result is significant in that as of November 15, 2019, when data for final analysis was confirmed, 55% of patients in combination placebo and ADT received treatment for Nubeqa or other life extension as follow-up treatment.
- Policy
- On-site inspections of overseas plants will resume next year
- by Lee, Hye-Kyung Sep 23, 2022 05:52am
- On-site inspections of overseas biopharmaceutical manufacturing plants, which have been suspended due to COVID-19, will resume. The Ministry of Food and Drug Safety's Biopharmaceutical Quality Management Division recently sent an official letter to representatives of biopharmaceutical importers, the KOBIA, the KPBMA, Korea Pharmaceutical Traders Association, and the KRPIA to announce the pre-GMP site implementation of biopharmaceuticals. Due to the prolonged COVID-19 situation, the Ministry of Food and Drug Safety revised the "Guidelines for Pre-GMP Evaluation of Biopharmaceuticals" on March 29 last year to convert overseas manufacturers that need on-site inspections into non-face-to-face inspections. Non-face-to-face due diligence targets include manufacturing plants located in corresponding areas such as exhibitions, infectious diseases, and natural disasters, the Ministry of Foreign Affairs and the Korea Centers for Disease Control and Prevention classifies it as a travel ban (cancellation, postponement), traveler's system (careful review), or travel significance. Through preliminary GMP evaluation, the Ministry of Food and Drug Safety is determining whether the manufacturing and quality management standards of biopharmaceuticals that have applied for permission to manufacture and report (hereinafter referred to as permission) and change permission are met. Document evaluation and fact-finding surveys include manufacturing plants subject to initial evaluation, manufacturing plants that have passed the period of omission of the fact-finding survey (aseptic 3 years, aseptic 5 years), manufacturing processes that are deemed necessary in the item approval stage, etc. As the on-site inspection will be conducted in more than two years, the Ministry of Food and Drug Safety will first gradually expand the number of items classified as new drugs to overseas manufacturers will not have a history of due diligence by the Ministry of Food and Drug Safety. The on-site inspection will be applied after January 1 next year, and even if the non-face-to-face inspection schedule is confirmed after January 1 next year, overseas manufacturers of new drugs will switch to on-site inspection. However, rare drugs and drug manufacturers subject to fast track are conducted through document evaluation and non-face-to-face investigation. The on-site inspection will be conducted by two or three GMP investigators from the Ministry of Food and Drug Safety within the deadline for responding to the relevant complaint. The deadline for reply refers to the maximum period during which the approval department notifies the requesting department of the evaluation results when requesting an evaluation from the GMP evaluation department according to the receipt of a complaint for drug item approval. If it is not possible to conduct it within the deadline for reply to the consultation due to the circumstances of the company (manufacturing plant), the workload of the Ministry of Food and Drug Safety, and the lack of manpower for the fact-finding survey, the period may be extended. The detailed schedule and due diligence method shall be notified in official letter after consultation.
- Policy
- Leclaza to receive first monitoring for PVA negotiations
- by Lee, Tak-Sun Sep 23, 2022 05:52am
- The National Health Insurance Service disclosed drugs subject to monitoring for Type A and Type B of the Price-Volume Agreement negotiations in the fourth quarter of 2022. The list is attracting attention as Yuhan Corp’s novel non-small-cell lung cancer drug Leclaza was also selected for monitoring, as well as domestic homegrown drugs such as Kanarb, Supect, and Pelubi. A total of 91 drugs that are subject to monitoring for PVA negotiations in the 4th quarter this year were disclosed in advance on NHIS’s webpage on the 20th. The NHIS selects drugs that are subject to monitoring for PVA Type A and B negotiations every quarter. Drugs receive negotiations under 'Type A' when the claims amount in their same therapeutic class exceeds the expected claims amount that the company had agreed upon with the NHIS through negotiations by over 30%. Leclaza will also be monitored for Type A negotiations. As Leclaza was listed on July 1st last year, its rate of increase will be calculated by comparing the claims amount accrued from July 1st last year to June 30th this year with the expected claims amount. Leclaza’s expected claims amount is known to be KRW 14.1 billion. However, based on IQVIA data, Yuhan Corp had earned KRW 11 billion in the period. Therefore, the analysis is that the drug will not be subject to negotiations, but as the amount of the actual claims may differ, it is difficult to prejudge whether it will be included in the negotiation list. Many novel homegrown drugs were also listed for monitoring for ‘Type B’ PVA negotiations, which are applied to drugs whose maximum amount had already been adjusted according to Type A PVA. Boryung Pharmaceutical’s hypertension treatment Karnab is one representative drug that will receive monitoring in Q4. Also, Il-Yang Pharmaceuticals’ leukemia treatment Supect, and Daewon Pharm’s antipyretic, anti-inflammatory, pain reliever Peluvi were included for monitoring this quarter. Among imported novel drugs, the oral anticoagulants Xarelto and Lixiana, and immunotherapy drugs Opdivo and Yervoy whose use has increased greatly recently were listed as monitoring subjects. The claims amount of the previous year and the year before are compared for drugs that are subject to ‘Type C’ PVA negotiations. 172 items have received negotiations under Type C and unilaterally discounted on the 1st of this month.
- Opinion
- [Reporter's view]Bio-Administrative Orders of the USA
- by Kim, Jin-Gu Sep 23, 2022 05:51am
- Korea's CDMO (consignment development production) industry, which has just begun in earnest, has a hurdle. U.S. President Joe Biden recently signed an executive order for the "National Biotechnology and Bio Manufacturing Initiative," which calls for the production of biopharmaceuticals in the country. The Biden administration is emphasizing "Made in USA" every day ahead of the upcoming midterm elections in November. Along with the automobile and semiconductor industries, CDMO, one of the pillars of the pharmaceutical bio industry, has become a target. The decision is based on political intentions, but the intention is expected to have a significant impact on the domestic industry anyway. In the pharmaceutical bio industry, Samsung BioLogics is expected to be affected the most. Samsung BioLogics has been investing generously for the past 10 years. Since two to three years ago, orders for consignment production of biopharmaceuticals have been pouring in from around the world, including the United States. When the fourth plant is completed next year, it will become the world's top production base. However, if the administrative order is materialized, Samsung BioLogics' plan to occupy more than 30% of global biopharmaceutical CMO production is also expected to be disrupted. Just last year alone, about 20% of the company's sales came from the United States. It is not just a problem for Samsung BioLogics. After Samsung BioLogics presented a successful model, many pharmaceutical companies in Korea have entered the CDMO business. As an industry, not a company of Samsung BioLogics, the seed of CDMO was sown. However, the crisis has hit even before it is properly sprouted. The bigger problem is the possibility of U.S. protectionism spreading around the world. Protectionism is highly contagious. This means that if the U.S. takes action first, the world, including Europe, will likely jump into protecting its industries. Concerns are raised about the K-CDMO industry in that most companies that have entered the CDMO business are limited to Korea. The government seems to be aware of these concerns. The Ministry of Health and Welfare and the Ministry of Trade, Industry and Energy plan to hold a joint meeting of government ministries in the near future and come up with countermeasures related to the U.S. executive order. It plans to summarize South Korea's position here and deliver it to the U.S. during the South Korea-U.S. ministerial meeting this week. A single diplomatic negotiation cannot solve all the problems. With all possibilities in mind, other additional measures should be prepared. It is time for the government, which said it will focus on fostering the pharmaceutical bio industry, to show its true will with diplomatic power.
- Company
- Aricept grows to make ₩70B ... Ebixa nears ₩15B
- by Nho, Byung Chul Sep 22, 2022 06:02am
- Eisai Korea’s Aricept (donepezil hydrochloride) continued on its solid lead in the original Alzheimer’s treatment market, occupying nearly 70% of the KRW 100 billion market. According to drug distribution performance data, Aricept’s made KRW 71 billion, 65.5 billion, 69.2 billion, and 70.3 billion in 2018, 2019, 2020, and 2021, respectively, virtually leading the market ever since its release. Aricept Evess, an orally disintegrating tablet formulation with the same ingredient that was approved in 2008 has been showing sales in the KRW 6 billion to 9 billion range. The runner-up in the market, Lundbeck Korea’s Ebixa (memantine hydrochloride), which had maintained blockbuster-worthy sales in the KRW 10 billion range for 3 consecutive years from 2018 to 2020, had seen halved sales last year, making KRW6.2 billion. However, as the company had recorded KRW 7.7 billion in sales in 1H this year, the company is expected to gross sales around KRW14 billion this year. In 2021, Novartis’s Exelon (rivastigmine tartrate) and Janssen’s Reminyl (galantamine hydrobromide) have made around KRW 6.2 billion each. Exelon’s sales in 2018,2019,2020 were KRW 2.9 billion, 4.5 billion, and 5.3 billion, respectively, and Reminyl PR made KRW 4.3 billion, 5.4 billion, and 5.8 billion, respectively, during the same period. Eisai Korea’s Aricept, which was the second dementia treatment to be approved by the US FDA in 1995, is a donepezil formulation that had improved the convenience of intake by allowing once daily intake before sleep. Unlike acetylcholinesterase inhibitors that have the inconvenience of requiring an initial dose-escalation phase, where patients need to start with a very low dose and then increase the dose until the patients achieve the therapeutic dose, the initial dose for Aricept is 5mg, and can be increased to 10mg for maximum effect. Aricept has the advantage as patients can maintain the treatment dose that it has better tolerability and does not cause liver damage. Due to the specificity of the formulation and its mechanism of action, patients who had suffered from ulcers in the past need to frequently monitor gastrointestinal bleeding. Novartis’s Exelon, which had been the third to be approved in the field in 2000, contains rivastigmine, Like Aricept, it works by blocking the enzyme that breaks down acetylcholine --acetylcholinesterase – which transmits excitement to the neuron synapse, a neuronal junction. By blocking these enzymes, Exelon allows patients to recover cognitive function. Exelon is effective in moderate-to-severe Alzheimer’s patients, but if symptoms such as nausea, vomiting, abdominal pain, weight loss, etc. are observed during the course of administering the dose should be reduced. The fact that this drug also does not show hepatotoxicity is evaluated as its greatest advantage. Janssen’s Reminyl PR is the fourth Alzheimer’s treatment that was approved by the FDA in 2001. Reminyl contains galantamine, a herbal ingredient derived from the bulbs of the daffodil, Narcissus pseudonarcissus. Although it has a similar mechanism of action as Aricept or Exelon, it does not have the ability to stop or repair nerve cell damage that is indicated as the cause of Alzheimer's. Therefore, the drug does not dramatically reverse the course of the disease but enables patients to defer progression in cognitive impairment damage or provide slight recovery. At a memory test conducted in a clinical trial, the control group’s memory had deteriorated by 5 to 11 points, compared with the high-dose Reminyl group that maintained its initial score. Also, patients with vascular dementia and mixed type dementia that took Reminyl were able to relatively preserve their memory, orientation, and language ability. Lundbeck’s Namenda (Ebixa) which was approved in 2003 as a severe Alzheimer’s treatment is an antagonist to the NDMA receptors in the nerve cells. It inhibits the overstimulation of NDMA receptors by excessive glutamate. Unlike acetylcholinesterase inhibitor class treatments that are indicated for moderate-to-severe Alzheimer’s, Namenda showed significant inhibition in the deterioration of cognitive or physical function in severe patients in a clinical trial where patients were administered 20mg of Namenda for 28 weeks. Also, the drug has been positively received for raising the level of treatment for dementia of the Alzheimer's type in a clinical trial in combination with Aricept. In June 2021, despite the overwhelming negative opinions from advisors, Aduhelm (Aducanumab), which was developed by Biogen/Eisa received FDA approval. Its launch in Korea is also in preparation. The FDA said Aduhelm provides significant benefits to patients by reducing the build-up of accumulated amyloid beta plaques. Its once-every-four-week method of administration had opened a new horizon in drug delivery, its cost of KRW 60 million per year remain a large burden for the patients. The first FDA-approved drug for Alzheimer’s is tacrine, which was launched in 1933, but the use of the drug is restricted due to hepatotoxicity. Other acetylcholinesterase inhibitors used for the treatment of Alzheimer's disease include donepezil, rivastigmine, and galantamine. Patients should start with a relatively low dose and gradually increase the dose of Alzheimer’s treatment according to the principle of geriatric pharmacology in principle, and must take the drug while closely monitoring its effect and side effects.
- Policy
- Janssen's Imbruvica succeeded in setting a standard
- by Lee, Tak-Sun Sep 22, 2022 06:02am
- Janssen's anti-cancer drug Imbruvica, which has started to expand its benefit, has succeeded in setting standards for now. The HIRA announced that it held the 8th Cancer Disease Review Committee in 2022 on the 21st and made the decision. Through this deliberation committee, Imbruvica has set benefit standards for monotherapy in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma, who are 65 years of age or older and have never been treated before. Since April 2018, Imbruvica has been receiving benefits for secondary therapy for recurrent and refractory chronic lymphocytic leukemia. Brukinsa, which challenged MCL benefit at this cancer screening, failed to set standards. This is the second failure following the Cancer Disease Review Committee in April. Bruckinsa of BeiGene has set a standard for monotherapy in adult patients with mantle cell lymphoma, MCL (MCL), who have previously received more than one treatment, but the Cancer Disease Review Committee has not recognized it. In April, the establishment of benefit standards for MCL indications failed. However, standards have been set for Waldenström's macro-globulinemia (WM).
- Company
- Moderna releases first Omicron-specific vaccine, Spikevax-2
- by Sep 22, 2022 06:02am
- On the morning of September 21st, vaccine transport vehicle loaded with Moderna On the 21st, Moderna announced it will be releasing ‘Spikevax-2,’ its Omicron-containing bivalent booster vaccine. When released, the vaccine will be the first Omicron-specific vaccine to be released in Korea. Modern’s mRNA vaccine, Spikevax-2 (elasomeran/imelasomeran) has been approved by the Ministry of Food and Drug Safety on the 8th for use in people aged 18 years or older as a vaccine to prevent COVID-19. The approval was based on Phase II/III clinical trial that evaluated the efficacy of Spikevax-2 that compared Spikevax-2 with Moderna’s previous vaccine (Spikevax) in seronegative participants (participants who have never been infected with COVID-19). Results showed that the new vaccine met all major efficacy endpoints, including neutralizing antibody response to Omicron BA.1. Trial results also showed that additional vaccination with Spikevax-2 increased neutralizing antibodies against Omicron by 8 times in the seronegative group. Also, the new vaccine induced a stronger neutralizing antibody response than the previous vaccine against Omicron subvariants BA.4/5. Changes in the geometric mean functional relationship (GMFR) before/after vaccination showed that Spikevax-2 boosted neutralizing titers against BA.4/5 by 6.3-fold. Such results were shown in all participants regardless of prior COVID-19 infection history. Moderna is in close discussions with the Korea Disease Control and Prevention Agency (KDCA) on using Spikevax-2 as a booster dose from early October.
