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- 2025-12-24 06:35:14
- Policy
- KHIDI “COVID-19 drug grants checks feasibility first"
- by Lee, Jeong-Hwan Oct 19, 2020 06:19am
- The Korea Health Industry Development Institute (KHIDI) noted the contingency budget on seeking the COVID-19 treatment and vaccine can only be provided for drugs submitted an application with realistic anticipation to result in treatment performance. At the National Assembly Health and Welfare Committee audit session on Oct. 15, President Kwon Deok-cheol of KHID answered so for the question raised by Lawmaker Jeon Bongmin. Lawmaker Jeon initially pointed out the South Korean government not properly executing the contingency budget after receiving the budget to urgently develop the COVID-19 treatment and vaccine. The lawmaker said only 40 percent of the budget has been used so far, which is 37 billion won out of total 94 billion won. Regarding the criticism, President Kwon Deok-cheol answered the execution of the budget would take a while as the government body has to verify performances and select businesses (pharmaceuticals) accordingly to grant the budget. The president explained, “The agency has currently opened the second round of the grant application submission. KHIDI would support development of the businesses with proven performance,” and “Surely, it is a difficult task. Either an existing drug should prove the repurposing efficacy, or find a new vaccine.” “The Minister of Science and ICT and the Minister of Health and Welfare are backing the program with a collaborative team,” and “We predict the treatment to be developed in the U.S. or Europe by the end of the year or the beginning of the next year. The Korean-made treatment has also initiated the Phase 3 clinical trial,” the KHIDI president added.
- Policy
- CKD-516, clinical approval for combined use of 'Imfinzi'
- by Lee, Tak-Sun Oct 19, 2020 06:19am
- Chong Kun Dang Chong Kun Dang's new anticancer drug candidate'CKD-516' is in a clinical trial to determine the effectiveness of the combination of immunotherapy for cancer ‘Imfinzi’ (Durvalumab, AZ). At the American Cancer Society (AACR) 2019 that was held last year, the possibility of combined use of immuno-cancer drugs was highlighted, and then the clinical phase I was immediately approved in Korea. On the 14th, the Ministry of Food and Drug Safety approved the clinical trial protocol of CKD-516 and Durvalumab (Phase 1 clinical trial) requested by Asan Medical Center in Seoul. This is a phase I test for the AMC. CKD-516 is better than after Chong Kun Dang's anticancer drug. It is known as an oral vascular disrupting agent (VDA) that selectively acts on tumor blood vessels as a mechanism to inhibit microtubule polymerization. In October last year, a phase III clinical trial was approved in Korea to compare efficacy and safety with Stivarga monotherapy as a combination therapy with Irinotecan, an existing anticancer drug, for colon cancer patients. Prior to this, in the American Society of Clinical Oncology held in April last year, the mechanism of co-administration of CKD-516 and immunotherapy and pre-clinical trial data were published. Imfinzi, which is administered together this time, is AstraZeneca's anticancer drug. It has a mechanism by which tumor cells disguise as normal cells and inhibit the protein PD-L1 that helps growth. In Korea, after platinum-based simultaneous chemoradiotherapy (CCRT), it was approved as a treatment for patients with unresectable local advanced non-small cell lung cancer, and the application of the benefit was decided in March. As a result, it recorded 5.3 billion won in sales (based on IQVIA) in the second quarter alone. Immunotherapy cancer drugs have emerged as a trend in cancer treatment due to their high patient response rate. Accordingly, many new drug candidates are expecting a better effect through combination with anticancer drugs. It is noteworthy whether CKD-516 will increase its commercialization potential as a new anticancer drug through combination with immunotherapy.
- Policy
- Immune checkpoint inhibitors require many considerations
- by Lee, Tak-Sun Oct 17, 2020 06:37am
- The MOHW showed a cautious attitude toward the expansion of the benefits of the primary lung cancer treatment for immune checkpoint inhibitors. This is because the patient's treatment opportunities expand, but enormous insurance finances may be required. The MOHW made this statement in a written answer to a question related to Jongseong Lee of a member of People Power Party at parliamentary audit of the administration on the 8th. The MOHW said, "If the benefit is expanded as a primary lung cancer treatment of immunotherapy drugs, the treatment opportunities for lung cancer patients can be expanded, but it is expected that enormous insurance finances of hundreds of billions of dollars will be required." and The MOHW explained, "We will try to make an insurance benefit by deriving a reasonable plan through active mutual efforts with pharmaceutical companies in the future." Currently, immuno-cancer drugs such as Keytruda are negotiating with the government to expand the benefits of primary lung cancer treatments. In addition, the MOHW explained to the 'non-reimbursement conversion problem when combined treatment of chemo-anticancer drugs and immuno-anti-cancer drugs' raised by Jongseong Lee. It is explained that the clinical utility and cost-effectiveness are reviewed for each therapy, not for individual drugs according to the approval of the MOHW in the case of anticancer drugs. The MOHW said that it would make an effort to provide insurance benefits as soon as possible for immunotherapy and combination therapy by devising a rational financial sharing plan through active mutual efforts with pharmaceutical companies. The MOHW responded to an inquiry from Chun Bong-min of the same party to strengthen the coverage of anticancer drugs that we are continuing to strengthen our coverage, focusing on treatments for severe diseases such as anticancer drugs, but the anticancer drug expenditure increased by 59% (₩1 trillion → ₩1.6 trillion). The MOHW said, "While maintaining the basic principles of health insurance, we will endeavor to ensure patients' treatment opportunities as much as possible and expand the application of insurance benefits along with measures to improve expenditure efficiency such as drug re-evaluation in the future. When asked Choi Hye-young, a memeber of Democratic Party of Korea, to use the National Health Promotion Fund to support the provision of anti-cancer drugs, the MOHW replied: "We agree with the need to support medical expenses including therapeutic drugs to expand treatment opportunities for cancer patients." In addition, the MOHW said that the National Health Promotion Fund provides annual health insurance funding for the amount prescribed by law, and that a careful review is necessary, taking into account the target, scope and required financial resources within the scope of the support.
- Policy
- Pirespa·Kanarb are the targets of drug price negotiations
- by Lee, Hye-Kyung Oct 17, 2020 06:37am
- Ildong's 'Pirespa 200mg (Pirfenidone)' and Boryung's 'Kanarb 30, 60, 120mg (Fimasartan potassium)' and other drugs with increased usage were targeted for the price-volume agreement negotiation system monitoring. Roche Korea's 'Zelboraf 240mg (Vemurafenib)', Pfizer Korea's 'Inlyta1·5mg (Axitinib)', and Ipsen's 'Dysport (Clostridium botulinum toxin type a)' are also monitored. The NHIS recently released 'the price-volume agreement negotiation system (Type A and B) monitored drugs for the fourth quarter of 2020 on its website. The price-volume agreement negotiation system is a method by which The NHIS and pharmaceutical companies share the risk of health insurance finances. For drugs with a sharp increase in usage, drug prices are reduced through negotiations with The NHIS. The targets for monitoring in the fourth quarter are 131 items in 75 drug groups. The monitoring targets include 'Kynteles (Vedolizumab)' from Takeda Korea, 'Repatha injection prefilled pen (Evolocumab)' from Amgen Korea, 'Taltz (Ixekizumab)' from Lily Korea, and 'Cosentyx (Secukinumab)' from Novartis Korea. Gilead Science Korea's 'Biktarvy', Guerbet's 'Lipiodol ultra soln (Ethyl esters of the iodised fatty acids of poppyseed oil)', Shin Poong's 'Inisia (Ulipristal acetate)' and 'Pyramax', and Young Poong's 'Zaronti (Ethosuximide)' are also subject to the price-volume agreement negotiation system. The price-volume agreement negotiation system type A is when the bill for the same product group with the expected billing amount agreed upon by the NHIS and drug price negotiations, the expected billing amount negotiations, the drug price increase adjustment negotiations, the scope of use expansion negotiations, etc. increased by 30% or more. Type B is the case of the same product group that has been negotiated for Type A, or four years have passed since the date of initial registration without Type-I negotiation. This is the case when the previous type is increased by 60% or more than the previous year's bill every year from the day after the end of the analysis target period, or 10% or more and ₩5 billion or more. Drugs with an annual billing amount of less than ₩1.5 billion, drugs with an upper limit lower than the arithmetic average price of the same ingredient, low-cost drugs, and shortage prevention drugs are excluded from the price-volume agreement negotiation system.
- Policy
- Atozet latecomer CKD Atoezy wins approval without PMS
- by Lee, Tak-Sun Oct 17, 2020 06:36am
- 종근당 충정로 본사 Chong Kun Dang has reportedly received the South Korean health authority’s approval on a follow-on drug of MSD’s dyslipidemia treatment Atozet. The approval preceded Atozet’s post-marketing surveillance (PMS) end date on Jan. 22 next year by three months, putting the latecomer on an advantageous position. However, the estimated launch date is still unknown as the South Korean company is to call for a CMO to manufacture the same substance drug. Chong Kun Dang’s Atoezy is not pressured to meet the PMS conditions as Atozet’s outstanding PMS period did not carry over. On Oct. 13, the Ministry of Food and Drug Safety (MFDS) green lit three doses of Atoezy by Chong Kun Dang. The drug shares the same substance (atorvastatin calcium hydrate plus ezetimibe) as Atozet. But Atoezy dropped the hydrate but contains atorvastatin calcium, instead. In a Phase 1 trial, the Korean drug proved the bioequivalence to its reference drug, Lipitor plus Ezetrol. And also it confirmed statistically significant reduction of low-density lipoprotein cholesterol (LDL-C) level in a group taking the drug against the control group during a Phase 3 trial conducted on 366 patients with primary dyslipidemia for eight to 12 weeks. Although it was predicted the outstanding PMS would be carried over to the Korean drug as it shares the same substance with Atozet, MFDS designated the drug as a subject to submit risk management plan (RMP) to verify its safety after the market release. Similar to PMS, RMP subjects have to hand in use-result surveillance outcomes after the market release. But for pharmaceutical companies, PMS could feel more burdensome as a certain period of use-result surveillance is set as an approval condition. For instance, it would have been almost impossible for Atoezy to meet the 600 cases of use-result surveillance until Jan. 22 next year to apply Atozet’s outstanding PMS. MFDS official explained the condition was replaced with RMP as the outstanding PMS period was only three months and the ministry has a precedent to refer to. As Atoezy was able to dodge the outstanding PMS carryover, consigned companies that applied for authorized generic approval last month seem to be relieved. Atoezy would be able to launch the product in January next year at earliest. But the Korean company could be releasing the product around April next year, as the company has reportedly agreed with consigned companies to release the product along with authorized generic. Even if the launch date gets scheduled in next April, it would be still earlier than other generics entering the market after Atozet’s PMS period. Moreover, the industry is unsure of Chong Kun Dang directly handling the sales, as the Korean company has been co-marketing MSD’s original drug Atozet. Some speculates Atoezy’s license could be transferred to other company.
- Policy
- 13,000 Allergan breast implant recipient data missing
- by Lee, Hye-Kyung Oct 17, 2020 06:36am
- Apparently, the information on 13,000 patients who received Allergan’s textured breast implant has not been fully surveyed, yet. In August last year, South Korea’s Ministry of Food and Drug Safety (MFDS) has ordered healthcare providers to halt using the implant and recalled the products as a patient, who received the implant, has been diagnosed with a rare cancer, the breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) Democratic Party Lawmaker Nam In-soon quoted the National Assembly audit materials submitted by MFDS on Oct 13 and projected approximately 130,000 of Allergan’s breast implants subject to recall have been sold to 1,242 healthcare institutes, which were implanted to 60,000 to 70,000 people. The information on 46,691 implant recipients treated from 1,023 healthcare institutes have been reportedly collected from affected healthcare institutes and public health center (for closed hospitals) from last January through the end of September. The information collected by 201 healthcare institutes and the contact information records left with the public health center were either incomplete or missing. The 18 healthcare institutes still in business have not submitted the patient follow-up monitoring data. According to the adverse reaction report on the recalled breast implant submitted by MFDS, total 1,670 cases have been reported from 2017 to September this year. Major adverse reactions like BIA-ALCL, capsular contracture, implant rupture, seroma, pain, infection, foreign body sensation, inflammation, foreign body reaction, dislocation, skin wrinkles and edema have been reported so far. A healthcare institute is supposed to register the information of artificial breast-implanted patient, who visited, got tested and diagnosed with BIA-ALCL, to the electronic database. As of Oct. 11, total 88 patients have been registered, where three ALCL-positive patients have been treated, 73 patients tested negative and 12 did not need further testing. Lawmaker Nam stressed, “ALCL-suspicious symptoms include swollen breast, clumps on capsular and skin rash. Any implant recipient seeing these symptoms should get tested and treated at hospital as Allergan is to compensate for the testing and treatment cost.”
- Policy
- Insurance benefits for Vizimpro·Ferinject were passed
- by Lee, Hye-Kyung Oct 15, 2020 06:05am
- Pfizer Pharmaceutical Korea's non-small cell lung cancer treatment 'Vizimpro (Dacomitinib)' was recognized as reimbursement drug. Eisai Korea's Equfina 50mg (Safinamide mesylate), an adjuvant therapy for Parkinson's disease patients, and JW Pharmaceutical's iron formulation,'Ferinject inj (Ferric hydroxide carboxymaltose complex)', also passed. The HIRA (President Kim Sun-min) released the results of the deliberation on the adequacy of medical treatment benefits for the drugs applied for decision deliberated at the 10th Pharmaceutical Benefits Advisory in 2020. The new drugs that were evaluated for reimbursement adequacy this time are 6 pharmaceutical companies and 6 products. 3 items are recognized as appropriate for reimbursement and drug price negotiations with the NHIS are in progress. It is possible to convert into reimbursed drug for Santen's intraocular pressure-lowering treatment 'EYBELIS 0.002% ophthalmic solution (Omidenepag isopropyl)' and Roche Korea's influenza treatment 'Xofluza 40mg (Baloxavir marboxil)' if the drug companies accept less than the deliberated amount.
- Policy
- The number of generics in Korea is more than 10 times higher
- by Lee, Jeong-Hwan Oct 14, 2020 06:24am
- It is pointed out that the number of generic drugs with the same active ingredient licensed in Korea is “more than 10 times higher” in foreign countries such as the United States and France. This is the result of comparing the top five items with the largest number of domestic marketing generics with overseas cases. In particular, it was added that generic drugs, which are more expensive than original drugs, are being prepared in Korea, and that the activation of generic substitution was necessary. On the 13th, nonpartisan representative Lee Yong-ho analyzed the top five products with the highest number of generic drugs in Korea and revealed as such. The top five items as of September this year were Rosuvastatin, Clopidogrel, Mosapride, Cefaclor, and Fluconazole. In Korea, the number of domestic generics for a drug reached 136 to 143. There were no generic or only 2 to 18 generics in the United States and France. Among these items, the lowest price for Fluconazole is from ₩395, the highest price is ₩1,784, and the original’s price is ₩1,726. The price difference between generics is ₩1,389, and the price of the generic is higher than that of the original. In addition, Rosuvastatin, Clopidogrel, and Mosapride, excluding Cefaclor, were also more expensive than the original drug price. He said, "The number of domestic generics is abnormally higher than that of other countries, and even though it is the exact same drug with proven bioequivalence, there is a large price difference between generics." He pointed out that there are too many, causing inconvenience in the people's prescription, dispensing, and drug selection due to information asymmetry. He said, "There are dozens of drugs that are cheaper than the drugs that the people are taking. Few people will know the facts whether or not the drugs they are taking are original, whether they are generics that are more expensive than the original, and whether they are the most expensive generics of the exact same generics with the same ingredients.” In addition, he said, "If bioequivalence testing and securing public confidence in the quality of generic drugs are preceded, drugs entrusted by the same manufacturing facility are exactly the same. As for the rights that the people need to know, generic substitution should be activated as much as for bioequivalence-approved items."
- Policy
- “Riavax problem even noticeable for incompetent officer"
- by Lee, Jeong-Hwan Oct 14, 2020 06:24am
- Former Clinical Trial Deliberation Committee Member of MFDS Kang Yoon-hee (left) and Professor Park In-geun of Gachon University Gil Medical Center Witnesses at National Assembly annual audit reproached Riavax, the immunotherapeutic peptide for pancreatic cancer treatment revoked from marketing approval, has apparently submitted review materials that every researcher at Ministry of Food and Drug Safety (MFDS) would notice how they were poorly prepared. Regardless of the failure in global Phase 3 clinical trial and clinical data with highly suspicious reliability, they claimed MFDS did not reject the item approval application but decided to approve the product and even ignored the request for post-review approval revocation. At the National Assembly Health and Welfare Committee’ audit session on MFDS conducted on Oct. 13, former Clinical Trial Deliberation Committee Member of MFDS Kang Yoon-hee (M.D.) and Professor Park In-geun of Gachon University Gil Medical Center answered Democratic Party Lawmaker Nam In-soon as witnesses. Lawmaker Nam summoned former Committee Member Kang, who reviewed Riavax approval materials, to point out the faults in Riavax approval review procedure MFDS sloppily handled. Former Committee Member Kang answered, “The submitted evidences were reviewed in August last year, and I sent an email to high-level executives in MFDS in charge of drug approval review to request revocation of the item approval as we found serious issues in the reviewed materials,” because “the eotaxin testing used in the approval review was not approved as itself, and its credibility is so low that it cannot properly prove anything.” She stressed, “The issues found during the review were noticeable even for an incompetent researcher at MFDS. The company submitted an approval application with retrospective analysis based on eotaxin and not a proper clinical trial,” and “it was approved for marketing without credible review standards.” Another witness Professor Park also addressed issues in the Riavax approval review. Professor Park urged, “I suspected there could have been some sort of special treatment for the company, when I read the news the ministry approved of Riavax by retrospectively analyzing eotaxin as a biomarker,” because “eotaxin is irrelevant to Riavax, and using the retrospective analysis on 80 patients out of over 1,000 clinical trial participants as an evidence for the approval was clearly problematic.” “An item approval should be based on evidence to confirm the item whether it would benefit patients in treatment or cause harm to them,” and “Riavax’ effect was weak, and approving these kinds of drugs could eventually take away patients’ treatment opportunity,” Professor Park added. Lawmaker Nam also raised suspicion that the Riavax received special treatment during the approval review as a former director of Review Coordination Division at MFDS was involved. Lawmaker Nam stated, “It is difficult to comprehend how it was possible to accept the result of retrospective analysis as Phase 2 clinical trial to grant an approval with evidence in development,” and “also, it was exceptional for the ministry to approve a treatment supplementary Leukine injection by individually purchasing it when it was not even approved in South Korea. The public criticized how the former director of Review Coordination Division was appointed as a vice-president of GemVax & KAEL and meddled with the review.” The lawmaker demanded, “It is problematic that a MFDS officer takes an executive position at a pharmaceutical company and leads the approval review procedure,” and that “the ministry should hand in results of its self-audit assessing the adequacy of the Riavax approval before the general audit.” A MFDS representative answered the ministry would follow Lawmaker Nam’s order. Minister Lee Eui-kyung said, “Although there was misunderstanding, the transfer of the former director of Review Coordination Division to GemVax & KAEL did not seem to have violated the employment review related regulation,”
- Policy
- What is the result of 759 illegal rebate-related drugs?
- by Lee, Jeong-Hwan Oct 14, 2020 06:23am
- In the last five years, 759 drugs were counted as having received administrative disposition for illegal rebates. Dong-A ST ranked first in the number of rebate disposals with 267 items, while CJ Healthcare ranked second with 114 items and Hanall Biopharma ranked third with 74 items. Among them, only 96 items were suspended from application of medical care benefits. On the 12th, Kwon Chilseung, a member of Democratic Party of Korea analyzed and released the data submitted by the MOHW. According to the data, 759 items of 32 pharmaceutical companies have received illegal rebates over the past five years. Of a total of 759 items, 532 were reduced in drug prices. 96 items were suspended from medical care benefits. The remaining drug disposal details are 94 penalties, 34 drug price cuts and warnings, and 3 warnings. The pharmaceutical company that received the most administrative disposition for drug rebates is Dong-A ST, which includes 267 items. Next, CJ Healthcare followed with 114 items, Hanall Biopharma with 74 items, and Inist Biopharma with 49 items. Kwon Chilseung, a member of Democratic Party of Korea, said, “For the rights that patients and citizens need to know, related information such as rebate providers, related drugs, and recipients should be continuously disclosed.” Also he added that administrative sanctions against providers should be strengthened in order to eradicate rebates.
