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Policy
Government unconvinced of pre-listing reimbursement
by
Kim, Jung-Ju
Oct 20, 2020 09:16am
The South Korean government has technically expressed its opposing stance at a National Assembly audit session questioning about the necessity of adopting the ‘pre-listing reimbursement and post-evaluation system’ that exempts a deliberation on reimbursement feasibility to enhance a severe-case patient’s treatment access. Considering the drug coverage enhancement process has been fast regardless of new drugs’ pricing surging, the government views focusing on listing speed would rather risk the pricing management or post-management, which could lead to worsening financial management. The Ministry of Health and Welfare (MOHW) submitted a statement with the said answer for the National Assembly Health and Welfare Committee audit. The written answer is an extension to the MOHW National Assembly audit convened for two days on Oct. 7 and 8. According to the material MOHW provided to Lawmaker Jeon Bongmin, the government is still in process of enhancing the National Health Insurance (NHI) coverage centering cancer and severe disease treatments. Compared to 2016, the government has spent 25 percent more on pharmaceutical expense in 2019. And the expense spent on anticancer treatment during the same time almost doubled to 59 percent. The overall pharmaceutical expense has surged from 15.4 trillion won in 2016 to 19.3 trillion won in 2019. From August 2017 to the base year, total 58 items have been listed and the expense was increased by 1.6 trillion won originally from 1 trillion won. Some argue the ‘pre-listing reimbursement and post-evaluation system’ should be introduced to limited subject to improve the treatment access even further. Regarding the issue, Lawmaker Lee Jongseong questioned the ministry if the pre-listing reimbursement and post-evaluation system is needed as an alternative listing system for severe and rare disease treatments. But in the end, MOHW rejected the suggestion. MOHW official said, “The pre-listing reimbursement would make drug pricing adjustment difficult when the company refuses to accept the evaluation result, and it could also weaken the National Health Insurance Service’ (NHIS) negotiation power,” so “The issue needs to be reviewed thoroughly as we foresee the difficulties in practical system operation and reasonable pharmaceutical expense management.” However, the ministry added other regulations and systems currently in effect are contributing in the enhancement of the treatment access. MOHW official answered, “The Ministry of Food and Drug Safety (MFDS) has been operating the ‘approval-evaluation linkage system’ that conducts a reimbursement feasibility evaluation on rare disease treatment prior to their approval. And also the ministry is actively seeking means to shorten the overall listing review duration with pharmacoeconomic evaluation exemption system and shortened drug pricing negotiation.”
Policy
Improvement of reimbursement standards for Prolia is needed
by
Lee, Hye-Kyung
Oct 20, 2020 09:15am
The government has announced that it will comprehensively review the reimbursement standards for osteoporosis treatments such as 'Prolia (Denosumab)'. The MOHW expanded Prolia, which was used as a second-line treatment for osteoporosis last year, as a first-line treatment, and recognized reimbursement even if continuous administration is necessary. However, Bong-min Jeon, a member of People Power Party, pointed out that the governement should actively take steps from checking for osteoporosis to creating a continuous treatment environment and establishing an integrated treatment system for preventing fractures in stages at the National Assembly Health and Welfare Committee's national audit held on the 7th. The MOHW replied, "We will comprehensively consider and review the principles of insurance reimbursement, such as clinical usefulness, cost effectiveness, and financial requirements," in relation to the improvement of the osteoporosis treatment reimbursement standards that he argued through a written questionnaire on the 15th. Currently, osteoporosis treatment is based on the Pharmaceutical Reimbursement Listing Standard and Method’s General Principles and drug-specific reimbursement standards, and when measuring bone density, within 3 years of confirmation of osteoporotic fracture, and within 1 year of bone density measurement T-score below -2.5 Reimbursement is recognized for 1 year. The MOHW said that the standards were continuously expanded by referring to textbooks, guidelines, and academic opinions. It explained that the duration of administration of the osteoporosis treatment is set differently according to the measurement of bone density and the presence of osteoporotic fractures, and that patients with low bone density measurements through follow-up tests are continuously administered regardless of the duration.
Policy
President Moon Jae-in visited the SK Bio Research Institute
by
Lee, Jeong-Hwan
Oct 19, 2020 06:19am
President Moon Jae-in visited the COVID-19 vaccine/treatment development site on the 15th and promised to become a 'strong supporter' that helps the final development while encouraging researchers to check the development status and participate in clinical trials. President Moon urged domestic COVID-19 vaccine and treatment developers to devote all their efforts so that the people can return to their daily lives as soon as possible. On this afternoon, President Moon visited the SK Bioscience Research Center in Pangyo, Seongnam-si, Gyeonggi-do, toured the laboratory according to the vaccine development process (cultivation→purification→fermentation→quality test), and he attended the conference named 'To the end! must! Let's apply and make'. Park Neung-hoo, Minister of the MOHW, Lee Eui-kyung, head of the MFDS, and Kwon Jun-wook, director of the Korea National Institute of Health participated. Science and technology advisor in Cheongwadae, Park Soo-kyung was present. SK Chairman Taewon Choi, CEO Jeongjin Seo of Celltrion, Jaeyong Ahn, CEO of SK Bioscience, and Secretary General of the International Vaccine Institute participated. In the medical field, Professor Won-seok Choi of Korea University, Professor Byung-min Sung of Yonsei University, researcher Hee-sook Lee, a nurse for infectious diseases at the National Medical Center, and Genexine·Gene One Life Science·GC Pharma officials also attended. This is the second time President Moon's on-site visit to COVID-19 vaccine and treatment was followed by Institut Pasteur Korea in last April. At the time of his visit to Institut Pasteur Korea, President Moon promised government support for the development of vaccines and treatments. Since then, 'Corona 19 Treatment and Vaccine Development Pan-Government Support Group' has been established and operated, centering on the MOHW and the Ministry of Science and Technology. President Moon has emphasized the need for vaccines and treatments since the COVID-19 outbreak, and has promised continuous interest and active government support for the development of vaccines and treatments by domestic companies. On the 7th, SK Bioscience, which President Moon visited, applied for approval for a phase I clinical trial for its own developed COVID-19 vaccine. President Moon observed the experiment and encouraged researchers by observing the cultured cells directly through a microscope in the cell culture room that produces corona vaccine antigens by culturing cells at high concentration on a tour of the SK Bioscience Lab. At the on-site meeting, they watched a video of an interview with a researcher who is engaged in the development of therapeutic agents and vaccines. President Moon said, "In order to end the long fight against COVID-19, it is necessary to develop vaccines and treatments." He then expressed his gratitude for the hard work of the companies and researchers, saying, "The government will be a supporter of vaccine and treatment development." Meanwhile, President Moon received a report on the development trends of COVID-19 vaccines and treatments in Korea and abroad from the head of the Korea Drug Development Fund and the head of the Korea National Institute of Health. Currently, in the case of vaccines, phase III clinical trials for 10 substances are in progress overseas, and SK Bioscience, Genexine, and Gene One Life Science are respectively developing vaccines in Korea. In addition to drug repositioning research, Celltrion is developing antibody treatments and blood plasma-based treatments at GC Pharma. Celltrion's CT-P59 was approved by the MFDS on the 8th as a clinical trial phase III (IND) as COVID-19 antibody treatment, and GC Pharma's COVID-19 blood plasma-based treatment was approved for a phase II clinical trial on August 20.
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.
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