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- 2025-12-26 13:07:30
- Policy
- Rucalo newly listed, Meqsel+Rafinlar expands reimbursement
- by Kim, Jung-Ju Feb 10, 2020 06:30am
- Healthcare reimbursement would be granted on Yooyoung Pharmaceutical’s chronic constipation treatment Rocalo tablet (prucalopride succinate) soon at a price of 100 won a unit. Used to treat BRAF V600E mutation-confirmed metastatic melanoma, Novartis Korea’s Meqsel (trametinib dimethyl sulfoxide) plus Rafinlar (dabrafenib mesylate) combination therapy would be additionally indicated for treating non-small cell lung cancer (NSCLC). But, only in condition of signing the expenditure cap type risk sharing agreement (RSA) for the financial issues. According to pharmaceutical industry on Feb. 5, the Korean government plans to reflect the said changes on ‘List of Reimbursed Drug and Maximum Reimbursed Price.’ ◆ Rucalo tablet: A selective serotonin 5-HT4 receptor agonist, Rucalo treats adults with chronic constipation, who does not respond to conventional laxative. After Ministry of Food and Drug Safety (MFDS) approved the drug as of Jan. 25 last year, the company immediately applied for reimbursement to Health Insurance Review and Assessment Service (HIRA) on Feb. 15 last year. Reimbursement on the drug was granted by Drug Reimbursement Evaluation Committee (DREC) in last October following the review by HIRA. Apparently, Korean Society of Neurogastroenterology and Motility’s claim that the doctors actually consider such prokinetic drug when a patient does not respond to first-line laxative (form-bulking or osmotic laxatives), has influenced the decision. In fact, the drug is listed in some of A7 countries like the U.K., Germany, Italy and Switzerland. Since then, the company successfully reached an agreement during pricing negotiation with National Health Insurance Service (NHIS) conducted from last November to early January, as ordered by MOHW. When the listing is completed, the drug’s maximum reimbursed price is predicted to be set at 127 won per 1 mg unit, and 191 won per 2 mg unit. ◆ Meqsel plus Rafinlar combination therapy expands reimbursement: Meqsel plus Rafinlar combination therapy has been indicated for treating metastatic melanoma in patient with confirmed BRAF V600E mutation. The combination has been receiving reimbursement since November 2017 in Korea. BRAF V600E mutation is a particular change in BRAF gene that affects growth and transmission of cancer cell and is frequently found in a number of specific cancers like melanoma. For the reimbursement review procedure, it took the pharmacoeconomic analysis exemption route. After a while, the pharmaceutical company added the therapy an indication to treat NSCLC patient with confirmed BRAF V600E mutation, and applied for expanded reimbursement to HIRA in February last year. HIRA’s Cancer Disease Deliberation Committee and DREC cleared reimbursement for the combination therapy in April and October last year, respectively. The combination therapy used on NSCLC, also recommended by clinical practice guidelines by National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO), was evaluated to have improved clinical efficacy when reviewed by DREC. However, the government and NHIS laid down a condition of signing RSA to cover the financial impact caused by expanding reimbursement on the combination therapy’s NSCLC-treating indication (NHI estimates yearly claim would be approximately 20 billion won). During the negotiation with the company later, the maximum prices of Meqsel and Rafinlar were lowered by 23% and 13%, respectively. When the new reimbursement is finalized, the maximum reimbursed price per unit is expected to be set at 128,344 won and 32,086 won per 2 mg and 0.5 mg of Meqsel, and 24,751 won and 36,336 won per 50 mg and 75 mg of Ranfilar.
- Policy
- NIH, urgently promotes 2019n-CoV vaccine research
- by Kim, Jung-Ju Feb 07, 2020 06:32am
- Health authorities urgently push forward research to develop 2019n-CoV treatments and vaccines. After the MERS outbreak, it will strengthen its research capabilities and begin research on viral pathogenicity within this month. The National Institutes of Health (Director Hyun-Young Park), in the Centers for Disease Control and Prevention (Director Eun-kyung Chung), announced on the 5th that it is urgently pursuing research on the development of treatments and vaccines to cope with 2019n-CoV that threaten public health worldwide. The National Institutes of Health has conducted research on new and variant viruses in Korea through the development of antibody therapeutics and high-sensitivity gene diagnostics after the MERS outbreak in 2015. Based on the accumulated technology, the NIH will collaborate with domestic researchers to launch 2019n-CoV treatment, vaccine development, and viral pathogenicity research in February. In detail, the cost of this research is ₩800 million, which is divided into clinical, therapeutic, vaccines, and pathogenic analysis. In the clinical and therapeutic sectors, the hospital-centered network is used to study the clinical immunological characteristics of domestic patients and to develop a wide range of antigens and antibodies for the development of therapeutic antibodies. The vaccine division studies DNA vaccines, major antigen production, various types of vaccines including vaccine antigen carriers and inactivated vaccines, and development of efficacy evaluation techniques for vaccines. Pathogenicity analysis includes the analysis of the major genetic variants of the 2019n-CoV and the prediction of its evolution. In addition, the Ministry of Health and Welfare and the Ministry of Science and ICT will cooperate with relevant ministries and industry-university research institutes to expand preemptively prepare for and respond to the emergence of new and variant viruses including 2019n-CoV. In the case of the Ministry of Welfare, the Ministry of Science and ICT and the Ministry of the Interior and Safety will undertake the National Life Safety Emergency Response Study. Sung-soon Kim, director of the Center for Infectious Disease Research at the National Institutes of Health, said, "This urgent research project will play a pivotal role in the research of new and transformed infectious diseases and lay the groundwork for the development of 2019n-CoV treatments and vaccines at the national level". Meanwhile, there are no specific treatments or vaccines for 2019n-CoV infections, so countries around the world are using symptomatic therapy and existing antiviral agents and developing vaccines and treatments. Overseas funding and technology are supported by the international cooperation, the Coalition for Epidemic Preparedness Innovations (CEPI). Ebola virus treatment (Remdesivir) and HIV treatment (Lopinavir, Ritonavir) are also being evaluated for efficacy.
- Policy
- Feb shortage prevention drug list: 641 items with Vivaquine
- by Lee, Hye-Kyung Feb 07, 2020 06:32am
- Myung In Pharmaceutical’s Vivaquine tablet (primaquine phosphate) has been designated as a shortage prevention drug as compensation for high production cost. The maximum price is set at 309 won. Health Insurance Review and Assessment Service (HIRA) recently disclosed new list of shortage prevention drug as of February 2020. ‘Shortage prevention drug’ is defined as an essential drug the government designates to prevent pharmaceutical company from stop supplying the drug due to poor profitability. The drug is then categorized as ‘compensation for usage incentive and high production cost,’ ‘compensation for high production cost,’ or ‘compensation for usage incentive.’ All shortage prevention drugs added to the list this month would receive National Health Insurance benefit as compensation for high production cost. Along with Vivaquine, Shin Poong Pharm’s Malafree tablet (primaquine phosphate) and Richwood Trading’s Richnight tablet (doxepin hydrochloride) have been designated as shortage prevention drugs with maximum prices set at 309 won and 89 won, respectively. The designation was finalized on Jan. 22, when Ministry of Health and Welfare (MOHW) revised the ‘List of Reimbursed Drug and Maximum Reimbursement Price.’ As the mandatory reporting regulation of drug manufacturing, importing or suspending supply stipulates, pharmaceutical manufacturer or importer with approved drug planning suspend the drug supply is required to report the plan with justifiable reason to Minister of Food and Drug Safety 60 days prior to the estimated date. Companies not complying with the regulation would be imposed with administrative measure of manufacturing or business operation suspension—three months for the first offence, six months for the second and business license revocation for the third.
- Policy
- DREC to deliberate drug reevaluation as originally planned
- by Kim, Jung-Ju Feb 07, 2020 06:32am
- Although committee meetings and events by Korean government and associated agencies have been either canceled or postponed due to the novel coronavirus, Drug Reimbursement Evaluation Committee (DREC) plans to push on with its original schedules as it plays the role of the first threshold to drug reimbursement listing and criteria negotiation. Pharmaceutical industry insider reported Health Insurance Review and Assessment Service (HIRA) has decided to convene DREC meeting on Feb. 6 as initially planned. DREC’s objective is to deliberate and decide on issues regarding new and generic drug listing, alleviating or adjusting reimbursement criteria and other National Health Insurance reimbursement. The committee regularly convenes a meeting on every first Thursday of a month, and reports outcomes to Ministry of Health and Welfare (MOHW). The ministry then sort out drugs for listing to either report them to Health Insurance Policy Deliberation Committee (HIPDC) or order National Health Insurance Service (NHIS) to schedule further negotiations with the pharmaceutical companies, if need be. The industry carefully assumed DREC would also postpone its meeting schedule, as HIPDC meeting, as well as other government and public events and meetings, have been affected by the novel coronavirus outbreak. But the industry was still skeptical of the committee rescheduling the meeting as DREC consists of only about 20 or so members and its decision-making procedure is more urgent than any other committee’s as it affects company’s business schedule and patient’s treatment access. The industry is naturally quite keen on this specific DREC meeting as it the agenda includes the pharmaceutical reevaluation standard and method. HIRA has been hinting the industry of a plan to adopt reevaluation system for already-listed drug and accordingly adjust pricing and reimbursement conditions, but it has yet to finalize related guideline and subject drug list. The industry has been highlighting the finalization of the reevaluation guideline and subject list as reevaluating last year’s hot potato, choline alfoscerate, would be also decided at the same time. Overall, the industry is mostly convinced the upcoming DREC meeting would deliberate and decide on the guideline and the list considering the general flow and time needed of Comprehensive National Health Insurance Plan and revised drug pricing system.
- Policy
- 2019n-CoV was successfully isolated from infected patients
- by Kim, Jung-Ju Feb 06, 2020 06:30am
- Health authorities have successfully isolated the new coronavirus (wuhan pneumonia) from patients with infectious diseases, It is very good news for developing vaccines and treatments The KCDC(Director, Eun-kyung Chung) announced on the 5th that 2019n-CoV was isolated and will share with the scientific community for the development of vaccines and treatments. The new isolate of Korean coronavirus is BetaCoV/ Korea /KCDC03/2020. STR of isolated new Korean coronavirus The KCDC inoculated the patient's respiratory specimens (sputum, etc.) into cells and confirmed the growth of the new coronavirus and analyzed the viral gene sequences to prove the new coronavirus. The culture is to divide, grow and multiply the cells, which are the basic life units, so that the population increases. Viruses can be cultured only in living cells. According to the virus genetic information released by the KCDC, the isolated virus was identical in sequence (99.5 ~ 99.9%) with viruses isolated from China (Wuhan, Guangdong), France, Singapore, Germany, etc. No significant genetic variation was found. .The nucleotide sequence information of the new isolates of the new coronavirus is registered in the GISAID of the World Health Organization (WHO) and can be used by researchers at home and abroad .GISAID is WHO's world influenza surveillance network, which contains information on the gene sequence of new coronaviruses in each country .The director, Eun-kyung Chung said, "Isolated viruses will be distributed to relevant ministries and relevant competent institutions so that they can be used for research and development as an indispensable resource for the development of diagnostics, treatments, and vaccines, and distribution procedures and methods will be announced later".
- Policy
- Illegal botulinum toxin dealing salesmen sent to prosecutor
- by Lee, Tak-Sun Feb 05, 2020 05:58am
- A couple of salespeople from a pharmaceutical company were caught red-handed illegally supplying botulinum toxin injections, used to reduced wrinkles, to unlicensed vendors. Korea’s Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) announced on Jan. 3, it sent two salesmen, aged 44 and 40, and four unlicensed brokers to prosecutor’s office after concluding their violation of Pharmaceutical Affairs Act and illegal distribution of prescription drug, botulinum toxin injection. According to the Pharmaceutical Affairs Act, an individual, neither a pharmacy owner nor working pharmacist at the pharmacy, cannot sell or purchase pharmaceutical products for sales purpose. An investigation uncovered salesmen “A” and “B” from a pharmaceutical company have schemed to illegally supply botulinum toxin injection (total 17,470 units worth 440 million won) to unlicensed broker “C” from December 2017 to August 2019. The injection was illegally distributed either by putting an order of the injection more than the actual order from plastic surgery or dermatology hospital or clinic and pocketing the remainder, or by putting a fake order in as a hospital or clinic and selling the supply to unlicensed brokers. Apparently the motive behind the illegal dealing with broker was to raise sales performance to gain incentives and earn advantage for promotion. Moreover, the four brokers sold off the botulinum injections acquired from the salespeople to foreign buyers, so-called “peddlers,” with cash transaction. Regarding illegal pharmaceutical dealing like the botulinum injection case, MFDS vowed to strictly investigate and manage such cases to prevent Koreans from abusing or overdosing food or drug.
- Policy
- The KOEDC, real-time check on 2019-nCoV treatment
- by Lee, Jeong-Hwan Feb 05, 2020 05:58am
- The KOEDC (President Young-mi Yoon) said it is checking the overseas status of alternative treatment candidates such as antiviral agents in real time in order to cope with a 2019-nCoV infection known to have no treatment. As the agency is in charge of domestic supply and demand of rare medicines worldwide, it is intended to support the rapid introduction of candidates in Korea when a situation worsens or a drug that can suppress infection is identified. An official of the KOEDC on the 2nd said, "We immediately reported our willingness to request and support the relevant medicine checklists from the KCDC and the MFDS immediately after the Lunar New Year holidays, when the 2019-nCoV crisis began to spread". Currently, the KCDC and the MFDS have delivered lists of antibiotics and antivirals to the KOEDC that may be effective in preventing 2019-nCoV proliferation. With about 10 items, the drug name was decided to be closed because the drug's efficacy was not clearly proven. The world is focusing on the prevention of the spread of 2019-nCoV, and at the same time working on the discovery of therapeutics. Hubei Province, Hubei Province, China, which is known as the source of new virus because there is no suitable treatment, is confirming the treatment effect of the confirmed patients by replacing antiviral drugs such as human immunodeficiency virus (HIV) treatment. In fact, US pharmaceutical companies have begun sending antivirals to China at the request of Chinese health authorities. AbbVie, Johnson & Johnson and Gilead are the most representative. AbbVie decided to donate about $2 million worth of Kaletra, the first approved HIV treatment 20 years ago, to China. Johnson & Johnson has also decided to ship China's HIV drug, Prezcobix, which combines two antiviral agents. Gilead is discussing with U.S. and Chinese researchers a trial of using Remdesivir, a drug for the treatment of Ebola, in 2019-nCoV confirmors. This drug is not yet available in the United States. First, the center is keeping an eye on the global 2019-nCoV trend, including the medicines, and is checking volume and distribution of related drugs overseas continuously. In addition, a visitor list was prepared for the safety of patients and guardians who visited the center directly to receive orphan drugs, and the center has also strengthened measures to identify visitor prior symptoms such as fever and cough. In particular, the center is expected to have a significant increase in the number of visitors to receive medicines as ‘delivery of orphan drugs consignment delivery service with keeping a fixed temperature during the shipping', which has been promoted over the past year, ends this month. Therefore, the center plans to strengthen further inspection. The center expects that the average daily number of orphan drug recipients will increase to 40 to 60 people daily, which has increased by 4 to 6 times for the time being due to the completion of the pilot project. An official of the center said, "The reason for the existence of the center is the domestic supply of rare drugs overseas. We informed the KCDC and the MFDS about necessary data support plans, including candidate materials, and have a consultation system among the working groups, when they candidate data that can be used as a 2019-nCoV treatment material, we grasp the volume and distribution of overseas pharmaceuticals”. The official said, “The level of protection was also increased for the safety management of patients and guardians who visited the center directly. Since relatively severe patients are visiting, it is necessary to reinforce the countermeasures of patients with low immunity, even if they are not 2019-nCoV infected, and we are strengthening the preventive measures of visitors such as coughing and adding & considering adding a waiting room for suspect visitors”.
- Policy
- Insurance not covered if Revlimid prescribed multiple up
- by Lee, Hye-Kyung Feb 04, 2020 08:16pm
- Insurance will not be covered if Revlimid’s lower dose such as 5mg in multiples by Celgene is prescribed instead of Revlimid 10mg, 15mg, 20mg, or 25mg. Reimbursed price of Revlimid 25mg is ₩101,768, whereas Revlimid 2.5mg, 1/10 dose of Revlimid 25mg, is ₩53,904. If 10 tablets of Revlimid 2.5mg is prescribed instead of 1 tablet of Revlimid 25mg, it will cost more than ₩500,000. The Health Insurance Review and Assessment Service recently released the list of reimbursed pharmaceuticals with cost-effective dose in January 2020. The list was made in accordance with the revision of the pharmaceutical list and reimbursed limit table on December 31 of last year. Effective date is from March 1st. The full reimbursed list is subject to automatic computerized checks for DUR information and review of reimbursed payments. Last year, the HIRA was in the process of reconfirming unmanaged items in batches, allowing DUR additions and deletions to be adjusted. In the newly added list of oral prescription with benefit cut in case of prescribing multiple up of lower dose, a total of 200 item combinations were added due to the confirmation of production items, and 92 item combinations were designated as shortage prevention drugs and were removed from the list. In addition, the following combinations of items that were subject to DUR adjustment due to the establishment of low-high doses; Allenaon 10·20mg, Mini Ressin 0.1·0.2mg, Glimedi 2·4mg, DaeWoongBio Atorvastatin 20·40mg, Intrack 6.25·12.5mg, Pitastin 2·4mg, Matiran 20·40mg, Crowon 5·10mg, Litor 10·20mg, Esomedin 20·40mg, Leviepil 0.25·0.5g, 0.25-1g, Eso-mp 20·40mg, Since January 1 of this year, due to the elimination of the low-high doses, Elosuva 10·20mg, Dulota 30·60mg, Lowgan 10·20mg, Omertec 20·40mg, Norvasc ODT 5·10mg , and Cavedia 12.5·25mg have been dropped from the DUR screening. Injectables include Genpenem 0.5·1g, Cralevo 50·150ml, Astriaxone 1-2g, Samsung Merophenem 0.5·1g, Copenem, 0.5·1g as a result of the product confirmation, Mecapem 0.5·1g and Cifloxin 0.2·0.4g will be automatically cut from DUR when prescribed multiple up of lower dose medication from next month.
- Policy
- Patent litigation to decide prospects of Olostar generic
- by Lee, Tak-Sun Feb 04, 2020 06:32am
- For the first time, a generic drug with same active ingredient (olmesartan medoxomil, rosuvastatin calcium) contained in Daewoong Pharmaceutical’s blockbuster co-morbid hypertension and dyslipidemia treatment, Olostar, has applied for approval. Presumably, the generic manufacturer would be either Kolmar Korea or a CMO as Kolmar Korea’s bioequivalence test protocol for the generic has been approved in last March. However, the company cannot immediately release the generic product despite acquiring the item approval, because Olostar’s pharmaceutical patent is valid until Mar. 22 of 2033. The pharmaceutical industry reported on Jan. 2 that olmesartan medoxomil-rosuvastatin generic has submitted an approval application to Ministry of Food and Drug Safety (MFDS). As Olostar’s post-marketing surveillance period has expired on Jan. 28, a follow-on drug has no problem applying for approval. But the generic would face restriction according to patent-approval linkage system, because the original’s drug patent is listed on MFDS’ patent list. The original manufacturer may request for sales ban on generics via patent litigation. And if generic manufacturer wins the patent litigation, the restriction protecting the original would be lifted. Kolmar Korea has already filed negative confirmation of scope on the original to evade patent infringement on June 3 last year. And Hutecs Pharmaceutical Korea, Mother’s Pharm, Daehan New Pharm, Sinil Pharmaceutical, Hana Pharm, White Life Science, Korea Prime Pharm, Hanpoong Pharm, and Crystal Life Sciences have also filed the same case. Kolmar Korea has been developing the generic until now. The company’s bioequivalence test protocol has been approved last March to prove equivalence between tentatively named Olmetin tablet 20/20 mg and Olostar tablet 20/20 mg in healthy adult subject. Kolmar Korea has highly likely to have developed the generic drug and other patent challengers would be supplied with the contract manufactured generic. Sources report review on the negative confirmation of scope filed on Olostar has almost been completed and is waiting for the last decision. If Intellectual Property Trial and Appeal Board are to cite the generic manufacturer, the generics could be released after clearing the approval. However, the pressure of patent infringement has not been resolved fully, yet, as the patent owner, Daewoong Pharmaceutical, has a possibility of filing an appeal at a higher instance. Since the approval in July 2013, Olostar has been enjoying its success in the hypertension and dyslipidemia treatment market. According to UBIST, the drug generated total 12.1 billion won of outpatient prescription volume last year, easily surpassing the standard of Korean blockbuster drug at ten billion won. Definitely, the original has the marketability attracting the generics to hurry the early launch. But, the success of generics in the market is not guaranteed. Although a generic with the exact same substance as the original is not available at the moment, a few combination drugs with telmisartan and rosuvastatin calcium in the same class as Olostar have been released already. And 11 companies are supplying the telmisartan-rosuvastatin drugs. Moreover, the competition would intensify by coming October, as the original’s post-marketing surveillance period is to be expired then. Other combination drug for co-morbid hypertension and dyslipidemia with amlodipine besylate and atorvastatin calcium (brand name: Caduet by Pfizer) had its post-marketing surveillance period expired in 2010 and now it has total 78 follow-on drugs. Basically, the market cannot get anymore saturated. Nevertheless, small and medium companies are still betting on the generic as the number of originals with soon-to-be-expired market exclusivity is limited, and an item earning over ten million won from outpatient prescription is even rarer. Meanwhile, the original manufacturer is expected to take aggressive legal action against the generic manufacturers, because the generic entering the market would impact the company with drug pricing reduction. Accordingly, Daewoong Pharmaceutical would likely to concentrate on patent litigation.
- Policy
- The HIRA approved 10 of 12 cases in Spinraza
- by Lee, Hye-Kyung Feb 04, 2020 06:31am
- Ten out of 12 applications for the 'Spinraza' reimbursement, which has a maximum insurance price of ₩92.3 million, were approved. One case was failed, and one case was withheld due to a request for supplementary data. The HIRA (Director Seung-Taek Kim) released result of deliberation example on the website on the 31st including ▲ Immune Tolerance Induction ▲ Nusinersen sodium injection (Spinraza) ▲ Eculizumab injection (Soliris) ▲ Valve assistive device therapy (VAD) Approval of Institutions ▲approval of institutions for hematopoietic stem cell transplantation. Spinraza has been on the list of reimbursed drugs since April 8 last year, but medical institutions that want to do so at an ultra-high price of ₩92,359,131 per 5ml bottle must apply for pre-approval. The details of one disapproval of the newly filed application indicate that one medical institution applied for Spinraza benefits to a 45-year-old female patient, but symptoms and signs of spinal muscular atrophy were apparent at age 3 (36 months). And, the claim was not accepted because it was not confirmed and objectively proved. Looking for Spinraza's reimbursement criteria, all three conditions including ▲ Genetic diagnosis of 5q SMN-1 gene deficiency or mutation ▲ SMA-related clinical symptoms and signs when under 3 years old ▲ Permanent ventilator not used must be met as 5q spinal muscular astrophy patient. In the case of a data supplement decision, a 39-year-old male was not approved because there was no evidence that he had symptoms of 5q spinal muscular atrophy from 3 years of age or younger. In the case of Soliris (Eculizumab), which had been subject to prior approval prior to Spinraza, there were prior applications of the total number of 59 cases (48 cases of Paroxysmal nocturnal hemochromatosis, PNH & 11 atypical hemolytic uremic syndrome, aHUS). In the case of a newly medication application, PNH had five approvals and two disapprovals, and aHUS had five disapproval decisions without approval. In addition, details reviewed by the review board can be viewed from the website of the HIRA.
