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- 2025-12-24 21:46:02
- Policy
- Antidepressant Pristiq’s first generic seeks approval
- by Lee, Tak-Sun Feb 13, 2020 06:27am
- Pfizer Apparently, generic makers are knocking on the door of depression medication Pristiq ER tablet. This is the first time the original’s saline base-modified drug is applying for an approval. On Feb. 10, Korea’s Ministry of Food and Drug Safety (MFDS) notified the Pristriq’s patent holder Pfizer that a drug with desvenlafaxine, the original’s active pharmaceutical ingredient (API), on modified saline base has applied for clearance on Feb. 6. The original Pristiq ER tablet used succinate as a base, but the investigational drug has based the API on benzoic acid. The generic’s approval application has been predicted long before, as Pristiq’s post-marketing surveillance (PMS) period of six years has expired on Feb. 5. Although a company launching a new drug in Korea is imposed with a duty to conduct PMS for a set period of time, the original is protected from generic makers with the same API applying for approval during the period. As a result, generic makers have waited for the original’s PMS period to expire on Feb. 5 and applied for approval straight away. However, the antidepressant generics are unable to launch immediately despite MFDS’ green light, as the original has patented the saline base, expected to expire on Oct. 7, 2022. For immediate release, the generic makers would have to challenge the patent, and the approval processing should undergo under the premise of launching the product regardless of the patent. The conditions are stipulated by the Drug Approval-Patent Linkage System. However, the group of applicants seeking for clearance on their generics seems likely to release the product right away. In last July, five companies have requested for negative confirmation of patent scope and successfully evaded patent infringement. Whan In Pharm, Myung In Pharm, Hanlim Pharm, Nexpharm Korea, and Samjin Pharm are the companies. As Pfizer is not filing an appeal against the case, their patent infringement is close to a done deal. If all the five companies have applied for desvenlafaxine generics on Feb. 6, they could win preferential sales rights on those items, because they have fulfilled three conditions—first to request trial, successfully challenged patent, and first to apply for approval. Pfizer’s Pristiq ER tablet has been evaluated as a next generation depression medication as it has lower risk of drug interaction and less frequent adverse reaction reported like body weight change or sexual dysfunction. According to UBIST last year, the original drug has generated 3.1 billion won from outpatient prescription. Although the drug has sold lesser than other 10-billion-won-club Lundbeck’s Lexapro and Lilly’s Cymbalta, the drug has promising prospective as the antidepressant market in Korea has skyrocketed recently and surpassed 150 billion won. Assessing the changes in the market, central nervous system (CNS) drug-specializing pharmaceutical companies have been eyeing on Pristiq’s follow-on drugs. Pristiq ER tablet is administered once-daily to adult with depression. The generics with modified saline base have applied for indication with same effect and administration method.
- Policy
- Optimal substance derived by AI, entering clinical trials
- by Lee, Tak-Sun Feb 12, 2020 06:31am
- New drug candidates using the artificial intelligence (AI) drug development platform entered clinical trials for the first time in Korea. The company plans to develop the material as a new global drug. The Ministry of Food and Drug Safety approved the Phase I trial of PHI-101, a candidate for the treatment of acute myeloid leukemia (AML) for Pharos IBT. According to the company, PHI-101 is a substance that overcomes the resistance of Quizartinib by Daiichi Sankyo and Gilteritinib by Astellas, which are targeted drugs for acute myeloid leukemia. In particular, the substance is evaluated to have a direct inhibitory mechanism not only for the FLT3-ITD mutation but also for the FLT3-TKD (D835, F691) resistant mutation. Clinical trials are underway in Korea last December with clinical approval from the Therapeutic Goods Administration Australian (TGA). PHI-101 was developed jointly by the DGMIF's New Drug Development Center and the Korea Institute of Science and Technology. The new drug development venture, Pharos IBT, is seeking to commercialize technology. In particular, the chemical discovery platform 'Cemiverse' owned by Pharos IBT is used in the material exploration process. It is known that there are few cases where substances derived from new drug development platforms enter the clinical trials in Korea. Pharos IBT explained that it is the first in the world when a bioventure company is approved for a phase I clinical trial based on its artificial intelligence drug development platform. Cemiverse, an artificial intelligence platform, is known to derive the optimal PHI-101 from hERG ion channel prediction model that causes kidney toxicity. "Most new drugs fail because of kidney toxicity issues, and PHI-101 increases commercialization success with artificial intelligence platform" said Ki yeop Nam, Pharos IBT’s director of Bio-Industrial Artificial Intelligence (CTO). Currently, the development of new drugs using artificial intelligence platform is actively underway in Korea. Hanmi Pharmaceutical recently signed a joint research agreement with 'Standigm', an AI-based new drug development company, and plans to derive optimal materials. In addition, Yuhan, JW-Pharma, and CJ Healthcare are collaborating with AI drug developer Synteka Bio. However, no new drug candidates have entered the clinical trials yet. According to the industry, the use of AI can shorten the period of new drug development by three to four years and reduce the development cost by ₩600 billion.
- Policy
- “Outbreak spreading locally, need to deny Chinese traveler"
- by Lee, Jeong-Hwan Feb 12, 2020 06:31am
- Professor Choi Jae Wook of Korea University College of MedicineProfessor Choi Jae Wook at Korea University Department of Preventive Medicine raised his voice and said, “How could government affirm that the novel coronavirus has not started transmitting throughout Korea? This is the government mocking the people and medical experts. We should not ignore the possibility of the current number of confirmed case of 27 exponentially increasing up to thousands and more. The government would need to promptly take proactive steps and strengthen the infectious disease control.” Medical experts have pointed out the infectious disease control alert level should be raised from 'warning' to 'severe,' and restriction on Korea-bound travelers from China should be expanded wider from 'Wuhan-outbound only' to properly prevent the novel coronavirus spreading locally in Korea. The strong arguments were made as the outbreak did not stop transmitting since the first confirmed patient was reported since Jan. 20, and total 27 patients have been confirmed to have been infected as of Feb. 10 through secondary and tertiary infection. On Feb. 10, the Liberty Korea Party's Novel Coronavirus Counterplan TF convened 'Emergency Expert-level Roundtable on Preventing Novel Coronavirus Infection and Transmission.’ Professor Jun Byung Yool at CHA University College of Medicine, a former Director of Korea Center for Disease Control and Prevention, and Professor Choi Jae Wook at Korea University Department of Preventive Medicine respectively gave presentation. Both Professor Jun and Professor Choi agreed the state-led infectious disease control level should be enhanced higher to prevent the worst case of the novel coronavirus spreading nationwide. Professor Jun claimed the novel coronavirus' human transmissibility is higher than previous case of SARS or MERS, but the fatality rate is at around 4 percent to 5 percent, relatively lower than that of SARS (10 percent) or MERS (30 percent). With lower fatality rate and higher transmissibility of the disease, the professor urged interregional transmission of the infectious disease should be stopped by tightening the state-led disease control at this point in time, when the travelers contracted the virus from China and other countries have not infected anyone came in contact. Professor Jun clarified actions like shutting out Chinese and other high-risk group entering the country, should be taken. Professor Choi diagnosed interregional spread of the novel coronavirus, originated from Wuhan, China, has begun in Korea. The professor reprehended the government, who is supposed to put all efforts to prevent the outbreak, is making a hasty judgment to say the interregional transmission has not started. Specifically, Professor Choi pointed out the government has failed and reached the worst case scenario of infecting other regions by failing to prevent the disease outbreak in Korea, followed by politically interfering quarantine system. The professor also said the current administration is repeating the same issue of national infectious disease control, which was apparent during the MERS outbreak five years ago. As a solution to the issue, Professor Choi proposed readjusting the infectious disease control approach from retrospective to proactive countermeasure, and forming Public-private Joint Emergency Response TF for the government and private healthcare institutes to cooperate. He said, “If the experts do not talk about the current state of government response, then it would repeat the misstep and the infected cases would surge from 27 to thousands and more in a matter of time. The interregional transmission has already begun. At the moment, only the people who came in contact with the confirmed patients are regarded as subject for testing. We need to switch from such retrospective response to proactive response.” “First, the infectious disease alert level should be pushed up to ‘severe,’ and all travelers from China should be temporarily denied. There is no other way to filter out infected patients with dormant symptoms. The regional community should test potential cases early and continue to monitor them,” the professor argued. He elaborated, “Proactive countermeasure cannot be taken only with government-run health centers and hospitals. Regional clinics’ cooperation and participation are essential. The number of infected patients in China started from 40 and now it surpassed 30,000. Infectious disease control should not ignore the people’s rights to health and let political bias get in the way.” Director Lee Sungsoon of Ilsan Paik HospitalDirector Lee Sungsoon of Inje University Ilsan Paik Hospital also claimed, the administration is repeating the same mistake occurred five years ago with MERS. More special clinics have been opened, but the government has not yet supplied anti-contamination suit or mask, making proper medical practice impossible. Moreover, the government has not offered any compensation for healthcare institute participating in the disease control. Director Lee pin pointed, “Quarantine and transmission prevention are the keys to overcoming infectious disease outbreak. Healthcare institutes are in charge of testing and treating patients, whereas quarantine and prevention are the duties of the government. However the administration is repeating the same problem caused during the MERS incident. Many of special clinic are working without even a mask.” “The loose unpreparedness is happening again after five years. Only a handful of State-designated Quarantine Hospitals around the country can properly operate a special clinic. The government advises private clinics to operate individual special clinic or safe clinic, but it would rather only increase the risk,” Director urged. He added, “Small local clinic doctors should be able to test patients when encountering suspicious patient. The medical professionals’ concern is their clinics closing when visited by an infected patient. The government has mentioned of appropriate compensation. But only sufficient compensation, and not ‘appropriate compensation,’ would encourage clinics to test and treat patients and prevent further local transmission.”
- Policy
- Meqsel+Rafinlar combination NSCLC indication reimbursed
- by Kim, Jung-Ju Feb 12, 2020 06:27am
- Korea’s top healthcare reimbursement decision-making body has passed listing of Yooyoung Pharmaceutical’s chronic constipation treatment Rucalo tablet (prucalopride succinate) and expanded reimbursement on Novartis Korea’s Meqsel (trametinib dimethyl sulfoxide) plus Rafinlar (dabrafenib mesylate) combination therapy. The revised List of Reimbursed Drug with the said changes came in effect from Feb. 10. Ministry of Health and Welfare (MOHW) has disclosed the outcomes on Feb. 6 of Health Insurance Policy Deliberation Committee (HIPDC) deliberating the changes on the List of Reimbursed Drug and Maximum Reimbursed Price. Rucalo tablet was released in Korean market in January last year as a treatment for adults with chronic constipation, who does not respond to conventional laxative The drug was waiting for the final call on reimbursement listing as Drug Reimbursement Evaluation Committee (DREC) under Health Insurance Review and Assessment Service (HIRA) has cleared reimbursement feasibility and pricing negotiation with National Health Insurance Service (NHIS) reached an agreement. The maximum price was set at 127 won per 1 mg tablet and 191 won per 2 mg tablet. Used to treat BRAF V600E mutation-confirmed metastatic melanoma, Meqsel plus Rafinlar combination therapy has been listed for reimbursement since November 2017. But as the combination therapy was additionally indicated for treating non-small cell lung cancer (NSCLC) patient with confirmed BRAF V600E mutation, the company applied for adjustment of maximum price and expanded reimbursement. The pricing negotiation of the combination therapy with NHIS immediately followed the reimbursement approval by HIRA’s Cancer Disease Deliberation Committee and DREC last year. However, the combination therapy was given a choice to get reimbursement with risk sharing agreement (RSA) in combination of expenditure cap type and induction therapy refund type, because the additional indication was estimated to cost approximately 20 billion won annually, according to NHIS’ estimated amount of claim. For the expenditure cap type RSA, when the actual amount claimed with reimbursement exceeds the cap of estimated amount of claim set during the pricing negotiation, the pharmaceutical company has to pay NHIS back the set ratio of exceeded amount. As for induction therapy refund type, the pharmaceutical company has to refund the cost of the treatment administration in induction therapy phase. The details of the agreement is undisclosed between NHIS and the company. The maximum reimbursed price for Meqsel was readjusted to 128,344 won per 2 mg tablet, 32,086 won per 0.5 mg tablet. Rafinlar’s price was set to 24,751 won per 50 mg capsule, and 36,336 won per 75 mg capsule.
- Policy
- Strensiq, a rare disease treatment, passed the Committee
- by Lee, Hye-Kyung Feb 11, 2020 06:28am
- Strensiq, a rare disease treatment , passed the Pharmaceutical Benefits Advisory Committee On the 6th, the HIRA (Director Seung-taek Kim) revealed the results of the review by the Pharmaceutical Benefits Advisory Committee on the adequacy of the medical benefits of the drug application. Only one drug has been evaluated for adequacy of reimbursement, and is used to treat bone symptoms in children with hypophosphatemia which is Strensiq. Strensiq is a medicine that Handok signed a domestic sales contract for Soliris to strengthen its strategic partnership with Alexion on November 17 2016. It is a long-term enzyme replacement therapy for treating bone symptoms in children with hypophosphatemia in childhood. Clinical results in neonates and infants with hypophosphatemia showed that the survival rate at 1 year of age for patients who received 48 weeks of strains was 95%, significantly higher than the survival rate of 42% for historical control. The Committee stated that "the adequacy of the benefits of the strain is recognized", and "The final evaluation result may be changed in the event of changes in the specific reimbursement range and standard items of the drug, changes in the permission of the requested item, and withdrawal (cancellation)".
- Policy
- Phase 3 trial for Korea-made DPP-4 + SGLT-2 approved
- by Lee, Tak-Sun Feb 10, 2020 06:31am
- Apparently, Phase III clinical protocols of two new Korea-made anti-diabetic treatments based on DPP-4 inhibitor, Suganon (evoglitin by Dong-A ST) and Zemiglo (gemigliptin by LG Chem), have been approved to test their combination efficacy with SGLT-2 inhibitor drug. Among nine new dipeptidyl peptidase 4 (DPP-4) inhibitor drugs competing in Korean anti-diabetic treatment market, the two investigational drugs are rare cases of Korea-developed drugs. But also two of them have not yet confirmed combined efficacy with sodium-glucose cotransporter-2 (SGLT-2) inhibitor drug. Currently, MSD’s Januvia, Bristol-Myers Squibb’s Onglyza, and Boehringer Ingelheim’s Trajenta are indicated in Korea as combination therapy with SGLT-2 inhibitor. And recently, a few DPP-4 inhibitor plus SGLT-2 inhibitor combination drugs have been approved, but none of them are developed by a Korean company. On Feb. 7, Ministry of Food and Drug Safety (MFDS) has approved Phase III protocols on Suganon plus metformin plus dapagliflozin combination therapy and Zemglo plus metformin plus dapagliflozin combination drug. The health authority green lit Dong-A ST Suganon’s multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III trial that aims to test efficacy and safety of metformin plus evoglitin (brand name: Suganon) combination therapy added with dapagliflozin, treating type 2 diabetic patients with insufficient control of blood sugar level. LG Chem’s Phase III protocol on gemigliptin (brand name: Zemiglo) plus SGLT-2 inhibitor combination drug has been cleared to test efficacy and safety of metformin plus gemigliptin plus dapagliflozin combination therapy treating type 2 diabetic patients, who cannot sufficiently control blood sugar level after treated by metformin monotherapy. The Phase III trial would be multicenter, randomized, double-blind, double-placebo, active-control, parallel-group study comparing the investigational combination with dapagliflozin plus metformin combination therapy. Dapagliflozin apparent in both combination therapies is AstraZeneca’s SGLT-2 inhibitor anti-diabetic treatment, Forxiga’s active pharmaceutical ingredient. So far, Suganon has been indicated as monotherapy and combination therapy with metformin. And Zemiglo has been indicated as combination therapy with metformin, combination therapy with metformin plus sulfonylurea, and combination therapy with insulin. The most frequently used substance for anti-diabetic drug, DPP-4 inhibitor, controls blood sugar level by blocking enzyme dipeptidyl peptidase-4 to activate insulin-secretion stimulating hormone incretin. SGLT-2 inhibitor inhibits sodium-glucose transport protein 2 to prevent reabsorption of glucose in the kidney to lower blood sugar level. The medication is the newest drug in the anti-diabetic drug market rapidly increasing the volume in the market. Experts evaluate the combined use of two drugs would be more effective as both DPP-4 inhibitor and SGLT-2 inhibitor medications have confirmed outstanding efficacy of controlling blood sugar level and safety. But only limited number of drugs has been indicated as DPP-4 inhibitor plus SGLT-2 inhibitor combination therapy. Moreover, those drugs are all imported. The industry expects the Korea-made Suganon and Zemiglo to enhance their market competitiveness, when they win the SGLT-2 combination therapy indication. According to UBIST last year, Suganon has generated 7 billion won for outpatient prescription, and Sugamet, an evogliptin plus metformin combination drug, generated 8.6 billion. Moreover, Zemiglo has made 34 billion won, and its combination drug with metformin, Zemimet raised 63.5 billion won. The overall DPP-4 inhibitor market volume in Korea is approximately 500 billion won.
- Policy
- HIRA to tighten personal data protection for committees
- by Lee, Hye-Kyung Feb 10, 2020 06:30am
- Drug reimbursement feasibility deliberating Health Insurance Review and Assessment Service (HIRA) plans to tighten operational regulation for its associated committees. The revised regulation would minimize collection of committee member’s private information and generally strengthen protection of personal information. HIRA’s Benefit Listing Department and Pharmaceutical Standards Department of Benefit Management Sector notified of revising operational regulation for ‘Drug Reimbursement Evaluation Committee (DREC)’ and ‘Cancer Disease Deliberation Committee (Cancer Committee),’ respectively. The current seventh DREC has a member pool of 100, where 19 of them are randomly selected to participate in regular meeting convened every first Thursday of a month. DREC decides listing of drug based on reimbursement standard, medical needs, clinical efficacy, cost-effectiveness and external reference country’s financial impact review result, when a pharmaceutical company applies for reimbursement covering a new drug. Six subcommittees associated under DREC—Drug Reimbursement Standards Subcommittee, Pharmacoeconomic Analysis Subcommittee, Risk Sharing Agreement Subcommittee, Financial Impact Assessment Subcommittee, Korean Herbal Drug Subcommittee, Drug Reevaluation Subcommittee—provide consultation on pharmacoeconomic analysis or review reimbursement standards for DREC to comprehensively evaluate feasibility of drug reimbursement. The eighth Cancer Committee has 43 members in its pool and regular meetings are convened on a Wednesday every month for two years from last Dec. 1. The committee deliberates standards of anticancer treatment reimbursement and off-label use of anticancer treatments. HIRA aims to revise their operational regulation to minimize collection of the 100 DREC members and 43 Cancer Committee members’ personal information and to clarify the personal data archiving period and third party personal data sharing record. Also, HIRA has decided to collect date of birth from the committee members, instead of Resident Registration Number. The revised regulation would remove the agreement for providing personal data and allowing personal identification information process, delete bank account number section on provided personal data, but substitute with ‘Consulting Fee and Travel Expense Certificate.’ The personal data archiving period would be stated as member’s term of two years, and the list of committee members would be posted on HIRA website.
- 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.
