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- 2026-04-17 11:08:06
- Policy
- “Genetic testing not required for reimbursed Soliris use"
- by Lee, Hye-Kyung Feb 17, 2020 06:25am
- Health Insurance Review and Assessment Service (HIRA) has disseminated a press release to explain a news article raising issues on preliminary review on atypical hemolytic uremic syndrome (aHUS) treatment Soliris injection (eculizumab). Apparently, a news article has reported the government deferring and rejecting preliminary approval on Soliris has caused 12 deaths out of 59 patients, and criticized patients are losing their golden time as the government is demanding genetic testing, not a part of the usual procedure, despite the drug qualifies 18 other reimbursement standards. Before using an expensive drug like Soliris, costing 6.04 million won per vial, a healthcare institute using the drug has to apply for HIRA’s preliminary review applied, and it can administer the approved drug to patient within 60 days. HIRA refuted, “In case of emergency, Soliris can be administered as soon as the preliminary review application is submitted. The news report on patients dying due to delayed or rejected approval is not true.” Reimbursement standard on Soliris stipulates qualification standard of administration subject (standard of disease determination, standard of active thrombotic microangiophathy, standard of renal damage) and also administration exemption (same type of malignant tumor, transplantation, thrombotic microangiophathy caused by infection due to autoimmune disease) HIRA’s press release explained, “The standards have been set based on foreign country guidelines, related academic societies’ consultation, and foreign country reimbursement listing standards. Korea's reimbursement listing is on par with other countries’ standards, such as Canada and Australia. HIRA requires healthcare institute to submit genetic testing results, when submitting a monitoring report after two months into the treatment.” In other words, HIRA says the administering standard of Soliris’ reimbursement does not stipulate genetic test, but it is required for the monitoring report. HIRA stated, “The news article claiming HIRA demanding genetic testing, regardless of qualifying other standards, is false. HIRA would continue to do its best to provide coverage on safe medical service and treatments saving patient’s life.”
- Policy
- Nocdurna to receive reimbursement from next month
- by Kim, Jung-Ju Feb 17, 2020 06:25am
- Nocdurna sublingual tablet identification photo (Source: Korea Pharmaceutical Information Center) Ferring Korea’s Nocdurna sublingual tablet (desmopressin acetate) is to get listed for reimbursement next month. On Feb. 12, Ministry of Health and Welfare (MOHW) issued an administrative notice on amending ‘Pharmaceutical Reimbursement Listing Standard and Method,’ and plans to collect public opinions until Feb. 20. Ministry of Food and Drug Safety (MFDS) has indicated the drug to treat nocturia due to idiopathic nocturnal polyuria. As other drugs with desmopressin acetate have different content, only a part of Nocdurna’s indication would be reimbursed. Desmopressin acetate has received reimbursement for treating patients aged over five with primary nocturnal enuresis and adult patient with any nocturia symptoms related to nocturnal polyuria. According to the government’s approval details, Nocdurna’s indication to treat primary nocturnal enuresis in patients aged over five would not receive reimbursement. The listing would be limited to treating adult patient with nocturia due to idiopathic nocturnal polyuria. The approved contents of Nocdurna are 25 μg and 50 μg. After reviewing collected public opinions until Feb. 20, MOHW would revise the reimbursement standard as of Mar. 1. Desmopressin acetate is available in Korea as Ferring Korea’s Minirin tablet, Hanmi Pharmaceutical’s Demoresin POWD, Nex Pharm Korea’s Newlitan tablet, Pharmbio Korea’s Denirin granule and Dongkoo Bio Pharm’s Demorin fine gradule.
- Company
- Delstrigo by MSD was approved
- by Eo, Yun-Ho Feb 14, 2020 06:36am
- MSD aims to expand market share in AIDS According to the industry, the MFDS recently approved a fixed-dose HIV complex, Delstrigo (Doravirine, Lamivudine, Tenofovir), once daily. Delstrigo has been approved for the treatment of human immunodeficiency virus (HIV-1) infections in adults without prior antiretroviral treatment. Doravirine 100mg is approved by the MFDS on November 22 2019 under the brand name 'Pifeltro' and is intended to be used in combination with other antiretroviral drugs. Both Pifeltro and Delstrigo approved indications for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients without previous antiretroviral treatment. This drug has been validated through the DRIVE-AHEAD trial. In this trial, Delstrigo demonstrated non-inferiority to Efavirenz, Emtricitabine, and Tenofovir such as Atripla. At 48 weeks, the percentage of patients who reached virological inhibition (less than HIV-1 RNA 40copies/mL) was 84% in the Delstrigo treatment group and 80% in the EFV/FTC/TDF treatment group. The rate of discontinuation due to adverse events was 3% and 6.6%, respectively, which was lower in the Delstrigo treatment group. An MSD official said, "The company is currently preparing for Deltrigo's insurance coverage and launching. We are also planning to expand further indications".
- Policy
- Opposition buys time with Covid-19 delaying HIPDC meeting
- by Lee, Jeong-Hwan Feb 14, 2020 06:35am
- Due to the Covid-19 outbreak, the pilot program for providing reimbursement on Korean herbal medicine would inevitably be delayed. Initially, the government was planning to particularly discuss of coverage on herbal medicine at a Health Insurance Policy Deliberation Committee’s (HIPDC) subcommittee meeting, right as Korean Herbal Medicine Reimbursement Consultative Committee unveils the pilot program plan. But all schedules have been halted, because of the state emergency. Some of healthcare and pharmaceutical professional organizations, who have been opposing against the pilot program, seem to be busy preparing statement and related resources regarding safety issues of the herbal medicine reimbursement system. According to healthcare and pharmaceutical groups on Feb. 13, Ministry of Health and Welfare (MOHW) has not finalized the schedule for the HIPDC subcommittee meeting on Korean herbal medicine reimbursement, originally scheduled on Feb. 6. Pharmaceutical industry explains the meeting has been indefinitely postponed until Covid-19 outbreak is contained and the country feels safe again. The industry source also added, individual issues like coverage on herbal medicine would be set aside for now, as MOHW has urged healthcare and pharmaceutical groups, such as Korean Medical Association, Korean Pharmaceutical Association, Association of Korean Medicine, and Korean Nurses Association, to focus on promptly responding to the state emergency and infectious disease prevention task. However, related organizations are showing anxiousness with the indefinitely postponed talks on the agenda, as the issue is strongly conflicted between medical, pharmaceutical and Korean medicine industries. Postponed HIPDC deliberation would mean delayed procedures of reimbursement feasibility evaluation and related industry negotiation, which would eventually push down the whole timeframe of the pilot program. In fact, MOHW is currently unable to pin down when the subcommittee meeting could be convened. MOHW insider hinted, “Discussion between Korean Herbal Medicine Reimbursement Consultative Committee and other related organizations is essential to the pilot program. While the government and the country’s interest and response capacity are all locked on Covid-19, related schedule would be unlikely to get fixed, yet. This would affect the entire schedule of the pilot program.” Now, the medical, pharmaceutical and Korean herbal medicine industries on the opposing side have earned some time to prepare data pointing out prospective issues and risks of reimbursement on herbal medicine. The urgency the organizations felt, when preparing for opposing statement until the initial HIPDC and subcommittee meeting schedules, seems to be somewhat relieved. Korean Medical Association and Korean Pharmaceutical Association have actually warned of the organizations cooperating to disapprove of the Korean herbal medicine reimbursement. Association of Korean Medicine also has been reprehending MOHW’s pilot program planning by constantly issuing an opposing statement. A member of the Korean Herbal Medicine Reimbursement Consultative Committee disapproving of coverage on the herbal medicine claimed, “As I have been on the side to stop the pilot program, the delay in schedule is a good news. By vastly researching more about the safety issues of Korean herbal medicine, we should strategize resistance against the plan with those on the same side from the consultative committee and HIPDC.” The member added, “All capacity of healthcare and pharmaceutical organizations is on containing Covid-19 at the moment. When it is in the fairly controlled state and MOHW notifies the HIPDC meeting schedule, the industry organizations’ conflict would surface.”
- Policy
- It is time to support quarantine with the 'COVID-19'
- by Lee, Jeong-Hwan Feb 14, 2020 06:35am
- The Democratic Party's COVID-19 Countermeasures Committee urged an agreement on the opposition party on the composition of parliament. With the intention that the national disaster should not be controversial due to naming conflicts such as Wuhan pneumonia, it is a suggestion that the government should support joint efforts on the prevention site by creating a joint special led by the Health and Welfare Committee by establishing a joint specialty centering on the new corona name 'COVID-19' finalized by the WHO. On the 12th, the Democratic Party's COVID-19 Countermeasures Committee (Chairman Sang-hee Kim) began hearing opinions on the site of defense at the Democratic Party's representative office in the National Assembly. On this day, Kyung Rim Shin, the chairman of the Korean nurses association, Senior Vice Chairman No-bong Park, the Korean health and Medical Workers’ Union, Senior Vice Chairman No-Bong Park of the National Health Care Industry, Senior Vice Chairman Mi-Kyung Kwon of the Federation of Korea Medical industry Trade Union(KMITU), Chairman Mok Huh, National public health center’s director council and Chairman Jung-Hyun Cho of the Korean Public Health Council. If the last meeting was to collect voices of macroscopic defense sites from the heads of doctors' associations and hospital associations, this time, The intention is to look into more detailed microprotective situations. Chairman Sang-hee Kim stressed the need for COVID-19 in the parliament. The WHO named the new corona official name as COVID-19 and the Ministry of Health and Welfare followed the domestic name as Corona-19, suggesting that the background for the rapid creation of undisputed privileges was provided. Chairman Kim said, "The WHO has set the official name of the new corona as COVID-19. So far, unnecessary controversy over the congressional narrative over the National Assembly Corona has been continued, this is deplorable. It would be reasonable to focus on welfare. The name is subsidiary and it is productive to support the defense by creating a parliamentary commission. It would be reasonable to focus on the welfare committee " Chairman Kim said, "The government is currently taking measures to deal with the serious stages of the prime minister. The patient is discharged, but there is no situation to be relieved yet, and we will try to provide enough budget to small businesses". Kyung Rim Shin, the chairman of the Korean nurses association asked the medical staff such as nurses who are involved in the quarantine service not to suffer social stigma. In particular, she mentioned the necessity of expanding nursing personnel in addition to disaster emergency. It is important to be prepared to avoid the hassle of increasing the number of nurses in a hurry due to Corona-19. Chairman Shin said, "It is very hard to work as a nurse once in a confirmed patient's quarantine. Two protective nurses have to go in every two hours, and the job itself is difficult and there is a fear that the nurse will spread the word to the family. A mother nurse is socially stigmatized and has trouble in her daily life". Chairman Shin said, “It is a big problem because they face and care for patients directly. Psychological treatment, physical support, and social follow-up measures are necessary, and it is also a way to have a regular nursing staff. It is difficult to recruit emergency personnel due to infectious diseases outbreak". Mok Hur, chairman of the National Health Center Directors' Council, said that even in the event of a national disaster, there is no support for public health centers, making night work a daily routine. Huh said, "There is no support for the public health centers for infectious diseases. We are actually fighting the situation with barehanded, and the reality is that even if we do not evade responsibility of the public health center in a national disaster. we have never left work since the last 20 days". "Health centers are directly affiliated with local governments and professional organizations, and people with a high level of administrative experience must be deployed, they move up like general auxiliary agencies, and they are upset, and we have asked the MOHW and the KCDC several times regarding the workforce but no change".
- Company
- Celebrex, resupplied as bottles of 100 capsules
- by Jung, Hye-Jin Feb 14, 2020 06:35am
- Cerebrex capsules, which are widely prescribed for rheumatoid and osteoarthritis pain medications, run out of stock. Pfizer Upjohn Korea recently announced that Celebrex 100mg 30 unit doses were sold out to distributors and medical institutions. Pfizer Korea explained that it will be resupplyed in early April and that Celebrex 100mg bottles of 100 capsules are normally supplied This is not the first time that Cerebrex is out of stock. Pfizer announced last June that Celebrex 100mg bottles of 100 capsules were out of stock. Out-of-stock period was for 6 months, and it has been resupply since early this year. However, as soon as Celebrex 100mg bottles of 100 capsules are resupplied, Celebrex 100mg cartons of 30 capsules are running at this time. Pfizer said the reason for the out of stock was a delay in production schedule.
- Policy
- “HIRA’s open ears and hearts for pharmaceutical industry"
- by Lee, Hye-Kyung Feb 14, 2020 06:35am
- "The Pharmaceutical Management Department had to move to Wonju, as the construction of second headquarter building of Health Insurance Review and Assessment Service has been completed. But its door is open. We plan to have our ears and hearts opened to the pharmaceutical industry." Kim Ae-ryun, appointed as a director of Pharmaceutical Management Department at Health Insurance Review and Assessment Service (HIRA), claimed 'integrity' as the top quality of a public Institute. But stated communication barrier should not be high. And she means HIRA is always ready to meet with pharmaceutical industry. First, the department had tried to manage the stakeholders visiting with an interview guideline. But now the department is gearing towards meeting everyone, and even with the director herself, if need be. Director Kim said, "The Pharmaceutical Management Department has opened a conference room for the visitor on the first floor of the first headquarter building. Pharmaceutical companies with questions can visit us without an issue. Transparency and integrity are the virtues a public institute should keep when working, but fundamentally the communication barrier should not hold them back." Previously a nurse, Director Kim started as reviewer at the DRG Department and served at Classification System Management Department. Later, she was in charge of healthcare reimbursement standard, fee-for-service management, new medical technology system operation and monitoring, and listing medical service at the Benefit Listing Department. With a lack of her experience in Pharmaceutical Management Department, pharmaceutical companies wondered of her personnel. The director explained, "Everyone knows that I do not have experience in Pharmaceutical Management Department. But I realized working here that my previous experience in reimbursement listing is similar to what I do now. I served as a director before and understood the common process. Now I see that the basic framework is similar and I plan to learn about the unique aspects of pharmaceutical listing as I go.” 40 days since her appointment as a director of Pharmaceutical Management Department, Director Kim has already had meetings with pharmaceutical industry organizations like Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA). When the Covid-19 outbreak subsides around March or April, the director plans to resume having quarterly conference with pharmaceutical industry. The whole office of Pharmaceutical Management Department has moved to Wonju last December. Regarding the issue of pharmacist officers leaving the office, Director Kim said, “One pharmacist resigned last December and another officer left this year. We’ve been here for two months and I think it’s a process. Korea spends about 25 percent of the total medical expense on pharmaceutical expense. And the Pharmaceutical Management Department takes care of most of drug items. Out of many other career choices a pharmacist can choose, a public office pharmacist is a great choice to feel worthwhile and find value in working.” “Aside from a type of occupation, we hope many of pharmacists can join us as they could be a huge help to the people’s health and patients. Government office pharmacist would be a great opportunity to help out with National Health Insurance finance management,” Director Kim added. The director did not comment much about the Drug Reimbursement Evaluation Committee selecting choline alfoscerate for the listed drug reevaluation pilot program. Director Kim assured, “I hope the reimbursed drug reevaluation system takes its root in Korea well as it takes a first step in Korea. This year’s goal for HIRA is to make a guideline to reasonably and transparently select subject drugs. The DREC’s decision has been made, but the department would listen to government and stakeholders’ voices along the way.”
- Policy
- Constipation drug Rucalo gets coverage but with condition
- by Lee, Hye-Kyung Feb 14, 2020 06:34am
- A new reimbursement standard has been added as Yooyoung Pharmaceutical’s chronic constipation treatment Rucalo tablet (prucalopride succinate) has been listed for reimbursement. Korea’s Ministry of Health and Welfare (MOHW) announced on Feb. 6 the authority has decided to grant reimbursement on Rucalo tablet by partially amending ‘Details of Pharmaceutical Reimbursement Standard and Method.’ The drug is currently indicated to treat patients with chronic constipation, who have failed to relieve symptoms regardless of administering two or more types of laxatives (form-bulking or osmotic laxatives and etc.) for over six months. According to the reimbursement standard, however, MOHW would renew reimbursement status after reviewing the patient’s state after four weeks of administration, and any other off-label use of the drug would be covered entirely by the patient. MOHW’s decision on the reimbursement was based on the drug’s indication, related academic society’s advice and external reference guideline. The drug is reimbursed in A7 countries like the U.K., Germany, Italy and Switzerland. So far, five Korean pharmaceutical companies have applied for reimbursement on chronic constipation treatment, including Yooyoung Pharmaceutical, Hana Pharm, Daewon Pharmaceutical, Ahn-gook Pharmaceutical and Huons. Result of DREC’s reimbursement feasibility review At the ninth Drug Reimbursement Evaluation Committee (DREC) meeting convened in last October, the committee had evaluated Rucalo, Prolo, Procal, Prucal, and Constipan demonstrated clinical efficacy, but they are expensive compared to other alternative options. The committee stated the reimbursement would be granted when the respective companies accept pricing under the evaluated price. Other than Yooyoung Pharmaceutical, another company has decided to accept the pricing lower than DREC’s evaluated price (weighted average of alternative options) and negotiated with National Health Insurance Service (NHIS) over pricing from last November. But only Yooyoung Pharmaceutical has reached an agreement and won the reimbursement. Rucalo is a selective serotonin (5-HT4) receptor agonist used to treat patients with chronic constipation, who does not respond to conventional laxatives.
- Company
- 4th IL inhibitor Skyrizi takes steps towards reimbursement
- by Eo, Yun-Ho Feb 13, 2020 06:29am
- The fourth interleukin medicine in Korean market, Skyrizi has started its reimbursement listing procedure. Pharmaceutical industry sources reported AbbVie Korea recently submitted an application for reimbursement on interleukin-23 (IL-23) inhibitor Skyrizi prefilled syringe (risankizumab). As a follow-on drug, the medication is predicted to accept the alternative drug weighted average price and promptly complete the listing process by the end of coming June. When the syringe receives reimbursement, the interleukin medicine market would be led by four competitors. Besides Skyrizi, Novartis’ IL-17A inhibitor Cosentyx (secukinumab), Lilly’s IL-17 inhibitor Taltz (ixekizumab), and Janssen’s IL-23 inhibitor Tremfya (guselkumab) are available in Korean market with reimbursement. All four medications are indicated for treating psoriasis and they are expanding indications on other autoimmune disease-treating fields. Professor Youn Sang Woong of Seoul National University Bungdang Hospital explained, “Severe psoriasis can seriously affect patient’s quality of life with physical, mental and social difficulties and pain. Each patient differs vastly in treatment response, and experiences various adverse reactions due to long-term treatment.” “During a Phase III trial, 90 percent of patient group administered with Skyrizi improved symptoms at over week 16, and 80 percent of them still maintained the improved state even after a year. The medication would be a new treatment option to improve symptoms of severe psoriasis and for maintenance therapy,” the professor added. In last December, MFDS indicated Skyrizi for treating adult patient, who needs phototherapy or systemic therapy (including biological therapy), with severe-level plaque psoriasis. Its indication was approved based on UltMMa-1 and UltMMa-2 trials, where patient group treated with Skyrizi showed high level of condition improvement at 16 weeks. 82 and 82 percent of the patients achieved Psoriasis Area and Severity Index (PASI) 90 at one year (52 weeks), and 56 and 60 percent of the patients achieved PASI 100, respectively. PASI 100 indicates the patient’s condition has achieved a complete resolution. Skyrizi administration starts with 150 mg initiation dose injected subcutaneously at week 0 and 4, followed by injection at every 12 weeks. Among the biologic IL-23 inhibitor class medicines approved in Korea, the treatment has the minimum administration frequency of four times a year, and it can be injected at a hospital or a patient can self-inject after training.
- Product
- Ebola drug Remdesivir is used to treat COVID-19
- by Lee, In-Bok Feb 13, 2020 06:28am
- Remdesivir by Gilead, which is being developed as an Ebola treatment, is expected to benefit significantly from the spread of COVID-19. The explosive demand for therapeutics around the world has led to unintended recruitment of clinical trials, which has resulted in significant time and cost savings. In some cases, the possibility of quick permits is also increasing. Clinical trials in the US, China, etc, Skip Prior Authorization The National Institute of Allergy and Infectious Diseases (NIAID) announced on the 12th that it will begin a clinical trial of Remdesivir with COVID-19. Remdesivir is a drug that Gilead Science is developing for the Ebola virus, and it is preparing for phase III full-scale after completing phase II clinical trials, However, the analysis predominates that the recruitment of the Ebola virus patient population will be limited and it will take some time due to the budget and time constraints for multinational clinical trials. It is a fact that some aspects of the permit has been placed in a somewhat opaque situation. However, with the rapid rise of Remdesivir in the treatment of new COVID-19, the demand has risen sharply and the environment is ready for immediate clinical trials without prior review and approval. This has been decisive in the case of the first COVID-19 patient from the United States. Indeed, researchers in the Centers for Disease Control and Prevention (CDC) have received a lot of attention from the New England Journal of Medicine (NEJM), with a case report describing the first patient prescribed Remdesivir. At the time, the patient was given other antiviral agents and antibiotics, but the symptoms got worse. Eventually, the administration of Remdesivir improved significantly. Since the Ebola virus is an RNA virus such as COVID-19, Remdesivir, which has a mechanism that prevents RNA replication, also inhibits COVID-19. NEJM Case Report Critical Leads to a quick permit As these effects become known, patients in China and Thailand are already taking Remdesivir in patients. The Chinese government has also urged Gilead to cooperate urgently and to expand the supply of Remdesivir. The same is true for large-scale clinical trials in China ahead of the United States. As soon as the potential for treatment was recognized, the Chinese health authorities immediately approved the medication in the form of clinical trials without prior review or approval. As a result, China has already entered into a controlled trial of 761 patients and is planning to proceed with the trial until April, and then review the rapid approval. This is not the only case in China. The U.S. Food and Drug Administration (FDA) and the CDC also mention rapid approval. Since the drug is already in the form of phase III clinical trials, it is in a position to grant a new drug based on this result. This fact has already been communicated to foreign countries through the New York Times and international press, and for this reason, China and Thailand are reportedly preparing for clinical trials and rapid approval. At the end of last year, the drug, which had even entered phase III clinical trials, was opaque, and in a few months, the phase III clinical trial could be approved for rapid approval. For Gilead, this is a great opportunity to save a great deal of time and budget in collecting patients, selecting institutions, and systematically analyzing them to prepare for permits. However, it is confirmed that clinical trials and rapid approvals are not being reviewed in Korea yet. As China's demand is so large that it attracts the world's quantity, it is not easy to consider prescription even in Korea. "Remdesivir is expected to be effective, but it is not easy to even prescribe it due to the lack of stock in our country, and for this reason, the policy recommendation was to exclude from primary treatment", said Jihwan Bang, the team leader of the central clinical task force (TF). An official from the Ministry of Food and Drug Safety said, "No immediate approval has been reviewed regarding COVID-19 treatment".
