- LOGIN
- MemberShip
- 2025-12-26 13:07:30
- Policy
- Value framework research explains why we need it
- by Lee, Hye-Kyung Feb 03, 2020 06:24am
- Experts claim value framework criteria and evidence fitting to Korean circumstances are needed to justify limited National Health Insurance (NHI) finance granting reimbursement on high-cost anticancer treatment with clinical uncertainty. The argument is that new value framework scales are needed for a new high-cost anticancer treatment with weak evidence of improving survival time and progression-free survival (PFS), because they raise an issue of uncertain efficacy when evaluating cost-effectiveness. Korean Cancer Study Group recently unveiled a final report on a study of pharmaceutical value framework, cosigned by Health Insurance Review and Assessment Service (HIRA). The research team evaluated six drugs—non-small cell lung cancer (SNCLC) targeted therapy Tagrisso (osimertinib), immunotherapies Tecentriq (atezolizumab), Keytruda (pembrolizumab), nivolumab, and multiple myeloma treatments Kyprolis (carfilzomib) and Pomalyst (pomalidomide)—with two tools applicable for Korean environment, American Society of Clinical Oncology’s (ASCO) Value Framework (VF) and European Society for Medical Oncology’s (ESMO) Magnitude of Clinical Benefit Scale (MCBS) ASCO VF and ESMO-MCBS assessed clinical efficacy, toxicity and quality of life, but had a gap in evaluation methods used with unclear aspects in each, which resulted in different assessment outcomes depending on investigator and drug. ASCO VF had an issue with clinical benefit indicators. Among three indicators including overall survival (OS), PFS, objective response rate (ORR), OR is meaningful as an ultimate target endpoint. So it may seem reasonable to set weighted value of OR lower than PFS or ORR, but weighted value or preference from the perspective of patient has not been reflected. The research team pointed out “Applying ASCO VF in Korea could result in a significant discrepancy in scores when respective evaluators assess randomized clinical studies of a drug. If a clarified guidance is not given on the scale of value framework, a tool originally designed to help the bilateral decision-making between a doctor and patient could actually cause confusion instead.” Meanwhile, the team found an issue of insufficient amount of ESMO-MCBS-based literature on anticancer treating blood cancer. When developing ESMO-MCBS, various drugs treating a variety of cancers were reviewed but drug for blood cancer was not included. “The tools have limitations in clearly answering the questions of how to define ‘clinical benefit;’ how would ASCO VF specify items evaluated for toxicity; what indicators could be used to assess quality of life; or what criteria could measure improved toxicity in ESMO-MCBS,“ nevertheless, “the value frameworks support the argument of rising medical expenditure, due to increased number of cancer patients and high-cost anticancer treatments, should develop ‘value-based’ scale evaluating ‘value’ more objectively,” the team assessed. The related expert survey and focused group interview drew a conclusion that the majority of the experts agreed value framework for anticancer treatment should be adopted in Korea, and they answered both of the external tools should be considered instead of preferring either of them. The weighted values from analytic hierarchy process (AHP) showed oncologists considering efficacy of an anticancer treatment more when prescribing than how much ASCO VF considers of relative importance of efficacy. The researchers stated, “This should be clarified when adopting ASCO VF as a Korean value framework. When applying clinical value framework for anticancer treatment, this part should be consulted with experts to better define and reflect it.” The report also recommended conducting follow-up studies to specify criteria to assess toxicity, alleviated symptoms, and improved quality of life. “Developing a unique value framework for Korea would require a series of discussions and studies in the future, and continuous efforts should be made to explore and generate value-based endpoint fully reflecting the Korean landscape and various stakeholders,” the researchers concluded.
- Policy
- 6-hour test kit targeting 2019-nCoV developed in Korea
- by Lee, Tak-Sun Feb 03, 2020 06:24am
- A laboratory test kit to confirm the 2019 novel coronavirus infection in six hours has been co-developed by a government body and private entity. From Jan. 31, the new test kit would used by Korea Centers for Disease Control and Prevention (KCDC) and Government Research Institute of Public Health and Environment to test suspected cases, and it would be available for use by private healthcare institutes from early February at earliest. KCDC (Director Jeong Eun-kyeong), Korean Society for Laboratory Medicine (President Kwon Gye-cheol), and Korean Association of External Quality Assessment Service (President Min Hong-ki) have developed, validated and assessed quality of real-time polymerase chain reaction (RT-PCR) to detect 2019 novel coronavirus. They announced KCDC (including National Incheon International Airport Quarantine Station) and 18 Government Research Institute of Public Health and Environment stationed nationwide are to use the kit from Jan. 31. The new test takes six hours or less to confirm the infection and the gene-amplifying PCR only requires a single test. The test can be manufactured domestically and it would significantly contribute in proactively response to the virus infection. The existing pan-coronavirus test kit takes a longer time (one to two days) and requires a two-step testing. KCDC stated the new highly credible test kit has been developed based on the 2019 novel coronavirus genetic information, World Health Organization (WHO) test method, and clinical samples, and it was fully disclosed to Korean laboratory test tool manufacturing companies to locally manufacture the kit. Except for China at the moment, an internationally approved and prevalently used test kit is not available, but the Korean-made kit would be distributed to private healthcare institutes in early February at earliest with the help of R&D by Korean manufacturer, assessment support by KCDC, the academic society and the association and emergency approval on medical device by Ministry of Food and Drug Safety (MFDS). Preparing to approve the emergency use of the test kit, MFDS plans to closely cooperate with KCDC and promptly process the reviewing of safety and accuracy with submitted product evaluation material. Korean Society for Laboratory Medicine and Korean Association of External Quality Assessment Service officials said, “The test kit holds a great meaning as public-private cooperation has resulted in an effective diagnostic system in such short period of time. The public-private cooperation would vastly contribute to end the outbreak of 2019 novel coronavirus.” Director Jeong Eun-kyeong of KCDC explained, “The new test kit would enable us to specifically target and diagnose the novel coronavirus, and to respond assertively depending on confirmed infection, even if the outbreak spreads.”
- Policy
- Government on new coronavirus, “All hands on deck”
- by Kim, Jung-Ju Feb 03, 2020 06:22am
- The Korean government body reported the Cheongwadae of pan-government response plan on the 2019 novel coronavirus after monitoring the current status of the outbreak. Along with the plan, the government officials discussed of a plan evacuating Korean residents in Wuhan, China, and providing other humanitarian support for China. At the Government Complex Seoul from 10:30 a.m. on Jan. 30, Ministry of Health and Welfare (MOHW) convened and President Moon Jae-in led a meeting on general countermeasure plan against the 2019 novel coronavirus, along with Deputy Prime Minister, related Ministers and 17 city and provincial leaders. ◆ Response status and pan-governmental support plan: At the meeting, the government officials first talked of the present status of response against the novel coronavirus outbreak and related pan-governmental support plan, and decided to put all efforts to block off inter-regional spread of the virus infection in Korea. First off, the government has decided to place more government officers at the quarantine centers to thoroughly shut out the spread of infection. Following the additional dispatch of 250 officers from MOHW, Ministry of National Defense (MND), Korean National Police Agency and others to quarantine centers nationwide including Incheon International Airport, MND has promptly dispatched 106 more officers to meet the needed reinforcements. And depending on the progression of the spread home and abroad, the government leaders have decided to dispatch epidemiologist to affected cities and districts. The Korea Centers for Disease Control and Prevention (KCDC) call center (1339) has increased the number of respondents from 19 to 329 to swiftly provide counseling and answer related questions from suspected case of the novel coronavirus. KCDC also plans to arrange more epidemiologists around cities and districts. Health Insurance Review and Assessment Service (HIRA) is also running a due diligence on overall 2,991 people traveled from Wuhan to Korea from Jan. 13 to 26. The travelers are checked upon everyday by phone call, and isolated for further inspection if they show respiratory symptoms. A child or school faculty returned from Hubei province, China, is refrained from coming to daycare center, kindergarten and school, but accordingly administrative measures like attendance processing are simultaneously executed. Also workers, who visited Hubei province, are also temporarily removed from welfare facility with senior citizens and the disabled for 14 days. The government plans to redirect public health center capacity to focus on special clinics for the outbreak and people who came in contact with infected people. To better accommodate the outbreak management, regional health centers adjusted and lessened workload of general medical service and health promotion programs. And regional emergency medical centers are to check visitors’ body temperature and to confirm infection of those with high fever in a separate special health center before they enter the hospital to minimize infection spreading within healthcare institutes. At the moment, 18 Government Research Institutes of Public Health and Environment are testing the suspected cases as soon as possible, but other private healthcare institutes may run tests by themselves from early February. Also the government has alleviated government support standard for medical professionals to judge the risk of infection at the field and quarantine and treat the suspected case immediately. Meanwhile, the government bodies are to cooperate monitoring and imposing strict measures on unknown source of information with unauthorized use of the government body logo distributed to the public and creating confusion and anxiety. ◆ On safely evacuating and aiding Korean residents in Wuhan: Temporary flights are sent to Wuhan to evacuate Korean residents in Wuhan and close vicinity, if they want to be. The temporary flights would be managed based on evacuation demand, and the government would finish up the related talks with the Chinese government soon. The Korean residents are to be tested for infection before boarding the plane and after landing in Korea. Dispatching government-led emergency response team, the Korean residents flying in from Wuhan would get an emergency flight support, quarantine testing, medical aid, and necessary supplies. Korean government is also sending medical aid supplies to China struggling with the fast-spreading novel coronavirus as a humanitarian gesture. As requested by Chinese government, Korean government is to review providing total of USD five million worth of supplies. ◆ Temporarily quarantined living quarter for returnees from Wuhan and local government reinforcements: Temporarily quarantined living quarter for Korean residents returning from Wuhan aims to protect both the returnees and local citizens. The site was designated generally considering the facility to accommodate quarantined treatment and proximity to healthcare institute. Each returnee is provided with a single room as a living quarter, but visitor access and exiting the facility would be strictly prohibited. Individual supply of toiletry and bedding would be given to each returnee for sanitary reasons, and also their disposal wastes would be dealt with care. Medical professionals would check their health status twice daily, and anyone showing symptoms at the facility would be immediately transferred to government-designated hospital for admission. Support team consisting of various government officers would strictly manage the temporary living facilities to ensure safety and health of neighboring communities. ◆ Economic impact and response plan: The government announced all governmental capacity and effort would be centered on securing public safety and security and in minimizing economic impact until the risk of novel coronavirus completely subsides. Also the impact, especially on the real economy in Korea, would be investigated closely and all capacity would be focused on minimizing the potential negative effect as much as possible. Referring the previous cases of SARS in 2003 and MERS in 2015, the impact on economy would be thoroughly examined and analyzed by various scenarios, and necessary initiative would be proactively prepared to be initiated when needed. And related budget would be allocated and spent on preemptive and watertight epidemic disinfection Total epidemic disinfection budget of 20.8 billion won, consisting of 6.7 billion won for responsive disinfection system, 2.5 billion won for quarantine and infection testing fee, and 2.9 billion won for quarantined treatment, already allocated for this year would be spent to assertively back up the preemptive epidemic disinfection. The government has announced two trillion won, initially allocated as contingency budget for this year, would be used if the secured budget is insufficient.
- Policy
- Chong Kun Dang's CKD-306 is approved for phase I
- by Lee, Tak-Sun Feb 03, 2020 06:20am
- Duvie, a new diabetes drug made by Chong Kun DangChong Kun Dang is continuing to develop a combination of diabetes drug 'Duvie' and DPP-4 inhibitor 'Sitagliptin'. In 2016, Chong Kun Dang, a candidate for the development of a combination drug known through clinical approval of drug interactions, was recently approved for phase I clinical trials and is now in full swing. The Ministry of Food and Drug Safety approved the Phase I clinical trial plan for CKD-396 by Chong Kun Dang on the 21st. CKD-396 is known to be a combination of Lobeglitazone, a diabetes drug called 'Duvie' and Sitagliptin, one of the DPP-4 inhibitor. In March 2016, a phase I trial protocol for drug interactions has already been approved. The trial will be conducted at Severance Hospital. The control drug is Januvia(100mg Sitagliptin phosphate hydrate) and Duvie 0.5 mg (Lobeglitazone sulfate). 26 healthy adults were compared with the pharmacokinetics and safety of CKD-396 and the control group. Clinical trials are scheduled from February to December. Duvie by Chong Kun Dang is a domestic new drug (No. 20) approved in July 2013. It is a Thiazolidinediones-based diabetes treatment drug that increases insulin reactivity, reduces blood sugar levels, and maintains pancreatic function. Chong Kun Dang has continued to develop complexes since Duvie was approved. In June 2016, Duvimet (Lobeglitazone sulfate-Metformin Hydrochloride), which was combined with Metformin hydrochloride, the first treatment for type 2 diabetes, was approved. The development of a combination of DPP-4-based therapeutic agents, Sitagliptin, is also part of the lineup. Pioglitazone (brand name: Actos by Takeda), already a competitor of Duvie, is commercially available as 'Nesina act', a combination of DPP-4 inhibitor, Alogliptin (brand name: Nesina by Takeda). Nesina act was approved in October 2014, and recorded last year's outpatient prescription amount of ₩11 billion based on UBIST, showing off as a blockbuster. In the medical field, the combination of Thiazolidinediones and DPP-4 series doubles the effect of diabetic treatment and is used as a treatment option. There are also several clinical data that show actual results. As a result, the Lobeglitazone-Sitagliptin combination may be useful in patients. It is noteworthy whether Chong Kun Dang's clinical research conducted in 2016 will bear the final commercialization.
- Policy
- Industry welcomes pricing benefit unchanged for IMD
- by Lee, Jeong-Hwan Jan 31, 2020 06:35am
- The Korean pharmaceutical industry is positively reacting to Ministry of Health and Welfare’s (MOHW) revised drug pricing system including the weighted pricing benefit for incrementally modified drug (IMD) as it would allow IMDs to remain as a cash cow generating finance for new drug R&D. Although they are regretful the weighted pricing is limited only to government-designated IMD and excluded other ‘drugs for data submission,’ the majority of the industry says the government started recognizing the value of IMDs. On Jan. 28, a pharmaceutical industry insider commented “MOHW reissued a notice of revised ‘Criteria for Decision or Adjustment on Drugs’ that saved IMD from leveling itself down with other generics. But it also highlighted the importance and need for Korean pharmaceutical companies to switch their core business model.” MOHW re-notified the revised generic drug pricing criteria including the weighted pricing for IMD on Jan. 28. The key change made was maintaining the pricing benefit for IMD until other generic is released, as the drugs work as a stepping stone to new drug development. Quoting the notice issued by the ministry, the weighted pricing benefit would be applied to “IMD (including incrementally modified combination drug) until other single or combination drug with same administration method, content, and formulation is listed.” The industry perceives the change as the government’s ultimatum for Korean pharmaceutical companies to shift away from generic development to better-priced IMD development. Among all drugs for data submission, the pricing benefit was limited to IMD designated by Ministry of Food and Drug Safety (MFDS), which also means IMD’s individual patent registration and four to six years of post-marketing surveillance (PMS) period would come in effect as well. For pharmaceutical companies, the revision would encourage them to explore patent difficult for competitors to replicate and to develop IMD to ultimately block off other generic competitors while making profit during the PMS period. The PMS period is valid for four years on extended release drug with prolonged effect, and six years on combination drug or drug improving benefit with alternative administration method. Until the PMS period expires, other generic launch is restricted for the IMD to dominate the market to some extent. As a result, IMDs that MFDS sees inventiveness in safety, efficacy and utility (drug compliance, convenience and etc.) based on pharmaceutical approval and registration review regulation would be provided with benefits of market exclusivity and pricing. A pharmaceutical company official commented, “Many opinions of IMD-focused companies have been reflected. As the purpose of the revision was to improve the weighted pricing system, MOHW seems to have widely accepted of the industry’s opinions,” but “limiting the pricing benefit only to MFDS-designated IMD, instead for all drugs for data submission, is regretful.” The official elaborated, “The restriction means drugs for data submission with change in saline base, isomer and formulation would be neglected from the pricing benefit. Accordingly, Korean pharmaceutical companies would have to act fast analyzing the changes and to plan for new business model,” as “the government has technically sketched out the prospective of the industry with pricing benefit, so lingering in the generic game would eventually risk the business.”
- Policy
- Besivo's reimbursement standards expanded
- by Kim, Jung-Ju Jan 31, 2020 06:35am
- If the patient progresses to liver cancer during treatment with Besifovir oral medications, the benefit is still acceptable. In the case of Ramosetron HCl oral medications, there will be no restriction on the duration of administration, up to 12 weeks. The Ministry of Health and Welfare was confirmed on 28th after hearing opinions by the 22nd on the partial amendment of 'Details on the Standards and Methods of Application of Medical Benefits (Pharmaceuticals)'. The effective date is the 1st of next month. Looking at the reimubrsement criteria to be applied next month, patients with chronic hepatitis B begin treatment with Besifovir (generic for Besivo), and if the disease progresses to liver cancer, the patient can continue to receive the benefits. This means that even if hepatitis B patients are diagnosed with cancer from now on, they will receive the benefit for continuous administration. There is no restriction on the duration of the administration of Ramosetron HCl oral medications such as Irribow by Korea Astellas. Currently, the duration of administration is limited to a maximum of 12 weeks, and further administration is being reduced. As Boryeong’s combination drug of Fimasartan, Amlodipine & Rosuvastatin is newly listed on the 1st day, it is added to the 'high blood pressure + hyperlipidemia' complex oral reimbursement standard. When using Infliximab products such as Crohn's disease treatment, Remicade by Janssen, immunoglobulin-resistant refractory Kawasaki disease (including typical and atypical) that exceeds the licensed range is also approved. Basiliximab injections, such as Simulect by Novartis , used in adult kidney transplantation, specify the dosage and frequency of heart, liver, lung, small intestine transplantation, and pancreatic and pancreatic transplants in excess of the approved range. This makes the standard clearer than before. In detail, according to the permission (use and dose), it is specified as 20 mg per dose and 2 doses. In case of Abatarcept injections, such as 250mg of Orencia inj and Orencia subQ pfs(125mg) by BMS Korea, benefits are expanded by adding 'expandable minority arthritis' among pediatric idiopathic arthritis. Agalsidase β 35mg injections, such as Fabrazyme from Sanofi-aventis Korea, an enzyme replacement therapy for Fabry disease's confirmed patients, are changed based on the amounts listed on the current insurance benefit list. The ingredient is actualized. In addition, Jext inj (children/adults, Epinephrine single use autoinjector) and Dibenyline capsules (Phenoxybenzamine oral drugs), which were reimbursed as urgent drug and decided to be deleted due to supply failure, as of the 31st of the six-month grace period, the benefit will be also deleted.
- Policy
- Cresemba, Pfizer Korea's antifungal drug, approved
- by Lee, Tak-Sun Jan 30, 2020 06:34am
- Pfizer Korea obtained the product license of the antifungal drug Cresemba (Isavuconazole Sulfate) in Korea. The drug is expected to have a lower mortality rate than Pfizer's Vfend. The Ministry of Food and Drug Safety approved on the 29th the sale of 'Cresemba capsule 100mg' and 'Cresemba injection 200mg' of Pfizer Korea. Cresemba is licensed for the treatment of invasive aspergillosis in adults 18 years of age and older and for invasive hair fungus in which Amphotericin B is not suitable for adults 18 years of age or older. The FDA approved this drug in March 2015. Cresemba is a drug jointly developed by Switzerland's Basilea and Japan's Astellas. Pfizer holds the EU release rights and the Asia-Pacific rights, including Korea. Astellas was approved in the United States and Japan. The drug has been shown to have a lower mortality rate than Voriconazole (generic for Vfend) in clinical trials in 516 patients with invasive aspergillosis. The mortality from all causes at 42 days was 18.6% (48/258) in the Isabuconazole group and 20.2% (52/258) in the Voriconazole group. Aspergillosis is a disease caused by a respiratory infection caused by a fungus called Aspergillus, and occurs when immunity is compromised due to leukemia or chemotherapy. Symptoms include chills, bleeding, chest pain and shortness of breath. Particularly invasive, the infection spread systemically can cause tissue damage, thrombosis, etc. due to impaired blood supply, severe sepsis can cause death. Voriconazole is the generic for Vfend sold by Pfizer. Vfend recorded annual sales of about ₩10 billion (Reference: IQVIA) in Korea. However, in the case of Vfend, Chong Kun Dang turned into a competitive system with the introduction of Vorico, the first generic in 2017. Cresemba is emerging as a new alternative to Vfend. Meanwhile, the MFDS approved MSD Korea's new AIDS treatment drug, Delstrigo (Doravirine-Lamivudine -Tenofovir disoproxil fumarate).
- Policy
- President Moon wearing a mask visited the NMC
- by Kim, Min-Gun Jan 30, 2020 06:33am
- President Moon Jae-in visits the National Medical Center in the morning on the 28th for a briefing on Wuhan pneumonia. Cheong Wa Dae announced at 10:31 am on the 28th that President Moon Jae-in visited the National Medical Center, which is treating a new type of coronavirus infection, and directly inspected the field response system and ordered a total response posture. Mr. Moon made this report at the spot where he received on-site response system reports such as patient selection criteria, response measures, and operation procedures for screening clinics from the Director of National Medical Center Ki-hyun Chung and the Director of operation support team, Yeon-jae Kim. Mr. Moon said, "The government needs to be powerful and speedy enough to evaluate the preemptive measures a little too much, and investigate all persons who have passed through the airport asymptomatically and quarantine those who have confirmed symptoms and take measures to prevent secondary infections as much as possible". President Moon emphasized that such measures should be made transparent to the public to relieve anxiety. In particular, Cheong Wa Dae said that President Moon called for greater awareness of where medical institutions did not use the contact function (to the KCDC or the public health centers) or are not complying with their obligations to do so. President Moon Jae-in visits the National Medical Center on the 28th and checks the field response system. On the other hand, President Moon visited medical staff, screening clinic, negative pressure ambulance, and on-site emergency clinic where mobile X-rays could be taken. He boarded the mobile CT vehicle and listened carefully to the explanations from the director and the officials. In addition, President Moon called for efforts to resolve local anxiety by asking whether the NMC has enough know-how as a nationally-designed quarantine bed when the MERS outbreak occurred.In addition, and the status of securing a nationally designated quarantine bed. President Moon also visited a negative pressure containment ward where a second Korean confirmed patient was admitted to the hospital to check the patient's condition, as well as concerns about the possibility of secondary infections caused by asymptomatic community activities and related measures. President Moon also received reports from the vice director, Im seok Ko, on the status of the wards and the system for responding to infectious diseases at each stage. President Moon asked if there were any concerns about the spread of infections in screening systems, quarantine beds, and negative pressure rooms. This is because inpatients during the MERS outbreak were infected with other patients, clients and medical staff. The vice director said, “The hospital was shut down in a severe stage during the MERS outbreak, treated 60 patients with MERS, and there was no hospital infection at all, and as it is more systematically developed, I don't think there is any possibility of infection in the hospital or transmission of local infections”. President Moon praised the medical staff at the National Medical Center, which had suffered during the New Year's holidays, and said he hopes to deal with it without slowing down until the end.
- Policy
- Amendment to cascading drug price revision revealed
- by Kim, Jung-Ju Jan 30, 2020 06:33am
- Finally came the result. The reinstatement of the cascading drug price system was revised and revised to change the generic insurance price according to whether or not it had its own bioequivalence test. As is known, there is a difference in the price of IMDs and generics. Revisions were included to keep the addition in recognition of the effort and innovation. However, in the case of listed drugs, the application sentence linking permit and drug prices after three years of preparation period is missing from the readministrative notice. This was confirmed that there would be no change as a result of the planned re-evaluation process (3 years) to be carried out through a re-evaluation procedure separately announced according to the 'Criteria for Decision or Adjustment on Drugs'. The Ministry of Health and Welfare announced ‘a partial revision of the Criteria for Decision or Adjustment on Drugs’ today (Jan 28) morning and looked up opinion in the industry. When the first notice amendment was issued on July 2 last year, the government decided to revise the notice in early September and enter into full-scale implementation this year. However, due to the high impact of drug price reform, some additions were inevitable due to continued protests and protests. ◆Standard to estimate the drug price (including eye drops)= Looking at the contents, the first relevant revision notice and the basic framework of July 2 last year are the same. The revised bill for the price standard system, which cuts the generic price by 15% according to its own and co-prosperity into 'stairs' and limits the same number of generics as the so-called 'cut line', was also included in the revised proposal. In detail, a new set of criteria for applying differential prices (submission of biometric data or evidence of clinical trials and the use of registered ingredients) has been established. The cascading reorganization will change the price of the drug depending on the criteria, provided that the same formulations are listed under 19 products. 53.55% if all are met, 45.52% if only one is met, and 38.69% if there is no requirement. In the case of 'A cut off point system', when more than 20 products of the same formulations are listed, it is calculated automatically 85% of the lower amount between the lower price of the upper limit of the same system and the amount calculated as 38.69%. Eye drops are also multi-use or single-use eye drops. However, if the applied product is a single-use or multi-use product, the calculation criteria will be pushed forward. Eye drops are also multi-use or single-use eye drops. However, if the applied product is a single-use or multi-use product, the calculation criteria will be pushed forward. If revised, it will take effect on July 1st. ◆Reorganization of Addition System= The industry's current focus is on this reform. The reorganization plan includes all the contents of the first draft made last year, including the comprehensive maintenance of synthetic and biologic drugs, and the extension of the period of addition. Looking specifically at the addition of IMDs, the IMD maintains the addition until the IMD or the individual single or complex constituting the product and the same route of administration, ingredient, and formulation are listed. This includes IMD complexes. Just this has a condition. Excludes two or more listed companies that have the same dosage, route, ingredient, and formulation as the individual single compound and compound listed in the combination. Also, products added after the addition period has passed cannot be added. In addition, the addition requirements for both synthetic (chemical) and biologics are the same as those published last year. The addition period and the number of companies that have been set for each standard have been unified and maintained. Specifically, the period for adding synthetic and biopharmaceuticals is one year, and if the number of companies is three or less, the period for adding and maintaining all of them is up to two years. However, if the pharmaceutical company wants to extend the addition period, the government prepared a system to adjust the addition rate and extend the addition period within the two-year limit through the review of the Pharmaceutical Benefits Advisory Committee. The government plans to implement this addition system by January 17, next year after receiving opinions.
- Policy
- Rafinlar-Meqsel combination done with pricing negotiation
- by Lee, Hye-Kyung Jan 30, 2020 06:33am
- A combination therapy of Rafinlar and Meqsel treating patients with ultra-rare late stage BRAF-mutant lung cancer would be available for reimbursed prescription from next month at earliest. Korea’s National Health Insurance Service (NHIS) has recently announced pricing negotiations on four items—Novartis’ Rafinlar (dabrafenib) 50 mg and 75 mg, and Meqsel (trametinib) 0.5 mg and 2 mg—have been wrapped. First released for the Korean market in December 2017 as a melanoma treatment, Rafinlar and Meqsel have been additionally indicated to treat patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation in March 2018. And to win reimbursement on the combination therapy of the two, they have been deliberated by Health Insurance Review and Assessment Service’ (HIRA) Cancer Disease Deliberation Committee and Drug Reimbursement Evaluation Committee (DREC) and started a drug pricing negotiation with NHIS from last year. Rafinlar and Meqsel combination therapy has been raised as an issue at the National Assembly audit session last year. During the audit, Liberty Korea Party Lawmaker Kim Se-yeon strongly appealed the need to provide reimbursement on the combination therapy of Meqsel and Rafinlar to treat patients with stage IV lung cancer. However, Ministry of Health and Welfare (MOHW) answered negatively by stating, “Reimbursement for a drug is decided by comprehensively reviewing clinical efficacy, cost-effectiveness and other various factors based on ‘Detailed Evaluation Standard of New Drug for Negotiation,” and “the combination therapy has uncertainty in cost-effectiveness.” While an alternative option of chemotherapy costs 20 million won a year with progression-free survival (PFS) of 8.9 months, MOHW claims the combination therapy of Meqsel and Rafinlar costing 120 million won a year to achieve PFS of 10.9 months is not cost-effective. However, the health authority and Novartis have negotiated financial means to cover the uncertainty in cost-effectiveness, and reached an agreement to complete the pricing negotiation in early January. Health Insurance Policy Deliberation Committee (HIPDC), under MOHW, is scheduled to discuss about the reimbursement decision on Rafinlar and Meqsel combination therapy and to finalize the data providing the reimbursement. Meanwhile, NHIS has also announced Yooyoung Pharmaceutical’s chronic constipation treatment Rucalo tablet (prucalopride succinate) 1 mg and 2 mg, and Astellas Pharma Korea’s overactive bladder treatment Betmiga PR (mirabegron) 25 mg and 50 mg have also finished the pricing negotiation as of Jan. 21.
