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- 2025-12-24 06:35:30
- Policy
- New osteoporosis drug Evenity passed deliberation
- by Lee, Hye-Kyung Sep 15, 2020 06:26am
- Amgen Korea's bone formation promoting and bone resorption inhibitor Evenity PFS (Romosozumab) passed the deliberation. On the 11th, the HIRA (President, Sun Min Kim) released the results of the deliberation on the adequacy of medical benefits for the drugs applied for decision deliberated by the '9th Pharmaceutical Benefits Advisory Committee in 2020'. The drug deliberated this time was one item of Amgen's Evenity, and the deliberation was made in writing for two days from 9 to 10 due to COVID-19. Evenity is a drug that has been recognized for the appropriateness of reimbursement in one year and four months after obtaining domestic approval in May of last year. Indications of Evenity are ▲treatment of postmenopausal female osteoporosis patients with a high risk of fracture ▲Bone density increase in male osteoporosis patients with high fracture risk. Effectiveness is based on phase III studies 'FRAME' and 'ARCH' studies and phase III clinical 'BRIDGE' study for male osteoporosis patients Through FRAME, a placebo-controlled phase III clinical trial, Evenity showed the effect of lowering the risk of vertebral fracture in postmenopausal female patients with a high risk of fracture, with a T-score of -2.5 to -3.5 in the total hip or femur neck. In the first year of treatment with Evenity, the risk of new vertebral fractures was reduced by 73% in the Evenity group compared to the placebo group. In the second year of treatment after 1 year of Evenity treatment, the risk of new vertebral fractures was reduced by 75% compared to the group of patients who switched from placebo to Prolia. On the other hand, the HIRA is evaluating the adequacy of reimbursement of medicines after deliberation on the committee in accordance with Article 11-2 of the Rules on the Standards of National Health Insurance Medical Care Benefits. In the case of drugs that have been evaluated for reimbursement appropriateness, the final evaluation result may be changed in the event of changes in the detailed drug reimbursement range and standard items, changes in the permission details of the item requested for determination, and withdrawal of permission (cancellation).
- Policy
- Fluarix Tetra, full-scale competition for flu vaccines
- by Lee, Tak-Sun Sep 14, 2020 06:15am
- Fluarix Tetra by GSKThe quadrivalent flu vaccine 'Fluarix Tetra', which was first introduced in Korea in 2015, was approved by the Ministry of Food and Drug Safety, and began to compete in the market in earnest. GSK's Fluarix Tetra is a representative imported vaccine that has been ranked at the top since its launch in 2015. However, it is expected to act as a variable in the competitive market as it does not participate in the quadrivalent flu vaccine NIP (National Immunization Program) project starting this year. On the 8th and 10th, the Ministry of Food and Drug Safety approved Fluarix Tetra PFS, an imported quadrivalent flu vaccine from GSK. As a result, the approval of most products expected to be sold this year was achieved. As the NIP began this week, the flu vaccine market entered a rebound competition. Among them, Fluarix Tetra is attracting attention as it is a quaternary vaccine aid and top-notch product. Fluarix Tetra was the first tetravalent vaccine to be launched in the domestic market in 2015. In Korea, it has been sold through Yuhan Corporation, and GC Pharma has been selling it since last year. Last year, sales amounted to ₩7.9 billion, followed by 'SKY Cellflu Quadrivalent (₩13.1 billion) by SK Bioscience and GC Pharma's 'GCFLU Quadrivalent (₩12.4 billion)'. The fourth place was Sanofi Aventis Vaxigriptetra with ₩4.6 billion based on IQVIA. Last year, it was pushed down to the third place after being pushed by domestic products, but from 2015 to 2018, it continued to be the number one. However, there are many variables this year. Above all, the tetravalent vaccine NIP starting this year is expected to have an impact. While most of the products participate in the NIP, Fluarix Tetra is only launching products in the market without NIP. Accordingly, it is unclear whether Fluarix Tetra will maintain its existing market share. It is also of interest how the sales company GC Pharma will conduct marketing through differentiation from its own 'GCFLU Quadrivalent'. For the first time, it is expected to take a dual strategy of actively promoting GCFLU Quadrivalent in the NIP, and putting the first tetravalent vaccine and imported product, Fluarix Tetra, in the market. However, as the price of products in the market is expected to decrease due to the participation of many products in the NIP, the price of which Fluarix Tetra chooses will also act as a variable. This year, the demand for flu vaccines is expected to be higher than ever due to the COVID-19 epidemic. The government also recommends influenza vaccination because COVID-19 and flu have similar symptoms, and confusion in quarantine is expected if they occur simultaneously. There are a total of 12 flu vaccines scheduled to be distributed in Korea this year. GSK and Sanofi are the only foreign pharmaceutical companies to import and sell flu vaccines.
- Policy
- GSK withdraws adult TD vaccine from Korea
- by Lee, Tak-Sun Sep 11, 2020 06:28am
- Green Cross TD vaccine successfully localized in 2016GSK will stop supplying the adult TD vaccine 'Td-pur', which was imported and sold in Korea. The company said there was no additional import after November 30. Until now, adult TD vaccines have been dependent on imports, but GC Pharma succeeded in localizing them in 2016. With GSK's supply discontinuation of Td-pur, the localization of GC Pharma is in the limelight. According to the MFDS, GSK announced the shutdown of the supply of TD-pur in July. TD-pur is an adult TD vaccine. It is a vaccine that prevents diphtheria and tetanus. Four adult TD vaccines are licensed in Korea. SK Td Vaccine Inj by SK Bioscience, Access Pharma's TD Booster SSI', 'Green Cross TD Vaccine PFS' by GC Pharma, and TD-pur by GSK have been competing. Among them, the only domestic product is Green Cross TD Vaccine PFS. It was approved for an adult TD vaccine made with its own technology in November 2016. This product is regarded as a case of successful localization by receiving consulting support from the MFDS since 2010. The MFDS at the time explained that the localization of the TD vaccine is expected to replace imports for 450,000 people every year. SK TD vaccine is a product that is imported from GSK Germany and sold as a finished product in Korea. In addition, DT Booster SSI is imported from Denmark SSI in finished form. With the withdrawal of GSK TD-Pur in Korea, the market will now compete for these three items. GSK said that it was unavoidable in the process of consolidating and overhauling the production line for business efficiency after the acquisition of Novartis Vaccine Division in 2015 due to the reason for the interruption of the supply of TD-Pur. In Korea, competitiveness has also been lost since the launch of Green Cross TDI vaccine. Last year, the sales of TD-Pur based on IQVIA amounted to about ￦300 million. On the other hand, SK TD vaccine and Green Cross TD vaccine ranked first and second with ￦1.9 billion and ￦1.3 billion. This year, the Green Cross TDI vaccine was ranked first for the first time. The cumulative sales in the first half of the year were ￦600 million for Green Cross TD vaccine and ￦460 million for SK TD vaccine. The domestic product has risen to the No. 1 market after 3 years of launch. The localization of Green Cross TD vaccine is shining even more with the withdrawal of TD-Pur from GSK. An industry insider said, "Since we can not guarantee a stable supply of imported vaccines as in this case of TD-Pur, there is no need to say the need for a domestic vaccine for the management of infectious diseases."
- Policy
- First drug for ultra rare Batten disease Brineura approved
- by Lee, Tak-Sun Sep 11, 2020 06:28am
- The first treatment for a pediatric rare disease, Batten disease, has received the South Korean health authority’s approval. As Batten disease is an inherited metabolic disorder that can cause loss of sight, the new treatment could give hopes to the patients and their families. Ministry of Food and Drug Safety (MFDS) has approved Brineura 150 mg injection, supplied by MediTip, on Sept. 8. The product is indicated to treat ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Recently, TPP1 or CLN2 is widely known as Batten disease. The disease is an inherited metabolic disorder, discovered by a Pediatric Doctor Batten in 1903. It is considered as an ultra rare disease with prevalence rate of one out of 100,000 in the U.S. Symptoms of Batten disease Symptoms, such as slow deterioration of eyesight, cognitive decline and behavioral change, would be expressed from age of four to 10. When the symptoms worsen, the patient could lose vision. The medication is injected with a catheter to cerebrospinal fluid once in two week. Developed by the U.S.-based BioMarin Pharmaceutical, Brineura won the U.S. Food and Drug Administration’s (FDA) approval as a first Batten disease treatment in April 2017. BioMarin Pharmaceutical is an emerging global pharmaceutical company specializing in rare disease treatment. For the Korean market, a healthcare consulting company MediTip applied and received the marketing approval on Brineura.
- Policy
- The MOHW’s new budget focuses on new drugs·COVID-19 trial
- by Lee, Jeong-Hwan Sep 10, 2020 06:23am
- While the budget plan of the MOHW for 2021 was released, it was found that the new budget focused on the treatment field, such as the national new drug development project and non-clinical support for COVID-19 treatment and vaccine. The new budget for the national new drug development project was ￦150.5 billion, and the new budget for non-clinical support for COVID-19 treatment and vaccine was ￦7.4 billion. In particular, compared to the previous year, the budget for clinical support for COVID-19 treatments and vaccines increased by ￦17.7 billion to ￦62.7 billion, and vaccines increased by ￦19.7 billion to ￦68.7 billion. Looking at the 2021 budget for the Ministry of Health and Welfare, Health Industry Policy Bureau of the Ministry of Health and Welfare on the 8th, 27.0% of the total ￦934.3 billion requested by the MOHW is adjusted to ￦79.37 million. Among them, the new net increase budget next year was ▲general government regenerative medical technology development project (R&D) ▲national drug development project ▲disease-centered mediation research project (R&D) ▲public interest medical technology research (R&D) ▲digital pathology-based Cancer-specialized AI analysis solution development project (R&D) ▲ Big data construction specialized for critically ill patients and AI-based CDSS development (R&D) ▲ Multilateral life research resource advancement project ▲ COVID-19 treatment/vaccine non-clinical support. What stands out are the national new drug development project and non-clinical support for COVID-19 treatments and vaccines. The national new drug development project, with a net increase of ￦15.1 billion, aims to become a competitive blockbuster new drug in the global market, and supports the entire cycle of new drug development from discovery of candidate substances to phase II clinical trials. It is conducted by the Ministry of Welfare, the Ministry of Science and ICT, and the Ministry of Industry, and the next year's budget is only reflected for six months, considering the preparation period for the first year. The main contents are the 'new drug base expansion research' budget of ￦3.93 billion, which aims to continue supplying excellent initial pipelines, and the'new drug clinical development' budget of ￦3.7 billion, to vitalize the entry of basic research results into the clinical stage. Non-clinical support for COVID-19 treatment and vaccine was allocated ￦7.4 billion. ￦6.4 billion is for non-clinical support, and ￦1 billion is for medical product evaluation support using advanced animals. ￦7.17 billion was allocated for the development of a digital pathology-based AI analysis solution specializing in cancer. It costs ￦2.62 billion for the expansion of the pathology data digital curation base, ￦1.68 billion for the development of a digital pathology data platform for AI development, and ￦2.62 billion for the development of intelligent pathology AI SW specializing in cancer. In addition, ￦6.41 billion was allocated for the regenerative medical technology development project of all ministries. It consisted of ￦1.98 billion for regenerative medicine source technology development, ￦2.64 billion for regenerative medicine-linked technology development, ￦702 million for regenerative medical treatment technology development, and ￦1,158 million for operating expenses. The government’s regenerative medicine technology development project secures core and source technologies in the field of regenerative medicine, and supports the development of linked technologies, treatments, and treatment technologies and early clinical application. The disease-centered mediation research project was allocated ￦3.63 billion, the public medical technology research project was ￦4,17 million, and the critically ill-specialized big data construction project was allocated ￦7.06 billion. The public medical technology research project aims to verify the concept and secure clinical basis by supporting the development of practical technology for solving public medical demand such as low birthrate, rare diseases, and patient safety. On the other hand, the MOHW has organized the budget for clinical support for COVID-19 treatment and vaccines, which is also higher than the previous year. In the case of clinical support for treatment, ￦62.7 billion was allocated, an increase of ￦17.7 billion (39.3%) from ￦45 billion, and vaccine clinical support was allocated ￦68.7 billion, an increase of ￦19.7 billion (40.2%) from ￦49 billion.
- Policy
- MFDS to shorten fast-track review by a month
- by Lee, Tak-Sun Sep 10, 2020 06:23am
- With the latest reorganization effective from Aug. 31, South Korea’s Ministry of Food and Drug Safety (MFDS) has formed ‘Fast-track Review Division’ and ‘Preliminary Consulting Division’ under National Institute of Food and Drug Safety Evaluation (NIFDS) to expedite the review process on innovative new drugs. The pharmaceutical industry is expecting the fast-track review on Korean-made new drug and incrementally modified drug (IMD) would expand as MFDS has added ‘new drug developed by Innovative Pharmaceutical Company’ to the expedited review subject scope. However, MFDS clarified only the drugs defined under the Article 58 of Pharmaceutical Approval Review Regulation are eligible for the fast-track review, which means even a new drug developed by an innovative pharmaceutical company may not be eligible for the fast-track review unless the regulation defines so. Recently, the pharmaceutical industry’s anticipation was heightened as MFDS newly established an operational plan to provide fast-track review on healthcare products meeting any one of following conditions—pharmaceuticals aiming to treat life-threatening diseases or severe diseases (including orphan drug or orphan drug in development), and have no alternative option or demonstrate efficacy significantly better than the existing option; pharmaceuticals aiming to prevent or to treat infectious disease with risk of threatening public health, such as bioterrorism or infectious disease pandemic (including outbreak of infectious disease with potential to develop as a pandemic), and have no alternative option or demonstrate efficacy significantly better than the existing option; new drugs developed by an innovative pharmaceutical company; rare medical devices; innovative medical devices; and innovative healthcare products with convergence technology. The MFDS operation plan would have the ministry to designate subjects for fast-track review among products the companies applied for. A MFDS official said, "The operation plan would cut the current fast-track review period by 30 days from 120 days and complete it in 90 days.” And the applicant may accelerate the commercialization by having a pre-review consulting and fully preparing for the review without submitting supplementary materials. The Korean pharmaceutical industry seems to be anticipating on adding ‘new drugs developed by innovative pharmaceutical company’ as subject for the fast-track review. So far, 31 companies—mostly Korean companies like Hanmi Pharmaceutical and Yuhan—are designated as ‘innovative pharmaceutical company.’ Moreover, MFDS elaborated IMDs could also be designated to take the fast-track review. Such MFDS regulation on fast-track review is nothing new. But such specific application procedure for pharmaceutical company did not exist. The fast-track review regulation is described in Article 58 of the Pharmaceutical Approval Review Regulation According to the regulations, companies with following pharmaceuticals may apply for the fast-track review—pharmaceuticals with treatment efficacy expected on life-threatening or severe diseases such as AIDS or cancer; urgently needed pharmaceuticals due to existing treatment options unable to treat or tend to develop resistance; and pharmaceuticals the Minister of Food and Drug Safety deems necessary for patient treatment or industrial development, such as anticancer treatment, orphan drug and DNA chip. Some of evidential materials can be submitted after the market release, and the review process can be prioritized to accelerate the procedure. Moreover, the regulation clarifies, the fast-track review would be accessible to pharmaceuticals meeting the following conditions—new drug or IMD; pharmaceuticals submitted evidence on clinical trial outcome conducted in South Korea; pharmaceuticals underwent preliminary review on evidential material submission standards regarding toxicity, pharmacology test, and clinical outcomes according to the Article 35-2; pharmaceuticals, applicable by Item 3 of Paragraph 2 of Article 25, that submitted common technical document (CTD) according to Paragraph 1 of Article 6. But as the fast-track review is not stipulated in the Pharmaceutical Affairs Act, the ministry would have limitations in expanding the system. Regarding the limitation, the ministry is in process of supporting a lawmaker’s bill. On the contrary, fast-track reviews on cell and gene therapies are stipulated under the recently legislated Advanced Regenerative Medicine and Biopharmaceutical Act. The newly established Fast-track Review Division would not handle pharmaceuticals managed under the Advanced Bio Act, but the Cell and Gene Therapy TF Team would process their fast-track review under the new law. For the time being, the Fast-track Review Division plans to prioritize and review COVID-19 treatments and vaccines over other subjects. A MFDS official noted, "The COVID-19 treatment and vaccine would be processed first,” and “the fast-track review subjects stated by the operational regulation would be processed under the Article 51 of Pharmaceutical Review and Approval Regulation." Meanwhile, MFDS plans to hold an online seminar on the issue from Sept. 9 to 10 to inform about the preliminary consulting and fast-track review system and related procedure in detail.
- Policy
- Kang Do-tae & Jeong Eun-Kyeong were promoted
- by Kim, Jung-Ju Sep 09, 2020 05:49am
- Kang Do-tae, the current head of the Planning and Coordination Office (51, Seoul National University, Master of Public Administration), was appointed as the first multiple vice minister to lead the health sector of the Ministry of Health and Welfare. The next Vice Minister, Kang Do-tae, the first multiple Vice Minister of the MOHW, is in charge of all areas of the health sector encompassing the pharmaceutical industry within the Ministry of Health and Medicine, including health care and medicine. In addition, the first director of the Korea Disease Control and Prevention Agency (KDCA), who is promoted to a central administrative agency, succeeds and continues the head of the Korean Centers for Disease Control and Prevention Jung Eun-kyung (56, MD & Ph.D Preventive Medicine of Seoul National University ) Through a briefing on the afternoon of the 8th, Cheong Wa Dae announced the new members of the Ministry of Health and Welfare and the KDCA, which are reorganizing the government in accordance with the partially amended laws of the Government Organization Act. First, Kang Do-tae was appointed as the second vice minister of the Ministry of Health and Welfare, the current head of the Planning and Coordination Office. Vice Minister Kang was a graduate of the 35th Public Administration Examination, and has been in charge of policy practices in various fields in the field of health, including the Welfare Administration Support Officer, the Health and Medical Policy Officer, and the Health and Medical Policy Officer at the Ministry of Welfare. When the new Vice Minister Kang is appointed, the Ministry of Health and Welfare plans to reinforce the health care policy capacity by reinforcing 3 departments and 44 people to implement more active health care policies. As expected, the first head of the KDCA, which is promoted from the headquarters unit to the central administrative agency, is Jeong Eun-Kyeong, the current head of the KCDC. She was from Department of Medicine, Seoul National University and worked as a health researcher at the Ministry of Health and Welfare to gain administrative experience. Afterwards, she served as the head of the emergency medical department and the head of the disease policy department of the MOHW, and then served as the head of the KCDC and the Head of the Emergency Situation Center, gaining high knowledge and experience in responding to infectious diseases. It is evaluated that the rapidly evolving performance was remarkable while promptly and accurately commanding the response to the COVID-19 incident. As a result, she is the head of the organization that conducts full-cycle management from Korea's infectious disease monitoring and research, health crisis response and prevention, while leading a total of 1,476 personnel from the 5 Bureaus 3 Offices and 41 divisions at the National Disease Administration, which will be launched in earnest on the 12th.
- Policy
- How Tenelia latecomers lost chances in preferential sales
- by Lee, Tak-Sun Sep 08, 2020 06:11am
- Although Kyungdong Pharmaceutical first received approval on antidiabetic Tenelia’s incrementally modified drug (IMD), the drug is apparently not eligible for the preferential sales right given to the generic market. Regardless of the preferential right, any Tanelia IMDs that successfully evaded the original’s salt base patent can be launched at the same time. And as the stepped drug pricing system stipulates, the first 20 items approved would also receive premium pricing benefit. According to the industry sources on Sept. 7, the first IMD to have applied for the government approval after evading Tenelia's salt patent and the expiration of the original’s post-marketing surveillance (PMS) period, was not eligible for the preferential sales right to begin with . In order to win the preferential sales right, a drug first has to either request for the first patent trial (or requested within 14 days from the first trial date), or to conclude the patent trial before the first company to request the trial. The second prerequisite condition is to win the patent challenge, and the third is to be a first to apply for the item license. Kyungdong Pharmaceutical’s IMD ‘Teneritine 20 mg tablet,’ approved as of Sept. 4, has met the second and third conditions. But it turns out that the drug has failed to meet the first condition. The original Tenelia has a substance patent, expiring on Oct. 25, 2022, and a salt-base patent, expiring on Feb. 17, 2026. Besides the substance patents the Korean pharmaceutical companies lost at a trial, the follow-on drug companies attempted to challenge the salt-base patent. The first patent challenges were made by Hana Pharm and Intro Biopharma. Hana Pharm first filed a patent trial on Apr. 10, 2015 to nullify Tenelia’s salt-base patent. The two Korean companies are currently developing drugs identical to Tenelia with same active pharmaceutical ingredients and salt base. Meanwhile, pharmaceutical companies with IMDs filed their first patent challenge on Oct. 19, 2018, three years after Hana Pharm’s trial. Kyungdong Pharmaceutical requested for a negative confirmation of patent right scope to evade the original’s patent. In order to acquire the preferential sales right, the IMD companies have to fulfill the prerequisite conditions. The first condition was to complete the legal proceedings before Hana Pharm. The possibility was still open as the Intellectual Property Trial and Appeal Board prioritizes the negative confirmation of patent scope. Unfortunately, however, the final decision on the IMD’s patent evasion was made on the same day as the patent invalidation trial with Hana Pharm and Intro Biopharma. Both trials on patent evasion and invalidation were concluded on Dec. 31 last year. Immediately after trial, the IMD companies applied for both item approval and preferential sales rights, but the Ministry of Food and Drug Safety (MFDS) reportedly denied the application due to the incomplete fulfillment of the prerequisite conditions. If the IMD trial decision was made even a day earlier, Kyungdong Pharmaceutical and other IMD companies would have acquired the preferential sales rights effective from Oct. 26, 2022. Although Hana Pharm and Intro Biopharma have requested the first patent challenge and met the requirements for a successful patent challenge, they failed to apply for the government approval on the day after when Tenelia's PMS ended on Apr. 29. As a result, none of Tenelia's latecomers would have the preferential sales rights. Nevertheless, the first 20 items to be licensed would receive premium pricing, according to the stepped drug price system. The said Korean companies may have failed to win the preferential sales rights through patent challenge, but at least the follow-on drugs would obtain the premium pricing benefit as long as their development speed is fast enough. Meanwhile, Tenelia is a seventh dipeptidyl peptidase 4 (DPP-4) inhibitor released in the South Korean market. Developed by the Japanese-based Mitsubishi Tanabe Pharma, Handok has licensed the sales rights in the Korean market. UBIST reported the drug has made 9.5 billion won from the outpatient prescriptions in the first half of this year.
- Policy
- NA burdened as dispute continues despite Gov-KMA agreement
- by Lee, Jeong-Hwan Sep 08, 2020 06:11am
- As the dispute among medical community is deepening regardless of South Korea’s Ministry of Health and Welfare (MOHW) and Korean Medical Association (KMA) settling on an agreement, the National Assembly is now burdened with a grave responsibility to deliver the agreed terms and to fairly execute the medical reform plan. The Young Doctors’ Emergency Committee representing medical interns, residents and fellows initially intended to protest against the government-medical organization agreement and to continue the collective strike. But they decided to temporarily suspend the strike and return to their jobs on Sept. 6. Nevertheless, the committee stresses the possibility of the young doctors going on a strike again at any time, if need be. The ruling and opposition parties have agreed on establishing a Special Medical Reform Committee under the National Assembly. Now, the both parties are expected to fully implement the agreement, and to calm the public and patient concerned about the agreement impeding the medical reform policy. On Sept. 6, the National Assembly seems to be carefully observing the medical community’s reaction to the agreement signed between the government and the medical organization. Especially, Chair Han Jeongae (Democratic) of Health and Welfare Committee, leading the mediation between the government and the medical professionals, is inevitably trying to read the air in political parties, civic and patient advocacy groups, as well as the medical community. Some of the Democratic Party lawmakers have criticized KMA won the battle against the government, while civic and patient groups are reprimanding the ruling party for waving the white flag to doctors on strike that took patients as hostage. Lawmaker Han said, "I disagree with the criticism that the ruling party raised the white flag. Rather, the party has raised the white flag to the people and patients," and “The lawmakers would continue to discuss the issues regarding the medical reform. And we would do our best to improve policies and regulations to execute measures stated on the government-KMA agreement.” The Young Doctors Emergency Committee, centering the Korean Intern Resident Association (KIRA), has decided to temporarily hold back on the resistance against the agreement and to report back for duty. However, the committee is firmly expressing its intention to take the collective action again as they would closely follow up with the lawmakers’ further support for the agreement. The young doctors are willing to go on the nationwide strike again immediately, if the government and the National Assembly fail to keep their promises with the medical community. The National Assembly is ultimately relieved the doctors halted the strike, but at the same time they now have serious task in their hands. Particularly, the public’s attention would be focused on the Special Medical Reform Committee’s prospective approach as it would consist of both the ruling and opposition parties. The initial implication the Special Committee would face is whether the committee would operate centering the ruling and opposition parties, or include the government and medical representatives. An official from a ruling party lawmaker's office noted, “The ruling party was taken back for a moment as the medical interns, residents and fellows opposed so strongly, when KMA, Democratic Party and the government signed the agreement," but “with the agreement, the government, medical community and the lawmakers can now come together to overcome the COVID-19 epidemic. The discussion on the medical reform can start from the scratch after we overcome the crisis.” The same official elaborated, "What the National Assembly can do right now is to form the Special Medical Reform Committee to sufficiently collect opinions from the medical community and the government." An official from the opposition party lawmaker also stated, "The party believes the lawmakers have done their job. The ruling and opposition parties have agreed on the urgency of halting the medical reform talks and returning the doctors for their duty. And also we are seeing eye-to-eye on arbitrating between the government and the medical community.” The official added, "The National Assembly cannot do anything about the conflict within the medical community escalated since KMA signed the agreement. It is the medical community's job to arbitrate the conflicted community. There is limitation to what lawmakers can do for them."
- Policy
- There is no disadvantage in the long-term Rx due to COVID-19
- by Lee, Hye-Kyung Sep 08, 2020 06:11am
- It has been emphasized once again that there are no disadvantages for appropriate long-term prescriptions within the scope of medically recognized health authorities. It has been clarified that it will not cut down on necessary and appropriate long-term prescriptions so that medical institutions can actively respond to medical gaps due to doctor strikes. The HIRA's Drug Standards Department recently announced a request for cooperation in response to the spread of COVID-19. The amount of work of pharmacists following the preparation of long-term prescriptions for more than 91 days, published in a research report conducted by the pharmacist society In addition to active treatment for the prevention and spread of COVID-19 at each medical institutions, it was made possible for the public to receive health insurance coverage even in the event of an infectious disease crisis. In the request for cooperation, it was stated that there was no disadvantage in the case of long-term prescriptions necessary and appropriate within the scope of medically recognized, excluding drugs for which the number of days of prescription was determined in accordance with the relevant regulations (psychiatric solutions, etc.). Relevant regulations include notification of details on the application standards and methods of medical care benefits, notification of details on application standards and methods of medical treatment benefits for drugs prescribed and administered to cancer patients, and approval from the MFDS. On the other hand, although the health authorities recognize appropriate long-term prescriptions to strengthen coverage, there is no pharmacists' compensation for dispensing fees due to long-term prescriptions, so increasing the work of pharmacists will be inevitable. It has been pointed out that the current pharmacy dispensing fee limits the number of dispensing days to 91 days, so it does not reflect the increase in the pharmacy's workload due to the increasing trend of long-term prescriptions. In addition, with the spread of COVID-19 and face-to-face treatment, long-term prescriptions by medical institutions are rapidly increasing, but there is no discussion on an appropriate compensation system. Looking at the 'Work Volume Relative Value Development Study for the Third Relative Value Reorganization' conducted by the Korean Pharmaceutical Association through the external research service of the HIRA, it is prepared for 91 days or more by properly reflecting the form, scope, and level of the dispensing service. There is a need for a drugstore dispensing fee calculation system such as subdividing the number of days.
