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- 2026-05-18 18:57:48
- Policy
- Opdivo's RSA renewed… benefit extended for use with Yervoy
- by Lee, Hye-Kyung Aug 17, 2021 05:52am
- ‘Opidivo inj. (nivolumab),’ the first cancer immunotherapy approved in Korea has successfully extended its contract ahead termination of its risk-sharing agreement (RSA) term. In addition to Opdivo, the breast cancer treatment ‘Kisqali (ribosiclib) was also included in the list of drugs that completed negotiations with the National Health Insurance Service (NHIS) that was recently disclosed by NHIS. The RSA contract term for Opdivo, which was granted reimbursement through the RSA scheme since August 21st, 2017, was set to expire by August 20th this year. Before expiry, Ono Pharma Korea and Bristol-Myers Squibb Korea Pharmaceutical had applied to the NHIS to extend Opdivo's RSA contract and to expand reimbursement for its use in combination with ‘Yervoy(ipilimumab)’ in first-line kidney cancer. The combination of the PD-1 inhibitor Opdivo and CTLA-4 inhibitor Yervoy was approved as a first-line treatment for renal cell carcinoma (RCC) in August 2017. The indication passed NHIS’s Cancer Disease Deliberation Committee review in June last year. In April this year, 9 months after the CDRC review, the combination’s indication for the ‘treatment of patients with moderate- and high-risk, previously untreated advanced renal cell carcinoma (RCC), was recognized appropriate for reimbursement by HIRA’s Cancer Drugs Benefit Appraisal Committee. Since then, the company has been in pricing negotiations with the NHIS. However, in the first 60-day negotiation period, negotiations fell through with the NHIS and pharmaceutical companies being unable to reach an agreement. The two parties finally signed an agreement in the second negotiation that followed. Specifics of the RSA extension for Opdivo and use in combination with Yervoy will be disclosed after amendments to the notice are deliberated and passed by the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee. In addition to Opdivo, the NHIS announced that it had also completed negotiations for Kisqali. Kisquali is approved in combination with an aromatase inhibitor in pre-, peri-, post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer; or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
- Policy
- SK Chemical will sell Zemplar
- by Lee, Tak-Sun Aug 17, 2021 05:52am
- The original Zemplar (Paricalcitol) will be sold by SK Chemical in Korea. It is imported and supplied by AbbVie Korea, and SK Chemical has been in charge of distribution, sales and marketing in Korea since July. SK Chemical is expected to compete fiercely with generic companies. According to industries on the 12th, SK Chemical has been distributing and selling AbbVie's Zemplar in Korea since July. Sales of Zemplar ampules, which had previously been distributed, were discontinued. Zemplar is used to treat and prevent secondary parathyroidism associated with chronic renal failure. It is especially used to treat complications in dialysis patients. Last year, IQVIA was sold at ₩7.9 billion, which is widely used in dialysis complications markets along with Kyowa Kirin Korea's Regpara. Last year, generic for Zemplar was launched for the first time in Korea. Boryung's Pacitol was granted permission on January 30 last year. Pacitol has been on sale since April of that year. As of last year's IQVIA, sales amounted to ₩1.3 billion. Since then, Huons' Hucitol has expanded its consignment production with permission. This change in Zemplar's domestic sales company is interpreted as a response to the generic's offensive. Its strategy is to win the competition with Generic through SK Chemical, which has a well-established distribution network in Korea. The reason why the ampule formulation was discontinued is because of the lower price due to the launch of generic products. Zemplar ampule formulation was twice as expensive as vial formulation, but since April, when generic items were released, both original and generic have become the same price. As a result, competition between original and generic companies is expected to intensify.
- Policy
- GBP510 has been approved for Phase 3, the 1st time in Korea
- by Lee, Tak-Sun Aug 17, 2021 05:52am
- Domestic developed COVID-19 vaccine has entered the final stage of commercialization. A candidate for the COVID-19 vaccine developed by SK Bioscience will conduct phase 3 clinical trial. The MFDS announced on Tuesday that it approved phase 3 clinical trial plan for the first domestic COVID-19 vaccine after thoroughly verifying its safety and scientific feasibility. With the approval, COVID-19 vaccine developed by a Korean company will enter phase 3 clinical trial for the first time. GBP510 is a recombinant vaccine that injects surface antigen protein of the coronavirus created using genetic recombination technology to induce immune response, stimulating immune cells in the body and neutralizing and eliminating the virus when it enters the body. This vaccine has been developed to enhance immune effectiveness by generating a large number of antibodies, especially by utilizing techniques that increase antigen exposure. The three-phase clinical trial approved this time is a clinical trial to evaluate the immune origin and safety of GBP510 for adults aged 18 and older. phase 3 clinical trial is conducted in a comparative clinical manner using Astrazeneca COVID-19 vaccine stocks, which are licensed in Korea and used for vaccination, as a control group. As a control group, AstraZeneca COVID-19 Vacine was selected, considering the absence of a licensed COVID-19 recombinant vaccine. and was designed to confirm the superiority of neutral antibodies and the non-equivalence of serum reactions. Neutralized antibodies are the amount of antibodies that can neutralize a particular virus, and the serum reaction rate is the percentage of test subjects whose antibody price increases more than four times compared to before vaccination. The total number of test subjects is 3,990, 3,000 for the test vaccine, and 990 for the control group will be vaccinated twice every four weeks with 0.5 mg each, and safety and immunogenicity will be evaluated. Phase 3 will be conducted simultaneously not only in Korea but also in Southeast Asia and Eastern Europe. Phase 3 clinical trial is a test to verify the safety and validity of a drug, and its validity is reviewed based on the results of a prior clinical trial, quality of a clinical drug, non-clinical data, etc. In the case of GBP510, phase 2 is currently in progress, but phase 1 showed sufficient safety and immunogenicity, showing the possibility of entering phase 3. After phase 1 and phase 2 was approved on January 26, a phase 1 clinical trial was conducted on 80 healthy adults (ages 19 to 55 years old) and a phase 2 clinical trial is underway on 240 people. As a result of phase 1 intermediate analysis, neutralized antibodies were produced in all vaccinators in terms of efficacy, which was more than five times higher than that of the International Standard Serum (perfection and autoclave). No special side effects have been reported other than cases (injection pain, fatigue, muscle pain, headache, etc.) that are common when vaccinated. In addition, the MFDS explained that it reviewed non-clinical test data such as reproductive toxicity and animal model attack tests, and quality data such as batch analysis results. The MFDS held an advisory meeting with clinical experts on the 9th and consulted on the appropriateness of the evidence data and feasibility of the clinical trial plan to enter phase 3. The MFDS said the approval of the clinical trial is meaningful that it has taken the first step toward self-sufficiency of the domestic vaccine as the first domestic vaccine enters phase 3 amid the coronavirus epidemic. Even though there is no global vaccine leader, it approved phase 3 clinical trials for the development of the COVID vaccines in Korea, and even before the establishment of the Immunological Correlate of Protection (ICP), it introduced a comparative clinical method with active and close screening. Immunological Correlate of Protection(ICP) is most commonly defined as a type and amount of immunological response that correlates with vaccine-induced protection against a clinically apparent infectious disease and that is consider The MFDS stressed that it will continue to communicate with the clinical site after the product's clinical approval so that clinical trials can proceed smoothly, and other products that are undergoing clinical trials in Korea can quickly enter phase 3. It also added that it will thoroughly monitor safety issues such as unexpected adverse reactions of clinical trial participants and medication information that affects clinical trials, and make sure clinical trials are carried out safely.
- Company
- Reimb. to be expanded for PARP inhibitor Lynparza and Zejula
- by Eo, Yun-Ho Aug 13, 2021 05:58am
- The PARP inhibitors ‘Lynparza’ and ‘Zejula’ both crossed the last hurdle in extending their insurance benefits. According to industry sources, AstraZeneca Korea and Takeda Pharmaceuticals Korea have both completed drug pricing negotiations with the National Health Insurance Service (NHIS) to expand their PARP (poly ADP ribose polymerase) inhibitor Lynparza (olaparib) and Zejula (niraparib)’s indications to first-line maintenance treatment in ovarian cancer. Negotiation for the two drugs concluded at the same time because Lynparza’s negotiation period had been extended once. Upon passing the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee meeting this month, the insurance benefit of the two drugs is expected to be extended without difficulty. The approvals are also expected to quickly translate into actual prescriptions. In April, AstraZeneca has already completed the landing procedures for the Lynparza tablet formulation that will be used for the new extended indication in the ‘Big 5’ general hospitals - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital. Zejula’s formulation does not differ by indication, therefore, its prescription code has already been inserted in most medical institutions. However, the expanded reimbursement coverage will not benefit the BRCA-negative patients that account for 80-90% of the total ovarian cancer population. The Lynparza tablet had been approved as a maintenance treatment in the BRCA-positive patient population from the start. Zejula had applied for an ‘All-Comer’ indication regardless of the BRCA mutation status, however, HIRA’s Cancer Disease Deliberation Committee only approved the BRCA-positive indication. Faced with the high barrier to reimbursement, Takeda Pharmaceuticals decided to take the safe road and be first listed for the BRCA-positive indication. Lynparza and Zejula both own the BRCA-negative indication as a second-line or later maintenance therapy, however, reimbursement for these indications was not passed yet. Professor Jae-won Kim of the Obstetrics and Gynecology Department at SNUH said, “Using a drug as maintenance therapy in the first-line and second-line or higher-line is very different, and using the drug earlier will increase the rate of survival. Personally, I believe that coverage for the PARP inhibitors as maintenance treatment should be extended to benefit as many patients as possible in the first-line.” Zejula was first listed for insurance benefit at ₩76,400 under the Risk-sharing agreement (RSA) scheme, and was determined cost-effective over its substitute, Astrazeneca’s ‘Lynparza (olaparib).’ However, as Lynparza was listed through the PE exemption track, both were applied the RSA Expenditure cap type of reimbursement.
- Opinion
- [Reporter's view] Unstable supply of imported vaccines
- by Lee, Tak-Sun Aug 13, 2021 05:58am
- Moderna's unstable supply and demand disrupted the vaccination. Moderna's vaccine was originally scheduled to come in 8.5 million doz in August, but Moderna informed that it would supply less than half of the vaccine due to laboratory problems related to production. As a result, not only Moderna but also the first and second vaccinations of the same mRNA vaccine, Pfizer vaccine, will temporarily increase inoculation interval from four weeks to six weeks. The quarantine authorities, which are preparing for the final vaccination in their 40s or younger due to the sudden supply disruption notice by Moderna, are also in trouble. However, since Pfizer vaccine is being supplied properly, it is expected that there will be no change in the primary vaccination plan for 70% of the nation until September. However, it is not known when the second vaccination will proceed normally because the supply and demand of modalities or vaccines will be resolved.. AstraZeneca vaccine is produced at SK Bioscience' Andong plant by several million doz at a time. It is much more stable in terms of supply and demand than Pfizer and Moderna vaccine, which are imported by airplanes below 1 million doz per week. The quarantine authorities used the amount of AZ vaccine contracted because the number of people aged 60 to 75 exceeded 10 million. However, since all of them are imported vaccines except for AZ, we should have prepared for possible supply accidents. It is the quarantine authorities that have not used the AZ vaccine well. In February, when AZ vaccine was first approved, the MFDS allowed the elderly to be vaccinated despite a lack of clinical data, but quarantine authorities failed to ensure administration of the age of 65. Since then, data has been accumulated abroad such as the UK, allowing vaccinations for older people aged 65 or older, but the government has decided to vaccinate the elderly aged 75 or older. In April, people under the age of 30 were excluded from the inoculation list due to rare thrombosis, and in July, people under the age of 50 were not allowed to be inoculated. As a result, those under the age of 50 who took the first AZ vaccine before July will be cross-inoculated with Pfizer vaccine during the second round. Such inoculation policies are largely responsible for the unstable public opinion and quarantine authorities created by the media. Of course, there are some reflections that reflect cases from other countries such as advanced countries, but it is questionable whether the conclusion was made based on public opinion rather than science. Although AZ vaccine played a role in preventing infectious diseases among the elderly, the quarantine authorities should reflect on the fact that it is recognized as the next-order mRNA vaccine due to negative public opinion. Also, for those aged 50 and 75 and older who can use AZ vaccine, it was changed to Moderna and Pfizer respectively, which prevented the use of AZ vaccine produced in Korea. If AZ had been used for these age groups according to the inoculation criteria, it would have dealt with both modalities and supply and demand instability. Quarantine authorities should think about the utilization of AZ vaccine. Although there are no vaccines developed in Korea yet, it is fortunate that there are vaccines produced in Korea. If the supply of imported vaccines such as Moderna is uncertain, it should take advantage of the fact that AZ domestic vaccine is being secured.
- Company
- Alvogen is targeting patents for Roche's Avastin
- by Kim, Jin-Gu Aug 13, 2021 05:58am
- Avastin Alvogen Korea has started patenting Roche's blockbuster anti-cancer drug Avastin (Bevacizumab). Two types of Avastin biosimilar are already licensed in Korea. According to the pharmaceutical industry on the 12th, Alvogen Korea recently filed an invalid trial on Roche's two patents of Avastin. Roche is registering a total of four patents with Avastin, including one material patent and three use patents. Material patent registered in Korea has already expired in April 2018. Two out of three patents are related to ovarian cancer treatment, and the other one is related to combined therapy. There are two patents related to single therapy that Alvogen is targeting. If Alvogen overcomes this patent, it will be able to release its product in Korea. Two Avastin biosimilars have been licensed so far. Samsung Bioepis' Onbevezy and Pfizer's Jairabeve. Boryung was in charge of domestic sales of Onbevezy. Both companies are expected to officially release them in the second half of this year. More companies are competing in the global market. Mvasi, co-developed by Amgen and Allergan, is competing with Avastin. In addition, Boehringer Ingelheim, Biocon, Astrazeneca, Kyowa Kirin Korea, Celltrion, Prestige BioPharma, and others are developing biosimilars. Avastin is used for metastatic colon or rectal cancer, non-squamous, non-small cell lung cancer, metastatic breast cancer, glioblastoma (GBM), metastatic renal cell carcinoma. As of 2019, it recorded about ₩8.8 trillion in sales in the global market. It recorded ₩118 billion in sales in the domestic market last year.
- Policy
- “Mooncare a success…37 million people saved ₩9 tril.
- by Lee, Jeong-Hwan Aug 13, 2021 05:57am
- President Moon Jae-in said the government will continue and accelerate its efforts to further broaden the NHI coverage in 2022 as in this year. Moon also stated that 37 million people in Korea were able to save a total of 9.2 trillion won in medical costs during the 4 years since Mooncare was implemented. Also, he personally announced that insurance benefits on thyroid and sinus ultrasounds will be applied in Q4 of this year, which is earlier than planned, and NHI coverage will be extended to severe heart diseases, psoriasis, and root canal treatment by next year. The news was announced by President Moon at the ‘Performance review meeting for the 4th anniversary of Mooncare’ that was held on the 12th. He assessed that Mooncar, which was announced in 2017, has played an integral part in realizing the goal of building a nation free from worries about hospital bills while exceeding the target level of health insurance reserves. Moon's understanding was that Mooncare is one of the policies that the people were most satisfied with. As such, the president plans to further broaden and accelerate the NHI coverage enhancement policy. Specifically, he pledged to implement NHI coverage to sinus and thyroid ultrasounds from Q4 this year, and to severe heart diseases, psoriasis, and root canal treatment by the next year. In addition, Moon said the government will expand support for children's public centers and establish a short-term hospitalization service center for severely ill pediatric patients to expand NHI support for children. Also, the government plans to designate a regional hospital as a base hospital for critically ill patients from the second half of this year so that the severely ill may receive treatment in hospitals near their residence. Furthermore, President Moon said that the health insurance will prime and accelerate the development of medical technology in Korea and that the government will make the effort to catch both birds – of securing NHI’s sustainability and expanding coverage. “Mooncare not only tended to disease of individuals, but it also allowed us to promptly and appropriately respond to all areas of healthcare related to infectious diseases, from prevention and diagnosis of COVID-19, its treatment expense, to securing support for medical personnel. In other words, NHI well-played its role as the last defender in controlling the COVID-19 crisis. I would like to express my gratitude to the NHIS and medical personnel for their efforts in strengthening NHI coverage.” The president continued, "The government had focused on enhancing coverage for severe diseases that bring a high medical burden such as cancer. We are also in the progress of abolishing the selective consultation fee system, applying insurance to upper-grade wards, expanding the integrated nursing care service, expanding insurance to MRIs and ultrasounds, and reimbursing non-reimbursed drugs. Also, we will institutionalize disaster medical expenses support for 4 major severe diseases in low-income families, and cover up to 30 million won for all diseases and lower the annual copayment ceiling.” “We enhanced the coverage rate for children who are 5 years or younger, as well as for seniors 65 years and older that more frequently visit hospitals. As a result, 37 million people have saved a total of 9.2 trillion won in medical costs. As a high level of citizenship is central to NHI’s sustainability, the government will make efforts to more transparently manage NHI finances.” MOHW·NHIS "will continue enhancing coverage next year” The Ministry of Health and Welfare and the National Health Insurance Service also added on details to support Moon’s performance report on Mooncare. In 2017, the MOHW had presented measures to lower the patients’ burden by reimbursing the medically necessary non-reimbursed items and drastically reducing the medical cost for the underserved population such as the elderly, children, women, and low-income families. ‘ The coverage enhancement measures that were planned to be implemented by 2022 focused on the following three core areas:▲reimbursing the non-reimbursed ▲relieving out-of-pocket costs for the underserved population ▲reinforcing the medical safety net. To reimbursee the non-reimbursed the authorities had abolished the selective consultation fee, and applied insurance to 2-person and 3-person wards in hospital levels or higher medical institutions. The integrated nursing care service was also expanded by over two times. Also, the non-reimbursed items that are necessary for treatment such as ultrasounds and MRI tests were applied insurance in phases to reduce the medical cost. As a result, NHI coverage in tertiary hospitals increased from 65.1% in 2017 to 69.5% in 2019, and coverage in general hospitals also increased from 63.8% to 66.7% during the same period. By easing the medical cost borne by the underserved population, the burden of hospital expenses for children, the elderly, the disabled, and women were reduced. For children, the copayment rate of the hospital treatment cost was reduced to 5% from 10-20%, and the outpatient cost was also reduced for children under the age of 1. The copayment rate for outpatient cost in premature infants and low birth weight infants was also reduced, and insurance was applied to cavity treatment, cleft lip treatment, and orthodontic braces treatment. For the elderly, the copayment rate for the treatment of severe dementia and other major conditions such as dentures and implants was lowered. For the disabled, eligibility in receiving reimbursement for assistive devices was expanded, and the reimbursed amount for prosthetic legs and hands was raised. In addition, in order to strengthen the medical safety net, the upper ceiling of the out-of-pocket cost paid by the bottom 50% of the income class was reduced to a level near 10% of their annual income, thereby increasing the reimbursed amount for low-income families. As a result, about 37 million people saved 9.2 trillion won in medical cost reduction from 2018 to 2020. Positive responses from the public regarding the coverage enhancing measures also jumped from 39.7 % at the time the policy was announced to 94% in August 2020.
- Policy
- Regkirona's indication expansion has been requested
- by Lee, Tak-Sun Aug 13, 2021 05:57am
- Celltrion's COVID-19 antibody therapy Regkirona is pushing for an expansion of indications based on global phase 3. Regkirona was conditionally approved to submit a clinical trial result report for therapeutic confirmation in February and was used only in patients with mild to secondary COVID groups. Celltrion submitted a report on the results of the clinical trial and applied for a change in efficacy from all mild cases over the age of 12 to secondary patients. The MFDS announced on the 10th that Celltrion has applied for a change in permission of the COVID-19 antibody treatment drug Regkirona (Regdanvimab) based on a global phase 3. Changes include ▲ deletion of permission conditions ▲ expansion of effectiveness ▲ reduction of time spent. Celltrion submitted a clinical trial report on August 10, which should be submitted by December 31. Regkirona's effectiveness was conditionally granted only for "improvement of clinical symptoms in patients with mild to secondary COVID-19" in high-risk groups, but it was changed to "treatment for patients with secondary COVID-19 in adults and 12 years of age and older." Celltrion also requested a change in administration time from IV for 90 minutes to IV for 60 minutes. "We plan to quickly and closely examine the application for the change," said an official at the MFDS. "We will continue to do our best to provide safe and effective treatments to our people quickly," he stressed.
- Company
- SGLT-2 inhibitor Forxiga lands in Korea with CKD indication
- by Eo, Yun-Ho Aug 12, 2021 06:05am
- An SLGT-2 inhibitor is soon expected to be available for use in chronic kidney disease (CKD) patients in Korea. According to industry sources, the indication of AstraZeneca’s diabetes treatment ‘Forxiga(dapagliflozin)’ will be expanded to ‘the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes' within a few days. After receiving approval from the US FDA in April, the company had immediately begun the approval process in other major countries including Korea. In September, the company received EMA approval for the additional indication in September. With the indication, Forxiga can be used to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or hospitalization for HF (hHF). The approval of Forxiga’s CKD indication is based on positive results from the DAPA-CKD Phase III trial. The FDA had granted Priority Review for Forxiga earlier this year. In the DAPA-CKD trial, Forxiga reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39% compared to placebo in patients with CKD Stages 2-4 and elevated urinary albumin excretion (UAE) levels. The absolute risk reduction of Forxiga was 5.3% in the 2.4 year median study period. CKD is a progressive condition that affects around 700 million patients around the world. With only a limited amount of treatment options available for CKD patients at present, a new treatment option had been necessary in the field as CKD increases the incidence of cardiovascular events such as heart failure and the risk of premature deaths. Forxiga is currently used as a treatment for Type 2 diabetes and chronic kidney disease. Its competitor, Boehringer Ingelheim’s ‘Jardiance (empagliflozin)’ also received the fast-track designation in the first half of last year and the company is conducting the EMPA-KIDNEY trial to expand the drug's indication like Forxiga. Unlike Forxiga’s DAPA-CKD trial, Jardiance's EMPA-KIDNEY trial includes severe CKD patients.
- Policy
- With Ultomiris, 9 items require prior approval for reimb.
- by Lee, Hye-Kyung Aug 12, 2021 06:05am
- Improvements are expected to be made to the ‘pre-approval' system that may be actively used in the process of reimbursement listings for ultra-high-priced drugs. Starting with the stem cell transplantation procedure in 1992, the Health Insurance Review and Assessment Service (HIRA) has been operating the pre-approval system to deliberate in advance whether an insurance benefit should be applied to high-risk, high-cost, irreplaceable drugs and procedures. With the most recent addition of ‘'Ultomiris inj.,’ a total of 9 items are on the list for deliberation for pre-approval of insurance benefits. The other 8 include ▲ Stem Cell Transplantation; ▲ Immune Tolerance Induction; ▲Soliris Inj. ▲ Implantable Cardioverter Defibrillator& Cardiac Resynchronization Therapy ▲ Ventricular Assist Device therapy ▲Spinraza inj. ▲Strensiq inj. ▲Clinical studies A total of 6,001 cases applied for pre-approval last year, 5,785 of which were approved for reimbursement. The approval rate is high at 96.4%. Among all the cases filed, 79 were disapproved, and 137 were dropped. Excluding Ultomiris, which was added this year as a pre-approval item, the medical and pharmaceutical expenses spent on pre-approval items last year recorded 231.43 billion won. Despite the increase in medical care benefits caused by the added items and the increase in the number of applications, no item has been removed from the list since the system was implemented in 1992. Also, no dedicated department exists for the pre-approval system, raising the need for systemic improvements. Jin-Su Lee, Chair of HIRA who met with the Korea Special Press Association reporters on the 10th, said, “As of last year, the number of applications seeking for pre-approval increased to 6,001 cases for 26,910 people. Therefore, we would need to review adding or removing items subject to the pre-approval, and systemize the approval process.” In other words, HIRA will analyze and review the whole operation process of the pre-approval system and collect the stakeholders' opinions for reflection to come up with a plan for improving the operation of the prior approval system. Kim Moo-sung, director-general of HIRA's Committee Operations, said, “Since the system was implemented in 1992, no items were excluded (removed) from the list. Opinions that items that have been constantly reviewed without change should be switched from pre-approval to the post-approval system have been raised, and we plan to discuss this with the Ministry of Health and Welfare after collecting expert and internal opinions." Regarding newly establishing a department for pre-approvals, Kim said, “Currently, 10 people in 2 teams are in charge of the prior approval review. With the government requesting more items to be added to the pre-approval list this year, the committee agrees on the need for a dedicated department that manages the pre-approval system.” Kin added, “We will discuss newly establishing an independent department for the pre-approval system with relevant departments during the next reorganization process."
