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- 2026-05-11 11:24:40
- Policy
- Triple-negative breast cancer tx Trodelbi approved in Korea
- by Lee, Hye-Kyung May 11, 2023 05:50am
- Meditip's Trodelbi (Sacituzumabgovitecan), an orphan drug triple-negative breast cancer treatment, has received domestic product approval. The Ministry of Food and Drug Safety (Minister Oh Yoo-kyung) announced on the 9th that it had approved the approval of Trodelbi to be used in breast cancer patients who lack estrogen receptor (ER), progesterone receptor (PR), and epidermal growth factor receptor 2 (HER2). Trodelbi is an antibody-drug conjugate that targets Trop-2 protein, frequently found on the surface of breast cancer cells, and provides a new treatment opportunity for patients with advanced or metastatic triple-negative breast cancer. Trop-2 is overexpressed on the surface of various cancer cells, including triple-negative breast cancer. Trodelbi is indicated for treating adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic treatments, at least one of which has been treated for metastatic disease. Trodelbi induces the death of cancer cells by releasing drugs (SN-38, SN-38 glucuronide) that inhibit cell division within the cell, while the antibody (Sacituzumab) binds to Trop-2 expressed on the cell surface and moves into the cell. do. The Ministry of Food and Drug Safety said, “We will continue to do our best to promptly supply treatments whose safety and effectiveness have been sufficiently confirmed based on regulatory science.”
- Policy
- ‘Pay more policy attention to advanced heart failures'
- by Hwang, byoung-woo May 11, 2023 05:49am
- [Interview with Medical Societies] Soo-Yong Lee, Administrative Secretary of the Insurance Committee at KSF Asks authorities to increase benefits for patients at high risk of health failure who have fewer treatment alternatives According to the ‘2020 Heart Failure Fact Sheet’ that was released by the Korean Society of Heart Failure (KSHF), Korea’s prevalence of heart failure in Korea had increased threefold in 16 years from 0.77% of the total population in 2002 to 2.24% in 2018 to exceed 1 million patients. Although drug options that can intervene in the early stages of heart failure have been increasing, options are still limited for severely ill patients with prior hospitalization experience. Therefore, Soo Yong Lee, Professor of Cardiology at Pusan National University Yangsan Hospital (Administrative Secretary, Insurance Committee, KSF) believes that appropriate policy intervention is needed in terms of patient benefits and insurance finance. Soo-Yong Lee, Assistant Administrator of the Insurance Committee at KSF#In particular, Professor Lee stressed how heart failure has a lower survival rate than most cancers. “The overall survival period of patients with heart failure is 2.6 years for first hospitalizations, 1.8 years for second hospitalizations, and 1.5 years for third hospitalizations. This means that the number of hospitalizations is proportional to the mortality rate of the patients, and 1-2 out of 4-5 patients are re-hospitalized within a month in practice.” Lee further explained that hospital readmissions also impose further financial burdens on the patients. The total medical expense paid by patients with heart failure who have experienced at least 1 hospitalization is around KRW 8-9 million per year, and the burden increases further if the patient’s condition requires the use of an intensive care unit or equipment for dialysis or ECMO. In fact, according to the 2017-2021 health insurance treatment Rep. Sun-woo Kang, member of the National Assembly's Health and Welfare Committee, received from the National Health Insurance Service, the number of patients treated for heart failure increased by 7.1% (158,916 in 2021) every year, increasing the treatment expense as well (an average of 15.6% in 5 years). The heart failure treatment paradigm has been changing with recent studies being conducted on reducing the mortality rate in patients with chronic, therefore, stable heart failure and the introduction of ARNi drugs. Lee said, “Recent studies have focused on how much the condition improves when drugs are used in acute patients after treatment and when drugs are used immediately after stabilization. With the release of SGLT2is and ARNis, the current trend is leaning towards the early use of such treatments” Re-hospitalization of patients despite the availability of early treatment options remains a concern..."Need to improve the treatment environment" However, despite the development of early treatments, the number of readmitted patients has increased constantly due to various factors including the lack of patients' compliance. One treatment that can be considered for use in this situation is vericiguat (product name Verquvo), and the KSF has been highly recommending it with a Class Ⅱa recommendation for preemptive use when a patient’s heart failure worsens even after ample standard therapy. The VICTORIA trial that became the basis of Verquvo’s approval drew attention because it enrolled patients who have recent hospitalization history and have been hospitalized at least once. Compared to most studies of other heart failure drugs that are conducted on chronic patients with good symptom control and low readmission rates, Verquvo’s patient group fundamentally has a higher mortality rate than other studies. Lee said, “In the VICTORIA study, 66.9% of patients were hospitalized for heart failure within 3 months, and 85.7% were HFrEF patients with a left ventricular ejection fraction of 40% or less. The study itself was a brave attempt as most of them were in a very bad condition, to the extent that no drugs would have been effective for them.” Study results showed that Verquvo reduced the risk of death from cardiovascular disease or first hospitalization due to heart failure by 10%, and achieved a 4.2% reduction in annualized absolute risk. Regarding the results, Lee explained that “Patients in the high-risk group used to have a poor prognosis. They were prescribed dobutamine before and are discharged if they seem better, and had to repeat hospitalization due to cardiac arrest until death or await heart transplantations. The study showed that its NNT was 24, which means that 1 out of 24 patients could be discharged because their symptoms improve after using the treatment, which is a very good figure and the best level achieved among heart failure drugs.” He added, “The drug holds great clinical significance as it gives high-risk patients the opportunity to leave the hospital. "In my practice of treating many patients with end-stage heart failure, Verquvo is definitely a welcome rain in the drought.” Emphasis on its benefit in patients at high risk of heart failure...will reimbursement discussions for Verquvo make progress? According to industry sources, Verquvo’s reimbursement has passed review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee and is awaiting to be deliberated by the Drug Reimbursement Evaluation Committee. To add its support, the KSHF has also conveyed its opinion regarding the expansion of Verquvo’s reimbursement standards as its role in the field is clear. Based on the VICTORIA trial, the KSHF expects that 10,000 to 15,000 patients can be treated with Verquvo every year. In particular, Lee judged that when the drug is administered to the high-risk group, this may reduce the need for a heart transplant or hospitalization in an intensive care unit, which can also provide benefits in terms of cost. He said, “The biggest feature of Verquvo is that it has confirmed its effectiveness in severely ill patients. When considering how patients with the LVAD indication incur KRW 150 million to KRW 250 million as expenses every time they use LVAD, if the drug can reduce the frequency of hospitalization or death, reimbursement would also be reasonable in terms of saving insurance finances.” However, Lee expressed concern over how the application of excessively restrictive reimbursement standards may act as a barrier to its use for patients even if the drug is positively considered for reimbursement in the future. In the VICTORIA clinical trial, about 60% of the patients received the three-drug therapy that included RAAS inhibitors. Patients who experienced worsening conditions despite being administered standard therapy according to the patient’s clinical condition were also allowed to use Verquvo in the trial, and therefore this indication may also be reflected in its reimbursement standards in the future. However, as standard therapy treatments are used in primary medical institutions in the early stages of heart failure, a barrier may arise for patients where they may not be eligible to use Verquvo even after being transferred to a general hospital or a tertiary hospital due to set reimbursement standards. Lee said, “I think Verquvo is a necessary drug for patients in the advanced stage, such as those who have used intravenous diuretics or have been hospitalized for heart failure. As a clear patient population exists for the drug, its reimbursement standards should be set promptly in consideration of the urgent need and allow its use in patients who experience worsening heart failure events after standard treatment.”
- Policy
- Rapidly changing breast cancer treatment
- by Choi, sun May 11, 2023 05:49am
- The Korean Breast Cancer Society revised the treatment recommendation on the 27th. Combination drug treatment using a combination of an antibody and an anticancer drug has emerged as a hot issue, and as the new anticancer drug Enhertu for HER2-positive metastatic breast cancer received domestic approval in September last year, the reflection of this is emerging as a concern. In the case of new drugs, society reflects them if there is evidence, while also preparing new recommendations for rare cases that have been neglected. It means that it presented an 'answer' based on expert consensus in areas where large-scale randomized clinical studies were lacking due to the small number of patients, such as male breast cancer, osteoporosis treatment in breast cancer patients, and familial breast cancer, which depended on individual judgment of medical staff. Given that the clinical field of breast cancer is rapidly changing due to the emergence of various new drugs and treatments, society adheres to preparing revisions every two years. Even with a 'short cycle' of 2 years, it contains a lot of changes. We met Ae-Ri Han (Department of Breast Surgery, Yonsei Wonju University) and In-Hye Park (Department of Oncology, Korea University Guro Hospital), chair of the Breast Cancer Society, to hear about major changes. Usually, guidelines and recommendations are based on data. After the evidence is accumulated and verified over time, it goes through the usual procedure reflected in the guidelines. The problem is in the case of rare cancers, where it is difficult to accumulate data despite the passage of time. The need for a minimum 'guidance' that relied entirely on the judgment of medical staff has been a demand in the clinical field. (From left) Han Ae-ri, chair of the breast cancer society, and Park In-hye, chair of the academic committee Chairman Han expressed the biggest change in this recommendation as 'interest in the minority. "Because recommendations are not standard medical guidelines, they do not mean that they must be done as they are," she said. Usually, for rare cases, foreign studies are referred to. It was not easy to find high-quality research data abroad for the rare cases included in this guideline. Chairman Han said, "The most reliable data is a randomized clinical trial involving a long period of time and a large number of patients, but the cases mentioned above have physical limitations in conducting such clinical trials. This is the same situation in Korea as well as abroad." Explained. The society decided to support smooth use through recommendations on the use of Enhertu, which is on the verge of reimbursement. Enhertu drew attention last year with a national consent petition urging 50,000 people to request rapid approval. Even after the domestic approval in September of last year, as 50,000 people urged public consent for health insurance, it emerged as a topic of interest in the breast cancer academic community. Park In-hye, chairman of the Academic Committee (Korea University Guro Hospital), said, “Enhertu’s insurance review has already been completed and some adjustments remain, so the review will begin again in May soon.” Since locals use it a lot, I think a similar level of decision will come out." She said, "I think that insurance benefits will be available to patients after the review in May in Korea." She said, “Especially, as the treatment indications for Enhertu are getting wider, the number of patients who can be treated with Enhertu is expected to gradually increase.” Chairman Han Ae-ri said, "Because the level of evidence must be high, it is difficult to unconditionally reflect in the recommendation that a new drug has been released, but all cases that meet the criteria such as Enhertu are reflected in this guideline." I thought it was, so I didn't reflect it," she explained. “The National Comprehensive Cancer Network (NCCN) has recommended Ribociclib as a first-class among CDK 4/6 inhibitors,” she said. “In Korea, Palbociclib was first launched in 2016 and is a generic drug. Abemaciclib and Ribociclib are competing, but experts are also divided on whether to switch to another drug if they are currently taking Palbociclib.” Although not enough data has been accumulated to change the recommendation, it was not easy to make a decision because the recommendation level for late-comer drugs is being raised overseas. In particular, it was also pointed out that if the prognosis worsens after first administering Ribociclib, there is no other drug that can be used. Chairman Han said, “There was an opinion that existing drugs should be used first and new drugs should be used as a last resort in preparation for a worsening prognosis, but in the end, there were more opinions that good drugs should be used from the beginning.” I also gave a lecture about using good medicine first from the beginning.” "Currently, the market is changing due to competition in generics such as Ribociclib, and the recommended level is also changing, so it is true that there is confusion in the clinical field," said Han. Chairman Han added, "If there is an effective treatment, I think it is the mission of the society to reflect and recommend it."
- Company
- Scemblix can be prescribed at general hospitals
- by Eo, Yun-Ho May 11, 2023 05:48am
- Novartis' new chronic myelogenous leukemia drug Scemblix is entering prescription rights in general hospitals. According to related industries, Novartis Korea's Ph+CML Philadelphia chromosome-positive chronic myeloid leukemia treatment drug Scemblix has been approved by the Drug Committee (DC) of medical institutions such as Seoul St. Mary's Hospital and Seoul Asan Hospital, as well as Kyungpook National University Hospital and Uijeongbu Eulji Hospital. As the insurance benefits process is currently underway, the prescription environment is being created quickly. Scemblix was approved in Korea in June last year for the treatment of Philadelphia chromosome-positive chronic myelogenous leukemia in the chronic phase, which was previously treated with two or more tyrosine kinase inhibitors. Chronic myelogenous leukemia is a malignant blood disease caused by myeloid cells making leukocytes. In this case, splenomegaly and frequent infections and bleeding may occur. Currently, TKIs are used for the treatment of patients with chronic myeloid leukemia, but treatment may be limited due to intolerance or resistance, and the failure rate increases as the treatment course is prolonged. According to the study results, up to 70% of the second-line treatment patients did not achieve a Major Molecular Response within 2 years. While existing TKIs may develop resistance due to mutations in the ATP binding site, Scemblix is also called a STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor. It shows high specificity to BRC-ABL1 and is unlikely to develop resistance due to mutations in the BCR-ABL1 gene associated with resistance and intolerance of patients with chronic myeloid leukemia, which have occurred with existing treatments. Scemblix proved its effectiveness through the ASCEMBL phase 3 study in chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia patients who received at least two or more TKI treatments. As a result of the study, Scemblix was used as a control group. Compared to the Bosutinib administration group, the 24-week MMR rate was found to improve by about 2 times, and even in the discontinuation rate due to adverse reactions, the Scemblix group reduced to 5.8%, about 1/4 of the control group's 21.1%, confirming the safety profile. Professor Kim Dong-Wook of the Department of Hematology at Eulji University Hospital said, “Patients with chronic myelogenous leukemia have to take targeted anti-cancer drugs for the rest of their lives. As they are experiencing difficulties such as economic burden, side effects from long-term use, and the development of resistance, it is a very important task to develop a treatment that overcomes these difficulties. was," he said. "Scemblix, a 4th-generation targeted anti-cancer drug, has achieved clinical usefulness, such as achieving a higher major gene response and long-lasting effect than existing targeted anti-cancer drugs, and safety with relatively few side effects through clinical studies, so it can solve the unmet needs of existing patients and medical staff." It will be a cure," he said.
- Opinion
- [Reporter’s View] MSD Korea ‘Calm before the storm’
- by Jung, Sae-Im May 11, 2023 05:46am
- “There were rumors from a month ago, but they proved true. I am at a loss for words at the announcement that the department will be closed down." With the news that MSD Korea’s blockbuster antidiabetic treatment ‘Januvia Series’ will be handed over to Chong Kun Dang, the employees at MSD Korea received the crushing news that the company’s General Medicine Business Unit that used to sell Januvia will be shut down. Blinded by the unexpected blow, the employees are currently at a loss for words. Although the company refrained from directly using the term, ‘closure of a department,’ the notice included phrases such as ‘we are deeply grateful to MSD Korea’s GM employees who have shown dedication and worked hard to fulfill their responsibilities’ and that the company is ‘preparing a competitive voluntary retirement and external career support programs,’ indicates the imminent abolishment of the business unit. No more drugs are left for the GM unit to sell. When MSD spun off Organon 3 years ago, it handed over a large number of its off-patent drugs to Organon including Atozet, Cozaar, and Singulair. Only the Januvia series whose patent term remained and the company’s new SGLT-2 inhibitor drug ‘Steglatro’ had survived the spinoff. From July, all rights to Januvia will be transferred to Chong Kun Dang, and Steglatro and its combination therapy Steglujan will also be sold independently by Chong Kun Dang. No follow-up drugs await release either. The reduction of the GM unit had been expected to some extent due to the company’s shift in focus to anticancer and personalized vaccines. However, no one would have imagined that a department with about 100 employees would disappear so suddenly. Moreover, MSD Korea currently does not have a leader to oversee the company's business affairs. MSD Korea's Managing Director’s spot has remained vacant ever since Kevin Peters, who had actively engaged in communication with the labor union, took office as the Managing Director of the German branch in January. David Peacock, president of the Asia-Pacific region, is temporarily serving as the manager of MSD Korea as well. This is why concerns are rising on whether the voices of Korean employees will be well conveyed amid the change with no head in place to lead the company. The company had always chosen to go with the most profitable decision for the company so far. At the time of the Organon spin-off, the company did not hand over Januvia as it was bringing in profit then and then chose to hand it over now because the patent is scheduled to expire this year. By keeping Januvia, the company had earned more than KRW 200 billion in sales over the past 2 years from June 2021. Employees in the GM unit who will now be eligible for voluntary retirement would also want to make the most profitable decision for themselves. Therefore, the key question is, how well will the company compensate the employees? For employees who may wish to remain, the company should also actively consider ways to relocate personnel. The livelihood of as many as 100 employees and their families is at stake. Employees are not products that can be handed over when it’s of no use to other companies at an appropriate price. MSD Korea said, “The company will use all its available resources to help employees adapt to the new circumstances and prepare for another opportunity for growth. We will have individual meetings with each employee to sincerely discuss their career plans and concerns." It is our sincere hope that the company will hold true to its statement and that it is not just a brief excuse to calm the confusion.
- Company
- Scemblix can be prescribed at general hospitals
- by Eo, Yun-Ho May 10, 2023 11:18pm
- Novartis' new chronic myelogenous leukemia drug Scemblix is entering prescription rights in general hospitals. According to related industries, Novartis Korea's Ph+CML Philadelphia chromosome-positive chronic myeloid leukemia treatment drug Scemblix has been approved by the Drug Committee (DC) of medical institutions such as Seoul St. Mary's Hospital and Seoul Asan Hospital, as well as Kyungpook National University Hospital and Uijeongbu Eulji Hospital. As the insurance benefits process is currently underway, the prescription environment is being created quickly. Scemblix was approved in Korea in June last year for the treatment of Philadelphia chromosome-positive chronic myelogenous leukemia in the chronic phase, which was previously treated with two or more tyrosine kinase inhibitors. Chronic myelogenous leukemia is a malignant blood disease caused by myeloid cells making leukocytes. In this case, splenomegaly and frequent infections and bleeding may occur. Currently, TKIs are used for the treatment of patients with chronic myeloid leukemia, but treatment may be limited due to intolerance or resistance, and the failure rate increases as the treatment course is prolonged. According to the study results, up to 70% of the second-line treatment patients did not achieve a Major Molecular Response within 2 years. While existing TKIs may develop resistance due to mutations in the ATP binding site, Scemblix is also called a STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor. It shows high specificity to BRC-ABL1 and is unlikely to develop resistance due to mutations in the BCR-ABL1 gene associated with resistance and intolerance of patients with chronic myeloid leukemia, which have occurred with existing treatments. Scemblix proved its effectiveness through the ASCEMBL phase 3 study in chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia patients who received at least two or more TKI treatments. As a result of the study, Scemblix was used as a control group. Compared to the Bosutinib administration group, the 24-week MMR rate was found to improve by about 2 times, and even in the discontinuation rate due to adverse reactions, the Scemblix group reduced to 5.8%, about 1/4 of the control group's 21.1%, confirming the safety profile. Professor Kim Dong-Wook of the Department of Hematology at Eulji University Hospital said, “Patients with chronic myelogenous leukemia have to take targeted anti-cancer drugs for the rest of their lives. As they are experiencing difficulties such as economic burden, side effects from long-term use, and the development of resistance, it is a very important task to develop a treatment that overcomes these difficulties. was," he said. "Scemblix, a 4th-generation targeted anti-cancer drug, has achieved clinical usefulness, such as achieving a higher major gene response and long-lasting effect than existing targeted anti-cancer drugs, and safety with relatively few side effects through clinical studies, so it can solve the unmet needs of existing patients and medical staff." It will be a cure," he said.
- Company
- Negotiation on the price of Onureg has started
- by Eo, Yun-Ho May 10, 2023 11:17pm
- Suggestion of treatment options for patients unable to undergo hematopoietic stem cell transplantation Onureg, an acute myelogenous leukemia maintenance treatment drug, recently entered into drug price negotiations for insurance coverage. After passing the HIRA Cancer Disease Review Committee in December of last year and the Pharmaceutical Reimbursement Evaluation Committee last month, it entered the NHIS procedure without any major changes. Considering the deadline for negotiations, the results are expected to come out in June at the latest. Onureg was approved on March 23, 2022, for maintenance therapy in adult patients with acute myeloid leukemia who achieved CR or CRi with incomplete hematologic recovery after induction therapy, with or without consolidation therapy, and who are not suitable for HSCT. Whether Oneurec can be recognized for its clinical value as the first and only treatment option that clinically extends the survival period for AML patients who cannot undergo hematopoietic stem cell transplantation and who have failed to extend their overall survival despite several R&D attempts over the years. Onureg confirmed efficacy and safety in phase 3 of QUAZAR AML-001 in 472 patients with acute myeloid leukemia. As a result of the study, the mOS of the patient group who took Onureg was 24.7 months, extending the survival time by about 10 months compared to 14.8 months of the placebo group. At 1 year and 2 years of treatment, the survival rate in the Onureg group was 73% (vs. 56% vs. placebo group) and 51% (vs. 37% vs. placebo group), respectively, both higher than those in the placebo group. RFS also confirmed that the Onureg group reached 10.2 months, 5.4 months longer than the placebo group (4.8 months), reducing the risk of recurrence. The proportion of patients without recurrence after 6 months of treatment was 67% in the Onureg group and 45% in the placebo group. Onureg has been recognized for its clinical usefulness in major overseas countries such as the UK and Australia and is being recommended for reimbursement to patients to be treated.
- Policy
- A benefit study of the Gardasil 9 NIP is also forthcoming
- by Lee, Jeong-Hwan May 10, 2023 11:17pm
- The KDCA is ordering an additional policy research service to apply the National Vaccination Support Project (NIP) of the 'HPV 9-valent vaccine' to female adolescents and male adolescents over 12 years of age. As the result of the HPV 9 commissioned by KDCA to NECA earlier was found to be low in cost-effectiveness in vaccine research, it is in effect a follow-up study. In addition, the KDCA plans to conduct a cost-effectiveness study when applying NIP to the shingles vaccine. On the 8th, KDCA Medical Safety and Prevention Director Lim Eul-ki made this statement at a meeting with the Professional Reporters Association. Director Lim Eul-ki explained, "The additional study on the cost-effectiveness of the male HPV 9 vaccine will be conducted as quickly as possible and an order will be placed in May." The policy of free vaccination of Gardasil 9, a vaccine against HPV 9, to female and male adolescents was a pledge of President Seok-Yeol Yoon during the presidential election. To this end, the KDCA commissioned NECA to conduct a cost-effectiveness study, but it was concluded that it was not cost-effective in all analysis scenarios. Specifically, the research team analyzed the economic effects of three scenarios: ▲ 12-year-old girl 9-valent conversion, ▲ 12-year-old male and female 9-valent vaccination, ▲ and 12-year-old male HPV vaccine NIP subject to NIP However, as a result, the cost-benefit ratio was not significant in all scenarios. Accordingly, KDCA decided to conduct a cost-benefit analysis again through additional research. The subject of the follow-up study was decided to be kept private for the time being to maintain research fairness. Regarding the background of the additional research, Director Lim Eul-ki explained, "There were many experts' opinions that the research design of the research service conducted by NECA was carried out excessively conservatively." Director Lim explained, "For example, we underestimated the diseases that occur in men during the HPV vaccine effect." Director Lim said, "There was an expert opinion that the effect on side diseases such as head and neck cancer was also underestimated. In follow-up studies, we plan to actively reflect this aspect." Director Lim added, “In particular, it should have been studied compared to female non-vaccinated people, but there was also an evaluation that the sensitivity was lowered because of the study compared to female non-vaccinated people.” Director Lim added, "In fact, research services have been conducted overseas as well, and additional research is being ordered in Korea under the same conditions." The KDCA will also embark on a NIP cost-benefit study of the shingles vaccine. The research will also be ordered in May. Director Lim said, "It would be nice if NIP was implemented for the shingles vaccine, but it was difficult to proceed due to budget limitations. This research service will include the recently released Shingrix vaccine." Lim said, "Unlike HPV vaccine research, the period required for research on shingles is planned to be about one year with time to spare."
- Policy
- Prior HIRA approval is required to administer Crysvita
- by Lee, Tak-Sun May 10, 2023 06:00am
- Prior approval from the Health Insurance Review and Assessment Service will be required to administer the pediatric rickets treatment Crysvita Inj which is set to be reimbursed from May this year. Accordingly, HIRA has prepared the specifics for Crysvita’s prior approval and applied it from the 3rd of this month. According to the specific criteria, medical institutions that seek to administer Crysvita’s to children with X-linked hypophosphatemia (XLH), a rare inherited form of rickets, must apply for prior approval to HIRA. The deliberation will be conducted by the Crysvita subcommittee under the Healthcare Review and Assessment Committee (HCRAC). The subcommittee will convene on the third Wednesday of each month and will be deliberating applications submitted until 14 days before the date of the meeting. Medical institutions that receive HIRA’s Prior approval must administer Crysvita within 60 days of being notified of the deliberation results. If the institution seeks to administer it after 60 days, it must reapply for prior approval. Medical institutions that have been approved in advance and administered Crysvita can file claims for health insurance benefits. The institutions are also required to submit monitoring data after administering Crysvita. The medical institution in charge is required to submit a monitoring report every 12 months after initiating treatment before administering the maintenance dose, which is again subject to the subcommittee’s review. The subcommittee can reverse its approval if the institution approved to receive the health insurance benefits is found to have falsely filed related data in the applications and monitoring reports or submitted false data. However, a medical institution that has been notified of the subcommittee’s decision to cancel or withdraw the approval of health insurance benefits may file an objection within 90 days. With the addition of Crysvita Inj., a total of 9 items now require prior approval before being insurance benefits: ▲Immune Tolerance Induction; ▲Soliris‧Ultomiris Inj. ▲Strensiq Inj. ▲Spinraza‧Zolgensma Inj.; ▲ Autologous Stem Cell Transplantation; ▲Implantable Cardioverter Defibrillator & Cardiac Resynchronization; ▲Ventricular Assist Device therapy; ▲Clinical studies; and ▲Crysvita Inj. However, in the case of autologous stem cell transplantation, institutions can opt to receive a review after administration without undergoing prior approval procedures.
- Company
- Forxiga, has the largest number of clinical trials
- by Jung, Sae-Im May 10, 2023 05:58am
- With the expansion of SGLT-2 inhibitor coverage, which began in April, combination prescriptions of various diabetes drugs and SGLT-2 drugs are expected to increase. However, as the clinical basis for each drug is a prerequisite for the expansion of this benefit, there are differences in detailed application depending on the presence or absence of clinical trials. Expectations are growing that AstraZeneca's Forxiga, which has the most clinical trials among SGLT-2 inhibitors, will rise further. Kim Jong-hwa, Director of Insurance, Korean Diabetes Association Kim Jong-Hwa, head of the Department of Endocrinology at Bucheon Sejong Hospital (insurance director of the Korean Diabetes Association), said, “Forxiga is the first SGLT-2 inhibitor in Korea and has the most related clinical studies among drugs in the same class, so it will become the same as Lipitor in the statin class. expected". From April 1, the Ministry of Health and Welfare applied the expansion of the combination benefit for diabetes treatment SGLT-2 inhibitors. According to the notice, the reimbursement of two-drug combination therapy with sulfonylurea (SU), which was limited to some drugs, has been expanded to all SGLT-2 inhibitors. ▲Metformin + SU + SGLT-2, ▲Metformin + DPP-4 + SGLT-2, and ▲Metformin + Thiazolidinedione (TZD) + SGLT-2 can be used as reimbursements for the three-drug regimen. Daewoong Pharmaceutical's Envlo, which has no evidence in the SU+SGLT-2 inhibitor dual therapy, is not covered by insurance coverage. This is because Envlo has not proven its effectiveness through clinical trials in combination with the SU series. Even in the metformin + TZD + SGLT-2 triple therapy, MSD's Steglatro and Envlo, which have no clinical evidence, are not covered by reimbursement. The drugs that can be used in the two-drug regimen that is not included in this reimbursement are also limited. In the DPP-4+SGLT-2 two-drug regimen, only Forxiga and Steglatro can be used together with Januvia at the full cost of the first type patient. Among various exceptions, the drug that can be used most widely is, of course, Forxiga. As explained by Director Kim, Forxiga has proven its efficacy and safety in combination with monotherapy and other diabetes drugs through a total of 15 clinical trials. Clinical trials included not only metformin, but also various combination therapies such as sulfonylurea, insulin, DPP-4 inhibitor, TZD, sulfonylurea + metformin, and DPP-4 + metformin. This is the background of the increased utilization of Forxiga. By demonstrating the effect of protecting heart disease and heart function along with blood sugar control, Forxiga had a significant impact on changing the treatment guidelines to prioritize SGLT-2 inhibitors in patients with comorbidities such as cardiovascular disease. “The obesity rate of type 2 diabetic patients in Korea is getting higher and the number of patients with heart failure is also increasing,” said Kim. shows good compatibility with DPP-4 inhibitors and TZD, so a good effect can be produced if the combination therapy is used appropriately." Director Kim expected that Forxiga would become the same as Lipitor, a statin drug used to treat hyperlipidemia, as it accumulated long-term prescription experience and clinical data. Lipitor is an old drug that has been released in Korea for 25 years as a treatment for hyperlipidemia containing atorvastatin. Although more than 100 generics have been launched on the market since the patent expired, Lipitor still boasts an annual prescription of about 200 billion won. Forxiga also faces a full-fledged generic competition system this year. About 150 dapagliflozin products (including complex drugs) registered for a benefit that was released last month are reached. From the standpoint of Forsh, the expansion of the combination benefit widened the utilization and at the same time had to defend against the offensive of generics. It is expected that the strengths of the original product will be maintained even in the generic competition. He believed that it was necessary to pay attention to the side effects of SGLT-2 that would arise from the surge in generics. "If using SGLT-2 inhibitors indiscriminately in diabetic patients, they can be poisonous. We need to clearly determine which patients need SGLT-2 inhibitor prescription so that it can be used for appropriate patients," he urged.
