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- 2026-04-04 09:01:26
- Policy
- Anticipating reimb for DPP4·SGLT2 combination drugs
- by Lee, Jeong-Hwan Nov 01, 2024 05:51am
- The government has announced a plan to address the necessity of the National Health Insurance reimbursement·expansion for two-drug combination drugs containing DPP-4 inhibitors and SGLT-2 inhibitors for the treatment of type 2 diabetes. In South Korea, reimbursement for combination drugs containing DPP-4 inhibitors and SGLT-2 inhibitors is only provided for three-drug combination therapy that involves an additional prescription of metformin. Approval of reimbursement for two-drug combination therapy, excluding metformin, is expected to offer more treatment options and convenience for diabetes patients while preventing unnecessary national health expenditures. On October 31, the Ministry of Health and Welfare (MOHW) and Health Insurance Review and Assessment Service (HIRA) responded to the question regarding the National Health Insurance coverage of type 2 diabetes treatments asked by Rep. Seo Miwha, a member of the People Power Party, during the parliamentary audit. Rep. Seo pointed out that reimbursement of combination drugs containing SGLT-2 inhibitors and DPP-4 inhibitors for treating diabetes must be approved to broaden treatment choices for diabetes. Rep. Seo stated that the current reimbursement for combination drugs is complicated for physicians to prescribe and restricts treatment choices for patients. Since May 2023, the scope of reimbursement for combination drugs containing DPP-4 inhibtors and SGLT-2 inhibitors prescribed to patients with type 2 diabetes has been expanded·changed so that it can be reimbursed when metformin is additionally prescribed. The problem is that the use of SGLT-2 inhibitors and DPP-4 inhibitors in combination or a combination drug is not covered by the National Health Insurance reimbursement. The current reimbursement policy is illogical for diabetes treatment because patients who can benefit simply from two-drug combination therapy are unnecessarily prescribed three-drug combination therapy because three-drug combination therapy is reimbursed, but two-drug combination drug are not. The HIRA responded to such criticism that they would review the need to expand the National Health Insurance reimbursement for a two-drug combination containing SGLT-2 inhibitors and DPP-4 inhibitors or a combination drug. "We will assess the safety·clinical utility of oral combination drugs for treating diabetes and communicate with related associations so that improved policy for two-drug combination drugs can be generalized," the MOHW said. "However, reimbursement expansion of diabetes drugs requires an impact on the National Health finance. We will discuss this with related associations." The HIRA explained the reason for the exclusion of two-drug combination drugs from the current reimbursement list, and they announced a plan to pursue improvements to the scope of reimbursement. "In 2018, we have written reimbursement criteria for the concurrent use of SGLT-2 inhibitors and DPP-4 inhibitors by discussion with an advisory committee. However, we retracted our stance that reimbursement of concurrent use by drug classes is appropriate and decided to maintain the current policy," the HIRA said. "After the previous discussion, we have checked the updated approvals from the Ministry of Food and Drug Safety (MFDS) and assessed the revision plan by comprehensively reviewing the latest resources and expert opinions, such as clinical practice guidelines, clinical research documents." "In addition to restricting the overall general policy for diabetes drugs, we plan to review issues related to reimbursement expansion for the combination therapy containing SGLT-2 inhibitors+DPP-4 inhibitors, prescription ease, and patient choices by discussing with related associations and experts," they added.
- Opinion
- [Reporter's View] Address Actions to drug substitution
- by Lee, Jeong-Hwan Nov 01, 2024 05:51am
- "We will foremostly activate drug substation to resolve the drug shortages issue," Cho Kyoo-hong, Minister of Health and Welfare (MOHW), promised during the parliamentary audit session commenced by the National Assembly's Small Committee for Health and Welfare. This is an answer from the MOHW director to an issue of essential medicines frequently in shortage, leading to chaos in pharmacies and lower patient access to medications. The issue has been unresolved for several years. Rep. Seo Youngseok and Rep. Nam In-soon of the Democratic Party of Korea have requested the implementation of active ingredient prescriptions for cold medicines and essential medicines to resolve the issue of frequent drug shortages. Minister Cho repeatedly answered that he would improve the current situation by enabling drug substitution rather than active ingredient prescription, as the latter requires agreements between officials. According to Minister Cho, activating drug substitution beyond the current 'lower-cost drug substitution incentive' policy by the Health and Welfare Committee requires specific administrative actions, policy establishment, and implementation. In other words, their plan cannot be attained by the way MOHW said to actively participate in the legislative session to review the National Assembly submitted bill for simplifying drug substitution procedure. Passing the plenary session of the National Assembly for the bill for implementation of drug substitution that has been submitted to the National Assembly would take several months after undergoing the legislative process. It has not been considered for the Legislation and Judiciary Small Committee for Health and Welfare. During the legislative procedure, it is unknown whether the bill would face opposite opinions, overcome oppositions, and pass all legislative hurdles. During the parliamentary audit, the MOHW answered a question about the restricted implementation of active ingredient prescriptions for cold medicines by stating, "It is the terms of the medical reform agreement. Therefore, the issue requires societal discussion and a procedural agreement." Then, the MOHW must consider detailed and active administration to implement drug substitution to resolve frequent drug shortages of cold medicines and pediatric medicines. In particular, lower-cost drug substitution must be increased because the government provides incentives to strengthen the stability of the National Health Insurance finance. According to the Health Insurance Review and Assessment Service (HIRA), the incentive for drug substitution increased temporarily during the COVID-19 pandemic. After the announcement of 'With COVID-19," it returned to that of pre-COVID-19. It shows that drug substitution policy has been conservative and passive unless drug substitution is inevitable, such as during the pandemic period. Not only during this audit but also during the previous parliamentary audit, the MOHW had agreed to the necessity of supporting drug substitution and increasing the incentive rate for lower-cost drug substitution. However, the concern is that they have not suggested a concrete method to specifically address when and how drug substitution can be actively implemented. As Minister Cho promised during the parliamentary audit that he would actively implement drug substitution to resolve the drug shortages, the MOHW must provide incentives and establish an administrative policy so that pharmacies can dispense drug substitution for drug shortages without hesitation. We must not passively wait for the legislative procedure after agreeing to the bill to simplify drug substitution, which is to be reviewed by the National Assembly. Aside from passing the bill to the National Assembly, we hope to hear about MOHW's updated policy to support drug substitution in resolving the drug shortage issue by actively implementing it.
- Company
- New AML drug Vyxeos can be prescribed at Big 5 hospitals
- by Eo, Yun-Ho Nov 01, 2024 05:51am
- The new acute myeloid leukemia drug ‘Vyxeos’ may now be prescribed at general hospitals in Korea. According to industry sources, Vyxeos (daunorubicin+ cytarabine), a treatment for adults with acute myeloid leukemia AML, has passed the drug committees (DCs) of the ‘Big 5’ tertiary hospitals in Korea including the Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary’s hospital, Sinchon Severance hospital, several medical institutions in Korea including the National Cancer Center, Samsung Medical Center, Seoul National University Hospital, and Asan Medical Center, and Sinchon Severance Hospital. The company also made progress in the drug reimbursement discussion. Vyxeos passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in August. If the company succeeds in completing pricing negotiations with the National Health Insurance Service and the drug is listed for reimbursement, it is expected to quickly lead to actual prescriptions. Vyxeos was developed by an Ireland-based global pharmaceutical company Jazz Pharmaceuticals headquartered in Ireland, and Handok owns the exclusive rights to its sales in Korea. Treatment-related adult AML and AML with myelodysplasia-related changes have a poor prognosis and are associated with lower remission rates and shorter overall survival (OS) when treated with intensive chemotherapy compared to other AML. Intensive chemotherapy, the 7+3 regimen of cytarabine and daunorubicin, has remained the standard therapy for over 50 years since its introduction in the 1970s. This is why an unmet need existed in the field for some time. Vyxeos is a liposomal formulation of a fixed combination of daunorubicin and cytarabine in a 1:5 molar ratio. Vyxeos liposomes accumulate and persist at a higher concentration in the bone marrow, where they are preferentially taken up intact by leukemia cells, maximizing synergistic antitumor activity. In a Phase III trial that demonstrated the efficacy of Vyxeos, the median overall survival of patients with t-AML or AMLM-MRC who were treated with Vyxeos was 9.6 months, which was longer compared with the 6 months in patients that received the 7+3 arm. Also, 48% of the Vyxeos-treated patients achieved complete remission (CR) and complete remission with incomplete neutrophil or platelet recovery (CRi), which was higher than the 33% in the 7+3 arm. The safety profile in both arms was similar.
- Policy
- Hyundai withdraws application for Mifegymiso approval again
- by Lee, Hye-Kyung Nov 01, 2024 05:50am
- Hyundai Pharm has reportedly voluntarily withdrawn the application it had filed for the marketing authorization of Mifegymiso (mifepristone and misoprostol), which the company had applied for approval as the first abortion pill in Korea. Hyundai Pharm has requested approval for the abortion drug twice in the past, first in 2021 and then in 2023, but the Ministry of Food and Drug Safety has repeatedly asked for supplemental data, due to which the company has not been able to receive proper review. According to the MFDS’s written response to a written inquiry made during the NA Audit by the Health and Welfare Committee on the 31st, the approval and review process for Mifegymiso was recently temporarily suspended due to the company’s withdrawal. “Currently, there are some conditions that only be reviewed and approved after the Criminal Act and the Mother and Child Health Act is amended to allow drug-induced pregnancy termination and the permissible period of pregnancy termination are established by law,” said MFDS. In other words, if the Criminal Act and the Mother and Child Health Act are not amended, it would be difficult to review Mifegymiso’s effect/efficacy, and risk management plan, among others. The MFDS said, “Currently, the approval review process has been temporarily suspended (withdrawn) by mutual recognition of the applicant and the MFDS,” adding, “If the relevant laws are amended in the future and the applicant submits data accordingly, we plan to speed up the review and promptly make a decision.” Hyundai Pharm signed an exclusive marketing and distribution agreement for Mifegymiso’s supply in Korea with the UK-based Linepharma International in 2020, but the company has not been able to launch the drug in Korea due to disruptions in the approval process. Mifegymiso comes in a combination pack that contains 1 200mg mifepristone tablet and 4 misoprostol 200ug tablets. The drug inhibits the action of progesterone, the progestational hormone that sustains pregnancy, while misoprostol works to contract the uterus. It is only indicated for use in the first trimester of pregnancy, up to 9 weeks, and is typically prescribed as one tablet of mifepristone followed by 4 tablets of misoprostol 36-48 hours later. In April 2019, the Constitutional Court ruled the criminal offense of abortion (termination of pregnancy) unconstitutional, citing respect for women's right to bodily self-determination. As of January 1, 2021, abortion was effectively legalized. Upon the ruling, the Constitutional Court ordered the National Assembly to come up with an alternative legislation to reflect the decision, but 4 years have passed without such legislation being enacted. In the 21st National Assembly, 7 bills to abolish the abortion law were introduced, including amendments to the Criminal Code and the Mother and Child Health Act, but were discarded with the closure of the 21st National Assembly.
- Company
- Novartis’s operating income grew 123% in Q3 with Entresto
- by Son, Hyung Min Nov 01, 2024 05:50am
- The Swiss global pharmaceutical giant Novartis' sales increased slightly compared to the previous year. Novartis showed even sales growth in various therapeutic areas, including cardiovascular, anticancer, and immunosuppressive agents. According to industry sources, Novartis reported a revenue of USD 12.823 billion in Q3 last year, up 10% YoY. The company’s operating income was approximately USD 3.627 billion, a 123% increase YoY. The largest revenue generator in Q3 was the heart failure drug Entresto. Entresto generated USD 1.865 billion in revenue, up 26% YoY. Entresto is an angiotensin receptor-neprilysin inhibitor (ARNI) class heart failure drug and is the only innovative drug that works directly on the heart. Its strength lies in its ability to be used as a first-line treatment for heart failure in combination with other medicines, including SGLT-2 inhibitors. Entresto’s sales have continuously increased with additional indications. Entresto was initially approved for use in heart failure patients with reduced ejection fraction, defined as a left ventricular ejection fraction of 40% or less. Through clinical trials, Novartis has been successful in expanding the indication of Entresto to patients with heart failure with preserved ejection fraction. Novartis' biologic treatment Cosentyx generated the second-largest revenue. Cosentyx generated sales of USD 1.693 billion, up 28% YoY. Cosentyx, which targets anti-interleukin (IL)-17, is effective in a wide range of inflammatory diseases and has emerged as a competitor to tumor necrosis factor alpha (TNF-α) inhibitors such as Humira and Remicade. The highest sales growth rate was seen in the PCSK9 inhibitor Leqvio. Leqvio’s sales totaled $198 million, a 119% year-over-year increase. Leqvio is a first-in-class siRNA drug approved in Korea, the U.S., and Europe. Leqvio uses naturally occurring siRNA to reduce LDL-C in the blood by inhibiting the production of the PCSK9 protein, which raises LDL-cholesterol (LDL-C). Leqvio has been shown to reduce LDL-C by up to 57% with twice-yearly dosing. The rise in sales of the prostate cancer drug Pluvicto was also notable. The company reported Q3 sales of USD 386 million, a 50% YoY increase. Pluvicto is a radiopharmaceutical Notavis acquired through the acquisition of US-based Endocytein in 2018. Sales of Pluvicto, which was introduced to the market in 2022, surpassed USD 200 million (KRW 260 billion) the same year. Since then, it has continued to grow, reaching nearly USD 1 billion (about KRW 1.3 trillion) in sales last year. Sales of the breast cancer drug Kisqali increased 43% year-on-year. Kisqali is a CDK4/6 inhibitor that targets HR+/HER2- breast cancer. The fact that it was the first CDK4/6 inhibitor to be prescribed to premenopausal women contributed to its rapid market growth. According to the National Comprehensive Cancer Network (NCCN) guidelines, Kisqali is recommended as a Category 1 in the first-line treatment of HR+/HER2- peri-menopausal breast cancer patients. In addition to its strong cardiovascular, oncology, and immunosuppressive pipeline, Novartis is also actively pursuing radiopharmaceuticals and cell therapies to reinforce its portfolio. Earlier this year, Novartis acquired the Dutch immunotherapy company Calypso Biotech for USD 425 million (about KRW 560 billion). Calypso owns a cell therapy candidate, ‘CALY-002,’ with other monoclonal antibodies in development for various immune disorders.
- Company
- Atopic dermatitis drug Ebglyss to enter Korea next year
- by Whang, byung-woo Oct 31, 2024 05:55am
- The atopic dermatitis drug Ebglyss (lebrikizumab), which is set to soon be released in Korea, has added competitivity by securing rationale for switching between biologics. The company plans to receive reimbursement after launching the drug without reimbursement early next year. Pic of EbglyssAt the recent Fall Clinical Dermatology conference that was held in the U.S., Lilly presented results from the ADapt Phase IIIb study, which confirmed the effectiveness of Ebglyss in patients with moderate-to-severe atopic dermatitis who were previously treated with Dupixent (dupilumab). Patients in the ADapt study were those who discontinued Dupixent due to insufficient response, intolerance, adverse events, or other reasons (e.g., burden of cost, loss of access to treatment). Results showed that among patients treated with dupilumab, the proportion of patients achieving an Eczema Area and Severity Index (EASI) of 75 after treatment with Ebglyss was 57% at Week 16 and 60% at Week 24. In addition, among patients who had an inadequate response to sarilumab, 46% achieved an EASI-75 at Week 16 on Ebglyss. These results were similar to those observed in two Phase III studies (ADvocate 1 and ADvocate 2) which evaluated the clinical utility of Ebglyss monotherapy in dupilumab-naïve patients. This confirms its competitive advantage, particularly as an alternative option for atopic dermatitis patients who have not responded to Dupixent, which owns the largest share of the atopic dermatitis treatment market. According to the drug research institution IQVIA, Dupixent generated KRW 105.2 billion in sales in 2022, but last year's pediatric reimbursement expansion led to a significant increase in sales to KRW 143.2 billion. In Q1 this year, the drug generated KRW 40.5 billion in sales, with further sales growth expected. Currently, Lilly Korea has applied for Ebglyss’s reimbursement in Korea. However, due to the time required to review its reimbursement, the drug will first be launched without reimbursement early next year. However, it is expected that the drug’s reimbursement approval will be a top priority for Lilly to enter the market even after the launch of Ebglyss, as it is difficult to penetrate the market due to the fact that several therapies, including Dupixent and JAK inhibitors, have received reimbursement. What Lilly is looking forward to is the possibility of allowing switching between treatments in severe atopic dermatitis. According to industry sources, HIRA established the standards for switching between biologics and JAK inhibitors through expert discussions in September. Although the follow-up procedures such as negotiations with the NHIS are scheduled, the fact that discussions have been initiated is receiving positive evaluations. “Due to the nature of severe atopic dermatitis, there are patients who cannot see an effect with currently available treatments, so I think there will be a demand to use Ebglyss,” said a professor of dermatology at University A Hospital. ”There is a positive trend for switching, but Ebglyss is not yet reimbursed, so it will be important to see whether it will be reimbursed in the future.”
- Company
- Oral ALS drug 'Radicava' likely to land in KOR
- by Eo, Yun-Ho Oct 31, 2024 05:55am
- Product photo of Radicava. 'Radicava,' an oral drug for the treatment of amyotrophic lateral sclerosis (ALS), is expected to be commercialized in South Korea. Sources said that Mitsubishi Tanabe Pharma Korea's Radicava (edaravone) is under consideration for domestic approval. The drug is a treatment for ALS, formerly known as Lou Gehrig's disease. Radicava is an oral suspension. It can reduce patient burden by lowering the number of hospital visits and pain compared to conventional drugs designed for intravenous (IV) injection. Radicava received accelerated approval designation from the U.S. Food and Drug Administration (FDA) in October 2019. The drug was approved in May 2022. It has significantly reduced the administration time compared to IV injection. Unlike IV injection administered as a single daily dose as a 60-minute intravenous drip infusion after 2 ampules (edaravone 60 mg) diluted in saline, 'Radicava ORS' takes only a few minutes to administer. Mitsubishi Tanabe Pharma has conducted a comprehensive clinical development program for 'edaravone' IV injection and oral formulation for over 10 years. The basis of 'Radicava ORS' approval was the Phase 3 MCI186-19 study, which involved 137 patients with ALS, in addition to several research data. In the MCI186-19 study, the ALS Functional Rating Scale-Revised (ALSFRS-R) was used to monitor the disease at 24 weeks. ALSFRS-R is a verified assessment tool. The results showed that the 'edaravone'-treated group had a 33% reduction in the loss of body function compared to the placebo group. Additionally, the company conducted seven Phase 1 clinical pharmacological studies. They have investigated the pharmacokinetics, safety, drug-to-drug interaction, dosage, bioavailability, and biological equivalence of 'Radicava ORS' in healthy patients or in patients with ALS who have or do not have percutaneous endoscopic gastrostomy (PEG) tube or NG tube. Also, its Phase 3 clinical study demonstrated the safety and drug tolerance profile of 'Radicava ORS' treatment at 24 weeks in 185 patients with ALS. The company is conducting a Phase 3 study evaluating the long-term safety and drug tolerance over 96 weeks. Meanwhile, Radicava received domestic approval as 'Radicut' oral formulation in December 2015. Currently, it is approved as 'Fra-Cut Inj' in South Korea.
- Company
- Pfizer's Q3 sales 31%↑amid increased demand for COVID-19
- by Son, Hyung Min Oct 31, 2024 05:55am
- The global pharmaceutical company Pfizer's sales are increasing compared to the previous year. Pfizer's growth has been driven by the sales of COVID-19 vaccines and treatments such as Paxlovid and Comirnaty. According to industry sources on October 30, Pfizer's sales in Q3 recorded US$17.72 billion (about KRW 24.48 trillion), up 31.2% year-over-year (YoY). Pfizer's combined sales from Q1 to Q3 were US$45.864 billion (about KRW 63.47 trillion), up 2.0% from the same period last year. Pfizer's sales growth in Q3 has been driven by COVID-19 medications. Paxlovid, a COVID-19 treatment, generated US$ 2.73 billion in Q3, up 1,238.1% YoY. Sales performances of Paxlovid (dark blue) and Comirnaty (light blue) (unit: US$ 1 million) in 2023 and 2024. The changes in the demand for COVID-19 medications significantly impacted Pfizer's sales. After recording US$4.069 billion in Q1 of 2023, Paxlovid generated US$143 million in Q2, down 96.4%. This is due to the decreased demand for COVID-19 medications in line with the time of the endemic announcement. However, many countries have recently focused on securing treatments as COVID-19 patients are on the rise due to new variants such as JN.1. The Korean government has listed Paxlovid for insurance reimbursement this month as part of its effort to secure treatments. The COVID-19 vaccine, Comirnaty, has recorded US$1.422 billion in Q3 of 2024, up 8.9% from the previous year. As the demand for the Comirnaty vaccine significantly dropped, the sales dropped to US$195 million in Q2. Pfizer released Comirnaty JN.1 this year to prepare against new mutations. The company also launched 'Comirnaty JN.1 0.033,' a COVID-19 vaccine for infants, and is expecting a sales turnaround. Besides the COVID-19 medications, Vyndaqel products significantly drove sales growth. Vyndaqel products generated sales in Q3 of US$1.447 billion, up 62.2% from the previous year. Vyndaqel products include 'Vyndaqel,' 'VYNDAMAX,' and 'VYNMAX,' which are used to treat amyloid multiple sclerosis and cardiomyopathy. Pfizer has expanded indications for these products to increase their use in countries worldwide. Pfizer expects growth of new drugs secured from acquiring Seagen. In March 2023, Pfizer acquired Seagen, a company specializing in antibody-drug conjugate (ADC), for US$43 billion (about KRW 55 trillion). Seagen developed various ADC cancer drugs, including Adcetris, Padcev, and Tukysa. Padcev, a drug approved to treat urothelial cancer, generated sales in Q3 of US$409 million, and Tukysa, a breast cancer treatment, recorded US$124 million. Adcentris, which is used for blood cancers, raised US$268 million, contributing to Pfizer's sales growth. As a mid-to-long-term strategy to foster growth, Pfizer has set a goal to strengthen its presence in the anticancer drug field by developing eight new drugs with sales of over US$1 billion (KRW 1.3 trillion) by 2023. Pfizer plans to establish a new blockbuster drug portfolio around Seagen's ADC, in addition to its targeted anticancer agents, such as Ibrance for treating breast cancer and Lorviqua for treating lung cancer. Additionally, Pfizer aims to reduce its expense by US$4 billion (about KRW 5.2 trillion) by the end of this year through the Cost Realignment Program. Pfizer announced that it plans to save an additional US$1.5 billion by 2027. Pfizer's Headquarters is also discussing restructuring. This month, the company dismissed employees from its Sanford, North Carolina, U.S. manufacturing plant.
- Company
- NIP inclusion of HPV vaccines on the horizon
- by Whang, byung-woo Oct 31, 2024 05:55am
- Amid high interest in the expansion of the National Immunization Program (NIP) to include HPV vaccines, the possibility of its inclusion in 2026 has arisen in Korea. Although the agenda is yet in the planning stage, attention is being paid to whether it can gain substance in line with the NA budget deliberation discussions next month. The NA Audit by the Health and Welfare Committee made 12 written inquiries related to HPV or the HPV vaccine this year. The inclusion of the HPV vaccine was mentioned in the last NA audits in 2022 and 2023, but interest in this year's audit was particularly high due to the interest of the ruling and opposition parties as the issue was included in the government's major national agenda. In response to the NA Audit inquiry, the Korea Disease Control and Prevention Agency answered that it had prepared the grounds for the introduction through cost-effectiveness analysis, and secured the feasibility of its introduction through priority assessment. In fact, in the study 'Establishing a Mid- to Long-term Plan for the Introduction of NIP,' including Gardasil 9 in the NIP for 12-year-old girls was ranked third in the overall priorities, and the vaccination of 12-year-old boys with Gardasil 9 was ranked sixth. However, regarding its future expansion plans, the KCDA provided a cautious response, saying that expanding subjects and introducing vaccines in the NIP requires a cautious approach due to the large budget investment required. The KDCA said, “We will closely discuss the introduction plan within the government while comprehensively considering age and gender characteristics, disease burden, vaccine availability, and the budget requirements.” However, the KCDA also provided direction on the timing of the expansion of HPV vaccination for boys in response to a written inquiry from NA Rep. Jin-sook Jeon (Democratic Party of Korea). According to the KDCA’s “Achievements and Plans for Expanding HPV Vaccination to Boys,” the KDCA plans to secure funding for expanding the target population and introducing a new vaccine in 2025 and consider introducing a new vaccine from 2026. If the agency secures the required funding, it is analyzed that NIP vaccination of boys for HPV may be possible in 2026. As HPV vaccination is on the government's agenda, the KCDA agrees on the need to introduce the vaccine, and academics and experts have emphasized the effectiveness of its addition to NIP, the industry expects that there will be no major hurdles once the budget issue is resolved. The budget issue is also likely to be resolved as the National Assembly plans to rediscuss the agency's budget cuts. Lawmakers on the National Assembly's Health and Welfare Committee are expected to discuss increasing the budget for NIPs during their budget review in November. According to the KCDA's 2025 budget and fund management proposal that it submitted in August, next year's NIP budget is 24.9% lower than this year's, but if this budget is increased, the inclusion of the HPV vaccine in NIP is likely to be discussed actively. However, it is unclear which vaccine will take center stage even if the budget is increased, as there are currently a number of vaccines that are in need of expansion to NIP, including the shingles vaccine. MSD Korea, which currently owns Gardasil 9, an HPV vaccine, said it will continue discussions with the government about expanding the NIP. “We will actively engage in discussions with the government, including the KDCA, on expanding NIP for HPV vaccines,” said an MSD representative.
- Policy
- Seretide withdraws from Korea due to poor performance
- by Lee, Tak-Sun Oct 31, 2024 05:55am
- GSK's asthma inhaler 'Seretide' is withdrawing from the domestic market. Once the market leader in the market, it seems that the company is reorganizing the product line as its performance has recently declined due to the entry of new products. According to industry sources on the 30th, GSK recently sent letters to long-term care organizations and distributors to notify them of the withdrawal of 6 seretide items and the removal of their reimbursement listing. The 6 currently licensed Seretide products are Seretide 100 Diskus, Seretide 250 Diskus, Seretide 500 Diskus, Seretide 50 Evohaler, Seretide 125 Evohaler, and Seretide 250 Evohaler. Among those, 3 of the Seretide Evohaler formulations have already withdrawn from the market as of April 29th. The remaining 3 Discus formulations have also applied for withdrawal and are expected to be removed in the near future. “We have carefully considered the fact that sufficient alternatives to the Seretide product line already exist in the Korean market and have decided to withdraw the Seretide product line in Korea to simplify and concentrate our respiratory portfolio,” said GSK. The company said the expected date of the items’ reimbursement withdrawal is Dec. 1, with prescribing and reimbursement available for approximately 6 months until the end of May 2025. Seretide was once the leading asthma inhaler in South Korea, but it has been on a downward spiral in recent years due to the entry of its generics and new drugs. Sales of Seretide Diskus have fallen to KRW 12.2 billion in 2019, KRW 11.7 billion in 2020, KRW 9.1 billion in 2021, KRW 7.6 billion in 2022, then to KRW 1.7 billion last year, according to IQVIA. Seretide Evohaler also generated only KRW 800 million in sales last year. In addition to Seretide, GSK has other asthma-COPD inhaler products such as Arnuity, Anoro, Flixotide, Relvar, and Trelegy. In particular, sales of Relvar Elipta was KRW 36.2 billion and Trelegy Elipta was KRW 8.1 billion last year.
