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- 2026-05-04 22:46:49
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- 'Verquvo is effective in high-risk heart failure patients'
- by Son, Hyung-Min Oct 17, 2023 05:28am
- Bayer Korea held a press conference celebrating the reimbursement listing of Verquvo in Korea at the Seoul Conrad Hotel in Yeouido. on the 16th Bayer’s new heart failure drug Verquvo (vericiguat) has been granted reimbursement listing in Korea, showing effect in high-risk patients. Based on the positive clinical results, experts have been claiming that Verquvo should be considered as a second-line treatment option. On the 16th, Bayer Korea held a press conference celebrating the reimbursement listing of Verquvo in Korea at the Seoul Conrad Hotel in Yeouido. Verquvo is an oral soluble Guanylate Cyclase (sGC) stimulator that plays an important role in the signaling pathway. The drug was approved in November 2021 and listed with reimbursement in September this year. Patients with symptomatic chronic heart failure (New York Heart Association [NYHA] class II-IV) whose left ventricular ejection fraction (LVEF) is less than 45%, and who satisfy specific conditions despite over 4 weeks of standard therapy may use Verquvo in combination with other standard therapies for heart failure. The drug's efficacy was demonstrated through the Phase III VICTORIA trial, which became the basis for its reimbursement listing. The trial enrolled 5,050 adult patients with symptomatic chronic heart failure, 1,132 of whom were Asian patients. Results showed that at a median 10.8 months of follow-up, the risk of death from cardiovascular disease or first hospitalization due to heart failure was around 10% lower than that of the placebo group, and the trial met its primary efficacy endpoint with an annual absolute risk reduction of 4.2%. Also, no significant difference was observed in terms of adverse reactions or serious adverse reactions between Verquvo and placebo. Both drugs also showed similar systolic blood pressure levels. Professor Eung-Ju Kim of the Department of Cardiology of Korea University's Guro Hospital said, “Unlike most clinical trials that exclude patients with reduced renal function, 41% of the patients enrolled in the VICTORIA were seriously ill patients. Even in high-risk patients such as those with an estimated glomerular filtration rate (eGFR) of 15 or higher, Verquvo showed significant clinical benefits. In terms of safety, there was no significant difference from the placebo group.” Kim emphasized, “Another point to note is that the drug secured significant results despite the high proportion of patients that were at high risk.” the prevalence of heart failure on a continuous rise in Korea… Verquvo’s role beomce important Professor Seok-Min Kang of the Department of Cardiology at Severance Hospital With population aging the prevalence of heart failure has also been steadily on the rise. The prevalence of heart failure in the total population increased from 0.77% in 2022 to 2.58% in 2020. Hospitalization rates and overall mortality due to heart failure have also continued to increase. Currently, treatment options such as RAAS inhibitors (angiotensin receptor blockers, beta-blockers, etc.) and SGLT-2 inhibitors that were originally used as a diabetes treatment are available for heart failure, but the risk of recurrence still remains. Major global guidelines, including those issued by the American Heart Association (AHA) and the European Society of Cardiology (ESC), recommend Verquvo’s use in heart failure patients whose symptoms have worsened despite standard therapy. Domestic guidelines recommend its use at a higher level than the ESC, so Verquvo is expected to play a significant role in secondary treatment of heart failure. Professor Seok-Min Kang of the Department of Cardiology at Severance Hospital said, “Patients with chronic heart failure whose symptoms are worsening have a higher risk of hospitalization and death despite standard treatment. “We need treatment options that can lower the death and hospitalization rates from heart failure and also reduce the burden of medical expense. Considering the comorbidities the patients can have such as high blood pressure and chronic kidney disease, Verquvo, which has shown effectiveness in clinical trials, can be a viable second-line treatment option. It is an attractive drug for patients who have been hospitalized multiple times.”
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- Xtandi closes coinsurance gap with Erleada
- by Eo, Yun-Ho Oct 17, 2023 05:27am
- 'Xtandi' has virtually overcome its difference in drug price with ‘Erleada.’ Dailpharm’s coverage found out that Astellas Pharma Korea recently reached a final agreement with the National Health Insurance Service to negotiate the drug price for its prostate cancer treatment drug Xtandi (enzalutamide) to convert its indication for metastatic hormone-sensitive prostate cancer (mHSPC) to full reimbursement. The conversion will likely be made in November. Through the negotiations, the company was finally able to close the out-of-pocket coinsurance difference between its Xtandi and Janssen Korea’s ‘Erleada (apalutamide).’ Controversy was raised over Xtandi’s coinsurance rate after Erleada’s reimbursement approval. Xtandi’s reimbursement was extended in August last year through the selective reimbursement system. Selective reimbursement allows companies to waive the economic feasibility evaluations and quickly extend the scope of reimbursement for a different indication of a listed drug, but with a differentiated coinsurance rate, when the expansion of coverage for a previously listed drug is deemed urgent. Xtandi was first listed for metastatic castration-resistant prostate cancer (mCRPC) in 2014, and when the mHSPC indication became eligible for selective reimbursement, Astellas chose to receive reimbursement through the option. But the situation differed for Erleada. As a newly listed drug, selective reimbursement was not an option for Erleada, so it had no choice but to conduct a pharmacoeconomic evaluation and undergo the mandatory reimbursement procedures. Of course, the time required for reimbursement between the two drugs also differed significantly. However, the issue lay in the coinsurance disparity that arose from the patient's perspective. The out-of-pocket rate for Xtandi is 30% with selective reimbursement, but only 5% for Erleada, which received essential reimbursement and special calculations, resulting in a disparity in drug prices between these two drugs that are the same class. But this problem is soon to be resolved. Xtandi's conversion to essential reimbursement can be seen as the result of quick action made by Astellas and the government to address the issue. Considering how Erleada was listed in April, Xtandi's rate of conversion to essential reimbursement has been made quite rapidly. Meanwhile, Xtandi’s reimbursement agenda passed the Cancer Disease Review Committee in June, the Drug Reimbursement Evaluation Committee reviewed its cost-effectiveness in July, and drug pricing negotiations began in August after the company accepted the conditions set by DREC.
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- Kwangdong and Moderna strengthen partnership
- by Nho, Byung Chul Oct 16, 2023 05:24am
- Kwangdong Pharmaceutical (CEO Choi Seong-won) announced on the 13th that it will begin full-scale activities to provide medical information to medical staff about Moderna's newly updated COVID-19 vaccine 'Spikevax X', which was recently approved by the Ministry of Food and Drug Safety. Moderna's monovalent vaccine against the XBB.1.5 mutation contains neutralizing antibodies against prevalent mutations such as BA.2.86, EG.5, and FL.1.5.1, as well as the Clinical data confirming the response has been published. The vaccine approved this time is for those 12 years of age or older, and is strongly recommended for the elderly, those with weakened immune systems, and members of facilities vulnerable to infection. Kwangdong plans to engage in various activities to provide product information on Spikevax The plan is to expand its position in the coronavirus vaccine market based on its own sales and marketing competitiveness. Previously, health authorities decided to use the FDA-recommended XBB.1.5 target vaccine for fall/winter vaccination due to the prevalence of the Recently, the World Health Organization (WHO) emphasized the need for vaccination in winter, citing the increase in hospitalizations of COVID-19-infected people in Europe and other countries. An official from Kwangdong Pharmaceutical said, “Moderna's COVID-19 vaccine is a vaccine that has proven excellent protective effect and safety in all age groups, including the elderly, immunocompromised, and those with underlying diseases through clinical trials and actual use evidence (single-use vial formulation) “The advantage is that it is manufactured with an increased ease of vaccination at medical institutions.” Meanwhile, Kwangdong Pharmaceutical established a relationship with Moderna, starting with a vaccine partnership in November last year. This is the first case where Moderna has signed a business partnership agreement with a local pharmaceutical company, and the industry says that the sales power that Kwangdong Pharmaceutical has built based on collaboration with multinational pharmaceutical companies has shone. Over the past 10 years since its establishment, Moderna has transformed from a research company that led the advancement of mRNA technology to a company with a diverse portfolio of clinical trials for vaccines and treatments. Based on mRNA platform technology, 43 research and development programs are underway in the fields of infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune diseases.
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- Lioresal Intrathecal can be prescribed in general hospitals
- by Eo, Yun-Ho Oct 16, 2023 05:24am
- The skeletal muscle relaxant and antispastic ‘Lioresal Intrathecal (baclofen injection)’ may now be prescribed in general hospitals in Korea According to industry sources, Novartis' Lioresal (baclofen), which will be supplied through the Korea Orphan & Essential Drug Center, has passed the Drug Committees (DCs) of tertiary hospitals including the Seoul National University Hospital and Seoul Asan Medical Center. Lioresal was listed for reimbursement last June. It is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses. It is reimbursed for when administered in patients who show insufficient response to orally administered muscle relaxants or cannot receive the drug due to side effects. The reimbursement price ceiling was set at KRW 148,375. Lioresal works by relaxing the muscles used to treat severe spasms and preventing spasms, caused by damage to the brain or spinal cord or other specific conditions. Severe spasms are caused by an injury to the brain or spinal cord or a disease and can cause muscles to feel tight, stiff, and difficult to move. Severe spasms may cause the muscles to feel locked up or cause muscles to move uncontrollably and irregularly when trying to use them. The intrathecal injectable formulation of Lioresal is used to manage such severe spasms. Meanwhile, Lioresal did not show carcinogenic potential in a 2-year study on rats. Pelvic ovarian cysts and enlarged hemorrhagic adrenal glands were observed at the highest doses (50 to 100 mg/kg) in female rats that were treated for 2 years.
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- Record number of reimbursed drugs listed in 1 yr
- by Chon, Seung-Hyun Oct 16, 2023 05:24am
- The number of drugs listed for health insurance reimbursement reached a record high in one year. After the generic market for the diabetes treatment drug ‘Januvia’ opened up, the number of reimbursed drugs expanded rapidly. With single-agent and combination-drug generics of Januvia that were approved under consignment contracts signed before the enforcement of joint development regulations pouring in, the amount of reimbursed drugs, which had been on a decline after the reform of the drug pricing system, rebounded. According to the Health Insurance Review and Assessment Service on the 12th, a total of 23,924 drugs were listed for reimbursement as of the 1st of this month. This is a 291 increase in one month from the 23,633 that were listed until last month. Last August, the total number of drugs listed for reimbursement was 23,427, which increased by 206 in September, followed by an increase of over 200 this month. Over the past 2 months, the number of drugs listed for reimbursement increased by 497 in total. This is the largest market expansion in one year after recording 24,661 in October last year. No. of drugs listed for reimbursement by month Recently, a large number of generic products containing the diabetes treatment ‘sitagliptin’ were listed for reimbursement. Sitagliptin is the active substance in the DPP-4 inhibitor diabetes drug, 'Januvia'. According to the Ministry of Health and Welfare, 284 medicines containing sitagliptin were listed for reimbursement on the 1st. Also, a total of 278 combination drugs that contain sitagliptin and another diabetes drug, metformin, in 7 dosage combinations, were listed. 6 types of sitagliptin and dapagliflozin combination drugs were also listed on the 1st. Dapagliflozin is the active substance in the diabetes treatment Forxiga. A large number of sitagliptin generics were listed last month after Januvia’s patent expiry. On the 2nd of last month, 236 sitagliptin-containing drugs, including 163 single-agent sitagliptin drugs, were listed on Korea’s reimbursement list. In fact, over the past 2 months, the number of drugs containing sitagliptin has increased significantly in the reimbursement list. The overall amount of drug coverage, which had been decreasing due to the government's drug price and licensing regulations, has rebounded with the expiration of Januvia's patent. The number of drugs listed for reimbursement has been on a decline since reaching an all-time high of 26,527 in October 2020. Last August, the total number of drugs listed for reimbursement was 23,427, which was a decrease of 3,100 in 2 years and 10 months. This indicates that over the past 2 years and 10 months, 3,100 more drugs were withdrawn or removed from the market than those newly listed for reimbursement under Korea’s health insurance. The reform of the drug pricing system in 2020 triggered this reduction in the number of new listings. The main point of the reform enforced in July 2020 was that only generics that satisfy both the ‘direct bioequivalence testing’ and ‘Regulation on Registration of Drug Substances (DMF)’ requirements may receive the highest price among generics at 53.55% of the original drug’s price. Also, the reform contains a stepped drug pricing system that lowers the price ceiling of generic drugs according to their listing period. If more than 20 generic drugs are listed in the market for a specific ingredient, the ceiling price for newly listed items thereafter can only be set by up to 85% of the existing lowest price. As the price of drugs falls drastically under this structure if the generic drug company does not develop the generic drug itself or conduct bioequivalence tests, the approval of generics that are wholly manufactured under consignments has decreased significantly. The regulatory barriers to licensing have also increased. With the implementation of the revised Pharmaceutical Affairs Act in July 2021, the number of incrementally modified new drugs and generic drugs that can be approved through a single clinical trial has been restricted. The new regulation, the so-called '1+3' regulation, contains provisions to limit the number of IMDs and generics that can be approved through a single clinical trial. If all manufacturing processes are manufactured identically with the same prescription and manufacturing method at the same manufacturing facility as the pharmaceutical company that directly conducted the bioequivalence test, the use of its bioequivalence data is limited to 3 times. This means that only 4 generic drugs can be approved through 1 bioequivalence test. Its clinical trial data can also be used for 3 other items in addition to the one by the company that directly carried out the trial. Before the reform, when a specific pharmaceutical company passed a bioequivalence test and received approval for a generic product, dozens of pharmaceutical companies often received generic approval using the same data. However, the joint development regulations rendered the ‘unlimited data copying for generic approvals' impossible. However, unlimited consignment of the recently approved sitagliptin preparation was possible because the contract was made before the implementation of development regulations. Consignment contracts entered into by pharmaceutical companies before the enforcement of joint development regulations are valid. In fact, many generics have received approval before the enforcement of joint development regulations, and are waiting to be listed with reimbursement upon expiration of the original drug's patent. According to the Ministry of Food and Drug Safety, a total of 785 drugs contain sitagliptin. Of these, 629 have been approved after 2020. 72 and 118 were approved in 2020 and 2021, respectively. Last year, 254 sitagliptin preparations were approved, and an additional 185 items were approved this year.
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- Will Paxlovid open a market for elderly people’s benefits?
- by Eo, Yun-Ho Oct 16, 2023 05:24am
- As the sense of crisis regarding COVID-19 infection is decreasing, attention is being paid to whether Paxlovid, a treatment drug, can successfully be registered for insurance benefits. Pfizer Korea is currently proceeding with the registration process for Paxlovid, which has been approved as an oral treatment for COVID-19, with the goal of listing it for insurance benefits in the first half of next year. The government announced that it will pursue the registration of Paxlovid insurance benefits within the first half of 2024 in accordance with the plan to ease the COVID-19 crisis level adjustment roadmap. This measure is due to the fact that Paxlovid, which is currently supplied free of charge, is about to be converted to a paid supply like general medicines. When stage 2 of the COVID-19 crisis level adjustment roadmap, which further relaxes the quarantine system, is implemented next month, COVID-19 will transform into a level 4 infectious disease like influenza. The government said that even if the second stage roadmap is implemented, it will provide oral COVID-19 treatments free of charge for the time being, but it is unknown how long the free provision period will last. Therefore, the smooth prescription of Paxlovid will be determined depending on whether or not it is registered for future benefits. The need for COVID-19 measures for the elderly was also raised during the National Assembly audit. At the Ministry of Health and Welfare inspection held at the National Assembly on the 11th, Secretary of the Health and Welfare Committee Koh Young-in (Democratic Party of Korea) said, "As COVID-19 has reached an epidemic level, free support such as PCR tests and treatments has been discontinued, and starting next year, health insurance coverage will also be extended to general medical care. "The system changes. For the elderly, the fatality rate is 50 times that of those in their 40s, and the treatment costs from about 800,000 won to 1 million won, and when the patient copayment becomes 30%, the treatment cost is about 300,000 won," he pointed out. The government also says it will consider a plan for this. Minister of Health and Welfare Cho Gyu-hong said, "There are cases where the epidemic trend increases at certain times, but it is currently decreasing. The transition to the medical system is being decided after listening to the opinions of the Korea Disease Control and Prevention Agency and experts." He added, "I agree that the fatality rate is still high for the elderly. “There is a burden on the cost of the treatment, so we will consider a plan. Even if it is not necessarily free support, we will discuss a plan to ease the burden,” he replied.
- Company
- Bayer Korea appoints JinA Lee as new Managing Director
- by Eo, Yun-Ho Oct 13, 2023 05:29am
- JinA Lee, new Managing Director of Bayer Korea Bayer Korea appointed JinA Lee (54) as the new Managing Director. With this appointment, Lee will become the first Korean head to be appointed to the establishment of Bayer Korea. The company recently announced through an internal announcement that it will appoint JinA Lee, former CDH (Country Division Head) of Pharmaceuticals and Managing Director of Bayer Thai, as the new Managing Director of Bayer Korea as of November. The current Managing Director, Freda Lin, who has led the Korean subsidiary since December 2019, will resign accordingly. After graduating from the Department of Pharmacy at Duksung Women’s University, Lee worked at Roche in 1994 and Merck Serono in 2006, and joined Bayer as the head of the cardiovascular disease BU in 2013. In 2018, she was assigned to take responsibility for New Launching Brand Lead at Bayer headquarters in Germany. She returned to Korea in February last year. From October 2018, Lee also served as the interim head of the Korean subsidiary's pharmaceutical BU due to the appointment of former Managing Director Ingrid Drechsel to Bayer Turkiye. Bayer consists of three divisions - Pharmaceuticals, Consumer Health, and Crop Science. The company has been led by foreigners including Friedrich-Wilhelm Gause, Niels Hessman, and Ingrid Drechsel as heads, and the appointment of Managing Director JinA Lee is the company’s first transition to a domestic head.
- Company
- Companies entering the Middle East caught in the crossfire
- by Kim, Jin-Gu Oct 12, 2023 05:38am
- On the 7th (local time), the Palestinian armed political faction Hamas attacked Israel (CNN photo) On the 7th (local time), the Palestinian armed political faction Hamas attacked Israel (CNN photo). As the situation in Israel and nearby regions has deteriorated rapidly due to large-scale airstrikes by the Palestinian armed political faction Hamas, domestic pharmaceutical and bio companies that have entered or are seeking to enter the Middle East appear to be paying close attention. The prevailing view is that the immediate damage will not be significant, but there is also the view that if the conflict spreads throughout the Middle East region, disruption to each company's long-term plans will be inevitable. Middle East pharmaceutical export companies, “Israel’s share is small… the damage will not be significant.” According to the pharmaceutical industry on the 11th, companies that export pharmaceuticals directly to Middle Eastern countries expect that the immediate damage from this dispute will be minimal. This is because Israel, where the conflict occurred, does not have a large export volume, and in the case of neighboring Middle Eastern countries, the terms of pharmaceutical export contracts are structured so that it is difficult to cause immediate damage. An official from a pharmaceutical company that exports medicines to Saudi Arabia and the United Arab Emirates (UAE) said, "Domestic pharmaceutical companies trading with Middle Eastern countries are generally not very shaken." “Because it’s not big,” he said. In fact, according to the Korea Customs Service, medicines exported from Korea to Israel last year amounted to $7.74 million. Compared to major export countries such as the UAE ($30.29 million), Saudi Arabia ($26.04 million), Egypt ($22.85 million), and Iraq ($18.88 million), it is around 25-40%. This year is also similar. As of last August, pharmaceutical exports to Israel amounted to $3.79 million, less than half of those to Saudi Arabia ($24.31 million), the UAE ($17.05 million), Iraq ($12.4 million), and Egypt ($9.77 million). The terms of contracts with Middle Eastern countries are also cited as a reason why immediate damage is not expected. It is said that usually, pharmaceutical export contracts with countries where there is a risk of conflict are concluded with the supply of medicines after receiving an advance payment. An official from another pharmaceutical company that exports medicines to Middle Eastern countries said, “In the case of major Middle Eastern countries where there is a possibility of conflict, contracts are written by exchanging cash instead of a letter of credit transaction.” He added, “Usually, 100% is received in advance or 50% is paid first. “We receive the remainder after supplying medicine,” he explained. He added, “Generally if a contract cannot be fulfilled due to war or other reasons, the contract period is automatically extended unless there are special circumstances.” However, it was also predicted that damage would be inevitable if this conflict spreads to nearby countries and is prolonged. He said, “The key export countries are Saudi Arabia, Egypt, and the UAE. We are closely watching the possibility of conflict spreading to these countries.” SK Bioscience, SK Biopharmaceuticals, Daewoong, etc. seeking to enter the Middle East “There will be no significant impact as it is in the early stages” Large pharmaceutical companies seeking to enter the Middle East region are in a similar mood. As expansion into the Middle East region has not yet been confirmed, the prevailing view is that the damage will be minimal. An official from SK Bioscience said, “We are just beginning to explore expansion into the Middle East,” and added, “This dispute will not have a significant impact on business discussions.” SK Bioscience proposed a partnership to build a base vaccine hub in the Middle East early this year. SK Bioscience's plan is to enter the Middle East market based on its successful experience in developing a COVID-19 vaccine. Officials from SK Biopharmaceuticals and Daewoong Pharmaceutical also agreed, saying, “We are closely monitoring the local situation, but we do not expect there to be a significant impact on the existing plan.” Last August, SK Biopharmaceuticals signed a technology export contract for the epilepsy treatment drug 'Cenobamate' with Middle Eastern pharmaceutical company Hikma. In addition, it was decided to grant priority negotiating rights to Hikma when products are launched in 16 Middle Eastern countries, including Saudi Arabia, the UAE, and Egypt. Daewoong Pharmaceutical applied for product approval for Fexuclue, a P-CAB-based gastroesophageal reflux disease treatment, to the Saudi Arabian health authorities at the beginning of the year. In May last year, product approval for botulinum toxin ‘Nabota’ was received in Saudi Arabia. Daewoong Pharmaceutical plans to target the Middle East region, including Saudi Arabia, focusing on Nabota and Fexuclue. In the case of Samsung BioLogics, it signed a CDMO contract with the Israeli pharmaceutical company KAHR Medical in 2021 for an immunotherapy drug (substance name: DSP502). It provides a one-stop service from cell line development of DSP502 to clinical raw drug production, finished product production service, and IND approval. Regarding this, a Samsung BioLogics official said, “CDO contracts usually do not have a long supply period.” He said, “It has been two and a half years since the contract was signed, and the contractual supply is now almost complete.”
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- Bukwang Pharm’s Ozanex lands in major general hospitals
- by Nho, Byung Chul Oct 12, 2023 05:37am
- Bukwang Pharm announced that its new topical antibiotic Ozanex cream(ozenoxacin)’ recently passed the drug committee of Seoul St.Mary’s Hospital and can be prescribed in major general hospitals in Korea. Ozanex, a topical antibiotic that Bukwang was first to introduce to Korea, is currently being prescribed at various major general hospitals nationwide including Seoul St.Mary’s Hospital, Samsung Medical Center, Seoul National University Hospital, Sinchon Severance Hospital, Asan Medical Center, Hanyang University Hospital, Korea University Hospital, Chonnam National University Hospital, and Kyungpook National University Hospital. Ozanex was approved by the U.S. FDA in December 2017 and newly released in Korea in December last year it is a prescription drug that is effective against staphylococcus aureus(S. aureus) and Streptococcus pyogenes(S. pyogenes), the main causes of infectious skin diseases, and is indicated for the short-tem topical treatment of impetigo in patients aged 2 months and older1. For infectious skin diseases, topical antibiotics need to be used for an appropriate period at an appropriate dose according to an expert's accurate diagnosis and prescription to reduce the development of resistance and provide effective treatment. According to Professor Jung-Soo Kim of the Department of Dermatology at Hanyang University Guri Hospital, “Topical antibiotics that can treat impetigo include ozenoxacin and mupirocin. Ozenoxacin is a new non-fluorinated quinolone antibiotic that offers improved resistance and safety. Staphylococcus aureus and Streptococcus pyogenes are the most common cause of various skin infectious diseases, including impetigo. Oozenoxacin demonstrated bactericidal activity against these two strains. In particular, in a large-scale clinical study that involved patients with impetigo, the bacterial culture test showed bacteriological eradication as early as day 3 of treatment, with a negative conversion rate of 87%. Based on such results, HCPs expect the drug will effectively reduce the contagiousness of impetigo in the early stages. A Bukwang Phamr official said, “Ozanex will settle as a new option for infectious skin diseases including impetigo. We expect Bukwang’s various skin disease treatments to support HCPS and their treatment practices in Korea.”
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- Pricing negotiations for Koselugo’s reimb start after 2 yrs
- by Eo, Yun-Ho Oct 11, 2023 05:36am
- Koselugo, which is a treatment for pediatric patients with neurofibromatosis, has entered its last gateway to receiving reimbursement in Korea. According to industry sources, AstraZeneca has recently started drug pricing negotiations with the National Health Insurance Service to set the insurance price for its new neurofibromatosis drug, Koselugo. Whether Koselugo, which passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review on the 7th of last month after 3 attempts, will be able to settle on a final drug price during negotiations and be listed for reimbursement remains to be seen. This drug has remained non-reimbursed for 2 years now. It has only been able to enter the NHIS negotiation stage after much trouble. Koselugo, which was designated as the first drug subject to fast-track review in October 2020, obtained marketing authorization from the Ministry of Food and Drug Safety on May 28, 2021, and submitted an application for its reimbursement in May 2021, but failed to pass the DREC gateway in March last year. The company quickly supplemented the data and restarted discussions in April this year, bringing the situation to what it has become now. Until now, patients had to rely only on symptomatic treatment for neurofibromatosis due to the lack of an appropriate treatment option. Neurofibromatosis is a rare disease. 85% of the patients with neurofibromatosis have neurofibromatosis type 1 (NF1), which is caused by a mutation in the neurofibromin tumor suppressor gene located on chromosome 17. The incidence of NF1 is approximately 1 in 3,000. Its first symptom is café-au-lait spots 1 to 3 centimeters in diameter early in life. Since then, the patients have experienced Optic nerve gliomas (brain tumor) at age 6, and scoliosis around age 6-10. In adulthood, lisch nodules, or iris hamartomas, occur predominantly in patients with NF1. If possible, treatment includes surgical removal of affected sites or chemotherapy and radiation therapy. However, most recur even after surgery, and as the patient must undergo a major operation, its treatment puts an immense burden on both the medical staff and the patient. Recurrence is even more frequent among pediatric patients, which means the patients must live with painkillers and often suffer from speech and movement disorders even after receiving several operations. Koselugo was jointly developed by AstraZeneca and MSD. The drug blocks the activation of MEK to inhibit the growth of cell lines. In the Phase II SPRINT study that became the basis for Koselugo’s approval, Koselugo reduced tumor size by over 20% in 68% of the patients who received Koselugo and achieved its primary endpoint of ORR. Also, 82% of the patients who showed a partial response had sustained responses lasting at least 12 months. In contrast to the non-treated patients, half of whom experienced disease progression 1.5 years after diagnosis, only 15% of patients using Koselugo showed disease progression at year 3.
