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- 2026-04-09 21:05:42
- Company
- MSD Korea appoints Albert Kim as new managing director
- by Eo, Yun-Ho Jul 26, 2023 05:41am
- General Manager Albert Kim On the 25th, MSD Korea announced that it has appointed Albert Kim (pic) as the new managing director, effective August 1st. The new managing director Kim is a seasoned pharma and bio expert who has served in global and Korean pharmaceutical bio companies for more than 25 years, accumulating extensive experience in local and global markets, including Korea. Kim has majored in Biochemistry at McMaster University and acquired an MBA at Schulich School of Business at York University, Canada. In various leadership positions, Kim led teams and groups in various countries and regions other than Korea, including the U.S., EU, Canada, Brazil, Switzerland, Sweden, Thailand, Singapore, Malaysia, and Taiwan. Before being appointed as a managing director of MSD, Kim served as the Vice President of the Commercial Division at Samsung Bioepis, where he oversaw the launch and growth of key major product portfolios in the U.S. and EU, in charge of global commercial strategy and operations. Kim had also served as the Chief Financial Officer (CFO) at Novartis, and as the founding General Manager of Menarini Korea where he led the establishment and growth of the Korean branch. GM Albert Kim said, “We will continue to live true to MSD's long-standing mission of saving and improving lives by improving medical access to MSD Korea's innovative medicines, vaccines, and pipelines.”
- Policy
- All Sandoz products removed from Korea’s reimb list
- by Lee, Tak-Sun Jul 26, 2023 05:41am
- All products that were registered by Sandoz Korea will be removed from Korea’s reimbursement list. The company had withdrawn from the Korean market in June. With the removal, the name Sandoz will no longer be visible in the Korean market. However, a grace period of 6 months has been granted for some items, and reimbursement for such drugs is valid until February 1 next year. Its CNS (central nervous system) items that have solidified their position in the domestic market will be transferred to Samil Pharmaceutical, and be changed accordingly in the reimbursement list. According to industry sources on the 25th, 18 products from Sandoz Korea will be removed from the reimbursement list as of August 1st. The company had voluntarily withdrawn the licenses of the 18 products. Currently, there are no effective Sandoz products on Korea’s drug approval list. All of them were withdrawn or were deleted in line with the company’s business closure in June. Sandoz withdrew from the Korean market following its spin-off decision made by its parent company, Novartis. Sandoz will be focusing on the biosimilar business in Europe. The license of some of the CNS (Central Nervous System) products sold by Sandoz in Korea has already been transferred to Samil Pharmaceutical. Samil received the sales and distribution rights to the antidepressant ‘Mirtax,’ ‘Sandoz Estical Opram,’ ‘Sandoz Paroxetine,’ the schizophrenia treatment ‘Sandoz Olanzapine Tab,’ and insomnia treatment ‘Sandoz Zolpidem.’ Accordingly, the name of the pharmaceutical company on the reimbursement list will also be changed from Sandoz to Samil Pharm. As a result, no Sandoz products will be left on the reimbursement list. Sandoz Korea had first established its branch in Korea in 2003 as Hexal Korea. Afterward, the company name was changed to Sandoz Korea, and it remained active in the generic market for 20 years thereafter, which is rare for a foreign pharmaceutical company, showing strength in the CNS and anticancer drug markets. Meanwhile, reimbursement for some generic items of its parent company, Novartis Korea, was also removed from the reimbursement list along with the deletion of the Sandoz products.
- Company
- Two types of JAK inhibitors start a full-scale competition
- by Eo, Yun-Ho Jul 26, 2023 05:40am
- The competition between two types of JAK inhibitors in the field of juvenile atopic dermatitis has begun in earnest. Following AbbVie Korea's Rinvoq last April, Pfizer Korea's Cibinqo was covered by insurance for the indication of atopic dermatitis in children and adolescents from this month (July). Cibinqo stopped the reimbursement process after passing the Pharmaceutical Reimbursement Criteria Subcommittee of the Health Insurance Review and Assessment Service in August last year, and at the beginning of this year, it expanded the scope from adults to teenagers over 12 years of age and resubmitted the application for reimbursement. After passing the Pharmaceutical Reimbursement Evaluation Committee in March, the drug price negotiations were concluded with HIRA in June. In terms of atopic dermatitis as a whole, the competition for JAK inhibitors is a three-way battle, but Lilly Korea's Olumiant has no indications for children and adolescents. Therefore, Rinvoq, Cibinqo, and Sanofi Korea's Dupixent, an interleukin drug, are expected to compete in this area. However, as Dupixent is relatively expensive and there are detailed differences in indications, competition among JAK inhibitors is expected to be fiercer. The prescription price of Rinvoq15mg for severe atopic adolescents aged 12 to 17 is 59,493 won, and the prescription cost of Cibinqo for the same age group is 53,217 won. The case of adults is similar. Rinvoq 30mg is 94,884 won and Cibinqo 200mg is 77,826 won, which is a similar drug price. The general hospital prescription environment is also stable on both sides. Both Rinvoq and Cibinqo have passed drug committees (DCs) of major medical institutions nationwide, including the big five tertiary hospitals, including Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Shinchon Severance Hospital. In the case of Rinvoq, the high-dose (30mg) formulation has also been coded at 30 medical institutions, including Seoul Asan Medical Center, Shinchon Severance Hospital, Seoul St. Mary's Hospital, and the National Medical Center. The two drugs can be applied for insurance coverage among adults (18 years of age or older) and adolescents (12 to 17 years of age) patients with chronic severe atopic dermatitis who have symptoms lasting for more than 3 years ▲ who are not properly controlled even after administering a topical treatment for 4 weeks or more as the first treatment, ▲ there is no response or cannot be used due to side effects, etc. even after administering systemic immunosuppressants for more than 3 months, ▲ and ▲ have an EASI of 23 or higher before starting administration.
- Policy
- Yuhan’s low-dose atorvastatin combo receives reimb
- by Lee, Tak-Sun Jul 25, 2023 05:46am
- Just as Hanmi Pharm preoccupied the market with its low-dose (2.5mg) rosuvastatin, Yuhan Corp has its hopes for its low-dose (5mg) atorvastatin to do the same. The companies’ strategy is to reduce the risk of side effects while maintaining efficacy with low-dose statins. According to industry sources, Yuhan Corp’s ‘Atovamibe Tab 10/5mg’ will be listed for reimbursement starting on August 1st. The drug is a combination of atorvastatin calcium trihydrate 5mg and ezetimibe 10mg and is the first fixed-dose combination drug for hyperlipidemia that combines 5 mg of atorvastatin with ezetimibe. No other atorvastatin 5mg product – as a combination drug or a single agent- has been listed for reimbursement until now. The atorvastatin+ ezetimibe combination is well known for the original Atozet (MSD Korea). The rosuvastatin+ ezetimibe combo market is estimated to be at KRW 500 billion, and the atorvastatin + ezetimibe combo market about KRW 200 billion. Recently, the popularity of low-dose statins has been rising in this market. In December 2021, Hanmi Pharmaceutical introduced Rosuzet Tab. 10/2.5mg which contains rosuvastatin 2.5mg, and fostered it as a blockbuster worth KRW 10 billion a year, after which Daewoong Pharmaceutical, Yuhan Corp, Samjin Pharm, and Shinpoong Pharm joined the market. The rosuvastatin+ ezetimibe combinations were evaluated to be more effective than statin monotherapies while minimizing the risk of side effects such as diabetes and myopathy that arise from the use of existing high-dose statins. Yuhan Corp’s Atovamibe 10/5mg is also similar in concept to the rosuvastatin 2.5mg + ezetimibe combo. The drug demonstrated a superior LDL-C change rate to treatment with atorvastatin 5mg monotherapy and the ezetimibe 10mg monotherapy at 8 weeks. The insurance ceiling price of Atovamibe 10/5mg is KRW 637 and was listed at a price lower than the calculated price. At KRW 637, it is priced at the same level as Atovamibe 10/10mg. Therefore, patients can choose 10/5mg or 10/10mg Atovamibe Tab as their initial dose without burden. Yuhan Corp is also currently the first in Korea to receive approval for an atorvastatin 5mg single-agent drug as well. With those products, Yuhan Corp is expected to bring a sensation as a pioneer in the low-dose atorvastatin market.
- Company
- Decreased drug price and inclusion of impurities in Januvia
- by Jung, Sae-Im Jul 25, 2023 05:46am
- Nitrosamine impurities management hidden ambush... The standard will be significantly strengthened. The diabetes treatment 'Januvia series', for which sales rights were recently transferred to Chong Kun Dang, is experiencing sluggishness in the prescription market. Following last year's drug price cut, the company suffered voluntary withdrawals due to excess impurities in the first half of this year, and the scale shrank by 13% in two years. According to UBIST, a pharmaceutical market research institute, on the 24th, the total outpatient prescriptions for the Januvia series (Januvia, Janumet, and Janumet XR) in the first half of this year were 75.4 billion won, down 8% from 81.9 billion won in the same period last year. By item, Janumet decreased by 9% from 36.2 billion won in the first half of last year to 32.9 billion won this year. Then, Januvia 10% (21.7 billion → 19.6 billion won) and Janumet XR 5% (24 billion → 22.9 billion won) each decreased. Sitagliptin is a treatment for type 2 diabetes. It is a representative DPP-4 inhibitory mechanism that led the domestic diabetes market. The Januvia series consists of a total of three products. ▲Sitagliptin single drug 'Januvia' ▲Metformin + Sitagliptin combination drug 'Janumet' ▲Janumet extended-release formulation 'Janumet XR' with enhanced convenience. Janumet, Janumet XR, and Januvia have the highest prescriptions in that order. MSD opened the DPP-4 inhibitor market with the domestic approval of Januvia and Janumet in 2007, and in 2013, it had a lineup with Janumet XR. DPP-4 inhibitors have become mainstream by replacing existing diabetes drugs with the advantage of having a good blood sugar-lowering effect and little concern for side effects. Among them, the Januvia series has emerged as the most widely used DPP-4 inhibitor in Korea. It is 2021 when prescriptions for the Januvia series reach their peak. The Januvia series, which recorded 164.3 billion won in 2019 and 173.8 billion won in 2020, raised 176.3 billion won in 2021. Janumet 79.2 billion won, Janumet XR 50 billion won, Januvia 47.1 billion won. In particular, the number of outpatient prescriptions recorded by the three products in the second half of 2021 was 89.4 billion won, the largest half-year prescription amount ever. The decline of the Januvia series started last year. The biggest factor is the drug price of the Januvia series. MSD has signed a 'trade-off' agreement with the government to expand reimbursement for Keytruda, an immuno-oncology drug that it has been pushing for. It is content that voluntarily lowers the price of the Januvia series in exchange for allowing the expansion of the primary lung cancer benefit for Keytruda. With this agreement, the prices of all three Januvia products have been lowered by an average of 6% since March last year. In the aftermath of drug price cuts, last year's Januvia series recorded 81.9 billion won in the first half and 80.6 billion won in the second half, down 6% and 10% year-on-year. In the first half of this year, the decline was even greater with an 8% decline. It is analyzed that there was an additional drug price cut of about 1% due to the expansion of insurance coverage for diabetes drugs and that some products were affected by voluntary recalls due to the occurrence of impurities that exceeded the standard. Compared to two years ago, the amount of prescriptions has decreased by 13%. In the second half of this year, the decline is expected to continue due to the expiration of the Januvia patent. The Januvia substance patent expires on September 1. Domestic pharmaceutical companies are preparing to release sitagliptin generics in time for expiration. If a generic with the same ingredients is registered for reimbursement, the price of Januvia is automatically reduced by 30%. A simple calculation of drug price cuts would result in about 50 billion won of annual prescriptions being subtracted. Attention is focused on the move of Chong Kun Dang, which acquired the Januvia series from MSD. Chong Kun Dang paid 45.5 billion won (down payment + milestone) to acquire all rights, including license, trademark, manufacturing, sales, and distribution of Januvia. Considering the annual prescription amount of the existing Januvia series, 45.5 billion won is an amount that can be recovered within half a year. However, considering drug price cuts and competition among generics, Chong Kun Dang is bound to be nervous. Some predict that the key to Januvia's future generic competition will be impurities. Januvia carries the risk of nitrosamine-like impurities, and the tentative daily intake is set at 246.7 ng. The global guidelines aim to lower the daily allowance to 37ng in the future. It is expected that the stricter standards will be applied at the end of the year or next year at the earliest. To this end, it is known that the Ministry of Food and Drug Safety recently instructed pharmaceutical companies to implement safety measures by setting the daily intake of Sitagliptin to 37ng. The original Januvia has already been fully prepared to meet the reinforced intake allowance. However, generic companies that have just entered the Sitagliptin market have a relatively short preparation time. It is expected that it will be a difficult fight for generic companies as it is to manage impurities within 30% of the current standard.
- Policy
- Be aware of interstitial renal tubulitis when taking Vimovo
- by Lee, Hye-Kyung Jul 25, 2023 05:45am
- When taking anti-inflammatory drugs containing Esomeprazole and Naproxen, care must be taken to prevent the occurrence of interstitial renal tubulitis. The Ministry of Food and Drug Safety recently prepared a change (draft) for permission based on the results of a review of safety information on formulations containing 'esomeprazole and naproxen' from the European Medicines Agency (EMA). The analgesic is used for the symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of gastric ulcer or duodenal ulcer associated with steroidal anti-inflammatory drugs (such as naproxen) and who are not satisfied with low-dose Naproxen or other non-steroidal anti-inflammatory drugs. Domestically approved items are LG Chem's 'Vimovo 500/20mg', Hanmi Pharm's 'Naxozol 500/20mg', Chong Kun Dang's 'Naxen S 500/20mg', SK Chemical's 'Nafmed 500/20mg', Korea PMG Pharm's 'Synflex 500/20mg', Korea Pharmaceutical's 'Esoroxen', Alvogen Korea's 'Esoroxen' Naprazole' and 7 items. If looking at the approval change plan prepared by the Ministry of Food and Drug Safety, the adverse reaction term 'interstitial nephritis' is deleted, and 'interstitial renal tubulitis' is added. A general precaution also includes 'Acute interstitial renal tubulitis: Acute interstitial renal tubulitis has been observed in patients treated with esomeprazole and naproxen-containing agents'. It is also added that acute interstitial renal tubulitis may occur at any time during the treatment period of this drug and may progress to renal failure, and that patients suspected of having acute interstitial renal tubulitis should discontinue administration of this drug and take appropriate measures. The Ministry of Food and Drug Safety said, "If you have a review opinion on the change, please submit the reason and supporting data to the Drug Safety Evaluation Division by August 7."다.
- Company
- 'Paxlovid reduces the risk of deaths in high-risk groups'
- by Jung, Sae-Im Jul 25, 2023 05:45am
- ‘Paxlovid,’ the oral COVID-19 treatment used to prevent progression to severe COVID-19, has finally removed its ‘temporary’ approval tag, 1 year and 7 months after its introduction to Korea. Although the drug has now been officially approved as a new drug, it is still not being well utilized on-site. Therefore, whether the misunderstandings and misconceptions regarding the drug can be cleared and be actively prescribed to patients by HCPs is gaining attention. The Ministry of Food and Drug Safety officially approved Pfizer’s COVID-19 treatment ‘Paxlovid (nirmatrelvir ritonavir tablets)’ on the 14th. The approval comes 1 year and 7 months after the company had received the emergency use approval (EUA) in December 2021. Paxlovid’s official approval was based on data from the Phase 2/3 EPIC-HR and EPIC-SR studies. The EPIC-HR study enrolled unvaccinated, non-hospitalized adults, aged 18 years and older, with confirmed COVID-19 who were at increased risk of progressing to severe disease. Results showed an 86% reduction in risk of COVID-19-related hospitalization or death from any cause through Day 28 in patients who initiated treatment with Paxlovid within 5 days of symptoms onset, compared to placebo. Recent real-world studies further support Paxlovid’s effect. According to a real-world study, the relative risk reduction effect of Paxlovid was confirmed in all high-risk patients regardless of whether they had been vaccinated or not. Based on this, the U.S. Food and Drug Administration (FDA) estimated in March that taking Paxlovid ‘could lead to 1,500 lives saved and 13,000 hospitalizations averted each week” in the U.S.’ Despite such supporting data, Paxlovid is not well used in Korea. The government and the company had carried out extensive promotional and education activities, but the prescription rate of Paxlovid in elderly patients remains in the 30% range, unable to break the 40% wall. Pfizer Korea Eun-Ji Kim, (COVID-19 Marketing Lead), and Hyemin Oh (Policy & Public Affairs Lead), Jae-Yoon Ryu, (Medical Sr. Manager), and Hyemin Oh (Policy & Public Affairs Lead) (Source: Pfizer Korea) On the 24th, Pfizer Korea held a meeting to celebrate the official approval of Paxlovid at its headquarters in Jung-gu, Seoul. Jae-Yoon Ryu, (Medical Sr. Manager) Eun-Ji Kim, (COVID-19 Marketing Lead), and Hyemin Oh (Policy & Public Affairs Lead) attended the event to correct the misunderstandings and explain the truth about Paxlovid. At the same time, the members shared the company’s plans on transitioning Paxlovid into a general medical system. The following are the common misunderstandings and truths about Paxlovid that were addressed at the event. # Misunderstanding 1: Paxlovid can only be used on patients with severe symptoms = Paxlovid’s is indicated for ‘the treatment of patients with mild-to-moderate COVID-19 whose condition is at high risk of progressing to severe disease, including hospitalization or death.’ However, in the field, there remains a strong impression that Paxlovid should only be used on patients whose conditions are so severe that they should be transferred to general hospitals immediately. And symptomatic therapy is still mainly used on high-risk patients with mild symptoms. This misconception is the biggest hurdle to increasing the prescription rate of Paxlovid in the high-risk group. To be clear, Paxlovid is not a symptomatic treatment- the drug was approved based on its evidence in preventing severe disease, in lowering the risk of serious illness and death in high-risk patients. Although the symptoms are getting milder with the mutation of the COVID-19 virus, the disease burden is still high and about 10 people still die from worsening COVID-19 every day. Even if the symptoms are mild, if you have any of the high-risk factors, you need to be prescribed Paxlovid. # Misunderstanding 2: Elderly patients that take many medications cannot use Paxlovid due to contraindications = That is one reason why patients find it difficult to receive Paxlovid prescriptions - Paxloivd has too many contraindications. Doctors avoid prescribing Paxlovid if a patient says they take other medications. 26 drug ingredients are known to be dangerous or are not allowed to be used in combination with Paxlovid. However, just the fact that you are using one of the 26 ingredients does not forbid your use of Paxlovid. Those who use 19 of the 26 ingredients can use Paxlovid if they discontinue use of their respective drugs or receive alternative medications. Paxlovid’s use is contraindicated only for the other 7 ingredients. # Misunderstanding 3: The drug is difficult to use as it is cumbersome to check all the contraindicated drugs = In Korea, HCPs can use the Drug Utilization Review (DUR) program to check for contraindications of each ingredient. If the doctor wants to use Paxlovid, Korea has a system in place that allows doctors to quickly check for contraindications. Of course, some ingredients like St. John’s Wort that are nutritional supplements are not listed in the DUR and have to be checked separately. However, most of the prescription drug ingredients can be checked automatically with DUR, and we have been distributing medication guides for pharmacists, educational material, and use guides for the elderly. We are also contemplating ways to increase patient convenience. For example, if patients need to be prescribed alternative medications, they have to pick through all of the medications they take to replace the ones in need. And they need to visit the pharmacy to do this. So we are trying to find ways to make it easier for patients to take alternate medications safely. # Misunderstanding 4: Paxlovid’s emergency use status will be converted and be subject to the general medical system in the first half of next year =Currently, the Korean government purchases Paxlovid in advance and supplies it free of charge to patients in need. We are discussing when this system should be converted into a general medical system. Please understand that there are still a lot of government purchases left, and we need to undergo the reimbursement process, therefore, it is not clear how its use will be converted to the private sector and whether there will be an overlapping period. However, the government and the company are continuing close discussions so that patients who need the drug do not experience inconvenience in the middle. It is not ordinary for a drug that is approved just now to be registered in the first half of next year. We will be going through all the procedures that existing new drugs go through, but are negotiating on the timeline for quicker listing. The company is doing its best to submit the data required for listing to the government in a timely manner.
- Company
- Cinqair’s quicker reimb renders reimb difficult for others
- by Eo, Yun-Ho Jul 25, 2023 05:45am
- Attention is rising on the progress of the two new asthma drugs that chose to receive reimbursement through the RSA track, unlike Cinquair. According to industry sources, GSK Korea’s ‘Nucala (mepolizumab)’ has recently been reviewed by the Health Insurance Review and Assessment Service’s Risk Sharing Agreement (RSA) subcommittee for reimbursement. However, no news has been heard for AstraZeneca Korea’s Fasenra (benralizumab)’ yet. Unlike Teva-Handok’s Cinqair (reslizumab), which opted to take the general reimbursement listing track, the two drugs faced difficulties after passing the Drug Reimbursement Evaluation Committee review in July. If Cinqair completes drug pricing negotiations and is listed with reimbursement, it becomes virtually impossible for the other two drugs to receive reimbursement through the RSA track. Although the RSA subcommittee reviewed Nucala’s reimbursement, whether it can continue on the reimbursement discussions for RSA also remains to be seen. No other drug has been reimbursed for severe asthma since the reimbursement approval of Novartis Korea’s ‘Xolair (omalizumab)’ in 2020 Although the three drugs seem similar to Xolair as all are indicated to treat ‘asthma,’ Xolair can only be used for allergic asthma. Therefore, the drugs’ indications do differ. However, the government used Xolair as a comparator for reimbursement review, and the drug price set using Xolair was too low for the three new biological agents to accept. This is why the companies had foregone the reimbursement listing process. Nucala’s efficacy was demonstrated through the Phase III DREAM, MENSA, and SIRIUS studies. Among these, MENSA is the main trial for the drug, and its results were published in the NEJM in 2014. The MENSA study was conducted on patients with severe asthma who experienced exacerbations despite the use of various controller medications including high-dose inhaled corticosteroids (ICS). In particular, patients whose blood eosinophil count was ≥150 cells/μL at screening (≥300 cells/μL in the previous year) enrolled in the study. The patients received mepolizumab or placebo and were assessed for the annualized rate of clinically significant exacerbations. Results showed that at Week 32, the rate of exacerbations was reduced by 47% among patients receiving intravenous mepolizumab 75mg and by 53% among those receiving subcutaneous mepolizumab 100mg, as compared with those receiving placebo. At week 32, patients receiving Nucala had also shown significant improvement in quality of life and showed higher levels of satisfaction in terms of asthma control.
- Company
- Original Forxiga’s sales strong despite generic entry
- by Kim, Jin-Gu Jul 24, 2023 05:26am
- Pic of Forxiga (left)·Xigduo Three months have passed since generic versions of the SGLT-2 inhibitor class diabetes treatment ‘Forxiga (dapaglifloin)’ were released en masse in Korea. Despite the release, the original product had successfully defended its lead, increasing outpatient prescriptions. The generic companies raised a combined prescription performance of KRW 5.9 billion in the first quarter after their release, increasing their influence to 18% of the total market. However, as more than 60 companies that have entered the competition, the average prescription performance per company was less than KRW 100 million. Despite entry of a large number of generics...Prescriptions of Forxiga, Xigduo rise 12% within the year On the 22nd, according to the market research institution UBIST, the outpatient prescriptions of single agent and combination dapagliflozin drugs in Q2 was KRW 32.2 billion. Among those, Forxiga and Xigduo posted combined sales of KRW 26.3 billion. Compared to the KRW 23.4 billion in Q2 last year, the sales of the two drugs rose 12% YoY. Generic drugs entered in bulk after Foxiga’s substance patent expired in April. Over 60 companies have released Xigduo generics in Q2 alone. The generic companies posted combined prescriptions of KRW 5.9 billion in Q2. Its share in the overall market increased to 18% in 3 months. Despite the increasing performance of generic drugs in the market, prescriptions of Forxiga and Xigduo have increased. Industry analysis that AstraZeneca is defending its performance by carrying out active promotion activities with its copromotion partner, Daewoong Pharmaceutical. Forxiga and Xigduo’s drug prices were not reduced despite the release of generics. Originally, the drug prices of Forxiga and Xigduo were scheduled to be reduced by 30% ex offico by the Ministry of Health and Welfare following the reimbursement listing of its same ingredient generics. However, AstraZeneca filed an administrative suit claiming that the disposition was unfair and requested that the disposition be delayed until the ruling is complete. The court cited the request for suspension of execution, and the drug prices of Forxiga and Xigduo had remained the same ever since. Combined prescription of generic drugs amount to KRW 5.9 billion...Average sales per generic company less than KRW 100 million As for the generic companies, each company produced less than KRW 100 million per company. So many companies have simultaneously released their generic versions that the prescriptions each company had made were at an insignificant level. In Q2, 62 companies had released their single-agent Forxiga generic drugs, raising KRW 3.9 billion in total. Each company made roughly KRW 62 million. Only 5 of the companies’ products - Boryung’s Trudapa, Hanmi Pharm’s Dapalon, Chong Kun Dang’s Exiglu, Aju Pharm’s Daparil, Dong-A ST’s Dapapro – made over KRW 200 million in Q2. 50 of the 62 companies (81%) that released their generic versions had made less than KRW 100 million in Q2. The situation was similar for the combination generic drugs as well. 32 companies had released their generic Xigduo versions and posted combined sales of KRW 2.1 billion. Each company made roughly KRW 65 million. Only 5 of the companies’ products - Hanmi Pharm’s Dapalon Duo, Boryung’s Trudapa M, Kyung Dong Pharma’s Dapamet SR, Daewon Pharmaceutical’s Dapawon-M, Aju Pharm’s Daparil Duo - made over KRW 200 million in Q2. 25 of the 32 companies (78%) that released their generic versions had made less than KRW 100 million in Q2.
- Policy
- Reimbursement extended for 18 Factor VIII hemophilia drugs
- by Kim, Jung-Ju Jul 24, 2023 05:26am
- The reimbursement for recombinant factor VIII therapies that are used to treat hemophilia is expected to be extended soon. The government accepted the requests of related medical societies and patients and analyzed its fiscal impact, and the pharmaceutical companies with relevant products accepted the government’s request and will share the fiscal burden of the reimbursement extensions with the government. Starting next month, the drug price of the recombinant factor VIII therapies will be cut in line with the reimbursement extensions. According to industry sources, the Ministry of Health and Welfare is working to revise its ‘drug reimbursement list and reimbursement ceiling price table’ to apply the abovementioned changes. The revised list and table will become effective as of the 1st of next month. There has been a constant demand for reimbursement extensions on Factor VIII therapies in Korea. Patients can only maintain daily life when the patient’s factor activity is maintained at 1% or higher during pharmacokinetic tests. Patients whose factor activity is less than 1%, have a high possibility of experiencing complications due to repeated joint bleeding and spontaneous bleeding. Thus, the Korean Society of Hematology had asked the government to grant reimbursement when patients receive the maximum dose allowed within the range approved in the indication to maintain their coagulation factor activity level at 1% or higher. Acknowledging the need, the government held a financial subcommittee to analyze the fiscal impact of the reimbursement extensions. At the June meeting, the subcommittee analyzed that the additional budget required annually will be in the KRW 6.57 billion range. However, the government’s ex officio adjustment on the price of the drugs would not be significant due to the small number of items that can be adjusted and the small amount of financial savings that would follow. Therefore, the government sought another way to extend reimbursement. Among pharmaceutical companies with related products, the MOHW requested 4 major pharmaceutical companies to share the fiscal burden, and 3 accepted and submitted a voluntary price-cut proposal to the authorities. As a result, the price of 18 items of 4 ingredients will be voluntarily reduced. The government expects that increasing the administered dose of the Factor VIII therapies will delay the timing of Hemlibra administration. Also, as the patients that benefit from the new reimbursement extensions may overlap with those already receiving reimbursement through the current standards, the MOHW believes the budget impact may be less than expected. The affected 18 products are Takeda Pharmaceuticals Korea’s Advate Inj and Adynovate Inj, Pfizer Korea’s Xyntha Solofuse Prefilled Inj, Sanofi-Aventis Korea’s Eloctate Inj. The companies decided to voluntarily reduce the price of their items from 0.1% to up to 5.6% each.
