- LOGIN
- MemberShip
- 2026-05-20 18:53:30
- Company
- Resumed supply of Terramycin delayed from Feb to July
- by Jung, Hye-Jin Jan 31, 2020 06:35am
- The supply resumption date of Pfizer Korea’s Terramycin ophthalmic ointment has been pushed back. On Jan. 28, Pfizer Korea notified distributors, pharmacies and hospitals that Terramycin supply would resume around July. Apparently, the delayed production schedule is pushing down the resumption date. In last November, the company has notified the ointment is out of stock and informed the stock would be supplied around February 2020. Terramycin has struggled with a long-term shortage for 20 months previously, and is now considered as a frequently used drug with frequent shortage problem. Priced at 385 won with reimbursement, Terramycin ophthalmic ointment 3.5 g is commonly used to treat a vast variety of superficial ocular infections like corneal ulcer and conjectivitis. According to pharmaceutical market research firm UBIST, the ointment has generated 354.76 million won from over 920,000 outpatient prescriptions last year.
- Policy
- Industry welcomes pricing benefit unchanged for IMD
- by Lee, Jeong-Hwan Jan 31, 2020 06:35am
- The Korean pharmaceutical industry is positively reacting to Ministry of Health and Welfare’s (MOHW) revised drug pricing system including the weighted pricing benefit for incrementally modified drug (IMD) as it would allow IMDs to remain as a cash cow generating finance for new drug R&D. Although they are regretful the weighted pricing is limited only to government-designated IMD and excluded other ‘drugs for data submission,’ the majority of the industry says the government started recognizing the value of IMDs. On Jan. 28, a pharmaceutical industry insider commented “MOHW reissued a notice of revised ‘Criteria for Decision or Adjustment on Drugs’ that saved IMD from leveling itself down with other generics. But it also highlighted the importance and need for Korean pharmaceutical companies to switch their core business model.” MOHW re-notified the revised generic drug pricing criteria including the weighted pricing for IMD on Jan. 28. The key change made was maintaining the pricing benefit for IMD until other generic is released, as the drugs work as a stepping stone to new drug development. Quoting the notice issued by the ministry, the weighted pricing benefit would be applied to “IMD (including incrementally modified combination drug) until other single or combination drug with same administration method, content, and formulation is listed.” The industry perceives the change as the government’s ultimatum for Korean pharmaceutical companies to shift away from generic development to better-priced IMD development. Among all drugs for data submission, the pricing benefit was limited to IMD designated by Ministry of Food and Drug Safety (MFDS), which also means IMD’s individual patent registration and four to six years of post-marketing surveillance (PMS) period would come in effect as well. For pharmaceutical companies, the revision would encourage them to explore patent difficult for competitors to replicate and to develop IMD to ultimately block off other generic competitors while making profit during the PMS period. The PMS period is valid for four years on extended release drug with prolonged effect, and six years on combination drug or drug improving benefit with alternative administration method. Until the PMS period expires, other generic launch is restricted for the IMD to dominate the market to some extent. As a result, IMDs that MFDS sees inventiveness in safety, efficacy and utility (drug compliance, convenience and etc.) based on pharmaceutical approval and registration review regulation would be provided with benefits of market exclusivity and pricing. A pharmaceutical company official commented, “Many opinions of IMD-focused companies have been reflected. As the purpose of the revision was to improve the weighted pricing system, MOHW seems to have widely accepted of the industry’s opinions,” but “limiting the pricing benefit only to MFDS-designated IMD, instead for all drugs for data submission, is regretful.” The official elaborated, “The restriction means drugs for data submission with change in saline base, isomer and formulation would be neglected from the pricing benefit. Accordingly, Korean pharmaceutical companies would have to act fast analyzing the changes and to plan for new business model,” as “the government has technically sketched out the prospective of the industry with pricing benefit, so lingering in the generic game would eventually risk the business.”
- Policy
- Besivo's reimbursement standards expanded
- by Kim, Jung-Ju Jan 31, 2020 06:35am
- If the patient progresses to liver cancer during treatment with Besifovir oral medications, the benefit is still acceptable. In the case of Ramosetron HCl oral medications, there will be no restriction on the duration of administration, up to 12 weeks. The Ministry of Health and Welfare was confirmed on 28th after hearing opinions by the 22nd on the partial amendment of 'Details on the Standards and Methods of Application of Medical Benefits (Pharmaceuticals)'. The effective date is the 1st of next month. Looking at the reimubrsement criteria to be applied next month, patients with chronic hepatitis B begin treatment with Besifovir (generic for Besivo), and if the disease progresses to liver cancer, the patient can continue to receive the benefits. This means that even if hepatitis B patients are diagnosed with cancer from now on, they will receive the benefit for continuous administration. There is no restriction on the duration of the administration of Ramosetron HCl oral medications such as Irribow by Korea Astellas. Currently, the duration of administration is limited to a maximum of 12 weeks, and further administration is being reduced. As Boryeong’s combination drug of Fimasartan, Amlodipine & Rosuvastatin is newly listed on the 1st day, it is added to the 'high blood pressure + hyperlipidemia' complex oral reimbursement standard. When using Infliximab products such as Crohn's disease treatment, Remicade by Janssen, immunoglobulin-resistant refractory Kawasaki disease (including typical and atypical) that exceeds the licensed range is also approved. Basiliximab injections, such as Simulect by Novartis , used in adult kidney transplantation, specify the dosage and frequency of heart, liver, lung, small intestine transplantation, and pancreatic and pancreatic transplants in excess of the approved range. This makes the standard clearer than before. In detail, according to the permission (use and dose), it is specified as 20 mg per dose and 2 doses. In case of Abatarcept injections, such as 250mg of Orencia inj and Orencia subQ pfs(125mg) by BMS Korea, benefits are expanded by adding 'expandable minority arthritis' among pediatric idiopathic arthritis. Agalsidase β 35mg injections, such as Fabrazyme from Sanofi-aventis Korea, an enzyme replacement therapy for Fabry disease's confirmed patients, are changed based on the amounts listed on the current insurance benefit list. The ingredient is actualized. In addition, Jext inj (children/adults, Epinephrine single use autoinjector) and Dibenyline capsules (Phenoxybenzamine oral drugs), which were reimbursed as urgent drug and decided to be deleted due to supply failure, as of the 31st of the six-month grace period, the benefit will be also deleted.
- Company
- Keytruda awaits Cancer Committee’s nod in February
- by Eo, Yun-Ho Jan 30, 2020 06:34am
- The pharmaceutical industry is keeping their eyes close to the Korean government and MSD’s tug-of-war over expanding reimbursement on immunotherapy Keytruda. The industry reported on Jan. 30, the Cancer Disease Deliberation Committee is scheduled to deliberate reimbursement on Keytruda’s five indications including first-line treatment for non-small cell lung cancer (NSCLC) in February. As recommended by the Cancer Committee, MSD Korea had two sessions of preliminary negotiation with Ministry of Health and Welfare (MOHW), each in May and September last year, but their talks fell through. Besides the indications of first-line treatment for NSCLC, bladder cancer, and Hodgkin’s disease, MSD is anticipating for the Cancer Committee to green light the reimbursement expansion in February on additional indications to treat metastatic non-squamous NSCLC as a first-line combination therapy with pemetrexed and platinum chemotherapy, and to treat metastatic squamous NSCLC as a first-line combination therapy with carboplatin and paclitaxel. So far, the key issues addressed at the attempted but failed negotiation were the conditions of granting reimbursement. The conditions are to limit to ‘patients showing response to the treatment,’ and the trade off card the government is pushing on to recognize the value of new drug while compensating the cost with reduced pricing of off-patent drugs. Considering the cards on the table, MSD has reportedly prepared somewhat of middle ground proposal to persuade the government at the next round of reimbursement deliberation. The global company official stated, “Over the span of two years, the company has been negotiating and narrowing the gap with the government over expanding Keytruda’s reimbursement, and we think the two parties have been engaged enough to have better understanding of each other. Based on the experience, the company is making sure to receive the expanded reimbursement this time.” Keytruda has been listed in August 2017 with a combination of risk sharing agreement (RSA) refund and expenditure cap types under the condition of PD-L1 expression rate. As immunotherapy alone, the drug is even trying to replace chemotherapy for first-line treatment. This holds a great meaning to the anticancer treatment scene. When the reimbursement expands on the drug’s indications, a patient diagnosed with stage IV lung cancer, but cannot be treated with targeted therapy due to EGFR mutation, could be instead prescribed with Keytruda.
- Policy
- Cresemba, Pfizer Korea's antifungal drug, approved
- by Lee, Tak-Sun Jan 30, 2020 06:34am
- Pfizer Korea obtained the product license of the antifungal drug Cresemba (Isavuconazole Sulfate) in Korea. The drug is expected to have a lower mortality rate than Pfizer's Vfend. The Ministry of Food and Drug Safety approved on the 29th the sale of 'Cresemba capsule 100mg' and 'Cresemba injection 200mg' of Pfizer Korea. Cresemba is licensed for the treatment of invasive aspergillosis in adults 18 years of age and older and for invasive hair fungus in which Amphotericin B is not suitable for adults 18 years of age or older. The FDA approved this drug in March 2015. Cresemba is a drug jointly developed by Switzerland's Basilea and Japan's Astellas. Pfizer holds the EU release rights and the Asia-Pacific rights, including Korea. Astellas was approved in the United States and Japan. The drug has been shown to have a lower mortality rate than Voriconazole (generic for Vfend) in clinical trials in 516 patients with invasive aspergillosis. The mortality from all causes at 42 days was 18.6% (48/258) in the Isabuconazole group and 20.2% (52/258) in the Voriconazole group. Aspergillosis is a disease caused by a respiratory infection caused by a fungus called Aspergillus, and occurs when immunity is compromised due to leukemia or chemotherapy. Symptoms include chills, bleeding, chest pain and shortness of breath. Particularly invasive, the infection spread systemically can cause tissue damage, thrombosis, etc. due to impaired blood supply, severe sepsis can cause death. Voriconazole is the generic for Vfend sold by Pfizer. Vfend recorded annual sales of about ₩10 billion (Reference: IQVIA) in Korea. However, in the case of Vfend, Chong Kun Dang turned into a competitive system with the introduction of Vorico, the first generic in 2017. Cresemba is emerging as a new alternative to Vfend. Meanwhile, the MFDS approved MSD Korea's new AIDS treatment drug, Delstrigo (Doravirine-Lamivudine -Tenofovir disoproxil fumarate).
- Policy
- President Moon wearing a mask visited the NMC
- by Kim, Min-Gun Jan 30, 2020 06:33am
- President Moon Jae-in visits the National Medical Center in the morning on the 28th for a briefing on Wuhan pneumonia. Cheong Wa Dae announced at 10:31 am on the 28th that President Moon Jae-in visited the National Medical Center, which is treating a new type of coronavirus infection, and directly inspected the field response system and ordered a total response posture. Mr. Moon made this report at the spot where he received on-site response system reports such as patient selection criteria, response measures, and operation procedures for screening clinics from the Director of National Medical Center Ki-hyun Chung and the Director of operation support team, Yeon-jae Kim. Mr. Moon said, "The government needs to be powerful and speedy enough to evaluate the preemptive measures a little too much, and investigate all persons who have passed through the airport asymptomatically and quarantine those who have confirmed symptoms and take measures to prevent secondary infections as much as possible". President Moon emphasized that such measures should be made transparent to the public to relieve anxiety. In particular, Cheong Wa Dae said that President Moon called for greater awareness of where medical institutions did not use the contact function (to the KCDC or the public health centers) or are not complying with their obligations to do so. President Moon Jae-in visits the National Medical Center on the 28th and checks the field response system. On the other hand, President Moon visited medical staff, screening clinic, negative pressure ambulance, and on-site emergency clinic where mobile X-rays could be taken. He boarded the mobile CT vehicle and listened carefully to the explanations from the director and the officials. In addition, President Moon called for efforts to resolve local anxiety by asking whether the NMC has enough know-how as a nationally-designed quarantine bed when the MERS outbreak occurred.In addition, and the status of securing a nationally designated quarantine bed. President Moon also visited a negative pressure containment ward where a second Korean confirmed patient was admitted to the hospital to check the patient's condition, as well as concerns about the possibility of secondary infections caused by asymptomatic community activities and related measures. President Moon also received reports from the vice director, Im seok Ko, on the status of the wards and the system for responding to infectious diseases at each stage. President Moon asked if there were any concerns about the spread of infections in screening systems, quarantine beds, and negative pressure rooms. This is because inpatients during the MERS outbreak were infected with other patients, clients and medical staff. The vice director said, “The hospital was shut down in a severe stage during the MERS outbreak, treated 60 patients with MERS, and there was no hospital infection at all, and as it is more systematically developed, I don't think there is any possibility of infection in the hospital or transmission of local infections”. President Moon praised the medical staff at the National Medical Center, which had suffered during the New Year's holidays, and said he hopes to deal with it without slowing down until the end.
- Policy
- Amendment to cascading drug price revision revealed
- by Kim, Jung-Ju Jan 30, 2020 06:33am
- Finally came the result. The reinstatement of the cascading drug price system was revised and revised to change the generic insurance price according to whether or not it had its own bioequivalence test. As is known, there is a difference in the price of IMDs and generics. Revisions were included to keep the addition in recognition of the effort and innovation. However, in the case of listed drugs, the application sentence linking permit and drug prices after three years of preparation period is missing from the readministrative notice. This was confirmed that there would be no change as a result of the planned re-evaluation process (3 years) to be carried out through a re-evaluation procedure separately announced according to the 'Criteria for Decision or Adjustment on Drugs'. The Ministry of Health and Welfare announced ‘a partial revision of the Criteria for Decision or Adjustment on Drugs’ today (Jan 28) morning and looked up opinion in the industry. When the first notice amendment was issued on July 2 last year, the government decided to revise the notice in early September and enter into full-scale implementation this year. However, due to the high impact of drug price reform, some additions were inevitable due to continued protests and protests. ◆Standard to estimate the drug price (including eye drops)= Looking at the contents, the first relevant revision notice and the basic framework of July 2 last year are the same. The revised bill for the price standard system, which cuts the generic price by 15% according to its own and co-prosperity into 'stairs' and limits the same number of generics as the so-called 'cut line', was also included in the revised proposal. In detail, a new set of criteria for applying differential prices (submission of biometric data or evidence of clinical trials and the use of registered ingredients) has been established. The cascading reorganization will change the price of the drug depending on the criteria, provided that the same formulations are listed under 19 products. 53.55% if all are met, 45.52% if only one is met, and 38.69% if there is no requirement. In the case of 'A cut off point system', when more than 20 products of the same formulations are listed, it is calculated automatically 85% of the lower amount between the lower price of the upper limit of the same system and the amount calculated as 38.69%. Eye drops are also multi-use or single-use eye drops. However, if the applied product is a single-use or multi-use product, the calculation criteria will be pushed forward. Eye drops are also multi-use or single-use eye drops. However, if the applied product is a single-use or multi-use product, the calculation criteria will be pushed forward. If revised, it will take effect on July 1st. ◆Reorganization of Addition System= The industry's current focus is on this reform. The reorganization plan includes all the contents of the first draft made last year, including the comprehensive maintenance of synthetic and biologic drugs, and the extension of the period of addition. Looking specifically at the addition of IMDs, the IMD maintains the addition until the IMD or the individual single or complex constituting the product and the same route of administration, ingredient, and formulation are listed. This includes IMD complexes. Just this has a condition. Excludes two or more listed companies that have the same dosage, route, ingredient, and formulation as the individual single compound and compound listed in the combination. Also, products added after the addition period has passed cannot be added. In addition, the addition requirements for both synthetic (chemical) and biologics are the same as those published last year. The addition period and the number of companies that have been set for each standard have been unified and maintained. Specifically, the period for adding synthetic and biopharmaceuticals is one year, and if the number of companies is three or less, the period for adding and maintaining all of them is up to two years. However, if the pharmaceutical company wants to extend the addition period, the government prepared a system to adjust the addition rate and extend the addition period within the two-year limit through the review of the Pharmaceutical Benefits Advisory Committee. The government plans to implement this addition system by January 17, next year after receiving opinions.
- Company
- ‘No Japan’ no effect on drug trade with Japan last year
- by Kim, Jin-Gu Jan 30, 2020 06:33am
- Apparently, imported drug volume from Japan has gone up in last year by 8.3 percent. Experts analyze Koreans boycotting Japanese products took off from the latter half of last year had not affected the pharmaceutical industry. According to import and export statistics disclosed by Korea Customs Service on Jan. 28, Korean drug export volume to Japan last year has reached USD 250.6 million, making a significant increase of 48.9 percent from 168.35 million dollars in 2018. The import drug volume was increased by 8.3 percent in the same period from 364.27 million dollars to 394.36 million dollars. Overall, Korea’s pharmaceutical trade deficit with Japan improved from 195.93 million dollars to 143.76 million dollars in the same period. The massive increase in drug export volume has narrowed the gap with the import volume. Trade with Japan in last five years (Unit: USD 1 million) Source: Korea Customs Service ◆ Drug trade unaffected by ’Boycott Japan,’ but trade deficit improved The industry experts see that the so-called ‘No Japan,’ or the boycott on Japanese product, had unnoticeable effect on drug trade and resulted in increased Japanese drug import volume. In fact, the Japanese drug import volume last year hit the highest peak in the recent five years (from 2015 to 2019). However, the trend vastly contrasts with other industry of food and beverage, automobile, consumer goods and tourism. Last year, 39.76 million dollars of Japanese beer was imported to Korea, which halved from 78.30 million dollars made in 2018. The polarizing trend was even more prominent with statistic data from July last year when the boycott was encouraged seriously. In the second half of last year, 202.91 million dollars of drugs were imported from Japan, which leaped by 22.39 million dollars (12.4 percent) from latest three years (from 2016 to 2018) with 180.52 million dollars. Japanese drug volume Korea imported in 2019 (Unit: USD 1 million) Source: Korea Customs Service ◆ Drug export volume hits highest at USD 3.7 billion Last year’s drug export volume from Korea has reached a historic high at 3.7 billion dollars. Regardless, the import volume also hit the highest and the overall trade deficit worsened by a bit. Korea exported 3.7 billion dollars worth of drugs in 2019. It jumped by 13.0 percent from 3.3 billion dollars in 2018. The export volume in last decade surpassed the one-billion-dollar line for the first time in 2012, and broke the two-billion-dollar and three-billion-dollar lines in 2016 and 2018, respectively. Korean drug export volume in last decade (Unit: USD 1 million) Source: Korea Customs Service Despite breaking the highest record of export volume, last year’s trade deficit has gotten slightly bigger from 2.8 billion dollars in 2018 to 3.0 billion dollars in 2019. The deficit worsened because the import volume was broke the highest record. The drug import volume last year marked 6.7 billion dollars, a 9.20-percent increase from 6.1 billion dollars in 2018. As a result, the trade gap widened from 2.8 billion dollars to 3.0 billion dollars. ◆ Top importing country rank changes from the U.S. to Germany The top ranking of countries importing Korean drug the most has been shuffled. The U.S. has been on the top since 2017, but Germany took over last year. Germany and the U.S. have respectively imported 521.31 million won and 435.16 million won worth of Korean drugs last year, and Turkey (402.12 million dollars), Japan (250.64 million dollars) and China (248.05 million dollars) followed the top two countries. Top 10 Korean drug importing countries (Unit: USD 1,000) Source: Korea Customs Service
- Policy
- Rafinlar-Meqsel combination done with pricing negotiation
- by Lee, Hye-Kyung Jan 30, 2020 06:33am
- A combination therapy of Rafinlar and Meqsel treating patients with ultra-rare late stage BRAF-mutant lung cancer would be available for reimbursed prescription from next month at earliest. Korea’s National Health Insurance Service (NHIS) has recently announced pricing negotiations on four items—Novartis’ Rafinlar (dabrafenib) 50 mg and 75 mg, and Meqsel (trametinib) 0.5 mg and 2 mg—have been wrapped. First released for the Korean market in December 2017 as a melanoma treatment, Rafinlar and Meqsel have been additionally indicated to treat patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation in March 2018. And to win reimbursement on the combination therapy of the two, they have been deliberated by Health Insurance Review and Assessment Service’ (HIRA) Cancer Disease Deliberation Committee and Drug Reimbursement Evaluation Committee (DREC) and started a drug pricing negotiation with NHIS from last year. Rafinlar and Meqsel combination therapy has been raised as an issue at the National Assembly audit session last year. During the audit, Liberty Korea Party Lawmaker Kim Se-yeon strongly appealed the need to provide reimbursement on the combination therapy of Meqsel and Rafinlar to treat patients with stage IV lung cancer. However, Ministry of Health and Welfare (MOHW) answered negatively by stating, “Reimbursement for a drug is decided by comprehensively reviewing clinical efficacy, cost-effectiveness and other various factors based on ‘Detailed Evaluation Standard of New Drug for Negotiation,” and “the combination therapy has uncertainty in cost-effectiveness.” While an alternative option of chemotherapy costs 20 million won a year with progression-free survival (PFS) of 8.9 months, MOHW claims the combination therapy of Meqsel and Rafinlar costing 120 million won a year to achieve PFS of 10.9 months is not cost-effective. However, the health authority and Novartis have negotiated financial means to cover the uncertainty in cost-effectiveness, and reached an agreement to complete the pricing negotiation in early January. Health Insurance Policy Deliberation Committee (HIPDC), under MOHW, is scheduled to discuss about the reimbursement decision on Rafinlar and Meqsel combination therapy and to finalize the data providing the reimbursement. Meanwhile, NHIS has also announced Yooyoung Pharmaceutical’s chronic constipation treatment Rucalo tablet (prucalopride succinate) 1 mg and 2 mg, and Astellas Pharma Korea’s overactive bladder treatment Betmiga PR (mirabegron) 25 mg and 50 mg have also finished the pricing negotiation as of Jan. 21.
- Company
- A Employee, ahead of retirement at Merck, took his own life
- by Eo, Yun-Ho Jan 29, 2020 10:55am
- There was a pity that a salesperson at Merck Bio Pharma, who was about to leave, took his own life. According to the industry, Mr. A, a sales representative from Daejeon Branch of Merck, was found dead. Mr. A was included in the Early Retirement Program (ERP) during the sale of Merck's General Medicine primary care (GM) division, and retirement was confirmed in May. The exact cause of suicide is not known yet, and companies, unions, etc. are trying to figure out the truth. Meanwhile, Merck Korea has been experiencing considerable labor and management conflicts until recently after the sale of its GM division last year. The company decided to sell its business units to strengthen its capabilities in areas such as oncology, infertility, neurology and specialty care. Merck signed a sales contract for Glucophage, a diabetes drug, with GC Green Cross in last October, formulating a business division in November. In last November, the company signed a sales contract with Daewoong Pharmaceutical for its hypertension drug 'Concor'.
