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- 2026-04-17 15:11:30
- Policy
- Diverse response for premium pricing policy for IMD
- by Lee, Jeong-Hwan Jan 15, 2020 06:37am
- The Ministry of Health and Welfare has virtually confirmed the premium pricing policy of excluding incrementally modified drugs(IMD) from generic drug price regulations, and since then, subtle airflow has been detected in the domestic and overseas pharmaceutical industry. The expression of the reform of the Ministry of Health's Welfare on Drug Price Regulations is mixed between multinational companies with a large proportion of original new drugs and domestic companies centered on generic and incrementally modified drugs. it tends to take domestic industry’s side. According to the pharmaceutical industry on the 14th, the direction of the reform of the premium pricing policy for incrementally modified drugs by the Ministry of Health and Welfare was quickly delivered to domestic and foreign pharmaceutical companies RA (development and licensing) and MA (pharmaceutical and loan) agents. As the scope of drug price regulation is reduced to generics, some domestic pharmaceutical companies that have been strategically focused on incrementally modified drugs become practical targets, and global companies with original drugs complain about unfair drug price management. To review directly at the background of complaints, the Ministry of Health and Welfare does not maintain the premium pricing policy for incrementally modified drugs, but rather establishes a reasonable price-listing environment for original new drugs, which are heavily invested in cutting-edge technologies and clinical trials and are the source of development of new drugs. The Ministry of Health and Welfare, which cut its original drug price as much as possible every time it is listed, is inconsistent with maintaining the premium pricing policy by overturning the regulation that the Ministry of Health and Welfare had noticed. Indeed, some foreign companies dissatisfied with the domestic drug price listing process have decided to pass in other Asian countries so called, 'Korea Passing' such as China and Japan while skipping Korea. In the end, Korea's drug price estimates are too low, which is the argument of foreign companies. Only incrementally modified drugs with overwhelming domestic market share were decided as the preferential key, which led to the dissatisfaction of domestic drug price policies. Indeed, in 2016, the Korea Multinational Pharmaceutical Industry Association (KRPIA), a group of international multinational pharmaceutical companies, criticized the government's plan to improve insurance prices for global innovative new drugs as a 'differentiated drug price premium pricing policy excluding multinational companies'. At the time of controversy, the government took out the policy that domestically developed new drugs applied 100% innovative drug price premium policy while globally introduced new drugs did not apply regardless of innovation. An official of Global A, who asked for anonymity, said, “The fair price policy for new drugs, generics, and incrementally modified drugs is a claim that foreign companies have consistently demanded. The premium pricing policy for incrementally modified drugs is not wrong, but a corresponding original drug price policy should be prepared”. A official said, “The need for drug price policy to protect its own industry is recognized, but Korea needs a new drug price policy that covers both its own and other countries to become a pharmaceutical power. The original drug price policy needs to be improved to reflect this value”. On the other hand, it is too much for the original company to try to involve the premium pricing policy for incrementally modified drugs, rather than generics. Incrementally modified drugs, which have improved administration and dosage compared to the original by changing the route of administration, dosage form, and salt, and improved the convenience of patient medication, are marked by the progress and significant cost and effort for actual development. Although it is not as difficult as a new clinical trial, the incrementally modified drugs that have advanced properties require animal studies and small-scale phase III clinical trials. In their opinions, current pricing policy is reasonable. The head of the development team of the domestic B pharmaceutical company said, “Honestly, simple salt-modified generics adopt the safety and efficacy data of the original new drug as it is, and there is no progress and it is easy to reproduce, and this is why generic drug price policy is not fair. However, it is hard to accept the opposition to the premium pricing policy for incrementally modified drugs with sufficient progress compared to the original”. The head of the development team of the domestic B pharmaceutical company said, “Korea's original drug price calculation standard is too low. Some multinationals claim that the authority to control drug costs is the responsibility of the government, not the company, the characteristics are different and individualized policies are needed”.
- Policy
- Company executives were accused of vaccine bidding bribe
- by Lee, Jeong-Hwan Jan 15, 2020 06:32am
- Foreign pharmaceutical company executives who received ₩ billions from drug wholesalers for trials of vaccine distribution such as bidding, supply, and price setting are tried. Employees of a large domestic pharmaceutical company accused of committing the same type of crime were also prosecuted. Both employees are accused of receiving payments in connection with the National Immunization Program (NIP). The prosecution is suspected that pharmaceutical companies set up wholesalers to supply vaccines to the Public Procurement Service to secure volume or price. According to the complaint filed by the Justice Department to Democratic Party of Korea's Representative's Office of Tae-Seop Geum on the 13th, the Seoul Central Prosecutor's Office recently filed employee Mr. Lee (57), a global S Pharmaceutical company and an employee Mr. An(48), a large domestic company, with dereliction of duty. Mr. Lee is accused of receiving a total of ₩1,694,400,000 from two wholesalers in return for convenience such as designation and unit pricing of pharmaceuticals and issuance of a supply letter of approval when bidding vaccines from 2004 to last August. Mr. Lee took a profit by handing a ATM card from a wholesaler and then remitting the money back and withdrawing. In addition, Mr. Lee has been receiving cash from the other wholesalers over nine rounds of cash, including the wons, euros and dollars. Mr. Ahn was charged with receiving the same purpose from 2010 to last November and gaining property benefits worth ₩262 million from a wholesaler. Mr. Ahn received a corporate credit card from a wholesale company to take advantage of his property and freely received a car worth ₩60 million. The prosecution arrested them on 17th last month and restricted them on 20th to continue the investigation. The prosecution is suspecting that pharmaceutical companies such as Korean vaccine, Yuhan, Guangdong Pharmaceutical, Boryung Pharmaceutical, and GC Green Cross will offer wholesalers as vendors to provide vaccines to the Public Procurement Service to secure volume or price. In particular, Korean vaccines were caught by the Fair Trade Commission after discontinuing the supply of intradermal BCG vaccine, also known as 'fire-injection', in order to increase sales of expensive transdermal BCG vaccines monopolistically. The prosecution is also investigating allegations of collusion and back-trade in the vaccine supply process, including tuberculosis, cervical cancer and pneumococcus, after taking over the findings from the FTC and PPS.
- Company
- Recommending ezetimibe, “The lower the LDL-C, the better”
- by Eo, Yun-Ho Jan 15, 2020 06:30am
- 김효수 교수 With robust evidences of efficacy, ezetimibe is now one of major options for treating dyslipidemia. “The lower the better.” The result of clinical trial IMPROVE-IT, with the slogan claiming the lower the low-density lipoprotein cholesterol (LDL-C) is the better the health benefit, earned its recognition when it was announced in 2015. Numerous pharmaceutical companies in Korea raced each other to release combination drugs with ezetimibe plus either atorvastatin or rosuvastatin. The products landed themselves on the market safe and sound. Given the positive response, some wondered about the unexpected recommendation addressed in Guidelines for the Management of Dyslipidemia 2018 published by Korean Society of Lipid and Atherosclerosis’ (KSoLA). While American Association of Clinical Endocrinologists (AACE) updated its guideline in 2017 with new ‘extreme risk’ category and advised medical professionals to bring the LDL-C level down to under 55 mg/dL, the KSoLA’s latest guideline maintained the target treatment level of LDL-C for ultra-high risk group at 70 mg/dL. Meanwhile, European Society of Cardiology (ESC) has recently recommended setting treatment target LDL-C level for extreme risk group at under 40 mg/dL. With an expectation of more assertive use, ezetimibe was also listed as second-line treatment option following statin treatment. Despite the release of new medicine like PCSK-9 inhibitors, the Korean guideline generally took the conservative approach. And what are the thoughts of Korean clinical doctors on dyslipidemia treatment strategy after the newest edition of the guideline was published more than a year ago? Daily Pharm interviewed Kim Hyo-soo, the then Professor at Department of Internal Medicine of Seoul National University Hospital, on the issue. At the time of publishing, he was the chairman of the society and has actively supported prescription of ezemitib at any time. - About setting 'treatment target of LDL-C level 55 mg/dL' and 'ezetimibe as first-line treatment,’ did you think it was too soon? In my opinion, ezetimibe is not in any way insufficient to be a first-line treatment. But many did not see a good reason to add ezetimibe to the first-line treatment option, when a patient can reach the target level with statin monotherapy. So the guideline recommended medical professionals to prescribe the medicine to patients struggling to manage the cholesterol level only with statin. Treatment target level of LDL-C actually differs among many clinical trials. When setting 70 mg/dL as an idealistic level, the needs for ezetimibe as a first-line treatment are low to be honest. But it’s another story when setting the level at 55 mg/dL. Usually the level is unreachable with statin monotherapy. It needs a combination therapy with ezetimibe. Personally, I prescribe statin-ezetimibe combination therapy as first-line treatment. In other words, each doctor’s level of lowest value varies, so the guideline had to take a rather careful approach. On a side note, I did suggest setting 55 mg/dL as target LDL-C level when we were updating the guideline. Now I’m looking into 35 mg/dL, even. - What had enabled ezetimibe to lower LDL-C level and to ultimately prevent cardiovascular events? LDL-C can be divided into apolipoprotein B (ApoB)-48 and ApoB-100. Previously, only ApoB-100 was considered to be accumulated as plaque, but apparently studies have found ApoB-48 also works the same. Now it’s more convincing that statin’s ApoB-100 synthesis inhibition combined with ezetimibe’s ApoB-48 absorption inhibition is lowering LDL-C level more effectively. For a long time, hyperlipidemia treatment was solely dependent on statin and the practice has prescribed a high dose of it. Combination therapy with non-statin class, previously quite unpopular, is now gaining the attention and PCSK-9 inhibitor, expensive but powerful in dropping LDL-C level, is also used more often. The time has changed, eventually. - Is there a particular patient group you would especially recommend ezetimibe combination therapy? Cholesterol absorption is accelerated in diabetic patients. With more favorable condition for cholesterol absorption than non-diabetic patient, ezetimibe could deliver more dramatic effect. Ezetimibe would also be effective for patient group with high blood sugar level, because it does not increase chance of diabetes onset when used, whereas statin does. Postprandial hyperglycemia is a vital issue for a diabetic patient, but newer studies say postprandial lipidemia is also as bad. Ezetimibe inhibits postprandial lipidemia, which would be beneficial to diabetic patients. For my clinical practice, I have often used ezetimibe to lower diabetic patients’ cholesterol level. As a matter of fact, I conducted a research on less explored area of effect of the drug on blood glucose. The researchers are currently analyzing data collected from about 200 people. - Many have mentioned of PCSK-9 inhibitor, but apparently it tends to be administered once-monthly (originally indicated for once-biweekly) as the drug use is mostly non-reimbursed, despite its outstanding efficacy. Is it alright to change the interval? For a patient, relapsed disease like acute coronary syndrome (ACS), myocardial infarction (MI) and peripheral artery disease (PAD) are critical to their condition. And those patients’ LDL-C level has to be lowered more aggressively. And if adding ezetimibe does not work, then PCSK-9 inhibitor has to be used. But, it is expensive. And that is why many of them are administered once a month, but their LDL-C level ranging from 70 mg/dL to 80 mg/dL is usually halved or more. A patient that ticks off more than two of high-risk conditions—diabetic, hypertension, age 65 and up, cigarette smoking, hypercholesterolemia—is advised to take PCSK-9 inhibitor. I personally consider using PCSK-9 inhibitor when a patient’s cholesterol level is not controlled with rosuvastatin-ezetimibe combination therapy.
- Opinion
- [FOCUS] 10 ‘global new drugs’ promised 10 years ago
- by Chon, Seung-Hyun Jan 15, 2020 06:28am
- In 2011, the government formed Korea Drug Development Fund (KDDF) to provide inter-ministerial level support for developing new drug. Ministry of Science and ICT (MSIT), Ministry of Trade, Industry and Energy (MOTIE) and Ministry of Health and Welfare (MOHW) laid down a plan to develop more than ten global-level new drugs by investing on R&D together. The initial plan was to invest 1.6 trillion won for ten years until 2020 (530 billion won by the government, 530 billion won by private investment). According to the plan, Korea should be able to release ten new drugs by the end of this year. But it seems unrealistic at the moment. Considering Korea’s pharmaceutical and bio industry’s reality, the barrier of global market was too high. When Hanmi Pharmaceutical signed a series of giant license-out deals on investigational technology in 2015, the Korean pharmaceutical and bio industry was exhilarated. Everyone celebrated the advancement Korea has achieved in pharmaceutical and bio sector. But the excitement did not last long. For a long while, no other news of notable out licensing deals was reported. And when a few of licenses were returned to Hanmi Pharmaceutical, the industry’s rosy dream subsided. In fact, many were skeptical about the exaggerated expectation on the industry. Only then, more voices spoke out about keeping the head cool. In hindsight, more realized the Korean pharmaceutical and bio industry’s landscape has not been progressing, except for the exceptional performance by Hanmi Pharmaceutical. Since then, not only traditional pharmaceutical companies, but also bio ventures, such as Dong-A ST, Yuhan, SK Chemicals, SK Biopharmaceuticals, Legochem Biosciences, BridgeBio Pharma, Alteogen, and iNtRON Biotechnology, inked out licensing deals. Global pharmaceutical giants like AbbVie, Janssen, and Boehringer Ingel Heim shook hands with Korean companies. And Celltrion and Samsung Bioepis are now leading the global biosimilar market. Now the Korean industry is yet again dreaming on about drawing level with global pharmaceutical powerhouses. But the truth is we still have a long way to go. Last year, the U.S. Food and Drug Administration (FDA) cleared two new drugs by SK Biopharmaceuticals, but only five investigational drugs developed with Korean-made technology have passed the U.S. health authority so far. None of them reached the level, what would be viewed as ‘global commercialization success.’ Finished pharmaceutical product export in 2018 generated 3.40 trillion won, which was not even 20 percent of overall manufactured volume of 18.54 trillion won. Contrastingly, 4.89 trillion won of overseas finished products, significantly higher than the export, were imported in the same year. Finished product made in Korea used in Korea has gone down lower than the previous year to 75.6 percent. Some of Korean pipelines transferred to other global companies were dropped before reaching the commercialization stage. And in the near future, more out-licensed technologies are likely to be returned than successfully made into a finished product. Recent global drug development trend has more progressive new drugs proceeding faster than Korean pipelines. In some cases, technology development partner companies have lost interest in pursuing Korean companies’ pipeline with other similar candidate medicines available. Even worse, many Korean bio companies reported disappointing news of failed pipeline and clinical trials to their investors last year. Stock market was shaken by rumors spreading with mixed facts and hopes. Share price fluctuated from maximum to minimum limit for days. Obviously, it is possible for a Korean company to soon bring surprise news of making a big global success. But even so, it would mean outstanding performance of the company and not the whole Korean corporate R&D landscape’s. For last few years, Korean pharmaceutical and bio industry has experienced a series of trial and error. The ‘world’s first gene therapy’ turned out to have switched out active ingredient in production and its approval was revoked. Such ridiculous ‘trial and error’ should not be repeated again. Hopefully, this year would be the time for the industry to grow further based on the rough experiences. This year, probably, Korean companies would hear many stories of hopes and failures. And the entire industry should not be agitated or swayed by them. Instead of heightened anticipation, what we need is keeping it calm and moving forward.
- Policy
- What criteria does the Pharmaceutical Committee judge?
- by Lee, Hye-Kyung Jan 14, 2020 08:49am
- 12 of 24 new drugs were successful in listed drugs, Unfortunately, there are four drugs that have failed the reimbursement challenge. The HIRA evaluates the adequacy of a drug through a review by the Pharmaceutical Benefits Evaluation Committee in accordance with Article 11 (2) of the Rules on National Health Insurance Benefits. Dailypharm analyzed new drugs that passsed by the HIRA's Pharmaceutical Benefit Committee from January to December last year. Of the 24 drugs, only 11 received reimbursed. The remaining 10 drugs were non-reimbursed, and 3 drugs were managed-entry. .Non-reimbursed drugs include 'Duodopa intestinal gel' (levodopa)' by Korea's AbbVie, 'Neuronata-R(autologous bone marrow-derived mesenchymal stem cells)' by Corestem, and 'Zerbaxa' (Ceftolozane/Tazobactam) by MSD Korea .Radicut(Edaravone), the treatment of amyotrophic lateral sclerosisby Mitsubishi Danabe, chose to withdraw its reimbursement during the drug price negotiations with the HIRA .◆Duodopa intestinal gel=This drug is Progressive Parkinson's disease drug with severe motor ups and downs despite Parkinson's drug treatment,and it was approved on April 6 2015, went through the Pharmaceutical Benefits Subcommittee on July 23 2015 and it was put on the Pharmaceutical Benefit Committee on March 21, 2019, four years later .However, the clinical data submitted by the pharmaceutical did not qualify as 'medical drugs deemed necessary for medical treatment' because clinically meaningful improvements such as prolonged period of survival have not been proved .As a result, it was concluded that ICER was impossible due to insufficient evidence, and drug prices suggested by the company were difficult to accept due to uncertainty .On the other hand, the related academics said that patients who are not controlled by existing Parkinson's disease drugs because they do not have adequate treatment in Korea are necessary for patients suffering from mental and physical pain and severe diseases due to exposure to medical blind spots .This drug is listed in the US, Germany, France, Italy, the UK, and Japan excluding Switzerland among A7 countries ◆Neuronata-R= This drug is used in combination with Riluzole to slow the progression of the disease in amyotrophic lateral sclerosis, went through the Pharmaceutical Benefits Subcommittee on March 21 2018, and it was put on the Pharmaceutical Benefit Committee on last April 25 .In patients with amyotrophic lateral sclerosis, clinical necessity was acknowledged by slowing functional decline than without Neuronata-R, The cost was higher than that of the alternative, and the corresponding cost effectiveness was unclear, and A non-reimbursement decision was made .The domestic neurology textbook mentions the approval of rare drugs in the applied products, and the stem cell treatment is introduced as a treatment under study in the ALS in clinical guidelines .However, Yakyeong said, “Riluzole is being given to Amyotrophic lateral sclerosis, and considering the possibility of substitution, it is hard to say that it is an essential drug for medical treatment” .The related academics also suggested that it would be advisable to review the Neuronata-R strains after the results of phase II and III studies have been reported .◆Zerbaxa=this drug received an item permit on April 7 2017 for complex intraperitoneal infections (with Metroidazole) and complex urinary tract infections (including Pyelonephritis) .The deliberation was conducted on November 21 2018, through the Pharmaceutical Benefits Subcommittee, and the deliberation was conducted by the committee on last June 20 .As a result of the deliberation, the clinical necessity is hardly considered inferior to the clinical treatment rate, but it was concluded by non-reimbursement due to the higher cost than the alternative drug .The relevant academics suggested that the introduction of an inferior therapeutic agent compared to Carbapenem has a clinical significance in the case of limited antibiotics against MDR-infected Gram-negative bacterial infections .Among A7 countries, Zerbaxa is registered in the US, Italy, the UK, and Japan .◆Radicut=This drug failed the reimbursement threshold in the 2018 but was reevaluated by the Third Committee in 2019 and was recognized for its adequacy .Radicut was approved as a drug that could slow the progression of dysfunction caused by amyotrophic lateral sclerosis, but the clinical necessity was recognized, but the cost was high .However, there are no drugs or treatments with the same therapeutic position, and it has passed the severity and social impact of the disease according to the risk sharing plan and the policy to strengthen health insurance coverage as a rare disease treatment drug .The problem was that Mitsubishi Danabe Pharma had been discussing reimbursement in Canada at the same time as Korea .However, Canada decided to refer to Korean drug prices, and withdrew Korea's reimbursement entry to enter Canada's reimbursement .At that time, Radicut was listed in the US and Japan among A7 countries .On the other hand, in order to be reimbursed again, submissions of new cost-effectiveness data should be evaluated and submitted to the Pharmaceutical Benefit Committee .
- Company
- Reimbursed ALL new drug Besponsa lands code at Big 5 fast
- by Eo, Yun-Ho Jan 14, 2020 06:29am
- After the green light from Korean health authority, the reimbursed Besponsa (inotuzumab) injection has quickly found its position on general hospitals’ prescription code list. According to pharmaceutical industry sources, an antibody-drug conjugate (ADC) prescribed for acute lymphoblastic leukemia (ALL), Besponsa injection has been listed for reimbursement in October last year and currently, landed its code on every Korea’s Big Five tertiary hospitals’ prescription code list. Drug Committee (DC) at Samsung Medical Center and Seoul Asan Medical Center passed the injection’s code, while Emergency DC at Seoul National University Hospital, Severance Hospital and Seoul St. Mary’s listed the code. Their prompt action proves how doctors had significant needs for Besponsa. Besposa’s reimbursed indications are for secondary or tertiary remission induction therapy in adult patient aged over 18 years with relapsed or refractory B-cell precursor ALL. To this day, the only therapy option a relapsed or refractory ALL patient could take for curing the condition is hematopoietic stem cell transplantation (HSCT). And for the patients to receive HSCT, they first have to reach complete remission (CR) before the procedure. So far, Glivec changed the whole landscape of chronic myelocytic leukemia (CML) in the leukemia treatment sector. Since then, a number of competitive target therapy options, such as Tasigna (nilotinib), Sprycel (dasatinib), and Supect (radotinib), were released in the market. But for acute leukemia, especially for ALL, there was no more novel treatment other than Blincyto. Compared to other existing anticancer therapy, Besponsa easily doubles CR rate and help the patient to go through HSCT and to get cured. Last year, National Comprehensive Cancer (NCCN) Guideline recommended Besponsa as a category 1 treatment option. A hematologic academic society official commented, “For patients with ALL, having an access t ADC or immunotherapy before their condition worsens would take them to completely different treatment landscape.” In the Phase 3 INO-VATE ALL trial, a randomized open-label study to compare Besponsa and other existing anticancer therapy, the CR rate or CR with incomplete platelet recovery (Cri) for patients treated with the ADC was 80.7 percent compared to 29.4 percent with chemotherapy. Also, 48 percent of patient administered with Besponsa had HSCT, demonstrating improved figure than the 22 percent patients treated with chemotherapy. Minimal residual disease (MRD) negative result indicates small number of cancer cells in the body after anticancer treatment and also provides important prognosis works as a prognostic factor. As for the clinical trial, patients treated with Besponsa showed MRD negative of 78.4 percent, and other group treated with chemotherapy showed 28.1 percent. Whereas two-year overall survival rate and three-year overall survival rate in patients treated with Besponsa reached 22.8 percent and 20.3 percent, respectively, comparatively higher than chemotherapy-treated patients with 10 percent and 6.5 percent, respectively.
- Policy
- New patent evasion strategy for Galvus follow-ons?
- by Lee, Tak-Sun Jan 14, 2020 06:28am
- A creative strategy to evade patent is attracting the pharmaceutical industry’s attention. If the strategy is found successful, pharmaceutical companies in Korea would be able to use it to evade the extended effective term of substance patent protection, as an alternative to the strategy of changing saline base of the original drug affirmed ineffective by the court. According to an industry source on Jan. 12, Korean companies preparing follow-on drugs of dipeptidyl peptidase-4 (DPP-4) inhibiting anti-diabetes treatment Galvus has presented a unique patent evading strategy unlike preceding ones. The companies are challenging the original’s patent by excluding an indication used as an evidence to extend the patent term. For instance, the follow-on drug would omit one out of five indications of Galvus Met 50 mg/850 mg tablet, specifically the indication for ‘treating a patient when sufficient blood sugar level control is impossible with metformin monotherapy.’ The industry claims follow-on drug without the indication would not infringe the extended term of the patent as it was used to extend the Galvus’ substance patent term for 26 months and 23 days. In fact, it was reported the vildagliptin-metformin 50 mg/850 mg tablet applied for approval on Dec. 24 last year, without the particular indication. And apparently, the follow-on drug developers, Korea United Pharm and Hanmi Pharmaceutical have filed defensive confirmation trial for the right of Galvus patent with the same strategy. The call would be made when Korea Intellectual Property Office (KIPO) decides whether or not to accept the follow-on drug developers’ claim. If KIPO affirms the companies’ claim, then United Pharm and Hanmi Pharmaceutical would be able to release their follow-on drugs within this year. It would be possible as Galvus’ other substance patent rejected from extension was expired Dec. 9 last year. And also those two companies may launch products regardless of Ahn-gook Pharmaceutical’s generic approved with preferential sales rights. After nullifying 187 days out of the extended patent term of 26 months and 23 days, Ahn-gook Pharmaceutical can legitimately start selling follow-on drug from Aug. 30, 2021. The company also won the preferential sales right to exclusively supply the vildagliptin generic from Aug. 30, 2021 to May 29, 2022. As a result, other drugs in the same class cannot be launched. However, the exclusive sales right is not effective on drug that completely evaded extended patent term. In other words, the follow-on drug developers could release their products before Ahn-gook Pharma. And this is not the first time the strategy has been used. Chong Kun Dang Pharmaceutical used the strategy to release benign prostatic hyperplasia (BPH) and hair loss treatment Avodart’s generic, Dutesmol, before the original’s extended patent was expired. Initially, however, Dutesmol’s indication did not include treating BPH as it was an evidence to extend the original’s patent. And after the substance patent was expired, the generic won the BPH indication and now the drug is available for prescription on treating BPH. Galvus follow-on drug developers are likely to exclude indication used to extend the original’s patent, but they are also likely to seek for approval on the omitted indication when the patent expires completely. As the old patent evasion strategy of changing saline base has been blocked by the Supreme Court’s decision made in January last year, the industry experts predict pharmaceutical companies in Korea have high chances of evading the extended term of the original’s patent protection by dropping an indication for their product. Currently, pharmaceutical companies that commercialized follow-on drugs with switched saline base from the original overactive bladder medication Vesicare and smoking-cessation treatment Champix have suspended their sales due to the Court of Appeals’ decision to affirm patent infringement.
- Policy
- Non-reimbursed Dupixent now covered with few conditions
- by Lee, Hye-Kyung Jan 14, 2020 06:28am
- Patients taking severe atopic dermatitis treatment Dupixent prefilled injection (dupilumab) as a non-reimbursement treatment option can now have an access to healthcare reimbursement without satisfying the newly established reimbursement criteria. Health Insurance Review and Assessment Service (HIRA, President Kim Seung-taek) published a Q&A on reimbursed use of Dupixent and presented detailed criteria of reimbursement. Starting from Jan. 1 this year, the Korean government cleared reimbursement on Dupixent for treating adult patient over the age of 18 with severe atopic dermatitis, who has uncontrolled condition after four-week topical treatment (corticosteroids or calcineurin inhibitor) as first-line treatment, and not showing more than 50 percent improvement in Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy (cyclosporine or methotrexate); has EASI score over 23 before administrating the treatment; and has a record of receiving topical treatment and systemic immunosuppressant therapy within past six months. However, HIRA has also decided to provide reimbursement on patients, who have been treated with non-reimbursed Dupixent, if they qualify either one of two conditions, regardless of passing the existing reimbursement criteria. The two conditions are either having a record of receiving systemic immunosuppressant therapy (cyclosporine or methotrexate) after being diagnosed with atopic dermatitis or having a record of atopic dermatitis severity indicator (EASI over 23, SCORAD over 40, or IGA 4) without receiving systemic immunosuppressant therapy for medical reason. But for the new special case of reimbursement, a patient needs to apply for reimbursement by June 30 with detailed medical record and the dermatologic condition-related doctor’s referral to prove qualification of the condition. And for patients, who have been treated with systemic immunosuppressant therapy without testing EASI score prior to the treatment, have to submit SCORAD or IGA score indicating the severity of the atopic dermatitis. Nevertheless, the reimbursement would be given when the patient is tested before the Dupixent treatment and scores over 23 on EASI testing. For patients struggling with chronic atopic dermatitis over three years, the government agency has to confirm medical record of atopic dermatitis diagnosed three years before the date of first Dupixent treatment to grant reimbursement. Meanwhile, a patient omitting the systemic immunosuppressant therapy to immediately follow the first-line topical treatment with Dupixent treatment has to pay the full price of the treatment. However, a patient who is unable to receive the systemic immunosuppressant therapy due to medical restriction, such as renal failure, uncontrolled hypertension, uncontrolled infection, malignant tumor, and severe liver condition, but has qualifying EASI score can receive reimbursement.
- Policy
- Only 1 in 2 new drugs listed last year
- by Lee, Hye-Kyung Jan 13, 2020 11:30pm
- Of the 24 new drugs that were applied for benefits last year, 12 were successful in listed drugs, with the listing rate remaining at 50%. Dailypharm analyzed new drugs that were deliberated and voted by the HIRA's Pharmaceutical Benefit Committee last year. Of the 24 drugs, only 11 received reimbursed. The remaining 10 drugs were non-reimbursed, and 3 drugs were managed-entry. In particular, Radicut(Edaravone), a drug for treating Amyotrophic Lateral Sclerosis in Mitsubishi Tanabe Pharma Korea Co., Ltd, received a reimbursement judgment at the Pharmaceutical Benefit Committee, and chose the reimbursement withdrawal during drug price negotiations with the NHIS. At the time, Radicut had been discussing the reimbursement in Canada at the same time as Korea, and withdrew Korea's reimbursement entry to enter Canada's reimbursement. Korea's passing of drugs started with Novartis' asthma treatment ‘Xolair (Omalizumab)’ last year. 10 of the 13 drugs besides reimbursed determination were clinical benefits but received managed-entry due to higher cost than alternative drugs. Among these, 'Agotin' (agomelatin) of Whanin Pharmaceuticals, 'Faslodex' (Fulvestrant) of AstraZeneca, and ‘Biktarvy’ (Bictegravir) of Gilead Science Korea, accepted the proposed expenses presented by the HIRA and put them on the reimbursed list. Since five domestic companies applied for benefits at the same time, the treatment for chronic constipation of Prucalopride succinate, which was put on the level in last October, was also managed-entry, but only Yooyoung Pharmaceutical is expected to negotiate with the HIRA. Liporaxel (oral Paclitaxel) of Dae Hwa pharmaceutical get approved as a managed-entry in last November after two attempts, and is struggling whether to make a decision. There were four drugs which is non-reimbursed at the drug committee, and Non-reimbursement is determined when both relative clinical usefulness and cost effectiveness are unclear. To challenge again, new cost-effectiveness data must be submitted, evaluated, and the agenda should be addressed to Pharmaceutical Benefit Committee. Non-reimbursed drugs include 'Duodopa intestinal gel' (levodopa)' by Korea's AbbVie, 'Neuronata-R(autologous bone marrow-derived mesenchymal stem cells)' by Corestem, and 'Zerbaxa' (Ceftolozane/Tazobactam) by MSD Korea, Imfinzi (Durvalumab) by AstraZeneca.
- Company
- Tae-han Kim, CEO of Samsung BioLogics, attends JP Morgan
- by Lee, Seok-Jun Jan 13, 2020 06:27am
- Samsung BioLogics will present the main event space (Grand Ballroom) for two consecutive years at the JP Morgan Healthcare Conference. It is the first Korean company to make a main event space presentation. President Tae-han Kim makes a presentation by himself. Kim's attendance at the JP Morgan conference was unclear due to the prosecution's investigation into Samsung Biologics intentional accounting fraud. Tae-han Kim, CEO of Samsung Biologics, is presenting at the 2019 J.P. Morgan Healthcare Conference.Samsung BioLogics announced on the 12th that it will participate in the JP Morgan Healthcare Conference, the world's largest global investment event, held in San Francisco, USA. Samsung BioLogics was assigned the Main Track in 2017 and 'Grand Ballroom' last year and this year. Both are the first Korean companies. The Grand Ballroom is a large 800-seat presentation venue. Only a few major global pharmaceutical companies, such as Pfizer, Roche and Johnson & Johnson, are known to be assigned. The announcement will be made by CEO Tae-han Kim and Vice President John Lim. Samsung Biologics will present its achievements, 2020 goals, and mid- to long-term visions under the theme of 'Innovation and Growth of Samsung in Biologics Industry' in a presentation on Wednesday afternoon 15th. Meanwhile, the JP Morgan Conference, which marks its 38th anniversary this year, is the largest investment event in the healthcare sector, in which 500 pharmaceutical bio companies from around the world, invited by the global investment bank JP Morgan, announce major business results and visions.
