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- 2026-04-17 19:19:01
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- Counterattack of Valsartan’s Pharmaceuticals
- by Chon, Seung-Hyun Dec 03, 2019 05:54am
- Pharmaceuticals filed an alleged class action lawsuit against health authorities. A lawsuit was filed preemptively that the government can not accept the Valsartan claim. Cost liability for follow-up of impurity drugs has been determined in court. According to the industry, 36 pharmaceutical companies recently filed a lawsuit to confirm the absence of debt against the National Health Insurance Service in the Seoul Central District Court. It is a lawsuit stating that it is not responsible for the valsartan damages claimed by the National Health Insurance Service. The NHIS asked to pay a donation of ₩2.03 billion to 69 pharmaceutical companies in last October. It is a follow-up to the Ministry of Health and Welfare's decision to return the amount of money invested in pharmacies after exchanging impurity valsartan for the remainder of their prescriptions last year. It is unprecedented that pharmaceutical companies filed a lawsuit against the government in a group. In 2012, the government made a move to file a lawsuit against the collective price cuts of health authorities, but did not lead to a legal workshop. In 2013, the NHIS and pharmaceutical companies filed a lawsuit for damages related to drug substance preferential treatment. However, at this time, the NHIS filed a lawsuit. Originally, pharmaceutical companies considered the joint response to the NHIS 'lawsuit. However, they agreed to take a hard-line response by preemptively bringing up class action. The number of companies participating in litigation is also on the rise. Pharmaceutical companies were the first to discuss whether they would co-operate for the first time immediately after receiving a bill from the NHIS in early October, at that time, 20 companies showed a positive position. When it decided to file a lawsuit last month, it increased to 35 companies, and it was reported that one large pharmaceutical company was willing to join an additional company immediately after submitting the complaint. Most companies with large damages have refused to pay. According to the data submitted to the Democratic Party's member, Nam In-sun, 26 pharmaceutical companies paid ₩440 million in compensation. The payment rate was only 21.5%. The pharmaceuticals refused to pay about 80% of the recourse amount. Pharmaceutical companies are claiming no responsibility for the government-claimed Valsartan damages. The NHIS has proposed a product liability law on the grounds of valsartan compensation. It is judged that there is a defect in the manufacturer's product and safety, and according to the product liability law, it is possible to claim for damages due to the product defect. It is based on Article 3 of the Product Liability Act, which states that 'manufacturers shall reimburse those who suffer damages to life, body or property due to defects of the product'. Pharmaceutical companies stress that there are no manufacturing and design flaws with impurity valsartan. Carcinogen N-nitrosodimethylamine (NDMA), detected in Valsartan’s issue, is a hazardous substance in the valsartan raw material that has no standard. Neither governments nor pharmaceutical companies were aware of the risk of NDMA detection in Valsartan. According to the Product Liability Act, it is clear that if the manufacturer proves that a defect was not found at the level of science and technology at the time the manufacturer supplied the product, it would be liable for damages. After the valsartan’s issue, the MFDS derived a test method for detecting NDMA from Valsartan raw materials and set new standards. The MFDS set the NDMA standard for Valsartan to 0.3 ppm or less by reviewing the guidelines recommended by the International Pharmaceutical Regulatory Coordination Committee (ICH M7), domestic and international data, and expert advice. Moreover, the hazard of impurity Valsartan was not revealed. The MFDS said, “ in last December, based on individual doses and duration of patients actually taking NHA-detected drugs using Valsartan by Huahai , the possibility of additional cancer was negligibly low“ Pharmaceutical companies argue that the National Health Insurance Service does not include claims for damages. The NHIS has charged Valsartan medical fees and dispensing fees, but pharmaceutical companies are not liable for compensation under the Product Liability Act. An official of a pharmaceutical company said, “We took huge losses from the recovery and disposal of products that are not exposed to human hazards, and it is unfair to pay for represription fee and redispensing costs. Following Valsartan, sales of Ranitidine and Nizatidine were stopped, and we decided we need to weigh the injustices of the government action”.
- Company
- ECCK “Revised Pricing Negotiation Guideline Violates FTA"
- by Kim, Jin-Gu Dec 03, 2019 05:53am
- Chair Julien Samson of ECCK Healthcare Committee (VP& General Manager of GSK Korea, fourth from the right) and other ECCK members presented White Paper 2019 and presented recommendations to Korean government. Europe-based global pharmaceutical companies with offshoots in Korea have filed official complaints on ‘additional requirements under side agreement’ added to drug pricing negotiation procedure in Korea. They claim the new changes could violate the principles of Korea-EU Free Trade Agreement (FTA). European Chamber of Commerce in Korea (ECCK) convened a press conference on Nov. 29 at Four Seasons Hotel Seoul, and addressed issues regarding each industry sector and 180 recommendations to the Korean government. ECCK’s Healthcare Committee (Chair Julien Samson, VP & General Manager of GSK Korea) also contributed 34 recommendations. The highlight of the recommendations was the ‘Revising the New Requirements Imposed through Drug Price Agreement.’ National Health Insurance Service (NHIS) imposed several ‘side agreement’, or ‘additional requirements’ to the pharmaceutical companies during the price negotiation since last year and regulated them in June, 2019. ECCK official warned the additional requirements were “regulated without any public comment period. Some of them are overly strict with little relevance to pricing negotiation. This could violate the principles of Korea-EU FTA”. The committee argues Korea-EU FTA stipulates when revising regulation or guideline regarding pharmaceutical pricing or insurance reimbursement, both government bodies should communicate with industry. “It is recommended to consult with the industry stakeholders on any new requirements or revisions in line with the principles of the Korea-EU FTA”, ECCK officially advised. In fact, the side agreement requirements have become the most talked about issue of recent drug pricing negotiation cases. Lipiodol incident was the critical point triggered the Korean government. The change is interpreted as the government’s effort to prevent any other already-listed item refusing to supply products to Korean market. The new requirements impose penalty on pharmaceutical company not fulfilling obligation to supply drug products, and stipulate the companies to provide compensation for patient when suspending supply. Also the side agreement requires both negotiating parties to keep negotiation details non-disclosed. Biogen’s Spinraza, Janssen’s Darzalex, Amgen’s Prolia and other items that completed pricing negotiation this year had to meet the additional requirements. Although it had the negotiation last year, CJ Healthcare’s K-Cab had to fill out the side agreement as well. And three new drug items exempted from negotiation were denied from the last reimbursement review procedure in April, because they were “missing side agreement”. It was unexpected as reimbursement used to be granted usually without an issue for an item passed by Health Insurance Policy Deliberation Committee (HIPDC). At the end, Whanin Pharm’s Agotin, AstraZeneca’s Faslodex and Takeda’s Alunbrig were successfully listed after compiling side agreement. But the happening reaffirmed the gravity of side agreement in the negotiation procedure. In June, the side agreement submission was regulated as a law. NHIS’ revised drug pricing negotiation guideline now requires pharmaceutical companies to submit an agreement about supply obligation, patient protection measures, and confidentiality when negotiating drug pricing. The Article 9 of Drug Pricing Negotiation Guideline was revised and now imposes new requirements to pharmaceutical companies to protect Korean patient, to provide compensation for patient damage, and keep negotiation confidential. The pharmaceutical industry is mainly complaining about the government omitting the industry comment period. For an instance, a global pharmaceutical company organization, or Korean Research-based Pharma Industry Association (KRPIA), submitted an official statement claiming “Imposing of additional requirement or obligation for drug pricing negotiation should come with an administrative notice according to the Administrative Procedure Act”. The organization also reprehended the new requirements are considered as ‘side agreement’, but it actually puts NHIS on an authoritative position for it to unilaterally impose obligations to pharmaceutical companies. The ECCK’s complaint is basically an extension of the criticism. Established in 2012, ECCK has headquarters in Europe and it consists of 360 active member companies. Every year the Chamber represents the voice of European businesses by collecting recommendations and relaying them to the Korean government. Last year, the Chamber has presented ECCK White Paper 2018 with 123 recommendations, and almost 40 percent of the recommendations received positive feedbacks from the Korean Ministry of Trade, Industry and Energy (MOTIE).
- Policy
- HIRA rejects reimbursed use of Spinraza on 14-year-old
- by Lee, Hye-Kyung Dec 03, 2019 05:53am
- Approval on reimbursed use of Spinraza (nusinersen) on a 14-year-old male patient with 5q spinal muscular atrophy (SMA) was denied. The application submitted by the hospital was rejected as it did not clarify if the patient had developed clinical symptoms of SMA before 36 months. On Nov. 29, Health Insurance Review and Assessment (HIRA, President Kim Seung-taek) posted seven cases of Treatment Review and Evaluation Committee deliberation in October. Although Spinraza was listed on the Drug Reimbursement List from last April 8, a healthcare institute planning to use the treatment has to submit a preliminary drug use approval application due to the ultra-expensive maximum reimbursement price reaching 92,359,131 won per 5 ml vial. In last month, 15 preliminary drug use approval applications on Spinraza, including 13 first loading doses and two maintenance doses (application submitted once every four months), were submitted. But the committee disapproved only one case, which involved a 14-year-old boy. Other 11 first loading doses and two maintenance doses were approved, and one first loading dose was approved with conditions. The conditional approval was granted to a five-month-old female infant trying to get detached from ventilator. The committee approved of reimbursed use of Spinraza as long as the patient submits medical profession’s statement on use of ventilator prior to Spinraza administrations and medical record of respiratory function. Before the Spinraza review, the committee reviewed 34 preliminary applications on use of Soliris (eculizumab), including 23 cases of paroxysmal nocturnal hemoglobinuria (PNH) and 11 cases of atypical hemolytic uremic syndrome (aHUS). For the first loading dose, one PNH case was accepted and other one was rejected. Whereas three cases of aHUS patients were accepted and other three were rejected. Use of Soliris on a PNH case denied as the patient’s medical record was missing repetitive abdominal pain-induced hospital administration, but showed a recent increase in use of narcotic analgesic. The patient’s record did not meet scope of reimbursed use of the treatment. An aHUS case was rejected because the patient’s status was not clear cut as stated in the criteria. The patient’s symptom was considered as a secondary thrombotic microangiopahty induced from rheumarthritis and its treatment, and from multiple myeloma and its treatment. And also the patient showed rise of CEA level, delayed prothrombin time and activated partial thromboplastin time (PT/aPTT), and fall of fibrinogen level. The committee also decided the patient cannot expect positive effect from the treatment as the patient needs dialysis for end-stage renal disease. A preliminary approval review on reimbursed ventricular assist device (VAD) treatment was conducted as well. A male patient aged 64 years was registered on the heart implant waiting list with dilated cardiomyopathy (DCM), who was diagnosed with end-stage heart failure by an echocardiography with dobutamine substance and motor function test. The patient did not recover from medication treatment and is dependent on intravenous cardiotonic agent. HIRA approved reimbursement on the patient’s VAD treatment, because the case met the reimbursement standard of ‘indication for VAD implant on end-stage heart failure patient, who has been registered on heart implant waiting list as a makeshift treatment’. Also the patient not showing any contraindication helped the decision. Other details of the Treatment Review and Evaluation Committee’s October meeting can be found on HIRA website (www.hira.or.kr).
- Company
- Drug Committees pass oral Fabry treatment Galafold
- by Eo, Yun-Ho Dec 02, 2019 05:57am
- Galfold (migalastat) The world’s first orally taken Fabry disease treatment ‘Galafold’ is landing its code on tertiary hospital drug list. According to pharmaceutical industry, Handok’s Galafold (migalastat) has been passed by drug committees (DC) in specialized healthcare institutes for rare disease care, like Seoul Asan Medical Center, Ajou University Hospital, and Pusan National University Yangsan Hospital. Other major general hospitals and Big 5 hospitals are also processing the drug code. Galafold is prescribed to patients aged 16 years or older with a confirmed diagnosis of Fabry disease and who have an amenable mutation. The treatment should be taken one capsule every other day. Galafold’s Phase 3 ATTRACT study switched therapy for 57 Fabry disease patients, who had enzyme replacement therapy (ERT) for at least 12 months, with Galafold. The investigational treatment demonstrated statistically equivalent annual change of estimated glomerular filtration rate (eGFR) with 18-month of ERT. While the group who remained on ERT had a decline of left ventricular mass index (LVMi) by -2.0 g/m2 over 18 months, the group who switched from ERT to migalistat had a significant decline in LVMI by -6.6 g/m2 over the same period. Developed by an U.S.-based Amicus Therapeutics, Galafold was approved by the U.S. Food and Drug Administration (FDA) in October, 2018, and it is now available in the U.S., EU, Australian, Canadian, Swiss, Israeli, and Japanese markets. The treatment has been designated as an investigational orphan drug to meet urgent medical needs, and received approval from Korean Ministry of Food and Drug Safety (MFDS) in 2017. Its insurance reimbursement was also granted from last March. Currently, Galafold’s competitive medicine are Sanofi Genzyme’s Fabrazyme (agalsidase beta) and Shire’s Replagal (agalsidase alfa). The two competitors are ERT sharing a similar mechanism in injection formulation. Replagal is injected once every other week into intravenous line with dose of 0.2 mg per kg body weight, whereas Fabrazyme is injected once every other week into intravenous line with dose of 1.0 mg per kg body weight. Fabrazyme is comparatively a high-dose treatment. Another notable difference is that Replagal is produced in a human cell line, and Fabrazyme is produced in Chinese hamster ovary cell line. An official from Korean Society of Medical Genetics and Genomics commented, “Rare disease like Fabry disease has small patient size to begin with, which makes conducting a credible clinical trial quite difficult. Therefore, medical professions are more likely to be loyal to older treatments. However, having more treatment option for the disease is good news”.
- Policy
- 'Ongentys' by SK Chemicals approved in Korea
- by Lee, Tak-Sun Dec 02, 2019 05:56am
- SK Chemicals obtained a domestic item approval for Parkinson's disease treatment,‘ Ongentys Capsule (Opicapone)’. This product is expected to be a new drug in the Parkinson's disease market after a long interval. The Ministry of Food and Drug Safety approved the marketing of SK Chemicals 'Ongentys Capsule 25mg, 50mg' on the 26th. This drug has been approved as an adjuvant therapy for levodopa/dopa decarboxylase inhibitors (DDCI) in patients with Parkinson's syndrome who have symptoms of locomotion that do not improve with levodopa/dopa decarboxylase inhibitor (DDCI) standard therapy. As a COMT inhibitor, it has a mechanism to improve the drug efficacy by increasing the plasma concentration of levodopa. Levodopa is a medicine that supplements dopamine, a brain neuron that Parkinson's patients lack. Ongentys has demonstrated efficacy and safety in a clinical trial in 1027 patients who are receiving Parkinson's treatment with levodopa/DDCI (alone or in combination with other anti-Parkinson medications) and who have symptoms of exercise fluctuations. Developed by BIAL, the largest pharmaceutical company in Portugal, SK Chemicals signed an exclusive sales contract with Bial in March 2018. Within a year since its first commercialization in Europe in 2016, the company is expanding its market rapidly, exceeding 10% market share in the same field market in Germany and Spain. The domestic Parkinson's disease drug market is estimated at ₩80 billion. As Ongentys is licensed as an adjuvant for levodopa, the market for product sales is expected to be smaller than the total market. Competitive drug 'Comtan' (ingredient name: Entacapone, Novartis Korea), which has a similar mechanism to Ongentys, recorded sales of 850 million won by IQVIA in last year. Comtan is also licensed as an adjunct to levodopa/dopa decarboxylase inhibitors, like Ongentys. An official of SK Chemicals said, "Ongentys will be a treatment alternative that will improve the motor agitation symptoms that are typical of Parkinson's patients". "We will strengthen our portfolio of central nervous system-related therapies to contribute to the establishment of a national health right," he said.
- Policy
- Generics for Galvus, focus on development strategy
- by Lee, Tak-Sun Dec 02, 2019 05:56am
- 노바티스 The development of generic drugs for Galvus (Vildagliptin by Novatis Korea), which is a DPP-4 inhibitor for diabetes mellitus is continuing. In particular, while Ahn-gook pharmaceuticals and Hanmi Pharmaceuticals have already completed their commercialization and anticipated market preoccupation, pharmaceutical companies' strategies to penetrate this gap and enter the market early on are drawing attention. According to the MFDS and the industry, pharmaceutical companies that are currently developing generics for Galvus include Ahn-gook Pharmaceuticals, Hanmi Pharmaceuticals, Korea United Pharm, inc, Kolmar Korea, and Alvogen Korea. The generic drug Angukvildaliptin tablets 50mg by Ahn-gook Pharmaceuticals approved on 22nd last month. Hanmi Pharmaceuticals also applied for a salt alteration drug in last July. Ahn-gook pharmaceuticals and Hanmi pharmaceuticals laid the groundwork for the market by the end of August 2021, citing a request for an extended trial invalidation filed in the Galvus material patent. In addition, both companies have a strong chance of obtaining a preferential selling license to monopolize the generic market for nine months. Both companies which have the rapid speed of patent challenge and commercialization has increased the likelihood to obtain benefit of first generics. Given this scenario, it is likely that other pharmaceutical companies except for Ahn-gook & Hanmi which are likely to get exclusivity for generic product , will enter the market late. But second-runners, Korea United Pharm, inc, Kolmar Korea, and Alvogen Korea. also have the opportunity to accelerate their time to market. They are developing generics for Galvus late for that niche market. In order to avoid the sale ban period under exclusivity for generic product of Ahn-guk and Hanmi, they must prevail over revised drugs such as salt changes, slow-release drugs, or through appeals of different nature. Korea United Pharm, inc, which received approval for the bioequivalence test plan last September, and filed a patent trial earlier last month, is conducting patent trials in a manner other than the successful patent challenge method of Ahn-guk and Hanmi. If Ahn-guk & Hanmi succeeded in the patent challenge through the extended period of invalidity trial, Korea United Pharm, inc raised the right to confirm the scope. There are different kinds of judgments, but there are similar aspects in attempts to neutralize extended durations. However, due to the different methods of patent challenge, if Korea United Pharm, inc wins the Scope of Rights Judgment, it could be a new exclusivity for generic product vendor. However, there is a premise that the company must win the referee. Alvogen Korea was approved last month on the bioequivalence protocol, which identified the drug as Vilagliptin sustained release tablets. In some cases, Galvus may be administered twice daily, and Vildaliptin sustained-release tablets appear to be a reduced version of the drug once daily. In any case, if sustained-release tablets are commercialized, they will be able to plan early market launches in their own way, regardless of previous generic patents. Kolmar Korea, who was approved for a bioequivalence test on the 25th of last month, has yet to disclose how to circumvent exclusivity for generic product because there is no patent challenge. However, there is an observation that it is asking for a passive jurisdiction judgment like Korea United Pharm, inc. What's important is that latecomers such as Korea United Pharm, inc, Kolmar Korea, and Alvogen Korea will have to succeed in product development and win a patent challenge in order to evade exclusivity for generic product and enable early release scenarios. So far, only scenarios have emerged, making it most likely that a licensed Ahn-guk will have a monopoly in the generic market. There are only nine new DPP-4 inhibitors, and competition among companies is fierce, but it is not open to generics. Among them, Vilagliptin formulations for Galvus are likely to become the first generic product in the DPP-4 inhibitor market.
- Policy
- “Cost-effectiveness review inevitable for high-cost drugs”
- by Lee, Jeong-Hwan Nov 30, 2019 05:51am
- Korean Minister of Health and Welfare Park Neung-hoo stated the ministry would approach the issue of National Health Insurance (NHI) coverage on super expensive drugs by evaluating cost-effectiveness of treatment and pharmaceutical opportunity cost. Particularly, Minister Park highlighted insurance covered drug pricing system in Korea is comparatively reasonable than other countries. At the recent annual audition session by National Assembly Health and Welfare Committee, Minister Park answered Lawmaker Chang Jung-sook’s questioning. Lawmaker Chang’s question was on the pharmaceutical benefit issue from the NHI coverage enhancement policy, the ‘Moon Jae-in Care.’ She argued patients with severe diseases are still struggling with insurance coverage on high-cost drugs, despite Ministry of Health and Welfare (MOHW) is positively evaluating Moon Care’s performance. The lawmaker specifically pointed out about increasing number of global pharmaceutical companies giving up on bringing in new treatment or immunotherapy for severe diseases to Korean market due to MOHW’s unreasonable pharmaceutical benefit policy for high-cost drugs. “I applaud the government’s endeavor in challenging negotiation to set favorable pricing for the NHI. However, the public would eventually reprehend the government for betting patients’ lives on the table if the government relentlessly press companies on to reduce drug price on severe disease treatment”, Lawmaker Chang claimed. “84 percent of the Citizen Council for NHI that formed last year agreed on providing insurance benefit on severe disease treatment with small patient size, and on removing mild health condition treatment from reimbursement listing. The government should urgently help those patients in severe condition and in desperate need for treatment access”, Lawmaker Chang added. Minister Park partially agreed with the lawmaker’s argument, but explained the reality of MOHW how it has no choice but to keep cost-effectiveness in mind when deciding on insurance benefit for high-cost drugs. “The lawmaker’s criticism is right, but partially. NHI coverage should be considered from all sides as there are extremely expensive drugs at an unbelievable price of over hundred million won. We need to ponder on whether to save one patient with hundred million won, or to save ten patients with cost-effective price”, the minister stated. Minister Park also elaborated, “The government is not neglecting patients with severe condition. But we are trying to balance out the cost-effectiveness. Recently I was in ministerial meetings with Dutch and Danish health ministers on the topic of medicine access. And they personally expressed gratitude towards Korean government for having a proper control over high-cost drugs. In some countries, the expensive drugs cost tenfold of price in Korea. Korea is actually keeping the balance in global market.” “Despite all, it is right for the NHI coverage to center treatments for severe condition. The government would continue to seek out for reasonable plan to expand coverage through discussion”, he added.
- Policy
- NHI billing soars and brings down Xeljanz price by 9%
- by Eo, Yun-Ho Nov 30, 2019 05:50am
- Starting from next month, reimbursed price of Pfizer Korea’s Janus kinase (JAK) inhibitor Xeljanz (5 mg) is to be lowered by 9 percent. The treatment is now included as subject for price-volume agreement (PVA), because the actual insurance billing amount was surged by 30 percent than the initially estimated amount. Also for Allergan Korea’s Pred Forte Eye Drop, its reimbursed price would be brought down by 1.7 percent as actual billing amount of the same class items was surged by 30% than the estimated amount. Human growth hormone injection Eutropin by LG Chem is now a subject for preliminary price reduction by 3.3 percent after securing an additional indication. According to pharmaceutical industry source on Nov. 22, the government is preparing an updated list of reimbursed drug price and upper limit price with the said changes. When the list is finalized, the updated prices would be in effect from Dec. 1. First, the weighted price of Myungmoon Pharm’s Taro Ammonium Lactate Cream (12 percent) is to be adjusted by discretionary arbitration from October, 2020. Its price would be brought down by 21.2 percent, from 16,650 won to 13,112 won. The treatment’s price is to be dropped when the discretionary price adjustment ends the weighted pricing period. The government provides weighted pricing at 70 percent of the original’s price to the first generic to get listed, which it lasts for a year. But if there are less than three manufacturers with the equivalent class of generics after a year, the weighted pricing can be maintained until the fourth one is listed. After negotiating with National Health Insurance Service (NHIS), three items now have PVA in type Ga (가) and Na (나). Their listed price would also fall and it would be reflected from next month. Categorized as type Ga, Allergan Korea’s Pred Forte Eye Drop was initially listed after pricing negotiation but actual NHI billing amount of other items in the same class surpassed the estimated amount by 30 percent since the point of negotiation. Pricing of the eye drop in 50 mg/5 mL vial and in 0.1 g/10 mL vial are to go down from 2,569 won to 2,525 won, and 5,138 won to 5,050 won, respectively, by 1.7 percent. Although not categorized as type Ga, Xeljanz tablet was categorized by PVA type Na after being listed for four years. The overall billing amount of other items in the same class has gone over the estimated amount by 30 percent, and the tablet was then included among the group of items in the same class with adjusted upper limit price. Xeljanz met the criteria of PVA type NA, which recognizes an item with actual insurance billing amount increased from the year before by either 60 or 10 percent, and by over 5 billion won. According to the negotiation result, the treatment price is to be reduced by 8.9 percent from 12,992 won to 11,836 won. Five items, including Pfizer’s Genotropin injections (16IU and 12 mg), LG Chem’s Eutropin Plus injection (24 mg), Eutropin injection and Eutropin Pen, are subject for preliminary drug price reduction with expanded indication. These drug items are to reduce prices beforehand considering additional estimated billing amount and increase rate based on expanded indications. Reimbursed prices of Genotropin injection 16IU and 12 mg vial are to get reduced by 2.6 percent, from 91,920 won to 89,530 won and 195,790 won to 190,699 won, respectively. All Eutropin injection prices are to get lowered by 3.3 percent each. Prices of Eutorpin Plus injection (24 mg), Eutropin injection, and Eutropin Pen are to be lowered from 172,626 won to 166,929 won, from 22,810 won to 22,057 won, and from 202,060 won to 195,392 won, respectively. Another item’s price was raised after a pricing negotiation with NHIS as its request for an adjustment on upper limit price was accepted. Access Pharma’s Tuberculin PPD RT 23 SSI/APC is a substance used for tuberculosis skin test, and the company submitted an application for upper limit price increase due to import price raised by privatization of its manufacturer. The substance price would be raised from 19,225 won to 24,000 won. Chong Kun Dang’s Raparobell tablet (2 mg) went through a discretionary adjustment last month as expected when the original Rapamune tablet’s price was voluntarily reduced in March, 2016. The reduction was made after negotiating with NHIS, as generics were getting listed. Raprobell’s current price, 3,018 won would be bumped up to 4,311 won. With the first generic getting listed, the price of Rapamune tablet (2 mg) was adjusted down to 70 percent at 4,438 won. Accordingly, the generic tablet’s price was increased up to 68 percent of the first-in class item’s price. Other three items’ prices are to be lowered by their companies, voluntarily. Il Yang Pharmaceutical is lowering Il Yang Choline Alfoscerate capsule price by 8.2 percent, from 523 won to 480 won. Whereas Nelson Korea is to reduce price of Nelson Donepezil tablet (5 mg) by 53.8 percent, from 1,300 won to 600 won, and Jinyang Pharm to reduce Tacromin capsule price by 16.9 percent, from 3,630 won to 3,015 won.
- Company
- The Answer is in RSA expansion and undisclosed pricing
- by Kim, Jung-Ju Nov 29, 2019 10:54pm
- Maybe the answer has been before our very eyes all along. If Korea Passing occurs when other foreign countries start referring to Korean drug pricing, then it could be avoided by preventing them from referencing. Otherwise, drug could be price at a moderate level to avoid Korea Passing regardless of other countries. Theoretically they are both simple, but realistically they are not. It is close to impossible for Korea to bring up the pricing level immediately. So the second option of making Korean pricing system unattractive for external reference pricing, or in other words, increasing number of ‘undisclosed drug pricing’ could be a better option. Ultimately, the industry is leaning towards risk sharing agreement (RSA). Daily Pharm’s survey on 21 market access personnel from multinational pharmaceutical companies clearly showed their intention. 16 out of 21 companies suggested ‘RSA expansion or splitting out the refund type’, or ‘undisclosed drug pricing’ as solutions for Korea Passing. RSA has a room to grow, “make the right decision for the people” Increase number of listed drugs with dual pricing to prevent disclosure of actual price. Raise the externally referenced pricing with higher labeled price. Dual pricing for refund type RSA system in Korea undergoes economic evaluation like any other generally listed drug, and receives actual price according to ICER value. In other words, the government may provide dual pricing, but it does not affect National Health Insurance financially. But the civic groups are opposing fiercely and the government cannot blindly ignore it. The government has also shown strong will to expand RSA. Korean Ministry of Health and Welfare (MOHW) recently presented three conditions for RSA application eligibility, regardless of treating ‘life-threatening level of health condition’ or not. Expanding scope of subject disease was one of the most demanded changes the industry has been asking for, besides making follow-on drug eligible. The government, reportedly, has ongoing discussions about additional expansion plan. The industry is welcoming the government’s action for now. But many are still craving for more changes. The pharmaceutical industry is urging the government to increase ratio of undisclosed drug pricing. One change they are pressing on is ‘splitting out the refund type RSA’. The industry demands the refund type RSA should not be a conditional listing route, but another route of general listing procedure. In fact, Korea’s RSA has narrower scope than other countries. On the contrary, foreign countries are deciding to keep more number of drug pricing undisclosed. A common example that multinational companies like to take are Italy and Australia. The European country now has more than 300 drug items with undisclosed pricing, and Australia has 95 items. Taiwan and Malaysia, following Singapore, amended their regulations for pharmaceutical companies to freely apply for dual pricing. Some are also pointing fingers at the labeled price itself. A pharmaceutical company can propose a labeled price in Korea, but under the limitation of ‘less than A7 adjusted average price’. The industry explains the existing labeled pricing model could become a reason for Korea Passing in a long term. A global pharmaceutical company’s market access expert claimed, “Many countries caring about their own people are trying to secure access to new drugs by expanding the ratio of undisclosed drug pricing, despite it being a second best option. Although the title of ‘transparent pricing’ in global community is admirable, Korean government should make a decision for their patients as well”. Views and criticism on Korea Passing All of the arguments mentioned make sense. But accepting all demands at once is impractical. Their demands need a series of discussions to reach a satisfying solution. As the survey study showed, China is playing the most prominent role in the Korea Passing phenomenon the industry is worried about. China refers to Korean drug pricing, but still there are two to three years of gap in point of listing between two countries. But as the gap is narrowing, the pharmaceutical companies are now feeling the pressure. Not all drug items are instantly faced with risk of Korea Passing. Some say RSA expansion is not the only option. MOHW, for instance, recently presented an option of ‘trade-off’. The ministry intends to save expenditure from drug with expired patent, and reinvest the saved finance on securing access to new drug. However, pharmaceutical industry expressed anxiousness as they claimed it is another means of reducing drug price. It makes a sense for companies who have experienced a series of regulatory changes centering drug expenditure control. But, could it be that the companies are more concerned about risking lowered sales profit from their drugs with expired patent? Recently, a company refused to hand in a list of items with expired patent to trade off with a compensation for new drug pricing. The company presented a list of items with expired patent but expected to drop price due to expanded indication. It was basically the company turning down the trade-off offer. “We wonder if RSA is the only option. The current RSA regulation has expanded its subject scope recently, and yet the government is constantly reviewing other means of improving the system, including another expansion of subject. We need put everyone’s heads together for this problem”, a government official said. Surely, there is something wrong with foreign country’s external reference pricing creating uneasy tension and causing Korea Passing. But the multinational pharmaceutical companies are not selling designer bags or luxurious cars. And some drugs are actually priced higher in comparatively less developed country, or countries with weaker negotiation power. World Health Organization (WHO) convened ‘Fair Pricing Forum’ and adopted a resolution on “improving the transparency of markets for medicines, vaccines, and other health products”. What the global community strives to achieve with ‘drug pricing’ may differ from the multinational pharmaceutical companies. Korea Passing should never justify pharmaceutical companies trying to generate a loophole in the reimbursement listing system in Korea. We need to get a clearer view on the matter. Is there a certain headquarters passing the Korean market with a slightest inconvenience? Are executives and MA experts at Korean offshoots indeed trying to convince headquarters while they urge the government to amend regulation? They are some questions to ponder on. Another multinational company’s MA expert said, “It depends on pipelines, but each multinational company’s different nature has also affected Korea Passing. Government regulation should be improved, but it should be backed up by pharmaceutical industry’s effort as well”.
- Policy
- Price competition for Donepezil’s generics is high
- by Kim, Jung-Ju Nov 29, 2019 07:06am
- Pharmaceutical companies with Donepezil have lowered their reimubrsement premium caps and intensified price competition. This time, drugs that voluntarily lowered were dropped from 36% to 67% below the current price. This would be less than one-third of the highest price. LG Chem's three lines of Eutropin are expected to be subject to additional drug price cuts due to the expanded range of use. According to the industry on the 26th, the Ministry of Health and Welfare is pursuing the revision of the list of drug reimbursement and the cap. When confirmed as scheduled, most will apply on the 5th of next month. ◆Lowered the upper limit due to price-volume aggreement negotiations= First of all, there are a total of eight drugs, which are priced in the price-volume agreement linkage and negotiated with the National Health Insurance Service. Among the new drugs listed in the drug price negotiations, the same product group charges increased by more than 30% from the estimated bill at the time of negotiation. Each falls by 2-3% from the current price. In the case of Stivarga, the price dropped 3.2% from ₩378,18 to ₩36,608 from the 5th of next month, Lartruvo will be down 2.3% from ₩1,064,000 to ₩1,039,446 from February 1 2022. Of the new drugs that have not been included in the 'Ka' group for four years, the total number of claims for the same product group has increased by more than 30%. The new drug application date is the 5th of next month. In other words, the total number of products cut by 'Na' group is six LG Chem's three Eutropin line items fell 6.1% each. By item, Eutropin Plus 24mg will be cut from ₩172,626 to ₩162,096 , Eutropin will be reduced from ₩22,810 to ₩221,419, and Eutropin pen will be reduced from ₩202,060 to ₩189,734, respectively. In particular, these products have extended their scope of use, resulting in advance drug price reductions based on the results of price-volume aggreement negotiations. Trulicity 0.75ml by Lilly Korea, a genetically modified drug, has a 8.8% decrease from ₩21,722 to ₩10,981 and a Trulicity 1.5mg decrease from ₩34,289 to ₩38,014, down 9.8%. Tresiva Flex Touch 100 units / ml by Korea's Novo Nordisk Pharm's fell 6.5% from ₩16,876 to ₩15,780. ◆Advance price reduction of extending the scope of use = There are a total of 15 products for which the pre-lower price for the expansion of the scope of use is effective on the 5th of next month. In particular, LG Chem's Eutropin lines, which signed a price-volume aggreement, has expanded its scope of use and has been eligible for pre-price cuts. In other words, the result is an additional 2.6% reduction in the price-volume aggreement negotiation. By item, Eutrophin Plus 24mg ranges from ₩162,096 to ₩15,788,288, Eutrophin range from ₩21,419 to ₩28,620, and Eutropin pen range from ₩189,734 to ₩184,801. Each is lowered. Concerta OROS Tab lines by Jansen Korea also fell 1.5% each. Concerta 18mg Tab will be lowered from ₩1,226 to ₩1,208, and Concerta 36mg Tab will be lowered from ₩1,849 to ₩1,821. Lilly Korea, Strattera capsule line is also in ₩1,030 is by 3.6% lower to ₩993, Korea Pfizer, Genotropin 16IU to note to ₩89,530 from ₩91,920, as if notes Genotropin 12mg at ₩195,790, It drops 2.6% to ₩19,699 each. ◆Adjusted upper limit of voluntary price cut= 12 items have been lowered due to the drug maker's voluntary decision to lower its insurance price. The government calculates and re-adjusts a manufacturer, a consigned manufacturer, or an importer to apply for a price cut at a price lower than the listed maximum drug price. In general, it is a measure of cuts in line with its policies following market competition. Prominent among these is the product of four donepezil preparations. They decided to voluntarily cut from 31.6 percent to as high as 67.8 percent. Considering that the highest drug content is ₩2,060, the price is lowered by a third or more. Looking at the items, Hanpung Pharmaceutical's Doneil 5mg Tab voluntarily lowered from ₩2,060 to ₩675, and Doneil 10mg tab from ₩2,460 to ₩1,000. They were reduced 67.2% and 59.3%, respectively. Hwail Pharmaceutical's Donewon 5mg Tab decided to voluntarily cut from ₩980 to ₩670 and Donewon 10mg Tab from ₩1,480 to ₩950, 31.6% and 35.8%, respectively, were lowered by content. In addition, Paroxat 20mg of Hallim Pharmaceuticals, will fall 23.4% from ₩560 to ₩690. The Green Cross, Cansar 16mg tab will fall 16.3% from ₩824 to ₩690 , and the Cansarplus tablet will be reduced 15.6% from ₩853 to ₩720.
