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- 2025-12-26 13:07:30
- 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.
- 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 .
- 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.
- Policy
- Generic exclusivity for ₩50 million Betmiga applied
- by Lee, Tak-Sun Jan 13, 2020 06:26am
- The first generic drug of 'Betmiga' (Mirabegron, Astellas), a potent overactive bladder treatment, coming soon in June this year applied for permission. The interest in the industry is amplified because generic exclusivity are given exclusive rights to the generic market based on who first applied for the permit. According to the MFDS and the industry on the 10th, the application for permission of the Betmiga was received on Dec 31. Since the re-examination period for the Betmiga was expired on Dec 30, the application for authorization was submitted the next day, Dec 31. However, the number of licensed items and company names have not been disclosed yet. Currently, 11 Korean companies have established the basis for early entry into the market, excluding the material patents of Betmiga, winning the decision to invalidate crystalline invalid patents. Accordingly, the first applicant of the 11 companies is likely to obtain a generic exclusivity, which is granted generic market monopoly for nine months. The 11 companies are Hanmi pharmaceutical, Chong Kun Dang, JW pharmaceutical corporation, Daewoong Pharmaceutical, Ildong Pharmaceutical, Intro biopharma, Alvogen Korea, Kyungdong pharmacetical, Shinil Pharm Ltd, Hanwha Pharma Co., LTD, and Shin Poong Pharm. Co., LTD. However, all 11 companies did not submit the application for permission last month. Some companies have reportedly failed to demonstrate bioequivalence with the original drug. As such, only a few companies are likely to win generic exclusivity. Generic exclusivity is expected to be granted for nine months from the day after May 3, 2020, when the Betmiga’s patent expires. During this period, the same ingredient generics will not be released, so it is highly likely that the rights holder will preoccupy the market. Accordingly, companies that have acquired generic exclusivity are expected to conduct aggressive marketing and marketing during that period. Betmiga is a large item of about ₩50 billion per year. In 2020, it is expected that Betmiga’s generics will struggle over the market.
- Policy
- Certican price reduced by ATP to KRW 5250 for 1mg
- by Kim, Jung-Ju Jan 13, 2020 06:22am
- The price of Novartis’ immunosuppressant Certican (everolimus) was lowered on Jan. 9, as a result of the recent actual transaction price (ATP) survey on reimbursed drugs. The price could be further adjusted when the final decision is made from the administrative litigation between the company and government about ex-officio adjustment of the drug pricing. On Jan. 8, Korea’s Ministry of Health and Welfare (MOHW) has issued the partially revised ‘List of Reimbursed Drugs and Maximum Reimbursement Price’ reflecting the price change. Last year, the government surveyed ATP of drugs supplied to healthcare institutes to calculate weighted average value, and lowered maximum reimbursed price of each drug item by no more than ten percent according to the survey result and calculation. Currently, Certican is in the midst of administrative litigation against the government’s decision to lower the drug pricing by 30 percent due to a first generic listing, but the company has requested for suspension on enforcement of the ex-officio adjustment. If the request had not been accepted by the court, the drug pricing would have been lowered by more than the ATP-based price reduction rate, which would not have been reflected. While the company is maintaining the original pricing with last year’s adjustment is suspended by the prolonged litigation, the government had to lower Certican’s pricing by ATP-based reduction rate like any other drugs. Accordingly, the new reimbursed maximum prices of Certican in different doses are 2,266 won for 0.25 mg, 3,617 won for 0.5 mg, 4,450 won for 0.75 mg and 5,250 won for 1.0 mg.
- Policy
- More rare diseases designated for special case NHI benefit
- by Lee, Hye-Kyung Jan 13, 2020 06:22am
- From Jan. 1 this year, the government expanded list of designated rare diseases and healthcare institutes examining rare disease eligible for the special case healthcare benefit. To reduce medical expense and to improve medical access for patients with ultra rare and unknown diseases, National Health Insurance Service (NHIS, President Kim Yong-ik) announced the extended list of rare disease and healthcare institute examining rare disease for special case National Health Insurance (NHI) benefit that came in effect from Jan. 1. The objective of the special case benefit system is to reduce patient’s copayment rate on expensive rare and severe disease treatment, which makes a rare disease patient to be responsible for 10 percent of inpatient and outpatient medical expense. Accordingly, the list of designated rare disease receiving special case benefit has been expanded to include 1,014 rare diseases, applying the benefit to around 270,000 patients. Before the change, it used to be approximately 265,000 patients receiving the benefit. Constantly listening to patients, their family, patient groups and related academic societies, NHIS increased the number of designated rare disease for the benefit after a series of deliberation by Rare Disease Management Committee (Korea Centers for Disease Control and Prevention) and Special Case Benefit Committee (NHIS). From last year, the government agency has opened a separate disease group dedicated for unspecified chromosome abnormalities, as patients with the condition could not receive any special benefit without a specific name of diagnosed disease. Rare disease patients with the designated special case disease are expected to access treatment with lessened financial burden, as supported by special case NHI benefit and Rare Disease Patient Medical Aid program. Also the NHIS has added more healthcare institutes to examine and diagnose rare disease. Since 2016, NHIS has appointed qualified healthcare institute to exam ultra rare disease and unspecified chromosome abnormalities to promptly but accurately provide special case benefit to the patients. In December, the agency called for a bidder among tertiary hospitals offering rare disease or genetics clinic, and selected seven more hospitals, making total of 28 hospitals available for rare disease examination from this year. The new appointment was to expedite examination procedure to diagnose increasing number of rare disease eligible for NHI special case benefit, and to resolve inconvenience of patients in regions without the designated institute, such as Jeonnam, Jeonbuk and Chungbuk. A NHIS official stated, “The agency would continue to improve rare disease patient’s access to treatment by providing special case benefit to growing number of newly diagnosed rare diseases found with fast-advancing technology, and by appointing more healthcare institutes capable of examining the diseases for the patients to receive adequate treatment.”
- Policy
- Choline alfoscerates, 82 generics were approved last year
- by Lee, Tak-Sun Jan 10, 2020 06:26am
- The most representative of choline alfosceratesDespite the controversy over last year's efficacy, choline alfoscerate formulations were found to have received 82 new licenses last year. Only 267 cumulative licensed items are available. On the 9th of last year, an investigation into the approved items of the same ingredient was conducted through MFDS' website. The choline alfoscerate formulation was found to have a validity issue during a national audit last October. In response, the Ministry of Health and Welfare announced plans to conduct a pay reevaluation by June this year, and the MFDS began validating in November. The industry believes that choline alfoscerate's reimbursement restrictions are strong. Nevertheless, pharmaceutical companies considered the high marketability of the formulation and continued to produce the product. Choline alfoscerate formulations form a large market with insurance claims amounting to about ₩300 billion. Irrespective of the size of hospitals and majors, the elderly are indiscriminately prescribed for the prevention of dementia. It is a perfect market for domestic pharmaceutical companies that do generic sales in the parliamentary market. In addition, consignment items poured out last year as new formulations such as liquid In hard capsules and syrups, which can be bottled, were released. Choline alfoscerate formulations, despite no original patent expiration issues last year, recorded a number of licensed items following Pregabalin (93) and Oseltamivir (87). Major generic drug licenses in 2019 Pregabalin and Oseltamivir formulations have recently expired. However, Pregabalin has three doses, and Oseltamivir is difficult to make an indirect comparison in that there are three capsule dosage forms and a suspension formulation. The MFDS is currently validating Choline alfoscerate preparations, but it is difficult to draw conclusions. Since it has already been validated through the 2018 update, it is difficult to conduct clinical reevaluation due to lack of literature data. However, the industry reports that reimbursement revaluation may result in reimbursement restrictions in order to reduce consumption.
- Policy
- 23 new drugs approved last year with no Korean-made
- by Lee, Tak-Sun Jan 10, 2020 06:25am
- Apparently, total 23 investigational new drugs have been approved in Korea last year. Compared to 2018, the number was increased by 14 but not one of them was made in Korea. Moreover, two incrementally modified drugs (IMDs) and three biosimilars have been cleared. According to Ministry of Food and Drug Safety (MFDS)’s pharmaceutical information website on Jan. 8, updated information of newly approved investigational drugs in 2019 found that total 23 drugs have been passed by MFDS last year. All of them were developed outside of Korea. Korean pharmaceutical companies JW Pharmaceutical, Jeil Pharm and SK Chemicals had their Hemlibra subcutaneous injection, Lonsurf tablet and Ongentis capsule approved, respectively, but all of them were developed from abroad. K-CAB tablet (tegoprazan, CJ Health Care), approved on July 5, 2018, is still the latest Korean-made new drug. 2019 new drugs Out of all drugs approved last year, five were biological drugs and 17 were synthetic drugs. MFDS has approved two IMDs last year, including; an amlodipine besylate-chlorthalidone-telmisartan triple combination drug, True Set tablet (Yuhan), and eight items of multiple combination drugs with pitavastatin calcium and fenobirate. Besides, three biosimilars—Samsung Bioepis’ Etolce 50 mg prefilled syringe (etanercept), Daewon Pharmaceutical’s Terosa cartridge injection and Pangen’s Panpotin prefilled syringe injection—were approved last year as well. Meanwhile, total 4,793 finished pharmaceutical products (661 OTC, 4,132 prescription drugs) have been approved last year. Compared to 2,056 products approved in 2018, year 2019 had significantly more finished products cleared. The surge in approved finished products could have been because of surge in number of CMO-manufactured generics with cosigned bioequivalence test. 4,207 generics have been cleared in 2019, which the number doubled from 1,754 in 2018. Sources analyze it was because many of the generics have applied for approval in a hurry before the cosigned bioequivalence test limiting policy came into effect.
