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- 2025-12-25 02:54:35
- Policy
- Dupixent, reimbursement in next January upon settlement
- by Lee, Hye-Kyung Nov 20, 2019 06:33am
- Treatment for severe atopic dermatitis, Dupixent are under drug price negociations. NHIS(National Health Insurance Services) recently released this fact on its website. NHIS concluded pre-negotiation with Sanofia aventis before entering into drug price negotiations. Drug negotiations will last up to 60 days. If the drug price negotiations between the NHIS and pharmaceutical companies proceed smoothly, the reimbursement is expected to be secured in next January. Dupixent passed the HIRA's Pharmaceutical Evaluation Committee on October 11th. After negotiating a drug price agreement with the HIRA, it is necessary to put a name on the final list of reimbursement after deliberation by the MOHW Insurance Policy Review Committee. Dupixent will follow the RSA process as a treatment for serious diseases through ‘the detailed evaluation criteria of new drugs’ in August. Once the price negotiations are concluded, they will be the first beneficiaries of the expansion of RSA. The existing RSA system was only applicable to drugs for cancer and rare patients. However, due to its high price, Dupixent was also a target of RSA in that there were some broken cases when there is too much finance.
- Policy
- All prescription drugs to hand in bioequivalence test result
- by Lee, Tak-Sun Nov 20, 2019 06:33am
- Subject for bioequivalence test is to expand out to all prescription drugs. Also, drug specification with test criteria and procedure would be required, as well as Good Manufacturing Practice (GMP) evaluation result from external contract manufacturing companies. Korean Ministry of Food and Drug Safety (MFDS) announced on Nov. 18 its plan to enact partially revised ‘Regulation on Pharmaceutical Safety’, as a follow-up to the excessive commercialization of generics and last year’s valsartan incident with carcinogen contamination. The ministry is to accept public opinion on the matter until Jan. 20, 2020. For Korean pharmaceutical industry that bases most of business off of generic products, the revised regulation is the most detrimental level of regulation to hinder the industry. Some of regulations were previously alleviated on a moderate level, but they are now tightened back again. ◆ Bioequivalence test for all prescription drugs: First, all prescription drugs are to be gradually obligated to hand in bioequivalence test data. Currently only prescribed tablet, capsule, suppository and other specific drugs designated to provide bioequivalence test result were required to submit the material. About 60 percent of prescription drugs are included in the said subject group. But from now on, the applicable drug regimen types would expand out to all kinds. The administration method types required to provide bioequivalence test material would expand on oral in 2020, aseptic techniques including injection in 2021, and all the other types in 2022. Based on its cost-benefit analysis, MFDS projects affected pharmaceutical companies would spend about 164.4 billion won according to the revised regulation. The analysis estimated a single case of bioequivalence test would cost about 220 million won. ◆ Specification submission exemption removed: All prescription drugs would be obligated to hand in specification material. Specification, containing pharmaceutical test procedures and acceptance criteria for new drug, is to provide information on the drug’s manufacturing and test methodology and criteria for quality control, which also includes evidence and test performance data. Except for biopharmaceuticals, currently a drug listed on an official compendium, such as Korean Pharmacopoeia, was exempted from the material submission. Some officially recognized compendium include Korean Pharmacopoeia, Korean Herbal Pharmacopoeia, Good Manufacturing Practice criteria, and other official compendium or pharmacopoeia acknowledged by Minister of Food and Drug Safety (i.e. U.S. Pharmacopeia, Japanese Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, German Pharmacopoeia, and French Pharmacopoeia). However, there would be no exception from now on. As of 2017, 51 percent of prescription drugs applying for approval were listed on the official compendium. MFDS suspects additional cost would be spent on evaluation service fee, as companies would already have documented specification related materials. The industry is expected to spend about 3.2 billion won, due to the revised regulation. ◆ CMOs to hand in GMP evaluation results: Besides the bioequivalence test, MFDS is also requiring contract manufacturing organizations (CMOs) to submit GMP status report and evaluation results. At the moment, the submission is exempted for drugs wholly manufactured in contracted manufacturer. GMP status report and evaluation result should include manufacturing plant floor plan, plant facility and environment management information, GMP-dedicated organization chart and related documentation rules, product specification related to applicant item, record of product and quality control, and copy of validation result. MFDS analyzed that annually 738 items are manufactured by CMOs. The ministry deduced the average number based on approved CMO products from 2012 to 2017, assuming items sharing joint bioequivalence test result are entirely manufactured in external facility. The health authority estimated the revised regulation would have companies to spend about total of 3.7 billion won. MFDS also clarified no additional documentation on GMP evaluation is required other than the materials filed by the client company, but explained additional cost would be probably spent on human resources and evaluation service fee.
- Policy
- Consigned items duty to produce on the rise, Overregulation
- by Lee, Tak-Sun Nov 20, 2019 06:33am
- As the MFDA foretells the resurgence of mandatory production of three batches of consignment items as a solution to the problem of generic stagnation, the pharmaceutical industry is pushing for excessive regulation. It is dissatisfied that consignment production is bound to be stopped if mandatory production of consignment items is obligated while abolishing consignment. The MFDA included these details when it announced legislation on the revision of some of the rules on safety of medicines and others. In addition, it is necessary to submit data on the evaluation of the GMP implementation status in the future manufacturing process. The GMP implementation assessment data also includes validation data to verify the uniformity of the product. Validation data is pre-checked through three batch productions. In other words, a drug produced at another plant will have to produce three batches of data from the plant when approved. Depending on the manufacturing facilities, as many as 100,000 tablets are produced per batch. When placed three times, 300,000 tablets are made. Pharmaceutical companies will not lose money if they sell 300,000 tablets produced for permits. In addition, submission of GMP data will also lengthen the license period. This is a big burden for the consignment company. Of course, trustees can benefit from additional production. However, most pharmaceutical companies are expected to suffer damage in the midst of active consignment production. In addition, the MFDA's stance is to phase out the allowance for joint and consigned living. The MFDA announced in a regulation notice that, starting from next June, the number of items allowed for joint and entrusted livelihood will be limited to three companies, and not allowed from June 2023. In addition, the MFDA is in a position to lower drug prices for consignment and joint livestock products. In the meantime, if consigned drugs are reinstated to become mandatory to produce three batches, the counterfeiting transaction between pharmaceutical companies will be markedly reduced. The provision of mandatory production data for three batches of consignment manufacturing items disappeared following the introduction of the 2014 GMP Conformity Decision. The revival will bring back regulation in almost five years An official in the pharmaceutical industry said, "In the event of last year's Valsartan, there was an opinion that we would revive the production of three batches of consignment items without leaving the co-provisioning regulations." The MFDA announced the revision of the rules on safety, such as the drugs, as well as mandating the production of three batches of consigned drugs, and expanding the subjects for submitting biotest data to all specialty drugs, and eliminating the exemptions for submitting the law. In addition, it will revise the report on overseas safety measures related to the suspension or withdrawal within from 15 days to 3 days, and the burden on pharmaceutical companies is expected to increase further.
- Policy
- Annual sales↑to ₩6.5 billion by generic exclusivity
- by Lee, Tak-Sun Nov 20, 2019 06:32am
- Myung-jin Chung, director of KHIDI, is announcing the results of the impact assessment on the patent linkage According to a survey result, the drug costs in 2018 were reduced by up to ₩4.8 billion due to generic drug exclusivity. Sales of generic pharmaceutical companies increased by up to ₩6.5 billion while the original company's drug costs were reduced by ₩11.3 billion. Myung-jin Chung, general manager of KHIDI, announced the results of the four-year impact assessment of the Patent linkage at the '2019 Drug Licensing Patent Linked System Policy Forum' held at the Four Points Hotel, Seoul Guro on the 19th. The impact assessment of the patent linkage began in 2016 under the applicable Act and was the fourth time this year. The study period was from April to October of this year, and the study was conducted on drugs that received prohibition of sale or generic exclusivity from January 2018 to December 2018, and their disposal were terminated (expiration of the period, expiration of effect, etc.). During this period, there were 29 items in generic exclusivity, and the targeted brand listed drugs were 5 items. The representative generic exclusivity drugs include 10 generic products of the osteoarthritis named “Layla” and 14 generic products of the hepatitis B named “Viread”. As a result, early entry effect of late drug market was 1.3 ~ 4.6 months. Early entry effect was based on 9 months from the date of notification to the original company following the application for the permission of generic exclusivity. If the original company asks for a prohibition of sale under the patent linkage system, it will not be able to enter the market for 9 months. The sales of generic companies, which acquired the generic exclusivity, increased from ₩5.696 billion to ₩6.473 billion. On the other hand, targeted pharmaceutical companies with the original listed drugs declined from a minimum of ₩9.9 billion to sales of ₩11.3 billion. In the case of Viread, pharmaceutical companies with listed drugs declined from ₩6.2 billion to ₩7.6 billion. On the other hand, Generics sales increase from ₩3.4 billion to ₩4.2 billion. As a result, the drug costs have been reduced from ₩4.53 billion to ₩4.76 billion. The indirect effect of generic exclusivity items is an increase in the research development costs and employment. According to the research results, the R & D expenditure increased from minimum of ₩180 million to maximum of ₩360 million. Employment also increased from a minimum of 19 people to a maximum of 38 people. Myung-Jin Chung said, "Prior to the 4th year after the implementation of the system, the approval of generic exclusivity has had a positive effect on the domestic pharmaceutical industry and health policy." He added. “Unlike concerns when introducing the system, original companies don't apply the prohibition of sale much. Activation of the genetic exclusivity has led to a rise in sales of domestic pharmaceutical companies.
- Policy
- Champix patent expires soon, follow-ons eager to launch
- by Lee, Tak-Sun Nov 18, 2019 10:21pm
- Despite a joint sales deal with Pfizer Korea on a quit-smoking medication Champix (varenicline tartrate), Yuhan Corporation is currently developing a follow-on medicine of the original. Seemingly, Yuhan is preparing for the Pfizer’s Champix’s patent to expire in next July. On Nov. 11, Ministry of Food and Drug Safety (MFDS) approved an investigational new drug application for Phase 1 clinical trial on Yuhan’s candidate medicine, ‘YHP190’. The study protocol states it aims to compare and evaluate pharmacokinetics of healthy adult subject arms taking 1mg of YHP1903 and 1mg of Champix tablet, respectively. The commercial clinical trial is to be initiated for the regulators to approve Champix’s follow-on medicine. Yuhan’s development of Champix’s follow-on drug and its clinical trial has gotten the industry’s attention as the company is currently co-promoting the original Champix with Pfizer Korea. In September last year, Yuhan signed a joint sales deal with Pfizer Korea. It was a co-promotion strategy to defend Champix’s market share from incrementally modified drug (IMD) launching in November same year. The IMD with a change in saline substance of Champix was able to enter the Korean market as it evaded extended term of the original’s substance patent. The Intellectual Property Trial and Appeal Board ruled the IMD does not infringe the original’s patent with extended term. However, the table turned in last January, as the Supreme Court on other case ruled that an IMD with changed saline substance does not evade extended patent. The Champix’s IMD released in November last year stopped most of its manufacturing after January. Korean court is expected to hand down the ruling on Champix’s IMD on coming Dec. 20. On the other hand, MFDS has already approved of 72 IMDs related to Champix. But initially Yuhan did not submit a follow-on drug approval application, due to its joint sales deal. Although the sales of IMDs are blocked at the moment, it would resume from July next year when the extended patent term expires on July 19, 2020. There are saline substance and composition variant patents expiring on Jan. 31, 2023, but most of Korean companies are evading the patent as they are using different substances. At last, July next year would be the long-awaited start of the heated smoking-cessation medication market competition. While many companies are eager to launch items in same class, the pharmaceutical industry is keeping a close eye on Yuhan with co-promotion deal over the original, to see if it would also join the follow-on drug market competition. Meanwhile, IQVIA reported Champix sales in the first half of the year plummeted by 51.1 percent, compared to same time last year, and that the drug only generated 11.5 billion won. The sudden drop of sales was affected by the original’s price reduction due to release of IMDs and decreased number of participants applying for government-supported quit-smoking program.
- Policy
- 5 or more medications were taken by 68% for older people
- by Kim, Jung-Ju Nov 18, 2019 05:34pm
- Korean proportion of 75 years and over who are taking more than 5 medications concurrently exceeded 68%. It is far exceeding the average of 48% of OECD –member countries. Diabetic prescription rate of first choice antihypertensive medication patientsis 78%, which is lower than the average of 83% in OECD-member countries, but is steadily increasing. In particular, more than eight out of 10 patients said they had enough consulation hours. MOHW(Ministry of Health and Welfare) announced on Nov 17th analyzing the level and status of Korea and each country based on the 2017 results of health care presented by the OECD. In Korea, ▲ the quality of acute care and outpatient care is continuously improving. ▲ In particular, the level of colorectal cancer and gastric cancer is the highest level among OECD countries. ▲ The level of outpatient prescription is gradually improved, but management by the multi combination prescriptions is required. The multi combination prescriptions means administration of five or more drugs with different ingredients for more than 90 days. Acute myocardial infarction and stroke 30 days mortality after admission to hospital ◆Acute care= Acute myocardial infarction and stroke 30 days mortality rate are representative indicators of the quality of the acute care area. within 30 days of acute stage patients over 45 years of age. The 30-day mortality rate for patients hospitalized for ischemic stroke (over 45 years) in 2017 was 3.2%, the superior level among OECD countries. The OECD average is 7.7%. The 30-day mortality rate for acute myocardial infarction has declined since 2008, but has increased since 2016, with 9.6% in 2017, higher than the OECD average. The OECD average is 6.9%. Cancer five year net survival ◆Chronic disease = Among the chronic diseases that are managed well in primary care areas, hospitalization rates for asthma and diabetes were 81 patients per 100,000 people and 245.2 patients per 100,000 people, respectively, higher than the OECD average. The OECD average is 41.9 patients per 100,000 people for asthma and 129 patients for diabetes. Chronic disease admission rates have only declined since 2008, and COPD disease admission rates are approaching the OECD average ◆Cancer care = The five-year net survival rate in Korea is the highest level of cancer care, with colorectal cancer of 71.8%, rectal cancer of 71.1% and gastric cancer of 68.9% Five-year net survival means the cumulative probability that a cancer patient will survive five years after diagnosis if cancer is the only cause of death. The 5-year net survival rate of lung cancer patients (25.1%) was higher than that of OECD countries (17.2%), and acute lymphocytic leukemia was 84.4%, slightly higher than the OECD average (83.7%). ◆ Outpatient prescription = Outpatient prescription level is determined by ▲ multidrug prescription ▲ opioid prescription ▲ antipsychotic prescription ▲ antibiotic prescription rate ▲ diabetes patient prescription ▲ benzodiazepines prescription. Data on multidrug, opioid and antipsychotic prescriptions were first collected this year. First, a multi-drug Prescription is defined as the proportion of patients 75 years of age or older who are chronically taking five or more drugs. In 2017, Korea accounted for 68.1%, the highest among the seven countries that submitted statistics (average: 48.3%). The total prescription for opioids, a narcotic analgesic, was 0.9DDD / 1000 people per day, the lowest next to Turkey. In Korea, narcotics prescriptions are low due to strict narcotics regulation and control , and repulsion from the term of “narcotics”. Defined Daily Dose (DDD) is the average dose that must be taken throughout the day for the main ingredients of the drug to take effect. The prescription rate for antipsychotics for patients 65 years of age and older is 36.2 per 1000 prescription populations, which is among the lowest in the 16 countries where statistics were submitted. Hospital admission rate In 2017, the amount of antibiotics for outpatient’s prescriptions in Korea was 26.5DDD / 1000 persons / day Medication prescription adequacy in diabetics is measured by first-choice antihypertensive * and hypolipidemic ** prescription rates. Primary antihypertensive agents are drugs used in the initial treatment of hypertension and include diuretics, beta blockers and alpha beta blockers, calcium antagonists, angiotensin converting enzyme inhibitors (ACE inhibitors), and angiotensin receptor blockers (ARBs). Lipid lowering agents are drugs that control blood lipids, such as cholesterol. For diabetics, higher prescription rates produce better results. Prescription rate to reduce the risk of diabetic nephropathy and to slow the progression of hyperalbuminemia in patients with diabetes with high blood pressure is 78%, which is lower than the OECD average (82.9%), but is increasing. In order to prevent cardiovascular disease in diabetic patients, the medical guidelines * recommend prescribing lipid-lowering drugs.In Korea, the level of drug prescription ** in diabetics increased by 23.3% p from 44.1% in 2011 to 67.4% in 2017. Hypnotic benzodiazepines are drugs that require caution due to the increased risk of side effects such as cognitive impairment and falls when taken over 65 years. The long-term prescribing of benzodiazepines was 10.1 patients per 1000 population over the age of 65, lower than the OECD average (33.9). Among the benzodiazepines, long-acting drugs were prescribed for 146.3 patients per 1000 people over the age of 65, more than the OECD average of 52 (52), but significantly lower than in 2011 (241.5). Long-term action of benzodiazepine drugs is expected to have a longer half-life when taken by the elderly, resulting in negative effects due to excessive sedation. Prescribing in primary care related patient safety Prescription and mental health related to patient safety = 80.8% of patients reported that their doctors had enough time to check out their consultation based on the 2018 medical service experience survey. In addition, 82.9% and 82.4% of the respondents explained that the doctor explained it in an easy-to-understand manner and participated in the decision-making process. The excess mortality rate for schizophrenia was 4.42 and 4.21 for bipolar affective disorder, higher than the OECD average (4, 2.9, respectively).
- Policy
- VMS treating fezolinetant Phase 3 approved in Korea
- by Lee, Tak-Sun Nov 18, 2019 06:23am
- An investigational medicine treating vasomotor symptoms (VMS) associated with menopause is to conduct a Phase 3 clinical trial in Korea. On Nov. 15, Ministry of Food and Drug Safe approved of Investigational New Drug (IND) application of fezolinetant for transnational Phase 3 clinical trial taking place in Korea. Acquired by a Japanese pharmaceutical company Astellas in 2017, a Belgium-based pharmaceutical company Ogeda SA has been developing the fezolinetant pipeline. The approved trial is to investigate efficacy and safety of fezolinetant on Asian women struggling with moderate-to-severe menopause-related VMS like hot flashes. Fezolinetant, an oral selective neurokinin-3 (NK3) receptor antagonist, is an emerging non-hormonal option for managing VMS. Reportedly, more than a half of women around the world in menopause experience VMS. The most prevalent symptoms are hot flush, heart palpitation, night sweating, anxiety and depression. To this day, estrogen-like hormone therapy was recommended the most. But hormone therapy should be taken with a caution as it could cause risk of breast cancer and other adverse reaction. The Phase 2 trial of fezolinetant reported significant reduction of the VMS frequency, specifically for hot flush, compared to a placebo group. The trial did not have any apparent adverse reaction reported. Having a high expectation on the innovativeness of fezolinetant, Astellas acquired Ogeda SA with a paycheck of EUR 800 million (about 1.29 trillion won). As soon as the non-hormonal VMS compound completes its late stage clinical trial in Korea successfully, it would initiate regulator’s approval procedure.
- Policy
- Doctors consider 'efficacy' over cost on anticancer Rx
- by Lee, Hye-Kyung Nov 15, 2019 06:29am
- Domestic oncologists have considered more efficacy and safety than the medicne expense when they prescribe anticancer drugs It implies that health authorities need to mix the ratio of anticancer efficacy and toxicity when applying the valuation tools of the European Society for Medical Oncology(ESMO) and the American Society of Clinical Oncology(ASCO). Korean Cancer Study Group (KCSG) has been conducting researches on 'Analysis of valuation tools for foreign cancer drugs and their application in Korea' as a service project of the HIRA (Health Insurance Review & Assessment Service) since June. KCSG conducted perception survey of 17 oncologists (1st), 165 stakeholders(2nd), and 20 specialists in hematology and oncology(3rd) in order to explore Wertform model of Korean anticancer drugs to evaluate the value of high-priced anticancer drugs using ESMO and ASCO. Prof. Ryu, Min-hee Prof Ryu, Min-hee, trustee of KCSG director presented the results of the 1st, 2nd and 3rd perceptions at the public hearing on Oct 23, and many respondents responded positively to using the value evaluation tool as an anticancer health insurance benefit or afterlife assessment criteria. In the first survey of 17 oncologists, efficacy was considered ranked first when prescribing general anticancer drugs and immune chemotherapy, 94.1% and 75%, respectively. Only 1 (5.9%) responded that the MD considered costs for generic anticancer drugs, while 3 (18.75%) answered that they considered costs for immune chemotherapy. Anticancer drug evaluation items of ASCO and ESMO consists of efficacy and toxicity. When asked about the appropriate ratio in Korea, 58.8% of respondents answered that 70% efficacy and 30% toxicity. The other 23.5% said 60% efficacy and 40% toxicity, and the remaining 17.6% said 80% efficacy and 20% toxicity. The ASCO anti-cancer drug value evaluation reflects additional scores in improving the quality of life (QoL) besides efficacy and toxicities. If the sum of the importance of anticancer efficacy and toxicity is 100, 47.4% answered 20% of the appropriate quality of life ratio. the remaining 37.5% chose 10%, and 6.3% over 30%. As a result of asking the oncologist about the cost of drugs that are not included in the two valuation tools, 43.8% of the respondents consider it to be 60% to 80%. Domestic clinicians are also considering the burden of drug costs. When the Korean anti-cancer drug value evaluation tool developed by the government is developed, 50% of respondents said 'use it as evaluation standard when applying health insurance', and 31.3% said 'use it for evaluating the efficacy of anti-cancer drug after marketing' and the rest ‘ used by MD to decide on patient treatments.'' The second perception survey was conducted by oncologists, nurses, and pharmacists at the ASCO in Busan in last August. Occupation rate was 49.4% of doctors, 35.5% of nurses, and 11.4% of the pharmaceutical industry. The rest chose a duplicate with the others. In the survey of stakeholders, more than half of the respondents said that more than half of the respondents chose to choose generic anticancer drugs or immunocancer drugs with the most importance of efficacy. In addition, 97.6% of the respondents said that it is necessary to develop an anti-cancer drug clinical evaluation tool for the Korean situation. In particular, the majority of opinions that the valuation tool should be used as a standard of health insurance benefits or afterlife assessment. 90.4% of respondents said that value evaluation tools that reflect clinical effects, toxicity, and quality of life should be used as criteria for determining health insurance benefits. 93.4% of respondents said they needed to use a value evaluation tool as a post-registration evaluation tool for conditionally listed anticancer drugs. The third recognition survey was conducted with 20 hematological oncologists from MM working party. More than 90% of the respondents consider the effects of selecting general anticancer drugs and immunocancer drugs. The drug costs were 5% and 10%, respectively. Respectively 80%, 90% of the respondents commented on the need to use a value evaluation tool as a basis for reimbursement decision and afterlife assessment. Prof. Ryu said, "The results showed that they takes count of the efficacy the most when prescribing general anticancer drugs and immunocancer drugs. Education and seminars were needed to utilize and apply the research tools." The response was positive for being used as reimbursement standards or fterlife assessment standards” Prof. Ryu said, "New Bio drugs such as anticancer drugs are shifting the paradigm of disease treatment with new treatment mechanisms and improved effects. However, some high-cost anticancer drugs raise questions about the uncertainty of cost effectiveness compared to the therapeutic effect." "We need to consider introducing an objective and standardized drug valuation tool for fiscal integrity and sustainability."
- Policy
- 4200 items subject to ATP-based price reduction by 1%
- by Lee, Hye-Kyung Nov 15, 2019 06:28am
- Korean regulators have decided to reduce drug prices of about 4,200 items based on actual transaction price (ATP) from Jan. 1 next year. Until Nov. 11, Health Insurance Review and Assessment Service (HIRA) informed details of price reduction to pharmaceutical companies with already-listed drugs subject to the reduction, and allowed them to visit and confirm the result. HIRA plans to accept their appeals until the end of the month, and to start re-evaluating the items from Nov. 30. The updated lists of reimbursed drugs and their upper limit price are to be in effect from Jan. 1, 2020. At a correspondent’s workshop held on Nov. 14, Director of Pharmaceutical Management Department at HIRA, Kim San stated, “Except for the exempted 4,398 items, weighted average price of 17,702 items, out of 21,732 reimbursement listed drugs, has been calculated. According to the first result, average reduction rate is about 1.3 percent, and it would be modified down to around 1 percent after the appeal review”. “Last year’s overall drug expenditure reached about 17.8 trillion won, and the figure would be decreased by around 90 billion to 100 billion won with price reduction rate around 1 percent. To provide reduced drug price from the beginning of next year, the span of National Health Insurance (NHI) benefit claim bill collection was shortened from three months to two months,” Director Kim added. This year’s ATP survey delved into NHI benefit claim made from July 1 of 2018 to June 30 of 2019, but 3,773 public healthcare institutes, four special veteran hospitals, and 40 military hospitals were excluded from 94,183 subject healthcare institutes. Price reduction subject drugs are to determine weighted average price based on healthcare institutes’ NHI reimbursement claim made on 17,702 listed drugs to HIRA during the surveyed period. Total of 4,398 items are exceptions to the upper limit price adjustment, which consists of 1,167 low-priced drugs, 638 shortage prevention drugs, 394 narcotics and orphan drugs, and 1,837 drugs newly listed during the survey period. Last year, overall 3,619 items had their prices lowered by average rate of 1.3 percent due to ATP-based price reduction, which apparently saved 80.8 billion won of drug coverage expenditure.
- Policy
- Pharmaceutical spending structure needs to be reorganized
- by Lee, Jeong-Hwan Nov 14, 2019 05:40pm
- We need to increase the expenditure of new drugs in drug costs far more than now. Patent expiration drugs must be left out of the market and replaced by generics for health insurance to be kept. However, since the structure could not be broken, the reform of the generic drug price system, which is a transitional measure, has started. It is solved only by redrawing the spending structure itself. There is often a conflict between estimating drug pricing and increasing reimbursement reflecting the social value of expensive innovative new drugs and the rational expenditure and management of limited health insurance financing. The government is trying to come up with a variety of tools to evaluate the value of innovative new drugs, but it is not easy to close the gap between regulators and profit-generating companies. Eventually, it was the government and experts' view that a massive restructuring of the financial spending structure in health insurance would be necessary to resolve this conflicting agenda. At the National Assembly Library on Nov 7, experts from the government, industry, and patients organization gathered in an open policy debate to solve the difficult task of balancing new drug?s social values and health finances. A panel discussion was held after the presentation of JiHong Bu, senior vice president of IQVIA Korea, which aims to increase the supply of new drugs by regulating the excessive use of chronic disease drugs. The discussion was attended by Myungseop Kwak, Director of insurance and pharmaceutical affairs at MOHW, Jinok Byun, director of the Center for Institutional Finance Research, Korea Institute for Health Insurance Policy, Prof.Lee, Wonbok, Graduate School of Law, Ewha Womans University, Sungjoo Kim, a member of Lee & Ko, and Representative Kijong Ahn , Korea alliance of patients organization ▲ Professor Wonbok Lee (left), Director of Jinok Byun he discussion was based on whether it would be reasonable to create a health budget for new drug benefits by regulating the use of mild and chronic disease drugs, and how to improve the expenditure structure of drugs cost. Prof. Lee, Wonbok, school of law of Ewha Womans University pointed to the lack of statistical or objective evidence that reducing the use of mild and chronic diseases and increasing new drug benefits would contribute to health and financial health. In particular, he introduced many cases where the cost-effectiveness of treatment for severe rare diseases was low and mentioned the risk of unconditional expansion of new drug benefits. Prof. Lee said, "Because the high-income countries except Japan and Korea are spending aggressively on new drugs, there is no justification for the expansion of new drug benefits." Prof. Lee said, "It must be accompanied by practical evidence. We need to provide quantitative indicators of what will help us in terms of health finance and public health." In particular, if the new cap expenditures are unconditionally increased due to the fiscal cap, there is a need for a solution to the backlash against the decrease in stakes in other sectors. � Jinok Byun, head of the Korea Institute for Health Policy Research, said people should not misunderstand that the government will not save or use health finances. Health insurance finances, after all, exist in order to be well spent, explaining that they are doing their best to meet the characteristics of medicines. In particular, the initial drug pricing negotiation of the original new drug is important in terms of financial financing. "The chronic leukemia drug Gleevec was the first targeted drug, called magic bullet because of its superior effect. When it was first introduced, the number of patients was 500," she said. "We have tens of thousands of patients a year and the Gleevec market is still active.� "This is the hallmark of the innovative new drug market. It is the case that Gleevec?s reimbursement was not stopped even after the Novatis?s rebate is caught." "If the new drug lie Gleevec is not managed by the government, it becomes a problem. It is the decision or adjustment process on drugs to agree on a reasonable basis for price in terms of overall price management." ▲ Sungjoo Kim (left) and Myungseop Kwak Sung-Joo Kim, Expert in Lee & Ko , said that the level of drug prices in Korea is not high compared to overseas, and that the application of innovative new drugs should be expanded quickly. "I agree with the significant improvement in the new drug registration rate, but the reimbursement approval is still limited. Cancer immunotherapy is a good example of this, we need to increase reimbursement level and expand the reimbursement drugs" said Kim. Mr. Kim said, ?In particular, we have to worry about creating surplus in financial fields other than pharmaceutical expenses. According to the analysis of the Health Insurance Review & Assessment Service bill data, The number of visits by the most visited clinics in Korea for one year was 300 times. It means that the patient went to clinics more than once per day, so we need to improve the efficiency of health finance. " Myungseop Kwak, the ministry's director of welfare, said that the drug expenditure structure should be redesigned for the social value of new drugs and sustainable health finance. The purpose of this study is to analyze the current spending structure and to rationalize as soon as possible to spend more on new drugs and to reduce the amount of money spent on patent expiration drugs and generics to secure sustainability of health and financial finance. However, since it is virtually impossible to break the spending structure at once, it is implementing measures that can be reformed, such as the reform of the generic drug system, which is a transitional stage. He said, ?Patients and the industry do not require reimubursement for patent expiring drugs. We pay only for new drugs.??We have established a rationalization plan and started research on expenditure structure analysis. We initiated expenditure structure analysis research, results will be released in the first half of next year.� He also said, "If you don't change the expenditure structure in the end, the answer will be microscopic. It's difficult to solve it without drawing a new macroscopic cost chart and digging into the details one by one." Sustainability can only be achieved if the patent expiry is released from the market and generics are replaced. " ?We started with the reorganization of the generic drug pricing system, which is a transitional measure because it is difficult to realize in the five-year health insurance guarantee plan. We plan to use the resources obtained through the reevaluation of patent expired drugs and non-payment drugs for high-cost anticancer drugs, rare incurable diseases treatments, and serious treatments."
