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- 2026-04-16 04:58:38
- Policy
- Orphan drugs introduced in Korea are 'increasing'
- by Lee, Tak-Sun Oct 14, 2020 06:22am
- As the orphan drug market has recently emerged as Blue Ocean, the introduction of Orphan Drugs by global pharmaceutical companies is increasing in Korea. In particular, as the MFDS has given a PMS of up to 11 years to Orphan Drugs through amendment of regulations, the market monopoly is expected to be prolonged. According to the MFDS on the 12th, two of the recently approved Orphan Drugs have been granted PMS for more than 10 years. PMS, which means re-examination of new drugs, is subject to investigation conditions after being marketed during the period, but it also has a data protection function, blocking entry of generic drugs, and thus gaining market monopoly. Since 2017, the MFDS has been granting PMS for 10 years, up to 11 years, in recognition of its contribution to the development of Orphan Drugs with fewer patients and no alternative drugs, and 11 years are granted for pediatric clinical trials. Until last year, only two drugs were given PMS for 10 years. The two drugs are 'NexoBrid', which removes the eschar without harming viable tissue by BL&H in 2018 and 'Raxone', a treatment for visual impairment caused by Leber Hereditary Optic Neuropathy by DKSH Korea in 2019. In August, Pfizer's PMS of 'Vyndamax (Amyloid Cardiomyopathy (ATTR-CM) treatment)' was given 10 years, and in September Kyowa Kirin's PMS of ‘Crysvita' was given 11 years. Crysvita is a treatment for hereditary hypophosphatemia (XLH), and PMS has been recognized for 10 to plus 1 year, up to 11 years because of the results of pediatric clinical trials. Accordingly, Crysvita is exclusive in the market, with data protected until September 16, 2031. An official from the MFDS said, "PMS is granted for 10 years, up to 11 years for orphan drugs that do not have alternative drugs. " In addition, he explained, "In order to support the development of orphan drugs with a small number of patients, we are operating the existing PMS grant period (6 years for new drugs and 4 years for improved drugs)."
- Policy
- Copayment unchanged for using reimbursed Dupixent
- by Lee, Hye-Kyung Oct 14, 2020 06:22am
- When processing atopic dermatitis patients visiting tertiary hospitals, the healthcare institutes should now be aware that the 100-percent outpatient copayment rate does not apply to the severe case patients. On Oct. 7, the Ministry of Health and Welfare (MOHW) and Health Insurance Review and Assessment Service (HIRA) provided information on the outpatient copayment rate billed to an atopic dermatitis patient at a tertiary hospital. The South Korean government is to enforce the revised regulation on healthcare reimbursement standard and methods from Oct. 8 that applies 100 percent of the healthcare reimbursement cost on patients visiting a tertiary hospital to treat cold and other mild cases. Previously, a mild case patient had to pay 60 percent of copayment rate for an outpatient treatment at a tertiary hospital, but it would be raised to 100 percent as the copayment rate ceiling system excludes the case from now on. Reflecting the change, the healthcare institute has to clearly distinguish between mild case and severe case of patients with atopic dermatitis. A mild case atopic dermatitis patient is to pay the entire copayment when visiting a general hospital, but a patient eligible to get prescribed with Dupixent (dupilumab) 300 mg prefilled injection would be applied with the previous 60-percent copayment rate. However, the issue is that hospitals may struggle to distinguish between the cases as they do not have an independent disease code for severe case atopic dermatitis, yet. The severe case disease code would be applied from Jan. 1 next year. MOHW official advised, “Even for severe case atopic dermatitis patients, their copayment rate may go up due to the revised regulation. The prescription of Dupixent from Oct. 8 through Dec. 31 to an atopic dermatitis patient would be calculated with premium rate by disease code and Healthcare Quality Evaluation Grant,” and “the hospitals should input general outpatient copayment rate instead of the unique code, ‘F025.'”
- Policy
- 'Adding CSO' to the target of rebate penalty
- by Lee, Jeong-Hwan Oct 13, 2020 06:05am
- A revision of the law is being promoted so that not only pharmaceutical companies that gave rebates to doctors and pharmacists, but also the Contract Sales Organization (CSO) that they delivered on their behalf, can be directly punished for violating the Pharmaceutical Affairs Law. It is to clarify the grounds for administrative disposition in case of illegal detection by including the pharmaceutical CSO in ‘Article 47 (Order in Distribution of Drugs, etc.) of the Pharmaceutical Affairs Act)’. On the 12th, Jung Choun-sook, a member of Democratic Party of Korea said in a phone call with Dailypharm that he plans to initiate a representative proposal next week as soon as possible on the revision of the Pharmaceutical Affairs Law. On the 8th, at the parliamentary inspection of the administration of the Ministry of Health and Welfare, she spoke to Minister Park Neung-hoo about the illegal rebates through CSOs of some pharmaceutical companies. Despite the fact that CSO is being abused as a place to provide new rebates, contrary to its basic purpose, it is criticized that the legal basis for punishment is insufficient due to the blind spot of Pharmaceutical Affairs Law. CSO was originally created to act as an agent for legal sales such as promotion of drug sales for pharmaceutical companies and to help pharmaceutical companies focus on new drug development. However, some pharmaceutical companies are exploiting CSOs by offering variant rebates because CSO is not considered a 'drug supplier' subject to a ban on rebates under the Pharmaceutical Affairs Act. According to the data submitted by the MOHW to her, it was unable to properly determine the current status of the number of CSO companies currently operating. In a survey of some pharmaceutical companies last year, only statistics were obtained that 27.8% of the 464 responding pharmaceutical companies were consigning sales. The MOHW said that there was only one illegal rebate through CSO, but this is also not an accurate statistics. Specifically, a pharmaceutical Company was prosecuted in 2018 on charges of providing rebates worth about ₩1.6 billion to a number of medical professionals with CSO and pharmaceutical wholesalers from 2013 to 2017. As a result, both executives and employees of pharmaceutical companies and CSO's CEO were notified of disposition for violating the Pharmaceutical Affairs Act. She is preparing an amendment to the Pharmaceutical Affairs Act that extends the provisions prohibiting the exchange of rebates so that CSO can't do anything related to rebates. This is a method of adding 'a person who has received drug business consignment from a pharmaceutical company or other business processing consignment' to the scope of drug suppliers in the Pharmaceutical Affairs Act. She said, "We will create a legal basis to directly punish those who act as pharmaceutical companies such as CSO through illegal rebates." In addition, she explained, "The scope of administrative disposition includes CSOs and wholesalers, thereby enhancing the eradication of illegality and the completion of the Pharmaceutical Affairs Act."
- Policy
- HIRA finally revises PE guideline after 9 years
- by Lee, Hye-Kyung Oct 13, 2020 06:05am
- Finally, the pharmacoeconomic evaluation (PE) guideline is to be revised after nine years. South Korea’s Health Insurance Review and Assessment Service (HIRA) is accepting public opinion until Dec. 6 for the unveiled draft of revised PE guideline that reflects most of the suggestions made in the 2019 research on PE guideline revision (Principle investigator: Professor Lee Tae-Jin of Seoul National University Graduate School of Public Health and Professor Bae Eun Young of Gyeongsang National University School of Pharmacy). HIRA has decided to partially amend the regulation on pharmaceutical reimbursement evaluation criteria and procedure to formulate detailed evaluation standards on projecting pharmaceutical efficacy and cost, to remove a clause on financial impact analysis and to bring down the discount rate from 5% to 4.5%. The new PE guideline is to remove the ‘financial impact analysis’ section. The financial impact analysis projects the total financial changes in National Health Insurance (NHI) caused by introducing the applicant drug, in which the analysis significantly affects the decision in drug pricing or listing decision. And HIRA means to include the part in the pharmaceutical decision application, but to completely omit it in the revised guideline. ◆Cost: In the consigned research report, the investigators pointed out there has been many cases where the guideline’s perspective did not match the cost scope the actual analysis included, because transportation cost, time cost, and nursing cost were omitted when analyzing from the limited social perspective. Therefore, the new guideline would rule out transportation cost, time cost, and nursing cost from the basic analysis as they are not caused within the healthcare system, although the patients and their families have to pay the cost. However, the applicant may separately elaborate on the items with increased or lowered cost, besides from the basic analysis, if the cost or benefit is substantial, such as for diseases with burdensome nursing cost or noticeable productivity loss. ◆Discount rate: HIRA also plans to lower the basic analysis discount rate from 5 percent to 4.5 percent. In South Korea, the Korea Development Institute’s (KDI) research in 2017 consigned by the Ministry of Economy and Finance (MOEF) estimated the social time preference to be 3.7 percent to 4.5 percent, and it lowered the social discount rate to 4.5 percent, generally considering the market interest rate and declining economic growth in last 10 years. HIRA evaluated reducing the discount rate is necessary for PE when the social discount rate is falling constantly due to the changes in social economic circumstances. When the PE guideline was first compiled, the social discount rate was as high as 7.5 percent. The discount rate of 5 percent has been applied so far considering it is a healthcare policy and the level of other countries’ discount rate. But for the revised guideline, HIRA adjusted it down to 4.5 percent to match the discount rate applied in preliminary feasibility evaluation. ◆Analysis techniques: The existing guideline recommended to conduct a ‘cost-minimization analysis,’ when the effects of applicant drug and reference drug can be proven to be equivalent, and to conduct ‘cost-effectiveness analysis’ or ‘cost-utility analysis,’ when the effects of applicant drug and reference drug differ. But the new revision clarified to conduct ‘cost-utility analysis as a basic analysis technique. A drug with evidence of unable to produce cost-utility analysis can conduct cost-effectiveness analysis instead, but in such case the indicator reflecting the outcomes of the drug should be used as endpoint. The endpoint for the cost-effectiveness analysis should use Quality-Adjusted Life Years (QALY). ◆Evaluation methodology: The revised guideline then presented a number of factors, other than market share rate, to be considered when selecting reference drug. The existing principle of selecting a reference drug with highest substitutability when listing a new drug would be maintained, but the guideline would now also accept alternative plans supported by decent quality evidence when the circumstances are limited. For instance, a new alternative reference subject along with the comparability-based reference subject can be considered when qualifying all following conditions; a reference drug is standard of care; it has no direct comparable grounds between a new drug and a reference drug with highest market share and the uncertainty is too big when indirectly comparing and the comparability becomes an issue; and it is used as a conventional therapy in South Korea regardless of the reference drug used in the clinical trial did not have the highest market share. When calculating the pharmaceutical expense, the unit price of the applicant drug has to be used. If other drug with same substance, content and formulation is not yet listed, then the price of the applicant drug would be used. And weighted average pricing would be applied to unit price of the reference drug, when multiple drugs with same substance, content and formulation are listed already.
- Policy
- Many companies apply for a patent challenge for Otezla
- by Lee, Tak-Sun Oct 13, 2020 06:05am
- Korean pharmaceutical companies' patent challenges are continuing on new psoriasis treatments that are not released in Korea due to the failure to apply insurance benefits. Otezla (Apremilast), which was approved in 2017 as a treatment for psoriasis and psoriatic arthritis in Korea, has recently received a patent challenge from domestic companies such as Daewoong. In particular, Otezla is not released in Korea, but is recognized for its marketability overseas. According to the industry on the 9th, Dongkoo Bio & Pharma filed a trial for a passive confirmation of the scope of rights for the patents of Otezla's use (expired on March 20, 2023) on the 8th and formulation (December 26, 2032) registered on the MFDS patent list. It started a procedure to evade a patent for generic drugs. Since Daewoong requested the first patent trial on the 29th of last month, four companies, including Dong-A ST, Chong Kun Dang, and Dongkoo Bio & Pharma, began to challenge the patent. Otezla is a drug that Celgene was approved in Korea in November 2017. As Amgen acquired the drug for $13.4 billion in August last year, it also acquired domestic copyright. Otezla is a prescription medicine approved for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate and for the treatment of adult patients with active psoriatic arthritis. In Korea, after approval, they tried to raise benefits, but the agreement failed due to differences of opinion between the company and the insurance authorities. Insurance authorities judged that Otezla was not cost-effective due to its high price compared to other drugs in psoriasis, and suggested less than the amount converted to the average price of alternative drugs, but importers and sellers did not accept this. It was not officially released in Korea after the reimbursement failure. However, in the global market, it is active as a blockbuster with annual sales of about ₩2 trillion. According to ESTEEM 1 and 2 studies in plate-shaped psoriasis patients (about 1250 patients), Otezla, a new family that specifically acts on intracellular cyclic AMP (cAMP) concentration, 33.1% of patients 16 weeks after taking the drug PASI 75 (75% decrease in PASI score) was reached, showing a significant improvement compared to the placebo group (5.3%). Moreover, it is evaluated as a drug that improves the life and quality of patients by improving symptoms of itchy nails, scalp, and itching, which are difficult to treat. Psoriasis treatments that were compared before insurance benefits as Enbrel records annual sales of over ₩10 billion (based on IQVIA), it is expected to guarantee high performance if reimbursement is carried out in Korea. Moreover, it is an oral medication unlike Enbrel. However, even if generic drugs have surpassed their patents, it is difficult to launch a product within a short period of time as new drugs still have reexamination. This is because Otezla's PMS remains on November 19, 2023, with about three more years left. It is expected that more domestic pharmaceutical companies will participate in the drug market.
- Policy
- Drugs exempt from economic evaluation are applied to RSA
- by Kim, Jung-Ju Oct 13, 2020 06:05am
- From today (8th), generic drugs under risk-sharing agreements (RSA), drugs exempt from economic evaluation, and drugs released with early permission under the condition of Phase III are also covered by RSA between insurers and pharmaceutical companies. A new legal basis for adjusting the limit upper price will be established in the case of drugs whose license requirements are changed. The MOHW revised and issued the 'Pharmaceutical Determination and Adjustment Criteria' on the 8th in accordance with Article 14 of the 'Rules on Standards for National Health Insurance Medical Care Benefits'. The biggest point among the revisions is to expand the scope of RSA application. Usually, RSA is applied in Korea as follows. ▲In case of being used for serious diseases that threaten survival as an anticancer drug or rare disease treatment that does not have an alternative or equivalent therapeutic range or treatment ▲The Pharmaceutical Benefits Advisory Committee's impact on disease severity, social impact, and other health care when it is evaluated that consensus on additional conditions is necessary in consideration of the impact, etc. ▲In the case of a drug that has the same therapeutic scope as the drug applied according to the preceding two criteria and is a cost-effective drug. According to the revised adjustment criteria, drugs judged to be cost-effective as a result of the adequacy evaluation of the benefits of the Pharmaceutical Benefits Advisory Committee, and drugs that were judged to be exempted from economic evaluation, and drugs with a conditional approval for phase III are included in the RSA. A new standard for price adjustment of drugs with changed licenses has been established. This includes drugs that the MOHW deems necessary to adjust the upper limit price. The decision was requested at the time of announcement, and the upper limit price is recalculated according to the reporting standards. However, the Pharmaceutical Benefits Advisory Committee can adjust it if deemed necessary.
- Company
- Daewoong's subsidiaries are all expected to turn profits
- by Oct 12, 2020 06:16am
- Daewoong's eight overseas subsidiaries are expected to make a profit this year. In the first half of this year, seven have already made a surplus. It has been about 10 years since the global organization has been in full swing. Daewoong has been the most actively seeking overseas expansion among domestic pharmaceutical companies. Starting with Indonesia in 2012, it established local subsidiaries in major Asian countries such as China, Philippines, Thailand, Japan, and the United States. Overseas subsidiaries, which have been reducing losses through steady investment for 10 years, began to turn to a surplus in the first half of this year. Daewoong Infion, an Indonesian subsidiary, recorded a net profit of ₩1.2 billion in the first half of this year from a net loss of ₩1.3 billion last year. Beijing Daewoong in China also turned to a surplus of ₩200 million in the first half from a loss of ₩500 million last year. Hyun-Jin Park, head of the global business division of Daewoong, said at a meeting with Dailypharm, “Although it has suffered a deficit while building infrastructure such as local research centers and factories, it is expected that most overseas subsidiaries will turn into a surplus this year as investments are completed and local sales continue to rise.” Director Park has been in charge of planning and executing Daewoong's global business strategy for 10 years from the organization of the global headquarters in 2010 to the present. In 2019, she succeeded Jeon Seung-ho as the head of the global business division. Daewoong seeks to enter the market in a way that targets the drug and potential market needed locally. It is focusing on biopharmaceuticals in Indonesia and liquids in China. It is a strategy that goes further from exporting flagship products that are usually sold well in Korea to foreign companies. There are many difficulties in the early stages, but if the foundation is built and successful, the synergy effect is great. In fact, Daewoong has enjoyed the infrastructure benefits it has accumulated over the years in COVID-19 situation. Due to the limited number of domestic patients, clinical trials were quickly approved through overseas subsidiaries. She said that we are thinking of a R&D corporation in Europe and other places as a plan to expand overseas in the future, and Daewoong's goal is to be among the top 10 pharmaceutical companies. The following is questions & answers of Park. Hyun-Jin Park, head of the global business division of Daewoong ▶This year, overseas subsidiaries are making a surplus. There are 7 local subsidiaries that showed a surplus in the first half of the year, including Daewoong Infion, Daewoong Thailand, Beijing Daewoong, and Daewoong India. In the meantime, it took a lot of cost and time to set up a local research institute, factory, and marketing. Sales grew steadily, but the infrastructure construction cost was forced to record a deficit. Now, most of the investments have been completed and sales are increasing, making a turnaround. All eight are expected to turn to profits by the end of the year. ▶Among the countries that entered the market, Indonesia, China, and Vietnam were selected as the core. What is the reason? All three countries are rapidly growing. However, it is only possible to enter the market only if there are local production plants. There are many advantages such as bidding if it is produced locally. Daewoong Pharmaceutical has already established a manufacturing plant and is implementing a strategy to operate it like a local company, so it was determined that this strategy can be maximized. However, the ways of entering the three countries are slightly different. Indonesia and China formed joint ventures with local companies, while Vietnam chose to invest in equity. While a local company called Trapaco already had a new factory, it was better to share R&D instead of using existing resources with equity investment, rather than investing in new plant resources because of lack of R&D know-how for the products produced. Trapaco's stake may be expanded in the future depending on the company's potential, etc. Each joint venture or equity investment has advantages and disadvantages. We are choosing an appropriate method according to each country's situation. ▶Daewoong is choosing and developing its flagship drugs according to local conditions. Indonesia's biopharmaceuticals, China's digestive medicines, and Thailand's aesthetics. In general, why do you go on a difficult path without choosing a method of using drugs that are popular in Korea as your flagship products? This is because the domestic and pharmaceutical environments are often different. For example, complex medications are popular in Korea, but not in Southeast Asia such as Vietnam. There is a way to lead a combination drug in advance, but Daewoong Pharmaceutical's strategy is to analyze and develop drugs needed locally. The Chinese plant analyzes and plans medicines needed for the Chinese market and develops them at the research institute. If locally planned and responded drugs are suitable for the Korean market, reverse export is possible. Planning and research can be done according to each local situation. ▶It has been seeking global advancement for 10 years, and it is paying off recently with a turnaround. It seems that building up infrastructure and networking for a long time was not easy. Both China and Indonesia are famous for having difficult licensing. Especially in Indonesia, where it first entered the market, it suffered a lot of trial and error. The important point was to derive a model of cooperation with health authorities while expanding local research cooperation. We have presented the Indonesian government with a vision to foster Indonesia as a bio hub in Asia. In addition, although it is a for-profit company, it is also important to present parts that can win-win with each other. Therefore, it contributed socially by lowering the insurance price of Epodion in Indonesia to 55%. By providing economic support to areas where the medical environment is less favorable than in Korea, many citizens can benefit from medical care. Currently, we are continuing cooperation with UI Universitas Indonesia, the best university in Indonesia, while conducting bio research, and we are providing support for nurturing such as establishing a bio research center and hiring local personnel to provide research opportunities in Korea. Presenting this vision, it was possible to complete the process from the factory to the license within 4-5 years. Not only domestic companies that were preparing to enter Indonesia, but also local companies were surprised that the speed was very fast. ▶Was building up local networking a great help in this COVID-19 outbreak? Since the local subsidiary has a network with both health authorities and clinical CRO companies, it was possible to quickly obtain clinical approval for the treatment of COVID-19. 'DWRX2003 (Niclosamide)', which is being developed as a treatment for COVID-19, was the first to be approved in India among countries that submitted a clinical approval plan at the same time. This was due to the fact that Daewoong Infion has been building a network so that it can be considered a local company, and has been conducting several clinical trials in India for a long time. It was also able to enter clinical trials quickly in the Philippines. ▶Over the past 10 years, it has advanced into the global market with the concept of creating 'another Daewoong'. What are the plans of the global business division for the next 10 years? If the process has been focused on generics locally until now, over the next 10 years, we will develop many new drug items through research cooperation. 'Fexuprazan', which is currently undergoing examination for approval of new drugs in Korea, is trying to enter the global market through simultaneous clinical trials in Asia. By accelerating new drug programs in Asian countries, we are trying to create a virtuous cycle in which the sales value of new drugs increases. To this end, we are considering a R&D company as a local corporation to be built in the future. In the local area, I felt that the amount of information shared and the level of collaboration change depending on whether or not there is research cooperation. Although no specific plan came out, I think it would be nice to have a research company in Europe that has not yet entered the market. we are also considering establishing R&D companies in Shanghai, China. Daewoong will try to make it one of the top 10 pharmaceutical companies in major global countries in the next 10 years.
- Opinion
- [Reporter’sView] Revisiting gene list for NGS panel testing
- by Eo, Yun-Ho Oct 12, 2020 06:16am
- Human epidermal growth factor receptor 2 (HER2), anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) would be familiar terms for the people who have been paying a close attention to those news articles regarding anticancer treatment. Depending on the genetic mutation a patient has, effective treatment varies while treatments specifically targeting these genes are emerging one after another. In particular, such changes are apparent in the anticancer treatment scene. In the age of precise medicine, the South Korean government has stated in 2016 the customized medicine would be realized through precise medicine and that the government would also seek new emerging driving force in it. And in March 2017, the government has started applying National Health Insurance (NHI) benefit on genetic testing based on next generation sequencing (NGS) as a part of establishing the foundation of the precise medicine. It was selective reimbursement with 50 percent copayment rate on patients with 10 types of solid tumor, six types of blood cancer and three types of genetic disorders. Closely following the changes in anticancer therapy trend, the NHI benefit on NGS-based genetic testing eligible patients was widened to all solid tumors and the copayment rate was also adjusted. List of required essential gene types by diseases The NGS is a DNA sequencing technology that breaks DNA into smaller countless pieces and puts them back together. Unlike the conventional single genetic testing, the NGS allows tens or hundreds of genes to be read as a single panel, making the process cheaper and faster than before. Besides it being convenient, seeking essential genes required for NGS-based panel testing as supported by latest researches is crucial to find the most effective treatment for patients. The importance of it cannot be stressed enough as the patients has to have the essential gene eligible for the reimbursement for the NGS-based panel test. However, the health insurance authority has not revisited the list of required essential genes for last four years, when numerous treatments have been developed and obtained marketing approval in South Korea. Moreover, innovative treatments like RET or MET treatments targeting a new gene type have been found. The Ministry of Food and Drug Safety (MFDS) is also in process of preparing a bill to promptly approve precise medicine-basis new drug. One of the objectives of precise medicine is to provide customized treatment for each individual patient. And testing technology grounded on latest research findings is essential to those customized treatments. The government should take a second look at expanding the list of essential gene types for the patients’ treatment, and reconsider on improving the NGS-based panel testing.
- Company
- Pfizer seeks for approval on NSCLC drug ‘lorlatinib’
- by Kim, Jin-Gu Oct 12, 2020 06:15am
- A product image of Pfizer’s ALK-positive NSCLC treatment lorlatinib (brand name Lorbrena) Pfizer has taken a first step to launch a non-small cell lung cancer (NSCLC) treatment ‘lorlatinib’ in the South Korean market. According to a pharmaceutical industry source on Oct. 7, Pfizer Pharmaceutical Korea has recently submitted an application to the Ministry of Food and Drug Safety (MFDS) to request an item approval on lorlatinib. After getting designated as an orphan drug in March by MFDS, the company initiated the approval application preparation in South Korea. In November last year, the product has been approved in the U.S. under the brand name Lorbrena. Lorlatinib is a latecomer to Pfizer’s anaplastic lymphoma kinase (ALK)-positive NSCLC treatment Xalkori (crizotinib). There are three generations of ALK-positive NSCLC treatments—after the launch of the first generation Xalkori, Roche’s Alecensa (alectinib), Novartis’ Zykadia (ceritinib), and Takeda’s Alunbrig (brigatinib) have emerged as the second generation drugs. Currently, Xalkori, Alecensa and Zykadia as first-line therapy and Alecensa, Zykadia and Alunbrig as second-line therapy are available to treat patients with ALK-positive NSCLC. Technically, however, there were no other treatment option for patients who have relapsed after using Xalkori as a first-line therapy and a second generation ALK-positive NSCLC treatment as a second-line therapy. Lorlatinib has received high expectation from those relapsed patients and their healthcare providers. In fact, MFDS approved of total 326 items for treatment purpose uses, and 134 cases (41 percent) were for lorlatinib. The item definitely topped the treatment purpose use approval record in this year. The clinical trials on lorlatinib disclosed so far have found the drug demonstrates meaningful level of treatment efficacy in patients who have developed tolerance to other options. Also, it was reportedly effective on patients with brain metastasis. Pfizer Pharmaceutical Korea avoided making an immediate comment about the plan after the item approval. An official from the company said, “The company would do its best to expand patients’ access to lorlatinib in South Korea.”
- Policy
- Pharmaceutical reimbursement standards should be updated
- by Lee, Hye-Kyung Oct 12, 2020 06:13am
- It has been argued that the government should be active from screening for osteoporosis to creating a continuous treatment environment and establishing an integrated treatment system for preventing fractures in stages. On the 7th, Bong-min Jeon, a member of People Power Party (Health and Welfare Committe, Suyeong-gu, Busan), published a national audit policy booklet with The Korean Society for Bone and Mineral Research and the 'the Osteoporosis Policy Task for Establishing a Virtuous Cycle of Health in Ultra-aged Societies', pointed out the low recognition rate for osteoporosis and urged social interest and national investment. According to the policy databook as a problem in the management of osteoporosis in Korea, there is a lack of an integrated management system that does not prevent the cascade of osteoporosis worsening, such as ▲low disease awareness and low treatment rate, and ▲limited drug reimbursement standards that make continuous treatment difficult. Currently, only patients with a T-score of -2.5 or less when measuring bone density can receive insurance benefits for one year as the subject of treatment. He said, “If the T-score exceeds -2.5, even though there is still a risk of fracture, it is excluded from the benefit.” He added, “It is necessary to create a continuous treatment environment by spreading awareness of demand, establishing a reimbursement standard that fits clinical evidence, and establishing a system for preventing fractures in stages within the health insurance system.” Meanwhile, according to the policy materials, the prevalence of osteoporosis is gradually increasing with the aging of the population, and the number of osteoporosis patients exceeded 1 million in 2020. Since the health problems of the elderly population are directly connected to the problem of participation in economic activities and the ability to live independently, he pointed out that diseases such as osteoporotic fractures that deprive the elderly population of mobility can be a primer to increase the burden of support for the entire society. He said, "If the osteoporosis is intensifying and the fracture is stored, it is serious if the probability of death is 17%, but if 66 out of 100 patients with osteoporosis stop treatment within one year, continuous management is not performed." He stressed that the work to improve the reimbursement standards, which are pointed as the main cause of the disruption, will be corrected by discussing with the government and academia.
