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- 2025-12-21 16:39:07
- Policy
- Incentives for phase 3 among Koreans raise public opinion
- by Nho, Byung Chul Aug 01, 2023 05:33am
- In order to prepare a reasonable drug price calculation for new drugs that have undergone phase 3 clinical trials in Korea, attention is focused on whether the special drug price system of Japan, Taiwan, and France can be applied and introduced. According to the industry, the public-private consultative body for improving the drug price system is conducting in-depth discussions to form a consensus on the introduction of a positive incentive system for innovative new drugs developed in Korea and to derive positive results. Furthermore, the basis for preferential drug prices for domestic new drugs, such as Article 17-2 of the 'Special Act on the Promotion and Support of the Pharmaceutical Industry' amended in December 2018, such as 'preferential treatment in addition to the maximum amount of drugs', is already in place. It is expected that it will be able to be institutionalized from next year. The purpose of the clinical drug pricing system for Koreans is to evaluate the appropriate value of new drugs by raising them from 90% to 95-100% of the current alternative drug market price in the case of skipping drug price negotiations for new drugs that have undergone phase 3 clinical trials for patients residing in Korea. is wearing Institutional strengths include ▲securing evidence for safety, efficacy, and clinical usefulness for Koreans, ▲easiness of tracking and management of clinical trials, improvement of R&D capabilities according to the full domestic clinical staff, ▲upgrade and employment of clinical trial institutions creation, and ▲compensation for contributions to the development of new drugs suitable for the health conditions and diseases of Koreans. Then, how about the case of Japan, which is most actively operating such a system? In this regard, Japan's additional system is largely classified and applied into four categories: innovation, usefulness, marketability, children, and preferential introduction. The usefulness bonus is a drug that meets two of the three requirements of the innovativeness supplement and can receive an incentive benefit of 5 to 60% depending on the detailed application criteria. Additives for children (5~20%) are drugs for which the contents of children and infants are explicitly included in the dosages related to the main or corresponding efficacy of the new listing, and drugs for which the comparator of the new drug is not subject to the additives for children. belong to this category Priority introduction (10%) includes new drugs approved for the first time in Japan and drugs with new mechanisms different from similar drugs already approved in foreign countries (US, UK, Germany, France) and Japan. It is understood that France determines the addition by focusing on improvements such as medical benefits, clinical value, and dental efficacy as well as the reduction of side effects. CT oversees technical reviews such as SMR and ASMR under the Ministry of Health, and CEPS determines drug prices through negotiations with pharmaceutical companies after consultation with the committee. When negotiating drug prices, the level of clinical benefit improvement of drugs, the price of alternative drugs, the expected amount of use, and the predictable status of prescriptions are reviewed from various angles. Contracts regarding refunds in case of exceeding expected usage and expenditures are made, and drug prices and drug expenditures are made accordingly. The level of clinical benefit improvement is classified into 5 grades according to the degree of improvement compared to existing treatments, and the drug price is determined according to the grade. New drug pricing categories in Taiwan are divided into Group 1, group 2A, and Group 2B. Group 1 is determined by the median price of drugs in A10 countries, and Groups 2A and 2B are finalized considering the lowest price in A10 countries, drug prices in countries of origin, relative comparison prices of foreign prices, and comparison of drug administration costs. As for the additional requirements, premiums of up to 15% are given for domestic clinical trials (10%), domestic economic evaluation (maximum 10%), pediatric drugs (maximum 15%), and improvement in therapeutic effect, safety, and convenience of taking. The public-private consultative body for improving the drug price system is composed of officials from the Ministry of Health and Welfare, the Korea Pharmaceutical Bio Association, and the Global Pharmaceutical Industry Association. It is understood that the government is working on a plan to improve and classify the new drug price system, such as maintaining the period for adding the maximum amount of drugs to stabilize the supply of drugs.
- Policy
- Decided to re-discuss reimbursement criteria for Mylotarg
- by Lee, Tak-Sun Jul 31, 2023 05:29am
- Acute myeloid leukemia treatment drug Mylotarg decided to re-discuss setting reimbursement standards. This drug received attention as the first Antibody-Drug Conjugate (ADC) treatment, but in May of last year, the Cancer Disease Review Committee failed to establish reimbursement standards. The HIRA (Chief Director Kang Jung-gu) announced that it decided to re-discuss Mylotarg as a result of the review of the reimbursement standards for drugs used in cancer patients, which were reviewed at the 5th Cancer Disease Review Committee in 2023 held on the 26th. This drug, licensed in Korea in December 2021, is an ADC consisting of a CD33-targeting monoclonal antibody and calicheamicin, a cytotoxic drug, and blocks cancer cell growth through a mechanism that acts on cells expressing the CD33 antigen that appears in 90% of all AML patients. induce extinction. In a clinical trial on 271 patients with acute myeloid leukemia, the Mylotarg+Daunorubicin+Cytarabine combination group showed a median event-free survival of 17.3 months, which was approximately 7.8 months longer than the daunorubicin+Cytarabine combination group's 9.5 months. As the deliberation committee decided to re-discuss it, attention is paid to whether it will succeed in setting the salary standard through data supplementation. BOSULIF, a treatment for Philadelphia chromosome inactive chronic myelogenous leukemia, failed to set reimbursement standards as a first-line treatment but succeeded as a second-line treatment. Therefore, criteria for use were established for Ph+ CML in the chronic phase, AP, or acute phase (BP) who showed resistance or intolerance to previous therapies. Oxaliplatin + Capecitabine combination therapy, which has been expanding the reimbursement standard, has also been set as adjuvant therapy after surgery for patients who have received chemotherapy before or after surgery for rectal cancer. On the other hand, Besremi, which is used for polycythemia vera that is resistant or intolerant to hydroxyurea, failed to establish reimbursement standards.
- Policy
- Bill proposed to allow Kymriah’s use at transplant hospital
- by Kim, Jung-Ju Jul 31, 2023 05:28am
- A bill was proposed to amend the law and improve patient access to Novartis’s Kymirah, the ultra-high-priced ‘one-shot drug,’ by realistically amending the requirements for institutions that use the drug. The main point of the amendment is to allow hematopoietic stem cell transplant institutions designated as transplant hospitals to provide Kymriah treatment. Rep. Young Woo Lee of the Democratic Party of Korea proposed the bill for the ‘Partial Amendment to the Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products’ that contained the proposal above on the 27th. Kymriah was approved in March 2021 as the world’s first chimeric antigen receptor T-cell (CAR-T) therapy and the first advanced biopharmaceutical under the ‘Advanced Regenerative Bio Act.' With the enactment of the Act, the Ministry of Food and Drug Safety classified Kymriah as a biodrug and stipulated the medical institutions that seek to use Kymriah to receive a permit for a human cell management business under the newly implemented ‘Advanced Regenerative Bio Act.’ However, to receive the permit, the law requires the institution to be equipped with a GMP facility that meets the pharmaceutical manufacturing management standards. Rep. Lee pointed out that the irony lies in how medical institutions that seek to use Kymriah for treatment only ‘draw, extract, and freeze’ the patient’s blood to send to Novartis. Lee criticized that requiring treatment institutions to have pharmaceutical manufacturing facilities is wasteful and unnecessary as the institutions are not in charge of making the drug itself. Due to such limitations, only the 5 large hospitals in Seoul - the ‘Big 5 Hospitals’ of Korea - were permitted to use Kymriah. Due to this restriction, patients living in rural areas had to come all the way to Seoul to receive treatment. The amendment aims to reduce the patient's suffering and waste and alleviate the concentration of medical care in the metropolitan area by allowing hematopoietic stem cell transplantation institutions designated as ‘transplant hospitals’ under Article 25 of the Organs Transplant Act to use Kymriah for treatment. In addition to Rep. Young Woo Lee, the bill was jointly proposed by Rep. Young In Ko, Ju Young Kim, Gab Seok Song, Soo Jin Lee, Sung Ho Jung, Il Young Chung, Pil Mo Jung, Oseop Jo, and Jung Min Hong.
- Policy
- Re-evaluation of the upper limit amt, scheduled for August
- by Lee, Tak-Sun Jul 31, 2023 05:27am
- The final result of the re-evaluation of the upper limit amount standard requirement will be presented as an agenda for the Pharmaceutical Reimbursement Evaluation Committee to be held on August 3. It is expected that negotiations with NHIS will proceed in earnest after the submission of the committee. The results of the re-evaluation of the adequacy of this year's benefits are expected to be presented in September. According to HIRA and the industry on the 28th, the committee meeting on the 3rd of next month will review the final result of the re-evaluation of the upper limit amount standard. This is the final review following the first review in May. HIRA notified pharmaceutical companies of the results after the first review by the review committee in May. After that, the final result will go to the committee on the 3rd of next month after the appeal. This is about two months behind the original plan to reflect drug price adjustment through re-evaluation in July. This is because data submissions were rushed all at once in February, and more than 1,000 objections came out after the first evaluation. After this committee is over, the NHIS is expected to hold negotiations with pharmaceutical companies regarding supply for the month of August. It is expected that the re-evaluation results will be reported to the health policy review committee in August, and the drug price adjustment plan will be reflected in the reimbursement list on September 1. The re-evaluation of the upper limit amount is being carried out by maintaining or lowering the upper limit amount depending on whether the drug has met its own BA test and DMF listing criteria for already-listed drugs. The upper limit is maintained if both BA and DMF requirements are met, and if one is met, the price is reduced to 85% of the adjusted standard price, and if both are not met, the price is reduced to 72.25%. Currently, the first evaluation of 14,000 items is underway, and the second round of about 5,000 drugs will begin in earnest after submitting data in July. The re-evaluation of the adequacy of wages this year is expected to be somewhat delayed due to the re-evaluation of the maximum amount. The original plan was to submit the re-evaluation results to the Drug Evaluation Committee in August, but it is likely to be presented in September at the earliest. This year, the target item for re-evaluation of benefit adequacy is peptic ulcer medicine Rebamipide, a drug for the circulatory system Limaprost Alfadex, an antipyretic, analgesic, anti-inflammatory drug Loxoprofen Sodium, a drug for the digestive system Levosulpiride, a drug for allergy Epinastine Hydrochloride, an ophthalmic hyaluronic acid eye drop. Among them, hyaluronic acid eye drops are the largest with a market size of 231.5 billion won (3-year average billing amount). Next, the pharmaceutical industry is paying attention to the results of the re-evaluation of the adequacy of reimbursement for these drugs.
- Policy
- Janssen’s MM drug Tecvayli Inj is approved in KOR
- by Lee, Hye-Kyung Jul 28, 2023 05:30am
- On the 26th, the Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) approved ‘Tecvayli Inj (teclistamab),’ a rare disease drug used to treat multiple myeloma. Tecvayli is used in adult patients with relapsed and refractory multiple myeloma who have received at least three previous lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Tecvayli is a bispecific antibody that binds to the B-cell maturation antigen (BCMA) on myeloma cells, and CD3 on T-cells. Tecvayli binds to BCMA and CD3 and induces myeloma cell death via activation of T cells. BCMA is a cell surface protein that is selectively induced during plasma cell differentiation. It is an ideal target for plasma cell cancer (multiple myeloma). The MFDS stressed that it will continue being committed to the rapid provision of safe and effective treatment for the Korean people based on its expertise in regulatory science.
- Policy
- Maintenance of grounds for original drug price
- by Kim, Jung-Ju Jul 27, 2023 05:40am
- The government will establish a legal basis so that the insurance price of the original drug can be reduced ex officio when a generic of an original drug whose patent has expired is listed on the drug reimbursement list. It is interpreted that they are trying to respond to pharmaceutical companies by preparing a clear basis for the ex officio adjustment drug price lawsuits that arise every time. The Ministry of Health and Welfare made a legislative announcement on the 26th and announced the implementation date of the 'Partial Amendment Decree of the Rules on the Standards of National Health Insurance Medical Care Benefit' with this content. The government is lowering the price of the original drug through an ex officio adjustment when the patent of the original drug expires and generic drugs are to receive insurance benefits to compete with it. However, as patent disputes with generic development companies heated up, there were many cases where lawsuits for suspension of execution, which neutralized the government's ex officio coordination, were filed together, so there was a need to prepare a legal basis. In response, the government decided to clearly establish the basis for 'whether a drug is eligible for medical care benefit and the disposition of ex officio adjustment of the upper limit amount' determined and announced by the Minister of Health and Welfare under the Health Insurance Act. This will have the effect of strengthening the legal basis for pharmaceutical companies to respond head-on when they file a drug price lawsuit against the Ministry of Health and Welfare in the future. This amendment is a follow-up measure to reorganize detailed regulations as Article 41-3 (5) of the Health Insurance Act was prepared. The government plans to implement both the detailed revision of the Health Insurance Act and sub-statutes related to this from November 20th.
- Policy
- NHIS extends Bavencio’s reimb...adds KRW 20 bil sales
- by Lee, Tak-Sun Jul 27, 2023 05:40am
- Merck Korea's 6th immuno-oncology drug, 'Bavencio Inj,’was granted a reimbursement extension and will be covered for the first-line treatment of urothelial cancer from next month. With the reimbursement extension, the drug is expected to secure annual sales worth more than KRW 10 billion like the other immuno-oncology drugs. 'Bavencio is the first drug to be granted reimbursement as a first-line treatment for urothelial cancer. The Health Insurance Review and Assessment Service announced the news through the 'Opinion Inquiry on Amendment to Public Notice for Drugs Prescribed and Administered to Cancer Patients (Draft),’ effective as of August 1st. Bavencio Inj (avelumab) was approved in Korea as the 6th immuno-oncology drug in March 2019. As an anti-PDl-L1 immunotherapy drug, the drug was granted reimbursement for the rare condition, metastatic Merkel cell carcinoma (MCC) in 2020. Currently, a total of 8 immuno-oncology drugs, starting with BMS’s ‘Yervoy (ipilimumab)’ in December 2014, followed by MSD’s ‘Keytruda (pembrolizumab),’ Roche’s Tecentriq (atezolizumab),’ AstraZeneca’s ‘Imfinzi (durvalumab),’ Merck’s Bavencio (avelumbab),’ GSK’s ‘Jemperli (dostarlimab),’ then AstraZeneca’s ‘Imjudo (tremelimumab).’ All immunotherapy drugs other than Jemperli and Imjudo are reimbursed in Korea. Immuno-oncology drugs are breaking new sales records every year, receiving reimbursement extensions based on groundbreaking effects on various types of cancer. Last year, based on IQVIA, Keytruda posted sales of KRW 239.6 billion, Opdivo KRW 109.9 billion, Tecentriq KRW 81.8 billion, Imfinzi KRW 52.4 billion, and Yervoy KRW 14.2 billion. Only Bavencio failed to meet the blockbuster criteria, posting KRW 500 million won in sales last year, but reimbursement as first-line treatment for urothelial cancer approved this time is expected to enable the drug to raise over KRW 10 billion in sales. Urothelial cancer is a common term used to refer to malignant tumors originating from the lining of the urinary system that constitutes the mucosal layer of the urinary tract. It includes bladder cancer, renal pelvic cancer, ureteral cancer, and urethral cancer, with the most frequently occurring cancer being bladder cancer. Platinum-based chemotherapy has been used as the standard first-line treatment, and when the disease progresses or recurs, platinum-based chemotherapy is re-administered or drugs such as Keytruda and paclitaxel were used as second-line treatments. Bavencio is the first immuno-oncology drug to be used as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial cell carcinoma who have not progressed on platinum-based chemotherapy. The NHIS estimated the number of urothelial cancer patients that would use Babencio to be about 670 per year and agreed with the pharmaceutical company on the estimated claims amount of KRW 21.65 billion. In other words, the reimbursement extension guarantees additional sales of KRW 20 billion won per year. However, actual sales are expected to be less as the company signed a refund type and expenditure cap type risk-sharing agreement (RSA). Bavencio also lowered its insurance price ceiling by 30% with the reimbursement extension, from KRW 1,226,243 per vial to KRW 854,864 per vial. However, Bavencio’s reimbursement extension is not expected to significantly affect insurance finances. Rather, it is expected to have the effect of saving NHI finances. This is because of the amount of Keytruda used. NHIS expects the use of Keytruda, which is being used as a second-line treatment for urothelial cancer, will decrease with the reimbursement extension of Bavencio. Immunotherapy drugs cannot be administered in the second line if another immunotherapy drug is used as first-line maintenance therapy. Therefore, the NHIS estimated that the actual amount of fiscal spending, unlike the expected claims amount, will range between KRW -1.84 billion to KRW 5.57 billion. Currently, Keytruda is granted reimbursement for 7 indications in 4 cancer types, including as a first-line treatment for metastatic non-small-cell lung cancer. In addition, as it has recently applied to extend reimbursement to 13 indications, its use in cancer is expected to expand further in the future. Therefore, the reimbursement authorities will have to continue to contemplate ways to minimize the spending of health insurance finances while expanding the reimbursement of effective immuno-oncology drugs.
- Policy
- All Sandoz products removed from Korea’s reimb list
- by Lee, Tak-Sun Jul 26, 2023 05:41am
- All products that were registered by Sandoz Korea will be removed from Korea’s reimbursement list. The company had withdrawn from the Korean market in June. With the removal, the name Sandoz will no longer be visible in the Korean market. However, a grace period of 6 months has been granted for some items, and reimbursement for such drugs is valid until February 1 next year. Its CNS (central nervous system) items that have solidified their position in the domestic market will be transferred to Samil Pharmaceutical, and be changed accordingly in the reimbursement list. According to industry sources on the 25th, 18 products from Sandoz Korea will be removed from the reimbursement list as of August 1st. The company had voluntarily withdrawn the licenses of the 18 products. Currently, there are no effective Sandoz products on Korea’s drug approval list. All of them were withdrawn or were deleted in line with the company’s business closure in June. Sandoz withdrew from the Korean market following its spin-off decision made by its parent company, Novartis. Sandoz will be focusing on the biosimilar business in Europe. The license of some of the CNS (Central Nervous System) products sold by Sandoz in Korea has already been transferred to Samil Pharmaceutical. Samil received the sales and distribution rights to the antidepressant ‘Mirtax,’ ‘Sandoz Estical Opram,’ ‘Sandoz Paroxetine,’ the schizophrenia treatment ‘Sandoz Olanzapine Tab,’ and insomnia treatment ‘Sandoz Zolpidem.’ Accordingly, the name of the pharmaceutical company on the reimbursement list will also be changed from Sandoz to Samil Pharm. As a result, no Sandoz products will be left on the reimbursement list. Sandoz Korea had first established its branch in Korea in 2003 as Hexal Korea. Afterward, the company name was changed to Sandoz Korea, and it remained active in the generic market for 20 years thereafter, which is rare for a foreign pharmaceutical company, showing strength in the CNS and anticancer drug markets. Meanwhile, reimbursement for some generic items of its parent company, Novartis Korea, was also removed from the reimbursement list along with the deletion of the Sandoz products.
- Policy
- Yuhan’s low-dose atorvastatin combo receives reimb
- by Lee, Tak-Sun Jul 25, 2023 05:46am
- Just as Hanmi Pharm preoccupied the market with its low-dose (2.5mg) rosuvastatin, Yuhan Corp has its hopes for its low-dose (5mg) atorvastatin to do the same. The companies’ strategy is to reduce the risk of side effects while maintaining efficacy with low-dose statins. According to industry sources, Yuhan Corp’s ‘Atovamibe Tab 10/5mg’ will be listed for reimbursement starting on August 1st. The drug is a combination of atorvastatin calcium trihydrate 5mg and ezetimibe 10mg and is the first fixed-dose combination drug for hyperlipidemia that combines 5 mg of atorvastatin with ezetimibe. No other atorvastatin 5mg product – as a combination drug or a single agent- has been listed for reimbursement until now. The atorvastatin+ ezetimibe combination is well known for the original Atozet (MSD Korea). The rosuvastatin+ ezetimibe combo market is estimated to be at KRW 500 billion, and the atorvastatin + ezetimibe combo market about KRW 200 billion. Recently, the popularity of low-dose statins has been rising in this market. In December 2021, Hanmi Pharmaceutical introduced Rosuzet Tab. 10/2.5mg which contains rosuvastatin 2.5mg, and fostered it as a blockbuster worth KRW 10 billion a year, after which Daewoong Pharmaceutical, Yuhan Corp, Samjin Pharm, and Shinpoong Pharm joined the market. The rosuvastatin+ ezetimibe combinations were evaluated to be more effective than statin monotherapies while minimizing the risk of side effects such as diabetes and myopathy that arise from the use of existing high-dose statins. Yuhan Corp’s Atovamibe 10/5mg is also similar in concept to the rosuvastatin 2.5mg + ezetimibe combo. The drug demonstrated a superior LDL-C change rate to treatment with atorvastatin 5mg monotherapy and the ezetimibe 10mg monotherapy at 8 weeks. The insurance ceiling price of Atovamibe 10/5mg is KRW 637 and was listed at a price lower than the calculated price. At KRW 637, it is priced at the same level as Atovamibe 10/10mg. Therefore, patients can choose 10/5mg or 10/10mg Atovamibe Tab as their initial dose without burden. Yuhan Corp is also currently the first in Korea to receive approval for an atorvastatin 5mg single-agent drug as well. With those products, Yuhan Corp is expected to bring a sensation as a pioneer in the low-dose atorvastatin market.
- Policy
- Be aware of interstitial renal tubulitis when taking Vimovo
- by Lee, Hye-Kyung Jul 25, 2023 05:45am
- When taking anti-inflammatory drugs containing Esomeprazole and Naproxen, care must be taken to prevent the occurrence of interstitial renal tubulitis. The Ministry of Food and Drug Safety recently prepared a change (draft) for permission based on the results of a review of safety information on formulations containing 'esomeprazole and naproxen' from the European Medicines Agency (EMA). The analgesic is used for the symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of gastric ulcer or duodenal ulcer associated with steroidal anti-inflammatory drugs (such as naproxen) and who are not satisfied with low-dose Naproxen or other non-steroidal anti-inflammatory drugs. Domestically approved items are LG Chem's 'Vimovo 500/20mg', Hanmi Pharm's 'Naxozol 500/20mg', Chong Kun Dang's 'Naxen S 500/20mg', SK Chemical's 'Nafmed 500/20mg', Korea PMG Pharm's 'Synflex 500/20mg', Korea Pharmaceutical's 'Esoroxen', Alvogen Korea's 'Esoroxen' Naprazole' and 7 items. If looking at the approval change plan prepared by the Ministry of Food and Drug Safety, the adverse reaction term 'interstitial nephritis' is deleted, and 'interstitial renal tubulitis' is added. A general precaution also includes 'Acute interstitial renal tubulitis: Acute interstitial renal tubulitis has been observed in patients treated with esomeprazole and naproxen-containing agents'. It is also added that acute interstitial renal tubulitis may occur at any time during the treatment period of this drug and may progress to renal failure, and that patients suspected of having acute interstitial renal tubulitis should discontinue administration of this drug and take appropriate measures. The Ministry of Food and Drug Safety said, "If you have a review opinion on the change, please submit the reason and supporting data to the Drug Safety Evaluation Division by August 7."다.
