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- 2026-05-04 12:43:52
- Policy
- Price of Dutasteride has fallen to the 200 won range
- by Lee, Tak-Sun Jan 30, 2023 05:54am
- Original AvodartThe upper limit of Dutasteride products used for prostatic hypertrophy and hair loss has fallen to around 200 won. The effect of cascading drug prices is large, and it is expected to affect the hair loss treatment market. According to industries on the 27th, TELCON RF PHARMACEUTICAL's Durid 0.5mg will be listed at the upper limit of 267 won on the 1st of next month. More than 20 of the same system were applied, 85% of the existing lowest price of the same system (315 won). Dutasteride tablets are evaluated as more convenient formulations than conventional capsule formulations. All 37 currently paid drugs are from domestic pharmaceutical companies. Domestic companies have put forward tablets as a differentiation strategy from Avodart, the original drug containing Dutasteride. Analysts say that it is easier to split and swallow than capsule formulation. As more than 20 are listed at once, the upper limit is gradually falling due to the cascaded drug prices implemented by late pharmaceutical companies since July 2020. The lowest price of 267 won is only 38% of the highest price (709 won). The lowest price for a month on the 30th is 8,010 won, while the highest price is 21,270, a difference of more than 10,000 won. The original Avodart is also 709 won per capsule, the highest price. As such, the falling upper limit of Dutasteride is expected to affect the non-reimbursed hair loss treatment market. This is because low prices are advantageous in the non-reimbursed market. If pharmaceutical companies supply products to nursing institutions in line with the upper limit, hospitals and pharmacies will put a margin based on the upper limit. Therefore, the lower the upper limit, the cheaper the non-reimbursed amount when prescribed for hair loss. Hair loss patients also visit hospitals and clinics that prescribe inexpensive products on purpose, so the lowest price is also helpful for market competition. As a result, it is understood that there are pharmaceutical companies that want to register salaries for competitiveness in the hair loss treatment market even if the upper limit is lowered due to cascaded drug prices. Since Dutasteride drugs are covered by benefits for prostate hypertrophy, most pharmaceutical companies have fewer factors to lower the upper limit. Currently, 28 out of 37 Dutasteride tablets are listed at 709 won, the highest price. It is said that a few pharmaceutical companies deliberately lower the upper limit and sell it as a non-payment for hair loss treatment because supplying it cheaper than the upper limit of the actual transaction price could be lowered. Ten of the same products currently licensed remain non-reimbursed.
- Policy
- Negotiating Erleada's price with the NHIS
- by Lee, Tak-Sun Jan 27, 2023 05:51am
- It has been confirmed that Erleada, Janssen Korea's prostate cancer treatment, is negotiating drug prices with the NHIS. This drug was conditionally passed at the deliberation of the HIRA Drug Benefit Evaluation Committee in December last year. According to industries on the 25th, it is negotiating Erleada's price with the NHIS. Erleada was passed at the 12th meeting of the Drug Benefit Evaluation Committee held in December last year on the condition that if the conditions for presenting the drug evaluation committee were accepted, it would be appropriate for benefit. The move to the stage of drug price negotiations is interpreted as meaning that Janssen Korea accepted the amount suggested by the Pharmaceutical Affairs Evaluation Committee. This drug is a hormone-responsive metastatic prostate cancer treatment and was approved in 2020. The efficacy and effect were approved as a combination therapy with androgen-blocking therapy, a treatment for hormonal-responsive metastatic prostate cancer patients. Phase 3 clinical trials (TITAN study) showed that the risk of imaging progression was reduced by 52% compared to the placebo group when frozen in patients with metastatic castration-sensitive prostate cancer, and the risk of death was reduced by 33% compared to the placebo group. At the time of approval by the U.S. FDA in February 2018, Janssen explained that Erleada would be an alternative option to delay metastasis when treating prostate cancer. Erleada is expected to be the next-generation treatment that connects Zytiga of Janssen and Xtandi of Astellas. If a smooth agreement is reached in the drug price negotiation with the NHIS, it will be applied after reporting to the Health Insurance Policy Review Committee of the Ministry of Health and Welfare. In the case of hormone-responsive metastatic prostate cancer, delaying metastasis is an important treatment goal, so if Erleada succeeds in entering the benefits range, the treatment effect will increase and the cost burden on patients will be greatly reduced.
- Policy
- The copyrights of Valcyte, Alvesco, & Bonviva changed
- by Lee, Tak-Sun Jan 27, 2023 05:50am
- As the domestic owners of major drugs such as Valcyte, Alvesco, and Bonviva changed, they were newly reflected in the salary list. All three items were previously copyrighted by the Korean branch of a global pharmaceutical company, but now domestic pharmaceutical companies are the owners. In the case of Valcyte 440mg, pharmaceutical companies will be changed from February 1st from Roche Korea to Chong Kun Dang. The transfer of permission rights has already been completed. The drug is used to treat CMV retinitis in adult AIDS patients. Roche has been copyrighted and sold in Korea in cooperation with Chong Kun Dang, but Chong Kun Dang will sell exclusively in the future. The global copyright of the drug has already been transferred from Roche to Cheplapharm. Chong Kun Dang acquired exclusive sales rights for Valcyte in Korea through a contract with Cheplapharm in March last year. The two asthma treatment Alvesco inhalants will also be changed from AstraZeneca Korea to SK Chemicals in February. As global copyrights moved, domestic copyrights were finally transferred to SK Chemicals. Along with this drug, SK Chemicals also acquired the domestic copyright of AstraZeneca's Omnaris nasal spray. Bonviva is changed from Handok to Jeil. Cheil Pharmaceutical announced last month that it will exclusively supply osteoporosis treatments Bonviva and Bonviva Plus in Korea. Bonviva was originally copyrighted by Roche Korea but later passed to Jeil via Handok. Currently, global copyright is held by the British pharmaceutical company Pharmanovia. Jeil signed an exclusive domestic sales contract for Pharmania and Bonviva, and began sales and marketing activities for hospitals and clinics. Only Bonviva pharmaceutical companies will be replaced in February, but Bonviva is also expected to revise its salary list soon as the license has been transferred to Jeil. Bonviva Plus is licensed by Alvogen Korea, which developed the drug, and Jeil is in charge of selling it. Drugs that are replaced by pharmaceutical companies this time do not change the upper limit.
- Policy
- MFDS preannounces temporary narcotics designation of 2 drugs
- by Lee, Hye-Kyung Jan 26, 2023 06:05am
- On January 20th, The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) preannounced the designation of two drugs including ‘Etazene’ that is being misused or abused as a narcotics substitute in Korea and abroad. Etazene is a synthetic opioid that has a similar structure and effect to Etonitazene, which has been designated as a narcotic drug, and is being controlled as a temporary-class narcotics drug in Japan. 6-Monoacetylmorphine, whose temporary narcotics designation expires on March 8th, will be redesignated as a Group 2 temporary narcotics drug. The temporary narcotics designation system is a system that manages and controls certain non-narcotics in the same manner as narcotics within a 3-year period due to concerns of such being misused or abused as an alternative to narcotics and posing risks to public health. Substances designated as temporary narcotics are handled and managed in the same manner as narcotic drugs from the date of the pre-announcement. Therefore, carrying, possessing, using, controlling, exporting, importing, manufacturing, trading, assisting in the trade of, giving, or receiving temporary narcotics will be completely banned, and relevant substances can be seized. Also, anyone who export, import, manufacture, trade, assist in the trade, give or receive Group 1 temporary narcotics after the pre-announcement on the list of temporary narcotics will be punished by imprisonment with labor for an indefinite term or not less than 5 years. Anyone who imports, exports, or manufactures Group 2 temporary narcotics shall be punished by imprisonment with labor for not more than 10 years or by a fine not exceeding KRW 100 million. Those who trade, assist in trade, give or receive Group 2 narcotics shall be punished by imprisonment with labor for not more than 5 years or by a fine not exceeding KRW 50 million. MFDS expressed hopes that the preannouncement will help block the distribution of new illicit drugs in advance and will cooperate with relevant prosecution, police, the Korea Customs Service, and other related agencies, and continue making efforts to protect public health from the harms inflicted by new and illicit narcotic drugs.
- Policy
- Penalties for rebate drugs can be replaced by fines
- by Lee, Jeong-Hwan Jan 20, 2023 06:07am
- Rep. Kim Min-seok A bill will be promoted to replace drug price cuts and suspension of salaries for illegal rebates on drugs with fines. It also includes a clause that further strengthens the penalty standard for effective illegal rebate disposal. The move aims to solve the problem of increasing drug costs for patients who have to continue taking drugs due to administrative measures such as suspension of salary. On the 19th, Rep. Kim Min-seok of the Democratic Party of Korea proposed a partial amendment to the National Health Insurance Act. Under the current law, if drug suppliers such as pharmaceutical companies are found to have provided economic benefits to medical personnel for the purpose of promoting sales, drug prices will be lowered and salaries will be suspended. Kim Min-seok agreed to punish illegal rebates strictly but pointed out the problem of patients being damaged by the suspension of drug benefits and drug price cuts. Kim points out that the burden of drug costs for patients who have to continue to take existing drugs will increase significantly, and the anxiety of eating other drugs will also be borne by the patient, which could infringe on the public's right to health. In particular, Rep. Kim was also concerned that prescribing and selling identical drugs that are more expensive than the insurance price of administrative disposition drugs for suspension of salary will increase drug expenditure, increasing the financial burden of health insurance. In addition, in 2018, the National Assembly revised the law to replace the suspension of salary for rebate drugs before the revision but criticized that the government is still applying the old law. In response, Rep. Kim proposed a bill that could replace the drug price reduction and benefit suspension system for rebate drugs with a penalty sound. Kim said, "We will set a strengthened level of penalty standards to enhance the predictability of administrative disposition and effective sanctions on rebates," adding, "We will also solve the problem of patient drug options and accessibility violations due to suspension of drug subsidies."
- Policy
- Rinvoq PR 30 mg & Fexuclu 10 mg listed
- by Lee, Jeong-Hwan Jan 20, 2023 06:07am
- The Ministry of Health and Welfare will overhaul Rinvoq, Procoralan, and Fexuclu (from left) standardsWith the new listing of high-content products of Rinvoq PR, a severe atopic drug, the salary standard changes. The angina drug Procoralan is a standard treatment drug and an angiotensin II receptor blocker is added. Fexuclu, a gastroesophageal reflux disease drug, will have four new benefits listed, including a low content of 10 mg oral medicine. On the 18th, the Ministry of Health and Welfare will collect opinions by the 27th after giving an administrative notice of "partial revision of the detailed (drug) on the application standards and methods of medical care benefits." The scheduled effective date is February 1. ◆ Rinvoq PR 30mg will be newly registered, adding '30mg' to the name of the notification. Considering that the permission matters for each drug are different, the phrase is changed to "dose within the scope of permission for each drug." Currently listed 15 mg has secured indications of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and ulcerative colitis. The newly listed 30 mg can only be used for atopic dermatitis and ulcerative colitis indications. ◆ Ivabradine= Ministry of Health and Welfare clarifies Procoralan as standard treatment drugs by referring to the Ministry of Food and Drug Safety's permits, guidelines, clinical papers, and expert opinions. Currently, the standard treatment drugs for oral drugs composed of Ivabradin are beta-blockers, ACE inhibitors, and aldosterone antagonists. The Ministry of Health and Welfare will add an angiotensin II receptor blocker to this. ◆Fexuclu=Procoralan, a treatment for improving gastric mucosal lesions of acute gastritis and chronic gastritis, will have a revised salary standard as 10mg is set to be newly registered. Specifically, the phrase "medical care benefits are recognized when administered within the scope of permits (treatment of erosive gastroesophageal reflux disease)" is changed to "medical benefits are recognized within the scope of each drug, and the patient pays the full price except for this recognition." The criterion refers to the treatment of erosive gastroesophageal reflux disease. In the case of "improvement of gastric mucosal lesions of acute gastritis and chronic gastritis", which is an additional permit from the Ministry of Food and Drug Safety, the entire amount is recognized at the expense of the person. As a result, the scope of benefit according to the content of Fexuprazan has become clear. Fexuprazan 40mg, which was listed in July last year, was approved to be used to treat erosive gastroesophageal reflux disease. Salary is recognized at the time of administration. The 10 mg product, which will be listed in February this year, has added indications of "improvement of gastric mucosal lesions of acute gastritis and chronic gastritis." When administered with the indication, the burden is recognized, not the benefit.
- Policy
- Grace period for foreign API mfg site registrations ends
- by Lee, Hye-Kyung Jan 19, 2023 05:58am
- Starting on the 21st, the foreign manufacturing site for all pharmaceuticals (including APIs) imported to Korea from abroad must be registered in advance. The Ministry of Food and Drug Safety announced that the grace period that had been granted in consideration of the industry’s state of preparations in registering foreign manufacturing sites for APIs imported to manufacture of finished products, will end as of January 20th. The mandatory registration of overseas manufacturing sites for all pharmaceuticals went into effect on July 21st last year after the amendment of the Pharmaceutical Affairs Act on July 20th, but a grace period on its immediate implementation was granted until January 20th. Therefore, from January 21st, companies not only would need to register the foreign manufacturing sites for their imported finished drugs and Drug Master File (DMF) drugs but would also need to register the foreign manufacturing sites for imported APIs that the companies use to manufacture their own finished products. The MFDS urged the companies to thoroughly make preparations in advance to prevent disruptions in domestic drug supply and production. The foreign manufacturing site registration system, which took effect in December 2019, was designed to promptly respond to relevant imported drugs in the event risk is identified overseas and mandates the registration of the workforce, facility, and GMP status of the overseas manufacturing site. Information on the overseas manufacturing site is systematically registered, updated, and managed for the latest information, and is used for risk assessment of overseas manufacturing sites and selection of sites subject to on-site inspection. The number of registered overseas manufacturing sites has been steadily increasing, from 1882 sites in 2020 to 2208 sites in 2021, then 2531 sites in 2022. The MFDS said, “We expect the overseas manufacturing site registration system to increase reliability in the quality of imported drugs and contribute to the more thorough and safe management of the drugs. We will continue our efforts to manage the safety of imported drugs to allow our people the safe use of high-quality drugs.”
- Policy
- Generic for Dukarb to be released next month
- by Lee, Tak-Sun Jan 18, 2023 06:04am
- DukarbGeneric for Dukarb, a compound combined with Amlodipine in the new hypertension drug Kanarb developed by Boryung pharmaceutical, is expected to release in time for the expiration of the patent next month. Eight items from four companies approved last month will go to the market first, and they will be calculated at 53.55% of the initial price of every single ingredient. Among the same ingredient products approved this month, consignment items will be 15% cheaper depending on the standard requirements, and salary registration is expected to be possible only in March. According to industries on the 17th, as generics for Dukarb, which was approved in December last month, applied for benefits, the salary is expected to be applied from February 2, the day after the patent expires. Items licensed in December last month are Dunarb 30/2.5mg, Dunarb 60/2.5mg, Fimadipine 30/2.5mg, Fimadipine 60/2.5mg, Hana Pharmaceutical Fimaone-S 30/2.5mg, Fimaone-S 60/2.5mg, Aliko Pharmaceutical Ardewka 30/2.5mg, and Ardewa. All of these products are produced on consignment by Alico Pharmaceutical, and since they applied for drug prices in the same month, they are all considered data-submitted drugs, and the upper limit is expected to be 53.55% of the first price of a single ingredient. The original Dunarb, which was added as an innovative pharmaceutical company, is also expected to go down at the same price. Dunarb's first generic is different from amlodipine. The original Dunarb is Amlodipine Besylate, whereas the late drugs are S-Amlodipine Besylate 2.5. Since it is not the same ingredient as Dunarb, the drug price is calculated at the highest price according to the drug price standard. However, the drug price of the product approved in January is different. Products licensed in January are also 2.5 mg of S-Amlodipine Besylate, which are considered generics of the four products listed first, and consigned items without direct BA will be 15% cheaper as the standard requirements are applied. Of course, entrusted items with direct BA and DMF requirements are expected to be equally calculated at 53.55%. There was a difference in drug prices depending on the time of approval. None of the items released this time have the same active ingredients and content as Dukarb 30/5mg. This is because Dukarb 30/5mg is registered separately as a patent, and the composition patent lasts until August 8, 2031. Late pharmaceutical companies filed a passive trial to confirm the scope of rights to avoid the patent, but it was rejected in March last year. As a result, an appeal is currently underway in the Patent Court. Due to the failure of patent avoidance, the license of the capacity item is being delayed. Since Dukarb 30/5mg is the flagship capacity of about half of the market along with Dukarb 60/5mg, generic pharmaceutical companies are expressing regret over the failure of the first trial to evade patents. In addition to the approved generics, Fimasartan salt change generics are also reportedly preparing for approval.
- Policy
- MOHW-NECA issues notice on colorimetric assay
- by Kim, Jung-Ju Jan 18, 2023 06:04am
- The National Evidence-based healthcare Collaborating Agency (President: Kwang Hyub Han) announced the amendments to the notice on the new health technology, ‘colorimetric assay’ for anti-Xa apixaban testing, that had been deliberated as a safe and effective health technology at the 10th MOHW New Health Technology Assessment Committee meeting in 2022. The New Health Technology Assessment system was introduced in 2007 to assess the safety and clinical efficacy of new health technologies (acts of medical practice including treatment method, and testing method), and is implemented to prevent indiscriminate use of unverified medical technology and to protect the people's right to health. The anti-Xa apixaban assay technology, the ‘colorimetric assay, ‘is a test that quantifies the concentration of apixaban in plasma samples through colorimetric assay for patients that were administered apixaban and require monitoring for apixaban concentration. As it is safe as an in vitro test that uses patient samples and is recommended as a test to monitor the concentration of apixaban in patients that are administered apixaban when clinically necessary in textbooks and guidelines, the technology was determined to be a valid technique with an acceptable level of correlation to the current standard test method, liquid chromatography-tandem mass spectrometry. Meanwhile, the results of the new Health Technology Assessment were notified under Article 53-3 of the Medical Service Act and Article 4 of the Rules on New Health Technology Assessment and may be found on the MOHW and NECA’s Center for New Health Technology Assessment website.
- Policy
- Dupxient deemed adequate for reimb in children with AD
- by Lee, Tak-Sun Jan 13, 2023 06:01am
- The atopic dermatitis treatment ‘Dupixent’ was deemed adequate for reimbursement in children and adolescents. Therefore, attention is now focused on whether Dupixent will become the first biological agent to be reimbursed for atopic dermatitis in children and adolescents. The Health Insurance Review and Assessment Service announced that it had passed the agenda at the first 2023 Drug Reimbursement Evaluation Committee (DREC) meeting that had been held on the 12th. At the meeting, DREC concluded that Sanofi-Aventis Korea’s ‘Dupixent Prefilled Inj. 200, 300mg (dupilumab, genetical recombination)’ was appropriate for reimbursement in treating 'atopic dermatitis in children and adolescents.' With the drug passing HIRA's stage, pediatric and adolescent atopic dermatitis patients will be able to receive reimbursement after the company completes drug pricing negotiations with the National Health Insurance Service. In Korea, Dupixent is reimbursed for adult patients with atopic dermatitis since January 2020.
