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- 2026-05-04 04:46:06
- Policy
- Why AZ’s vaccine was used as comparator for SKY Covione
- by Lee, Hye-Kyung Aug 16, 2022 05:46am
- The minutes of the Central Pharmaceutical Affairs Council’s meeting that reviewed the first homegrown COVID-19 vaccine - SK Bioscience’s 'hasCovione multi inj.’ – have now been disclosed. The minutes contained discussions on the reason why a vaccine from a different platform was selected as the control vaccine for SKY Covione, whether its safety is acceptable, and on the adequacy of post-approval safety assurance measures. The CPAC meeting that was held on June 26th, whose minutes were disclosed by the MFDS recently, sought counsel on the safety and efficacy of the homegrown COVID-19 vaccine SKY Covione, which applied for manufacture, sale, and marketing authorization in Korea. An employee from SK Biosience’s Andong L House is filling the Sky Covione formulation (Pic: SK Bioscience) On why a vaccine from a different platform was selected as a control vaccine for SKY Covione, the MFDS explained, “Although it is best to use a comparator from the same platform, a recombinant vaccine using the same platform had only been approved in January this year in Korea, and at a similar period in Europe as well.” “The clinical trial for SKY Covione had been approved in August last year, and no approved vaccines were using the same platform at the time. Therfore, the company had to find the most appropriate control vaccine among available vaccines, all of which were being supplied by the state. The multinational pharmaceutical companies have not approved the use of their vaccines as control vaccines, therefore, AstraZeneca’s vaccine was used as control vaccine in consideration of the approval status and availability of vaccines.” The World Health Organization also states that although using vaccines from the same platformas a control vaccine is advisable if the company cannot secure a vaccine from the same platform, it may use other vaccines as control as long it can demonstrate clear immunogenicity compared to that control vaccine. The MFDS said, “Unlike in the past, all of the vaccines for COVID-19 are being contracted and used by the state. This was why it was difficult for latecomers to obtain a control vaccine, and only AZ’s vaccine was available for use as a control vaccine." Explaining how vaccines based on bridging immunogenicity data are approved under the condition that it submits efficacy evaluations, the MFDS added, “The Ministry will add a condition for the drug’s approval to follow-up for a certain period post-approval to evaluate how much infection is prevented after actual vaccination."
- Policy
- The regulation for shortening the period will be revised
- by Lee, Hye-Kyung Aug 16, 2022 05:46am
- As announced by the government, if the RSA-applied drugs are subject to PE submission, the registration period will be shortened, and even drugs that have proven improvement in children's quality of life will be excluded. The HIRA will pre-announce the "Partial Amendment Regulations on the Evaluation Standards and Procedures for Medical Care Benefits" containing such information and receive opinions by the 30th of next month. The revised regulations are designed to promote national tasks such as shortening the listing period of drugs related to diseases that threaten survival and strengthening access to patients through the expansion of risk-sharing systems. In accordance with Article 11-2 (1) of the Medical Care Benefit Standard, the legal processing period for insurance registration is within 120 days, and in the case of the world's first new drug approved in Korea, the processing period is within 100 days. However, in the case of drugs that manufacturers under Article 7 (2) of the Decision and Adjustment Standard or drugs that fall under Article 13 of the Medical Care Benefit Standard, the treatment period was 150 days, and the drugs evaluated as Table 2 (b) and (c) of the Decision and Adjustment Standard were shortened by 30 days. The HIRA said, "We have prepared an amended regulation to shorten the legal deadline for insurance registration of PE submission exemptions, which are methods of evaluating expensive anticancer drugs and treatments for severe and rare diseases." In addition, PE-submitted omitting drugs included "when there is no product or treatment that is used in children with equal therapeutic location, and clinically meaningful improvement in quality of life or other committees recognize it." The HIRA explained, "Even drugs to prove the quality of life for children can be omitted to submit PE data, allowing RSA to be expanded."
- Policy
- The Price of 4 Xarelto will be cut from the 22nd as planned
- by Kim, Jung-Ju Aug 12, 2022 05:58am
- As the court sided with the government for the four items of the Bayer Korea Xarelto (Rivaroxaban) series, which the government has lowered the insurance drug price through ex officio adjustment and ended the additional application, the drug price cut schedule was set. On the 22nd, the drug price will fall as originally planned by the government. The 11th part of the Seoul High Court recently sided with the Ministry of Health and Welfare in the case of the Xarelto Drug Abatement Cancellation Action (2021-Guhap 65811) filed by the company against the Ministry of Health and Welfare. As the company filed a lawsuit, the price was lowered as the suspension of execution of the drug price cut, which the court accepted, was lifted. Earlier, on May 24, 2021, the Ministry of Health and Welfare lowered the price of four items of the drug series through the revision of the Notice of the Drug Benefit List and the upper limit amount table (Notification No. 2021-147). The government is ex officio adjusting the upper limit price of products with the same administration route, ingredients, and formulations as the first registered products and the lowest registered products when registered as generics. If the first genomic is registered, it is 53.55%, which is added to 70% for one year after adjustment. At that time, the Ministry of Health and Welfare decided to reduce the Xarelto 10mg content, 15mg, 20mg, and 2.5mg content by 30% each, and to drop 23.5~23.6% each as of May 1, 2022, a year later. As a result, the company protested and the suspension of execution has continued for about a year along with the lawsuit. With this close, the price will fall to the official price at the time, and the fixed date will be on the 22nd. However, the Ministry of Health and Welfare said it will inform the company further if there is a change in the price because the possibility of appeal remains, and the court may accept the suspension of execution again.
- Policy
- CKD completes acquiring 3 exclusive licensed items
- by Lee, Tak-Sun Aug 12, 2022 05:58am
- Chong Kun Dang completed the acquisition process for the three items that it signed exclusive sales agreements for with foreign pharmaceutical companies last year. All three items are known to have a prior history with Chong Kun Dang. According to industry sources on the 11th, Chong Kun Dang has been receiving insurance reimbursement for the tranquilizer drug ‘Valium 5mg Tab. (diazepam)’ starting this month. The approval and reimbursement rights for the drug had previously been owned by Roche Korea. However, after the global commercial rights of the drug were transferred from Roche to Pharmanovia, Chong Kun Dang signed an exclusive sales agreement for Valium in Korea with Pharmanovia in August last year. Under the agreement, Chong Kun Dang transferred and acquired the license for Valium Tab. 5mg in Korea, and the reimbursement entity was also changed accordingly. The sales right for the epilepsy treatment Rivotril (clonazepam) in Korea, whose license was also held by Roche Korea, had also been transferred to Chong Kun Dang through a transfer and acquisition process prior to Valium. Accordingly, Rivotril’s reimbursement entity was switched from Roche Korea to Chong Kun Dang in March this year. , whose sales rights was transferred from Roche Korea to Chong Kun Dang In March last year, Chong Kun Dang acquired the exclusive domestic sales right for Rivotril from Cheplapharm, which owns the global commercial rights to Rivotril. Cheplapharm had purchased the global commercial rights for Rivotril from Roche. Both of the drugs had previously been sold by Chong Kun Dang under a joint sales agreement with Roche Korea. Therefore, the interpretation is that the company acquired the exclusive domestic sales right of the two drugs to sell in its pre-established sales networks. In June, the company also completed the transfer and acquisition of the domestic sales right for the anticancer drug ‘Leustatin Inj. (cladribine) ' which had been previously owned by Janssen Korea. Its global commercial rights are also owned by Pharmanovia, and an exclusive domestic sales agreement had been signed for the drug in October last year. This is not the first time Chong Kun Dang had signed exclusive domestic sales agreements with new owners of drugs after the transfer of global commercial rights. The company had previously signed an exclusive sales agreement and acquired the sales rights for the antihypertensive drug ‘Dilatrend’ and obesity treatment ‘Xenical' from Cheplapharm. Chong Kun Dang owns the license and right to reimbursement for the drugs in Korea.
- Policy
- Ceprotin, Takeda's rare dz, gives 11 yrs for reexamination
- by Lee, Hye-Kyung Aug 12, 2022 05:57am
- On the 2nd, Takeda's Ceprotin, which was first approved as a treatment for severe congenital protein C deficiency in Korea, was given an 11-year review period after marketing. Severe congenital protein C deficiency is a rare genetic disease that causes fatal defects in blood clot control due to a lack of protein C, a type of vitamin K-dependent anticoagulant, and is defined when protein C levels are less than 1% (less than 1 IU/dL), and the incidence rate is estimated to be 1 in 4 million newborns. Ceprotin is the first human protein C drug approved for patients with severe congenital C protein deficiency and was approved for "prevention and treatment of venous thrombosis and fulminant purple hemiplegia in patients with severe congenital protein C deficiency in children and adults." Prior to Ceprotin's approval, the Central Pharmaceutical Review Committee's Pharmaceutical Affairs Subcommittee-Rare Medicine Subcommittee discussed the validity of the re-examination period when licensing biopharmaceutical items. On this day, the committee members decided that it was appropriate to set a period under the Rare Disease Control Act in consideration of the prevalence rate as an item prescribed for rare diseases. It also said that 11 years of re-examination, including pediatric indicators, should be given to secure sufficient safety information. It is reasonable to grant a 10-year re-examination period, including a pediatric indication, and a 10-year re-examination period, which was consulted by the central pharmacy, considering the pharmacological law, the re-examination system, and the characteristics of rare diseases. "It is difficult to judge that there is no appropriate treatment for severe congenital protein C deficiency because there are standard treatments," a member said. "However, it is confirmed that there are limitations on standard treatments and risks to be applied to children." The opinion is that it is difficult to evaluate post-marketing safety due to a lack of patients by granting a 4-6 year review period for congenital genetic diseases, which have symptoms mainly in the early stages of newborns and have a very high mortality rate from complications. Considering the nature of special diseases and the characteristics of the domestic medical environment, a total of 11 years of re-examination period, including pediatric diseases, will be given.
- Policy
- Gov is reluctant to demand that infants be exempted from PE
- by Lee, Jeong-Hwan Aug 11, 2022 06:03am
- The government expressed reluctance to apply PE omission to rare drugs for infants, children, and adolescents. They say that it is a matter to be carefully considered in consideration of other drugs. On the 10th, the MOHW responded to a written question by Choi Hye-young of the Democratic Party of Korea, a member of the National Assembly's Health and Welfare Committee. Choi asked if there is a plan to expand rare drugs for infants, children, and adolescents to PE omission even if they are not treated for rare diseases. The Ministry of Health and Welfare expressed its position that it is difficult to exempt PE from rare drugs for infants, children, and adolescents, along with fundamental answers, such as explaining the criteria for omission of PE data. The Ministry of Health and Welfare said, "The submission of PE data can be omitted for rare drugs used for diseases that threaten survival as alternative or therapeutic drugs or anticancer drugs without treatments." The Ministry of Health and Welfare explained, "In addition, the process of revising the regulations of the Korea Appraisal Board, which includes drugs that improve the quality of life of children with anticancer drugs or rare disease treatments, is in progress. In addition, the expansion of rare drugs for infants, children, and adolescents to PE omission is a matter to be carefully considered in consideration of other drugs and equity."
- Policy
- Reyvow, a migraine drug aimed at clinicians
- by Lee, Tak-Sun Aug 11, 2022 06:03am
- Ildong Pharmaceutical, which is seeking to introduce the new migraine drug Reyvow in Korea, has decided not to accept the upper limit offered by the Pharmaceutical Benefit Evaluation Committee of the Health Insurance Review and Assessment Service. The measure was decided in consultation with Lilly, who holds the global copyright of the drug, and they say they will continue to make efforts to register their salaries. On the 7th of last month, the Pharmaceutical Benefit Evaluation Committee of the HIRA Committee reviewed Ildong Pharmaceutical's acute migraine treatment Reyvow 50mg and Reyvow100mg and judged that the benefit was appropriate if it was accepted below the evaluation amount. If Ildong Pharmaceutical accepted less than the evaluation amount, there was a possibility of benefit registration. However, it is said that the amount was not acceptable for pharmaceutical companies. The committee presented a weighted average price of existing treatments, including Tryptan-based drugs, which differed greatly from the price desired by pharmaceutical companies as the prices of existing drugs fell significantly due to the expiration of patents. Reyvow has attracted attention as an expected replacement for Tryptan-based drugs, which are most commonly used to treat migraine headaches. This drug targets serotonin (5-HT) 1F receptors like conventional Tryptane drugs, but it has the advantage of not having cardiovascular side effects by acting selectively. Tryptane-based drugs were limited in their use because they contract blood vessels on the mechanism and cause cardiovascular diseases such as myocardial infarction and stroke. An industry official said, "We needed a migraine treatment that can be used comfortably in clinics because existing drugs have side effects risks," adding, "Reyvow is an oral drug and has a low risk of side effects, so we expected Reyvow to be reimbursed." All procedures were suspended as everyone did not accept the price offered by the HIRA. However, they say they will continue to push for efforts to register benefits in the future. It is known that products will be released in the second half of this year. Reyvow, which was approved by the U.S. FDA in 2019, is a drug that Ildong Pharmaceutical has secured copyrights in eight Asian countries, including domestic sales licenses, in partnership with its developer CoLucid in 2013. When Lilly acquired CoLucid in 2017, the drug's global copyright was also transferred to Lilly. All of them accelerated the introduction of Bridging Study in Korea. Meanwhile, Lilly Emgality and Teva's Ajovy, which are new drugs for the same migraine, are also seeking to register their salaries. In particular, Emgality has completed negotiations with the NHIS and is expected to be listed soon. However, the both are injection typed medication and expensive, so it is not expected to be prescribed much in clinics.
- Policy
- "May bring 60M courses of Omicron-adapted COVID-19 vaccines"
- by Lee, Jeong-Hwan Aug 11, 2022 06:03am
- The disease control authorities announced that they may introduce the adapted, so-called ‘Omicron-specific COVID-19 vaccines’ as newly introduced amounts if the vaccines receive marketing authorization. In other words, if Moderna’s ‘Moderna Spikevax-2 inj.’ and Pfizer’s ‘Comirnaty-2 inj.’ that are being reviewed by the Ministry of Food and Drug Safety are approved, the authorities will bring in these vaccines as newly procured vaccines. On the 9th, the Korea Disease Control and Prevention Agency responded so to a written QA on pending issues related to COVID-19 that was submitted by members of the National Assembly’s Health and Welfare Committee. Adapted vaccines refer to multivalent mRNA vaccines that express antigens for both the original COVID-19 virus (Wuhan strain) and its variant virus (Omicron strain, BA.1) that was developed as a booster vaccine after receiving primary vaccination to be administered in the endemic stage. Moderna Spikevax-2 inj. and Comirnaty-2 inj. are both under review by the MFDS for approval. The KDCA explained that the purchase agreement made with Moderna and Pfizer in 2022 contains the supply of adapted vaccines. If approved, the 60 million courses of vaccines set to be introduced to Korea may all be adapted vaccines. To the question of when the adapted vaccines will be administered, the KDCA said the specific date will be announced at the end of the month after a comprehensive review of the vaccine’s efficacy, development progress, and introduction situation. However, the specific strategies such as vaccination subjects, period, and method would need to be determined based on the variant in circulation at the time of vaccination and the effect of the adapted vaccine against that variant. The KDCA added that it will continue to monitor the development of adapted vaccines in Korea and abroad and cooperate with the MFDS for the prompt introduction of adapted vaccines. Meanwhile, the U.S. companies Pfizer and Moderna are currently developing adapted vaccines that include recently circulating variants. Pfizer is yet to apply for the approval of its vaccine in Korea, and Moderna has completed submitting its application for approval on the 29th of last month.
- Policy
- Will approval of brain function enhancers be revoked?
- by Lee, Hye-Kyung Aug 10, 2022 05:53am
- Whether acetyl-L-carnitine, which failed to verify its efficacy in its ‘secondary degenerative diseases caused by cerebrovascular disease’ indication during clinical reevaluations, will be able to maintain its marketing authorization status will be determined within September this year. The Ministry of Food and Drug Safety issued a Dear Healthcare Professional Letter on the 5th recommending the use of alternative drugs and discontinuing the prescription and dispensing of drugs that contain acetyl-L-carnitine. At the MFDS correspondents’ briefing held on the 9th, Kyung Seung Shin, Director of the Pharmaceutical Safety Evaluation Division at MFDS, said, “We have disclosed the reevaluation results in compliance with our administrative procedure, and will be receiving objection submissions for 10 days starting on the 20th day of the public announcement. When the final result will be announced may vary depending on whether or not an objection is filed and other circumstances." Director Shin said, “The process will likely be completed within September. If the Ministry does not accept the objections submitted by the companies, acetyl-L-carnitine drugs will be recalled, suspended from sales, and revoked of their marketing authorization.” Currently, 39 acetyl-L-carnitine products from 35 companies are sold in the Korean market, with representative products being Dong-A ST’s ‘Dong-A Nicetile Tab.’ and Hanmi Pharmaceutical’s ‘Carnitil Tab.’ Pursuant to Article 33 of the Pharmaceutical Affairs Act, the MFDS ordered related companies to reevaluate and verify the efficacy of acetyl-L-carnitine through domestic clinical trials based on the latest scientific standards. The companies have already failed to demonstrate acetyl-L-carnitine’s efficacy in ‘primary degenerative disease’ in a previous clinical trial that was conducted in June 2019, which resulted in the deletion and removal of the indication. Shin said that the most frequent request made by the companies during clinical reevaluations is to extend the reevaluation period. “The companies wish for more time. We have partially accepted such requests per claims that patient recruitment is difficult due to COVID-19.” However, the ministry takes thorough reports on the interim progress of the clinical reevaluations for the safety of the consumers. Shin said, “Although the companies say that conducting domestic trials within the period is difficult, as their drugs are still being sold in the market during the period, it is our responsibility to confirm the progress for the consumers. We receive interim result reports so as to prevent delays or discontinuation." Regarding the increased burden borne by the industry due to MFDS’s clinical reevaluations and HIRA’s reimbursement evaluations, Shin said, “The companies may feel burdened by the reevaluations being separately conducted by different institutions on one product, but this is just standard procedure that needs to be carried out by each institution." “HIRA conducts reevaluations on the adequacy of a drug’s reimbursement, while the MFDS reevaluates whether the clinical effectiveness of a drug meets the latest scientific standards. Although the institutions closely share their progress, as the reevaluations are conducted for different purposes, their evaluation systems have to be operated separately." Shin also explained the risk management plan system that was included in the new government's regulatory reform innovation plan, which will be operated in integration with the post-marketing safety management system after the abolition of the re-examination system. Shin said, “There had been industry burden of additionally needing to conduct risk mitigation measures if a drug is designated as a drug subject to risk management while conducting mandatory PMS for 4-6 years from a drug’s marketing date. The two laws in effect have many similar and overlapping parts, so a plan was made to integrate the laws into a single risk management system. We will promptly work to amend the Pharmaceutical Affairs Act for this.” Shin also mentioned the pharmaceutical equivalence reevaluations that are set to begin next year and end in 2025. The MFDS recently disclosed the total list of items subject to pharmaceutical equivalence reevaluations for the next 3 years, which includes 130 ingredients such as levodropropizine in 2023, 420 ingredients including amlodipine in 2024, and 286 ingredients including piroxicam in 2025. Shin said, “We plan to receive supplementary documents for items subject to reevaluations this year until the end of the year. Some companies requested deadline extensions due to difficulty generating data, so we may receive data until early next year."
- Policy
- AZ seeks reimb of its triple inhaled therapy for COPD
- by Lee, Tak-Sun Aug 10, 2022 05:52am
- The first single-inhaler triple therapy for COPD in Korea, New triple drug inhaled therapies for COPD (Chronic Obstructive Pulmonary Disease) are working to receive insurance reimbursement in Korea. After GSK cut the first tape to reimbursement with its ‘Trelegy Elipta’ in June last year, AstraZeneca has also applied for the reimbursement of its ‘Breztri Aerosphere,’ which was approved in November last year. According to industry sources on the 8th, AstraZeneca applied for reimbursement of its Breztri Aerosphere to the Health Insurance Review and Assessment Service. Breztri Aerosphere is a single-inhaler, fixed-dose triple-combination of budesonide glycopyrrolate (undifferentiated), budesonide (undifferentiated), and formoterol fumarate (undifferentiated). The inhaler is indicated for the maintenance treatment of moderate-to-severe COPD in patients who are not adequately treated by a combination of a long-acting beta2-adrenergic agonist (LABA) and inhaled corticosteroid (ICS) or a combination of a long-acting muscarinic antagonist (LAMA) and LABA. In other words, this triple therapy emerged as a new alternative for patients with COPD that did not respond well to existing ICS-LABA or LABA-LAMA combination therapies. Triple inhaled therapies have first entered the Korean market with the reimbursement approval of GSK’s Trelegy Elipta in June last year. The insured ceiling price of the drug was set at ₩45,602 for 30-day supply. At the time of listing, its price received attention for being similar to that of existing dual combination therapies. Trelegy Elipta’s price is expected to act as a benchmark for the other drugs that will follow. Triple inhaled COPD therapies that are currently approved in Korea are: Trelegy Elipta, which was approved in 2018,; Breztri Aerosphere, which was approved in November last year; and Kolon Pharma’s Trimbow, which was approved in September 2019. Although Kolon is yet to apply for the reimbursement of Trimbow, AstraZeneca is quickly pushing to reimburse Breztri Aerosphere. AstraZeneca’s hastening the release of its triple therapy combination to prevent GSK's monopoly in the COPD inhaler market. However, the key is price. AstraZeneca cannot help but consider price competitiveness as Trelegy Elipta was listed with reimbursement at a relatively nice price'. Currently, it is estimated that around 50,000 COPD patients in Korea will be in need of treatment with triple inhaled therapies. With so many patients present, the competition between GSK and AZ is expected to heat up in the market.
