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- 2026-04-13 10:24:10
- Policy
- No companies have won suits on Gov's price cut dispositions
- by Lee, Hye-Kyung Nov 16, 2021 05:53am
- The National Health Insurance Service said it needs to be granted the authority to urge or dispose of arrears in order to efficiently collect the losses that were caused by the non-price cuts that occurred during the stay of execution when preparing a bill to recover and refund the drug price cut amount. The NHIS delivered its opinion on modifying and accepting the ‘Partial Amendment of the National Health Insurance Act (bill No.12727) that NA member Woni Kim presented as representative for the recovery and refund of drug price cuts after adding the request stated above. The bill allows the NHIS to collect the loss incurred due to the drug price not being discounted during the suspended period if the company loses the original case after the suspension of execution is applied in the administrative suit. On the other hand, if the pharmaceutical company wins the trial regarding the disposition of drug price reduction, the bill allows the pharmaceutical company to compensate for its loss. According to the analysis data disclosed by NHIS on the status of drug price cut lawsuits filed by pharmaceutical companies, 40 out of the total 58 cases have been ruled upon in the first or subsequent trials since 2011. Among these, pharmaceutical companies have partially won 17 cases (42.5%). The NHIS said, “One thing to note is that there had been no cases in which the pharmaceutical company won the suits regarding price cut dispositions of original drugs. The stay of execution has only become a means of delaying the price cuts by pharmaceutical companies.” Data on the suspension of execution of drug price cuts and the status its original lawsuits since 2018 showed that the court accepted the suspension of execution in 38 out of 39 administrative lawsuits. The court’s acceptance rate of the stay in execution is 100% as the pharmaceutical company did not apply for suspension of execution for the 1 remaining case. On the other hand, the government won 15 of the 20 cases (75%) that have been ruled upon in the first or subsequent trials after the suspension of execution was applied. The NHIS explained, “Pharmaceutical companies have only won 25% of the suits filed regarding the price cut dispositions. However, as the suspension of execution on the price cut dispositions is accepted 100%, this has been causing losses in NHI finances. In this context, we fully agree with the purpose of the proposed bill.” The reimbursement expense is the actual transaction price of a drug that does not exceed the price cap (as notified by the MOHW). However, in reality, drug transactions are being made at the set upper limit, so the decision to suspend execution of the disposition that lowers this upper limit allows the companies to maintain the previous drug price during the period set by the decision. The NHIS said, “ It may seem excessive that the company needs to bear the loss when the court decides on the stay of execution. However, on the other hand, the NHIS will also be allowing pharmaceutical companies to preserve their loss if the companies win. In this sense, the bill is not disadvantageous to any parties and can be implemented." However, the NHIS added that the scope of the legal provisions, the location of the provisions, and the accepted provisions need to be more specifically stipulated.
- Company
- Drug price negotiations for Xospata began
- by Eo, Yun-Ho Nov 16, 2021 05:53am
- The new leukemia drug Xospata is in the final procedure for insurance benefit registration. According to related industries, Astellas recently entered into drug price negotiations with the NHIS for Xospata(Gilteritinib), a treatment for Acute Myeloid Leukemia (AML). The negotiation deadline is until the 20th of next month. After receiving a conditional benefit decision at the HIRA's Drug Reimbursement Evaluation Committee in September, the drug accepted the proposed valuation amount and went through a drug price negotiation process. It remains to be seen whether Xospata will be able to complete negotiations with the government until the end and be listed. Xospata is the first FLT3 targeted anticancer drug in Korea to be approved by the MFDS as a target treatment for FLT3 mutation positive (FLT3mut+) recurrence or refractory (R/R) AML. This drug targets both FLT3-ITD and FLT3-TKD, which are divided into two mutant forms, and is a monotherapy that is taken once a day and can be treated on its own at home without frequent hospital visits. It also showed higher effectiveness and safety than conventional chemotherapy. In addition, Xospata has been classified as 'Category 1', the highest recommended grade for the treatment of patients with recurrent or refractory AML with positive FLT3 mutation in the latest guidelines of NCCN. Kim Hee-je, a professor of hematology at Seoul St. Mary's Hospital, said, "With the approval of Xospata in Korea, patients can relieve anxiety. Of course, there are still cost issues, but we expect it to become a standardized treatment as soon as possible after registering benefit, the professor said.
- Policy
- Chong Kun Dang is approved for its Jardiance Duo latecomer
- by Lee, Tak-Sun Nov 16, 2021 05:52am
- Chong Kun Dang became the first to receive approval for its latecomer of the SGLT-2 inhibitor combination drug for diabetes, ‘Jardiance Duo (empagliflozin-metformin hydrochloride). In addition, the company received the first generic exclusivity provided to companies that succeed challenging the original patent and be the first to apply for approval. On the 12th, the Ministry of Food and Drug Safety approved three doses of the ‘Chong Kun Dang Empagliflozin Metformin Tablet.’ The product is a combination of metformin hydrochloride and empagliflozin L-proline. Unlike the existing Jardiance Duo, Chong Kun Dang’s product has added an amino acid, L-proline to its Empagliflozin. Chong Kun Dang has also used empagliflozin L-proline in its single-agent Jardiance latecomer, ‘Chong Kun Dang Empagliflozin Tablet.’ The company received generic exclusivity for both its combination and single-agent drug. Chong Kun Dang succeeded in challenging the crystalline form patent of Jardiance and Jardiance Duo that is set to expire on December 14th, 2026. The company was the first to file a negative patent scope declaration trial in January 2018, and a partially valid decision in May, and the court confirmed the decision in June. Like for the single agent, the company was the first to apply for approval of the combination. However, the company’s acquisition of the first generic exclusivity does not mean that the company monopolized the market, as many domestic companies are seeking to enter the first latecomer market for Jardiance and Jardiance Duo. Jardiance DuoMany other companies have also succeeded in avoiding the original’s patent through salt modification. 94 products were approved for generic exclusivity with latecomers of the single-agent Jardiance. The generic exclusivity for Chong Kun Dang’s Empagliflozin Metformin Tablet applies only to products that use the same ingredient, empagliflozin L-proline, and therefore the drugs subject to sales prohibition are limited. However, the possibility that the company may enter the market before other companies through patent strategies remains. Jardiance and Jardiance Duo’s substance patient will expire on March 11th, 2025. Therefore, the companies may release their latecomers from March 12th, 2025 when the patent expires. Jardiance and Jardiance Duo sold 35.4 billion and 15.8 billion each in outpatient prescription sales last year (UBIST).
- Company
- Somavert can be prescribed at general hospitals
- by Eo, Yun-Ho Nov 16, 2021 05:52am
- According to related industries, Pfizer Korea's Somavert (Pegvisomant) has currently passed the Drug Committee (DC) of medical institutions such as Seoul National University Hospital and Sinchon Severance Hospital, and is also undergoing procedures at medical institutions such as Seoul National University Bundang Hospital, Wonju Severance Hospital, and Samsung Medical Center. In the case of terminal hypertrophy, Sinchon Severance Hospital is taking care of the largest number of patients, so it is expected to lead to prescription fast. Somavert has been listed on the insurance benefit list since September. Somavert demonstrated its validity through a 12-week randomized, double-blind study of 12 patients with terminal hypertrophy. The study found that the median serum IGF-I concentration at 12 weeks of study compared to the baseline was 4.0±16.8%, 26.7±27.9%, 50.1±26.7%, and 62.5±21.3%, respectively, in the placebo group, Pegvisomant 10 mg group, Pegvisomant 15 mg group, and Pegvisomant 20 mg group. The proportion of patients whose serum IFG-I concentration returned to normal compared to baseline was also found to be significantly higher than that of placebo, Pegvisomant 10 mg/day administration group, Pegvisomant 15 mg/day administration group, and Pegvisomant 20 mg/day administration group, respectively, indicating that Pegvisomant was significantly higher than placebo. Meanwhile, Somavert was approved in Korea in September last year for the treatment of adult terminal hypertrophy patients who do not respond appropriately to surgery and radiation therapy, or whose IGF-I (Insulin-like growth factor I) concentration is not normalized by somatostatin analog therapy, and was designated as a rare drug in 2018.
- Company
- Sales of Arcoxia (Etoricoxib) are sluggish
- by Kim, Jin-Gu Nov 16, 2021 05:52am
- Generics for Arcoxia, an anti-inflammatory pain reliever based on COX-2 inhibitors (Etoricoxib) have been released, but sales in the market are sluggish. This is because there is still a high preference for original drugs at the medical site, and even the original drugs are pushed back by Celebrex, a leading item in the same family market. According to UBIST, a pharmaceutical market research firm on the 11th, the total prescription amount for generics for Arcoxia from June to September is around 31 million won. During this period, the original prescription amount is around 730 million won. Generic prescriptions account for only 4% of the original. Generics challenged Arcoxia's patent in September 2019. In April last year, it won the passive trial to confirm the scope of rights. It succeeded in avoiding patents that were scheduled to expire in 2023. Theragen Etex, Guju, Hana, Hutechs, Union Korea, Aju, Daewoo, Boryung, Arlico, and Reyon received generic for exclusivity from April this year to January next year. Generics have been released in earnest since June this year. Aju, Arlico, Hutechs, Hana, Theragen, and Etex are confirmed to have released generics one after another. However, for four months, their total prescription amount is only 31 million won. Hana's sales are the highest at 19 million won, and sales of the other generics are less than 10 million won. This is because the original preference is still high at the prescription site. As of last year, outpatient's prescription for Celebrex amounted to 44.7 billion won. It is more than 12 times Arcoxia's sales of 3.5 billion won.42 billion won and 2.7 billion won worth of prescriptions were prescribed by the third quarter, respectively, widening the gap by 15 times. Since 2010, more than 200 generics for Celebrex have been competing. Generics for Arcoxia have little time to compete. The generic for exclusivity period will end in January next year, but no company has started developing generics for Arcoxia yet.
- Company
- The price reduction of PE waiver drugs
- by Eo, Yun-Ho Nov 15, 2021 06:29pm
- KRPIA expressed serious concern in a comment on the 10th that the HIRA was confirmed to evaluate the cost effectiveness at 80% of the lowest A7 adjustment price when asked about the cost-effectiveness criteria of Kim Mi-ae, a member of the National Assembly. KRPIA said, "In the course of discussions with the HIRA, we have repeatedly expressed opinions that uncertainties arising from the application of the risk-sharing system in A7 countries should be flexibly evaluated according to the characteristics of each drug." In addition, it pointed out, "If the figure of 80% for which the basis for calculation is not clear is applied collectively, access to drugs subject to PE exemption, which are limited to patients with rare and severe diseases, may be severely reduced." The PE waiver drug system is mandatory to limit the total amount of annual use in response to uncertainties in A7 national indicators, and if overseas prices are further lowered during the follow-up period, tight financial management is already taking place. KRPIA said, "If we have to further cut the drug price by 20% to 80% of the lowest price in A7 countries, PE waiver drugs will actually be privately cultured. In addition, considering the purpose of the system to guarantee drug prices for drugs that need to be registered, if the HIRA sets the lowest price as an internal operating standard and applies it collectively to all drugs, there is a possibility of abuse of discretion in violation of the principle of trust protection." In addition, it pointed out that it could violate the national treatment regulations of the Korea-US FTA and the Korea-EU FTA, stressing that if the administration is operated based on an undisclosed internal operation standard and the evaluation criteria of PE waiver drugs are changed, it can be seen as a de facto discrimination measure. KRPIA said that the HIRA-industry meeting on June 17 and the MOHW's public-private consultative body on July 28 consistently argued that the application of specific figures is inappropriate and should be evaluated according to the characteristics of each drug.
- Company
- Will sales of flu treatments be recovered?
- by Chon, Seung-Hyun Nov 15, 2021 05:56pm
- According to UBIST, a drug research institute, on the 14th, the amount of outpatient prescriptions for flu treatments in the third quarter was only 7.97 million won. It fell 31.1% year-on-year. It decreased by 75.2% from the same period two years ago. The flu treatment market has been prescribing less than 100 million won for six consecutive quarters since the second quarter of last year. The market size has been insignificant since it plunged 99.8% to around 10 million won in the second quarter after hitting 8.4 billion won in the first quarter of last year. The prescription amount in the fourth quarter of last year and the first quarter of this year, which are flu epidemic seasons, was only 20 million won and 10 million won, respectively. Quarterly outpatient Rx amount for flu tx (unit: 1 million won, data: UBIST) Sales in the Oseltamivir market, the most prescribed flu treatment, have decreased significantly. Oseltamivir is the active ingredient of Tamiflu. In the third quarter, the prescription for Oseltamivir was only 7.97 million won. It fell 31.1% year-on-year and 74.3% year-on-year. Oseltamivir prescription performance soon becomes sales in the entire flu treatment market. Since the third quarter of last year, the overall prescription performance of Oseltamivir has occurred only in one item of Tamiflu. Since the third quarter of last year, there seems to be no flu treatment except for Tamiflu. This is a change in the prescription market due to the prolonged COVID-19. This is because after the spread of COVID-19, the incidence of infectious diseases has decreased significantly due to strengthening personal hygiene management such as washing hands and wearing masks, and only Tamiflu has been prescribed when patients occasionally occur. According to The KDCA, the number of suspected flu patients per 1,000 outpatients has never exceeded the epidemic standard of 5.8 this year. Status of influenza suspected cases per 1,000 outpatients (unit: name, data: the KDCA) In the ninth week of last year, the number of suspected flu patients per 1,000 outpatients recorded 6.3 and remained at the level of two to three. There have been few flu patients for about a year and eight months since early March last year. Even this month, when the winter season began in earnest, the number of suspected flu patients per 1,000 outpatients was only 3.3. In this situation, the possibility of the spread of infectious diseases such as the flu is being raised as face-to-face contact expands due to the lifting of the time limit for multi-use facilities due to the daily recovery of COVID-19. However, it is unlikely to lead to a sudden spread of infectious diseases as hygiene management such as wearing a mask is still strictly observed. An industry official said, "Since there have been few flu patients this year, production and supply of flu treatments have been virtually suspended," adding, "We will consider expanding the production and supply of treatments while looking at the increase in the number of patients."
- Opinion
- [Reporter’s View] On HIRA's price cuts for PE waiver drugs
- by Eo, Yun-Ho Nov 15, 2021 05:56am
- HIRA’s unilateral notice of its decision leaves a lingering question on whether this really was the best way to conclude the discussions. Couldn't the government have included its favorite words - "in discussion" or "in coordination" - that it uses best? The Health Insurance Review and Assessment Service responded that the criteria for evaluating the cost-effectiveness of drugs that are waived submission of pharmacoeconomic evaluation data was set at ‘80% of the lowest A7 adjusted price’ rather than the lowest A7 adjusted price to a written QA submitted by NA member Miae Kim of the People Power Party during the NA audit. This is a sort of forced conclusion and a line drawn to the persistent resistance and controversy raised by the industry. On the news, the Korean Research-based Pharma Industry Association immediately issued its criticism, expressing strong regrets. KRPIA said, “During discussions with HIRA, we have continuously expressed that the uncertainties caused by the application of the risk-sharing system in A8 countries should be flexibly evaluated according to characteristics of each drug. A blanket application of the 80% standard without clear grounds on its calculation will seriously undermine access to drugs that are subject to pharmacoeconomic evaluation exemptions that are being allowed limited use in rare and severe disease patients.” The association added that such a standard would invalidate the system in itself. Some may consider the industry’s sullen response as a natural course of making transitions. However, the response provided for the NA audit was a blow in the back from the industry’s view as the issue had not been discussed after the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits had said it will continue to collect stakeholder opinions following the serious concerns that were raised in the two meetings the HIRA held with the industry (industry roundtable in June and the private consultative body in July). The pharmacoeconomic evaluation exemption system is the only way for drugs that cannot undergo economic evaluations but is necessary to receive reimbursement. Various fiscal management systems are included in the scheme, and the ‘Expenditure Cap’ design has been embraced ever since the system was implemented. With the increasing number of drugs being eligible for the system, the government could have deemed some improvement is necessary. However, the way how they implemented the system is regrettable. “We will continue discussions with stakeholders. We will review the issue.” Why HIRA was unable to implement the caution and ambiguity that it had so often implemented in the written response to the NA remains in question.
- Company
- K-COVID-19 vaccine developers will ‘power through till end'
- by Kim, Jin-Gu Nov 15, 2021 05:56am
- Domestic vaccine developers have been accelerating the last phases of their clinical trials. SK Bioscience and Genexine have started Phase III trials in Korea and abroad, and Cellid has submitted its Phase IIb/III clinical trial plan. Domestic developers have come up with new strategies to continue the development of their vaccines with the value of latecomer vaccines lowering due to the domestic vaccination rate reaching nearly 80% in Korea and the introduction of oral COVID-19 treatments imminent. ◆Cellid applied for Phase 2b/3 trial… starts development of a vaccine against variants If the clinical trial protocol is approved, the Phase IIb clinical trial will be conducted on 125 participants, and Phase III on 4,100 participants. The Phase III trial will compare AdCLD-CoV19-1 with AstraZeneca’s COVID-19 vaccine. Cellid has started a new clinical trial for its existing candidate ‘AdCLD-CoV19' after revising its virus vector. The production yield rate change has improved with the revision of the virus vector. Upon completing the phase 2a trial, Cellid said in June that it would newly develop AdCLD-CoV19-1, a revised version of the virus vector vaccine, for mass production. In addition, the company obtained the regulatory nod for a phase 1 study of AdCLD-CoV19. Apart from this, Cellid is also concurrently developing a new vaccine candidate that responds to COVID-19 variants including the Delta variant. Animal testing is currently underway for the new vaccine candidate. Cellid expects it would be able to enter Phase I clinical trials for its variant vaccines next year at the earliest. The company’s experience with its Phase IIb/III trial for AdCLD-CoV19-1 is expected help accelerate its development. Cellid’s two-track development strategy is not unrelated to the COVID-19 vaccine and treatment development situation in Korea and abroad. With the market value of latecomer vaccines decreasing, the companies have explained that the changes in their development strategies were inevitable. As of midnight on the 12th, the domestic COVID-19 vaccination rate in Korea reached 77.6 % (full vaccination rate). Therefore, the possibility of not many candidates being left for vaccination even if the company completes its vaccine development by the first half of next year as planned. Remains. In addition, the value of the latecomer vaccine has been rated even lower with the imminent introduction of oral coronavirus treatments. ◆SK Bioscience signs agreement to supply its vaccine to developing countries… Genexine to develop a vaccine as booster shot SK Bioscience and Genexine, which have started their Phase III trials ahead of Cellid, have also been facing the same dilemma. SK Bioscience plans to finish development and expand its supply to developing countries around the world by early next year. SK Bioscience signed a supply agreement with CEPI (The Coalition for Epidemic Preparedness Innovations) for the provision of its vaccines. After GBP510 is developed and is selected for the “Wave 2” (next-generation COVID-19 vaccine) project, the vaccine will be supplied globally, in Africa, South America, and Southeast Asia through the COVAX Facility. The global vaccination rate has reached around 51.3%. In developing countries, the rate is around 10% or less. Therefore, unlike in the domestic market, a sufficient supply market remains for the vaccines globally. SK Bioscience initiated its Phase III trial in August. The company expects the trial to be finalized and be approved by 1H next year. In the case of Genexine, the company changed its vaccine development strategy to developing booster shots. In August, the company applied to change its clinical trial plan for the global Phase II/III trial it has been conducting for ‘GX-19N’ in Indonesia in August. The new strategy is to develop a booster vaccine with its vaccine candidate. The clinical trial will confirm the protective efficacy of GX-19N in 1,000 participants who had been vaccinated with Sinovac or Sinopham’s inactivated vaccines 3 months earlier. Genexine plans to expand the clinical trials in Indonesia to Argentina and other countries in 14,000 patients. However, the analysts are that the decision may have been influenced by the fact that the drug, if developed, will not have much marketability, like other vaccine developers.
- Policy
- Rx drugs,allowed according to CTD starting from next year
- by Lee, Tak-Sun Nov 15, 2021 05:56am
- The MFDS announced on the 11th that it will partially revise the Regulation on Drug Product Authorization, Declaration, & Review to secure the quality reliability of generics in accordance with international standards. The revision includes improving the management of manufacturing methods such as Rx drugs manufacturing processes, deleting some submission data exemption regulations upon approval based on foreign drugs, process documents, and specifications, establishing standards for packaging disposable eye drops, and listing active ingredients in the product name. Accordingly, from November 12 next year, when licensing Rx drugs, it will be improved to describe in detail according to CTD when describing manufacturing methods such as manufacturing processes. Currently, it is summarized mainly in major manufacturing processes. In addition, the manufacturing method of the product submitted by CTD will be changed. Some submission data exemption regulations will be deleted upon permission based on the acceptance of foreign pharmacies, process documents, and specifications (Pharmacopoeia). Some data, such as toxic and pharmacological data, could have been exempted if they were listed in a foreign drugstore, but in the future, they will be required to submit data to examine safety and effectiveness based on scientific evidence. Along with this, a new standard for limiting the packaging unit of disposable eye drops will be established. In order to relieve public anxiety caused by the reuse of disposable eye drops and to provide a safe use environment for medicines, the packaging unit considering the amount of eye drops used once is defined as 0.5ml or less. Only single-component drugs are currently marked with active ingredients in the product name, but in the future, information provision will be expanded by marking active ingredients in the product name of combinations with three or less main ingredients. The revision to the drug equivalence test standards includes the preparation of biological equivalence test evaluation standards reflecting the formulation characteristics of enteric agents, and harmonization of international standards and regulations for biological equivalence test exemption standards according to the BCS. From November 12 next year, criteria for evaluating biological equivalence tests reflecting the characteristics of preparations of Enteric-coated preparations will be prepared. Starting today, the BCS exemption criteria for biological equivalence tests will be met with international standards. In accordance with the enactment of the ICHM9 guidelines, the standards for exemption from biological equivalence tests for drugs will be newly established to align international and domestic regulations equally. The MFDS said it expects the revision to raise the quality of medicines to the next level, and it will strengthen its drug licensing and management system based on Regulatory Science so that doctors, pharmacists, and patients can use quality drugs with confidence. Details can be found on the MFDS' website (mfds.go.kr > statutes/data > statute information > amendment notice, etc.).
