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- 2026-04-11 18:24:59
- Policy
- NHIS negotiations complete for Erbitux·Zerbaxa·Eylea
- by Lee, Tak-Sun Sep 20, 2022 05:56am
- The National Health Insurance Service’s pricing negotiations for Merck’s anticancer drug Erbitux and MSD’s next-generation antibiotic Zerbaxa among others have been completed. In the case of Erbitux, Merck has been conducting drug pricing negotiations with the NHIS upon the expiry of its risk-sharing agreement (RSA) contract. For Zerbaxa, its company, MSD, had been conducting pricing negotiations for its new reimbursement. As both agendas were not listed for deliberation at the MOHW’s Health Insurance Policy Deliberative Committee (HIPDC) meeting last month, industry analysis is that the agendas may likely receive reimbursement approvals at the HIPDC meeting this month. Merck’s Erbitux and Zerbaxa were included in the drug pricing negotiation completion list that NHIS disclosed on its webpage on August 31st. Erbitux (cetuximab) is an anticancer drug indicated for metastatic colorectal cancer and head and neck squamous cell cancer that was approved for reimbursement in March 2014 under the Refund-type RSA in Korea. The company had already succeeded in renewing the agreement once in 2018. Upon its expiry in June this year, Merck has been in negotiations with the NHIS to renew its agreement for the third time. Industry’s prospects on the possibility of RSA renewal have been increasing as Erbitux was included in the negotiation completion list of the NHIS, In the case of Zerbaxa, news of its negotiation completion had already been announced last month. As a result, it is expected that the drug will be added to the reimbursement list after going through the HIPDC review this month. The drug had attempted reimbursement since it was approved in April 2017 in Korea, but had difficulty being listed, being unable to demonstrate adequacy of its reimbursement. However, the government’s coverage expansion plan allowed antibiotics like Zerbaxa to also be included and be eligible to waive pharmacoeconomic evaluations, based on which Zerbaxa was recognized adequate for reimbursement at HIRA’s Drug Reimbursement Evaluation Committee meeting in June. Since then, MSD had been conducting drug pricing negotiations with the NHIS, which were successfully concluded at the end of last month. The NHIS’s disclosure of such has made the negotiation completion official. Zerbaxa is a next-generation antibiotic indicated for use in combination with metronidazole for complicated intra-abdominal infections (cIAI) and complicated urinary tract infections. The antibiotic is receiving particular attention as a ‘super antibiotic’ that can be used against multidrug-resistant bacteria. In addition, the NHIS also announced the completion of drug price negotiations for Takeda's anticancer drug 'Adcetris (brentuximab vedotin)' and Bayer's age-related macular degeneration drug ‘Eylea.’ The drugs have been in negotiations with the NHIS since June under category ‘Type B’ of the Price-Volume Agreement. PVA negotiations under Type B are applied every year when the claims amount increases by over 60% from the previous year, or the rate of increase is over 10% and exceeds KRW 5 billion for drugs in the same therapeutic class for which the maximum amount had already been adjusted according to type A or exceeded 4 years since its initial listing but had not undergone type A negotiations. The price of subject drugs are discounted within the 10% range after pricing negotiations with the NHIS.
- Company
- Patent term extensions for advanced biologicals under review
- by Kim, Jin-Gu Sep 20, 2022 05:56am
- The Korean Intellectual Property Office (KIPO) is pursuing a plan to apply the patent term extension system to advanced biological products that were left unattended within the system through law amendments. According to the pharmaceutical and biopharmaceutical industry on the 19th, KIPO prepared a systemic reform plan that contained the amendments above and is collecting industry opinion. Under the current Patent Act, the subjects eligible for the patent term extensions are stipulated in Article 7 of the Enforcement Decree of the Patent Act. However, the application of the regulation is limited to ‘drugs’ that are allowed marketing authorization under the Pharmaceutical Act or to ‘psychotropic substances’ under the Narcotics Control Act. When the Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals was separately enforced from the Pharmaceutical Affairs Act, it resulted in advanced biopharmaceuticals such as the latest gene and cell therapies being omitted from the extension list. In fact, Novartis had applied for two patent term extensions for Kymriah, which was approved as an advanced biopharmaceutical product, but its patent term extension is not being recognized due to the continued incomplete legislation. Industry concerns are rising over the confusion that would increase in the scene with more than 20 advanced biopharmaceuticals from pharmaceutical companies in Korea and abroad being approved one after another since Kymriah, including Novartis’s Zolgensma and Luxturna. To address this, KIPO is reviewing a plan to add ‘Advanced biopharmaceuticals approved under the Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ to subjects eligible for patent term extensions in Article 7 of the Enforcement Decree of the Patent Act This reform plan is expected to be discussed with the other reforms being prepared by KIPO, including ▲adjusting the number of patent rights that can be extended per item ▲introducing an upper limit on the duration of valid patent rights and ▲ introducing remedies after extension rejection decisions. However, unlike other reform plans, including advanced biopharmaceuticals in the patent term extension regulation, is expected to proceed more smoothly, as the position between the original and generic companies is not that different.
- Company
- 41 were vaccinated in 11 days with K-COVID-19 vaccines
- by Sep 19, 2022 05:57am
- SK Bioscience’s COVID-19 vaccine is being released To address the low vaccination rate for Korea’s first homegrown COVID-19 vaccine, SKYCovione, the government has greatly expanded the eligibility for the vaccine. With the expansion, whether allowing the use of domestic vaccines to those who received their 1st to 3rd vaccinations will increase utilization of homegrown vaccines is gaining attention. However, the release of the Omicron-specific vaccine in Kores that is scheduled for next month is expected to act as a variable. During the opening remarks made by the first general coordinator of the Central Disaster and Safety Countermeasures Headquarters, Ki-Il Lee (2nd Vice Minister of Health and Welfare), during the CDSCH meeting held on the morning of the 16th, Lee said, “The CDSCH will expand the scope of vaccine eligibility for SKYCovione from the primary (1st and 2nd) vaccination to 3rd and 4th booster shots.” With the decision, people may reserve their 3rd and 4th vaccinations with SKYCovione through http://ncvr.kdca.go.kr or the call center, or receive same-day vaccinations at public health centers or some assigned medical institutions. The government explained that SKYCovione can be used as booster shots as its safety and efficacy of the SKYCovione have been demonstrated. Clinical trials for SKYCovione booster vaccinations, an investigator clinical trial led by KDCA, are currently in progress, and its results have not yet been released. According to the interim results of the trial, SKYCovione induced neutralizing antibody responses an average of 11 times higher in the original COVID-19 virus (Wuhan strain), 51.9 times higher for Omicron BA.1, and 28.2 times higher for Omicron BA.5 after vaccination with SKYCovione in 5 treatment groups. After the CDSCH meeting, Young-rae Sohn, Head of the Social Strategy Unit of the Central Disaster Management Headquarters, explained, “We first recommend mRNA vaccines for those who are receiving booster shots, however, those who do not wish to further receive vaccinations with mRNA vaccines for various reasons, such as discomfort after receiving primary and secondary vaccinations with mRNA vaccines, may receive additional vaccinations with SKYCovione.” In other words, Pfizer and Moderna’s mRNA vaccines are first recommended as boosters until formal approvals are granted to SKYCovione in that indication, but those aged 18 years or older who cannot or do not want to receive mRNA vaccines can receive SKYCovione as boosters. Such a decision has been deemed to be made despite the non-availability of clinical trial results for the indication as a preemptive measure to increase the utility of domestic vaccines. Although vaccinations started for SKYCovione on the 5th, the rate has been very low. According to the KDCA, the cumulative number of people that received vaccination with SKYCovione as of midnight on the 16th was 41 (1st vaccination), a mere 5.8 persons per day. This is less than 0.1% of the initial lot of 609,000 SKYCovione vaccines of the 10,000,000 vaccines purchased in advance by the government. This is because 97% of those eligible for primary vaccinations with SKYCovione have already received vaccinations. On the other hand, as the vaccination rate dropped greatly to reach 75.1%, for the 3rd vaccination and 16.5% for the 4th vaccination, allowing the use of SKYCovione as such booster shots are expected to greatly increase the use of SKYCovione. However, one variable that lies in its use is that foreign vaccines targeting the Omicron variant have already arrived in Korea and will begin vaccinations next month. On the 15th, 805,000 doses of the bivalent vaccine by Moderna that targets both the original strain (Wuhan strain) and the BA.1 subvariant arrived in Korea. 806,000 courses of the bivalent vaccine additionally arrived on the 17th. Pfizer’s bivalent vaccine is also being reviewed. The KDCA has recommended the new bivalent vaccine as a priority for high-risk groups, such as those aged 60 years or older, those hospitalized or serving in long-term care facilities, and those who are immunocompromised, and as a second priority for people in their 50s, those with underlying diseases, and healthcare workers. In addition, group facility officials and adults aged 18 to 49 are also allowed to receive vaccinations but were excluded from subject recommendations. Therefore, it is expected that demand for the Omicron-targeting vaccines will become higher than that for SKYCovione in October. The demand for SKYCovione may increase in groups who are not subject to the recommendations made for the bivalent vaccines, but whether this alone will increase the vaccination rate for SKYCovione remains in question, as the overall will to receive vaccinations in itself had dampened greatly. According to the ‘COVID-19 vaccine awareness survey’ published by Byung Chul Chun’s team of the Department of Preventive Medicine and Vaccine Innovation Center at Korea University College of Medicine, less than half –45.7%-- of the 1,500 adult survey respondents over the age of 19 responded that they are willing to receive COVID-19 vaccinations this winter. 30.5% responded that they have no will to receive COVID-19 vaccinations at all. In other words, 3 of 10 respondents said they would not receive vaccinations. Furthermore, with Moderna and Pfizer hastening the introduction of their bivalent vaccines that target Omicron subvariants (BA.4/5), their gap with domestic vaccines is expected to widen further. The authorities are discussing the possibility of receiving marketing authorization for its Omicron subvariant-targeting bivalent vaccines that were approved by the US on the 31st of last month.
- Opinion
- [Reporter's view] Reform of the innovative system
- by Lee, Jeong-Hwan Sep 19, 2022 05:56am
- Will the "innovative pharmaceutical company certification system," which has been operating unchanged for 10 years since its introduction in 2012, be able to pave the way for reform through the disclosure of the reorganization plan? The Ministry of Health and Welfare announced plans to announce the reform of the innovative pharmaceutical company certification system at the end of the year. It is a relatively large reorganization plan, including subdivision of certification types and customized support measures, and attention is being paid to whether it can be a turning point to remove the stigma of the certification system that is low in effectiveness. Strengthening support for innovative pharmaceutical companies has been an agenda that has been needed for years. The pharmaceutical industry demanded that actual drug treatment or tax support for innovative pharmaceutical companies should be greater to encourage innovative pharmaceutical companies to develop new drugs and encourage non-selected companies to select new drugs, but the government has not been able to provide enough budget or come up with innovative drug measures due to trade friction. The Ministry of Health and Welfare continued to make efforts to improve the certification system for innovative pharmaceutical companies to resolve such criticism, and the reorganization plan, which will be unveiled at the end of the year, will be the first result to determine whether it will improve. First of all, the reorganization plan is expected to discriminate against the actual support method as the certification screening criteria for each size and type of pharmaceutical companies are different. As the customized support plan for innovative pharmaceutical companies has been discussed several times, such contents are expected to be included in the reorganization plan to be unveiled at the end of the year. More important than improving the framework and extension of the certification system is the government's reinforcement of support for innovative pharmaceutical companies, which is the purpose of operating the certification system. If designated as an innovative pharmaceutical company, the government should provide benefits such as preferential drug prices, tax support, and R&D support, but the pharmaceutical industry has long complained that it is difficult to expect sufficient benefits. Innovative pharmaceutical companies are given symbolic titles, but they do not have significant benefits that directly benefit from the development of new drugs. Among the companies selected by innovative pharmaceutical companies, there is also a pessimistic response that they will not be hit much even if the certification is canceled because they do not enjoy any practical benefits. The National Assembly also urges the government to strengthen support for innovative pharmaceutical companies every year. It is pointed out that the overall fostering of the domestic pharmaceutical industry can be achieved only when both the quantity and quality of support measures for innovative pharmaceutical companies are improved. The Ministry of Health and Welfare, which is set to unveil the certification system, also agreed with the criticism that the budget and policy support in line with the reorganization plan should follow, so we hope that the reform will be repeated starting with the reorganization plan.
- Policy
- Empagliflozin's permission changes
- by Lee, Hye-Kyung Sep 19, 2022 05:56am
- Epilepsy neurosurgery is added to the abnormal reaction of a formulation containing Empagliflozin, an SGLT-2 inhibitor used to treat type 2 diabetes. The Ministry of Food and Drug Safety announced a change in permits based on the results of a review of safety information on Empagliflozin-containing drugs by EC and EMA. The drugs that announce the change of permits are 104 items such as Jardiance, an Empagliflozin-based drug of Beringer Ingelheim Korea, 106 items such as Jardiance Duo, an Empagliflozin and Metformin complex, and SGLT-2, an Empagliflozin and Linaglipin complex. As a result of a review by the Ministry of Food and Drug Safety, "interstitial neurosurgery" is added to the abnormal response term for both Empagliflozin and complex drugs. Serum Li concentrations should be observed more frequently after administration and dose change of Empagliflozin, and patient care should be referred to the doctor who prescribed Li for observation of serum lithium concentrations. The review opinion inquiry on the change of permission (proposal) will be held until the 30th. Meanwhile, SGLT-2 inhibitors, which started as type 2 diabetes treatment, are expanding their scope to heart failure. Last year, SGLT-2 inhibitors were recommended as a major drug for chronic heart failure treatment in domestic heart failure treatment guidelines.
- Company
- Breast cancer drug Nerlynx can be prescribed
- by Eo, Yun-Ho Sep 19, 2022 05:56am
- Breast cancer drug Nerlynx can be prescribed in general hospitals. According to related industries, the oral tyrosine kinase inhibitor Nerlynx, which inhibits Bixink Therapy's HER2 protein, passed the Drug Committee (DC) of the Big 5 Advanced General Hospital, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital. However, as it is still a non-reimbursed drug, it is expected to take some time until the prescription is reimbursed. This drug was submitted to the Health Insurance Review and Assessment Service in February, but it was judged that the benefit standard was not set. Bixink Therapetics plans to submit it again in the second half of this year. HER2-positive early breast cancer has a 1.89 times higher tendency of brain metastasis than HER2-negative breast cancer. The high incidence of brain metastasis is interpreted to mean that it directly affects the survival rate. When comparing the 5-year survival rate of metastatic breast cancer in Korea, the 5-year survival rate of patients with cerebral metastasis is only 10.7%, which is a significant difference compared to the 34% of patients with metastatic breast cancer. Compared to the past, a number of HER2-positive early breast cancer target treatments have been developed. However, in the case of current standard therapy treatments, drugs that prevent brain metastasis or prove treatment effects are still insufficient. In a five-year long-term follow-up study, Nerlynx reduced the risk of recurrence or death in HER2-positive early breast cancer women by 42% and reduced the risk of developing or dying of brain metastasis by more than 59%. Nerlynx was originally a drug developed by Puma Biotechnology in the U.S., and was first approved by the U.S. FDA as an extended adjuvant therapy for early HER2 positive breast cancer patients in July 2017. In February 2020, the indication for the treatment of metastatic HER2 positive breast cancer was expanded. Bixink introduced Nerlynx in Korea in October last year, and the current indication is "extension adjuvant therapy for early breast cancer patients who are HER2 positive and hormone receptor positive within one year of the completion of Herceptin-based treatment after surgery."
- Policy
- Drug price negotiation completed 307 drugs in 2022
- by Lee, Tak-Sun Sep 16, 2022 05:53am
- The number of drugs that completed drug price negotiations between the NHIS and pharmaceutical companies increased significantly from 15 years ago. As drug price negotiations began in earnest in 2007, the expansion of PVA negotiations is believed to be the cause. According to the NHIS' recent list of drugs that completed drug negotiations, the number of drugs that completed drug negotiations exploded from only 10 in 2007 to 307 in 2020. Drug price negotiations began in May 2006 with the introduction of a "plan to optimize drug costs" to stabilize health insurance finances. At the end of that year, guidelines for drug price negotiations were enacted, PVA negotiations as well as new drug drug negotiations, and later RSA were introduced. Looking at the number of drugs that have completed annual drug price negotiations, the number exceeded 100 for the first time in 2009 and surpassed 200 in 2011. 2020 is the only drug that has completed more than 300 negotiations. Last year, 238 drugs completed drug price negotiations, and 273 drugs have already completed drug price negotiations by August this year. As 172 items completed negotiations in the PVA multi-type negotiations in August, the number of drugs that completed drug negotiations has already exceeded last year. This year, Lutathera, Vitrakvi , Rozlytrek, Lorviqua, Zolgensma, Fexuclue, Donerion patch, Zerbaxa also successfully completed drug price negotiations. However, the number of drug price negotiations completed is increasing, but there are also disappointing opinions in the pharmaceutical industry. In particular, there are many calls for quick registration of salaries by shortening the duration of drug price negotiations. The corporation recently revised the guidelines for drug price negotiations, predicting that drug price negotiations will be shortened from 60 days to 30 days for treatments for severe and rare diseases without alternative drugs.
- Policy
- “GOV to prove causal relationship of vaccine side effects"
- by Lee, Jeong-Hwan Sep 16, 2022 05:53am
- The ruling party has set out to enact a Special Act to obligate the nation to compensate for damages caused by COVID-19 vaccinations. The Special Act was proposed because the compensation for damages caused by COVID-19 vaccinations currently implemented by the government is too passive in recognizing the causal relationship between vaccination and its side effects. To address this, the new law strengthened the government’s duty of post-vaccination management by obliging the Commissioner of the Korea Disease Control and Prevention Agency to bear the burden of proof when a dispute related to side effects, such as diseases caused by vaccination, arises. On the 14th, People Power Party member Gi-yun Kang submitted a bill to enact a ‘Special Act on Compensation for Damages from COVID-19 Vaccinations’ as a representative. Currently, vaccinations are being conducted and the damage compensated by the state under the “Infectious Disease Control and Prevention Act” to prevent the spread of infectious diseases and to promote public health. NA Rep. Kang pointed out that the current national compensation system is very passive in recognizing the causality between adverse reactions from vaccinations and vaccine’s side effects. To address this, Kang proposed a bill that can provide compensation to victims by including the adverse events and side effects from vaccinations as damages caused by vaccinations. If passed, the bill will prioritize compensation for damages arising from vaccinations above other laws. Also, for damages caused by vaccination, the state will pay national compensation after deliberation and resolution by the Vaccination Committee. In particular, in resolving disputes about damage caused by vaccination, the burden of proof will be borne by the Commissioner of the Korea Disease Control and Prevention Agency. Also, the Special Act included a provision to establish a Vaccination Committee that can check the causal relationship between vaccination and arising diseases to raise the public’s credibility.
- Opinion
- [Reporter’s View] Evrysdi awaits reimb review for over 1 yr
- by Eo, Yun-Ho Sep 16, 2022 05:53am
- One year has passed since the company applied for insurance reimbursement but to no avail. No progress has been made on the matter, not even the frequent news of the agenda being rejected by the Drug Reimbursement Evaluation Committee has been heard on the matter. Although the reimbursement application for the spinal muscular atrophy (SMA) treatment ‘Evrysdi (risdiplam)’ had been submitted in July last year after its approval in November 2020, the agenda has not been listed for deliberation on any of the lists disclosed by the Health Insurance Review and Assessment Service. There is a deadline for each stage of HIRA’s reimbursement assessment. The current overall reimbursement review period is 150 days, and the government had announced a systemic reform to reduce the period to 120 days. However, this period is often not kept. This is why the industry was not so enthusiastic about the reform plan. In the case of Evrysdi, its review period had already exceeded 150 days earlier this year, as the company had once failed to pass the Drug Reimbursement Standard Subcommittee and reapplied for reimbursement after supplementing data. On this, the Solidarity Against Disability Discrimination issued a statement last month when Zolgensma started being reimbursed, asking HIRA to abolish the reimbursement discontinuation standards set for another SMA treatment, ‘Spinraza (nusinersen),’ and the prompt reimbursement discussion to be made for Evrysdi. SADD had pointed out that SMA patients are being left unattended in the blind spot because HIRA is postponing discussions on Evrysdi just to discuss it in line with the adjustment made for Spinraza’s reimbursement criteria. So Evrysdi, which has applied for and is awaiting review, is still waiting in line after a year without even a single discussion made for its reimbursement and remains a ‘pie in the sky' for the patients. The importance of providing a clear explanation of an administrative decision is essential in the process of handling administrative affairs. This becomes all the more important when an exception arises in the application of a system, which raises more questions than an introduction or abolition of a system. However, the government has never provided an explanation on drugs that were extended their drug pricing negotiation period after passing the set deadlines. And more and more drugs receiving reviews for reimbursement listing or standard extensions or are being left without news. In the current “high-priced drug era,” plenty of very effective but expensive drugs are being introduced to the market. Therefore, it can be difficult for the government and the pharmaceutical company to reach an agreement within the set ’60-day’ period. In particular, the area of SMA treatments had been an ongoing issue due to their high price. However still, the emphasis needs to be laid on the word, deadline. Deadline is a promise. Also, the NHIS has described the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new drugs. In other words, the period is set for the final negotiation period to speed up listing and allow others to estimate the time to listing or rejection. Also, the people need to know why the negotiation fell through so that they could criticize the faulty party and find a compromise.
- Policy
- The introduction of Moderna COVID-19 vaccine has begun
- by Kim, Jung-Ju Sep 16, 2022 05:53am
- Moderna's omicron mutation (BA.1) bivalent vaccine of 1.611 million doses will be introduced in Korea sequentially from today (15th). According to the Korea Centers for Disease Control and Prevention, 805,000 doses will arrive at Incheon International Airport on the 15th and 806,000 doses on the 17th, respectively, and will be used for winter vaccinations in October after the Ministry of Food and Drug Safety approves the lot release. The vaccine to be introduced this time is a divalent vaccine containing two antigens (the virus and omicron mutation BA.1), and was approved by the Ministry of Food and Drug Safety on the 8th. The detailed implementation plan for winter vaccinations using divalent vaccines will be announced at the end of September when divalent vaccines are prepared. The government will continue to closely consult with pharmaceutical companies for a stable supply of vaccines, and will promptly guide the additional supply schedule as soon as it is set. The authorities have contributed to the international community through overseas donations along with related ministries such as the Ministry of Foreign Affairs, and have donated a total of 4.86 million doses to nine countries since last year. In addition, 4.83 million doses of the AZ vaccine, which was distributed through COVAX, were also provided to COVAX without introduction in Korea.
