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- 2026-05-19 23:46:03
- Policy
- RSA's collateral period was reduced by 3 months
- by Lee, Hye-Kyung Nov 26, 2020 08:38am
- The amount of collateral that pharmaceutical companies have to pay when signing an RSA drug is expected to decrease by 25%. According to the 'Detailed Operation Guidelines for Drug Price Negotiation of the Risk Sharing Agreement' revised by The NHIS on October 8, the period of collateral has been changed from 12 months to 9 months. This is because if the actual formula is substituted, the amount of collateral will decrease. The NHIS held a 'RSA drug price negotiation system and follow-up management online briefing' for about 100 pharmaceutical companies from 2 pm on the 25th. "Pharmaceutical companies have made a lot of requests to reduce the amount of collateral that is collectively entered at first," said Oh Se-rim, a team leader in the NHIS Drug Price Negotiation Department, who was in charge of announcing the revised matters. Following that, Team leader Oh said, "It has been shown that the amount of collateral is arithmetically reduced by 25% by reducing the amount of collateral by three months from 12 months to 9 months." In the case of the Refund type, as the amount of collateral is reduced, it becomes 'estimated billing amount (maximum) x refund rate x 130%' to 'estimated billing amount (actual) x refund rate/1-refund rate x 9/12 x 130%'. The reason that the estimated billing amount has changed from the upper limit (indicated price) to the actual price is that, while revising the guidelines, the 'actual fiscal impact criterion' was set in consideration of the refund of the estimated billing amount. Based on the revised guidelines, if the amount of the collateral is calculated assuming a drug with a labeling price of ₩10,000, an actual price of ₩80,000, a refund rate of 20%, and an estimated billing volume of 1 million vials, it was previously '10 billion won (maximum amount) × 20% (refund rate) × It had to pay ₩2.6 billion as '130%', but '₩8 billion (actual) x 20%/(1-20%) (1-refund rate) x 9/12 x 130%' is applied as a change between collateral. If so, it will reduce ₩650 million to ₩1.95 billion. Team leader Oh explained, "The initial guideline was released and there was no change in the formula that was not in the refund rate part, but it was corrected by changing it to the actual price minus the refund rate. There was a reduction in the amount of about 25%." Since its introduction in 2014, RSA has signed a total of 48 drugs and 85 items as of October 30. By type, there are 13 Refund types (26 items), 18 Expenditure Cap types (29 items), 1 Refund type for initial treatment (2 items), and 3 Utilization Cap/Fixed Cost per Patient type (6 items), other type (1 item), and a combination of 12 items (21 items). Expenditure Cap Change = According to the guidelines changed by The NHIS, the Expenditure Cap was changed from 130% to 100% of the estimated billing amount when negotiating the Article 6 risk sharing proposal. At the time this guideline was published, the pharmaceutical industry was most opposed to it. The team leader said, "The omission of Profitability Evaluation changed the total amount based on financial impact." The team leader said, "There is a lot of worries in the pharmaceutical industry. As a result of analyzing Expenditure Cap-type drugs, most of them have reached the 100% standard. It will not have a big impact as expected." In addition, the standard of the estimated billing amount was changed from the upper limit to the actual price. Depending on the nature of the drug, it is possible to set the estimated billing amount based on the upper limit amount, and when monitoring the Price-Volume (PV), they can specify whether the refund amount is included in the agreement. Nam-seon Choi, Director of Drug Price Negotiations, said, "If we assume that an estimated billing amount of ₩20 billion and a refund of ₩5 billion, whether for initial treatment Refund or Utilization Cap/Fixed Cost per Patient, we will set ₩15 billion as the estimated billing amount." "Pharmaceutical companies can decide whether to set it based on the actual fiscal impact excluding the amount of refund or the details of the claim.“ Nam-seon Choi is explaining the amendment to the RSA drug price negotiation guidelines However, in principle, it is only stated in the guidelines that it is based on the actual price. "In the past, only one type was applied," said Choi, "a part that changed as the guidelines were revised and various types were mixed and the standard for the total amount was set together." He explained, "The principle is based on the actual price, but if the actual price cannot be made according to various types, it can be discussed in the negotiation and entered in the agreement." Expenditure Cap contract obligation for phase III conditionally licensed drugs = As risk-sharing targets expanded in this guideline, conditional drugs in phase III clinical trial were also included. This drug will sign an Expenditure Cap contract, and team leader Oh interpreted, "For these drugs, it is not easy to submit profitability evaluation data, but the possibility of benefit registration may have increased" However, the definition of conditional drugs in phase III was specified in accordance with the 'Examination Regulations for Declaration of Product Permission for Drugs', and limited to drugs that were approved by submission of data for phase II and approved under the conditions of clinical data for phase III. Team leader Oh said, "The drugs that have only partially submitted data on conditional drugs in clinical III or whose overall survival rate (OS) is released after approval are not considered conditional, but only drugs according to the review regulations." Expiration of contract term = One of the biggest changes from the revision of this guideline in The NHIS is the treatment method after the RSA contract term expires. In the past, before the expiration of the RSA contract period (4+1 years), the NHIS requested the evaluation of the risk-sharing system of existing RSA drugs in the Pharmaceutical Benefits Advisory Committee of the HIRA However, only the changed guidelines do not allow the Pharmaceutical Benefits Advisory Committee to determine whether or not to be eligible for a risk-sharing system. The clinical usefulness and cost-effectiveness of drugs near the expiration of the RSA contract will be evaluated. And the NHIS will be able to re-contract or terminate the contract by negotiating risk-sharing plans such as the upper limit amount of the drug, the estimated billing amount and the refund rate, and the cap based on the result. The NHIS, the parties to the contract, will have the overall risk-sharing contract. “In the past, the Pharmaceutical Benefits Advisory Committee evaluated whether or not to be eligible for RSA, and the contract was terminated because it was difficult to evaluate most of the risk-sharing when alternative drugs came in.” He added, "In the future, we will see the clinical utility and cost-effectiveness of RSA drugs, rather than evaluating whether the HIRA is subject to risk sharing." It means that if an alternative drug comes in or other issues arise, it will decide whether to continue the contract based on the cost-effective aspect. Team Leader Oh said, “The Leader decides whether to re-contract or negotiate based on the evaluation results of the HIRA, and continues the contract considering the upper limit amount, estimated billing amount, and refund rate in consideration of changes in the clinical environment over the past 4 to 5 years. We will discuss whether or not with a pharmaceutical company."
- Company
- Beovu treating AMD passes the first gate to reimbursement
- by Eo, Yun-Ho Nov 26, 2020 06:05am
- A novel neovascular age-related Macular Degeneration (AMD) treatment Beovu (brolucizumab) has passed the first threshold to win the healthcare reimbursement in South Korea. The pharmaceutical industry sources reported the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) recently green lit Novartis Korea’s Beovu. On Nov. 13, DREC approved of the drug reimbursement feasibility, but it was ultimately decided as a conditional non-reimbursement due to the conflict in drug pricing. However, as Novartis Korea accepted the offered conditions, the drug’s reimbursement feasibility was then cleared. A next generation treatment for wet AMD, Beovu is an anti-vascular endothelial growth factor (anti-VEGF) drug that suppresses endothelial cell proliferation and vascular permeability. The drug is administered once-monthly for the first three months, and once every three months then after. A Phase II HAWK study and a Phase III HARRIER confirmed Beovu’s efficacy by comparing against Eylea (aflibercept). The two studies, incorporating 1,817 patients aged 50 and over with wet AMD, found the drug to have non-inferiority versus the reference group through the primary endpoint—the change in best-corrected visual acuity (BCVA) at year one (week 48). In both clinical trials, approximately 30 percent of patients gained at least 15 letters at year one. In HAWK and HARRIER, Beovu showed superior effect of improving retinal fluid compared to the reference drug, as fewer patients had intra-retinal (IRF) and/or sub-retinal fluid (SRF) after receiving Beovu as a treatment. A professor of ophthalmology at Seoul National University College of Medicine, Yu Hyeong Gon said “Beovu’s outstanding anatomical effect is proven based on the clinical data showing improved vision and fewer numbers of patients with remaining retinal fluid compared to the reference drug. As the treatment can be administered in three month interval, the patients with wet AMD would enjoy the new treatment option that comes with convenience and less burden.”
- Company
- Janssen's young man who saved her life after a hit & run
- by Eo, Yun-Ho Nov 26, 2020 06:04am
- Ji Hyun-joo, Director "When I got my mind, I knew I was under the car. I was just shouting for help, but someone talked to me." At eleven o'clock on the night of February 17, Ji Hyun-Joo (48 yrs old) Korea Johnson & Johnson (J&J), general director of Consumer Health Care AP, returned to the company (LS Yongsan Tower) after a dinner in late winter, when it was still cold. She lost her mind when she recognized the car rushing towards her after getting off the taxi at the back door of the building. The car struck her as it was, and crushed her left arm. She fell stunned and injured her right shoulder, which could endanger her life. Was she lucky? Im Ji-hoon (37 yrs old) Korea Janssen (located in the same building as a J&J subsidiary), who left the office late after work, heard the sound of a bang and ran to the site. A bigger crisis awaits at the site of the accident. What happened to the car that caused the accident, it was a situation where the director would step on the body without stopping. He ran straight away and pushed the vehicle first. It is a later story, but he said that he thought that he was "already dead" when he saw Ji director at the time. He intuited,'Oh, this driver is drinking.' He told the driver to get out of the car. The driver was drunk as expected. It is said that he smoked a cigarette while jovializing at him taking pictures for evidence. He left the driver first, called 911 and approached her. Fortunately, she came back to consciousness, and he got her husband's phone number and contacted her. Thirty minutes after the accident, a 911 ambulance was able to carry her to the hospital emergency room, and she underwent emergency surgery. The driver left the car as it was at that time, and later surrendered, and a trial is currently underway. Director Ji Hyun-Joo, who returned after an unexpected accident, and Deputy General Manager Im Ji-hoon, a lifesaver◆6 months of rehabilitation and return to work With a fracture of both humerus and the resulting rotator cuff tear, she almost lost both arms. She couldn't move her arms right after the surgery to pin her muscles, and her daily life was impossible at all. She expected to be able to use her arm after removing the cast, but she couldn't listen because her muscles were already stiff. A caregiver, who resides 24 hours a day, had to stand by her for about five months. Eventually, after six months of long rehabilitation, she was able to return to work. The company's help was great for her return. J&J suggested returning to work in a part-time form first, checking her physical condition from time to time. Her arm condition (left) and the monitor and chair supported by the company The company, which had implemented a flexible work system due to the aftermath of COVID-19, provided a dedicated monitor and ergonomics chair at her home for her with discomfort. She is currently working at J&J through telecommuting. “The company has helped me a lot for my return. Even after I return to work, the company checks my condition regularly and discusses the timing of the full-time transition. There is no anxiety about returning to normal, nor the pressure for a quick return. We are sending encouragement and support in line with 'me'." Deputy Director Im Ji-hoon◆Joint donation made with life saver and settlement money "He is literally a lifesaver. I can't really thank you in words. I wanted to somehow compensate, so I offered some of the settlement money as a token of gratitude, but I refused. But I said again that my heart was too heavy. , They offered to donate to the Children's Foundation under a joint name." It saved a person's life, but he did not come forward and commended his work, awarded a citation, and shared examples of talks through town hall meetings, but he is still embarrassed. "I'm glad she was just alive. If anyone other than me saw the situation, she would have run to help. I could go to the hospital 5 months after the surgery, but she recovered to some extent. I was really grateful to see it. Oh, the Children's Foundation was originally a place where there was exchange such as voluntary activities at the company level, and it was a personal support. Her accident is, of course, an accident that should never happen again. However, due to this accident, J&J and Janssen, which felt like subsidiaries but actually different companies, united as one. The company also offered psychological counseling using in-house programs to prepare for the trauma that may have been received by him. J&J and its subsidiary Janssen are emphasizing 'Credo', which has been passed down since its inception. The first is the patient and the doctor, the second is the staff, the third is the community, and the company's Credo, which respects the care and values of people, hangs everywhere. Credo, which has been spreading consistently, is perhaps deeply engraved in the company's employees.
- Policy
- ₩965 billion for COVID-19 vaccine should be reflected
- by Lee, Jeong-Hwan Nov 26, 2020 06:03am
- People Power Party Rep. Kang Ki-yoon, urged the Democratic Party of Korea and the government to reflect the cost of COVID-19 vaccine in next year's budget so that the nation can get COVID-19 vaccine. Earlier, a bill containing COVID-19 vaccine budget of ₩965 billion was voted in the Budget Adjustment Subcommittee of the Health and Welfare Committee, but the Democratic Party of Korea rejected the opinion by opposing the reduction in the cost of establishing a public medical school by ₩230 million, and the government draft proposed a special committee for budget settlement. It is a demand for follow-up measures. On the 24th, Kang Ki-yoon, a member of People Power Party said, "The Budget Adjustment Subcommittee of the Health and Welfare Committee, which includes COVID-19 national vaccination budget of ₩965 billion, which is not included in the government proposal, was canceled due to a reduction of ₩230 million in the cost for public medical schools in Namwon, Jeollabuk-do." He criticized that the Democratic Party of Korea and the government only insisted on reflecting the budget of the public medical school, so that the cost of purchasing COVID-19 vaccine was omitted. He argues that the government should not secure COVID-19 vaccine for 30 million people, which is 60% of the nation, but buy 51 million people. He said, "The Welfare Committee has agreed to reflect the national vaccination fee, but it is a pity that we cannot pass the general meeting of the Welfare Committee due to the controversy on the reduction of design cost for public medical schools." Also he said, "I urge the Democratic Party and the government to proactively cooperate and take action so that next year's government budget can be a budget to save people's health and lives by increasing the national vaccination fee again, even in the Special Committee on Budget & Accounts."
- Product
- Struggling with dementia drug, Aβ-targeting drug unapproved
- by won-jong-hyuk Nov 26, 2020 06:03am
- Although many of Alzheimer's disease-targeting novel drugs are in development, the market is struggling to receive the health authority approval with troubles found during efficacy validation To this date, multinational pharmaceutical companies have initiated investigation on antibody agents targeting a number of therapeutic targets, such as amyloid-β (Aβ), Tau protein and ApoE4. But they all halted their clinical trials with the same reason. And academic scholars are also skeptical that such antibody drugs for a single target mechanism would result in significant benefit in treating Alzheimer's disease, which has complicated pathophysiology. # The U.S. Food and Drug Administration (FDA) Advisory Committee (AdCom) has reportedly disapproved Biogen and Eisai Pharmaceuticals’ investigational antibody targeting amyloid aducanumab in preparation for a New Drug Application (NDA). "Two cases of submitted clinical data insufficient to prove treatment efficacy" Biogen’s analysis on two Phase III studies—EMERGE and ENGAGE—were the controversial evidences assessed during the clinical evaluation. After comparing EMERGE and ENGAGE data, the AdCom voted eight-to-one against on aducanumab, claiming they could not confirm concrete enough clinical evidence to validate the efficacy. Biogen has actually halted both EMERGE and ENGAGE studies in March last year based on the outcomes of a futility analysis. But the brake on the NDA was listed after the company gave a presentation at a major academic conference and announced its plan to submit Biologics License Application (BLA) to FDA in late last year as they acquired more analytical data after they decided to halt the studies in March. When Eisai in partnership with Biogen unveiled a new set of analysis arguing a high dose of aducanumab demonstrates significant slowing of decline in cognition and in the EMERGE study, FDA announced it would resume reviewing the marketing approval. After collecting a large-scale data on 2,066 out of 3,285 patients, who continued the treatment for 18 months after participating in the original trial, aducanumab resulted in statistically meaningful decrease in clinical progression of Alzheimer's disease. The retrospective analysis on EMERGE study found aducanumab met its primary endpoint, where the patients treated with high dose aducanumab showed a statistically significant reduction of clinical decline from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) scores at 78 weeks. Compared to the placebo group, the investigational drug group was improved by approximately 23 percent. The study’s secondary endpoints were also met as the clinical decline continued to lessen. The aducanumab group, in comparison to the placebo group, improved the Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale scores by 15 percent and 27 percent, respectively. Also the scores on Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI) marked 27 percent and 40 percent higher than the placebo group, respectively. However, AdCom official stated, “It is still difficult to confirm the treatment’s benefit with the company raising the dose of the investigational drug higher than what is mentioned in the initial clinical protocol.” Competition heightens among Alzheimer’s disease targeting drugs, experts reserve judgment on single target mechanism # In the current Alzheimer's disease treatment pipeline market, a wide array of antibody agents targeting Aβ, Tau protein and ApoE4 are in development to treat patients with Alzheimer's disease. Regardless, most of these drugs are not targeting the patients with Alzheimer's disease, but focusing on customizing the treatment to patients with a specific mutation. An academic society reported clinical trials are now actively investigating novel drugs targeting Aβ and Tau protein for Alzheimer’s disease treatment. However, Aβ-targeting drugs only brought disappointment to many of multinational companies, although it was considered the most potent candidate. Roche failed to meet the endpoints in late phase clinical trial on crenezumab targeting Aβ in last February and March, and Biogen and Eisai also had to quit the last Phase III trial on aducanumab. The Aβ-targeting drug development seems to have slowed down noticeably at the moment, while Eli Lilly and MSD have also announced stopping the investigation on beta amyloid cleaving enzyme (BACE) inhibitors. And AstraZeneca, Jansen, MSD and Roche are on a same boat as they all announced they have closed their clinical trials on the drug due to reports of adverse reaction and issues with efficacy in late-phase studies. Reviewing all the news, the academic scholars are more reserved on their opinions on developing Alzheimer's disease targeting treatments. Suk Seung-han, a professor of neurology at Wonkwang University Sanbon Hospital, noted, “The academic scene agrees that accumulated Aβ and Tau protein expressing toxicity effect in nerve cells cause functional problems like killing of nerve cell and deteriorating cognitive function. But the problem is that some patients, according to their medical records so far, abnormally show deteriorating cognitive function regardless of the low level of accumulated Aβ and Tau protein.” The professor added, “Now the academia is saying there is a high possibility of other risk factors like cerebrovascular lesion and other complications that could develop into dementia in patients, besides Aβ and Tau protein. We are still not convinced that dementia or decline in cognitive function can be prevented by simply hindering the mechanism of a specific factor.”
- Policy
- NSCLC treatment Vizimpro coverage effective from December
- by Lee, Hye-Kyung Nov 25, 2020 06:26am
- The healthcare reimbursement on Pfizer’s non-small cell lung cancer (NSCLC) treatment Vizimpro (dacomitinib) would be granted from Dec. 1. But the drug has to pass the Ministry of Health and Welfare (MOHW) Health Insurance Policy Deliberation Committee (HIPDC) on Nov. 27 to be fully approved. Prior to the HIPDC deliberation, the Health Insurance Review and Assessment Service (HIRA) is to accept the public opinion on the revised ‘Notice on Drugs Prescribed and Administered to Cancer Patients’ that contains the detail of establishing the reimbursement standard for Vizimpro. In last February, Vizimpro was approved for the South Korean market as a first-line treatment for patients with locally advanced or metastatic NSCLCL with epidermal growth factor receptor (EGFR) exon 19 deletion or L858R substitution on exon 21. After reviewing textbooks, guidelines and clinical literatures to set reimbursement standard on the initial administration for NSCLCL, HIRA found a textbook mentioning Vizimpro as a new drug categorized as second generation Tyrosine kinase inhibitor (TKI). And the National Comprehensive Cancer Network (NCCN) guideline recommends the drug as 'category 1’ for treatment patients with sensitizing EGFR-positive advanced, metastatic NSCLC, when the European Society for Medical Oncology (ESMO) recommends it as I and B, and the Pan-Asian ESMO guideline as I and A. Apparently, a randomized, open-label, Phase III clinical trial compared Vizimpro and Iressa (gefitinib) head-to-head with a group of patients with newly diagnosed stage IIIB/IV NSCLC along with exon 19 deletion or L858R substitution on exon 21. The trial found the each drug marked median overall survival (mOS) of 34.1 months vs. 26.8 months, median progression-free survival (mPFS) of 14.7 months vs. 9.2 months, and objective response rate (ORR) of 75 percent and 72 percent, respectively. HIRA official said, “The guideline currently recommends the applicant drug to the patient group with the EGFR-activating mutation, and other EGFR-TKI clinical trial did not find many of patients without 19 deletion or L858R substitution. The reimbursement standard was set considering the limited size of patients, who have an off-label EGFR-activating mutation.” Vizimpro has completed the pricing negotiation with the National Health Insurance Service (NHIS), after the Drug Reimbursement Evaluation Committee (DREC) green lit the reimbursement on Nov. 12.
- Company
- Yuhan secured ₩230 billion in two years
- by Chon, Seung-Hyun Nov 25, 2020 06:24am
- Yuhan has secured about ₩230 billion in new drug technology fees over the past two years. It has signed five technology transfer contracts, and has also collected milestones of more than ₩100 billion in the development stage after technology export. Front view of Yuhan headquartersYuhan announced on the 24th that it will receive a staged technology fee (milestone) of $65 million (₩72.3 billion) for the anticancer drug Lazertinib from Janssen Biotech. An additional milestone occurred as Janssen started recruiting subjects for a phase III clinical trial of its own anticancer drug, Amivantamab and Lazertinib. Lazertinib is a third-generation EGFR targeted anticancer drug that Yuhan handed over to Janssen Biotech in November 2018. The total contract size, including a down payment of $50 million without obligation to return, is up to $1.25 billion. Lazertinib's additional milestone is the second since the temporary export. Yuhan received $35 million milestone for Lazertinib from Janssen Biotech in April. Janssen paid an additional milestone to Yuhan when he began a trial of Amivantamab and Lazertinib combination therapy at the time. Yuhan has secured a total of $150 million, including a down payment of $50 million, only by the transfer of Lazertinib technology. 40% of Lazertinib's technology fees are redistributed to the original developer, Oscotec. For Yuhan, technology fees have been a major source of revenue since 2018. Yuhan has signed a total of five new drug technology export contracts since July 2018. In July 2018, it transferred the technology of YH14618, a treatment for degenerative disc disease, to Spine Biopharma in the United States. It received a down payment of $650,000, and was guaranteed $217.5 million for milestones in stages according to development, licensing and sales. In November 2018, it signed a technology export contract with Janssen for Lazertinib. In January of last year, it signed a license and joint development contract with Gilead Sciences for new drug candidates that act on two drug targets for the treatment of non-alcoholic steatohepatitis (NASH). It is a condition of receiving a down payment of $15 million and receiving $777 million in milestones for each stage of development, licensing and sales. In July of last year, Yuhan signed a technology transfer contract with Boehringer Ingelheim for a total of $870 million related to the NASH treatment YH25724. The down payment without obligation to return is $40 million. Out of the $40 million down payment, they agreed to receive $10 million upon completion of the non-clinical toxicity test, but after the nonclinical toxicity test was completed in 9 months, the remaining down payment was received in April. In August, it signed a technology transfer contract with Processa Pharmaceuticals of the United States for a functional gastrointestinal disease treatment candidate YH12852. Yuhan received a down payment of $2 million as shares, which were not obligated to return. Yuhan has secured a total of $2,765 million (about ₩230 billion) in technology fees for about two years since 2018. It is more than 18 times the operating profit of ₩12.5 billion last year. Quarterly Yuhan technology fee operating profit (Unit: ₩million, Source: Yuhan, the FSS) Yuhan's recent technology fees are higher than operating profits. As of this year, Yuhan has recognized a total of ₩77.9 billion in technology fees. In the first and second quarters, ₩1.1 billion and ₩35.7 billion were reflected, respectively, and an additional ₩16.9 billion was recognized in the third quarter. Yuhan's cumulative operating profit in the third quarter was ₩57.1 billion. It is calculated that if there was no inflow of technology fees, it would have recorded a deficit. Yuhan's technology fee revenue was ₩23.2 billion last year, far exceeding its operating profit (₩12.5 billion). From 2019 to the third quarter, Yuhan recognized a total of ₩101.1 billion in technology fees. In the future, additional technology fee revenues reflected in earnings exceed ₩100 billion.
- Policy
- The duration of administration of Maviret was reduced
- by Kim, Jung-Ju Nov 25, 2020 06:24am
- A plan to reduce the dosing period of Maviret (Glecaprevir/Pibrentasvir), a chronic hepatitis C virus treatment in Korea, from 12 weeks to 8 weeks in patients with chronic hepatitis 3 C infection in adults with targeted cirrhosis. Is promoted. Sumatriptan succinate, such as Myungin's migraine treatment Sumatran, doubles the daily reimbursed dose. The MOHW announced an administrative notice on the 23rd with the aim of implementing a partial amendment notice of the'Pharmaceutical Reimbursement Listing Standard and Method' on December 1st. First, the duration of some administration of AbbVie's Maviret is shortened. The government and the HIRA will change the dosing period of targeted liver cirrhosis from 12 weeks to 8 weeks among adult chronic hepatitis 3 hepatitis C patients who have no previous treatment experience, referring to clinical practice guidelines and expert opinions regarding the change of food and drug approval. The daily dose of Sumatriptan succinate oral medications such as Myungin's Sumatran, among migraines treatment, is doubled from 100 mg to 200 mg. The benefit of off-label use of Janssen Korea's adult Crohn's disease treatment Remicade (Infliximab), which has recognized the benefit even with off-label use, is not recognized. The MOHW is scheduled to register'Remsima PFS', which is licensed for Crohn's disease, ankylosing spondylitis, ulcerative colitis, and rheumatoid arthritis, for adults only. Benefits are recognized when administered internally, but will be excluded from benefits that recognize off-label use. Valsartan, Atorvastatin calcium hydrate, and Anlodipine Besylate combined oral drugs, Daehan New Pharm, for hypertension are scheduled to be listed and added to the subject of the compound oral notification. In addition, Rivaroxaban formulations such as Bayer Korea's stroke treatment Xarelto 2.5mg will be revised to clearly show the description of multivascular coronary artery disease. In addition, the government decided to expand the benefits of administering related drugs to Rifampin-resistant/multi-drug-resistant tuberculosis patients in accordance with the recommendations of the WHO guidelines and the principles of drug composition, reflecting the revisions of the WHO guidelines for tuberculosis treatment last year. Zyvox (Linezolid) tablet type, 2 mg/ml injection type, Augmentin (Amoxicillin/Potassium clavulanate), Tienam injection (Cilastatin Sodium/ Imipenem Monohydrate), Meropen inj (Meropenem Hydrate), Finibax (Doripenem monohydrate) are the targets. In addition, the government reflected the revisions of the WHO guidelines last year regarding tuberculosis treatment, and exceeded the scope of the approval of Bedaquiline fumarate such as Sirturo100mg and Delamanid such as Deltyba. · We plan to expand the benefit if it is approved by the Korea Disease Control and Prevention Agency in advance for continuous administration. The MOHW will receive group or individual opinions by the 25th, and if there are no specific matters, the MOHW will be implemented as the original plan. The effective date is December 1st.
- Company
- HCP and patients waiting for new T-cell lymphoma option
- by won, jong-hyuk Nov 25, 2020 06:24am
- The performances of anticancer therapies are improving as time goes by. But some cancer types still use chemotherapy as a standard of care (SOC) developed in 1970s to this date, regardless of the technological advancement in the anticancer area. One of them is Peripheral T-Cell Lymphoma (PTCL). Typically, PTCL is one kind of non-Hodgkin lymphoma found in T lymphocytes. The condition is categorized as a malignant tumor and an aggressive lymphoma. The tumor frequently spreads in liver, spleen and skin, and also has high risk of relapse and rapid advancement speed. The problem is that the patients usually do not respond to the current SOC of a combined chemotherapy, and the prognosis of PTCL patients who fail in the first-line therapy or show relapse is not so positive with the median survival period lasting about 5.8 months. Rare blood cancer area stuck with ‘70s chemotherapy showing low survival rate and frequently observed toxicity #The current first-line SOC in PTCL treatment is a combination of chemotherapy including cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate, and prednisone, or also known as CHOP, used from the ‘70s. The CHOP chemotherapy has been used as a first-line treatment for decades, but the academic societies are torn about the therapy’s survival rate and toxicity. According to a clinical trial in Japan, PTCL patients’ three-year survival rate was only about 52 percent after receiving CHOP chemotherapy. And high dosage of chemotherapy causing adverse reaction is considered as the biggest problem when treating the patients. Blood toxicity, such as leukopenia, anemia, thrombopenia could be caused by myelosupression, or the patients usually experience loss of hair, peripheral neuropathies, infection and nausea. The reason why such high risk SOC is still used until today is because the disease has no other alternative options. The treatment scene is not so different in South Korea. The National Cancer Information Center explains there are cases of the patients with PTCL or other non-Hodgkin lymphoma participating in clinical trials using new drugs, when they did not respond well enough to the SOC. A professor of hematology and oncology at Samsung Medical Center, Kim Seok Jin explained, “Patients with PTCL are usually diagnosed in their 50s or 60s, and they are likely to get complications due to bone marrow suppression triggered by chemotherapy. Especially the patients in their 70s, some give up their treatment as they cannot endure the adverse reaction, and a lot of them see underwhelming treatment effect as they have to reduce the dosage considering the high risk of adverse reaction.” ”Desperately need to improve PTCL treatment access in South Korea” with the updated NCCN guideline Although the PTCL treatment scene lacks varying treatment options with the said situations, a lymphoma treatment Adcetris (brentuximab) earned a new indication to treat PTCL and expanded the treatment option in December last year. Adcetris is an antibody-drug conjugate (ADC) directed to CD30, expressed on the surface of several types of PTCL. A Phase III ECHELON-2 study evaluated the drug’s clinical benefit, where patients with CD30-positive PTCL have improved the overall survival (OS), compared to the SOC CHOP chemotherapy, without discovering more issue with adverse by using brentuximab as a first-line treatment. During the study, a patient group receiving brentuximab plus CHP (cyclophosphamide- doxorubicin-prednisone) combination lessened the risk of death by 34 percent and significantly enhanced the OS, in comparison to the patient group using CHOP. Also the Adcetris combination therapy demonstrated an outstanding treatment efficacy proven with other indicators of anticancer treatment efficacy like progression-free survival (PFS), objective response rate (ORR) and complete remission (CR). The median PFS in the Adcetris combination therapy group reached 48.2 months, which almost doubled the median PFS in the CHOP patient group with 20.8 months. The statistics prove that the combination therapy has brought down the risk of disease progression by 29 percent. Based on the reported clinical efficacy, the current National Comprehensive Cancer Network (NCCN) guideline recommends using Adcetris plus CHP combination therapy for a first-line treatment in patients with CD30-positive PTCL as a ‘preferred regimen.’ However, the PTCL treatment scene in South Korea has a long way to go. The drug expanded the indication late last year, but it still has not resolved the healthcare reimbursement required for more practical prescription. The drug faces the first threshold of winning the healthcare reimbursement, the Cancer Deliberation Committee meeting schedule on Nov. 25. And regarding the drug Professor Kim commented, “Both the patients and healthcare providers are happy to have a new treatment option with superior efficacy than the existing SOC, as there were limited prescription options for patients with PTCL. There is definitely a big difference between not having an option at all and having option that cannot be accessed.” The professor continued, “It is regrettable the patients are giving up on treatment, because of financial reasons, regardless of the new available option with lessened toxicity and good efficacy. I wish their access to treatment can be better as soon as possible for them to live longer. And granting the healthcare reimbursement on the drug would be cost-effective as there are only a handful of PTCL patients in South Korea.”
- Policy
- Full listed drug reevaluation subjects to be revealed soon
- by Kim, Jung-Ju Nov 24, 2020 09:04am
- The government plans to finalize and announce the list of second listed drug reimbursement feasibility evaluation (clinical reevaluation) and the first full-fledged reevaluation in next month. However, conducting the reevaluation using international reference pricing (IRP) would be physically impossible in a mean time, because of clashing opinions and standard and principle establishment requiring extra time to establish. As for the immunotherapy Keytruda, the Cancer Deliberation Committee is expected to talk about the drug this week as the Reimbursement Standard Expansion Council has failed to reach an agreement. On Nov. 18, the Ministry of Health and Welfare (MOHW) presented a series of insured drug policy plans centering pharmaceutical reimbursements, such as the progress on the pilot and full clinical reevaluation and the immunotherapy reimbursement expansion. First, the list of the first full reevaluation subject substances and drugs, following the pilot reevaluation on the cognitive function enhancer choline alfoscerate would be unveiled in December. While MOHW is currently reviewing the list of subjects, the ministry said the Post-marketing Evaluation Subcommittee and Drug Reimbursement Evaluation Committee would select and announce the final list of subjects for the full reevaluation. The full reevaluation would follow a guideline constructed based on the pilot reevaluation on choline alfoscerate. However, the government is likely to set different standards and principles on reevaluation with IRP as the stakeholders are deeply conflicted with the approach. Expecting the government to take more time on the reevaluation type, the IRP reevaluation would be unlikely to be included in the first list of full reevaluation. Moreover, the government official stated it could not reach a final decision on the cost sharing plan submitted by MSD Korea, although the ministry convened a meeting with the Reimbursement Standard Expansion Council on Nov. 17 to discuss about immunotherapy Keytruda. As the council demanded additional review, so the government would have to report the discussion progress to the Cancer Deliberation Committee at a meeting scheduled on Nov. 25. The government disclosed the weighted drug pricing benefit reevaluation standard and plan (for reevaluated drugs), compiled based on the ‘Standard and Regulation on the National Health Insurance Reimbursement’ and the’ Standard of Drug Decision and Adjustment.’ And regarding the plan, the government would hold a meeting with the pharmaceutical industry organization in the last week of the month to survey their opinions. The key part is the condition to extend the weighted pricing benefit, because MOHW plans to have the Drug Reimbursement Evaluation Committee to use the new conditions reflecting the collected opinions.
