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- 2025-12-24 10:00:02
- Policy
- Ongentys and Rekovelle soon to receive healthcare benefit
- by Kim, Jung-Ju Aug 11, 2020 06:02am
- The South Korean health authority is readying for healthcare reimbursement listing on SK Chemical’s new Parkinson’s disease treatment Ongentys (opicapone) capsule and Ferring Korea’s assisted reproduction techniques (ART) add-on Rekovelle (follitropin delta) prefilled pen as they have reached an agreement on their negotiations. During reimbursement review by the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC), the both companies have decided to accept the weighted average pricing. Reportedly, the rest of the procedure was to negotiate and sign side agreements regarding projected claim amount with National Health Insurance Service (NHIS). NHIS has recently announced the reimbursement negotiations on Ongentys capsule and Rekovelle prefilled pen have reached a settlement. First, Ongentys capsule is a catechol-O-methyltransferase (COMT) inhibitor, which increases density of levodopa in blood plasma and enhances the drug effect. Levodopa is a medicine that supplements a neurotransmitter dopamine the Parkinson’s disease patients lack. SK Chemical has exclusively licensed the sales rights over Ongentys, developed by the biggest Portuguese-based pharmaceutical company BIAL, for the Korean market in March 2018. Ongentys is used as an add-on treatment for Parkinson’s disease patients experiencing motor fluctuation, but their symptoms not improving from levodopa/ dopa-decarboxylase inhibitor (DDCI) therapy. On Nov. 26 last year, the Ministry of Food and Drug Safety (MFDS) approved the drug for the Korean market. Rekovelle prefilled pen is indicated for use in controlled ovarian stimulation (COS) inducing the development of multiple follicles in women undergoing ART, such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Unlike other existing options, the drug uses a human recombinant follicle stimulating hormone and provides individualized dosing. Passed by MFDS on Dec. 27 last year, Rekovelle would be soon listed for healthcare reimbursement after completing the eight-month-long negotiation. By overcoming the biggest hurdle of NHIS negotiation, Ongentys and Rekovelle would likely to receive the healthcare reimbursement from next month at latest after MOHW Health Insurance Policy Deliberation Committee (HIPDC) gives them a nod.
- Policy
- Benefits for combination therapy with DM can be expanded
- by Lee, Tak-Sun Aug 10, 2020 06:01am
- Combination therapy between diabetes treatment drugs that are not currently approved for efficacy and effectiveness can also receive benefits. As the MFDS simplifies the method of describing the efficacy and effect of type II DM combination therapy, the insurance authorities can apply benefits to the existing off-label combination therapy (uses other than permitted). The MFDS announced on the 7th that it would simplify the description of the combination therapy among the efficacy and effect items of the license for type II DM treatment. First of all, it is applied from new items, and it will be processed according to the improvement plan if a change permit is applied for existing items. The MFDS announced that this improvement plan has been promoted to harmonize with permits in the United States and Europe, and to reflect the demands of the medical and industrial sectors. In particular, the medical community has argued that benefits for combination therapy should be applied in addition to the license requirements. Until now, the application of benefits has been based on the efficacy and effectiveness of the permits approved by the MFDS. The Korean Diabetes Association recently submitted an opinion to the HIRA that the combination therapy between SGLT-2 inhibitors and TZD (thiazolidinone)-based drugs should also be reimbursed. Currently, the approval of the SGLT-2 inhibitor by the MFDS lists combination therapy by ingredient in efficacy and effect. For example, SGLT-2 inhibitor Forxiga and Suglat are described in the efficacy and effectiveness of the combination therapy with the TZD-based 'Pioglitazone'. It is based on evidence of efficacy in clinical trials. The Diabetes Association further argues that it is expanding the benefits by category rather than by ingredient. In the TZD family, not only Pioglitazone but also Lobeglitazone, and SGLT-2 inhibitors are also available. In this proposal to improve the method of describing the efficacy and effect of the combination therapy by the MFDS, the parts listed by the existing ingredients were grouped together and abstracted into 'other hypoglycemic agents'. However, if only one of the combination therapies submitted clinical trial results, the ingredients were specified and indicated. As a result, it became an opportunity for the insurance authorities to apply benefits for each group rather than for each ingredient based on the approval of the MFDS. An official from the MFDS also explained that the measure reflected the demands of the medical community to expand joint benefits among affiliates. However, in order for the actual insurance benefits to expand, other evidence to prove the efficacy other than corporate clinical trials is expected to be needed. Based on this, it is expected that physician's prescription will be flexible and the treatment means will be expanded if there is actually an increase in the combined benefits between the departments. Pharmaceutical companies can also benefit from sales growth from prescription expansion.
- Policy
- Pricing reduction-evading drug relisting to be rejected
- by Kim, Jung-Ju Aug 10, 2020 06:00am
- Now a new regulation would stop companies from attempting to technically relist a drug to avoid pricing reduction. Following the administrative procedure, the newly revised regulation would be enforced from September at earliest. The Regulatory Reform Committee categorized the Ministry of Health and Welfare (MOHW)-revised ‘Regulation on National Health Insurance Healthcare Reimbursement Standard’ as ‘non-critical’ issue and passed it immediately. According to the Regulatory Reform Committee on Aug. 3, the revision that passed the latest preliminary review aims to stipulate rejection of a drug seeking for reimbursement listing again to avoid pricing reduction. The amendment is considered as a base work for the government’s drug pricing system reform. The ministry’s drafted revision includes four following changes; setting detailed reimbursement decision principle and prioritization listing system supplementing the existing healthcare reimbursement review principle; passing a regulation to reject reimbursement listing application for drug attempting to evade pricing reduction; unifying drug listing review procedure; and establishing and revising procedure of government authorization. The Regulatory Reform Committee reviewed the revised regulation to deny a drug from applying for relisting to avoid pricing reduction. The reviewed regulation stipulates the government to reject a pharmaceutical company’s application to list a drug that has received pricing reduction order, but attempts to maintain the existing sales level. Such case in loophole has prevalently occurred in drug pricing reduction order authorized by the government for providing illegal rebate. The Regulatory Reform Committee categorized the revision as a ‘non-critical’ issue and breezed through the review and clearance. Passing the most important threshold, the revision would come in effect from September at earliest.
- Policy
- Pre-approval of benefits for Spinraza were approved
- by Lee, Hye-Kyung Aug 10, 2020 06:00am
- 5 out of 6 cases for pre-approval of benefits for Spinal Muscular Atrophy (SMA) treatment 'Spinraza (Nusinersen)' last month were approved. After approval of Spinraza benefits, a monitoring report must be submitted every four months before administration of maintenance doses, and all 24 cases of administration monitoring have been approved. In the case of Soliris (Eculizumab), which was the subject of pre-approval prior to Spinraza, 3 new applications for pre-approval for paroxysmal nocturnal hemoglobinuria (PNH) and 40 monitoring were all approved. However, only one out of two applications for reconsideration was approved. Kim Sun-min, President of the HIRA released the results of the 5 items deliberated by a medical treatment review committee in June. Spinraza is an ultraexpensive new drug with ₩92.3 million per 5ml bottle, and medical institutions that want to administer it must apply for prior approval. Spinraza’s Benefits are recognized when 5q spinal muscular dystrophy patients are genetically diagnosed with 5q SMN-1 gene defects or mutations, SMA-related clinical symptoms and signs are expressed under the age of 3, and permanent ventilators are not used. However, in the case of disapproval, it was rejected at the age of 3 years (36 months) or younger, without clearly identifying symptoms and signs related to spinal muscular dystrophy and not being objectively proven. Twenty-four cases applied for monitoring reports were recognized as targets of medical care benefit because the maintenance of motor function was confirmed compared to the time of the previous evaluation as a result of the submitted motor function evaluation. Clinical evaluation (development stage, motor function, respiratory function, etc.) is conducted before the initial administration, 5 times after administration of the introductory dose (4 times), and before each administration thereafter to evaluate the maintenance of administration. In the case of approval as a target for medical care benefits, Medical institutions that have applied for pre-approval of Spinraza and Soliris must administer them within 60 days from the date of notification of the deliberation result, and reapply if it is intended to be administered after 60 days. Details of the deliberation by the medical treatment review committee can be inquired on the website of the HIRA (www.hira.or.kr) and on the medical institution business portal (biz.hira.or.kr).
- Policy
- Kcab, compared clinical trial with Nexium
- by Lee, Tak-Sun Aug 07, 2020 06:27am
- HK inno.N's new domestic drug ‘Kcab’ is specifically compared with the reference drug, Nexium. The company said it will explore new indications through the trial. The MFDS approved IND of Phase I clinical trial to explore the pharmacokinetics, Pharmacodynamic properties and safety of Tegoprazan twice a day dosing regimen in healthy subjects' submitted by HK inno.N on the 31st of last month. 64 healthy adults participated in this clinical trial. It is interesting that the reference drug is Nexium injection. In clinical trials, Kcab is administered twice a day to compare the pharmacokinetic and pharmacodynamic properties of Nexium injections. Kcab is currently used in the market once a day. AstraZeneca Korea's Nexium injection is a product administered intravenously once a day, and is mainly used when oral method is not appropriate. .A company official said, "This trial is for exploring new indications." If so, it is presumed to be for the purpose of acquiring the indications possessed by Nexium through comparing the equivalence with Nexium .Accurate indications of Nexium are in the case of adult ▲when oral method is not appropriate, as an alternative to oral therapy, GERD with severe esophagitis or severe symptoms due to gastroesophageal reflux, ▲Prevention of rebleeding after endoscopic treatment of acute hemorrhagic gastric ulcer or duodenal ulcer .In addition, for children aged 1 to 18 years, ▲ when oral method is not appropriate, it is used as an alternative treatment with erosive reflux esophagitis or severe GERD .It is observed that Kcab are attempting clinical trials to obtain indications for 'prevention of rebleeding after endoscopic treatment of acute hemorrhagic gastric ulcer or duodenal ulcer' .K-Cap is currently providing indications including antibiotic therapy for the treatment of H .pylori in patients with peptic ulcer and/or chronic atrophic gastritis, ▲ treatment of erosive GERD, ▲ treatment of non-erosive GERD .Additional clinical trials for maintenance indications of patients with erosive GERD treatment confirmed through an endoscope and clinical trials to investigate the possibility of using NSAIDs in combination are also being conducted .Kcab (Tegoprazan) is a P-CAB (Potassium-Competitive Acid Blocker)-based drug that has a mechanism of reversibly blocking a proton pump that secretes gastric acid from the stomach wall .The industry analyzes that Kcab is leading the evolution of the P-CAB family by conducting clinical trials with PPI-based drugs such as Nexium as a reference drug .So far, PPI drugs have led the market in GERD related diseases .Meanwhile, Kcap has successfully increased sales by recording an outpatient’s prescription amount of ₩30.7 billion only in the first half of this year, based on UBIST .
- Policy
- SNUH participates in COVID-19 trials using Rebif
- by Lee, Tak-Sun Aug 07, 2020 06:27am
- Seoul National University Hospital participates in a multinational clinical trial using 'Rebif' (Interferon Beta-1A, Merck), which has recently been cited as a candidate for COVID-19 treatment. Rebif is a pre-filled injection that is also approved in Korea. It is used for multiple sclerosis, and has recently been mentioned as a candidate for COVID-19 treatment in Europe. The MFDS approved a multinational sponsor-investigator trials plan for 'multi-center, randomized, double-blind, placebo-controlled study on the safety and effectiveness of new drugs for COVID-19' submitted by Seoul National University Hospital on the 4th. This clinical trial explores the effectiveness of a combination of Remdesivir and Interferon Beta-1A in admitted patients due to COVID-19. There are 1,038 test subjects worldwide, and 100 will participate in Korea. Clinical trials are conducted at Seoul National University Hospital and Bundang Seoul National University Hospital. This is the first clinical approval of COVID-19 using Rebif in Korea.
- Policy
- Generics was applied in 7 years after Pelrubi’s PMS ended
- by Lee, Tak-Sun Aug 07, 2020 06:26am
- #The application for generic for Pelubi was received 7 years after the PMS of the original drug was terminated. There have been reasons for not being able to apply because of patents, but it is an analysis that Pelubi's popularity in the market lately has influenced the generic development of pharmaceutical companies. According to the MFDS, on the 29th of last month, Pelubiprofen 30 mg, generic for Pelrubi, applied for permission. However, the generic missed the original indication for antipyretic effect. Pelrubi is also used for the fever of acute upper gastritis along with osteoarthritis, rheumatoid arthritis, and low back pain. However, this generic drug has submitted an application for permission only for osteoarthritis, rheumatoid arthritis, and low back pain (back pain) indications. This is because the PMS of acute upper gastritis indication is ending on September 18, 2021. Before obtaining an antipyretic indication, Pelrubi's PMS expired on April 19, 2013. Therefore, the application for generic permission was made 7 years after the PMS was terminated. Generic drugs are developed at the end of PMS, so it is unusual for Pelrubi’s generic. This is also believed to have influenced that the new drug Pelrubi's prior patent expires in November 2028. Generic companies have been challenging patents since the end of last year. Starting with Yungjin, Mothers Pharm, Hutecs Korea, Huons, Nexpharm, and Chong Kun Dang have filed for a trial to confirm passive scope of rights to avoid patents. At the same time, generic development was also underway. Starting with Mothers Pharm in March, Huons, Yungjin, Nexpharm, and Hutecs Korea have been approved for bioequivalence tests. The key to future success is patent challenge with the recent applications for generic drugs, This is because it is possible to release the product even if the item is approved only by winning the patent evasion judgment. Pelrubi is a large-scale domestic drug with a record of ₩28.9 billion in outpatient prescriptions based on UBIST last year. After the approval in 2008, the indications were expanded through additional clinical trials, and In 8 years, 2017, sales exceeded ₩10 billion. The reason for the delayed development of the generics is that Pelrubi's sales rose late, so the generic companies began to take an interest in it later.
- Policy
- Pricing settled Prevymis to get listed in Aug. at earliest
- by Kim, Jung-Ju Aug 07, 2020 06:25am
- The MSD Korea’s new drug Prevymis (letermovir) settled on a pricing negotiation with the South Korean health authority and successfully passed the biggest hurdle of the path to healthcare benefit. The novel drug helps to prevent cytomegalovirus (CMV) infection in patients who have received an allogeneic hematopoietic stem cell transplant (HSCT). The prescription drug would be listed for the pharmaceutical reimbursement within this month at earliest after the final reviewer Ministry of Health and Welfare’s (MOHW) Health Insurance Policy Deliberation Committee approves it. Ministry of Food and Drug Safety (MFDS) has indicated the drug ‘to prevent CMV infection and diseases in adult patients who have received HSCT.’ According to National Health Insurance Service (NHIS) on Aug. 3, all four items under the brand—240 mg and 480 mg doses of Prevymis tablets and injections—have concluded the pricing negotiation. In the U.S., the medication has been designated as a breakthrough therapy, priority review drug and fast-track drug and received an approval by the U.S. health authority. After it was green lit for the Korean market by MFDS on Dec. 26, 2018, Prevymis started the pricing negotiation with NHIS immediately following the clearance for reimbursement by Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC). The allogeneic HSCT is essential to completely cure severe blood cancers like acute myeloid leukemia (AML) and acute lymphocytic leukemia. Accordingly, both the patients and healthcare professionals have been constantly demanding for the healthcare reimbursement on the drug. The pharmaceutical company insider said, “The company was actively engaging in the negotiation with the utmost care to meet the high expectation of healthcare providers and patients waiting for the benefits of Prevymis preventing infection and improving overall survival of patients receiving allogeneic HSCT.” The insider added, “We expect to receive the reimbursement soon when HIPDC deliberates and notifies the result. And we would do our best to promptly bring the innovative, CMV infection and disease-preventing Prevymis to the patients who had HSCT.
- Policy
- Zytiga, Mavyret and 161 items monitored for PVA negotiation
- by Lee, Hye-Kyung Aug 05, 2020 06:24am
- The South Korean health authority added Korea Otsuka Pharmaceutical’s Iclusig tablet (ponatinib hydrochloride hydrate), Jassen Korea’s Imbruvica capsule (ibrutinib), Zytiga tablet (abiraterone acetate) and Darzalex (daratumumab) as subject for the third quarter price-volume agreement (PVA) negotiation and monitoring. Merck’s Erbitux injection (cetuximab), MSD Korea’s Zepatier tablet and AbbVie Korea’s Mavyret tablet are other addition to the list. On its website, National Health Insurance Service (NHIS) recently posted the list of drugs to be monitored for the PVA negotiation (Type Ga and Na) during the third quarter. The PVA system stipulates NHIS and pharmaceutical companies to share the NHI finance risk, and lowers pricing of a drug with surged use volume after negotiating with NHIS. In the third quarter, 163 items in 89 classes would be monitored. The PVA monitoring list included Sam-oh Pharm’s Vimizim injection (elosulfase alfa), Sanofi-Aventis Korea’s Mozobil injection (plerixafor), SK Plasma’s SK Albumin, and Roche Korea’s Mircera prefilled injection (methoxypolyethyleneglycol-epoetin beta). Korea Otsuka Pharmaceutical’s Samsca tablet (tolvaptan spray dry powder) and Yuhan’s Prakanon tablet (pranlukast hydrate) have also been added to the list. The Type Ga (가) PVA negotiation is applicable on a drug that exceeded the benefit claim amount by 30 percent over the projected claim amount set according to pricing negotiation with NHIS, projected claim negotiation, pricing increase adjustment negotiation and indication expansion negotiation. The Type Na (나) PVA negotiation is applicable on a drug either completed the Type Ga negotiation or reaches annual claim amount after a year since the day the Type Ga monitoring period ended without a negotiation in four years that exceeds previous year’s claim by 60 percent or 10 percent but surpassing 5 billion won. However, drugs claiming less than 1.5 billion won annually or having upper limit pricing lower than average pricing among same class drugs, low-priced drug and shortage prevention drug are exempted from the PVA negotiation.
- Policy
- COVID-19 vaccine release time can be judged in phase III
- by Lee, Hye-Kyung Aug 04, 2020 05:54am
- Mook Hyun-sang, Head of the KDDF With the time to release the COVID-19 vaccine, a domestic expert said that it is not yet in the stage of discussion. Mook Hyun-sang, the head of Korea Drug Development Fund (KDDF) announced the results at the future open discussion with the theme of 'COVID-19 vaccine, global development trend and securing strategy' co-sponsored by the MOHW and the KHIDI. He said, "In the WHO announcement as of July 28, there are five COVID-19 vaccines in progress in phase III, and there are opinions among foreign experts that if the phase I/II drugs are confirmed, the vaccine can be released within this year, and safety must be carefully considered." In relation to the release of the vaccine, the director of the NIAID, Fauci, said, "If only phase I and II drugs are confirmed, a licensed vaccine can be released within this year." Ken Frazier, the president and CEO of MSD, who developed the Gardasil said, "we have developed most of the new vaccines in the last 25 years, but it's not a simple thing to prove safety." He said that Dr. Fauci is hopeful, and President Frazier is in a position to go safely. No one can say that the vaccine will be released within six months, a year or two. The conclusion emphasized that it is possible to discuss the timing of vaccine release only after confirming the data of the inoculated patients after 3 and 6 months in phase III. In addition, regarding the price of vaccines, AstraZeneca predicts that supply contracts will be made at around $8 per person and Moderna at around $50 per person. He was concerned that vaccine prices range from $8 to $50 depending on how they are negotiated, If the Korean population is 1 billion, it will receive a good price, but negotiations are ambiguous in the situation of 50 million. He judged that it is reasonable for the government's strategy to make efforts to develop and secure the COVID-19 vaccine through a two-track strategy, such as the introduction of the vaccine itself and the introduction of overseas vaccines. He said, "Since we haven't made efforts on the vaccine source technology, it is not easy to enter into global joint research and development. Therefore, the government is pursuing a strategy to introduce the vaccine itself and introduce it into overseas development. Japan has also signed a CMO contract with AstraZeneca and Daichi Sankyo, and the MOHW is also making efforts to sign a CMO contract with SK Biosciences."
