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- 2026-04-16 11:26:58
- Policy
- Administrative court rules against Lilly on Forsteo pricing
- by Lee, Tak-Sun Aug 11, 2020 06:03am
- The administrative court rejected Lilly Korea’s litigation against the government-authorized drug pricing reduction ordered due to the reimbursement listing of biosimilar. Lilly argued Daewon Pharmaceutical’s biosimilar Terosa cannot be considered equivalent to its original drug, the court rejected the argument. Accordingly, the upper limit pricing of Lilly’s original Forsteo would be lowered by 30 percent. Terosa and Forsteo are indicated to treat patients with osteoporosis. A pharmaceutical industry source reported on Aug. 10 that the Seoul Administrative Court ruled in favor of Korea’s Ministry of Health and Welfare (MOHW) on July 30 for the litigation filed by the company to revoke the ministry’s order to lower the upper limit pricing. MOHW has initially pre-announced its plan to bring down Forsteo’s (teriparatide) upper limit pricing from 326,358 won to 228,451 won as of last March. The pricing reduction was decided as a biosimilar version of the original was listed for healthcare reimbursement. In October last year, Forsteo’s biosimilar version by Daewon Pharmaceutical Terosa passed the government’s review and received the reimbursement in February. Opposing against the decision, Lilly requested a reevaluation but the company took the case to the court when Health Insurance Review and Assessment Service (HIRA) dismissed the request. The pricing reduction order has been postponed until Aug. 24 as the court accepted the request to halt the administrative action before the case concludes. At the court, Lilly consistently claimed the government’s action to lower Forsteo was unjust as the original is different from Terosa. Specifically, the company pointed out the two drugs hardly share the same substance and structure as they have different host and vector. However, the court ruled against Lilly’s claim by referring to the equivalence test conducted with the reference drug based on Ministry of Food and Drug’s (MFDS) standard. The court also elaborated it would be reasonable to evaluate the two drugs demonstrate equivalent effect and benefit from equivalent pharmacological mechanism with equivalent active pharmaceutical ingredient. In last May, Daewon Pharmaceutical released Terosa to the market. IQVIA data found Forsteo is a blockbuster drug that has generated 21.7 billion won last year. When the pricing reduction is enforced, the sales revenue would unavoidably drop as much as the decrease in pricing. And with Terosa entering the competition, Forsteo may lose its upper hand in the market.
- Policy
- GC Pharma begins clinical trial for new type of Fenofibrate
- by Lee, Tak-Sun Aug 11, 2020 06:03am
- In the triglyceride treatment market, GC Pharma, which is running on top of the Fenofibrate 'Lipidil supra', has begun clinical trials for a new formulation of the same ingredient. It seems to be an attempt to improve the shortcomings of Lipidil supra, which should be taken after meals. The MFDS approved a phase I clinical trial protocol to evaluate the safety and pharmacokinetics of GC7009 in healthy adult volunteers submitted by GC Pharma on the 3rd. GC Pharma used Abbott's Tricor 145mg as a reference drug in this clinical trial. Tricor 145mg is a new formulation of Fenofibrate that was approved in 2004, and unlike conventional formulations, it is absorbed quickly in the gastrointestinal tract, so it can be taken regardless of meal. However, existing Fenofibrates such as Lipidil supra are mainly 160mg, and must be administered orally immediately after meals to promote absorption. In order to improve these disadvantages, Hanmi and Daewon have released improved new drugs that can be taken regardless of meals. The drugs are Hanmi's Fenocid ( Fenofibric acid) and Daewon's 'TG Fenon' (Fenofibrate choline). Looking at the amount of outpatient Rx for the first half of 2020, based on UBIST, Lipidil supra recorded ₩7.7 billion, Fenocid ₩4.8 billion, and TG Fenon ₩4.9 billion. In particular, Fenocid and TG Fenon continued to grow after their launch in 2013 and 2017, respectively, putting pressure on the No. 1 item, Lipidil supra. Lipidil supra is a drug introduced from Abbott. GC Pharma is continuing its relationship with Abbott by selling Abbott's licensed Simvastatin-Fenofibrate combination 'Cholib'. Cholib’s Fenofibrate 145mg can be taken regardless of meals. Previously, Abbott had been approved for 'Trilipix' of Fenofibrate choline that can be taken regardless of meals in Korea, but it was withdrawn due to termination of the expiration date in January 2018. Daewon’s TG Fenon is a product that has been improved from Trilipix capsules into tablets. GC Pharma submitted a plan to conduct this clinical trial in 40 healthy adults from this December to next December. If GC Pharma has Fenofibrate tablets that can be taken regardless of meals, it is expected that it will be able to dominate the competition between Hanmi and Daewon and continue its market position established as Lipidil supra.
- Policy
- The HIRA deliberated on benefits for Rinvoq & Kisqali
- by Kim, Jung-Ju Aug 11, 2020 06:02am
- The HIRA (Director Sun-min Kim) deliberated on the adequacy of benefits for these two new drugs at the Pharmaceutical Benefits Advisory Committee held on the 6th and concluded that AbbVie Korea's new drug for rheumatoid arthritis 'Rinvoq ER 15mg (Upadacitinib)' was to be eligible for reimbursement, and Novartis’ advanced or metastatic breast cancer drug 'Kisqali 200mg (Ribociclib)' gives reimbursed benefit if the evaluation amount is received or less. Rinvoq ER 15mg is a drug used for the treatment of moderate to severe active rheumatoid arthritis in adults who do not respond adequately to one or more antirheumatic drugs (DMARDs) or tolerate it. It is a drug that is administered orally at 15mg once a day regardless of meals, and its ease of use is improved compared to the TNF alpha-blocking injection, which is often used in patients with rheumatoid arthritis. The drug has proven effective in patients with rheumatoid arthritis in 5 cases of phase III clinical trials. In addition, it showed a better response rate compared to control drugs such as MTX monotherapy or placebo group. Kisqali 200mg was approved in Korea on October 30 last year as a combination therapy ▲with aromatase inhibitors as the first endocrine therapy in pre-menopausal, postmenopausal, or postmenopausal women, ▲ with Fulvestrant when the disease progresses after the first endocrine therapy or endocrine therapy in postmenopausal women in advanced or metastatic breast cancer patients with hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative. According to this result, Rinvoq ER 15mg will immediately enter into a drug price negotiation with the HIRA in accordance with the order for drug price negotiations from the MOHW. They may step on or remain non-reimbursed or challenge themselves to be reimbursed again.
- 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.
- Company
- Appropriate use of NOAC in patient with major bleeding risk
- by Eo, Yun-Ho Aug 10, 2020 06:02am
- Images of NOAC products released in Korean market As the prescription cases of new oral anti-coagulant (NOAC) have been accumulating, the prescribers are paying a closer attention on adequately prescribing for patients with high risk of bleeding. HAS-BLED score, the most well known scoring system for measuring major bleeding risk, indicates patients scoring over three are equivalent to tripling the major bleeding risk of patients scoring zero to one. Especially because the ratio of patients with atrial fibrillation scoring HAS-BLED over three has been rising constantly, the bleeding control during an anti-coagulant treatment became a significant factor. Data on patients with atrial fibrillation in Korea shows the ratio of elderly patients aged over 80 is noticeably growing. And the risk of major bleeding has heightened even more as the ratio of patients with other underlying diseases like hypertension, diabetes and heart failure is increasing sharply. A study found patients who scored over three in HAS-BLED took approximately 40 percent of total patients who have been diagnosed with atrial fibrillation in 2006, but the figure rose up to 60 percent in 2015. The average score also climbed from 2.07 in 2006 to 2.75 in 2015. Considering various factors, atrial fibrillation patient with high risk of bleeding has to use controlled dose of NOAC according to the guideline. Patients showing creatinine clearance (CrCl) of less than 50 mL/ min would be prescribed with Xarelto (rivaroxaban) 15 mg (low-dose). And Eliquis (apixaban) and Lixiana (edoxaban) would be prescribed in 2.5 mg and 30 mg doses, respectively, depending on body weight and age as well as the patients’ renal function. Professor Kim Namho of internal medicine department at Wonkwang University Hospital commented, “An elderly female patient aged about 80 and underweight at around 40 kg would be considered high risk when treating anti-coagulation. But a patient manifesting CrCl of over 50 mL/ min or at the borderline, prescribing the indicated dose may not be advisable. And cases of using low-dose NOAC have been reported in one out of two atrial fibrillation patients.” The professor added, “If the dose control is inevitably needed for the patients’ condition, basing it on evidences collected so far would be crucial. As real world data on Korean patients have been accumulated, the prescribers should refer to the evidences accordingly when prescribing the right drug in right dose.” Meanwhile, the renal function may start to fail irreversibly depending on the age or heart function of the patient. As the renal function heavily affects bleeding, the next issue to be addressed and explored would be which NOAC to use in atrial fibrillation patient with expected failure or already low renal function.
- 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.
- Company
- Hanmi, promotes COVID-19 tx, Ambroxol HCl Sln for Inhalation
- by Aug 10, 2020 06:00am
- Beijing Hanmi’s Ambroxol HCl Solution for Inhalation Hanmi's Chinese subsidiary, Beijing Hanmi Pharmaceutical, announced on the 6th that it will develop a secretolytic agent, 'Ambroxol HCl Solution for Inhalation' as COVID-19 treatment. Earlier, top expert consensus in Chinese pediatrics and two organizations at the drug management control center in Guangdong Province, China, commented on 'Ambroxol HCl Solution for Inhalation' as a recommended drug for COVID-19. In China, prognosis that significantly lowers the risk of hypoxia death due to 'acute respiratory disorder symptom (ARDS)' and 'cytokine release syndrome (CRS)', an overactive immune response, has been reported in patients with COVID-19 who received 'Ambroxol HCl Solution for Inhalation' for the purpose of treating expectorant. 'Ambroxol HCl Solution for Inhalation' is a treatment for a secretolytic agent in the form of a vaporizer that is inhaled by mouth. Since its first commercialization in Germany in 1979, it is based on 'Ambroxol', which is widely used around the world. Alveolar Type II Cells secrete surfactants so that expectorants do not stick to the alveoli and are easily discharged. It was approved in July of last year in China. Hanmi plans to promote a clinical trial that uses the expectorant in combination with COVID-19 treatment. Starting with Hyeophwa Hospital affiliated with Wuhan University of Science and Technology, which is a 5,000-bed high-level university hospital in Wuhan, China, a full-scale clinical discussion has begun with Beijing Ditan Hospital and Shanghai Public Health Clinical Center. Hanmi is in the process of obtaining approval for this expectorant in the US, Europe, and Korea. An official of Hanmi said, "This expectorant's clinical trial will be linked to the 'Hanmi Covid MDT Program', an innovative integrated treatment regimen of Hanmi that covers the entire COVID-19 treatment."
- 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).
- Company
- AZ, Takeda and Pfizer to compete in PARP inhibitor market
- by Eo, Yun-Ho Aug 07, 2020 06:28am
- The competition ground among poly ADP ribose polymerase (PARP) inhibitors targeting BRCA gene has widened as Pfizer entered the South Korean market following the footsteps of AstraZeneca and Takeda Pharmaceutical. According to the pharmaceutical industry sources, the Korean health authority approved of Pfizer Korea’s Talzenna (talazoparib), indicated to treat patients with germline BRCA (gBRCA)-mutated breast cancer, on July 30. Unlike AstraZeneca’s Lynparza (olaparib) and Takeda Pharmaceutical’s Zejula (niraparib) with initial indication for treating ovarian cancer, Talzenna started off with the indication for treating breast cancer. Talzenna was approved as a single therapy to treat patients with gBRCA-mutated human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. A PARP inhibitor, Talzenna suppresses PARP1 and PARP2 genes that produce proteins involved in DNA repair. As a result, the medicine hinders the DNA repair in gBRCA-mutated cancer cell and induces cancer cell death. The latest approval was based on Phase III, open-label, randomized EMBRACA trial outcome that tested Talzenna against healthcare provider’s choice of chemotherapy in 431 patients with a gBRCA mutated and locally advanced or metastatic HER2- breast cancer, who may have received up to three prior chemotherapies. The primary endpoint of EMBRACA trial evaluated median progression-free survival in Talzenna-only group (8.6 months) against chemotherapy group (5.6 months), and confirmed significant improvement made by Talzenna. The study also found the drug reduced the risk of disease progress or death by 46 percent more than the chemotherapy. The key subgroup analysis among patients with triple-negative breast cancer, hormone receptor positive, and relapsed metastasis in central nervous system also confirmed the benefit of improving PFS. For the second endpoint objective response rate (ORR), the Talzenna group demonstrated 62.6 percent and doubled the chemotherapy group’s ORR at 27.2 percent. Meanwhile, the two other PARP inhibitors in the market are already hectic preparing for the indication and healthcare coverage expansion. Lynparza took the pharmacoeconomic evaluation-exemption route and settled on the expenditure cap type risk sharing agreement (RSA) in October 2017. It was initially listed for maintenance therapy in patients with ovarian cancer after chemotherapy, but it is now in progress of expanding healthcare coverage on indications—first-line maintenance therapy in patients with BRCA mutated metastatic ovarian cancer, single maintenance therapy in patients with platinum-sensitive recurrent high-grade epithelial ovarian cancer, and in patients with HER2- metastatic breast cancer. In late last year, Zejula was also listed as a maintenance therapy in patients with ovarian cancer who have received chemotherapy. Now the drug is seeking for reimbursement expansion as a maintenance treatment in gBRCA mutation-negative patients with recurrent epithelial ovarian cancer, who are in a complete or partial response to platinum-based chemotherapy, and also as a single therapy treating patients with relapsed ovarian cancer, who have received more than four chemotherapies. However, the Cancer Deliberation Committee, the starting point of the coverage expansions, has been skeptical about Lynparza in mBRCA and Zejula in gBRCA-negative indications and denied the expansion.
