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- 2025-12-26 22:50:17
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- Domestic supply of Nimbex has been discontinued
- by Oct 27, 2020 06:11am
- NimbexAccording to the distribution industry on the 23rd, 'Mitsubishi Tanabe, which is in charge of distribution and sales of Nimbex in Korea, sent an official letter to the wholesale industry and announced that Nimbex will cease distribution in Korea on November 3rd. Mitsubishi Tanabe said, "Due to internal circumstances such as the productivity problem of the manufacturer Aspen, there is no additional supply and demand plan since the imported volume in May." The company said that it can only be sold until November 3rd. Nimbex was changed once from GSK to Aspen. In June 2018, GSK transferred the Nimbex rights to South African pharmaceutical company Aspen, and the domestic seller was changed to Mitsubishi Tanabe. Mitsubishi Tanabe has been distributing the product for two years, but this time Aspen decided to stop supplying it. It is believed that there are no plans to resupply in the future. Nimbex's inventory is 1,542 cases for 10ml/5amp and 20 cases for 2.5ml/5amp. The validity period is December 1, 2021 and January 23, 2022, respectively. Nimbex is a drug with two or less identical ingredients (No. 3) among drugs with production and import records in the previous year, and a drug with a market share of 50% or more (No. 4) among product groups with the same ingredient. Mitsubishi Tanabe recently reported the discontinuation to the MFDS. MSD's Esmeron and Hana Pharm's Atra are mentioned as generics for Nimbex.
- Company
- Pfizer’s EGFR TKI Vizimpro to get listed by the year-end
- by Eo, Yun-Ho Oct 26, 2020 06:15am
- Pfizer’s epidermal growth factor receptor (EGRF) tyrosine kinase inhibitors (TKI) Vizimpro (dacomitini) is predicted to get listed for National Health Insurance (NHI) reimbursement within this year. The pharmaceutical industry sources reported the fifth ERGR TKI Vizimpro is to begin the pricing negotiation with National Health Insurance Service (NHIS) soon. As the negotiation is due within 60 days, the drug could receive reimbursement by the end of the year if the administration procedure is processed promptly. Currently, the first generation EGFR TKI ‘Iressa (gefitinib)’ by AstraZeneca and Tarceva (erlotinib) by Roche, and the second generation Giotrif and the third generation Tagrisso (osimertinib) by AstraZeneca are prescribed in South Korea. The key competition takes place in the non-small cell lung cancer (NSCLC)-treating indication. As the direct competitor Giotrif has already taken root in the market, Vizimpro decided to take the weighted average pricing as an alternative drug and took the fast-track review route. Without the burden of setting the upper limit pricing, the negotiation with NHIS is expected to cruise on without much of issue. Vizimpro’s efficacy has been confirmed in Phase III ARCHER 1050 trial. The study compared Vizimpro and the first-generation Iressa head-to-head with total 452 patients fighting against NSCLC. In the trial, the medicine reduced the risk of progression-free survival (PFS) by 41 percent compared to Iressa, as Vizimpro patient group’s median PFS was at 14.7 months and Iressa group’s was at 9.2 months. Nevertheless, Vizimpro showed worse cases of adverse reactions. In the Vizimpro group, the frequently demonstrated severe adverse reactions included dermatological issues with pimple (14 percent) and diarrhea (8 percent), whereas changes in liver enzymes (8 percent) were significant in the Iressa group. Around 60 percent of Vizimpro patient group had to adjust their medication dose due to adverse reaction. Vizimpro is a second-generation targeted therapy indicated to treat patients with EGRF-mutation-positive NSCLC. The U.S. Food and Drug Administration (FDA) approved the anticancer treatment in September 2018 after granting Priority Review in January same year. Currently, the drug is approved and used in the U.S., EU and Japan. In South Korea, the medication has been approved as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC, and it is also indicated to treat patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations, who have not been treated before.
- Company
- Whanin·Myung In successfully evaded patent for Fycompa
- by Kim, Jin-Gu Oct 26, 2020 06:15am
- Fycompa Myung In and Whanin succeeded in circumventing some of the patents of 'Fycompa (Perampanel anhydrous)', an epilepsy treatment. The two companies will be able to launch generics as early as October 2023. On the 21st, the Intellectual Property Trial and Appeal Board issued a trial decision for ``establishment of claim'' at the judgment on the passive scope of rights for crystal patent of Fycompa (October 14, 2026), which Myung In and Whanin claimed against Eisai. As a result, the two companies met two of the three requirements for the early release of generics (first request for trial and trial decision for claim establishment). One of the remaining requirements is 'application for approval for the first generic'. For now, it is very likely that both companies will achieve this requirement at the same time. The two companies are conducting bioequivalence tests for the generic for Fycompa. Whanin has started bioequivalence tests in May of this year and Myung In in July. Fycompa's PMS expires July 9, 2021. Considering that it is possible to apply for an item permission after the expiration of the PMS, this means that about 9 months will be given. It's time to end the bioequivalence test. Assuming that the two companies apply for product license at the same time, the generic release is expected to be on or after October 14, 2023. It is when Fycompa's material patent expires. The two companies did not file a separate patent trial for material patents. Fycompa is a new drug for epilepsy that was launched in Korea in February 2016. In particular, it can be used as a monotherapy for adolescents 12 years of age or older with partial epilepsy seizures, and prescription performance is increasing. According to UBIST, Fycompa's annual prescription amount increased more than three times in three years to ₩1.3 billion in 2016, ₩3 billion in 2017, ₩3.7 billion in 2018, and ₩4 billion in 2019. Fycompa's prescription amount was worth ₩3.2 billion until September this year.
- Company
- CKD top candidate for Amgen’s Evenity co-promotion partner
- by Oct 26, 2020 06:14am
- A product image of Amgen Evenity. As Amgen’s novel osteoporosis drug Evenity (romososumab) is expected to get listed for reimbursement by the end of the year, the multinational company is reportedly seeking for a co-promotion company. The current partner company for Prolia (denosumab) co-promotion, Chong Kun Dang, is considered as the strongest candidate. According to pharmaceutical industry sources on Oct. 22, Amgen is in process of searching for a South Korean co-promotion partner as they aim to receive the National Health Insurance (NHI) reimbursement within this year. The sources claim Chong Kun Dang is on top of the list. In September 2017, Chong Kun Dang signed a co-promotion deal with Amgen for other osteoporosis drug Prolia, which is still effective to this date. Prior to its reimbursement listing in October 2017, Amgen shook hands with the South Korean company to leverage the sales in Prolia. Boosted by the coverage approval and the co-promotion deal, Prolia’s sales surged soon after. The sales marked 2.4 billion won in the fourth quarter of 2017, almost doubling the initial quarterly sales at launch of 1 billion won. The quarterly sales skyrocketed to 12.3 billion won in April last year, after its reimbursement standard was expanded to first-line therapy. The cumulative sales up to the first half of 2020 reached 100.6 billion won. And because Amgen is to take the marketing strategy of introducing Evenity as a sequential combination therapy with Prolia, Chong Kun Dang is the most likely candidate. Prolia is a bone resorption inhibitor, launched earlier, and Evenity is a bone-builder and a bone resorption inhibitor. Amgen set down a therapeutic strategy to administer Evenity first to postmenopausal women fracture and men with osteoporosis at high risk for fracture (maximum 12 months), and to continue on with Prolia as maintenance therapy. In fact, their clinical trial has been conducted as a sequential therapy. Compared to the placebo group after 12 months, the Evenity group had 73 percent lower risk of new vertebral fracture. The patient group that switched to Prolia (denosumab) at year 2 after 12 months of using Evenity showed 75 percent lower risk of new vertebral fracture, compared to the placebo group switching to Prolia. Considering Evenity’s marketing strategy has to be in accordance with Prolia’s, the existing co-promotion partner Chong Kun Dang would be the most efficient option. Sources confirmed, the two companies are already in talks to expand their deals to also cover Evenity. When the final contract is inked, Chong Kun Dang is expected to initiate the co-promotion activities from next year after the novel osteoporosis drug is listed. The industry source commented, “We are anticipating to a see a positive level of synergy effect created from Evenity as Amgen and Chong Kun Dang are already in a good collaboration for Prolia.”
- Company
- Rosuzet soars despite COVID-19, Lipitor tops market again
- by An, Kyung-Jin Oct 23, 2020 09:46am
- On Oct. 23, a pharmaceutical market research firm UBIST reported a dyslipidemia treatment Lipitor defended its top spot again in the outpatient prescription market this third quarter reaching a cumulative prescription volume of 140.1 billion won. Compared to the third quarter last year at 143.1 billion won, the figure dipped 2 percent, but its prescription volume doubled Daewoong Bio’s Gliatamin’s. In 1999, Pfizer Pharmaceutical Korea launched a hyperlipidemia treatment Lipitor (atorvastatin) in the South Korean market. After its patent expired, about 130 generics were released but it has never fell below second place in the prescription drug market for over a decade. Daewoong Bio’s cognitive function enhancing choline alfoscerate, Gliatamin generated a cumulative prescription volume of 73.8 billion won and stayed at the second spot. Compared to the previous year at 70.2 billion won, the prescription volume grew by 5.1 percent. During the same time, another competitor Chog Kun Dang Gliatirin marked 63.3 billion won this third quarter and leapt by 12.4 percent. Regardless of the controversy on the choline alfoscerate efficacy and the novel coronavirus (COVID-19), the two drugs were able to maintain their prescription volume. 2020 Q3 cumulative outpatient performance rank (Unit: KRW 1 million) Source: UBIST Among the top products in the prescription drug market, Hanmi Pharmaceutical’s Rosuzet had the highest growth. For nine months, Rosuzet generated f 72.8 billion won and had a 24.3-percent surge compared to last year. Basically, the average monthly volume was over 8 billion won. Launched in the Korean market in late 2015, Rosuzet is a dyslipidemia treatment consisting of rosuvastatin and ezetimibe. Hanmi Pharmaceutical licensed in the use of ezetimibe from the patent owner MSD and allowed itself to take the generic market faster than other competitors. While the competition among rosuvastatin plus ezetimibe combination drug market is intensifying day by day, Rosuzet has been on the top of the charts with a significant gap from the competitors. Despite the difficulties in the sales and marketing activity amid COVID-19, Rosuzet’s quarterly prescription volume showed over 20 percent growth every quarter and marked a record high prescription volume. The drug kept a steady prescription volume in the second and third quarters, when the confirmed cases of COVID-19 exploded. The industry experts predict the drug’s annual prescription volume could break through the 100 billion won line. Meanwhile, the off-patent drugs had contrasting results. Boehringer Ingelheim’s hypertension combination drug Twynsta had prescription volume of 70.6 billion won and grew by 2.0 percent from last year same time, but Sanofi’s anticoagulant Plavix had a 1.2-percent dip. AstraZeneca’s dyslipidemia treatment Crestor also stepped down by 5.5 percent. But the market experts claim the fluctuating growth is not too concerning as the government has ordered stricter social distancing measures from last August and the country’s general economy was stagnant. AstraZeneca’s anticancer treatment Tagrisso (osimertinib) placed itself on the sixth place after climbing up 4.8 percent from last year and generated 65.9 billion won. The anticancer treatment is prescribed to non-small cell lung cancer patients who have developed tolerance on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as Iressa (gefitinib), Tarceva (erlotinib) and Giotrif (afatinib). Its prescription volume has been skyrocketing since its National Health Insurance (NHI) listing green lit in December 2017. Although its price is still high at 120,000 won with the reimbursement, the convenient oral drug is the only anticancer treatment found among the top prescribed drugs for outpatients. A hepatitis B treatment Viread (tenofovir disoproxil fumarate) that used to top the prescription drug market took a steep 25.9-percet fall in just within a year, raising 64.9 billion won. In the same year, the prescription volume of Bristol-Myers Squibb (BMS) Pharmaceutical Korea’s hepatitis B treatment Baraclude (entecavir) was brought down by 10.8 percent from 39 billion won to 34.8 billion won.
- Company
- Rinvoq is in the process of prescribing general hospitals
- by Eo, Yun-Ho Oct 23, 2020 09:44am
- The third JAK inhibitor Rinvoq was received for prescription in general hospital. The synergy is expected as the application of insurance benefits became visible from November. According to related industries, AbbVie Korea recently concluded a drug price negotiation between the NHIS and the oral autoimmune disease treatment Rinvoq (Upadacitinib), and listed. Applications of DC to major general hospitals including Big 5 are in progress from October. It recently concluded a drug price negotiation with the NHIS, and listed. AbbVie focused on the pace of Rinvoq's listing by accepting the weighted average price of alternative drugs because Pfizer's Xeljanz (Tofacitinib citrate) and Lilly's Olumiant (Baricitinib), which have the same mechanism, are already listed. Rinvoq's permit-reimbursement linkage system was also very useful. As a result, the drug, which was approved in Korea in June, was put on the reimbursement list in about five months. Janus kinase (JAK) inhibitors, such as Xeljanz, Olumiant, and Rinvoq, were the first oral options that proved equivalent to anti-TNF drugs in the area of autoimmune diseases, and have received a lot of attention. However, it has not yet exerted as much influence as biological agents in the market. Anti-TNF drugs and anti-interleukin drugs are also active, but the indications for JAK inhibitors were relatively narrow in areas other than rheumatoid arthritis. JAK inhibitors have potential. Xeljanz, which was first developed last year, secured additional indications such as ulcerative colitis and psoriatic arthritis, and generics, including Rinvoq, are also conducting research to expand indications for autoimmune diseases such as atopic dermatitis, Crohn's disease, and ankylosing spondylitis. Rinvoq proved its effectiveness through five phase III SELECT clinical trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE, SELECT-EARLY) in which 4,443 patients with moderate to severe active rheumatoid arthritis participated. In phase III clinical results, Rinvoq showed lower disease activity and improved clinical response rate compared to placebo, MTX or Humira(Adalimumab) group when used alone or in combination with a conventional synthetic antirheumatic drug (csDMARD). Seong-Hwan Park, a professor of rheumatology at Seoul St. Mary's Hospital, said, "Rinvoq shows a 20% higher remission rate compared to MTX at week 12 in SELECT-COMPARE, a phase III clinical trial administered in combination with MTX, which is a standard therapy. and he said that it will be used as a new treatment option that provides an opportunity to improve the quality of life.
- Company
- Kisqali to be listed November starting three-way competition
- by Eo, Yun-Ho Oct 22, 2020 06:32am
- The cyclin-dependent kinase 4/6 (CDK4/6) inhibitor market is expanded to a three-way competition. A pharmaceutical industry source reported, Novartis’ hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer treatment Kisqali (ribociclib) has concluded the pricing negotiation with National Health Insurance Service (NHIS). The drug is expected to get listed for reimbursement through a refund type risk sharing agreement (RSA). As a third CDK4/6 inhibitor, Kisqali entered the market the last but its position is not completely negative. The main competition in the market centers the Faslodex (fulvestrant) combination therapy, in which Pfizer’s Ibrance (palbociclib) and Lilly’s Verzenio (abemaciclib) are already in the game with five months gap apart from the point of reimbursement listing. Ibrance and Verzenio were approved in South Korea in August 2016 and May last year, respectively. But considering Kisqali was approved last year October, its gap of reimbursement listing with those two drugs was relatively short. Moreover, Kisqali’s reimbursement standard is looser than the first two drugs. The drug can be prescribed not only to postmenopausal patients who have never had an oophorectomy, but also to premenopausal patients, which would make Kisqali a favorable option. Professor Im Seock-ah of Hemato Oncology Department at Seoul National University Hospital explained, “The MONALEESA-7 study was mainly proposed and led by an Asian researcher, and had 30 percent of Asian patients as registered sample. These findings reflect how Asian region still has a great need for a new treatment option in premenopausal women with breast cancer”. The Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as a first-line treatment in pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer, and confirmed the drug’s effect of significantly extending patient’s overall survival (OS). Specifically, the Kisqali combination group demonstrated median progression-free survival (mPFS) of 23.8 months, whereas endocrine therapy only group had 13 months. In a subset analysis on Asian patients only, the Kisqali combination group’s mPFS was at 24.7 months, which was about 14 months longer than the endocrine therapy only group’s. Also in Phase 3 MONALEESA-3 study, Kisqali confirmed its effect of extending the OS in pre and postmenopausal women. At the point of 42 months, the OS in Kisqali combination group was at 58 percent, and fulvestrant only group was at 46 percent.
- Company
- Samsung-AZ joint venture contemplates on Mabthera biosimilar
- by Kim, Jin-Gu Oct 22, 2020 06:30am
- Mabthera product image. A subsidiary of Samsung Biologics, Archigen Biotech (“Archigen”) has successfully completed clinical trials but it has not yet disclosed its further plan on the product in development. While Archigen’s sole portfolio is a Mabthera (rituximab) biosimilar in development, the industry is paying attention to the correlation between Archigen’s silence and the saturated Mabthera biosimilar market. A source from the pharmaceutical industry told on Oct. 19, Archigen has completed a Phase III trial on 'SAIT101' treating patients with follicular lymphoma and published the outcome. The study was conducted in the U.S., Europe, Japan and South Korea. According to the clinical trial information website ‘ClinicalTrials.gov’ managed by the U.S. National Institutes of Health (NIH), the study started from June 2016 and ended in last January. The outcome of the study was presented in last August after data analysis. The trial had total 315 participating patients with follicular lymphoma, in which 158 patients were treated with Mabthera and the rest of 157 patients treated with SAIT101. The outcome seemed generally successful. The primary endpoint, overall response rate (ORR) in the Mabthera group marked 70.6 percent and the SAIT101 group marked 66.3 percent. Prior to the disclosure, a Phase I trial outcome comparing the Korean-made biosimilar against Mabthera in treating rheumatoid arthritis was published in last February. The outcome was also deemed successful as the biosimilar’s efficacy was on par with Mabthera. Disclosed information on Archigen’s Phase III trial on SAIT101 treating patients with follicular lymphoma (top) and Phase I trial on treating rheumatoid arthritis (Source: ClinicalTrials.gov) However, the company has not spoke of any prospective plan on the drug for two months and even for eight months. The industry sources say it is an exceptional case. Usually, a company would announce additional clinical trial or item approval plan around the point of announcing the clinical trial result. Archigen’s parent company, Samsung Biologics gave an explanation in principle only. The company official said, “We would have an opportunity in the future to speak of the prospective plan.” Archigen is a biosimilar-specializing company established in 2014 as Samsung Biologics and AstraZeneca’s joint venture with 50/50 partnership. With that in mind, the South Korean company would not be able to make a prospective plan by itself. Regardless, the pharmaceutical industry has a different view in why Archigen is contemplating for a long time. It is a convincing story that SAIT101, as a latecomer, would not have a favorable position entering the market. At the moment, Celltrion, Pfizer and Sandoz are having a heated competition in the Mabthera biosimilar market. In the European market, Celltrion’s Truxima, Sandoz’ Rixathon, and Pfizer’s Ruxience have been released. And due to the series of biosimilars launched in the market, the original Mabthera’s sales have been halved. Meanwhile, Sandoz has decided to pursue sales in the world’s biggest market, the U.S. with low marketability expected. The industry experts analyze the company felt the strain to enter the market after Celltrion promptly expanded its market share. When launching its latecomer drug Ruxience in the biosimilar market, Pfizer lowered 15 percent of Truxima’s price. On the contrary, some claim Samsung Biologics and AstraZeneca would push ahead with the product launch to retrieve the investment made so far, worth approximately 250 billion won. A pharmaceutical industry source explained, “The Mabthera biosimilar market is a tough one as even Sandoz, considered as the biggest competitor of Celltrion, backed out from the U.S. market and Pfizer also had to lower the price of its follow-on drug by 15 percent,” so “Samsung Biologics would have to make a difficult decision to break through the challenging market.”
- Company
- Submission of α-GPC clinical reevaluation plan is imminent
- by Chon, Seung-Hyun Oct 20, 2020 06:35am
- Pharmaceutical companies are preparing in earnest with two months ahead of the deadline for submitting data for the clinical reevaluation plan of Choline alfoscerate. They are contemplating the indications for clinical trials and clinical work. The method of paying the cost of clinical trials and the process of selecting participating companies will not be easy. According to industry sources on the 19th, the MFDS announced in June that it would conduct a clinical reevaluation of Choline alfoscerate. The MFDS requested that 134 companies submit the results of domestic clinical trials for 255 items. In case of conducting a clinical trial, it was instructed to submit a clinical trial protocol by December 23rd. Accordingly, companies that hold Choline alfoscerate are busy preparing clinical trial plans. According to the existing clinical re-evaluation practice, it is highly likely that companies with large sales will take the lead in conducting clinical trials and other companies will participate in a way that shares the cost. Companies such as Chong Kun Dang and Daewoong Bio have started to set up a full-fledged clinical trial plan. It is said that these companies will soon meet with the MFDS representative to discuss clinical trial design, etc. Choline alfoscerate is a drug that has three indications: ▲Secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral temperamental syndrome ▲Emotional and behavioral changes, and ▲senile pseudodepression. In principle, clinical trials for each indication should be conducted and data proving efficacy should be submitted. However, pharmaceutical companies are also considering how to set targets and conduct clinical trials by slightly changing existing indications. The MOHW acknowledged that it is effective against 'secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral stromal syndrome' of patients diagnosed with dementia, and determined the positive list system for patients diagnosed with dementia and other patients. The method of separating and conducting clinical trials was also being considered. A method of separately conducting clinical trials by dividing the indication area for each pharmaceutical company could also be promoted. Another brain function improvement agent 'Acetyl-L-Carnitine' was also divided by company and clinical reevaluation was conducted. Acetyl-L-Carnitine, generic for Dong-A ST's Nicetile, has been approved for use in 'primary degenerative diseases' or 'secondary degenerative diseases caused by cerebrovascular disease'. When The MFDS ordered a clinical re-evaluation in 2013, Dong-A ST took the lead in conducting a “primary degenerative disease” clinical trial. Hanmi was in charge of the clinical trial for "secondary degenerative diseases caused by cerebrovascular disease." In July last year, Acetyl-L-Carnitine was removed from the indication for a “primary a degenerative disease” because the clinical results conducted by Dong-A ST did not meet the efficacy. Hanmi is still undergoing clinical trials. When the clinical trial design and clinical method of Choline alfoscerate are determined, the recruitment process for participating companies is expected to proceed. At this time, it is also an issue of how each company will bear the cost of clinical trials. If each company decides to pay the same clinical cost, companies with small sales volume of Choline alfoscerate will have to consider participating in reevaluation. If the submission of clinical reevaluation data is abandoned, the authorization will be revoked. The risk of redemption due to the price-volume agreement is also a burden for pharmaceutical companies. Recently, some pharmaceutical companies with Choline alfoscerate agreed to adjust drug prices according to the price-volume agreement negotiation system. The agreement stipulated that when a clinical trial is conducted for the renewal of the MFDS's product license and re-evaluation of drugs, the relevant facts should be notified to the NHIS. If the approval is withdrawn as a result of reevaluation, etc., the pharmaceutical company has a clause that requires the NHIS to return the full amount of the bill from the date the MFDS makes the clinical trial to the date of the removal of the list. If a pharmaceutical company has agreed to reduce the drug price of Choline alfoscerate according to the price-volume agreement negotiation system, and withdrawal from the market as a result of a re-evaluation later, all sales sold so far must be returned to the NHIS. If pharmaceutical companies fail to demonstrate the efficacy of Choline alfoscerate in clinical trials, approval may be revoked in the worst case. At this time, for products that have undergone the price-volume agreement negotiation system, all prescription amounts must be returned from negotiation to cancellation of the license. For example, if Choline alfoscerate with an annual prescription amount of ₩10 billion is canceled due to a clinical trial failure 5 years after the price-volume agreement negotiation system, ₩50 billion will be required. Drug price agreement based on the Price-Volume agreement Pharmaceutical companies are inevitably burdened with clinical reevaluation. An industry official said that there are a lot of homework from setting up clinical design to recruiting participating companies with about two months left until the submission of the clinical reevaluation plan. He said, "With the burden of uncertainty about the revaluation results, a lot of pain between pharmaceutical companies is inevitable."
- Company
- Can novel bone-builder Evenity win reimbursement this year?
- by Eo, Yun-Ho Oct 20, 2020 06:34am
- Apparently, a novel bone-builder Evenity is making its last push to nab the National Health Insurance (NHI) benefit by the end of the year. The South Korean pharmaceutical industry sources reported, Amgen Korea and National Health Insurance Service (NHIS) have recently initiated a pricing negotiation on an osteoporosis drug Evenity (romososumab) indicated to promote bone formation and inhibit bone resorption. As the 60-day negotiation is due next month, the drug could be listed for reimbursement within this year if the administrative procedure rushes on. After receiving an approval for the South Korean market in May last year, the drug applied for reimbursement listing after a year. The Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) green lit the listing after confirming the feasibility. The drug is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, and for bone formation in men with osteoporosis at high risk for fracture. The specialists have been anticipating for the novel drug as it is the only bone-builder to have proven the effect of lessening hip fracture. As any of novel osteoporosis drugs had struggled through most of their reimbursement listing process in South Korea, Evenity would have to see if it could successfully get listed. For about a decade, 70 percent to 80 percent of osteoporosis patients in South Korea have been using bisphosphonate, which was tackled on its strict limitation for drug administration and efficacy lacking sufficient data. In fact, a bone formation medicine Forsteo (teriparatide) has taken a decade from item approval to reimbursement listing. Amgen’s Prolia was also approved for the South Korean market in 2014 and launched as a non-reimbursed treatment in November 2016, but finally got to list its name in October 2017. President of Korean Society for Bone and Mineral Research (KSBMR) Chung Ho-yeon noted, “Osteoporosis treatment prioritizes prevention of bone fracture. So a treatment option preventing bone loss while forming new bone would induce prompt treatment benefit.” The efficacy of Evenity has been confirmed during Phase III FRAME and ARCH studies, as well as in Phase III 3 BRDIGE study for the indication treating male patients. In the Phase III placebo-controlled FRAME study, Evenity has demonstrated effect of reducing the risk of new vertebral fracture in postmenopausal women with osteoporosis at risk for fracture resulting in bone mineral density (BMD) T-score of -2.5 to -3.5 at the total hip or femoral neck. Compared to the placebo group after 12 months, the Evenity group had 73 percent lower risk of new vertebral fracture. The patient group that switched to Prolia (denosumab) at year 2 after 12 months of using Evenity showed 75 percent lower risk of new vertebral fracture, compared to the placebo group switching to Prolia. And in Phase III alendronate-controlled study ARCH, Evenity confirmed preventive effect of reducing risk of vertebral fracture and clinical fracture superior than alendronate. Compared to the patient group treated only with alendronate, the patient group switched to alendronate after being treated with Evenity for 12 months had 50 percent lower risk of new vertebral fracture at 24 months.
