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- 2026-04-13 17:39:02
- Policy
- DUR check for more than 28 days of Zolpidem combined Rx
- by Lee, Hye-Kyung Sep 29, 2021 05:54am
- In the future, 49 drug ingredients, such as "Zolpidem," that should be careful during the administration period, will also be checked for drugs that exceed the maximum administration period by adding up the number of prescription days. The HIRA announced that it will apply "improvement of DUR inspection standards" to 345 items (213 reimubrsed drugs and 132 non reimbursed drugs) of 49 medicines that need to be careful of the administration period from November. Currently, DUR inspections on drugs that are subject to the period of administration are conducted only on drugs that exceed the maximum administration period per Rx. If 20 days' worth of Zolpidem-based drug A and 20 days' worth of B-based drug are prescribed in one prescription, the maximum administration period of 28 days. However, if a patient visits two medical institutions and receives 20 days' worth of prescriptions for Zolpidem-based drug at medical institution A and 20 days' worth of Zolpidem-based B drug at medical institution B, it is excluded from the DUR inspection as a separate prescription. As a result, out of the 102 million outpatient DUR information provided by the HIRA last year, 1.6 million cases, or 1.6%, were provided with medication information for the period of administration. Therefore, it was decided to check all prescriptions prescribed, induce proper use of medicines, and strengthen patient safety.
- Policy
- Delstrigo listed at ₩19,491 … Zejula’s price cut 6%
- by Kim, Jung-Ju Sep 29, 2021 05:53am
- MSD Korea’s fixed-dose combination product Delstrigo (doravirine·lamivudine·tenofovir disoproxil fumarate) will be listed with insurance benefit next month, at ₩19,491. Also, reimbursement for Takeda Korea’s Zejula cap. 100mg (niraparib) has been extended to cover monotherapy for ovarian cancer, upon which the price was cut by 6% and will be reimbursed at the price. The Ministry of Food and Drug Safety held a Health Insurance Policy Deliberation Committee (HIPDC) meeting today and passed the ‘proposed amendment to the drug benefit list and price ceiling table.’ The amended list and table will be effective from October 1st. ◆Pifeltro·Delstrigo tab.= MSD Korea’s Pifeltro tab(doravirine) and Delstrigo tab(doravirine·lamivudine·tenofovir) are oral HIV medications that are taken as one tablet, once daily. One year after receiving approval from the MFDS on November 22nd, 2019, the company applied for insurance listing of the two products in December last year and received deliberation for the insurance benefit by HIRA’s Pharmaceutical Benefit Assessment Committee in early June. Delstrigo tab(doravirine·lamivudine·tenofovir disoproxil fumarate르). At the time, the PBAC determined the drugs to be cost-effective, as they are recommended for the treatment of HIV infections in textbooks and clinical practice guidelines and accepted the price of less than 90% of the weighted average price of its alternatives. The alternatives to Pifeltro are the non-nucleoside reverse transcriptase inhibitors Stocrin and Edurant tablets. And alternatives to Delstrigo are 2 NRTI + NNRTI combo therapies such as Triumeq and ‘Troubadour+stocrin, ‘Descovy+Edurant’. Pifeltro is listed in all A7 countries abroad, and its weighted average price is ₩24,099 per tablet. Delstrigo is listed in the U.S, France, Germany, Italy, U.K, Switzerland among the A7 countries, and is its weighted average price is ₩36,483 per tablet. In the same month, the company had made negotiations with the National Health Insurance Service on the amount of expected claims of each drug. The NHIS expected no additional funds The final listed insurance price of each drug was set at ₩7,975/ tablet for Pifeltro and ₩19,491/tablet for Delstrigo. ◆Lynparza 100mg and 150mg = AstraZeneca Korea’s Lynparza tab(olaparib) is a treatment for ovarian cancer including fallopian tube cancer or primary peritoneal cancer. The drug was listed through the risk-sharing agreement scheme (RSA) in October 2017, using the pharmacoevaluation exemption system. However, its reimbursement was first only allowed for up to 15 months as maintenance therapy after chemotherapy, and then the restriction was lifted in May 2019 after discussions between the government and the company to extend reimbursement. After then, the company received MFDS approval on October 29th 2019 and applied for insurance benefits in January 2020. In June of the same year, the agenda was deliberated by HIRA’s Cancer Drug Review Committee, but the company had to reapply for reimbursement in October of the same year. The drug was finally put on the agenda for deliberation by HIRA’s PBAC in April this year. In April, the PBAC confirmed that the drug prolonged PFS compared to placebo from a clinical trial. Also, the committee decided that the ICER is at an acceptable level for use as first-line maintenance therapy and that the drug was cost-effective as second-line maintenance therapy as it cost less than its alternatives, Lynparza cap, and Zejula cap. The adjusted price of Lynparza tab that is listed in all A7 countries is ₩62,062 for the 100mg tab and ₩67,911 for the 150mg tab. Based on the calculated price, the company had been negotiating with the NHIS on the drug’s price and expected claims amount. During the pricing negotiations, both parties agreed on incorporating two types of reimbursement where the company pays back to NHIS a specific portion of the claims amount and a specific portion of the amount of claims that exceed the expected cap. The final price was set at ₩38,842 for 100mg and ₩48,553 for the 150mg dose. Zejula cap. 100mg (niraparib).◆Zejula cap. 100mg = Like Lynparza, Takeda Korea’s Zejula cap 100mg(niraparib) is also a treatment for ovarian cancer including fallopian tube cancer or primary peritoneal cancer that is already receiving reimbursement for the indication. 200mg of the targeted therapy is taken orally twice a day and has been reimbursed as second-line maintenance therapy for ovarian cancer since December 2019, and the reimbursement has been extended to treat patients with recurrent ovarian cancer who have received 3rd-line or higher chemotherapy since February this year. This time, discussions had been held to extend reimbursement to maintenance monotherapy in ovarian cancer for patients who have responded to first-line platinum-based chemotherapy. The company succeeded in adding the indication by MFDS on August 3rd last year and has requested an extension of reimbursement in the same month. In January, the drug has passed CDRC deliberations and was deliberated by the PBAC in June. At the time, HIRA had determined for reimbursement is appropriate as the drug is recommended as maintenance therapy in ovarian cancer patients who have responded to first-line platinum-based chemotherapy and is cost-effective as it is cheaper than alternative drugs. Also, it is listed in the U.S, France, Japan, Italy, U.K, Switzerland among A7 countries and its weighted average price is set at ₩129,886 per tablet Since then to earlier this month, the company had negotiated with the NHIS on the drug’s price and expected claims amount. Both parties had agreed that the company should pay back a specific portion of the amount of claims that exceed the expected cap, and the price to be set at 6% lower than the current cap of ₩74,184 and at ₩69,733.
- Company
- ST Pharm’s new cash cow ‘oligonucleotide’
- by Kim, Jin-Gu Sep 28, 2021 05:54am
- The oligonucleotide API business has become a major business of ST Pharm. The company has signed many deals over the past three years and the expansion and expectations for contract extensions have also greatly contributed to improving the company’s performance. Experts expect the oligonucleotide API business to stay as a cash cow for ST Pharm for a decade to come, with the global surge in demand for oligonucleotide API and the fact that most contracts signed by ST Pharm are long-term contracts. On the 27th, ST Pharm publicly announced that its oligonucleotide API supply contract with a biotech firm A in the U.S. has been expanded. In November 2019, ST Pharm had signed a contract with the company to supply 5 batches (150kg) of raw materials for clinical trials. The contract at the time was signed for ₩13.6 billion. Company A had requested to add 1 batch to its contract. With the request, the ST Pharm will be supplying a total of 6 batches (180kg) of its API to Company A. The contract amount also increased to ₩18.1 billion with the added ₩4.5 billion. With the addition, ST Pharm’s total contract for oligonucleotide has increased to ₩270 billion, which is more than twofold the sales made by the company last year. Since November 2017, the company had made a total of 14 deals to supply oligonucleotide API to companies, with most of the deals made in the past 3 years since 2019. ST Pharm had jumped into the oligonucleotide API business in 2018 after completing its Banwol plant in 2018. With its API business on track, the company’s performance has significantly improved. ST Pharm had recorded an operating loss for 9 consecutive quarters from Q2 2018 to 3Q 2020, then marked a turnaround in Q4 last year. The company e explained that its oligonucleotide API business was the cause of the turnaround. ST Pharm’s turnaround is drawing greater expectations as most of ST Pharm’s oligonucleotide API deals being long-term contracts. Industry experts foresee that its oligonucleotide business will contribute as a stable cash cow for 10 years at the most. The company has completed delivery of ₩80 billion’s worth of APIs from the ₩270 billion contracts. This means that the company still has around ₩190 billion left to be reflected in its performance from 2H this year to 2023. Also, expectations for additional sales being made from contract extensions exist. Most of the company’s contracts are for the supply of raw materials for clinical trials or initial commercialization. Therefore, if the drug succeeds in commercialization and enters full-scale production, this may lead to further requests for more supply of oligonucleotides.
- Policy
- Domestic venture introduces new imported breast cancer drug
- by Lee, Tak-Sun Sep 28, 2021 05:54am
- As domestic startup is imminent to introduce new breast cancer drug from overseas, Geo-Young is in charge of third-party logistics of the drug, drawing attention. This is because it is different from the existing anticancer drug distribution method that foreign pharmaceutical companies and large domestic pharmaceutical companies used to supply. According to the MFDS on the 27th, the screening of Nerlynx (Neratinib), a treatment for adult patients with early breast cancer positive for HER2, will be completed, and the final approval will be decided soon. It is introduced by Bixink, a subsidiary of KOSDAQ-listed company KPS, which focuses on OLED business, from Puma Biotech, Inc. in the U.S. Neratinib was approved by the U.S. FDA in July 2017 as an auxiliary treatment for HER2 positive early breast cancer adult patients under Trastuzumab-based therapy. Last year, it was additionally approved as a tertiary treatment for HER2 positive progressive and metastatic breast cancer patients through combination therapy with Capecitabine. The company explains that unlike conventional HER2 targeted anticancer drugs, it has been developed with a small molecular weight to penetrate blood vessel-brain barriers and overcome limitations in treating and preventing brain metastasis. If Nerlynx is approved, it is the first drug sold by Bixink. In addition to Nerlynx, Bixink also secured Asian copyrights for Mucosamin PO liquid, which helps prevent and treat oral mucosal inflammation caused by chemotherapy such as radiation and chemotherapy, from PDI, an Italian amino acid pharmaceutical company in December last year. Founded in 2016, the company is focusing on developing digital treatments in addition to the project to introduce anticancer and anti-cancer aids. KPS is looking forward to the synergy between IT and bio-business units. Bixink, which has no domestic distribution network as a new venture, will supply products through Geo-Young, the No. 1 pharmaceutical distribution company.
- Policy
- Will Rinvoq be approved for atopic dermatitis?
- by Lee, Tak-Sun Sep 28, 2021 05:54am
- Whether AbbVie Korea’s ‘Rinvoq SR,’ which has been prescribed with reimbursement as an oral rheumatoid arthritis treatment since last year, will add an indication for atopic dermatitis, is gaining attention. The industry believes it is highly possible, as the higher-dose formulation is soon to be approved in Korea, and the drug was approved for the atopic dermatitis indication in Europe in August last month. According to industry sources, the Ministry of Food and Safety’s review for AbbVie Korea’s ‘Rinvoq SR 30mg’ is now complete, and the drug is pending approval. Currently, only the 15mg dose is approved in Korea. Rinvoq SR 15mg is used to treat adults with moderate to severe active rheumatoid arthritis who had an inadequate response or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). It is the 4th approved JAK inhibitor for rheumatoid arthritis. It is currently being prescribed at 21,085 won per tablet with reimbursement since November last year. In addition to rheumatoid arthritis, Rinvoq had verified its efficacy in atopic dermatitis through a clinical trial. Last year, the company had released the results of the Phase III study (Measure Up 2) that demonstrated Rinvoq’s efficacy and safety in moderate to severe atopic dermatitis patients. The drug was then approved as a treatment for atopic dermatitis in August in Europe and become the first JAK inhibitor to be approved for the atopic dermatitis indication. At that time, Rinvoq was approved in Europe for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. The recommended dose of Rinvoq in adults patients was 15 mg or 30 mg once daily, and 15 mg once daily for adolescents. In this respect, industry experts believe that it is highly likely that the atopic dermatitis indication will concurrently be approved with the approval of Rinvoq SR 30mg. Analysts believe that oral JAK inhibitors have a competitive edge in the atopic dermatitis treatment market due to their better accessibility over the only biologic that has occupied the EU market, Dupixent prefilled syringe (dupilumab, Sanofi). The company may be more intent on adding the atopic dermatitis indication as oral JAK inhibitors are under the risk of being restricted as a second-line treatment to be used after TNF inhibitors. Eli Lilly’s ‘Olumiant’ has already been approved for the atopic dermatitis indication in May in Korea. Also, Pfizer is working to add the atopic dermatitis indication to its ‘abrocitinib.’ Whether AbbVie's Rinvoq, following Lilly Korea’s Olumiant, will open the era of JAK inhibitors for 'atopic dermatitis in Korea remains to be seen.
- Policy
- Pfizer vaccine for 1.67 million doses, about to be discarded
- by Lee, Jeong-Hwan Sep 28, 2021 05:53am
- Among the COVID-19 vaccines supplied in Korea, the vaccine with the most imminent expiration date was the Pfizer vaccine. Pfizer had about 1.67 million in stock and Janssen had about 720,000 in stock for supplies that remained within a month of expiration. Kang Ki-yoon, a member of the People Power Party, made the remarks in a data submitted by KDCA on the 23rd. The amount of pfizer left within one month of expiration date is about 1.67 million times, and Janssen had about 720,000 doses in stock. The Janssen vaccine also showed 719,600 doses left within a month of expiration, and 28,000 doses left between one and two months. He points out that products with an imminent expiration date had no choice but to ship them by marking the expiration date of the product itself, not the expiration date after thawing. Most of the products marked in this way were Pfizer vaccines. Among these products, 87,730 were delivered with only 10 days left, and 166,000 were delivered with 18 days left in Janssen's case. Representative Kang said, "Vaccines take about two weeks from the time of entry to delivery to medical institutions." In the case of vaccines with less than two weeks left, it is highly likely that they will lead to vaccination if they are not rushed, he pointed out. Looking at the cases of vaccinations that have passed the expiration date, AstraZeneca had 34 cases as of September 13, while Pfizer had 689 cases, indicating that Pfizer was overwhelmingly high. He said, "Most of the vaccines whose expiration date is imminent are Pfizer vaccines that have been received through Israel or Romania." He pointed out, "At the time of introduction, many people were concerned that they would be vaccinated against expired vaccines." He then said, "The expired Pfizer vaccine is overwhelmingly large." "With vaccine booster shots considered, the government should be extra careful not to receive vaccines from third countries that are about to expire due to failure in vaccine supply and demand," he stressed.
- Policy
- 129 drug price reduction starting in October
- by Kim, Jung-Ju Sep 28, 2021 05:53am
- Drugs that sell a lot or have a high price range will be lowered as of the 1st of next month. It will be reduced by up to 10%. It also included seven Choline alfoscerates that negotiated the redemption of drug costs for clinical revaluation. AstraZeneca's Lynparza 50mg, Kadcyla 100mg, and Kadcyla 160mg succeeded in risk-sharing contracts (RSA), respectively, with drug prices cut from 1% to 9%. According to the industry, it will be applied as of October 1 if the revision is finalized soon. This drug price cut corresponds to the type 'Na' and 'Da' of the Price-Volume Agreement. First of all, the type 'Na'' is a new drug which price has not been adjusted according to type 'Ka' and four years have passed since the date of registration, and the total amount of claims for the same product group has increased by more than 30%. Among them, the NHIS negotiates with the company if the amount of ▲ claims has increased by more than 60% from the previous year's claim, or if the amount of ▲ claims increases by more than 10% and the increase is more than 5 billion won. The type 'Na' drug, which will be applied as of the 1st of next month, is Bayer Korea's Eilea, which has been decided to cut 2.5% in the negotiations. There are as many as 128 items. In particular, some of the Price-Volume Agreement drugs include recently completed Choline alfoscerate negotiations. A total of three drugs have succeeded in renegotiating RSA and will be maintained at a reduced price next month. AstraZeneca's Lynparza 50mg will fall 9.1% from the existing drug price, while Kadcyla 100mg and Kadcyla 160mg by Roche will be reduced by 1.7%, respectively.
- Company
- First progress to SGLT2i combo reimb. made in 3 years
- by Eo, Yun-Ho Sep 27, 2021 05:52am
- Patients in Korea have come one step closer to receiving reimbursement extensions to SGLT-2 inhibitor combos. This is the first progress that has been made in three years. According to industry sources, the diabetes expert committee that was convened by the Health Insurance Review and Assessment Service earlier this month concluded in the direction of integrating and allowing reimbursement for DPP-4 inhibitor and SGLT-2 inhibitor class and triple therapy combos. However, regarding TZD class drugs with cardiovascular issues, the committee decided to determine the combined use of each TZD class drug separately. Therefore, prescription restrictions on the use of TZD in combos are expected to continue. HIRA is currently discussing formal procedures, including when to put the agenda up for deliberation to the Pharmaceutical Benefit Assessment Committee. The issue has been ongoing for almost 3 years since 2018 when the government’s proposal to ‘amend the reimbursement standards to approve combined use of drugs by class’ to improve convenience and coverage for the patients. However, the amendment was put on hold due to the lack of efficacy data in some drugs that have no clinical studies conducted, and the academia’s opposition that reimbursement should be only allowed according to each drug’s indication. However, academia had first ignited the discussion on expanding reimbursement for diabetes drug combos as the different indications of drugs in the same class lead to confusion in the field and insurance cuts. The case was no different in 2013 when reimbursement was extended to DPP-4 inhibitor and thiazolidinedione class drug combinations. However, the end results were completely different. However, academia, which had always stressed the importance of clinical experience and expert judgment over indications or fiscal impact, had made a very different decision for the use of SGLT-2 inhibitor combos. As a result, the ‘class effect’ of SGLT-2 inhibitors were the only ones not recognized under the reimbursement standards among all oral diabetes drugs in Korea. However, academia had later submitted a statement recognizing the need for reimbursing SGLT-2 inhibitor combos, under which the MFDS had announced that it will ‘simplify’ the method of listing indications of diabetes treatments from ingredients to just ▲single or ▲combination therapy. And HIRA came to a positive conclusion this time. Currently, four SGLT-2 inhibitors - ‘Forxiga (dapagliflozin),’ ‘Jardiance (empagliflozin),’ ‘Suglat (ipragliflozin),’ and ‘Steglatro (ertugliflozin) – are being sold in Korea. For all 9 DPP-4 inhibitors in the Korean market to establish grounds for combined use according to principle, clinical studies on 36 combinations need to be conducted. In the same sense, 8 clinical studies are required to establish evidence for the combined use of 2 TZDs and 4 SGLT-2 inhibitors.
- Policy
- Is the third Avastin biosimilar coming out?
- by Lee, Tak-Sun Sep 27, 2021 05:51am
- Attention is focusing on whether another company will release an Avastin (Bevacizumab) biosimilar approved by Samsung Bioepis and Pfizer. This is because it was found that a new item was approved by the MFDS in August. If the item is approved, a total of four items, including the original Avastin by Roche and three biosimilars, are expected to compete. According to the MFDS on the 24th, a new biosimilar with Bevacizumab, the same ingredient as Avastin, was applied on August 30. The item was found to have applied for permission, excluding ovarian cancer-related indications that could cause patent disputes. Samsung Bioepis' Onbevezy and Pfizer's Jairabeve were also approved except for some of the ovarian cancer indications. This is because the patent will last up to March 2033. Onbevezy and Jairabeve were approved on March 11 and May 17 this year, respectively. Among them, Onbevezy has been on sale by Boryung since September. It is 37% cheaper than the original product, and the expiration date is 36 months long. Pfizer is also expected to release its products in the domestic market soon. The fact that another biosimilar is aiming for the domestic market also appeared in the recent patent challenge trial. Alvogen Korea filed a trial for invalidation of Avastin's ovarian cancer-related patent in August. Alvogen is reportedly planning to release biosimilars in Korea. However, it is analyzed that it may not be an item developed by Alvogen.Samsung Bioepis has also been participating in the patent invalidation trial. Celltrion has also terminated phase 3 clinical trials of "CT-P16," an Avastin biosimilar, and is in the process of product approval. Including Alvogen Korea and Celltrion, there are five domestic Avastin biosimilars. As Avastin is with a performance of about 120 billion won in Korea alone, competition for market share is expected to be fierce. Amgen, Samsung Bio, and Pfizer are already competing in the European market. On top of that, as Beringer Ingelheim and Celltrion are about to be approved, competition for biosimilars is expected to be fierce in the Avastin market.
- Company
- Eliquis generics pull out from market after losing suit
- by Kim, Jin-Gu Sep 27, 2021 05:51am
- With major Eliquis (apixaban) generics products removed from the insurance benefit list after losing the patent suit, the Eliquis generics have now completely withdrawn from the market. As a result, the only dispute left between the original and generic companies for Eliquis is the claims for damages, and a fierce legal battle is expected on the calculation of compensation for damages. According to the pharmaceutical industry on the 23rd, 26 products (13 companies) of Eliquis generics were removed from the reimbursement list this month. The drugs include Chong Kun Dang’s ‘Liquisia,’ Samjin Pharm’s ‘Elxaban,’ Yuhan Corp’s ‘Yuhan Apixaban,’ Hanmi Pharm’s ‘Apixban,’ and Jeil Pharmaceutical’s ‘Jerixaban.’ The other generics that were left on the reimbursement list were drugs that haven’t been sold after listing. With the removal, the market withdrawal of Eliquis generics has been officially complete in 2 years since the generics were released in the market. Chong Kun Dang and others had succeeded in targeting Eliquis’ substance patent in February 2018 (first trial), then succeeded in nullifying Eliquis’ composition patient, which led to the sequential release of its generics from June 2019. However, the situation took a downturn with the Supreme Court ruling, which overturned the first and second trial and ruled in favor of the original company. Companies that sold Eliquis generics voluntarily discontinued sales of their products to reduce the claims for damages from patent infringement. With the exit of the generics, the only dispute left between the original and generic companies is the compensation suit filed by BMS against generic companies. BMS filed a claim for damages against generic companies in 2019. However, the progress of the damages suit was sluggish as the Supreme Court ruling remained. And after the Supreme Court ruling came out in April, not many further pleadings were held due to the influence of the COVID-19 incident. The pharmaceutical industry predicts that lawsuits for damages will speed up with the Supreme Court ruling. And a fierce battle between the two sides is expected over how the specific amount for damages will be set. In general, the amount of damages for patent infringement is set at 14.2% of actual sales sold for each generic, as the judiciary considers the operating profit of the industry to be around 14.2%. However, the calculation becomes much more complex when damages are specifically calculated by category because the 'profit' made from patent infringement is considered the amount that should be compensated for damages. For example, the cost of the raw material sand APIs is generally excluded from charges, because the ingredients would not have been purchased if not for the generics’ release. Calculation of labor, sales, and promotion expenses is more complex. This is the part where the two parties clash the most. As each generic company invests different amounts in labor, sales, and promotion expenses, the original company is having the most trouble calculating this amount. Also, some have mentioned that the original company is preparing new reasoning to increase the compensation that should be paid by generics companies. Until recently, generic companies have earned a total of 12.7 billion won in 2 years by releasing Eliquis generics. According to the pharmaceutical market research firm UBIST, Liquisia earned 4.1 billion won; Elxaban 2.4 billion won; Yuhan Apixaban 1.7 billion won; and Apixaban 1.1 billion won. An industry official said, “Based on previous rulings, the generic companies will have to pay around 1.8 billion won in compensation for damages incurred, so each company will be paying less than 0.6 million won. However, the companies may have to pay more under the new reasoning the original company is preparing.
