- LOGIN
- MemberShip
- 2026-05-18 16:29:41
- 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.
- Policy
- The per capita GDP reference standard was deleted from ICER
- by Lee, Hye-Kyung Sep 27, 2021 05:51am
- The per capita GDP phrase was deleted from the ICER threshold used in the economic evaluation process of the first stage of new drug benefits. Although it has been changed to refer to the results of the existing deliberation, the phrase GDP per capita has been deleted, and the application of ICER values, one of the pharmaceutical industry's long-cherished projects, remains to be seen. On the 23rd, The HIRA unveiled the "Detailed Evaluation Criteria for Drugs Subject to Negotiation, such as New Drugs (Completed Amendment)." The revision of this standard includes the evaluation criteria deliberated and resolved at the 8th Pharmaceutical Benefit Appeal Committee held on September 3. The HIRA changed the standard, saying, "We will flexibly evaluate the disease by referring to the results of the existing deliberation considering its severity, social disease burden, impact on quality of life, and innovation." An additional content was added, "Refer to the results of the existing deliberation." The existing evaluation criteria will be applied first without linking GDP per capita in cost effectiveness. Kim Ae-ryeon, head of the drug management office, said, "We have decided to delete the application of per capita GDP standards to ICER values through meetings in the pharmaceutical industry, expert advice, and civic group opinions." She explained, "In the early days, expert advice was dominant that it was to apply health care priorities." She said,"Instead of deleting GDP standards to ICER, we need other standards." She added, "As we have accumulated experience while running the committee, the revision was carried out as opinions were gathered that it was reasonable to refer to the results of the existing deliberation." The pharmaceutical industry has been demanding expansion, pointing out that the domestic ICER threshold remains at the level of 25 million won, a reference to GDP in 2013.
- Company
- When does Sputnik ship in Korea?
- by Kim, Jin-Gu Sep 27, 2021 05:51am
- SputnikShipment of the domestic finished product of the COVID-19 vaccine Sputnik developed in Russia will begin as early as next month. The consortium centered on Korus has already secured 10 million finished products, and the Huons Global Consortium plans to start producing finished products by the end of this year. ◆Prospects of shipment of finished products next month, Russian media also report "imminent" According to Korus on the 17th, the Korus consortium, which consists of seven companies and institutions, plans to ship the finished product of Sputnik as early as next month. Korus has already started producing finished products and has completed the production of undiluted solutions for 10 million people. An official from the company explained that if a request is received from RDIF, it can be shipped immediately after filling. Korus has completed the submission of relevant data and is waiting for certification from the Russian government. It explains that initial shipments are possible as soon as authentication is completed. There have also been reports in Russia that shipments are imminent. Russian news agency TASS reported on the 16th (local time) that GL Rafa will ship Sputnik Light in the near future, and RDIF is planning a commemorative event related to this. Huons Global product production has begun, "The forecast of production of finished products by the end of this year Korus signed a contract with RDIF for consignment production of Sputnik V in September last year. Since then, Korus has formed a consortium with six companies and one institution, including Binex, Boryungbio, Isu Abxis, CKD Bio, Quratis, and Andong Animal Cell Demonstration Support Center. The consortium plans to build production facilities of more than 100 million doses per month. However, as product production and local approval were delayed due to local circumstances in Russia, questions were raised over the specific timing of shipment of finished products. An official from Korus said, "We signed the first Sputnik V consignment production contract, but with the release of Sputnik Light, which was improved with one inoculation, the originally planned schedule has been slightly delayed," adding, "We expect to be able to ship as early as next month." ◆Huons Global product production has begun, The forecast of production of finished products by the end of this year Huons Global Consortium also predicts that it will be possible to produce finished products within this year. Prestige Biopharma, Humedix, and BoranPharma are participating in the Huons Global Consortium. Huons Global announced on the 17th that it has started production of Sputnik V's products since this week. Prestige Biopharma is in charge of this production. Prestige Biopharma is in charge of manufacturing undiluted solutions at the Huons Global Consortium. After a Russian official checks the product, a Huons Global official predicted that production of the finished product will be from November to December. A meeting with Russian officials last August with Huons Global Consortium An official from Huons Global said, "It is expected that the validation confirmation process will be completed within this month. We will be able to start producing finished products within this year, he said. The produced products will be supplied to more than 70 countries that have approved Sputnik at the request of Russia, he said. Huons Global signed a contract with RDIF for consignment production of SputnikV in April.
- Policy
- Reimbursed generics pour in with Xarelto's patent expiry
- by Kim, Jung-Ju Sep 24, 2021 05:57am
- More than 100 reimbursed generics of Xarelto will be pouring into the market next month with the substance patent expiry of the novel oral anticoagulant (NOAC) Xarelto (rivaroxaban). Among the drugs, products that are subject to premium pricing for being drugs from innovative pharmaceutical companies, etc. are Chong Kun Dang’s Riroxia Tab. 15mg, and 20mg that was released earlier in May. The two drugs will receive premium pricing for 7 months based on the release date of the 20mg strength. According to industry sources on the 23rd, the Ministry of Health and Welfare is working to amend the ‘Drug reimbursement list and reimbursement ceiling price table’ to include such changes. The changes will be effective from October 1st. First, the price of Korea Prime Pharm’s Xaito Tab. 10mg has been set at 85% of the highest price of same ingredient drugs that are already listed as it met only one of the two standards set for pricing of generic drugs, and only one other same ingredient drug is currently listed and priced at 53.55% of the ceiling price of same ingredient drugs. Twelve products will be listed at the same price as the highest price set for same ingredient drugs, 6 of which are rivaroxaban products. Sixty-eight products will be listed at 85% of the highest price of already listed same ingredient drugs. Among these, 60 products, including Han Poong’s Rivarell tab. 15mg, Boryung Biopharma’s Xarox tab. 15mg, Daewoong Bio’s Varelto tab. 15mg and 20mg, are rivaroxaban products. Also, the price of 32 products was set lower than the ceiling price of its higher strength product that was filed for listing at the same time. Such drugs include Daewoong Bio’s Varelto tab. 10mg, GC Pharm’s Neoroxaban tab. 10mg, Yuhan Phram’s Yuhan Rivaroxaban tab. 10mg, Yuyu Pharm’s Yuvaro tab. 10mg, Dong Wha Pharm’s Rivacor tab. 10mg, Aju Pharm’s Zatol tab. 10mg, Kolmar Pharma’s Newroxban tab. 10mg, and Whanin Pharm’s Jaroban tab. 10mg. Also, a new 10mg strength product of Chong Kun Dang’s Riroxia tab. that was already released in May will be newly listed. The drug’s price had been set at a price lower than the ceiling price of its already listed higher strength product. The government sets the ceiling price of lower strength products at a lower price than the ceiling price set for its higher strength counterpart when a higher strength drug with the same company, route of administration, ingredient, and formulation is already listed. Therefore, Chong Kun Dang’s Riroxia tab. 10mg’s price was set at ₩1,312 per tablet. Thirty-four products were set at the expected sales price. The government allows a drug’s price to be set at the expected sales price submitted by the manufactuer·congisnged manufacturer·importer applicant when the price is lower than the price set according to standards. Drugs that will be listed at the expected price are Boryung Biopharma’s Xarox tab. 10mg, Yooyoung Pharm’s Yooroxaban tab.10mg, Yungjin Pharm’s Xarex tab. 10mg, Samjin Pharm’s Rivoxaban Tab. 10mg, Hanmi Pharm’s Riroxban tab. 10mg, GC Pharm’s Neoroxaban tab. 15mg, Yuhan Pharm’s Yuhan Rivaroxaban Tab. 15mg, and JW Pharmaceutical’s Livalozet tab., etc. Meanwhile, 11 rivaroxaban products from 4 companies will be listed with a premium. The premium will expire in 7 months, on April 30th, 2022. The government allows premium pricing for one year from the first generic was listed for some drugs. For innovative pharmaceutical companies, the premium is set at 68% of the original drug price in the first year, then subsequently lowered to 53.55% after the term is terminated. Products that benefit from this premium pricing are Chong Kun Dang’s Riroxia Tab 15mg and 20mg that was released first among generics in May. As the premium pricing period is set based on the 20mg strength drug, the premium will be in effect for only 7 more months.
- Policy
- Lynparza RSA renewed, adds reimbursement for ovarian cancer
- by Lee, Hye-Kyung Sep 24, 2021 05:56am
- In addition to the ongoing negotiations for RSA renewal, an insurance benefit standard will be newly established for ‘Lynparza (olaparib)’ as maintenance monotherapy. The Health Insurance Review and Assessment Service (HIRA) has announced that it has posted a public notice on the ‘Details of the standards and methods for applying insurance benefit to pharmaceuticals prescribed or administered to cancer patients,’ and will be reviewing opinions until the 27th. The amended details will be effective from October 1st. After reviewing the reimbursement standards for Lynparza in ovarian cancer, HIRA decided to allow its reimbursement as ‘first-line maintenance treatment for patients newly diagnosed with BRCA-mutated advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have responded to first-line platinum-based chemotherapy (partial or complete response)’; and ‘as second-line maintenance treatment for patients with BRCA-mutated advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have responded to second-line or higher platinum-based chemotherapy (PR or CR).” As for the administration period, reimbursement for maintenance treatment after first-line platinum-based chemotherapy will be allowed up to 2 years from initial treatment. For ovarian cancer, etc. that responds to second-line or higher platinum-based chemotherapy, reimbursement will be restricted to patients with a BRCA mutation. Details on the platinum-based chemotherapy that is administered immediately before the maintenance therapy will be specified in footnotes in consideration of the inclusion/exclusion criteria in its clinical trials, and eligible patients should have received platinum-based chemotherapy (excluding therapies that use bevacizumab) for at least 4 cycles with no history of PARP inhibitor use. Also, the increased scope of eligibility for ‘Zejula cap. (niraparib)’ in ovarian cancer and ‘Sprycel (dasatinib)’ in acute lymphoblastic leukemia led to an expansion in their reimbursement standards. For Zejula, a new reimbursement standard was added for BRCA mutated patients as ‘maintenance monotherapy for ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) in adult patients who have shown response to first-line platinum-based chemotherapy (partial or complete response).’ For Sprycel, reimbursement standard was set for ‘use in combination with chemotherapy in pediatric patients aged 1 or older with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)’
