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- 2026-05-05 20:40:13
- Policy
- PAGs request expedited new drug listing system to candidates
- by Kim, Jung-Ju Jan 10, 2022 05:55am
- With the presidential election two months ahead, patient groups have asked the presidential candidates to introduce an expedited listing system in the National Health Insurance for new drugs directly related to life. On the 7th, the Korea Alliance of Patients' Organizations had set out to propose and deliver ‘4 key patient policies’ for patients in the healthcare industry to the presidential candidates of each party. The 4 key patient policies that were delivered to the candidates were: ▲ Introduction of an expedited NHI listing system for new drugs that are directly related to life ▲Establishment of an integrated patient support platform ▲ Severe disease and patient-focused innovation to the integrated nursing care system ▲Enactment of a basic law for patients Among these, the introduction of an expedited NHI listing system on new drugs that are directly related to life is an agenda being frequently discussed with the advent of 'one-shot treatments’ that can cure a disease with a single dose, on to what extent society may cover such ultra-expensive new drugs. The new drug paradigm has shifted from the era of chemotherapy that had large side effects but less effect to the era of targeted therapies/immunotherapies/ and CAR-T therapies that are groundbreaking in terms of effectiveness and side effects. In line with such a trend, enhancing coverage of the ‘one-shot treatments’ has emerged as a key agenda. KAPO pointed to “the fact that the new drugs are extremely expensive and that it takes over a year for drugs that are directly related to life to be reimbursed after gaining approval due to the ‘pricing tug-of-war’ between the government and pharmaceutical companies” as a key issue, and reminded that these delays are life-threatening issue to those affected. Economically wealthy patients or patients with private insurance can purchase these new drugs to extend their lives, but low-income patients with less economic affordability or those who do not have private insurance are dying because they are unable to receive the benefits of these new drugs. Therefore, KAPO believes that Korea’s universal health insurance should address this life-related issue. For this, KAPO proposed to the candidates that an expedited NHI listing system should be established for new drugs that are used in life-threatening diseases. The expedited system allows rapid reimbursement of new drugs by allowing the company to concurrently apply for the marketing authorization and reimbursement listing to the MFDS (authorization) and HIRA (reimbursement listing) and concurrently review both applications. KAPO said, “The authorities can set a tentative drug price when a new drug is first sold in the market after MFDS approval so that patients could be saved using NHI finances. The difference between it and the final price should be settled after the reimbursement procedures are completed - going through the CDDC and DREC’s reimbursement procedure, pricing negotiations between the company and NHIS, and deliberation by the HIPDC. This way, the government could guarantee patients’ right to promptly access new drugs as stipulated in the Constitution.” However, on how to define and set the scope for ‘new drugs directly related to life,’ KAPO proposed that a ‘social consultative body’ should be established with participation by the government, experts, pharmaceutical companies, public, consumer, and patient groups. KAPO said, “We need to reinforce the patient-focused health insurance system by ensuring low-income patients’ access to new drugs to allow everyone who is ill to be treated and increase public and patient trust in health insurance to reduce dependence on private insurance. Also, the system enables the government to ensure access to new drugs that are directly related to life for all patients – the tax-paying public - regardless of their economic ability.”
- Policy
- Dong-A ST applied for Forxiga's Prodrug license
- by Lee, Tak-Sun Jan 07, 2022 06:06am
- Jegi-dong office building of Dong-A ST It was found that Dong-A ST applied for permission to the MFDS for Forxiga (Dapagliflozin Propanediol Hydrate, AZ), which has been devoted to development. Dong-A ST succeeded in avoiding material patents (scheduled to expire on April 7, 2023) through prodrug for Forxiga, so there is a possibility that it will dominate the generic market when commercialization is completed. According to the pharmaceutical industry on the 6th, Dong-A ST recently applied for permission to the MFDS for prodrug for Forxiga. Prodrug improves it slightly differently from the original substance. Prodrug differs from simple salt changes because the chemical structure is partially changed. Dong-A ST focused on avoiding Forxiga's material patents through the development of Produg. As a result, on June 23, 2020, it was the first domestic company to win a passive trial to confirm the scope of rights filed for Forxiga's first material patent. Currently, the case has been appealed by AZ, which objected to the results. As a result of the patent trial, Dong-A ST can be sold to the market after completing the product license and payment process. Other domestic generics cannot be sold until April 7, 2023, when Forxiga's material license is terminated even with product approval. Dong-A ST has been conducting phase 1 clinical trials to confirm equivalence with Forxiga 10mg since two years ago. Based on this, the plan was to apply for permission. There are cases where product approval was obtained after confirming the equivalence in phase 1 clinical trial with Prodrug. Developed by CTC Bio in 2013, Olmesartan Cilextil is a product that changed Prodrug Olmetec's isomer and was approved only for phase 1 clinical trials. Dong-A ST's Prodrug is expected to have a greater effect on preoccupying the market as soon as the item is approved. Analysts say that at least three months before the late-release market opens in April next year, it will have a proper preemptive effect. Dong-A ST has its own DPP-4 diabetes drug Suganon, which is expected to create considerable synergy in the diabetes treatment market if it secures SGLT-2 drugs with Forxiga's Prodrug. Sugaron has grown into a large drug worth 30 billion won per year. Forxiga is also leading the diabetes treatment market, which recorded 36.1 billion won in outpatient prescriptions (based on UBIST) as of 2020.
- Policy
- An additional purchase contract of pfizer tx has been signed
- by Kim, Jung-Ju Jan 07, 2022 06:06am
- The government said it has signed an additional purchase contract for oral treatments (Paxlovid) with Pfizer Korea. According to the KDCA, a total of 1,004,000 oral treatments were pre-purchased through the contract, including 762,000 with Pfizer and 242,000 with MSD Korea. Pfizer's oral treatment (Paxlovid) will be introduced in Korea in mid-January as scheduled. It is in the final stage of finalizing details with pharmaceutical companies, and plans to guide the public on how to introduce and utilize oral treatments next week. With the introduction of oral treatments, the government expects that they will greatly help treat home patients, while also contributing to quarantine and medical responses against Omicron mutations. The government will continue to review plans and purchases of treatments by synthesizing quarantine situations, medical response situations, domestic and foreign treatment development status, and clinical results of treatments.
- Policy
- Is the KRAS gene-targeted drug also released in Korea?
- by Lee, Tak-Sun Jan 06, 2022 06:09am
- The first KRAS gene-targeted anticancer drug approved by the U.S. Food and Drug Administration (FDA) in May last year is expected to be approved soon in Korea. It is Amgen's Lumakras (Sotorasib), which is expected to provide new treatment opportunities to KRAS mutant patients in about 5% to 8% of non-small cell lung cancer patients in Korea. According to the pharmaceutical industry on the 5th, the MFDS recently ended the safety and effectiveness screening of Lumakras. Analysts say that as the safety and effectiveness screening has ended, there is a high possibility of obtaining permission soon if there are no other variables. The drug drew attention when it was approved by the FDA in May last year. This is because it was the first KRAS gene-targeted anticancer drug. Lumakras demonstrated the efficacy of ORR at 36% in a clinical trial (CodeBreaK 100) in 124 patients with KRAS G12C mutation-positive non-small cell lung cancer. The median reaction duration was 10 months. The KRAS gene was the first mutant gene discovered in lung cancer in 1982, but unlike the EGFR and ALK genes, no targeted treatment was available. The KRAS gene itself has many types of mutations and is due to its structural characteristics that are difficult to develop target substances. Lumakras also targets the G12C gene among KRAS gene mutations. In Korea, it is known that KRAS mutation patients account for about 5-8% of all non-small cell lung cancer patients. The patients have been using Taxane therapy because they do not have other targeted treatments, and it is said that immuno-cancer drugs are also being used recently. Amgen reportedly applied for permission to the MFDS immediately after Lumakras received FDA approval. Currently, not only Amgen but also several pharmaceutical companies are focusing on developing new drugs for KRAS mutation. Seven pharmaceutical companies entered clinical trials related to KRAS last year. These include multinational pharmaceutical companies such as Novartis, Roche, Beringer Ingelheim, MSD, and Lilly. Clinical research is also underway to see if Lumakras can be applied not only to non-small cell lung cancer but also to direct bowel cancer. This is because 3-5% of patients with direct bowel cancer are caused by KRAS mutations.
- Policy
- There were no applications for Ultomiris·Soliris benefits
- by Lee, Hye-Kyung Jan 06, 2022 06:09am
- In November last year, it was confirmed that there was no pre-application for Ultomiris and Soliris benefits for new patients with paroxysmal night hemoglobin (PNH). There were only two applications for pre-approval of Soliris and one application for re-examination approval for new patients with atypical hemolytic uremic syndrome (aHUS), all of which were rejected. In the case of Spinraza, a treatment for Spinal Muscular Atrophy (SMA), two applications for new patient benefits have been approved. The HIRA conducted deliberation on 11 items, including ventricular adjuvant therapy (VAD), short-term hospitalization (2–4 days) with neuroblocking treatment, including Soliris and Ultomiris, short-term hospitalization with percutaneous epidural ganglion neoplasty (2–4 days), short-term hospitalization (2–4 days) with neuroblocking treatment, short-term hospitalization due to trauma (2-5 days), short-term hospitalization for pain control (2–4 days), mid- to long-term hospitalization (13 days), long-term hospitalization (27th~40th), Spinraza, and hematopoietic stem cell transplantation. Soliris costs 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price alone reaches 400 million won per year. Ultomiris was listed at 5,598,942 won per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris and Ultomiris are ultra-high-priced new drugs, so they implement a pre-approval system to determine whether they are eligible for medical care benefits, and the agency must administer Soliris or Ultomiris within 60 days from the date of notification of the results of the pre-approval application. If it is intended to be administered after 60 days, it must be re-applied. Medical institutions approved for medical care benefits by Soliris or Ulromiris must submit monitoring reports every 6 months, and in the case of aHUS, additional initial monitoring reports must be submitted at 2 months after treatment commencement. Spinraza is an ultra-high-priced new drug with 92.35 million won per bottle of 5ml, and medical institutions that want to take it must apply for pre-approval and submit a monitoring report every four months after approval of benefits. Details of the deliberation can be found on the website of the HIRA (biz.hira.or.kr) or the medical institution's business portal (biz.hira.or.kr>examination criteria>standard>examination criteria>public deliberation cases).
- Policy
- Companies obtain generic for exclusivity in proportion
- by Lee, Tak-Sun Jan 06, 2022 06:08am
- Among pharmaceutical companies that use generic for exclusive in the licensed patent linkage system that took effect in 2015, it was found that companies with large sales are more likely to obtain generic for exclusivity. As a result, it was suggested that small and medium-sized pharmaceutical companies need more support such as consulting. Sungkyunkwan University's Industry-Academic Cooperation Group made the remarks in the "2021 Pharmaceutical Patent-approval linkage system Impact Assessment Research Service Result Report". The result report was released by the MFDS on the 29th of last month. This study is conducted annually to establish a stable patent-approval linkage system and minimize side effects, which has been fully implemented since March 2015, as a revision of the Pharmaceutical Affairs Act to implement follow-up measures to the FTA. Through research, the relevant status and status are identified, and the impact of the implementation of the system is analyzed and evaluated annually. The basis for the impact assessment is specified in Article 50-11 of the Pharmaceutical Affairs Act. As of 2020, the analysis targets the current status of obtaining generic for exclusivity of 171 domestic pharmaceutical companies with finished products. As a result of the evaluation, when other variables were controlled, companies with large sales were more likely to obtain generic for exclusivity. As of 2019, 20 pharmaceutical companies with annual sales of more than 300 billion won applied for generic for exclusivity (28.7%), 31 pharmaceutical companies with sales of more than 100 billion won (40.2%), 22 pharmaceutical companies with sales of more than 50 billion won to less than 100 billion won (17.1%), and 31 pharmaceutical companies with less than 50 billion won (14.0%). If the sales of the applied pharmaceutical company are more than 300 billion won, the average number of applications is 11.0, and the average number of applications tends to increase as sales increase. There was a high probability that a company with a large number of items would obtain generic for exclusivity. Through this, the researchers analyzed that companies with large sales and a large number of items are more likely to obtain generic for exclusivity. In response, the researchers said, "As large-scale pharmaceutical companies tend to gain generic for exclusivity, it is required to strengthen SMEs' capabilities in first-generation development. Consulting support for SMEs is needed to encourage SMEs to obtain patent challenges and approval." The researchers also analyzed the impact of generic for exclusivity on generics before and after the introduction of the parent-approval linkage system (March 14, 2015) in terms of market share. As a result of the evaluation, the number of items significantly decreased due to the introduction of the system. However, there was no significant change in the duration of generics' entry into the market. However, it was found that the period of entry into the market was shortened in the case of generic for exclusivity. The researchers said, "Unlike concerns at the time of introduction, stable operation continues, and it is evaluated to have a slight positive effect on health policies and employment in the pharmaceutical industry."
- Policy
- Request for non-reimbursed use of Pahtension in Loop's pts
- by Lee, Hye-Kyung Jan 06, 2022 06:08am
- Application for Pahtension 20mg was rejected for non-reimbursed patients with systemic erythema lupus accompanied by immunosuppressants, vasculitis that does not improve even with antibiotics, and peripheral ulcers. The HIRA is receiving applications in advance for use exceeding the MFDS' permission to prevent the use of drugs that lack medical evidence or are concerned about safety. According to the details recently released by the HIRA, a total of 237 cumulative cases were rejected due to insufficient medical evidence for the submitted data, including Pahtension. Cases added this time include Previmis 240mg tab, Previmis 480mg tab, and Previmis inj, which will be non-reimbursed to pediatric and adolescent patients receiving hematopoietic stem cell transplantation. The request to prescribe My-Rept 250mg to Sjogren's syndrome patient with steroid dependence that recur during steroid loss after diagnosis of MCD and renal syndrome was also rejected. After hematopoietic stem cell transplantation, prescriptions of R-A 10mg and R-A 20mg were also rejected for patients with BK virus-related hemorrhagic cystitis who did not respond to existing antiviral drugs or could not be used as side effects of existing antiviral drugs. All attempts to prescribe Premina 0.625mg and Premina 3mg to patients with hemorrhagic cystitis who do not respond to existing treatment after hematopoietic stem cell transplantation or after high-dose cyclophosphamide treatment have not been approved. Among patients with circular hair loss, frontal hair loss, or systemic hair loss aged 8 years or older, it was also rejected to prescribe Xeljanz to patients with severe intractable skin lesions or interstitial pneumonia who do not respond to SALT score changes of less than 25% or high dose glucocorticoid and at least two immunomodulatory treatment. Approval to prescribe Previmis 240mg and Previmis 480mg was also rejected if there was no improvement in the use of other antiviral drugs for more than two weeks due to giant cell virus infection and peripheral organ disease after hematopoietic stem cell transplantation. Among children with persistent tachycardia after heart transplantation, approval to prescribe Procoralan 5mg was also rejected to patients with tachycardia persistent tachycardia despite the use of drugs such as beta blockers.
- Policy
- ‘Lowest-ever’ number of drugs approved in 4 years
- by Lee, Tak-Sun Jan 05, 2022 05:59am
- The year 2021 is likely to be remembered as the year of reduced marketing authorizations for drugs. This was greatly influenced by the changes in the market and the new regulations that were introduced last year. In particular, the pricing penalty imposed on indirect bioequivalence tested drugs and the restrictions set on consigned bioequivalence tests had greatly contracted the development of consigned generic drugs, significantly decreasing the number of approved items compared to the previous year. ◆ In 2021 = a total of 2,057 items were approved, recording the lowest-ever number of approvals during the past 4 years. 2,112 items were approved in 2018, 4,893 items in 2019, and 3,350 items were approved in 2020. In the case of prescription drugs, the number of approvals is on a decline for 2 consecutive years since 2019. After reaching the peak of 4,193 in 2019, the number of approved prescription drugs decreased to 2,614 in 2020 and to 1,596 in 2021. The situation had worsened significantly due to the introduction of the penalty system that additionally discounts the price of drugs that did not directly conduct bioequivalence tests. Moreover, the so-called "1+3 restriction” system that was introduced in July regulates the number of pharmaceutical companies that can share a company’s bioequivalence test to three other pharma companies, greatly reducing the foothold of CMO generics. Therefore, the number of incrementally modified new drugs and generics that conduct their own bioequivalence tests is expected to increase greatly. OTC drugs are at greater peril. Compared to the past when OTC development increased when stricter drug pricing regulations were imposed on the industry, the number of approved items decreased to an unusual extent this year. By month, approvals peaked in February with 441 with a flood of generics of the hyperlipidemia combo ‘Atozet Tab’ being approved. Since then, the average number of approvals remained in the 100 range, dipping to 88 in September. ◆OTC = Among the 461 OTC drugs that were approved in 2021,6 were data submission drugs, 63 were herbal medicines, and 211 were drugs subject to the Standard Manufacturing Criteria for Drugs, and others including generics accounted for 181. The drugs ‘subject to the Standard Manufacturing Criteria for Drugs’ that accounted for 46% of the OTC drugs approved this year were allowed sale after simply reporting to the Ministry of Food and Drug Safety. The MFDS designates the type, standard, and limit of the ingredients, formulation, dosage·regimen, efficacy·effect, and precautions for such drugs so that they may be easily sold. It is the most preferred type of drug for pharmaceutical companies as it saves development costs. The reality is that companies cannot invest so much into R&Ds of OTCs that have a small market size and require immense marketing costs. ◆Prescription drugs = Although generic drugs account for a substantial amount of the 1,596 prescription drugs that were approved in 2021, the number of new drugs and data submission drugs are also on the rise. Among the 45 new drugs that were approved last year, 3 were advanced biological drugs that were newly approved other than reregistered drugs, and 304 were data submission drugs. These accounted for 22% of all prescription drugs approved in 2021. The trend was also evident in new drugs approvals. A record-high number of new active ingredients in 4 years was approved last year. Many new drugs and vaccines were introduced due to the DOVID-19 pandemic, and 4 homegrown new drugs were also approved last year. Starting with Yuhan Corp’s anticancer drug ‘Leclaza’ in January, Celltrion’s COVID-19 treatment ‘Regkirona’ in February, Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis’ in March, and Daewoong Pharmaceutical's ‘Fexclu’ was approved in December. Also, under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ that was implemented in 2020, 3 new advanced biopharmaceutical drugs have entered the market. These cell therapy and gene therapy products would have been categorized as new drugs in the past. All three advanced biopharmaceuticals that were newly approved this year are Novartis’ products. The first advanced biopharmaceuticals ‘Kymriah’ was approved in March, followed by ‘Zolgensma’ in May and ‘Luxturna’ in September. Novartis’ advanced biopharmaceuticals are all ‘one-shot’ treatments that are leading the pharmaceutical revolution. However, the drugs have a long way to go before receiving health insurance benefits in Korea as these one-shot treatments for rare diseases are very expensive.
- Policy
- Combination drugs of PPI+ antacid have also been released
- by Lee, Tak-Sun Jan 05, 2022 05:57am
- In the anti- ulcer drug market, combination drugs of PPI+ antacids have been released. This time, it is a drug that combines Rabeprazole and sodium bicarbonate. The PPI+ antacids, which started with Chong Kun Dang's Eso Duo (Esomeprazole Magnesium Trihydrate+Sodium Bicarbonate), continues to develop new products. The MFDS approved Youngjin Pharmaceutical's Rabenew, Ildong Pharmaceutical's Rabietduo, Dongwha's Rabeduet, Samjin's Rabeol Duo, Whanin's Rabemore, and Dong-A ST Rabiduo on the 31st. These products are combination drugs that combine the PPI formulation Rabeprazole Sodium and the antacids Sodium Bicarbonate. Youngjin is in charge of all production. The new combination drugs are used fir ▲ gastric ulcer/duodenal ulcer, ▲ erosive or ulcerative GERD, ▲ relieving symptoms of GERD, and ▲ for long-term maintenance therapy for GERD, and can be taken once a day. The usage is similar to the existing Rabeprazole only indication. However, the use of PPI+ antacids in the prescription market is expected to change as they complement the side effects of night acid secretion and late drug effects, which are disadvantages of PPI single drugs that are weak against stomach acid. It is already the third time this year that combination of PPI+ antacid has been used. Yuhan Corporation, GC Pharma, and Kyung Dong were approved in February, and Hanmi Pharmaceutical in October. This is the first drug that combines Rabeprazole and antacids. Analysts say that the successive development of new PPI+ antacid products is due to the popularity of Chong Kun Dang's "Eso Duo," which was launched in 2018. As soon as Eso Duo was released, it grew into a blockbuster worth 10 billion won a year, recording 7.8 billion won in outpatient prescriptions based on UBIST in the first half of this year. The new product is expected to further strengthen Ildong Pharmaceutical's market competitiveness. Ildong has the number one generic called Rabiet in the single Rabeprazole market. This is because it recently decided to start selling co-promotion of Nexium, the original PPI sales top. Competition in the anti- ulcer drug market is expected to heat up next year as Daewoong Pharmaceutical is releasing new products such as Fexuclue (Fexuprazan HCl), a new P-CAB drug, on the 30th.
- Policy
- Recovery Action held by the Legislation/Judiciary Committee
- by Lee, Jeong-Hwan Jan 04, 2022 05:56am
- The recovery system of drug prices bill, which drew attention from the government and domestic and foreign pharmaceutical companies, has been held by the National Assembly's Legislation and Judiciary Committee and is in trouble to deal with it. As it was excluded from the Legislation and Judiciary Committee agenda again during the extraordinary National Assembly in December last year, even the screening committee failed to rise, and there are concerns that it will not be passed even if it is barely introduced this year. The second subcommittee of the Legislation and Judiciary Committee, which is in charge of reviewing other standing committees' resolutions, tends to be rarely reviewed once handed over, so it is often called the "black hole in the bill" and the "tomb of the bill." On the 3rd, the National Assembly's Legislation and Judiciary Committee did not review the alternative of the chairman of the National Health Insurance Act on the resolution at a plenary session held within last year's extraordinary session. Some pharmaceutical and legal circles are strongly opposed to the review and processing of bills on the redemption and refund of drug prices, which reportedly affected the unknown agenda of the Legislation and Judiciary Committee. Some say that it will not be easy to deal with even if a plenary session of the Legislation and Judiciary Committee is held at the extraordinary National Assembly to be held in the new year and a revision to the Health Insurance Act, which includes a bill to return and refund drug prices, is on the agenda. It could be held by the Legislation and Judiciary Committee if some members of the Legislation and Judiciary Committee hold the bill at the plenary session or hand it over to a second subcommittee that examines other standing committee bills.If it is handed over to the second subcommittee on bills, it is not clear whether it will be able to obtain a proper opportunity for examination until the end of its 21st term in the National Assembly. The government and the ruling party plan to continue to urge the opposition party and the judiciary committee to review the agenda ahead of the need for a bill to recover and refund drug prices. The MOHW is expected to push ahead with the introduction of a refund system as planned through the revision of the health insurance care benefit rules and related notices reported to the Health Insurance Policy Deliberation Committee late last year. An official from the ruling party of the National Assembly's Health and Welfare Committee said, "The Pharmaceutical Affairs Committee and the opposition party are boycotting the agenda, even though the Restitution and Refund Act is a bill that settles and compensates for unnecessary damage to both pharmaceutical companies and the NHIS. Because of this, bills such as regulations on office managers' illegal hospitals, illegal pharmacies lending licenses, and mandatory identification of patient health insurance are also delayed." The official said, "The ruling party plans to select the revision of the health insurance law as an intensive promotion bill and continue to urge it to be processed. I understand that the MOHW is also repeatedly appealing to the Legislation and Judiciary Committee to pass the bill."
