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- 2025-12-24 07:46:18
- Policy
- Roche’s Herceptin+Perjeta combo is approved in Korea
- by Lee, Tak-Sun Sep 07, 2021 05:53am
- Roche’s developed a fixed-dose combination using two of its breast cancer treatments, Herceptin (trastuzumab) and Perjeta (pertuzumab). The Ministry of Food and Drug Safety approved Roche Korea’s ‘Phesgo (trastuzumab/pertuzumab) on the 6th. Trastuzumab and pertuzumab are commonly used ingredients for breast cancer. The original brand name of trastuzumab is ‘Herceptin,’ a blockbuster drug that sold ₩69.9 billion last year according to IQVIA The original brand name of pertuzumab is ‘Perjeta.’ It sold ₩74.1 billion last year according to IQVIA. As the combination of the two drugs is also commonly used in metastatic or early breast cancer., the release of a combined, fixed-dose formulation is expected to greatly improve the dosing convenience of patients. Phesgo is a subcutaneous formulation injected in the thigh that offers faster administration than standard intravenous administration. Herceptin is available as a subcutaneous formulation, however, Perjeta is only approved as an intravenous formulation. Patients who are receiving Herceptin and Perjeta intravenously may switch to Phesgo. Also, patients who receive Phesgo subcutaneously may switch to intravenous injection of Herceptin and Perjeta. Phesgo is approved for use in combination with docetaxel in patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer. Phesgo may be used as neoadjuvant treatment in combination with chemotherapy in patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (tumor is greater than 2 cm in diameter). In addition, Phesgo is used as an adjuvant treatment in combination with chemotherapy in patients with HER2-positive early breast cancer who have a high likelihood of coming back. At the PHranceSCa(MO40628) clinical trial on 160 patients, 136 patients, 85% (136 participants) had reported that they prefer Phesgo over intravenous administration of trastuzumab and pertuzumab. The patients chose the reduced period of administration in the hospital as the reason for their preference. Biosimilars of Herceptin’s trastuzumab are being sold by various companies including Celltrion and Samsung Bioepis. Roche expects the release of Phesgo to provide an edge in its competition with biosimilars. Phesgo was approved by the US FDA in July last year and by the EMA in December last year.
- Policy
- Letrozole for ovulation-inducing use is not allowed
- by Lee, Hye-Kyung Sep 07, 2021 05:53am
- An application to use Letrozole (Bretra, Femara, Letrozole) as non-reimbursment has been rejected. The HIRA is receiving applications in advance for the use of non-reimbursement from the MFDS to prevent the use of drugs that lack medical grounds or are concerned about safety. According to The HIRA's recent details of "disapproval of use for non reimbursement drugs," nine cases of non-approval, including Letrozole, have been added, bringing a total of 212 cases of non-approval. The medical institutions prescribed Bretra, Femara and Letrozole applied to the HIRA to combine ovarian stimulation with reproductive gland stimulants for preservation of fertility in breast cancer patients, but were rejected due to insufficient medical evidence. Clipper Enteric Coated Tab 5mg has not been allowed for patients with GVHD symptoms, and 'Lucentis Prefilled Syringe' has been approved for retinal hematoma patients with no improvement due to laser photocoagulation and cryotherapy. Non-reimbursment applications for Botox for chronic hypothritis patients and adult peritoneal pain syndrome patients over the age of 20 have also been rejected to use "Vfend 200mg" for patients with guided inflammation suspected of fungus alone or simultaneously. An application to administer "Xeljanz 5 or 10mg" to patients with combustible skin musculitis who are 2 years old or older who do not comply with other drugs has also not been approved. The application to dilute the Isopto Atropine 1% eye drops to 0.9% Sod. Chloride in pediatric patients with myopia of minus 1.0 diopters or more between the ages of 4 and 12 has also been rejected.
- Policy
- Insurance benefit denied for 3 Soliris and 1 Ultomiris cases
- by Lee, Hye-Kyung Sep 06, 2021 05:58am
- Last month, ‘Soliris (eculizumab)’ and ‘Ultromiris (ravulizumab),’ which both require prior approval to be administered with reimbursement, saw mixed results in the rate of approval of their preliminary applications. In July, the Health Insurance Review and Assessment Service’s Healthcare Review and Assessment Committee deliberated reimbursement applications for Soliris, Ultomiris, ‘Spinraza inj. (nusinersen),’ ‘Strensiq inj.,’ and hematopoietic stem cell transplantation. Deliberation results that were released on the 3rd showed that 3 new applications were filed for Soliris for its atypical hemolytic uremic syndrome indication but were denied. For Ultomiris, 40 of the 41 applications filed were approved for its paroxysmal nocturnal hemoglobinuria indication. One application for Soliris was denied as the patient was deemed unsuited for administration as defined in Soliris' indication as active thrombotic microangiopathy due to observed improvement in his/her schizocytes, or has secondary thrombotic microangiopathy due to malignant tumor or use of anticancer drugs. One application for Ultomiris was denied as the patient exceeded the normal upper limit of LDH by 1.5 times and was determined ineligible for administration as paroxysmal nocturnal hemoglobinuria. Among 37 applications filed for Spinraza month, 3 were new applications. Among the 3, 2 were approved and 1 was denied. The other 34 monitored cases were all approved. One application for Spinraza’s reimbursement was denied as the patient’s symptoms and signs related to SMA were not clearly identifiable in patients less than 3 years (36months) of age. Further details of the deliberation can be found on HIRA’s business portal, biz.hira.or.kr.
- Policy
- JAK Inhibitors increases heart attack
- by Lee, Tak-Sun Sep 06, 2021 05:58am
- The health authorities warned that taking JAK inhibitors, which are used as a treatment for rheumatoid arthritis, could cause serious heart problems such as heart attacks. The target items are Tofacitinib, Baricitinib, and Upadacitinib, which have been actively used in the market recently, so medical professionals will need to examine them more closely. Sales in related markets are expected to be rapidly reduced as the FDA will restrict the drug to certain patients who do not respond to TNF inhibitors or are not drug resistant. The MFDS includes Tofacitinib, Baricitinib, and Upadacitinib, which are used in the treatment of rheumatoid arthritis. The company announced that it has distributed the Dear Health Care Professional Letter, which states that preparation of Upadacitinib can increase the risk of developing severe heart-related diseases such as heart attacks. Tofacitinib, Baricitinib and Upadacitinib are JAK inhibitors and used to treat chronic inflammatory diseases such as arthritis or ulcerative colitis, and a total of 51 items (46 companies) are licensed in Korea. The items include Pfizer's Xeljanz, Lilly's Olumiant, and AbbVie's Rinvoq SR. After checking and reviewing the contents of the U.S. Food and Drug Administration (FDA) letter on the 1st, it explained that it was necessary to provide related safety information to domestic medicine experts and consumers. The U.S. FDA reported that a large randomized trial of Tofacitinib's safety confirmed that the risk of heart attack, stroke, cancer, thrombosis and death increased when the drug was taken. In addition, Baricitinib and Upadacitinib, which have the same mechanism as Tofacitinib, are considered to carry similar risks, adding ▲ severe heart disease, cancer, thrombosis, and death risks and ▲consider the benefits and risks of patients at the initiation or continuation of the drug administration. It also announced that the use of ▲ TNF inhibitors will be restricted to certain patients who do not react or are not drug resistant. The MFDS announced that it plans to quickly take necessary safety measures for patients by reviewing domestic and foreign licensing status, and action status of the drug, including expert advice. Hospitals in South Korea stressed that the information should be checked when administering the ingredients to patients.
- Policy
- The Committee discusses the permission for Mifegymiso
- by Lee, Tak-Sun Sep 05, 2021 08:25pm
- Mifegymiso, which Hyundai has applied for permission, will be discussed at the Central Pharmaceutical Advisory Committee, the MFDS' legal advisory body. The Central Pharmaceutical Advisory Committee's consultation is expected to determine whether Mifegymiso will conduct a bridging study in Korea. The MFDS will hold a meeting at the Central Pharmaceutical Advisory Committee on the 2nd to ask whether Mifegymiso-related safety and validity are reasonable. The meeting is expected to receive comments on the current controversial Bridging Study. "We will discuss Mifegymiso's Bridging Study at the Central Pharmaceutical Advisory Committee," said an official at the MFDS. "Based on the results of the consultation, we will review the direction of the item permit review." If Mifegymiso is granted, it will be the first for the medical termination of a regency in Korea. The MFDS has changed its registration to allow abortion to be introduced in accordance. Since there have been no medications for termination of pregnancy, other medications have been used for termination of pregnancy. In July, Hyundai applied for permission from Mifegymiso (Mifepristone and Misoprostol), an oral medication. The drug is supplied by British pharmaceutical company Linepharma International and will be supplied exclusively by Hyundai. The MFDS has also begun a full-fledged review. It is heard that screening such as safety, validity, quality, and GMP is currently underway. Some in the medical community argue that bridging study should be carried out to secure safety for Koreans before using the drug. The women's community argues that Mifegymiso's Bridging Study should be omitted and approved quickly because Bridging Study has no substitute and can be exempted if necessary. As a result of social controversy, the MFDS has formed an expert to ask whether it is bridging study. If the Central Pharmaceutical Advisory Committee decides on the pros and cons of Bridging Study, the MFDS is likely to accept it. If bridging study is carried out, the item permit is expected to be delayed due to a period of about a year. Attention is focusing on what scientific conclusions the MFDS will reach amid controversy.
- Policy
- GOV to bring 1.5 mil COVID-19 vaccines from Romania
- by Kim, Jung-Ju Sep 03, 2021 06:03am
- The Korean government has secured 1,503,000 doses of Pfizer and Modena’s COVID-19 vaccines from Romania and will bring the vaccines to Korea in two shipments this week and next week. The swap was made in line with cooperation for preventive measures against the pandemic that was discussed between the two countries from last month to exchange vaccines with medical supplies. Presided by Vice Head 2 Hae-Cheol Jeon, The COVID-19 Central Disaster and Safety Countermeasures Headquarters (Head: Prime Minister Boo-Kyum Kim) today reported on the progress made for the ‘KOR-RO vaccine cooperation’ to central ministries and 17 metropolitan councils at the Central Government Complex’s virtual meeting room. According to the CDSCH, a total of 1,503,000 doses - 1,053,000 doses of the Pfizer vaccine and 450,000 doses of the Moderna vaccine – will arrive on the 2nd and 8th at the Incheon International Airport through the KOR-Romania vaccine cooperation, 526,500 doses of the Pfizer vaccine will first arrive on the 2nd, then the 526,500 doses of the remaining Pfizer vaccine as well as 450,000 doses of the Moderna vaccine will arrive via DBI at 3:00 p.m. on the 8th next week. The two governments had started discussions on the 10th last month to exchange vaccines and medical supplies to cooperate in areas needed to prevent and control the pandemic, at a time when the world was suffering vaccine shortages. As a result, Korea was able to purchase 1,053,000 doses of Pfizer’s vaccine and receive a contribution of 450,000 doses of the Moderna vaccine from Romania in exchange for a contribution of needed medical supplies from Korea. The two countries have been strengthening healthcare cooperation as strategic partners since the COVID-19 crisis. Romania had expressed gratitude to Korea for providing diagnostic kits to Romania in the early stages of the COVID-19 outbreak, which was the 60th year since establishing diplomatic ties with Romania. This vaccine cooperation is part of the country’s efforts to boost global solidarity and efficiency in cooperation to overcome the pandemic. The government expected the vaccine cooperation to further strengthen the ties between the two countries. The 1,053,000 doses of Pfizer’s vaccine supplied are from Pfizer Belgium and are set to expire on the 30th of this month. The 450,000 doses of the Moderna vaccine are from Rovi in Spain and are set to expire from November 12th to December 5th. The 1,503,000 doses of the Pfizer and Moderna vaccines will be used to inoculate those aged from 18 to 49 as soon as it arrives in Korea. The government also announced its plans to continue various efforts to ensure a stable supply of vaccines in Korea. Also, as global exchange, donation, and repurchase of vaccines are actively being implemented to make up for the gap in vaccine procurement between countries, the Korean government also plans to contribute to the efficient use of vaccines and international cooperation to respond to COVID-19.
- Policy
- Eligibility for adjustment applications improved
- by Lee, Hye-Kyung Sep 02, 2021 05:59am
- The criteria for adjustment applications that affect drugs subject to pricing calculations will be improved. On the 2nd, the Health Insurance Review and Assessment Service (HIRA) will present the ‘proposal to improve the assessment criteria for drugs that apply for drug pricing adjustments’ as an agenda for deliberation for its Drug Reimbursement Evaluation Committee (DREC). For drugs whose price changes after listing, a pharmaceutical company can request adjustments, upon which HIRA’s Drug Pricing Calculation Department adjusts the price. However, the drugs that may request adjustments were limited to single-brand drugs that are medically essential and have no alternatives, etc. An official from HIRA said, “Until now, not many adjustment applications were filed, so we applied the criteria to DREC’s deliberation for operation. However, with the increase in applications for adjustments that will arise after the reassessment for premium-priced drugs are complete and the complaints from the industry, we presented the agenda on easing the criteria for adjustment applications for DREC’s deliberation.” Companies that have items subject to reassessments of premium pricing had written an agreement regarding their supply obligations etc. after negotiations with HIRA. Since the reassessments were announced, the companies have been ardently awaiting the day to apply for adjustments. In the process, the pharmaceutical industry had requested the government to expand the scope of eligibility for adjustment applications to single brand drugs or drugs that occupy over 90% of its market, national essential medicines or rare diseases, and drugs that are cheaper than other drugs of the same class or cheaper than other countries. A HIRA official said, “Not all the requests made by the pharmaceutical companies were reflected due to concerns over its fiscal impact or rise of other side effects, but we have sent the draft to a public-private consultative body and collected opinions.” If the measures to ease the adjustment criteria pass the DREC meeting, the authorities plan to apply the changes to applications for adjustments filed from September without collecting opinions from pharmaceutical companies. The official added, “The adjustment criteria are currently operated based on an undisclosed internal guideline applied on DREC’s deliberation cases. We plan to reorganize the existing standards to set as operation regulations, then disclose and revise them continuously. Unlike new drugs that undergo the reimbursement listing application process, incrementally modified drugs (IMDs), combination drugs, and generics are listed for reimbursement in 45-75 days after receiving pricing according to a set calculation criteria (a fixed rate of the original’s price) and evaluation for appropriateness of reimbursement. These drugs are subject to the drug premium system, which allows a drug to be sold with a premium at a specific rate for a specific period of time (unlike price increases) for the following purposes: to mitigate the shock of price cuts experienced by original products; to ensure a stable supply of generics (3 or fewer companies); to encourage the entry of generics while providing preferential treatment for technology development, among others. However, the premium pricing criteria was adjusted last year, faced with criticism the system has fallen to become a system that prevents drug price reductions (for originals) and raises drug prices (for generics), as well as the existence of so many products that have maintained their premium long-term. According to the adjusted criteria, the base premium period for all drugs regardless of whether it is a small molecule drug or a biologic is set at 1 year, with a 2-year extension approved for drugs produced with identical ingredients by 3 or fewer companies. Accordingly, 416 generics that exceeded the premium pricing period by over 3 years had undergone price cuts starting September 1st.
- Policy
- The MOHW objected to improved benefit for Prolia
- by Lee, Jeong-Hwan Sep 01, 2021 05:57am
- The MOHW objected to the criticism that it should continue to apply health insurance benefits of advanced bio-new drug Prolia (Denosumab), which treats osteoporosis, regardless of bone density figures. The MOHW said patients who still have low bone density measurements in follow-up tests after administering osteoporosis treatments such as Prolia continue to recognize their benefits regardless of time. On the 31st, the MOHW responded to a written question about the benefit standards for osteoporosis drugs by Rep. Lee Jong-sung, People Power Party. Rep. Lee requested that the standard for osteoporosis treatments be changed to improve Prolia's benefit regardless of bone density levels. Improving the benefit standard for osteoporosis treatments has continued to be needed by domestic medical staff and medicine experts. The benefit standard is to stop paying for osteoporosis patients if their bone density levels, T-score, are improved to "2.5 or less" due to the use of treatments earned by them. Osteoporosis drugs, which have already earned salaries, are converted to non-salary based on patient bone density figures. Previously, bisphosphonate drugs, which are used once a day, were mainly prescribed for osteoporosis treatment, but recently, Prolia prescriptions, which are injected once a six-month period, are mainly used. Rep. Lee also agreed with the request and asked the MOHW about its willingness to improve it, but it gave a theoretical answer that it would review it in accordance with the principle of standards. In particular, if bone density levels are still low in patient follow-up tests, Prolia's benefit continues to be recognized regardless of the period of time. "Prolia has expanded its primary treatment pay in 2019," it said. The MOHW also said, "The duration of administration of osteoporosis drugs depends on the measurement of bone density and whether or not osteoporosis fractures occur. Patients with low measurements in follow-up tests continue to pay Prolia." "We have continuously expanded the benefit standards for osteoporosis drugs by referring to textbooks, guidelines, and academic opinions," it added. "We will consider the principles of insurance benefits such as clinical usefulness, cost effectiveness, and required finance."
- Policy
- Lucentis biosimilars have been applied to the MFDS
- by Lee, Tak-Sun Sep 01, 2021 05:57am
- Along with Chong Kun Dang, Samsung Bioepis also applied for permission to the MFDS for Lucentis biosimilar. Lucentis (Ranibizumab) is a treatment for ophthalmic diseases that treat macular degeneration and various eye damage, and it is a blockbuster with annual global sales reaching ￦4.6 trillion and sales of ￦37 billion in Korea as of last year. According to the MFDS on the 31st, Lucentis biosimilar, a candidate from Chong Kun Dang and Samsung Bioepis, has received an application for permission. Chong Kun Dang announced to the media that it applied for permission for items on the 28th of last month. The company explained that from September 2018 to March this year, 25 hospitals, including Seoul National University Hospital, conducted the clinical phase 3 of Lucentis biosimilar candidate "CKD-701" for 312 macular degeneration patients. Macular degeneration can lead to blindness if the macula, a tissue that accepts light from the retina, loses its function or becomes severe due to aging and inflammation. Chong Kun Dang said it confirmed that there were no statistically significant differences in drug efficacy and other pharmacokinetics, immunogenicity and safety in indicators of less than 15 letters of vision loss and improved vision, average changes in maximum calibration vision, and thickness of the central retina. Samsung Bioepis also completed its domestic clinical trial for Lucentis Biosimilar candidate "SB11 shares" and applied for permission from the MFDS. Samsung Bioepis proved its equivalence with the original drug in phase 3 of the multinational market for 705 people. From March 2018 to December 2019, clinical equivalence and validation criteria were met through comparative studies between SB11 and Lucentis in clinical trials of a total of 705 wet age-related macular degeneration (nAMD) patients. In August, the company received approval for the first Lucentis biosimilar product in Europe. In November last year, the U.S. FDA began reviewing permits. The Korean patent for Lucentis ended in April 2018. As a result, biosimilar can enter the market as soon as it is approved. If the two companies start selling their products around the same time, fierce competition is expected.
- Policy
- DREC to include patient and civic groups' recommendations
- by Lee, Hye-Kyung Sep 01, 2021 05:57am
- In addition to experts recommended by consumer groups, experts recommended by patients and civic groups will also be included in the 8th Drug Reimbursement Evaluation Committee (DREC) that will be commissioned next month. Also, detailed guidelines that did not exist before for DREC’s subcommittees were newly established to aid the organization and smooth operation of subcommittees. The National Health Insurance Review and Assessment Service (HIRA) had recently finalized the ‘partial amendment to the operating regulations for DREC’ that contained the abovementioned changes. The amendment was made to improve fairness, objectivity, and transparency in the operations of DREC and its subcommittees. The new and changed provisions include: ▲Adding civic groups as a recommending body for DREC members (Article 3-1), ▲New regulations on the organization and operation of subcommittees (Article 6-2), and ▲ Clarification of terms to be observed by DREC members including the obligation to report and avoid unfair solicitation (mandatory provision) (Article 16-1), etc. The provision that stipulated recommending bodies for DREC members to ‘consumer organizations (including patient groups)’ was specified to include consumer, patient, and civic groups. With the increased number of recommending bodies, the 8th DREC member pool increased from 99 to 102. New operation guidelines on the specific organization and operation were newly established for DREC’s subcommittees that were operated for the effective evaluation of eligibility for medical insurance benefits, etc (reimbursement standards, PE evaluations, RSA, fiscal impact assessment, herbal medicine, post-evaluation), to be consistent with the subcommittee guidelines set for similar committees such as the Professional Review Committee. DREC's subcommittees are composed of 6-7 members including one chairperson, one or more clinical experts recommended by medical and pharmaceutical societies, and one or more experts with expertise and experience in health insurance and drug benefit evaluations. Agendas in subcommittees are passed with attendance by a majority of members and a majority vote. Also, reports of solicitation, which was a voluntary provision, was amended to a mandatory provision. Also, the existing provision that stipulates that members can apply for evasion to the chairperson for reasons of unfair solicitation, has been changed to “must apply for evasion.” If the Committee chair (or director) who received the evasion application believe that the fairness, objectivity of the member cannot be trusted for an agenda, the chair may reject attendant or opinion of the member, and collect opinions from other members on the agenda to remove the agenda from the plate or withhold discussions for a period set by the committee.
