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- 2026-04-13 14:48:10
- Policy
- MFDS will quickly & thoroughly verify Merck's COVID-19 tx
- by Lee, Tak-Sun Oct 13, 2021 05:46am
- Minister KIM Ganglip It was pointed out that Merck's oral treatment, which is considered a COVID-19 game changer, should be quickly introduced in Korea. Kang Ki-yoon, a member of the People Power Party, said in a parliamentary audit of the MFDS held at the National Assembly on the 8th, "Oral treatments are needed during the With Corona," stressing, "Not only domestic pharmaceutical companies but also overseas development products applied to the FDA should be introduced late." Minister KIM Ganglip explained, "The drug is currently in phase 3 overseas," adding, "We understand that it has applied for emergency use approval." Rep. Kang said, "The KDCA purchased 18,000 and plans to purchase 20,000 more." "We need to prepare for approval as soon as possible," he stressed. Minister KIM said, "We will do our best to quickly and thoroughly verify safety and effectiveness of oral treatments."
- Policy
- ‘Skilarence’ may be reimbursed if it accepts PBAC's price
- by Lee, Hye-Kyung Oct 13, 2021 05:46am
- Kolon Pharma’s plaque psoriasis treatment 'Skilarence Enteric Coated Tab. (Dimethyl fumarate)' will be reimbursed if the company accepts a price lower than the price assessed by the Pharmaceutical Benefit Assessment Committee. On the 8th, the National Health Insurance Service (President Sun-min Kim) disclosed the deliberation results on the adequacy of medical care benefit for pharmaceuticals that applied for decisions at the ‘2021 9th PBAC meeting.’ Skilarence is a treatment for adult patients with moderate-to-severe plaque psoriasis in adults subject to systemic or light therapy. The drug received marketing authorization on May 14th. Developed by Almirall, a Spanish pharmaceutical company, Skilarence achieved PASI 75 response after 16 weeks of treatment in a clinical trial conducted on 671 patients in Europe. Kolon Pharma had applied for its reimbursement with the aim to release Skilarence in October this year. Meanwhile, PBAC deliberation results on Boehringer Ingelheim’s ‘Ofev soft cap. (nintedanib esylate),’ was to not provide benefit for the new orphan drug. Ofev is approved in Korea to treat people with idiopathic pulmonary fibrosis (IPF) or to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD), or to treat chronic interstitial lung disease. Under Article 11-2 of the ‘Regulation on Criteria for Providing Medical Care Benefit,’ NHIS has been assessing the appropriateness of granting medical care benefits to pharmaceuticals through deliberation by PBAC. However, the assessment results may change with alternations in the detailed range of reimbursement and base items or with changes in the indication of the drug that applied for such decision, or in the case of license revocation (cancellation).
- Policy
- Drug prices are the key to easing the PAH benefit standard
- by Choi-sun Oct 13, 2021 05:46am
- There is a possibility that PAH tx benefit standard, which has been criticized by strict standards, will be eased. As the HIRA mentioned that it has prepared an amendment that fully reflects the opinions of the society on the application indicators of combination therapy and the initial three-drug combination pointed out as a problem, the public has passed over to the MOHW. On the 15th, the Korean guideline for diagnosis and treatment of treatment and the Korean Pulmonary Hypertension Association held a National Assembly debate with Heo Jong-sik, a member of the National Assembly's Health and Welfare Committee, to establish measures to improve the survival rate of patients with PAH. In Korea, the three-year average survival rate of patients with PAH is only 54.3%, ranking the lowest among OECD countries, and very low compared to 82.9% in Japan and 73% in the United States. The main reason for this is that unlike global treatment guidelines, which are recommended to use combination therapy from the beginning, combination therapy is only possible in high-risk groups in Korea. As a result of The Korean Society of Cardiology and the Korea Lung Arterial Hypertension Patients Association filing complaints about the revision of standards, the HIRA held an expert advisory committee with related societies in July to discuss the validity of the revision. Pulmonary hypertension, a rare disease, improves the prognosis if diagnosed quickly and treated appropriately. As the mortality rate varies significantly depending on the active use of drugs in the early stages, the association requested to ease the indicator criteria for combination therapy and increase the choice of combination therapy drugs from the beginning. Park Jae-hyung, a cardiology professor at Chungnam National University Hospital, said, "The problem with the treatment of pulmonary hypertension in Korea is that the treatment is delayed because the conditions for starting the combination therapy are high," adding, "Please lower the standard and lift the restrictions on the choice of combination therapy." In this regard, the HIRA also said it reflected the opinions of academia and patient associations as much as possible. Ha Sung-hee, head of the drug standard department at the HIRA Drug Management Office, said, "There are not many diseases in which domestic treatment guidelines are made, but it is quite encouraging that domestic treatment guidelines have been established for rare diseases such as PAH." She said, "Based on this, we had a meeting with experts from the society in July to prepare an amendment to the benefit standards, and we organized the contents and reported them to the MOHW." In the debate, questions flooded about the exact timing of improvement in the standard because the survival rate within three years was only half. "We need to take a close look at various financial capabilities," Ha said adding, "We know that many people are waiting because there are follow-up procedures such as administrative notices to announce, but please understand that it takes time." The MOHW also suggested the possibility of expanding the salary standard through drug price negotiations with pharmaceutical companies. Yang Yoon-seok, head of the insurance drug division at the MOHW, said, "As the association has created medical guidelines, it seems desirable to meet health insurance benefits as much as possible." He said, "We are looking at the revision that came up after a meeting of the expert advisory committee in July." He said, "We will review from the patient's point of view how those suffering from the disease can be properly treated." He explained, "We are reviewing whether to expand benefits based on cost effectiveness, and we think PAH needs measures not only in drugs but also in the areas of diagnosis and follow-up management."
- Company
- ‘Rinvoq’ tries AD reimbursement following ‘Olumiant’
- by Eo, Yun-Ho Oct 12, 2021 05:50am
- Companies have been actively seeking insurance benefits for their JAK inhibitors in atopic dermatitis. According to industry sources, Abbvie Korea has also applied for the reimbursement of its ‘Rinvoq (upadacitinib)’ in atopic dermatitis after its indication expansion, following Lilly Korea’s reimbursement application for ‘Olumiant (baricitinib) in May. Rinvoq had been additionally approved for atopic dermatitis, ankylosing spondylitis, and psoriatic arthritis on October 5th. Also, with the application for Pfizer Korea’s ‘Cibinqo (abrocitinib)’ in process in addition to the two drugs, whether a viable new treatment option will be introduced to the field of atopic dermatitis following Sanofi-Aventis Korea’s ‘Dupixent (dupilumab),’ is receiving attention. For Dupixent, discussions are ongoing with the health insurance authorities on whether the drug’s reimbursement should be extended to cover pediatric·adolescent patients with atopic dermatitis. Rinvoq became the second JAK inhibitor following Olumiant to be approved to treat atopic dermatitis, a field that had few treatment options. Unlike Olumiant, which can only be used in adults, Rinvoq can also be used in adolescents 12 years or older. Rinvoq’s efficacy was verified through the Heads Up study, a head-to-head trial between Rinvoq and Dupixent. Study results showed that 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group. More recently, the patients’ eczema area was divided into 4 (head and neck, body, arm, leg) to assess the rate of EASI 75 response at Week 16 in the areas. EASI 75 rates at Week 1 in all 4 areas were higher for Rinvoq and continued until Week 16. In other words, the study indicated that Rinvoq can relieve symptoms faster than Dupixent, regardless of the affected area. However, the safety issue of JAK inhibitors as a whole is on the board. Based on the post-marketing safety study of Xeljanz, the US FDA had issued a Dear HCP letter warning of the risk of heart attacks in JAK inhibitors such as Xeljanz, Olumiant, and Abbvie's 'Rinvoq (upadacitinib).’ Whether this issue can be resolved and the drugs can settle as a treatment option in the field of atopic dermatitis remains to be seen.
- Policy
- Hanmi's HM15912 is approved for phase 2 in Korea
- by Lee, Tak-Sun Oct 12, 2021 05:50am
- Hanmi Pharmaceutical is developing a rare disease treatment aimed at the global market and is conducting phase 2 clinical trials in Korea. With HM15912 as a candidate for the treatment of Short bowel syndrome (SBS), clinical trials will be conducted at Samsung Medical Center. The MFDS approved Hanmi's phase 2 clinical plan for HM15912 on the 8th. This is a phase 2 clinical trial (DOLPHINS-2) to evaluate the safety, pharmacokinetics and pharmacokinetics of HM15912 in adult subjects with SBS-IF. A total of seven patients will participate in this test, of which two are domestic. Short bowl syndrome (SBS) is a disease in which the small intestine is naturally short in length or more than 60% of the small intestine is lost by surgical resection. This is known to cause rapid malnutrition due to food absorption. It is a rare disease in which less than five people occur per 100,000 people. Patients receive nutrients through blood vessels, which makes normal daily life difficult and can cause side effects such as liver failure and thrombosis in the long run, so treatment is urgent. Hanmi Pharmaceutical is developing this drug in the global market. In particular, Hanmi Pharmaceutical's own technology, the Labscovery platform, is being developed as a formulation drug administered once a month. Earlier this year, phase 2 clinical trials were approved by the U.S. FDA and began clinical trials in June. The U.S. FDA and the MFDS have designated this drug as a rare drug in the development stage to support rapid commercialization. If designated as a rare drug by the FDA, benefits such as tax reduction, exemption from the cost of applying for permission, and exclusive rights for seven years upon approval for the first time among products of the same affiliate will be granted. Few patients are suffering from rare disease treatments, but global pharmaceutical companies are also focusing on development due to high costs. Rare drugs with high effectiveness receive high value. If Hanmi Pharmaceutical proves its validity in phase 2 clinical trials, it is also expected that overseas big perm will buy it. Attention is focusing on whether South Korea and the U.S. will be able to reach the global stage through their own technology in the rare disease treatment market.
- Policy
- Gov “It was the experts’ decision to not list Kymriah”
- by Kim, Jung-Ju Oct 12, 2021 05:49am
- In response to NA’s criticism regarding the delayed reimbursement listing of Kymriah, the government has expressed its difficulties as the decision was a result of an expert assessment. Also, the government denied the claim that that insurance coverage is only being extended for mild diseases. This was the response Health and Welfare Minister Deok Cheol Kwon gave to the claims that were made by NA member Jong Sung Lee at the NA Health and Welfare Committee’s audit of the Ministry of Health and Welfare that was held on the 7th. Lee had previously pressed the government for the prompt listing of Kymriah, using Soliris in 2012 and Spinraza in 2019 as examples of how the government is passive in listing new drugs. Lee said, “A clinical trial had shown that Kymriah could increase the survival rate by 60%. It feels that the government is immersing itself in populist policies - those that benefit a large number of mild patients - and neglecting the small number of severely ill patients.” He continued, “How hard could it be for the government, which had once announced that it could spend 1 trillion won as phone bill support for the public, list one single drug for our young patients?” Minister Kwon immediately refuted Lee’s claim. Kwon said, “The claim that only the coverage for mild disease patients has increased during President Moon's administration is not true. The coverage rate of severe disease patients is currently over 70%. I believe there is a misunderstanding here. The government also believes that we should promptly provide insurance benefit for severely ill patients.” He explained that the decision on Kymriah was not made by the government and was a result of an expert assessment. “Kymriah is an ultra-high-priced drug, and is being reviewed by the experts.”
- Policy
- The MOHW expressed reluctance to Keytruda's primary benefit
- by Lee, Jeong-Hwan Oct 12, 2021 05:49am
- Minister Kwon Deok-cheol (photo = provided by the National AssemblyMinister of Health and Welfare Kwon Deok-cheol expressed reluctance to applying MSD immuno-cancer drug Keytruda as a primary treatment for lung cancer, citing enormous health insurance financial needs. On the 6th, Minister Kwon responded to a question from Kang Sun-woo (the Democratic Party of Korea) at the National Assembly Welfare Committee's parliamentary audit. He pointed out that when lung cancer was first treated with Keytruda, it was more effective in treating diseases than when used as a secondary treatment. He introduced that the U.S. NCC guidelines also recommend Keytruda as a priority in single and combined therapy. He criticized that unlike overseas countries such as the United States, Korea is applying benefits so that Keytruda can only be used as a secondary treatment in the event of a traditional chemotherapy failure, increasing the burden on patients. He said, "It costs 7 million won a month for lung cancer patients to spend Keytruda at their own expense from the first treatment. He said,"if it is administered every month, about 100 million won per year is needed. 52 countries around the world have already applied the primary benefit, and 31 OECD countries have also recognized the primary benefit." He then asked Minister Kwon Deok-cheol if he had any plans, such as a system that is registered first and then evaluated for Keytruda benefits or a separate cancer fund. Minister Kwon replied that the pre-registration & post-evaluation system is also under comprehensive review in consideration of the financial burden of health insurance and difficulties in managing drug prices. He explained, "If Keytruda, the current secondary treatment, is allowed as the primary treatment, it will affect huge health insurance finances, so there should be a (cost-effectiveness) evaluation." He said, "In the system, it becomes reasonably difficult to manage drug prices because the health insurance finance has to pay the drug price at the time of pre-registration." "We need to comprehensively review that," he added.
- Company
- SK Bioscience will also produce COVID-19 vaccines next year
- by Chon, Seung-Hyun Oct 12, 2021 05:49am
- At an agreement ceremony held in Brussels, Belgium on the 5th, SK Bioscience President Ahn Jae-yong (right side of the picture) and CEPI CEO Richard Hatcht are signing a contract to use the Andong L House facility SK Bioscience will also entrust production of COVID-19 vaccines from global pharmaceutical companies next year. SK Bioscience announced on the 5th that it has signed an extension contract for the use of Andong L House facilities with CEPI in Brussels, Belgium. It will extend the period of using some of the undiluted production facilities in Andong, which were signed in June last year and are about to expire at the end of this year, to the end of 2022 for the production of COVID-19 vaccines by CEPI-supported companies. The contract said that by the end of next year, three of SK Bioscience's facilities in L-house will be used first to entrust production of the COVID-19 vaccine developed by a company supported by CEPI. The two companies agreed to continue close cooperation to overcome the current pandemic situation and expand cooperation in research on various infectious diseases that have frequently occurred recently and the development of vaccines accordingly. SK Bioscience participated in the world's efforts to prevent the spread of COVID-19 infection and discussed "1 Euro" with only symbolic meaning as an initial down payment to maintain friendly cooperation with international organizations such as CEPI and COVAX facilities. CEPI has decided to continue to utilize SK Bioscience's facilities as a public goal to secure fair vaccine access by supplying additional COVID-19 vaccines around the world through the COVAX facility. COVAX facility currently plans to supply a total of 2 billion doses of COVID-19 vaccine to the world by the first quarter of next year. SK Bioscience plans to accelerate the development of its own COVID-19 vaccine, which is currently in phase 3 clinical trials, in close cooperation with CEPI. The COVID-19 vaccine candidate GBP510 jointly developed by SK Bioscience and Institute for Protein Design (IPD) and using GlaxoSmithKline's Pandemic Technology is currently in phase 3 clinical trials. CEPI cooperated with the Bill & Melinda Gates Foundation from the initial development stage of the GBP510 and provided SK Bioscience with up to USD 213.7 million in development funds. GBP510 was selected as the first target of the 2nd generation COVID-19 vaccine project operated by CEPI last year to support differentiated COVID-19 vaccine candidate materials. When GBP510 is commercialized, hundreds of millions of vaccinations will be supplied worldwide, including underdeveloped countries. SK Bioscience and CEPI are additionally discussing the development of GBP510 in preparation for variations and research on booster shots. "The additional facility use contract with SK will provide an opportunity to approach the promise of COVAX facilities to protect vulnerable populations through fair vaccine supply, while further strengthening the relationship between CEPI and COVAX facilities and South Korea," said Richard Hatchett, CEO of CEPI. Ahn Jae-yong, president of SK Bioscience, said, "The proven production system and technology shown by global companies during consignment production of the COVID-19 vaccine led to an extension contract with CEPI." Next year, we will secure and supply our own COVID-19 vaccine, which will serve as a hub for global vaccine supply, he said.
- Company
- Dupixent reimbursement in pediatric AD is being discussed
- by Eo, Yun-Ho Oct 08, 2021 05:57am
- Discussion on prescribing ‘Dupixent’ to pediatric patients with atopic dermatitis is now showing visible progress. According to industry sources, the National Health Insurance Service has started expert inquiries to start discussions on applying insurance benefits to the lower-dose (200mg) formulation of Sanofi-Aventis Korea’s Dupixent (dupilumab). This is 7 months since the company had applied for reimbursement in April. Accordingly, other processes including its deliberation date by the disease subcommittee, etc. are expected to be soon set. The lower-dose Dupixent was approved in Korea in adolescent patients aged 12 or older with severe atopic dermatitis who are less than 60kg. After an initial dose of 400mg, the patient is administered 200 mg every other week. Since then, Sanofi added the indication for treating pediatric patients aged 6 to 11 with severe atopic dermatitis for its low-dose formulation and then applied for its reimbursement listing. The health insurance benefit for Dupxient is approved for adult patients aged 18 or older with 3+ years of medical history with severe chronic atopic dermatitis that meets all three standards: ▲ unable to control symptoms even with first-line topical therapy for 4 or more weeks; ▲ cannot use systemic immunosuppressants due to no response or side effects despite 3 or more months of use; ▲ had an EASI (Eczema Severity Assessment Index) of 23 or higher before using Dupixent. This is for the 300mg dose. The efficacy and safety of 200mg Dupixent were verified through the LIBERTY AD ADOL clinical trial. 251 adolescent patients with severe atopic dermatitis patients who were treated with Dupixent 200mg and 300mg showed a 66% improvement in the size of lesion and severity at week 16, as well as clinically significant improvement in their quality of life index. 75% of the group that was administered Dupixent in combination with topical corticosteroids, achieved EASI 75 (EAST improvement of 75%) at week 16, demonstrating a more significant improvement compared to the 26.8% of the placebo group. Since Dupixent, other JAK inhibitors used for autoimmune diseases like rheumatoid arthritis have also been seeking to enter the atopic dermatitis treatment market. In June, Lilly Korea submitted a reimbursement application for ‘Olumiant (baricitinib),’ and Abbvie Korea has recently added an AD indication for its ‘Rinvoq (upadacitinib).’ Also, Pfizer applied for domestic approval of ‘Cibinqo (abrocitinib)’ recently.
- Company
- PARP inhibitor Zejula, which is partially covered
- by Oct 08, 2021 05:57am
- PARP inhibitor Zejula could be reimbursed as the primary maintenance therapy for ovarian cancer. However, it is pointed out that "regulatory agencies should change their perspectives" due to benefit standards. Kim Jaewon, professor of obstetrics and gynecology at Seoul National University Hospital, is taking Korea on the 7th. At the Zejula online meeting held by the restriction, he pointed out, "It is regrettable that only ovarian cancer patients with BRCA mutations have recognized primary maintenance benefits. This is in accordance with the stereotypes of regulators, and we need to change our perspective like in the United States." Earlier, the Health Insurance Review and Assessment Service recognized the clinical usefulness of primary maintenance therapy only for BRCA positive. Regulatory authorities believe that Zejula can be used regardless of the BRCA mutation, but the application of benefits is insufficient. Professor Kim Jaewon The underlying PRIMA clinical results showed that Zejula showed a median progression-free survival (mPFS) of at least twice as long as that of placebo groups in the entire patient group, regardless of BRCA mutation and covalent recombinant deficiency (HRd) (21.9 months vs. 10.4 months). The risk of disease progression and death also decreased by 57%. The effect was highest in the BRCA-positive patient group. The mPFS of BRCA-positive patients in the HRd patient group was 22.1 months in the Zejula-administered group and 10.9 months in the placebo group. However, even in the BRCA negative patient group, mPFS satisfies statistical significance to 19.6 months in the administration group and 8.2 months in the placebo group, allowing Zejula to extend the progression-free survival period regardless of the BRCA mutation. Jang Hyun-ah of Takeda Pharmaceutical Korea said, "In terms of PRIMA results, Zejula showed consistent treatment effects regardless of biomarkers, including patients in high-risk groups." She also explained, "We also confirmed that the dose can be adjusted and used according to the patient's condition, and that even if the capacity is low, there is no difference in effect and the safety profile improves." The reason for dissatisfaction with the disapproval of benefits in the BRCA negative group is that more than 80% of ovarian cancer patients do not have a BRCA mutation. Patients are suggesting expanding their salaries so that many people can take the first PARP inhibitor that can be used regardless of BRCA mutation. Professor Kim Jae-won also said, "There are quite a few patients who benefit from HRp, not HRd, without biomarker mutations." He said, "A similar thing happened in the United States five to six years ago, but the PARP inhibitor was accepted by changing the perspective to an advanced survival period according to the characteristics of ovarian cancer. "I think the government should cover all of them regardless of mutations with insurance benefits because many of them can be cured if they use drugs," he said. 제줄라 국내 허가사항과 급여 현황(자료: 한국다케다제약)
