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- 2021-08-05 02:48
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- Company
- Restylane Kysse has been approved in Korea
- by jung, sae-im Aug 5, 2021 12:41am
- Galderma Korea announced on the 2nd that Hyaluronic acid filler Restylane Kysse was approved by the MFDS on July 26 for the purpose of temporarily expanding the volume of lips for adults aged 21 or older. Restylane Kysse, which received Korea's first permission for lip fillers, was developed by Galderma as Optical Balanced Technology( OBT). Customized procedures can be performed to suit the patient's skin condition, and lip volume can be restored to create natural and beautiful lip volume. More than 78% of all patients who participated in Restylane Kysse's clinical trial said they were still satisfied with the results of the procedure a year later. The effect of Restylane Kysse was confirmed by a clinical trial. A total of 270 people were evaluated for the validity and satisfaction of the product by measuring changes after the lip enlargement procedure every eight weeks for 12 months. Clinical results showed that it lasted up to a year and showed high treatment satisfaction not only in middle-aged people who lost lip volume due to aging but also in young patients who wanted natural and thick lips. Based on this, it was approved by the FDA on March 26 last year as a lip filler. Lee Jae-hyuk, executive director of Galderma Korea's Aesthetic Division, said, "We reaffirmed the technical skills of Galderma, which developed the Hyaluronic acid filler Restylane Kysse. We will continue to make efforts as a helper to complete each person's skin through products like Restylane Kysse. We have been constantly innovating for healthy and beautiful skin."
- Policy
- No prior approval req. filed for Soliris, 47 for Ultomiris
- by Lee, Hye-Kyung Aug 4, 2021 06:01am
- ‘Ultomiris (ravulizumab),’ a follow-on drug of ‘Soliris (eculizumab)’ that was approved for reimbursement from June, has taken away all new prescriptions for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) from Soliris. Reimbursement for Ultomiris, like Soliris, needs to be authorized in advance through a prior authorization application process to the NHIS before administration at a medical care facility equipped with the personnel and facilities as specified in the ‘Criteria on the medical care benefit for hematopoietic stem cell transplantation.' According to the eligibility for reimbursement of Soliris and Ultomiris deliberated in July by HIRA’s Healthcare Review and Assessment Committee, new approval applications filed by PNH patients were 0 for Soliris and 47 for Ultomiris. The doctors and new PNH patients were seen to have selected Ultomiris, which can be administered every 8 weeks as maintenance therapy 2 weeks after the initial dose, over Solaris, which needs to be administered biweekly. Ultomiris received approval from the U.S. FDA in December 2018, and from the EMA in July 2018. The drug received marketing authorization in Korea on May 21st, 2020. After receiving approval, Handok applied for the insurance benefit listing on August 31st last year. After receiving approval from HIRA’s Pharmaceutical Benefit Assessment Committee, going through NHIS’s drug pricing negotiations, and deliberation by MOHW’s Health Insurance Policy Deliberative Committee, Ultomiris was listed at &8361;5,598,942 per vial from June 7th. Based on the clinical trial results, Ultomiris was found to be clinically non-inferior to its substitute Soliris. Also, Ultomiris was considered cost-effective if its price is set at Solaris's weighted average price of &8361;5,598,942 or less. Meanwhile, 43 PNH patients receiving Soliris that were monitored received approval to continue administration of Soliris. 6 cases that were filed to newly administer Soliris for atypical hemolytic uremic syndrome (aHUS) were all disapproved, and 2 monitoring cases for Soliris were approved and the other 2 were disapproved.
- Policy
- Will changes be made to Hemlibra’s reimbursement standards?
- by Lee, Jeong-Hwan Aug 4, 2021 06:01am
- As the Anti-Corruption & Civil Rights Commission (ACRC) in addition to the National Assembly raised the need to ease the reimbursement standards for the hemophilia treatment Hemlibra (emicizumab), the growing sense of urgency on the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA)’s behalf to take follow-up actions is expected to increase. The NA and ACRC requested the standards be changed so that pediatric patients under the age of 12 can use the subcutaneous injection Hemlibra immediately without prior use of the intravenous drug treatment ‘immune tolerance induction (ITI) therapies. Sun-Woo Kang of the Democratic Party of Korea had first criticized the inappropriateness of Hemlibra’s reimbursement standards in June, then the ACRC had also made recommendations to the MOHW to change the reimbursement standards. The NA member pointed out that the existing reimbursement standards that acknowledge reimbursement of Hemlibra in pediatric patients aged under 12 only after they fail intravenous injections that accompany great pain should be changed. The ACRC also decided that it was harsh to recognize insurance benefits for Hemlibra only after the pediatric patients that have weak blood vessels undergo ITI therapy that require intravenous injections for 2-3 years. The NA and ACRC’s move was influenced by the appeals made by guardians of pediatric patients with hemophilia that were posted on the National Petition board of Cheong Wa Dae. A total of 4 requests to change the reimbursement standards of Hemlibra had been posted on the national petition board from November 2019 to date. 2019 was when JW Pharmaceutical had received marketing authorization for Hemlibra. JW Pharmaceutical received approval for Hemlibra from the Ministry of Food and Drug Safety on January 20th, 2019. In the earlier petitions, the request was focused on approving reimbursement for Hemlibra, but from last year, the content of the petitions changed to request modification or ease of reimbursement standards for patients aged less than 12 years. Recently, the caregivers of patients (parents) had requested MOHW and HIRA to delete the mandatory ITI therapy prerequisite for Hemlibra’s reimbursement in pediatric patients aged 1 to 12 years old. They criticized that the current reimbursement standards violate human rights by forcing pediatric patients to receive intravenous injections even though Hemlibra, a subcutaneous injection option, is available. Upon receiving such criticism, the MOHW and HIRA are making a move to improve the reimbursement standards. HIRA had held an expert advisory meeting on the efficient operation of ITI therapies for hemophilia A, and the MOHW is planning to amend the reimbursement standards for pediatric patients based on HIRA’s discussion results. In particular, the need to improve the standards grew with the NA strongly criticizing Hemlibra’s reimbursement standards as “standards that approve reimbursements based on the pain and suffering of our children.” Also, the fact that other countries do not limit reimbursement of Hemlibra by age raises the validity on the need for the health authorities to improve the benefit standards. The U.K .approves reimbursement of Hemlibra when the patient satisfies any one of the following conditions: those who fail ITI therapy, or cannot control bleeding, or administers the drug as maintenance therapy or bleeding therapy with bypassing agents, or as maintenance therapy to prevent bleeding symptoms during ITI therapy. In response to the continued criticism from the NA, ACRC, and caregivers of pediatric patients, the MOHW and HIRA are expected to present a bill to revise the benefit standards in the near future. On Sun-Woo Kang’s criticism, the Minister of Health and Welfare Kwon Deok-Cheol said that he would “comprehensively review the issue with experts and discuss how to improve the reimbursement standard of Hemlibra in consideration of the characteristics of pediatric patients.”
- Policy
- Daewoong has added a line-up of osteoporosis treatments PO
- by Lee, Tak-Sun Aug 3, 2021 08:27pm
- Daewoong's Evimax 45mg was approved on July 29. It is generic for Raloxifene HCl 45mg. The original for Raloxifene HCl is Evista from Alvogen Korea. Evista contains Raloxifene HCl 60 mg. Raloxifene HCl 45mg was first developed by Yuhan. In September 2019, Yuhan was granted 'Raboni 45mg', a product containing Raloxifene HCl 45mg. The company explains that safety has been increased by lowering the content of Raloxifene HCl by improving its bioavailability. Daewoong's approved product is also manufactured and supplied by Yuhan. In June, Daewoong was previously granted "Evimax D," a combination of Raloxifene HCl 45mg and a concentrated vitamin D powder. This is also an item produced by Yuhan. As a result, Daewoong will have three Raloxifene preparations, including Daewoong Raloxifene HCl 60mg, which was approved in March last year. Daewoong has been selling Daewoong Zoledronic Acid as a treatment for osteoporosis and Ricen Plus as an oral medicine. The performance is not bad either. Based on IQVIA last year, Daewoong Zoledronic Acid recorded &8361;11.2 billion and Ricen Plus, which is a combination of Risedronic acid and Cholesterol, recorded &8361;1.5 billion. In terms of sales, oral products are less competitive than injection products. For this reason, Daewoong needed the latest treatment for oral osteoporosis. It is believed that the company introduced Raloxifene HCl 45mg developed by its competitor Yuhan first. In the past, Daewoong sold original osteoporosis drugs such as Fosamax Plus D and had the largest share in the oral market. However, due to the termination of the contract for MSD's Fosamax, it suffered from losing its main items. Zoldronic Acid, which had little sales at the time, was successful by co-promoting with Sandoz. Since then, the Zoldronic Acid injection has been manufactured by Daewoong by purchasing copyrights. Considering Daewoong's business competitiveness in the osteoporosis treatment market, the introduction of Raloxifene HCl 45mg is also likely to be successful. Attention is focusing on how much sales Daewoong will make in the osteoporosis treatment oral market through the launch of a new product.
- Policy
- The number one treatment for mild COVID is Kaletra
- by Kim, Jung-Ju Aug 3, 2021 08:24pm
- The number one drug used to treat mild COVID in the first half of this year was AbbVie's Kaletra, which amounted to &8361;596 million. The total amount of drugs spent on the entire treatment, including severe cases, amounted to &8361;12.1 billion. Among the data on "COVID-19 Treatment Expenditure in the first half of the year," the "Status of Drug Administration by severe cases" showed this. According to the current status, the amount of drugs used to treat COVID-19 in the first half of this year amounted to &8361;12.1 billion, or 2.5% of the total medical expenses. AbbVie's Kaletra (&8361;596 million) is the number 1 based on drug costs . Then, Chong Kun Dang's Tazoperan 4.5g , &8361;107 million, Samsung's Combicin 3g, &8361;98 million, Ukchemipharm's Trison Kit 2g is &8361;88 million, Boryung's Maxipim 1g is &8361;83 million, SK Chemical's Huthan 50mg is &8361;72 million, Bayer Korea Avelox 400mg, &8361;68 million, and Yuhan's Meropen 0.5g, &8361;65 million. Following oxygen, cost of AbbVie's Kaletra is the most at &8361;128 million, Yuhan's Meropen 0.5g, &8361;112 million, Chong Kun Dang's Tazoperan 4.5g, &8361;99 million, Maxipim 1g, &8361;72 million, Huthan, &8361;51 million, Avelox 400mg, &8361;47 million, and Clexane, &8361;45 million, Vfend 200mg, &8361;4400 million. Excluding oxygen, Fresofol 2% of Fresenius Kabi Korea was the most used, followed by Meropen 0.5g of Yuhan with &8361;238 million and Huthan 50 with &8361;1.9 million. Greencross Human Serum Album 20%, &8361;173 million, Human Serum Album 20%. &8361;127 million, Vfend 200mg, &8361;120 million, Boxter's Phoxilium Phosphate Solution 1.2 mmol/L, &8361;85 million, and JW Life Science's Winuf, &8361;83 million, respectively.
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