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- Product
- Illegal errand companies deliver Wegovy for ₩10,000
- by Jung, Heung-Jun Oct 22, 2024 05:52am
- Amid the craze for obesity treatment drug Wegovy, errand companies are also thriving by offering pharmacy proxy pick-up and delivery services. These are illegal businesses that take advantage of the fact that consumers are looking for a low-priced source of the non-reimbursed drug, as the price varies greatly depending on the pharmacy. There are posts on diet communities that claim to have purchased Wegovy at a low price in the KRW 400,000 range. Some people said that they called the pharmacy to check the price, while others said that they found a lower price through non-face-to-face treatment venues. Some people also wrote that they received Wegovy packaged in a cooler from another region. When the reporter checked with the pharmacy that offered Wegovy delivery, they were using an errand delivery service. The pharmacy representative said, ‘We don't offer delivery services for Wegovy,” but gave me the contact details of a courier service. They explained that the pharmacy has been contacted repeatedly due to the courier service’s promotion. Although the pharmacy does not deliver directly, they are tacitly allowing the act. “They charge KRW 10,000 for 1-2 pens and KRW 12,000 for 3-5 pens,” said A, who introduced himself as an errand-running company. If you use non-face-to-face treatment services, you can send the prescription to the pharmacy and then contact them for us to receive and deliver the medicine,” A explained. After submitting the prescription to the pharmacy, the customer can exchange the detailed address and account number for the Wegovy delivery through A. A also added a condition that the customer should leave a review on online cafes and communities. “I don’t make much with the deliveries. To make a profit, we need multiple delivery orders,’ said A, adding, ’Please leave your reviews online.’ Meanwhile, pharmacies are also focusing on stocking up and selling Wegovy in line with shifting attention from Saxenda to Wegovy. Low doses are selling out quickly. Lawmakers are also posting reviews of Wegovy use on social media to promote in-patient prescriptions. The selling price of the drug, which can be checked through non-face-to-face treatment websites, varied greatly on the first day of its release, but as of today (21st), the drug’s price is set in the KRW 500,000 range.
- Policy
- Dongkook receives reimb for s-amlodipine triple-drug combo
- by Lee, Tak-Sun Oct 22, 2024 05:52am
- Dongkook Pharmaceutical has succeeded in becoming the first Korean company to receive reimbursement for a three-drug combination drug for hypertension that combines the CCB ‘s-amlodipine,’ ARB ‘olmesartan’ and diuretic ‘hydrochlorothiazide’. The combination therapy is expected to be useful for patients whose blood pressure is not adequately controlled with the company's combination product, s-amlodipine+olmesartan. Only Dongkook Pharmaceutical and Ahngook Pharm owns an s-amlodipine+olmesartan combination drug. According to industry sources on the 21st, Dongkook Pharmaceutical will start selling three types of Olmevikar HCT Tab beginning November, 1 with reimbursement. Olmevikar HCT Tab is a three-drug combination of S-Amlodipine Besylate 2.5 Hydrate, Olmesartan Medoxomil, and Hydrochlorothiazide. Compared to Daiichi Sankyo's existing Sevikar HCT, the only difference is the amlodipine and s-amlodipine ingredients. S-amlodipine is a component derived from only the S-enantiomer of amlodipine, which is the active isomer of amlodipine. Therefore, it is equally effective with half the dose of amlodipine with no difference in terms of stability. In Korea, there are 28 amlodipine 3-drug combination drugs like Sevikar HCT. However, Dongkook Pharmaceutical is the first to develop a 3-drug combination containing s-amlodipine. Olmevikar HCT is a combination of s-amlodipine besylate 2.5 hydrate and olmesartan medoxomil that was approved in late May for the treatment of essential hypertension, a condition in which blood pressure is not adequately controlled. It is indicated as a second-line treatment following amlodipine+olmesartan combination therapy as well as s-amlodipine+olmesartan. There are only two as s-amlodipine+Olmesartan combination drugs on the market, Dongkook Pharmaceutical ‘Olmevikar Tab’ and Ahngook Pharm’s ‘Levomos Tab.’ Last year, Olmevikar generated KRW 3.8 billion in outpatient prescriptions and Levomos KRW 1.2 billion, according to UBIST. “Looking at the indications, Olmevikar HCT tablets are expected to be useful for patients who are not sufficiently treated with Olmevikar Tab,” said a pharmaceutical industry insider. “Dongkook’s product competitivity by strengthening its hypertension combination product lineup.” The price has been set in line with the original Sevikar HCT. The company has applied for the 5 (s-amlodipine)/40 (olmesartan)/12.5 mg (hydrochlorothiazide) dose at KRW 821 per tablet, the 2.5/40/12.5 mg dose at KRW 765, and 2.5/20/12.5 mg dose at KRW 703 for, which is lower than the calculated price. This is the same as the price of the same dose Sevikar HCT.
- Company
- "Multiple myeloma dynamics require changes to reimb strategy
- by Whang, byung-woo Oct 22, 2024 05:51am
- "Multiple myeloma is a cancer type that has a great ripple effect depending on new drugs provided in a certain environment. Reimbursement of multiple myeloma treatment requires discussion following a thorough evaluation of the impact of the treatment depending on the treatment environment." Multiple myeloma is one of the cancer types with increased treatment options following new drug entries. There are concerns about extending the relapse period and progression-free survival (PFS) as the number of treatments increases due to relapses. However, the discussion for reimbursement is hindered by cost issues. Youngil Koh, Professor of the Department of Hemato-Oncology at Seoul National University Hospital, emphasizes the importance of discussing appropriate disease-specific environments. According to Koh, the development of new drugs for blood cancers is active because of disease characteristics. Because cancer cells tend to exist in the blood and it is easy to obtain samples, the research is relatively simple. Understanding of blood cancer yields significant results compared to solid cancers. "Almost all new drugs begin from blood cancers, including TKI, therapeutic antibody, bispecific antibody, and ADC, and expand to solid cancers. Bispecific antibodies and ADCs are used as the standard treatment for blood cancers and expand their indications to solid cancers," Koh said. In South Korea, a bispecific antibody treatment, Tecvayli (teclistamab), is available for treating multiple myeloma. This drug was approved in July. The use of Tecvayli is limited because it is not reimbursed, but the expansion of market presence is expected following the announcement of long-term follow-up research results of the drug's clinical trial, MajesTEC-1, at the American Society of Clinical Oncology (ASCO 2024) meeting. The results of evaluating the efficacy of Tecvayli in 165 study participants at 30.4 months interim follow-up showed that Tecvayli reduced tumor sizes by 63% (overall response rate, ORR) in patients who had failed or were non-responsive to third-line treatments or higher. 46.1% of the patients reached complete remission (CR). The study confirmed consistent, long-term clinical effectiveness and positive safety profile. "The 30-month follow-up outcome did not differ from the data presented in 2022; therefore, it is significant that we have confirmed the anticipated outcome," Koh said. "Specifically, 4 out of 10 patients showed great responses and maintained response over two years." "We have observed that the real effects observed in 30-50 patients administered with the drug at the Seoul National University Hospital did not differ greatly from the research," added Koh. "1/3 of the patients benefited from the treatment, and close to half experienced great responses." In conclusion, Koh says that the result should be highly regarded because Tecvayli's long-term follow-up data demonstrated that patients showed a significantly long response period after almost two-years of treatment. Will Tecvayli, demonstrating its long-term effects, be adminstered earlier in the treatment course? Based on the assumption that there are no differing opinions about the effect of Tecvayli, the question is 'when' to use the drug. There are concerns about using the good drug first or last, regardless of disease. However, multiple myeloma requires a more careful approach because the treatment order is particularly important. Koh says it is difficult to determine at this point, but Tecvayli is likely to be placed earlier in order since the data supporting its use of Tecvayli in earlier treatment course are now available. "Tecvayli is the only bispecific antibody to be used for the treatment of multiple myeloma in South Korea and it targets BCMA, which the conventional treatments haven't targeted," Koh said. "Based on the clinical data of Tecvayli used in combination with already effective treatments that are currently used, Tecvayli is likely to be employed earlier in the treatment and will be able to extend overall survival," Koh said. However, Koh assessed that it is too early to mention whether bispecific antibody, known as the next-generation treatment, or CAR-T therapy should be placed earlier. "The positions of bispecific antibody and CAR-T for treating multiple myeloma have not been established yet. We now know that two treatments successfully treat multiple myeloma, but it is early to determine which one is superior. Upcoming clinical data will determine their positions," Koh emphasized. "Multiple myeloma is highly dynamic…changes to reimbursement strategy should be considered" Besides the Tecvayli effect, the dilemma for new drugs is the cost. Patient burden increases when high-cost drugs are not covered by reimbursement. Since multiple myeloma treatment tends to use 2-3 treatments in combination, the government is hesitant to opening the door to reimbursement. Regarding this issue, Koh advises that rather than simply comparing the cost of the drug, a reimbursement strategy reflecting the characteristics of multiple myeloma should be discussed. "The dynamic of treatments for multiple myeloma is changing due to new drugs, and the disease is greatly influenced by the type of new drugs and the type of reimbursement. We need to discuss reimbursement after anticipating the potential impact of reimbursement on overall treatment outcomes," Koh explained. "The landscape of multiple myeloma is diverse and constantly changing; therefore, instead of simply comparing costs, the government can strategize better reimbursement plan taking into account various outcomes," Koh said. Koh stated that we need to discuss patient access to clinical trials while reimbursement for new drugs is limited. "New drugs are being developed faster than the reimbursement process. It is inevitable that patients cannot benefit from new drugs because reimbursement cannot cover all," Koh said. "In other words, drugs are available at clinical stages, so we could discuss increasing patient access to new drugs."
- Policy
- MFDS grants EUA to COVID-19 variant vaccine for infants
- by Lee, Hye-Kyung Oct 22, 2024 05:51am
- The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on October 21st that it has granted Emergency Use Authorization for 'Comirnaty JN.1 Inj 0.033 mg/mL (bretovameran),' a SARS-coV variant (JN.1) vaccine for infants aged 6 months-4 years. Emergency Use Authorization is a system designed to respond appropriately to a public health crisis, including infectious disease pandemics. In this system, the MFDS minister enables the supply of medical products that do not have domestic approval by ordering manufacturers and importers to manufacture or import upon requests from the central administrative agency. The Korea Disease Control and Prevention Agency (KDCA) requested the Emergency Use Authorization to provide immunization for infants (6 months-4 years old), and the MFDS quickly reviewed it and granted approval. For Emergency Use Authorization, MFDS gathers expert opinions by reviewing company's submitted clinical and quality documents through the official posting of the emergency use authorization upon request from the central administrative agency. Then, after review and voting from the committee for the 'Public Health Emergency Preparedness and Responses for a Medicinal Product,' the MFDS makes a final decision. "We will continue to put efforts in enhancing public health by quickly supplying medical products that are effective in overcoming COVID-19, based on our scientific knowledge and regulatory expertise," the MFDS stated.
- Company
- Will combination therapies for cancer be reimbursed in KOR?
- by Whang, byung-woo Oct 21, 2024 05:49am
- As the government has begun to prepare the principles for the reimbursement review of combination therapies that use new anticancer drugs, attention is being paid to whether the discussion will progress further. According to industry sources, the Health Insurance Review and Assessment Service recently held a Cancer Disease Deliberation Committee meeting and decided to prepare deliberation principles to discuss whether to approve benefits for major combination therapies. The decision is in line with the growing calls for a change in the reimbursement paradigm for prescribing anticancer drugs based on accumulated evidence on ‘combination therapies’ between treatments from various clinical studies. Recently, multinational pharmaceutical companies have been seeking the reimbursement of combination therapies using new anticancer drugs, calling for an institutionalized process. When considering reimbursement for combinations of non-reimbursed new drugs and reimbursed chemotherapy drugs, the industry has suggested that discussions on previously reimbursed drugs should be reserved and only the non-reimbursed drugs should be discussed. A case in point is AstraZeneca's immuno-oncology drug Imfinzi (durvalumab), the reimbursement of which had been discussed for biliary tract cancer last year. At the time, CDDC only approved gemcitabine and cisplatin in combination with chemotherapy (the GemCis regimen) for first-line treatment of biliary tract cancer, while leaving Imfinzi non-reimbursed. The government will discuss setting a deliberation principle where a drug, which is already reimbursed, is used with a non-reimbursed new drug as part of combination therapy and should continue to be reimbursed without further discussions. This can be observed in the results of the 7th CDDC Review, which reviewed the combination of ‘endocrine therapy’ and ‘Verzenio (abemaciclib)’ for the treatment of early breast cancer. The outcome of the deliberations was to keep the previously reimbursed adjuvant endocrine therapy as is and make the newly added Verzenio available on a ‘100% coinsurance’ basis, reducing the cost burden on the patients. In other words, it means that the process will be simplified by allowing the reimbursement of existing treatments within the combination to be recognized. However, these principles are not automatically applicable to all new combination therapies, and as it leaves the existing framework in place, it is far from the improvements to the new drug approval approaches the industry had hoped for. Nevertheless, it is positive as it has opened the door to further discussions. There are also expectations that such discussions will lead to solutions for ‘new drug+new drug’ combination therapies. A pharmaceutical industry official said, “It is still a drug-by-drug approach, so it's not a one-size-fits-all approach, but it's positive that the discussions have been officially made. We understand that KRPIA and others are also having discussions on what kind of processes will be required for the reimbursement of new drugs for combination therapies in the future,’ “With the number of combination therapy cases increasing, there is currently no set process for how applications should be submitted for listing and how they should be reviewed. We are looking forward to the various approaches that may be developed through discussions as individual cases have come to light.”
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