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- 2026-05-18 18:57:47
- Company
- MSD’s Keytruda becomes the 'symbol' of cancer immunotherapy
- by Eo, Yun-Ho Aug 25, 2021 05:57am
- Pic. of Keytruda “Reinforcing the body’s immunity to attack cancer cells” By some, the idea was regarded improbable. Not many were convinced that immunotherapy would rise to the position it is in now. Even without reference to the famous story of how the former US president Jimmy Carter cured melanoma with immunotherapy, cancer immunotherapy has become an important pillar in the management of cancer disease nowadays. Among the many drugs introduced, MSD’s (Merck in the US) ‘Keytruda (pembrolizumab)’ has risen to become the symbol of ‘cancer immunotherapy.’ The drug, which was first approved in March 2015 as a treatment for melanoma, is currently approved for 18 indications in 14 cancer types in Korea. One thing to note is that Keytruda is yet far from reaching its turning point. ◆A neglected substance becomes an all-around anticancer drug Keytruda’s history goes all the way back to 2003. Keytruda was developed as a humanized antibody by Organon, a Dutch pharmaceutical Company. In 2007, Organon was acquired by Schering Plough, and the substance was approved for clinical trials by the FDA in December 2012. In 2014, only 3 years after trial approval, the company submitted a New Drug Application to the FDA and received approval as a treatment for melanoma in September of the same year. This was how Keytruda’s journey began. One interesting aspect to note is that MSD was not a prominent player in the field of oncology. The company, whose key areas focused on chronic disease, women’s disease, and vaccines, realized the potential of Keytruda and established a business division for the single drug. MSD’s insight and drive in making the decision to invest in a substance that was neglected by the initial developer is also one key strength of the company to note. After the initial melanoma indication, Keytruda was approved as a second-line treatment for non-small cell lung cancer in 2016, an area in fierce competition. Then, the drug became the first among cancer immunotherapies to receive approval as a first-line treatment for Stage 4 metastatic NSCLC. Afterward, by adding the combination therapy option to its treatment regiment, the drug’s indication was expanded from patients with high PD-L1 expression to all patients to position itself as the standard treatment option for all patients with metastatic NSCLC. Also, Keytruda transformed the concept of cancer treatment by becoming the first to be approved for ‘tumor agnostic' use in all cancer types based on specific genetic features regardless of the initial cancer site. In Korea, the drug was approved as a second-line treatment for 7 types of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, and more recently, as a first-line treatment for metastatic MSI-H/dMMR colorectal cancer. Keytruda ◆MSD Reaps rewards for its foresight… No.1 in sales in both Korea and the global market The company reaped rewards from its aggressive investment. Keytruda recorded No.1 in global sales in 2020, earning $14.38 billion (₩16.8 trillion as of August 18th, 2021). The same went for Korea as well. According to IQVIA, Keytruda recorded ₩155.7 billion in the domestic pharmaceutical market in 2020 to rank first among all pharmaceuticals in sales and has maintained the lead in the first half of this year. In the early years of its release, in 2016 and 2017, Keytruda sold around ₩10 billion’s worth; however, its sales hit ₩70 billion in 2018. The upsurge was driven by its reimbursement approval as second-line treatment for NSCLC in August 2017. As previously mentioned, much potential remains for Keytruda. MSD is conducting more than 1,400 global clinical trials focusing on Keytruda. Korea’s contribution is also quite significant in the area. Around 120 of the global anticancer therapy trials being led by MSD are being conducted in Korea and consist of around 88% of all trials conducted by MSD Korea. Based on the number of participating patients, Korea has ranked 1st among Asia-Pacific countries and 4th in global. ◆The remaining challenge...a rough ride to reimbursement extension However, obstacles do exist in Keytruda’s winning strides as well. Reimbursement is an issue as the insurance benefit is only approved for two indications, as second-line treatment for melanoma and lung cancer. The drug was not able to extend its scope of reimbursement since September 2017. In MSD’s discussions with the health authorities to reimburse Keytruda as second-line treatment for lung cancer, its competitor, the ‘all-comer’ drug ‘Opdivo (nivolumab),’ took away a partial win by strategically narrowing its scope of reimbursement, however, Opdivo also had not seen much progress in expanding its reimbursement ever since. The discussion for Keytruda’s reimbursement as first-line treatment in NSCLC has been ongoing for around 4 years now. It took 9 attempts for the agenda to pass the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) meeting, however, the committee still requested further revisions to be made to the cost-sharing plan. With the burden of re-revisions in mind, MSD is waiting for the agenda to be put up for deliberation by the Drug Reimbursement Evaluation Committee. With the negotiations for contract renewal of the Risk-sharing Agreement (RSA) also overlapping, Keytruda is now at its highest inflection point since its entry into the Korean market. Due to its versatility, expanding the scope of reimbursement for Keytruda may indeed result in the creation of a budget-gobbling monster. In every field, the industry always moves faster than the system. Whether Keytruda will be able to continue making progress in the sea of unprecedented, advanced new drugs that are being introduced remains to be seen.
- Policy
- Will the voluntary recovery of AZBT be expanded?
- by Lee, Tak-Sun Aug 25, 2021 05:57am
- More and more drugs are voluntarily recovered due to the excessive detection of impurities AZBT(Azido Methyl Bipheny Ttetrazole). On the 6th, the recovery of items produced before 2021 among three items containing Irvesartan (Rovelito, CoAprovel, and Arovel) was decided, and AZBT was also detected in a Valsartan compound produced by a domestic pharmaceutical company. The results of the AZBT detection test for the finished product containing Sartan shall be submitted to the MFDS by the end of this month. The voluntary recovery of AZBT-exceeded pharmaceutical companies will continue. According to an industry on the 24th, AZBT detection exceeded the standard and related items began to voluntarily recover from Valsartan-Rosuvastatin, which is produced by a domestic pharmaceutical company. AZBT is a mutation-causing substance that is estimated to occur in response to the synthesis process of tartan, a hypertension drug. In late May (Health Canada recalled Sartan drug with AZBT) and drug regulators around the world began investigating it. In early June, the MFDS said, after ordering AZBT impurity evaluation and test results from medicines containing Losartan, Valsartan, and Irvesartan, it was ordered to submit AZBT test results for all finished product manufacturing numbers by the 31st of this month. On the 6th of this month, companies with three items (Rovelito, CoAprovel, and Aprovel) containing Irvesartan manufactured before 2021 voluntarily recovered. Sanofi, which supplied Irbesartan, limited the products before 2021, saying that AZBT is managed below the acceptable limit in the deployment of products produced after January 2021. However, combination of Valsartan & Rosuvastatin, which exceeded the AZBT acceptance standard, is known to be the target of recovery regardless of lot numbers and expiration date. Industries expect that pharmaceutical companies that have received test results that they exceeded the AZBT standard will voluntarily recover. An official of a small and medium-sized pharmaceutical company said, "As the MFDS ordered companies to conduct their own tests, the pharmaceutical company that obtained the test results first will voluntarily collect items exceeding AZBT." "As the results of the recent test are coming out, we expect to decide on the recovery," he said. In particular, as Sartan products are distributed through consignment production, items with the same manufacturer are likely to be connected to recovery at the same time. The MFDS is asking pharmaceutical companies to voluntarily investigate the carcinogen NDMA (Nitrosodimethylamine) detected in Valsartan or Ranitidine in the past, so it is not expected that all items will be recovered or banned from sale. Instead, it is expected that items that exceed the impurity standard will be voluntarily recovered, and only normal items will be released after the verification process.
- Policy
- Opdivo's benefit extends for kidney cancer & parietal cancer
- by Lee, Hye-Kyung Aug 25, 2021 05:57am
- As domestic No. 1 immuno-cancer drug "Opdivo (Nivolumb)" renewed its contract with RSA, the benefit standard has also been expanded. The HIRA will issue a "proposal to revise the announcement of drugs prescribed and dispensed to cancer patients" and will inquire about their opinions by the 25th. If there is no disagreement, the benefit will be applied from the 1st of next month after the Health Insurance Policy Review Committee's resolution this week. According to Opdivo-related standards, Yervoy (Ipilimumab) and combined therapy were recognized in the first stage of kidney cancer, and it was recognized in the second or more solo therapy for parietal cancer and the third or more Hodgkin lymphoma. Yervoy 50mg and Yervoy 200mg was licensed as a "medium- or high-risk, progressive neocarcinoma treatment with Optdivo and combined therapy," which has no previous treatment experience. As a result of the review of benefit criteria for Opdivo and Yervoy combination therapy, NCCN guidelines recommend preferred category 1 for primary treatment of moderate or high-risk transparent cell carcinoma, and 'I, A' for ESMO guidelines. The benefit standard was set by limiting the tissue type of kidney cancer to patients with moderate or high-risk IMDC risk classification to clear cell carcinoma. Based on Opdivo's criteria for treatment of parietal cell carcinoma, the NCCN guidelines recommend "second-line and subsequent therapy" as "category 1" for recurrent, non-abstructive or metastatic cancers during or after platinum-based chemotherapy. However, if the expression rate of PD-L1 is less than 1% in open-label clinical trials, the standard was set only when the expression rate of PD-L1 was 1% or higher considering the median value of the entire survival period (mOS 5.7 months vs. 5.8 months) similar to alternative therapy. HSCT is also recognized for typical Hodgkin lymphoma patients who have recurred or progressed with Brentuximab Vedotin. Children were also included in the list, considering the nature of Hodgkin's lymphoma disease and the addition of permission for children in excluded countries. According to the HIRA's review, premenopausal patients intentionally performed ovarian resection to induce menopause for use in line with the current benefit criteria, or the expected additional financial requirements were not significant.
- Opinion
- [Reporter's view] Controversy over α-GPC
- by Lee, Hye-Kyung Aug 25, 2021 05:57am
- Negotiations on the return of benefits of the 'Choline alfoscerate' legislation, which was the subject of the revaluation project of the listed drugs, have been concluded. However, the controversy over the return rate has not ended. The NHIS negotiated with 58 pharmaceutical companies that owned 123 Choline alfoscerate on August 10. It announced that it has agreed with 44 pharmaceutical companies on a 20% return rate. Chong Kun Dang, which had been conducting PVA in the third quarter of this year, also finished negotiations. There are about 10 pharmaceutical companies that have not agreed. Negotiations on the repatriation of Choline alfoscerate lasted about eight months from December 14 to August 10. In the process, the timing of recovery was changed from "the day of submission of a clinical trial to the MFDS" to "the day when the MFDS approved the clinical trial," and the amount of recovery also fell from "full 100%" to "20%." The controversy erupted when three pharmaceutical companies that had already signed a 100% return rate in PVA negotiations before the benefit revaluation Choline alfoscerate filed complaints with the Anti-Corruption and Civil Rights Commission for equity reasons. Negotiation about Choline alfoscerate is the first conditional recovery negotiation in conjunction with the MFDS' clinical reassessment. However, all the NHIS negotiations in accordance with the safety and validity verification and quality control requirements have a redemption clause related to revaluation. This is a revised guideline after the 2019 Lipiodol crisis. In the second quarter of last year's PVA negotiations, Arlico, Hana and Kyongbo agreed that if the authorization for revaluation is dropped, the pharmaceutical company should return the full claim from the date of clinical testing to the NHIS. Anti‑Corruption and Civil Rights Commission has conveyed to health authorities that the NHIS and the three pharmaceutical companies should maintain a contract following a clinical trial revaluation, but set a 100% return rate equal to 20%. Anti‑Corruption and Civil Rights Commission's recommendations are not compulsory. However, it is unlikely to raise the rate again, as the rate of return of Choline alfoscerate, which is undergoing simultaneous re-evaluation and clinical re-evaluation, has been agreed to 20% with an eight-month negotiation process. The NHIS should set out what guidelines to maintain in future drug price negotiations in accordance with AAnti‑Corruption and Civil Rights Commission's recommendations. Through revaluation, it is necessary to clarify whether there is a possibility of maintaining the existing "health insurance claim in full" or changing it to 20% agreed with pharmaceutical companies.
- Policy
- Janssen’s acetaminophen tablets may replace Tylenol
- by Lee, Tak-Sun Aug 24, 2021 06:06am
- Janssen Korea, which locally manufactures and sells Tylenol in Korea, has received import authorization for its product. The company is presumed to be making the move to secure alternatives in advance before stopping the operation of its Hyangnam plan at the end of this year. On the 23rd, the Ministry of Food and Drug safety approved Janssen’s import of acetaminophen tablets that contain the antipyretic analgesic ingredient, ‘acetaminophen.’ The product is identical in ingredient, strength, and formulation to the Tylenol 500mg tablets that are locally made by Janssen. With the surge in demand for Tylenol 500mg as a means to relieve the side effects of COVID-19 vaccinations, the drug has made the highest sales performance among all OTC drugs. A large amount of the Tylenol tablets that are currently in the market are known to be stockpiled items that were produced in preparation for the shutdown of Janssen's Hyangnam plant. With the amount in the market being rapidly depleted, the amount left in stock after the shutdown of the Hyangnam plant may be less than expected. This was why a new product from a new manufacturing facility had to be secured in advance for import. Jannsen’s acetaminophen tablets that will be imported will be those that are manufactured in Indonesia and are expected to replace the Tylenol 500mg tablets that are being manufactured in the company’s Hyangnam facility. One thing to note is that the company did not use the brand name ‘Tylenol,’ but rather listed its generic name in the import authorization. This is noteworthy as pharmacies in Korea had trouble securing Tylenol after the Korean authorities had mentioned the specific brand name as a treatment for COVID-19 vaccine’s side effects. However, this may only be due to the fact that Janssen’s marketing authorization for the brand name in Korea is still in place. The industry expects that the company will consider changing the generic name authorization to the brand name after the company withdraws its license for the Hyangnam plant's Tylenol. The dominant opinion is that it will not be easy for the company to give up the name because of the high brand recognition. As such, Janssen has been preparing alternative products in preparation for the Hyangnam plant shutdown. Janssen’s ‘Ultracet Set Tab,’ which is a combination of acetaminophen and tramadol hydrochloride, has also been granted import authorization. Technology transfer for the extended-release formulation of the Ultracet brand has been made to a domestic pharmaceutical company, Handok. As there are many products in the Tylenol brand, these are also expected to undergo technology transfers or be switched to imports. Therefore, 'Tylenol' manufactured from Janssen's Hyangnam plant will not be seen in the market from next year. Established in 1983, Janssen’s Hyangnam plant was one of the few manufacturing bases established by multinational pharmaceutical companies. Hwanin Pharmaceutical acquired the facility in November last year at 46 billion won, and Janssen will be withdrawing its plant that had been in operation for 38 years.
- Company
- Keytruda monopolizes the domestic pharmaceutical market
- by Chon, Seung-Hyun Aug 24, 2021 06:06am
- MSD's immuno-cancer drug Keytruda has taken the lead in the domestic pharmaceutical market for the sixth consecutive period since the first quarter of last year. New drugs recently released by domestic and foreign pharmaceutical companies such as Perjeta, Prolia, and K-CAB are growing. According to IQVIA, a pharmaceutical research firm on the 23rd, Keytruda recorded the highest sales of ₩93.3 billion in the first half of last year. It is up 29.% from the same period last year. Keytruda saw its sales rise 27.0% year-on-year to ₩44.1 billion in the first quarter, and continued its growth rate of 31.0% with sales of ₩49.2 billion in the second quarter. Keytruda has topped the list for the sixth consecutive quarter since its first quarterly sales of ₩34.7 billion in the first quarter of last year. Keytruda, which was released in Korea in 2015, is an immune checkpoint inhibitor that inhibits 'PD-1' protein on the surface of immune cell T cells to treat cancer through activation of immune cells. It is showing outstanding performance in more than 30 cancer species including lung, parietal, gastric, and cervical cancer. Keytruda's quarterly sales remained around ₩3 billion shortly after its release, but sales began to rise at a rapid pace since August 2017 when insurance benefits were applied as a secondary treatment for non-small cell lung cancer. Keytruda surpassed ₩10 billion in sales in the first quarter of 2018 and ₩30 billion in sales in the second quarter of 2019. In the first quarter of last year, Lipitor, which had never missed the lead in quarterly sales since the fourth quarter of 2015, was ranked No. 1 overall. In the second quarter, Keytruda had a sales gap of more than ₩10 billion with the second-largest Lippitor (₩38.3 billion). The gap with Avastin (₩30.2 billion) is close to ₩20 billion. Sales of new drugs recently released by domestic and foreign pharmaceutical companies such as Perjeta, Prolia, and K-CAB have risen sharply. Roche's Perjeta saw its first-half sales rise 29.6% year-on-year to ₩45 billion. Perjeta is a metastatic or localized HER2-positive breast cancer patient who has never received HER2 targeted chemotherapy or chemotherapy. It is a drug used in combination with Trastuzumab or Docetaxel. Perjeta is a primary treatment for HER2-positive metastatic or intemperable breast cancer patients who have never received anti-HER2 treatment in 2017, and sales also surged as Trastuzumab and combination therapy became the standard for preoperative supplementary therapy in May 2019. Perjeta ranked seventh overall in the second quarter, with sales rising 34.7% year-on-year to ₩23.6 billion. Amgen's Prolia ranked ninth overall, with sales rising 21.6% year-on-year to ₩42.4 billion in the first half. Prolia, which was released in Korea in November 2016, is a biomedicine osteoporosis treatment that targets protein RANKL, which is essential for the formation, activation and survival of bone-destroying skeletal cells. Prolia's sales have exploded since April 2019 as insurance benefits have been recognized in primary treatment therapy. Chong Kun Dang is jointly selling Prolia with Amzen. HK inno.N's new drug K-Cap, an anti-orgel drug, was the only one among the top 10 developed drugs in Korea, with sales rising 57.4% year-on-year to ₩41.7 billion in the first half. K-CAB, which was released in March 2019, is an anti- ulcer drug of the potassium competitive gastric acid secretion inhibitor (P-CAB) family of Tegoprazan. It is a new mechanism for inhibiting gastric acid secretion by competitively combining proton pumps and potassium ions located in the final stage of acid secretion in stomach wall cells. K-CAB secured an indication of gastrointestinal reflux disease as its first indication, and added gastrointestinal ulcer treatment adaptation in July of the same year, showing more sales growth. Sanofi's anti-thrombotic drug Plavix increased sales by 21.3% year-on-year to ₩46.8 billion in the first half of the year. Patent of Plavix expired in 2007 and more than 100 generics were released. It has been more than 10 years since the patent expired and is showing rather steep growth even though it competes with more than 100 generics.
- Company
- Tylenol sales jump 140% due to the pandemic
- by Chon, Seung-Hyun Aug 24, 2021 06:05am
- Sales of the OTC antipyretic analgesic ‘Tylenol’ have soared. With the increased demand among people receiving the COVID-19 vaccinations, Tylenol sold ₩43.6 billion in the first half of this year, which is twice more than that sold in the whole term of last year. There has been criticism that the government’s recommendation to take Tylenol in the early phases of inoculation has promoted sales of specific brands. According to the pharmaceutical research institution IQVIA on the 23rd, sales of Tylenol Tab. and Tylenol 8 hours ER Tab. had sold 139.6% more year-on-year to record ₩43.6 billion in the first half of this year. Tylenol’s sales increased 167.9% YOY to record ₩33.6 billion, and sales of Tylenol 8 hours ER Tab. increased 77.0% YOY to record ₩10 billion. Tylenol and Tylenol 8 hours ER are both antipyretic analgesics containing the single-ingredient acetaminophen. Sales of both Tylenol and Tylenol 8 hours ER had surged in Q2 this year. Tylenol’s sales in Q1 increased 25.9% YOY to ₩8.1 billion, but expanded further in Q2 to increase 318.6% YOY to record ₩25.5 billion. Tylenol 8 hours ER sold ₩2.5 billion in Q1, which was a 27.9% decrease YOY to ₩2.5 billion, but sales of the product rebound in Q2 to rise 253.5% YOY and record ₩7.5 billion. Sales have increased with those receiving COVID-19 vaccinations buying Tylenol in advance to prepare for fevers or muscle aches. Inoculations started in Korea in late February, and with the number of people receiving vaccination increasing, demand for antipyretic analgesics has also surged. Also, there has been criticism over the government’s contribution to the surge of sales. The government authorities have informed people receiving COVID-19 vaccinations that “it is good to take Tylenol when fevers or other side effects arise after vaccination.” Since then, the demand for Tylenol took a sudden leap and led to shortages in its stock. Due to the continued instability in the supply of Tylenol, the government belatedly set out to address the issue. In May, the Ministry of Food and Drug Safety had announced that around 60 single-ingredient acetaminophens products are being sold in the market, and guided citizens to purchase other products. In June, the Ministry of Food and Drug Safety, Korean Pharmacists’ association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Pharmaceuticals Distribution Association, and Tylenol’s manufacturer Johnson & Johnson had agreed to work together to stabilize the supply of acetaminophen. The Korea Pharmaceuticals Distribution Association had made emergency measures to promptly supply the acetaminophen that they received to all pharmacies nationwide. The MFDS also discussed measures with the Korea Pharmaceuticals Distribution Association and Johnson & Johnson Korea to expand the supply of Tylenol to pharmacies nationwide. However, other acetaminophen products did not enjoy such an increase in their sales. Sales of major acetaminophen agents in Korea have shown that sales of Samjin Pharm’s ‘Geborin’ fell 30.3% YOY to record ₩6.6 billion in the first half of this year. Geborin’s sales fell 6.9% YOY in Q1, then increased 8.3% YOY in Q2, and did not benefit from the increased number of COVID-19 vaccinations. Sales of Chong Kun Dang’s ‘Penzal Q’ and ‘Penzal 8 hours ER’ fell 7.2% YOY to record ₩2.2 billion in the first half of this year. In fact, acetaminophen’s position in the market had become unstable with the constant safety issues that were being raised recently. The MFDS has strengthened the safety measures for prolonged-release forms of acetaminophen-containing agents in 2018 to reduce risks from overdose such as liver damage etc. The authorities reduced the package units to less than the maximum daily dose and indicated the dosing interval (8 hours) in the product name. In 2011, the strength of each dosage unit of prescription acetaminophen products was restricted to 325mg due to the risk of liver damage and allergic reactions. In addition, an impurity concern arose last year. In July last year, the acetaminophen API manufactured and supplied by the Chinese API manufacturing company Anqiu Lu'an Pharmaceutical was found to be contaminated by 4-Chloroaniline. The Ministry of Food and Drug Safety announced that it had collected and inspected a total of 60 lot numbers from all manufactories and that the impurity in question was not detected. However, the sudden spread of the pandemic and the increase in vaccinations have brought an upsurge in sales of Tylenol. Sales of the 4 Tylenol series products including Tylenol Cold S and Women’s Tylenol have recorded ₩45.1 billion, increasing 122.2% compared to the previous year.
- Company
- Ono Pharma Korea’s Braftovi has been approved in Korea
- by Aug 24, 2021 06:05am
- Ono Pharma Korea announced on the 23rd that it has been approved by the MFDS on the 19th by Braftovi (Encorafenib), a direct bowel cancer treatment. BRAF inhibitor Braftovi can be used as a combination therapy with Erbitux (Cetuximab) in adult patients with direct colon cancer with previous treatment experience and confirmed BRAF V600E mutation. In Korea, the positive BRAF V600E gene mutation is found in 4.7% of patients with direct bowel cancer. There were no approved drugs based on effectiveness in BRAF gene-variant bowel cancer, requiring a new treatment choice. This approval is based on the results of BEACON CRC study in patients with non-ablastic progressive or recurrent direct colon cancer showing BRAF V600E mutation after primary or secondary treatment. In the study, combined therapy of Braftovi-Cetuximab is a control group, and the overall survival period (OS) compared to Irinotecan (Iritecan)-Cetuximab based combination therapy showed statistically significant extensions (HR 0.60, p=0.0003). OS median was 8.4 months for Braftovi group and 5.4 months for control group.
- Policy
- The effectiveness of NIP expansion policy?
- by Aug 24, 2021 06:05am
- Moon Jae-in president announced to expand under the age of 17 for vaccine against cervical cancer vaccination for free, while the few people seemed to be criticizing as 'show off'. President Moon said he would expand the vaccination target from the age of 12 to the age of 17 to mark the 4th anniversary of the petition. In the past, people aged 13 to 17 were eligible for free vaccination, and 70 to 80% had already been vaccinated. Some point out that it is a show off policy because the number of people actually receiving support is small. President Moon said in a video on the 19th, "We will allow all women and teenagers to receive free vaccination benefits," marking the 4th anniversary of the introduction of Cheongwadae's petition. Cervical cancer is the only cancer that can be prevented by vaccination, but many asked for more support due to the cost of ₩600,000. Recently, the price of inoculation has increased and the burden has increased, leading to a national petition. If the expansion plan is implemented, women aged 13 to 17 will also have a chance to receive a free vaccine. However, not many people are expected to receive actual benefits. The expanded number of female teenagers aged 13 to 17 was already eligible for free vaccination. The human papilloma virus (HPV) vaccine to prevent cervical cancer has been designated as NIP since 2016 and has been implemented for 12-year-old girls. People born in January 2003 and December 2004 were the first targets. These are the 17-year-olds, the highest-age group President Moon said he would expand. It is pointed out that it seems to include an age that was not previously applicable while targeting people who were vaccinated for free in the past. Even if the expansion plan is implemented immediately, only those of female teenagers aged 13 to 17 who missed the timing of vaccination in the past can receive support benefits. According to the KDCA, the primary vaccination rate in 2003 was 61.5% in the first year. The primary inoculation rate was 72.6% for those born in 2004. 87.2% of those born in 2005 have already been vaccinated. President Moon said, "For women aged 18 to 26, we will gradually expand the scope of vaccinations by allowing low-income people to receive free vaccinations." Also, there was no mention of men implemented by half of the 36 OECD countries, including advanced countries such as the United States, Canada and the United Kingdom. Kim Jae-yeon, chairman of the Korean Association of Obstetricians & Gynecologists, said, "It is an ineffective demonstration policy to expand the scope to female teenagers aged 13 to 17 who have already received free vaccinations." He pointed out that "in effect, the government should suggest ways to increase the vaccination rate and prevent cervical cancer."
- Company
- Will the issue of GLT-2 inhibitors be resolved in 3 years?
- by Eo, Yun-Ho Aug 23, 2021 10:28pm
- Attention is focusing on whether the issue of combined benefits of DPP-4 inhibitors and SGLT-2 inhibitors will finally be solved. According to academia, the HIRA will hold a meeting of experts on September and discuss the combined benefits of oral diabetes treatment DPP-4 inhibitors and SGLT-2 inhibitors. The issue, which has been almost three years, was put on full hold in 2018 when the government planned a "public notice of improvement of the benefits standard for each drug" to strengthen convenience at the medical sites and patient guarantee, but pointed out that there was insufficient evidence of validity of drugs without separate clinical research. It was the opinion of the medical community that the government should discuss expanding the combined benefits of diabetes drugs. Each drug in the same category has different indications, causing side effects such as confusion at the prescription site and cuts in insurance benefits. The same was true when the combined benefits between DPP-4 inhibitors and TZD-related drugs expanded in 2013. However, the results are different. The medical community, which has emphasized the importance of clinical experience and expert judgment rather than permission and financial impact, is also unusual. It started in 2013 when Yoon Gun-ho, a professor at Seoul St. Mary's Hospital who actively expressed his opinion to expand the benefit of diabetes drugs, became the chairman of the Korean Diabetes Association. He conveyed to the government that health insurance can be applied by affiliates as an expert's recommendation, and in August last year, the MFDS said it would "simplify" the registration method of diabetes drugs. It said that it was to reflect permits from the U.S. and Europe and the demands of the medical community and industry, but many in the industry believed that it was a cornerstone for preparing standards for combination therapy. As a result, pharmaceutical companies submitted simplified labels for the efficacy of diabetes treatments from November of the same year, and the MFDS approved Jardiance, Forxiga, Suglat, and Steglatro sequentially in the first half of this year. Companies with such drugs immediately submitted applications for expansion of combined benefits, but so far, the agenda has not been submitted to the Subcommittee. An industry official said, "We hope that this expert discussion will solve the unfulfilled demand of clinical sites. As we have accumulated experience in prescribing SGLT-2 inhibitors in Korea, we expect positive results."
