- LOGIN
- MemberShip
- 2025-12-19 22:26:22
- Opinion
- [Reporter’s View] Disclose PVA results in advance as well
- by Lee, Tak-Sun Sep 04, 2023 05:04am
- The government announced the 7,000 drug items whose insurance price ceiling will be lowered according to the reevaluations that were conducted in advance. This preemptive measure was made out of concern over the large settlement of price differences and returns that may occur with the price adjustment. The product list and upper limit price were released on the 23rd of last month and were publicly notified on the 1st. The price adjustment will be applied in the field from the 5th. The public health authorities accepted the opinion of the Korea Pharmaceutical Association and others who requested sufficient time to prepare for returns and settlement of differences before the price adjustments. However, there remains some to be desired. In addition to those that were adjusted post-reevaluations, the insurance price ceiling of 134 other items had also been adjusted through the PVA (price-volume agreement) system. The adjusted price for the PVA price cuts will also become effective as of the 5th. Among the PVA price cut items, the prices of some have been further reduced due to the reassessment of the price ceiling, so the implementation of the PVA price adjustments was changed to match the price ceiling reevaluation schedule to prevent confusion in the field and reduce administrative costs. 18 items have undergone both PVA and price ceiling reevaluations. If the PVA price cuts were first implemented on the 1st of this month as scheduled, then the price ceiling reevaluation adjustments implemented on the 5th, these drugs would have had to change their price twice in one month. In this sense, setting the same implementation date for the two was reasonable and correct. However, it would have been better if the government had disclosed the PVA-adjusted drug items in advance as well. The price ceiling reevaluation results were released on the 23rd of last month, but the PVA list was released only on the 31st, after completing the Health Insurance Policy Deliberative Committee (HIPDC) review. Wholesalers and pharmacies have expressed the opinion that more preparations were needed for items on the PVA list, due to the high volume of returns necessary for some of the frequently used items. However, unlike the price ceiling reevaluations, the adjusted insurance prices were not announced in advance for the PVA items, increasing inconvenience in the field. Why the PVA list was not disclosed in advance, unlike the price ceiling reevaluation results, remains a question, as the effective date for the price ceiling adjustment for the two drugs was set at the same date, on the 5th. It is interpreted this may have been in line with the principle of non-disclosure before HIPDC review, but it is regrettable that the government was unable to show some flexibility, given that the price ceiling reevaluation results that were disclosed were also yet to receive HIPDC review at the time of disclosure. As a result, while 14 days were given to prepare for the return of items that underwent price ceiling reevaluations, only 6 days were given to prepare for the return of the PVA items. Another problem is that the prices of some items that are on the price ceiling reevaluation list will further be reduced due to PVA. If companies had prepared to settle their accounts based on the prices indicated in the price ceiling reevaluation list that was disclosed on the 23rd, they would have had to make re-readjustments to their accounts. In this sense, the imperfect data that was disclosed to prevent on-site confusion has burdened the site. This too could have been prevented if the PVA results had been transparently disclosed on the 23rd. The government's pre-release of the list of drug price cuts and postponement of the PVA implementation date are commendable in that they considered the confusion that will be caused by returns and balance settlements after the price adjustments. However, the measure should have been more well thought out. It would be best if the Ministry of Health and Welfare, which is in charge of the price ceiling reevaluations and PVA, put some more considerations into its measures.
- Opinion
- [Reporter’s View] M&A storm blows through industry
- by Lee, Seok-Jun Aug 30, 2023 05:32am
- At a dinner party with a second-generation owner in his 40s, I asked what the company’s goal is for the second half of the year. It was sort of an icebreaker question to warm up the party atmosphere. What I expected was a routine response, such as 'we will be building growth engines by investing in R&D or facilities', ‘we will promptly develop new products into blockbusters’, 'We will maximize profitability by reducing costs', or 'We will increase efficiency in management through the integration of the organization and personnel relocation.’ But the response he gave was completely unexpected. “We plan to prepare for an M&A.” The simple response indicated how the industry has changed over the years. The perception of M&As in the pharmaceutical industry has changed in line with the generation shift in its management, which has been passed on from the founder to second or third generation owners. The plan was also specific. The owner knew the characteristics of the business structure, the stake of the largest shareholder, and the market cap of the companies he was eyeing. He said, “There are many old pharmaceutical companies with weak governance structures. If they can create synergy with our company, there is no reason not to consider an M&A. We are considering several candidates. Our company has a lot of cash, so we can buy companies whose largest shareholder's stake is around 10-15%. The era of selling generics to grow the company is now in the past. Instead of paying commissions for CSO sales, M&A is more cost-effective.” ' I also asked another second-generation owner in his mid-50s whether he had plans for M&As as well. ‘Of course’ was the answer. He said, "If the need for M&A was recognized in the past, this is now the time to act on it." Citing the case of GC Pharma and Ildong Pharmaceutical, he emphasized that being tied to past relationships will only hinder efficient business management. “Whether the owner can lead his/her employees well is a core competency required for owners. You may miss opportunities if you give up M&As because you have known each other for a long time. If GC Pharma and Ildong Pharmaceutical's big deal had occurred, it would have been another milestone for the pharmaceutical industry. At that time, the deal was criticized as a hostile takeover, but the view on M&As has now changed. It has now become one of the pillars of business management." To collect a more collective opinion of the industry, I continued to ask the same question to second and third generation owners on their opinion of M&As. Most of the owners had a positive attitude towards M&As. Some also hinted at specific plans, such as a specific pharmaceutical company and accompanying financing plans. However, a conservative mindset regarding M&As remains in the industry still. There are cases where companies acquire bioventures, cosmetics, and functional health food companies as a means of business diversification, but large-scale M&As between pharmaceutical companies are rare. PharmaResearch and CTC Bio, which have been fighting over shares, is the M&A possibility that currently exists in the field. The change is palpable. Following the attitude of its second and third generation owners, the companies’ attitude towards M&A has changed to take on a more pro-M&A stance. Times have changed, and things that seemed impossible in the past are now being taken for granted. In this context, could it be that an M&A storm is blowing through the industry? At least, the second and third generation owners' perspectives are more pro-M&A for sure. Although M&As are not the answer for everything, if it can be considered as a means of business management and used wisely, it has ample potential to bring another boom in the pharmaceutical industry.
- Opinion
- [Reporter's view] Hemophilia drug war of nerves
- by Kim, Jin-Gu Aug 24, 2023 05:46am
- GC Pharma snipes JW Pharmaceutical. Hemlibra, a hemophilia treatment that JW Pharmaceutical is introducing and selling in Korea, became the target. GC Pharma distributed a press release on the 21st. It is a press release titled, 'The report rate of abnormal blood clots in Hemlibra was 2.8 times higher than Factor XIII.' This press release was written based on the information presented at the American Society for Bleeding Disorders Conference. Based on the U.S. Food and Drug Administration (FDA) adverse event reporting system, JW Pharma's Hemlibra and GC Pharma's XIII formulation were compared. As a result, Hemlibra's thrombotic adverse event reporting rate was 4.07%, which was 2.83 times higher than Factor XIII's 1.44%. it was the content. It is unusual. It is true that cases of sending a press release directly mentioning and comparing competing drugs to the company's official e-mail address were rare, except for a few biopharmaceutical companies. In the biopharmaceutical industry, rather than directly mentioning the product name of a competing drug, it used to be expressed in terms of ingredient names. It was read with the intention of highlighting the side effects of competing drugs and finding fault with them, rather than revealing the advantages of the company's products and comparing them with competing drugs. Moreover, it was completely omitted from the press release that GC Pharma's Factor XIII drug showed a higher number of total adverse event reports and serious adverse event reports in the same data. There are many cases in which the pharmaceutical industry directly compares two drugs. However, this is based on the results obtained through elaborately designed clinical trials. This is because there are many external variables to evaluate the superiority or inferiority of the two drugs based on the simple reporting rate, as in the GC Pharma press release. JW Pharma expressed strong displeasure. In a separate statement, he said, "I am very sorry for the act of officially disparaging a competitor's drug." GC Pharma responded, saying, “There is no intention to disparage,” and that it was “to monitor the side effects of blood clots.” The dominant evaluation is that GC Pharma did something useless over the untimely war of nerves between the two companies. GC Pharma already dominates the domestic hemophilia treatment market through the Korea Hemophilia Foundation. There is no need to distribute press releases with poor comparison results. You just need to confidently compete with clinical data and sales power. Rather, there are opinions that this press release had an adverse effect. This is because the awareness of Hemlibra has increased as a result of this nerve war. At the same time, with Hemlibra accelerating its pursuit, GC Pharma has admitted to being nervous.
- Opinion
- [Reporter's view] There should be no recurrence of the Champ
- by Lee, Hye-Kyung Aug 17, 2023 05:29am
- On the 10th, the Ministry of Food and Drug Safety lifted the suspension of manufacturing and sales of Dong-A Pharmaceutical's Champ Syrup and Daewon Pharmaceutical's Coldaewon Kidsfen Syrup. Champ Syrup, which represents children's antipyretics containing acetaminophen, was produced and distributed again in 128 days, and Coldaewon Kidsfen Syrup in 85 days. Dong-A issued a recall order four times on April 25th, April 28th, and May 31st, starting with the recall of commercially distributed products due to 'concern about unsuitable quality (characteristics, microbial limit) on April 4th. On the other hand, Daewon Pharmaceutical recalled business operators for commercially available products as a precautionary measure following the phase separation phenomenon (concern) on May 18. Although the reasons for the recall of the two items are different, it is unknown when and how the order to recall and destroy the drug will occur. First, Champ Syrup, which had been recalled, went through the return and refund process through pharmacies and online. In addition, when a customer brings a product to a pharmacy, even in the case of products purchased at other pharmacies, normal product exchange or return and refund measures are to be carried out first. Suffering from the Champ Syrup recall process became the pharmacy distributing the product. Perhaps for this reason, Daewon Pharmaceutical, which was advised to recall the business operator, went through the process of returning and refunding the drug directly to the pharmaceutical company without going through the pharmacy. Of course, there was also Coldaewon Kidsfen Syrup, which was confused with Champ Syrup and brought to pharmacies, but pharmacies did not have to accept the product. Champ Syrup and Coldaewon Kidsfen Syrup, which had been discontinued for nearly three months, were canceled at the same time, and it was the pharmacy that was confused again. This is because it was not easy to order antipyretics for children whose production was resumed due to sales at specific hours and restrictions on the number of purchases per pharmacy. As Champ Syrup and Coldaewon Kidsfen Syrup went through a series of incidents such as manufacturing, suspension, and cancellation, pharmaceutical companies were insufficiently prepared to resume distribution due to inconsistent recall procedures and the Ministry of Food and Drug Safety's unilateral cancellation of manufacturing/suspension. Looking at this process, there is a need for support measures such as preparing a consistent procedure for recalls of business operators rather than compulsory recalls in the future and providing time to prepare for preparations such as pre-announcement by pharmaceutical companies in case of the lifting of manufacturing or suspension of drugs with issues such as supply and demand instability. seems to be
- Opinion
- [Reporter's view] Fight between AZ/Janssen
- by Jung, Sae-Im Aug 17, 2023 05:29am
- Since the discovery of EGFR gene mutation in non-small cell lung cancer patients in 2004, EGFR-targeted anti-cancer drugs have made remarkable progress over the past 20 years. Tyrosine kinase inhibitors (TKIs) targeting this genetic mutation have been established as standard therapy through the first generation (Iressa), second generation (Giotrif ·Vizimpro), and third generation (Tagrisso). Among them, Tagrisso is currently the only third-generation EGFR-TKI in the global market and has maintained its top position for more than five years without any competing drugs. The strength of Tagrisso is that it shows better effects than the first and second generations, especially in brain metastasis, which lung cancer patients often experience. Lung cancer is one of the most diagnosed cancers in the world, and EGFR is a major mutation in lung cancer, so global pharmaceutical companies are interested in it. For this reason, pharmaceutical companies have measured the effect of EGFR mutations with various new drugs, and immuno-anticancer drugs are representative. Immunotherapy has changed the paradigm of lung cancer treatment and brought about groundbreaking results. However, even this was not as effective as expected in patients with EGFR mutations. Only the recognition that EGFR-mutated lung cancer should be treated with targeted anticancer drugs has become more solid. Since then, the attention of pharmaceutical companies has been focused on 'Next Tagrisso'. AstraZeneca is betting on combination therapy using Tagrisso to protect its status, while competitors are betting on a combination therapy that has developed a new drug with a new mechanism. In the second half of this year, a true swordsman battle will unfold between those who want to protect and those who challenge. AstraZeneca plans to present the results of the FLAURA2 study, a phase 3 clinical trial comparing Tagrisso with chemotherapy alone, at the World Lung Cancer Society in September. In October, Janssen will present at the European Society of Oncology (ESMO) the results of a phase 3 clinical MARIPOSA study comparing Rybrevant, an anti-cancer drug targeting EGFR exon 20 insertion mutation, and Leclaza, an EGFR-targeting anti-cancer drug introduced from Yuhan Corporation, compared to Tagrisso. Currently, the two clinical trials that are directly compared with Tagrisso, the global first-line standard therapy, are both trying to change the standard treatment. Of course, it was Janssen who had a greater ripple effect in case of success. This is because it combines a TKI with a new mechanism called Rybrevant and a TKI similar to Tagrisso. Global market research firm 'Evaluate Vantage' explained the market value of the two studies earlier this year, "The MARIPOSA study has two chances to beat Tagrisso by comparing Rybrevant + Leclaza combination therapy and Leclaza monotherapy, respectively, with Tagrisso." did. The market research firm also commented, "Given the advantages MARIPOSA holds, the results of the FLAURA2 study may reduce the threat of Leclaza, but may not completely eliminate it." While AstraZeneca has already announced that it has demonstrated improvement in the primary endpoint in the FLAURA2 study, the market is paying keen attention to how much improvement Tagrisso + chemotherapy would have shown, and how the results of the MARIPOSA study, which are still veiled, will come out. It is very likely that standard treatment options will increase in EGFR-mutated lung cancer. This means that the patient's prognosis will be further improved. In addition, within EGFR, customized treatment may be possible depending on the subtype and health condition. This is good news for Korea, which has a high proportion of EGFR mutations. So, the results of the second half are expected.
- Opinion
- [Reporter's view] Prompt benefit registration
- by Eo, Yun-Ho Aug 10, 2023 05:33am
- These days, the word 'expedited' appears frequently in the reform of the insurance benefit system. The plan is to speed up the listing of necessary new drugs by linking approval, and evaluation, and shortening the listing period at each stage. This is a good intention to quickly expand drug coverage for patients who are waiting. Shortening the insurance benefit registration period for pharmaceuticals has been discussed almost every year, and in fact, the regulatory period is getting shorter and shorter. Both the HIRA and the NHIS' evaluation and negotiation phases are similar. However, it is only a deadline for pharmaceutical companies to apply and review them. First of all, not a few pharmaceutical companies spend a considerable amount of time in the process of obtaining approval from the head office and requesting actual reimbursement. In other words, they are thoroughly flirting with an idea. If the registration process of drugs that have long passed the review period is traced back, there are many cases in which the Subcommittee on Drug Reimbursement Standards voluntarily withdraws after the decision to delay the review. However, there are many cases where this voluntary withdrawal is not 'voluntary'. In drug price negotiations between the NHIS and pharmaceutical companies, delayed decisions are made as if they were eating rice. The 60-day negotiation period is a promise. While announcing a proposal to shorten the deadline for domestically produced new drugs, is called a 'benefit'. However, there is no transparency in this whole process of the NHIS and the HIRA. Before simply promoting 'speed', concerns about transparency should be added. Just as the results of the Pharmaceutical Reimbursement Evaluation Committee and the Cancer Disease Review Committee were switched from non-disclosure to disclosure, discussions on the disclosure of information as much as possible in the new drug reimbursement process are now necessary. If drug price negotiations break down and additional disclosure of drugs that have been delayed after the application for reimbursement is made, the predictability of those waiting and watching will increase, which will lead to the establishment of effectiveness in shortening the evaluation period.
- Opinion
- [Reporter's view] When will Enhertu's benefit be available?
- by Jul 31, 2023 05:29am
- Daiichi Sankyo and AstraZeneca's Enhertu are continuing their unstoppable moves. Enhertu, which has achieved remarkable results in breast cancer, has expanded the types of carcinoma to include gastric cancer and lung cancer and is expected to be used in a number of solid cancers that show HER2 expression, such as cervical cancer, endometrial cancer, and ovarian cancer. Several ADCs have been approved, but none have been as scalable as Enhertu. Indeed, Enhertu is writing ADC history. The phase 2 results for Enhertu announced at ASCO 2023 in June were very positive. Although it was not at a stage that deserved a standing ovation like last year's announcement of low-expression breast cancer of HER2, this announcement raises the possibility that Enhertu will be reborn as an anti-cancer drug regardless of cancer type. The Enhertu DESTINY-PanTumor02 clinical trial announced at ASCO was a study that examined the effects of Enhertu by forming a cohort of cervical cancer, endometrial cancer, ovarian cancer, bile duct cancer, pancreatic cancer, bladder cancer, and other solid cancers without a control group. For each cohort, 40 patients were recruited and Enhertu was administered. ORR was set as the primary evaluation index, and DOR, DCR, PFS, OS, and safety were established as secondary evaluation indexes. What is noteworthy is the response rate that Enhertu showed. It recorded a response rate of 50% or more in cervical cancer and endometrial cancer. In particular, the response rate for endometrial cancer reached 57.5%. Seven out of 40 endometrial cancer patients (17.5%) showed complete remission (CR) and 16 (40%) showed partial response (PR). At 12 weeks, 80% (32 patients) of endometrial cancer patients had their disease under control. In conclusion, Enhertu recorded a response rate of 30% or more in all cancer types studied, except for pancreatic cancer, which had a response rate of only 4%, and biliary tract cancer, which had a relatively low response rate of 22%. About a month later, on the 27th, additional analysis results of DESTINY-PanTumor02 were announced. In summary, Enhertu demonstrated improvement in PFS and OS, which were set as secondary evaluation indicators. Follow-up clinical trials should be supported, but it is clear that Enhertu is rapidly taking off as an anti-cancer drug regardless of cancer type. Domestic patients looking at Enhertu's rapid development were very distressed. Although approved, access to treatment is low due to non-reimbursement. Enhertu is an oasis for patients not only in breast cancer but also in gastric cancer where new drug options are limited. Daiichi Sankyo's commitment to Enhertu's fast benefit was also quite large. It is known that several measures were prepared, such as offering the drug price at the lowest price in the world and considering additional RSA. Patients urged Enhertu's speedy reimbursement listing. The national consent petition for this was so supportive that it obtained the consent of 50,000 people last February. The health authorities seem to be paying attention to Enhertu's benefit, as if conscious of public opinion. It can be seen from the fact that even when the review committee was first eliminated, it was concluded through a re-examination rather than not setting a standard. Considering the time it takes for a new drug to be registered for reimbursement in Korea, Enhertu's reimbursement process is fast. Currently, Enhertu has passed the cancer disease review committee after re-examination and is undergoing a PE review. However, it is unclear when it will be presented to the pharmaceutical reimbursement evaluation committee, which is in the final stage. Patients are anxiously awaiting news of the assumption. In about two months, it will be a year since Enhertu was approved in Korea. Even after passing the Drug Evaluation Committee, all procedures for insurance coverage are completed only after drug price negotiations with the NHIS and the health insurance policy deliberation committee of the Ministry of Health and Welfare. By the end of the year, after Enhertu's first global launch, it will take 48 months to receive benefits in Korea, exceeding the OECD average of 45 months. We hope that patients' wait for Enhertu will not be too long.
- Opinion
- [Reporter's view] A groundbreaking policy is needed
- by Lee, Tak-Sun Jul 24, 2023 05:26am
- Controversy is in full swing over Madopar, a Parkinson's disease drug that withdrew from the Korean market early this year due to profitability issues. Patients want Madopar again, saying that the only remaining generic drug after Madopar was withdrawn has severe side effects. Furthermore, it raises the question of calculating the drug price of the original drug. First of all, the government extended the grace period for Madopar's insurance benefit deletion from July 31st to December 31st. During this period, benefits can be applied even if Madopar is prescribed in stock. However, extending the grace period is only a short-term solution. After December 31st, it is clear that patients' dissatisfaction will increase. Accordingly, some are discussing ways to recall Madopar within the current drug pricing policy. It is said that the upper limit amount will be raised through the drug ceiling amount adjustment system so that the Ministry of Food and Drug Safety must obtain re-permission. The Ministry of Health and Welfare also said that it would speed up the related procedures if it applied for reimbursement after re-permission by the Ministry of Food and Drug Safety. But even this is not a fundamental solution. In the future, such a situation may arise again in the market where the original is withdrawn and only the generic remains. This has a problem in that it is difficult to maintain order in the drug price system, and above all, it can further accelerate distrust of generic drugs. We need the best way to calm patients' dissatisfaction right away, but we also need to come up with measures to cut off distrust of generics in the long term. If patients cannot trust generics because of side effects, health authorities should consider verifying their effectiveness through various data and patient interviews. Through this, it is necessary to verify whether some side effects are inflated or whether side effects actually appear only in generic drugs. If side effects appear only in generic drugs, the background should be found and reflected in the improvement of the approval system. This is because the Ministry of Food and Drug Safety may miss something just by verifying the equivalence of drug efficacy. The measures currently put forward by the authorities are only short-term prescriptions aimed at calming patients and public opinion. Even if things become complicated, we must take a broader perspective and respond preemptively. That's the only way for generic trust.
- Opinion
- [Reporter's view]Time to think about price by indication
- by Eo, Yun-Ho Jul 19, 2023 05:20am
- Now is the time to think. The increasing number of non-insured indications and the steadily increasing number of indications for new drugs have now become quite a big snowball. In an age when a single drug has multiple indications and is used for multiple diseases, the emergence of drugs that target specific gene mutations and further activate the immune system itself has made it possible to focus on the mechanism, not the disease, and apply its efficacy to a wide range. The domestic drug price system, which has a mechanism of decreasing as the amount of use, that is, increases, makes negotiations between the government and pharmaceutical companies lengthy, and patients wait longer. How should we accept the existence of 'drugs that some people use and others can't' and the 'drug prices by indication' that are discussed along with them? 'Drug price by indication' is a method of setting drug prices separately according to the innovativeness of each indication, reflecting the current situation in which a drug is approved for various indications. KRPIA, a representative organization of multinational pharmaceutical companies, has already insisted on the necessity of introducing drug prices by indication several years ago. However, the government was closer to a stronger 'No' than 'I will review'. The problem is that there has been only the answer that it is difficult, but there is no alternative so far. Not long ago, the immune anti-cancer drug 'Keytruda' became a hot topic by submitting an application for insurance benefit registration for as many as 13 indications at once. In other words, 13 indications of cutting-edge new drugs called immuno-anticancer drugs were not actually being prescribed. In Korea's billing system, tracking by indication is difficult, and it may be difficult for patients to accept paying different amounts depending on the disease. However, it is also true that drugs that are clearly useful are not being used for the right patients. First of all, it is important to start a discussion in some way. Even after only 3 to 5 years, the problem of expanding indications for new drugs and accessibility to them will inevitably emerge much more than now. It does not have to be a differential application of refund rates or drug prices for each indication. It's time to put our heads together to find an alternative.
- Opinion
- [Reporter’s View]Kudos to Keytruda for filing 13 reimb apps
- by Eo, Yun-Ho Jul 05, 2023 05:45am
- A truly extraordinary case has emerged. MSD Korea has applied for the reimbursement of 13 Keytruda indications at once. This is an unprecedented event, the first time such a large amount of applications had been filed for a single drug since the positive list system was implemented for drug reimbursement in Korea. After submitting the applications, MSD explained “Cancer is in itself an aggressive and life-threatening condition, and we saw that there was a dire need for improved access to Keytruda in the field due to the lack of alternatives or reimbursed latest treatment options. To address the need, the company decided to apply for the extended reimbursement of Keytruda to cover indications with high clinical need or reimbursement. We seek to improve treatment access to all patients that can benefit from Keytruda.” We should first applaud the company for its effort. Considering the rising number of non-reimbursed immuno-oncology drug indications piling up in the field, MSD duly served its mission as a pharmaceutical company by applying for the reimbursements, regardless of success or failure. Keytruda is currently reimbursed for 7 indications in 4 cancer types in Korea. Applying for the reimbursement of 13 indications is not an easy task. As a drug under the Risk Sharing Agreement scheme, its each and every indication must undergo an evaluation process comparable to that of a new drug to extend reimbursement. Pharmacoeconomic evaluations must be performed for indications that were approved based on a Phase III trial to demonstrate cost-effectiveness, and those approved based on a Phase II trial must undergo negotiations to receive pharmacoeconomic evaluation waivers. The relevant health authorities including the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service also have a lot on their hand as they must concurrently evaluate numerous indications of a single drug. Therefore, the reimbursement extension process will also require considerable effort on the government’s part. Considering how this is an unprecedented situation and that the pharmaceutical companies would not have applied for the reimbursement of 13 indications without prior discussion with the government, anticipation is rising on how the results will turn out for Keytruda. In an era where a single drug owns multiple indications, I hope Keytruda’s case will set a milestone and serve to resolve the rising issues in Korea’s reimbursement extension process. Meanwhile, the 13 indications Keytruda applied for were: ▲ early-stage triple-negative breast cancer; ▲locally recurrent or metastatic triple-negative breast cancer, ▲metastatic or with unresectable, recurrent head and neck squamous cell carcinoma, ▲ locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma, ▲adjuvant treatment of patients with renal cell carcinoma, ▲non-muscle invasive bladder cancer, ▲persistent, recurrent, or metastatic cervical cancer, ▲ advanced endometrial carcinoma, ▲metastatic endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ▲ unresectable or metastatic MSI-H or dMMR colorectal cancer ▲metastatic MSI-H or dMMR small bowel cancer, ▲ metastatic MSI-H or dMMR ovarian cancer, and ▲ metastatic MSI-H or dMMR pancreatic cancer.
