- LOGIN
- MemberShip
- 2025-12-21 18:18:52
- Policy
- Pemazyre received domestic product approval
- by Lee, Hye-Kyung May 02, 2023 03:40pm
- Handok's locally advanced or metastatic cholangiocarcinoma treatment Pemazyre received domestic product approval on the 25th. The Ministry of Food and Drug Safety (Minister Oh Yoo-kyung) announced that it had approved three doses (4.5mg, 9mg, 13.5mg) of Pemazyre, an orphan drug. Pemazyre is an oral FGFR inhibitor that inhibits the proliferation of cancer cells caused by the fusion or rearrangement of fibroblast growth factor receptor 2 (FGFR2), which is involved in cell growth and differentiation. It is expected to provide a new treatment opportunity for adult patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement who have received one or more systemic treatments. Pemazyre is approved in the United States, Europe, and Japan for the treatment of adult patients diagnosed with locally advanced or metastatic cholangiocarcinoma with a fusion or rearrangement of the FGFR2 gene who have received at least one prior systemic therapy. In Korea, after being designated as an orphan drug in November 2021, it has been designated as a treatment for life-threatening or serious diseases since December. Previously, the US FDA designated Pemazyre as a breakthrough therapy for the treatment of previously treated patients with advanced, metastatic, or unresectable FGFR2 translocation cholangiocarcinoma, and designated it as an orphan drug, conducting an expedited review through a priority review program. Cholangiocarcinoma is a rare type of cancer and is classified according to its anatomical origin as iCCA and extrahepatic cholangiocarcinoma arising from the bile duct outside the liver. Cholangiocarcinoma is often diagnosed at an advanced or advanced stage with a poor prognosis. FGFR2 fusions or rearrangements are found in 10-16% of patients with intrahepatic cholangiocarcinoma. FGFRs play important roles in the proliferation, survival, migration, and angiogenesis of tumor cells. FGFR fusion, rearrangement, translocation, and gene amplification activities are closely related to the development of various cancers. Pemazyre is an oral FGFR inhibitor and is the first and only treatment approved by the FDA for this indication.
- Policy
- Dual punishment for CSO rebate excluded from review
- by Lee, Jeong-Hwan Apr 28, 2023 05:49am
- An amendment to the Medical Service Act that applies a dual punishment system when doctors receive rebates paid by pharmaceutical contract sales organizations (CSOs) and an amendment to the Pharmaceutical Affairs Act to prohibit potential hospital/pharmacy owners and brokers from exchanging illegal hospital subsidies in exchange for prescriptions has been omitted as an agenda of the plenary meeting of the National Assembly’s Legislation and Judiciary Committee that was set to be held in the afternoon (27th) However, the amendment to the Pharmaceutical Affairs Act, which legislates the factual survey of illegally opened and operated pharmacies and publicly announces the results of illegally confirmed pharmacies, and the Narcotics Control Act, which grants pharmacies the right to refuse prescriptions of insolvent drugs that are suspected of forgery or missing some of the mandatory information, will be reviewed by the Legislation and Judiciary Committee. The bill for the illegal pharmacy factual survey and their public disclosure and refusal to dispense poor drug prescriptions are expected to be reviewed at the NA’s plenary session scheduled for tomorrow (27th) if they pass the Legislation and Judiciary Committee review. If the two bills pass the plenary session, pharmacies that have not gone through proper procedures, such as face-to-face pharmacies, will be regularly managed and regulated through factual surveys, and punitive public announcements will be possible. If passed, the difficulties front-line pharmacies have dispensing prescriptions for drugs that are suspected of being counterfeit or poor drug prescriptions issued by medical institutions without essential information such as the patient's resident registration number, will be improved. However, the bills to ban CSO rebates and illegal hospital subsidies for doctors and pharmacists will not be passed at the plenary session held this month due to the delay in their Legislation and Judiciary Committee review. In particular, the exclusion of the bill to ban CSO rebates for doctors from the Legislation and Judiciary Committee review leaves room for regret. This is because the CSO reporting system passed the plenary session of the National Assembly last month, and regulatory synergies were expected in the future when the National Assembly passed the CSO rebate ban bill this month. Legislation of the bill to ban collusion activity between pharmacies and medical institutions for prescriptions was supposed to add 'a person who intends to open an institution’ and the bill to eradicate illegal hospital subsidies and punish brokers who mediate collusions has also been delayed with the exclusion of their review by the Legislation and Judiciary Committee. In addition, a partial amendment to the National Health Insurance Act, which will enable stable financial support for health insurance by extending the effective period of state treasury support for the National Health Insurance Service to 'December 31, 2027' will also be proposed for review by the Legislation and Judiciary Committee today.
- Policy
- JW Pharma Hemlibra will be reimbursed starting in May
- by Lee, Tak-Sun Apr 25, 2023 05:56am
- JW Pharma's Hemlibra will also be covered for patients with severe non-antibody hemophilia A from May. Previously, this drug was covered only for hemophilia A patients with antibodies. This increase in coverage is expected to greatly contribute to the quality of life of patients with severe non-antibody hemophilia A, especially pediatric patients. According to the industry on the 21st, Hemlibra has been used as a daily prophylaxis to reduce or prevent bleeding frequency in patients with severe hemophilia A (congenital factor VIII deficiency) who do not have factor VIII inhibitors since May. Even if you use it, the salary will be applied. In other words, severe hemophilia A patients without antibodies can receive health insurance benefits when using Hemlibra. In the meantime, non-antibody hemophilia patients have been using intravenous treatment two to three times a week. Hemlibra is expected to be more convenient than existing intravenous treatments because the preventive effect lasts with subcutaneous injections from once a week to once every 4 weeks. In particular, it is analyzed that it will help improve the quality of life of pediatric patients. In the parliamentary audit last year, the rapid payment of Hemlibra for pediatric patients with non-antibody hemophilia was also an issue. According to the 2019 Hemophilia Foundation White Paper, among a total of 1,746 patients with hemophilia A in Korea, 78 were antibody patients and 1589 non-antibody patients were resistant to the existing treatment (factor 8 drug). Among them, severely ill patients accounted for 1259 (72.1%). Hemlibra is a treatment for hemophilia A developed by Chugai, a subsidiary of Roche, in Japan. This time, Hemlibra's drug price will be reduced as reimbursement increases. The 30mg/1mL product is adjusted to 2.28 million won per bottle, 60mg/0.4mL to 4.56 million won, 90mg/0.6mL to 6.84 million won, 0.105g/0.7mL to 7.98 million won, and 0.15g/1mL to 11.4 million won. From May, Chinese pharmaceutical company BeiGene's anti-cancer drug 'Brukinsa 80mg' will be covered. This drug is reimbursed for the treatment of Waldenstrom's macroglobulinemia (WM). Waldenstrom's macroglobulinemia (WM) is a rare blood cancer in which the bone marrow produces large numbers of abnormal white blood cells that crowd out healthy blood cells. The US FDA approved Brukinsa as a treatment for WM in September 2021. In Korea, it is attracting attention as it is the first case in which a Chinese new drug entered the right to benefit. Brukinsa is priced at 34,100 won per capsule. Expenditure cap RSA is applied to this drug.
- Policy
- Original Concor voluntarily reduced the price
- by Lee, Tak-Sun Apr 25, 2023 05:56am
- Concor (Bisoprolol fumarate), the original β-blocker antihypertensive drug, voluntarily lowered its drug price, gaining recognition and price competitiveness. Many generic drugs are more expensive than original drugs, so marketing activities are expected to be difficult. According to the industry on the 24th, the price of Concor 5mg will go down from next month from 222 won to 200 won. The price of Concor 2.5mg will be reduced from 132 won to 120 won. The company lowered the price itself. Concor is a second-generation β-blocker that has been sold in Korea since 2001 and has established itself as a treatment for hypertension, angina pectoris, and chronic heart failure. In particular, as the awareness of original products increases, there is a big gap with generic products. As of last year, Concor's outpatient prescriptions amounted to 18.6 billion won. Since 2020, Daewoong Pharmaceutical has exclusively sold the drug in Korea. As the company's performance is sound and the market share of generic drugs is low, the market is also showing a skeptical response to the voluntary lowering of the drug price this time. The fact that Elyson's lowest-priced generics continued to increase their market share was a potential cause for concern. Bisoprolol fumarate 5mg has eight products, including Concor and Elyson Conbloc. Previously, Concor and six generics were priced the same at 222 won, and only Conbloc 5mg was listed at 198 won. For Bisoprolol fumarate 2.5mg, Elyson Conbloc 2.5mg was 124 won and Concor tablet 2.5mg was 132 won. With this price cut, Concor narrowed the gap with Conbloc by 2 won in the 5mg product and became 4 won cheaper in the 2.5mg market. Currently, in the generic market, all but Elyson are producing less than 1 billion won a year. On the other hand, Conbloc, which boasts drug price competitiveness, is increasing every year to KRW 3.6 billion last year according to UBIST. Conbloc is drawing an upward trend with 1.1 billion won in 2017, 1.8 billion won in 2018, 2.3 billion won in 2019, 2.9 billion won in 2020, 3.5 billion won in 2021, and 3.6 billion won in 2022. Compared to Concor's performance of 18.6 billion won in 2022, there is still a gap. However, Concor's 2022 performance is down 3% from the previous year. If this trend continues, Conbloc's market share may increase and Concor's market share may decrease. This drug price cut is interpreted as the intention of Concor to gain an absolute advantage in generic competition. It is expected that the six generic companies, which had the same drug price as Concor, could suffer damage. Previously, these six companies only produced less than 1 billion won per year, but it is expected that their market competitiveness will further weaken as the original drug price cut overlaps. There is also a way to lower the price of the drug depending on the original, but in this case, it seems that it will worry about whether to continue the business because it comes back to the cost burden. Elyson, which has put forward a low price, is expected to become a burden on marketing activities as the price becomes similar to the original. It remains to be seen what effect the original drug's voluntary price cut will have on the market.
- Policy
- Price of Eliquis reduced by 3.5%... Kanarb by 1.7% each
- by Kim, Jung-Ju Apr 24, 2023 05:52am
- Merck's Mavenclad tab. (cladribine), which is used to treat relapsing-remitting multiple sclerosis, has become subject to price cuts under the price-volume agreement and will be sold at a 6.9% lower price starting next month. The price of Boryung’s flagship hypertension drug, Kanarb (fimasartan potassium trihydrate), will be reduced by 1.7% for each dose, and the price of BMS Korea Eliquis will also be reduced by 3.5% for each dose. According to industry sources on the 21st, the Ministry of Health and Welfare is planning to revise the 'Drug Reimbursement List and Reimbursement Ceiling Amount Table' and apply it on the 1st of next month. A total of 6 products will be applied PVA price cuts. One is subject to ‘PVA Type A’ and the other 5 are subject to ‘PVA Type B’ and the subject drugs have been conducting negotiations with the National Health Insurance Service until now. ◆PVA Type A = Price of only 1 drug classified as 'type A' will be reduced after completing negotiations with the government. Among new drugs listed as negotiable after the introduction of the drug price negotiation system, the government applies PVA A type to drugs whose claims amount in the same product category exceeds the expected claims amount by over 30%. By same product category, drugs that have the same company name, route of administration, ingredient, and formulation are classified as drugs of the same product category. The drug subject to ‘Type A’ price reduction is Merck’s Mavenclad Tab. Its price is set to be reduced by 6.9%, and the price cut will be applied starting on the 1st of next month. ◆PVA Type B = Also, 5 drugs that were classified as Type B will receive price discounts this time. The government applies PVA Type B and reduces the price of drugs ▲whose price ceiling had been already adjusted according to Type A, ▲ whose claims amount increased by over 60% from the previous year without undergoing Type A negotiations, or 4 years after receiving Type A negotiations, or ▲ has increased by over 10% but the increased amount exceeds KRW 5 billion and does not fall under PVA Type A. By each item, the price of 60mg and 120mg doses of Boryung’s Kanab Tab. will be reduced by 1.7%, respectively. The price of its 30mg dose product will be reduced by 1.8%. Eliquis's insurance drug prices will fall by 3.5% each for both the 2.5mg and 5mg doses.
- Policy
- The price of Envlo is 611 won & Qtern is 833 won per tab
- by Lee, Tak-Sun Apr 23, 2023 09:42pm
- Leading diabetes treatments such as Daewoong Pharmaceutical's new SGLT2i diabetes drug Envlo and AstroGeneca's SGLT2i+DPP4i complex Qtern will be poured out at once in May. In line with the expansion of the Forxiga patent expiration and diabetes drug combined salary standards this month, the application of new product benefits was concentrated in May. According to the industry on the 20th, Daewoong Pharmaceutical's salary will be applied to 611 won per table of 0.3mg per table on the 1st of next month. Envlo is known to have been determined at less than 90% of the price of existing SGLT2i drugs. It is lower than the existing SGLTi treatment Jardiance 10mg 660 won, Sugar 50mg 685 won, and Steglatro 5mg 666 won. The price of Envlo is higher than that of Forxiga, because at the time of calculating the Envlo price, Forxiga was before the patent expired. Forxiga 10mg will be reduced from 734 won to 514 won from May. Hanall Biopharma, an affiliate of Daewoong Pharmaceutical Co., Ltd. with Envlo, Eaglex and Daewoong Bio Benavo's price is the same. The SGLT2i+DPP4i compound will be reimbursed for the first time. Korea's AstraZeneca Qtern 5/10mg, Korea's Beringer Ingelheim's Esglito 10/5mg, Korea's MSD's "Stegluzan 5/100mg" and LG Chem's Zemidapa will be on the list in May. Qtern costs 833 won per tablet, Esglito costs 755 won for 10/5mg, Stgluzan costs 846 won, and Zemidapa costs 940 won per tablet. Chong Kun Dang Exiglu-S will also be on the list in May. It will be four months ahead of the expiration of the Sitagliptin material patent (September 1), drawing keen attention to Chong Kun Dang's strategy. The Dapagliflozin+Sitagliptin combination licensed by domestic companies is expected to be listed after September. These SGLT2i+DPP4i combination are only eligible for benefits in the third system combined with metformin according to the standard. It is on the list for 677 won per tablet, with Hutecs Korea Pharmaceutical's "Gluxiga 10/4mg," Jinyang Pharmaceutical's "Dapagreen-G 10/4mg," Kyungdong Pharmaceutical's "Dapamepi 10/4mg," and Mothers Pharm's Pharmaceutical's "Xig Double M 10/4mg."
- Policy
- CPAC 'Reducing PMS cases for Zerbaxa deemed valid'
- by Lee, Hye-Kyung Apr 21, 2023 05:56am
- Experts in Korea have agreed that it is valid for MSD Korea to change its post-marketing surveillance plan for ‘Zerbaxa inj (ceftolozane/tazobactam),’ which is used to treat severe multidrug-resistant Pseudomonas aeruginosa infections, in consideration of its usefulness and usage. The biggest reason was due to the company’s difficulty in collecting cases for surveillance caused by its low use due to long-term out-of-stock status, reimbursement restrictions after receiving marketing authorization, and a voluntary recall measure. According to the minutes of the Central Pharmaceutical Affairs Council that was recently disclosed by the Ministry of Food and Drug Safety, the CDDC decided to reduce the required number of cases from 3,000 to 460, and change the surveillance period from 6 years to '6 years + 4 years'. The minutes showed that one committee member said, “The drug is an essential medicine that is necessary for the treatment of carbapenem-resistant patients, and its reason for the sluggish collection of surveillance cases is reasonable. The company's PMS plan that was submitted includes efforts to collect cases in the future, therefore it is deemed appropriate for the council to allow the company to reduce the number of required surveillance cases.” Another member said, “ceftolozane and tazobactam formulations had been voluntarily recalled for a considerable amount of time. Considering its narrow scope of reimbursement and indication, I agree on changing its PMS plan." MSD Korea had previously recalled its products as a precautionary measure due to the non-conformity of sterility tests before shipping them to overseas manufacturing plants in 2020. Also, the drug was granted reimbursement approval only in October 2022, although it was approved in 2017. One committee member said, “I agree on the usefulness of the drug as a national essential drug used to treat patients with multidrug-resistant bacteria. I also agree that the sluggish case collection rate is attributable to the low prevalence rate of its indication, supply disruptions, and non-reimbursement matters.” In other words, experts saw that it was necessary to adjust the drug’s PMS plan and order the collection of 460 cases and extend the surveillance period by 4 years, and wait for the company’s efforts on the low prevalence and supply disruption part. In response, the CPAC said due to its non-reimbursement until recently and out-of-stock issue, it was difficult to report 3,000 cases of Zerbaxa use in the current 6-year period and agreed that around 100 patients commonly register in trials for efficacy evaluation, etc. for ceftolozane and tazobactam use.
- Policy
- SGLT2 Domestic new drug/combined drug market
- by Lee, Tak-Sun Apr 20, 2023 05:58am
- Forxiga, Jardiance, Suglat, and Steglatro have been market-leading SGLT-2 inhibitors as weight-loss diabetes drugs. Domestic pharmaceutical companies are also fighting back. Domestic pharmaceutical companies that have relaxed with Generic for Forxiga are anticipating a full-fledged offensive from next month with Daewoong Pharmaceutical's new domestic drug and LG Chem's DPP4+SGLT2 complex. ◆ Daewoong Pharmaceutical's Envlo= SGLT-2 inhibitor, which appears at an amazing timing, selectively inhibits sodium-glucose cotransporter 2 (SGLT2), which plays a major role in glucose reabsorption and discharges excessive glucose in the blood to lower blood sugar. Weight loss can also be seen in this process. Envlo is the only SGLT-2 inhibitor developed by a domestic pharmaceutical company. It was approved on November 30th and will be on the market in almost 5 months. The timing of the release is amazing. Envlo passed HIRA on March 2nd under the condition of accepting less than the appraisal amount. The evaluation amount is the weighted average price of commercially available SGLT-2 inhibitors. If Forxiga had passed the committee after April, after the patent expired, the weighted average price would have been much lower. Daewoong Pharmaceutical agreed to negotiate with NHIS on the 10th, skipping upper limit negotiations by accepting 90% of the weighted average price. It is expected to be on the payroll list on the 1st of next month. The benefit standard changed in April is also applied. Envlo has proven its combined effect with a DPP-4 inhibitor through clinical trials, so a combination of met + Envlo + DPP-4 is possible. However, since there is no verification data for TZD combination use, combination use of 3 drugs including met+TZD is not possible. It can be seen that pharmaceutical companies with other SGLT-2 inhibitors and DPP-4 inhibitors were registered for reimbursement at an amazing time in that they had to lower their drug prices on their own in accordance with the expansion of the standard for concurrent use. Generic for Forxiga has also been released less than a month, so Envlo's promotion is expected. ◆133 billion won performance LG Chem's Zemidapa = LG Chem, which first introduced a domestically produced DPP-4 inhibitor, is not a new SGLT-2 drug, but Forsyga is expanding its market area with a combination drug in line with the patent expiration. LG Chem is recording 133 billion won (Uvist 2022 standard) of outpatient prescriptions in the 1 trillion won diabetes treatment market only with the Zemiglo product line. LG Chem went further than Zemiglo and released Zemidapa with Forxiga's Dapagliflozin attached. On the 4th of this month, the non-payroll was released, and the payroll will be applied next month. LG Chem verified the effectiveness of met + Zemiglo + Dapagliflozin through a clinical trial in which more than 20 billion won was invested. The three-drug combination therapy showed a greater improvement in blood glucose than met+Dapagliflozin or met+Zemiglo. Since the benefits of the met+ddp4i+sglt2i 3 system will be applied from April, Zemidapa, a ddp4i+sglt2i combination drug, is also expected to benefit. ◆Dong-A ST, the first player in the Generic for Forxiga market, has a diverse lineup = Dong-A ST has been approved for 9 SGLT-2 drugs. Dong-A ST, which launched Dapapro, a prodrug of Forxiga through a patent strategy, as the first late-breaking drug in December of last year, received reimbursement for six late-breaking drugs of Forxiga and Jardiance this month. In addition to eight products, Sugadapa, a combination of Suganon and Dapagliflozin, an in-house developed drug, is expected to be released as reimbursements in June. With only nine dapagliflozin, the lineup is the most solid among pharmaceutical companies. Dong-A ST recently announced that it had applied for permission for 'Sugadapa met', a combination of metformin and Sugadapa. The product is planned for release next year. Dong-A seems to have established itself in the diabetes treatment market with Suganon, a domestically developed DPP-4 drug. However, although it is sluggish compared to competing drugs, it seems to be trying to expand its market share with dapagliflozin.
- Policy
- NA presses for Targrisso’s reimb in the first line
- by Lee, Jeong-Hwan Apr 20, 2023 05:58am
- The NA Health and Welfare Committee decided that reimbursement for AstraZeneca's lung cancer drug ‘Tagrisso (osimertinib)’ in the first line is necessary and requested its prompt reimbursement listing to the government. Min-soo Park, the 2nd vice minister of the Ministry of Health and Welfare, and the Health Insurance Review and Assessment Service also agreed to the National Assembly's decision and promised to promptly go through the reimbursement procedure. On the 18th, the Health and Welfare Committee's Petition Review Subcommittee (Chair Young-Hee Choi) reviewed the petition which requested reimbursement of the lung cancer drug Tagrisso as a first-line treatment. The subcommittee members decided to continue to review such drug-related issues including Tagrisso without immediately deciding whether to refer the petition for consideration to the plenary session. Its aim seems to be to closely monitor the progress of the petition until the results of the drug petition issues including Tagrisso's first-line reimbursement are confirmed. In Korea, Tagrisso is putting a heavy burden on cancer patients and their families due to its high drug price and non-reimbursement even though it has a superior effect as a first-line treatment in lung cancer. This is why the issue was submitted to the petition subcommittee, after achieving 50,000 National Assembly petition consents. Tagrisso had received marketing authorization from the Ministry of Food and Drug Safety as a first-line treatment for EGFR-positive non-small-cell cancer patients diagnosed with exon 19 deletion or exon 21 L858R substitution mutations and as a second-line or higher therapy for NSCLC patients with positive EGFR T790M mutations. However, its reimbursement has only been approved as a second or higher line of treatment since December 5, 2017. Currently, the reimbursement standards for Tagrisso as a first-line treatment were set to be established in March this year at the Cancer Disease Review Committee, and the agenda is being deliberated by the Economic Evaluation Subcommittee. The drug must still undergo Drug Reimbursement Evaluation Committee evaluations, HIRA-pharmaceutical company negotiations, and review by the Health Insurance Policy Review Committee to receive reimbursement. In response to the petition, the Health and Welfare Committee's expert members acknowledged the need for Tagrisso’s reimbursement in the first line. The experts believed that there is a need to improve public health and ease the economic burden by reinforcing patient access to new drugs for severe diseases. Also, MOHW and HIRA announced that it agrees on the need for Tagrisso's reimbursement in the first line and will make efforts to deliberate it as soon as possible. The MOHW said, “The agenda is currently under HIRA review, and HIRA will be reviewing the reimbursement extension after fully considering its cost-effectiveness." HIRA said, “Our Economic Evaluation Subcommittee and Drug Reimbursement Evaluation Committee will conduct deliberations based on data that will be submitted by the pharmaceutical company. We will work to proceed with the deliberation as soon as possible.” The validity and urgency of the first-line reimbursement of Tagrisso have also been known to have been stressed during the Petition Subcommittee’s review. The members of the subcommittee had asked Vice Minister Park to “conduct the reimbursement review as quickly as possible,” and Vice Minister Park accepted the request and promised their prompt reimbursement.
- Policy
- Enhertu, re-discussing with supplementary materials
- by Lee, Tak-Sun Apr 19, 2023 05:51am
- Attention is focusing on whether the reimbursement standards for Enhertu, an anti-cancer drug from Daiichi Sankyo Korea, will be prepared through re-discussion by the Cancer Disease Review Committee. The drug has received more than 50,000 national petitions and is currently accelerating its reimbursement review. However, at the HIRA held last month, it was decided to discuss again without reaching a conclusion on the setting of the salary standard. According to the industry on the 14th, Enhertu's Daiichi Sankyo recently submitted complementary data to HIRA. Previously, at the review committee held on the 22nd of last month, supplementary data was requested on the grounds that the level of evidence for Enhertu's gastric cancer indication was low and that additional supplementation of financial sharing was necessary for the applied drug price. The indications for Enhertu, whose reimbursement criteria were discussed by the review committee, are ▲the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have previously received two or more anti-HER2-based therapies, and ▲two or more therapies including prior anti-HER2 therapies. Treatment of locally advanced or metastatic HER-2-positive gastric or gastroesophageal junction adenocarcinoma. Among the two, the review committee explains that the basis for gastric cancer indication is weak and the price of the applied drug is high, so it is difficult to set the reimbursement standard right away. However, there is still the possibility of prompt reimbursement as the company decided to re-discuss it through supplementary data rather than deciding not to set the standard for reimbursement. As the pharmaceutical company submitted additional supplementary data, attention is focused on whether Enhertu's reimbursement standard will be successful in the next review committee. Cancer screening is scheduled for the 26th of this month. The key is also the price of the drug. It is known that Daiichi Sankyo applied for 2.4 million won per bottle as a salary indicator, which costs about 160 million won per year. It is explained that the key to passing the reimbursement standard is how the insurance authorities and pharmaceutical companies will share the financial burden because the health insurance budget is high. The health authorities seem to have the willingness to pay for this drug. Another positive factor for Enhertu's reimbursement is that the approval review for drugs that have been referred to the National Assembly is speeding up, with more than 50,000 petitions for reimbursement through the National Consent Petition website. Among the drugs referred to the Welfare Committee as a result of a national application, Crysvita, a treatment for pediatric rickets, is expected to be listed as a benefit next month, and Tagrisso, a first-line treatment for non-small cell lung cancer, has passed the review committee. Enhertu is a next-generation ADC (antibody-drug conjugate) drug that selectively acts only on cancer cells to increase treatment effects and minimize side effects. In clinical trials, it showed higher efficacy than existing drugs, raising expectations as a second-line treatment for HER2-positive breast cancer and a third-line treatment for gastric cancer. Enhertu applied for reimbursement to the HIRA in December of last year and launched non-reimbursement in January.
