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- 2026-03-12 07:27:40
- Policy
- SGLT2 + DPP4 combi benefit expansion has increased
- by Lee, Tak-Sun Mar 14, 2023 05:50am
- As the insurance authorities decided to expand the combined coverage of major diabetes drugs from April, applications for reimbursement for related complex drugs are continuing. MSD Stegluzan's application for benefits was recently confirmed, and Dong-A ST Sugadapa, which was approved on the 13th, plans to apply for benefits this month. Accordingly, it is understood that a total of five items will be applied for benefits within this month. According to the industry on the 13th, two-dose items of MSD Stegluzan were applied for and the HIRA was calculated. Stegluzan is a combination of the SGLT-2 inhibitory ingredient Ertugliflozin L-pyroglutamic acid and DPP-4 inhibitory ingredient Sitagliptin Phosphate Hydrate. For Ertugliflozin, the original single drug product is Steglatro, and the ingredient Sitagliptin is Januvia. All of these items are owned by MSD and are listed on the list. Stegluzan will be calculated based on the upper limit of Steglatro and Januvia. Prior to this, Boehringer Ingelheim Esglito and AstraZeneca Qtern were also known to have applied for benefits. Since the company that owns the original single drug is launching it on the market as a combination product that combines the single drug, there is no possibility that the market launch will be delayed due to patents. LG Chem is also said to have applied for Zemidapa benefits. Gemigliptin is a DPP-4 inhibitory ingredient developed by LG Chem, and its brand name is Zemiglo. Accordingly, among the SGLT-2+DPP-4 combination drugs, 3 items from foreign companies and 2 items from domestic companies are expected to be reimbursed within the first half of the year. Since the upper limit of the single system is voluntarily lowered according to the April benefit expansion, the upper limit of the combined system is set based on this. LG Chem and Dong-A ST's combination drugs are paying close attention to the voluntary reduction rate of the original Forxiga because Dapagliflozin is combined. Meanwhile, the insurance authorities plan to expand reimbursement for the combined use of drugs between classes, such as Metformin + DPP-4 + SGLT-2, from April.
- Policy
- Voluntary withdrawal of reimbursement for Tepmeko
- by Lee, Tak-Sun Mar 14, 2023 05:50am
- It was found that Tepmeko, a MET mutated anti-cancer drug that failed to set reimbursement standards, recently voluntarily withdrew its application for reimbursement. Tepmeko has not been recognized as valid as a result of discussing the reimbursement standard in HIRA. According to the industry on the 10th, Merck announced its intention to voluntarily withdraw Tepmeko's application for drug reimbursement decision to HIRA. Tepmeko is a treatment for locally advanced or metastatic non-small cell lung cancer with confirmed MET exon 14 deletion. In Korea, in November 2021, it was approved simultaneously with Tabrecta, a drug in the same family, and has been undergoing a full-scale reimbursement review since last year. Metastatic non-small cell lung cancer patients with MET mutations, which Tepmeko is targeting, appear in about 3-4% of all non-small cell lung cancer patients. Although the number of patients is small, the prognosis is poor, so a cure is desperately needed. According to a presentation by Prof. Han Ji-yeon, Department of Oncology, Lung Cancer Center, National Cancer Center, at the International Conference of the Korean Lung Cancer Society last year, an analysis of 79 Asian patients who participated in the Tepmeko VISION clinical trial showed a significantly high objective response rate of 66.7%, and the second-line treatment group The response rate was 48.1%. Despite this effectiveness, the non-insured prescription price of Tepmeko in the US reaches 25 million won per month in Korean money. For this reason, patients are eagerly waiting for the application for reimbursement. Tabrecta has also failed to set reimbursement standards, so it will take more time to apply for the benefits. It is not known whether Tepmeko will reorganize its data and apply for benefits. However, since the previous application for benefits was withdrawn, even if you apply again, it will take longer than before to apply for health insurance. Assuming the worst-case scenario, if Tepmeko gives up on the domestic market, there is a possibility that Tabrecta will also be affected. In this case, only the patients are expected to suffer.
- Policy
- Innovative plans for domestic vaccines/txs to face post-pand
- by Lee, Jeong-Hwan Mar 13, 2023 05:53am
- Lim Sook-young, leader The government will promptly import vaccines and treatments for new infectious diseases that will occur in Korea after Corona 19 and improve laws and systems so that domestic products can be produced quickly. For now, only the big direction has been set, and the government plans to announce a comprehensive plan in May after consultations with related ministries and experts to prepare specific countermeasures. Attention is focused on whether government support measures can be prepared to speed up the development of domestic vaccines and treatments. On the 8th, Lim Sook-young, head of the Central Disease Control Headquarters, said at a regular Corona 19 briefing, “The government is establishing a mid-to-long-term plan to prepare for a new infectious disease pandemic that will occur in the future.” Based on the COVID-19 response evaluation over the past three years, Director Lim's will is to establish a mid-to-long-term plan to expand quarantine and medical response capabilities so that vaccines and treatments can be quickly secured and large-scale long-term epidemics can be stably managed. It plans to consult with related ministries in each field, including new infectious disease monitoring, initial response, large-scale epidemic management, daily recovery, research and development of treatments and vaccines, and improvement of laws and systems. She said, "Prevention of new infectious diseases is important first. That is why it is necessary to strengthen the surveillance system." he explained. She added, "When the scale of the epidemic increases, it is necessary to be fully prepared for hospital beds and medical response," adding, "We also need to review the compatibility of social distancing measures and various compensation issues." In particular, he said, "In the next pandemic, we need to develop vaccines and treatments more quickly and respond to infectious diseases with our own vaccines and treatments." She emphasized, “We will discover improvement tasks for each area and announce a comprehensive plan after consulting with related ministries and experts.”
- Policy
- Pfizer’s Cibinqo to undergo NHIS negotiations for reimb
- by Lee, Tak-Sun Mar 13, 2023 05:53am
- (From top to bottom) Dupixent Prefilled Inj., Rinvoq ER Tab., and Cibinqo Tab attempts reimb to treat pediatric and adolescent AD Pfizer has accepted the conditions set by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee for the reimbursement of its Cibinqo Tab (abrocitinib) in Korea. The drug received conditional approval at the DREC meeting that was held on March 2. The committee deemed Cibinqo’s reimbursement will be adequate if the company accepts a price less than the assessed amount. According to industry sources on the 12th, Pfizer accepted DREC’s conditions and is moving on to the pricing negotiation stage with HIRA. DREC’s proposed assessment price is expected to be set at the same level or below the weighted average price of its alternatives. Other JAK inhibitors that are currently available in the market include Olumiant Tab (baricitinib, Lilly) and Rinvoq ER (upadacitinib, Abbvie), therefore, Cibinqo’s price is expected to be set below the weighted average price of these drugs. After the Ministry of Health and Welfare orders pricing negotiations, Pfizer will be conducting negotiations with the NHIS for Cibinqo’s reimbursement. Although the statutory period set for NHIS negotiations is 60 days, if Pfizer accepts a price less than the upper limit set and receives negotiation exclusions, the company can further reduce the NHIS negotiation period to 30 days. If negotiations are completed in a short period of time, the industry expects Cibinqo may be listed for reimbursement in May at the earliest. Currently, Dupixent (dupilumab, Sanofi), Cibinqo, and Rinvoq are undergoing the reimbursement listing process as a treatment for pediatric·adolescent patients with atopic dermatitis. Among the three drugs, Dupixent has been making the most rapid progress. The drug entered negotiations last month and is expected to be listed for reimbursement next month at the earliest. Rinvoq ER, which is already listed as a treatment for atopic dermatitis in adult patients, is also attempting to extend its reimbursement as a treatment for adolescent patients aged 12 years or older with moderate-to-severe atopic dermatitis. Rinvoq ER’s reimbursement to the indication has passed HIRA review by applying the scope of use expansion formula and is set to receive NHIS negotiations soon. As Rinvoq and Cibinqo are both oral JAK inhibitors aiming to receive reimbursement as a pediatric atopic dermatitis treatment, their pricing negotiations will likely be conducted at the same time and be listed at a similar period.
- Policy
- Industry unsatisfied with the proposed PVA improvements
- by Lee, Tak-Sun Mar 10, 2023 05:50am
- Companies that have released new drugs in Korea have expressed discontent over the measures to improve the price-volume agreement (PVA) system that had been recently disclosed by the National Health Insurance Service. The new measure will put drugs that undergo PVA Type A negotiations at a relative disadvantage. According to the measures for the improvement of the PVA system that were disclosed at a roundtable meeting with the press corp, the improvement contained measures to change the ‘drugs whose claims have increased by 30% or more’ condition for PVA Type A negotiations to ‘drugs whose claims have increased by 10% or more or have claims amount that exceeds KRW 5 billion.’ PVA Type A had currently only been applied to drugs whose annual claims amount increased by 30% or more from the expected claims amount during the 3 years after reimbursement listing. Each company agrees to a certain amount during negotiations with the NHIS. However, if the NHIS applies the additional measures to the system, even drugs whose claims amount had increased by only 10% will be subject to PVA if the total amount exceeds KRW 5 billion. Regarding the measure, an industry official said, “If the KRW5 billion and 10% increase condition is added to PVA Type A, this will come as a burden to companies that develop new drugs in Korea. Adding more price discount mechanisms to homegrown new drugs may discourage the local pharmaceutical companies from developing new drugs.” The official added, “The measure to vary the drug price discount rate according to the claims amount is nothing new as this was previously announced by the NHIS, but the conditions that are being added to PVA Type A require some thought. The NHIS’s improvement plan contains measures to differentiate the price cut rate into three categories according to the magnitude of the claims amount and proposes calculating the maximum discount rate based on a reference formula. In other words, the NHIS plans to differentiate the discount rate according to the claim size. On the other hand, small and mid-sized pharmaceutical companies seem to be looking forward to NHIS’s additional measures. This is because the plan offers measures that raise the annual claims amount of drugs subject to PVA negotiations from KRW 2 billion to KRW 3-5 billion. If this exclusion criteria is applied to products with an annual claims amount of KRW 5 billion as well, most products by small and mid-sized pharmaceutical companies will be excluded from receiving price discounts. Another industry official said, “The research service results that contain HIRA’s proposals have not been disclosed yet, and a working group to promote the system is scheduled to commence in May, so we are not at the stage to guess how the final plan will come about. We will have to internally discuss and weigh the advantages and disadvantages of the proposed measures.”
- Policy
- Dupixent, Cibinqo, Rinvoq to be reimb for pediatric AD in 1H
- by Lee, Tak-Sun Mar 10, 2023 05:49am
- The three drugs that are attempting to receive reimbursement as a treatment for pediatric·adolescent patients with atopic dermatitis - Dupixent (dupilumab), Cibinqo (abrocitinib), and Rinvoq (upadacitinib) – are expected to be approved for reimbursement within the first half of the year. With all 3 drugs passing the Health Insurance Review and Assessment Service’s deliberations, only the pricing negotiation process with NHIS remains for the three drugs. This is why analysts believe the drugs will be listed for reimbursement within June this year. In the case of Sanofi’s Dupxient Prefilled Inj (200·300mg), the drug’s reimbursement adequacy was accepted by HIRA’s Drug Reimbursement Evaluation Committee on January 12 and has been going through the drug price negotiation process with the NHIS from February. As Dupxient will be reimbursed through the risk-sharing agreement (RSA) system, there is a high possibility that negotiations with the NHIS will focus on the required financial expenditures and the pharmaceutical company’s contribution amount If the negotiations end this month, reimbursement may be applied as early as April and May. Pfizer’s Cibinqo (50·100·200mg) received conditional approval from DREC on March 2. The drug’s reimbursement was deemed adequate when the company accepts a price less than the assessment amount, and the industry expects that it is highly likely that Pfizer will accept the said conditions. This is because another JAK inhibitor and competitor, Abbvie’s Rinvoq ER, is also speeding up its reimbursement process. The company is attempting to expand Rinvoq ER’s reimbursement to its pediatric and adolescent indication and will be carrying out negotiations with the NHIS through the drug price discount formula that is used with the scope of use expansions. Rinvoq ER tab is listed at KRW 21,085 per tablet, and when applied the scope expansion formula, its price may be reduced by up to 5%. Industry analysis is that Cibinqo will likely be listed for reimbursement at Rinvoq’s price as well. The two drugs are both attempting to receive reimbursement as a treatment for patients aged 12 years or older with moderate-to-severe atopic dermatitis. The industry expects that all three drugs may likely be reimbursed within the first half of the year. An industry official said, “In the case of Dupixent, pricing negotiations will be made within the scope of its RSA contract, and pricing negotiations for Cinvinqo and Rinvoq will be conducted together and be applied the same reimbursement standards.”
- Policy
- Multiple myeloma CAR-T therapeutic agent CARVYKTI, imminent
- by Lee, Hye-Kyung Mar 09, 2023 06:00am
- CARVYKTI compares self -hematopoietic stem cell transplantation (ASCT) after administration of Daratumumab, Bortezomib, Lenalidomide, and DVRD in December last year. The clinical trial was conducted. According to the industry on the 8th, the Ministry of Food and Drug Safety recently completed the safety and validation of Carvykti. If the Efficacy & Safety screening is completed without any problems, product permission will be made soon. CARVYKTI is a T -cell immunotherapy that is derived from BCMA targeted genetic variant. The US FDA has previously been allowed to treat reissue or rebel-resistant multiple myeloma adult patients with four or more treatments, including proteasome inhibitors, immunomodulators, and CD38 monoclonal antibodies. The European Executive Committee (EMA) has granted CARVYKTI a conditional sale of at least three treatments, including immunomodulators, protease inhibitors, and CD38 monoclonal antibodies. Japan has no experience in receiving BCMA target CAR positive T cell injection treatment and has approved Carvykti as a treatment for recurrent or rebellious adult patients with three or more treatments. Korea is also likely to be permitted as a patient treatment that has performed ASCT after the administration of DARATUMUMAB, BORTEZOMIB, Lenalidomide, and DVRD. CAR-T therapeutic drugs that challenge hematopoietic stem cell transplantation include BMS's Breyanzi and Gilead's YESCARTA.
- Policy
- Gov expands SGLT-2 diabetes drug combi benefit from April
- by Lee, Jeong-Hwan Mar 08, 2023 05:53am
- The Ministry of Health and Welfare will be the first to recognize the 3-drug combination benefit for diabetes treatment with SGLT-2 inhibition mechanism from April and expand the scope of the 2-drug combination benefit compared to the previous one. Specifically, 'Metformin + SGLT-2 inhibitor + DPP-4 inhibitor' and 'Metformin + SGLT-2 inhibitor + TZD-type drugs' are covered by health insurance benefits when 3 drugs are prescribed together, and sulfonylurea (SU)-type drugs and When using SGLT-2 inhibitors together, the number of covered drugs will be increased from the current one to four. In the case of insulin injection and SGLT-2 inhibitor combination therapy, the number of covered drugs will be expanded from the current two to four. On the 5th, Director Oh Chang-hyeon of the Insurance Pharmaceutical Division of the Ministry of Health and Welfare met with the Ministry of Health and Welfare Professional Correspondents Association and announced the plan to expand the SGLT-2 inhibitor combination benefit. If the health insurance benefit is revised as announced by the Ministry of Health and Welfare, all three-drug and second-drug combination benefits for all SGLT-2 inhibitory diabetes drugs currently approved for marketing in Korea will be recognized. AstraZeneca Forxiga, Boehringer Ingelheim Jardiance, Astellas Suglat, and MSD Steglatro Korea are a total of four SGLT-2 single-drug original diabetes drugs prescribed under domestic approval. There are a total of seven therapies for which the Ministry of Health and Welfare announced the expansion of SGLT-2 combination benefits, including generics that are identical to the original ingredients, from next month. There are 2 oral 3-drug therapies, 3 oral 2-drug therapies, and 2 insulin-oral combination therapies. First of all, the health insurance benefits for the oral triple therapy are 'metformin + SGLT-2 inhibitor + DPP-4 inhibitor' and 'metformin + SGLT-2 inhibitor + TZD-type drugs'. Oral double-drug therapy is a combination of a SU-type drug and an SGLT-2 inhibitor. Currently, dapagliflozin is the only SGLT-2 diabetes drug that is approved for concurrent benefit with SU. Ministry of Health and Welfare from next month following Dapagliflozin, Empagliflozin, Ertugliflozin, and Ipragliflozin will be approved for SU concomitant benefit. The combination therapy of insulin and oral medication will be expanded compared to the current one. Currently, two drugs, Dapagliflozin and Empagliflozin, are approved for reimbursement when insulin and SGLT-2 diabetes drugs are prescribed together. The Ministry of Health and Welfare will expand insulin combination benefits to Ertugliflozin and Ipragliflozin starting next month. Oh Chang-hyun said, "We plan to implement 7 therapies in April that will expand the 3-drug and 2-drug combination benefits for diabetes drugs with SGLT-2 inhibitory mechanisms." explained.
- Policy
- PVA, the higher the bill, the greater the discount rate
- by Lee, Tak-Sun Mar 08, 2023 05:52am
- Lee Sang-il, executive director of NHIS, held a meeting with the Korea Special Press Association on the 7thThe NHIS plans to increase the reduction rate of the upper limit for drugs with high claims in the PVA, and lower the reduction rate or exclude drugs with low claims. This is based on research conducted last year. The results of the research service (performance evaluation and improvement plan of PVA (researcher: Bae Seung-jin, Ewha Womans University)) has not yet been disclosed, but will be disclosed at the end of this month and discussed at the Workie Group, which will be held from May. At the Korea Special Press Association meeting held on the 7th with Lee Sang-il, executive director of the NHIS, this PVA improvement plan was revealed for the first time. Director Lee said, "In order to improve the effectiveness of drug cost management, we conducted a research service last year to evaluate the performance of the PVA system and improve it." As a way to improve the system, we suggested selective management of drugs with high fiscal impact and efficient system operation.” Accordingly, a plan was devised to expand the selection criteria for usage type 'Ka' by adding 5 billion won and 10% increase conditions from the existing 30% increase condition for the selective management of drugs with high financial impact. The reference formula is differentiated by dividing it into three sections according to the size of the bill, and a plan to increase the maximum reduction rate in consideration of the coefficient of the reference formula was proposed. As a result, the plan is to increase financial efficiency by increasing the reduction rate for drugs with high claims. Currently, the maximum reduction rate is limited to 10%, but the maximum reduction rate is expected to exceed 10% for drugs with high claims through improvement measures. Conversely, a plan was proposed to further include drugs with low claims, which have a small reduction rate and are excluded from negotiations. For efficient operation of the system, the exclusion criteria will be raised from 2 billion to 3 to 5 billion, and a temporary refund system will be introduced. In addition, a plan to lower the maximum reduction rate for small-amount drugs was also proposed. The temporary refund system refers to a one-time refund to the NHIS by a pharmaceutical company for a price cut instead of a price cut for a drug whose usage has temporarily increased due to a pandemic or other reasons. The target and materialization plan will be discussed in the working group to be held in May, but this plan is not expected to be promoted immediately as a mid-term task. Jeong Hae-min, head of the NHIS Pharmaceutical Management Office, said, “The rest of the parts except for the temporary refund system are short-term tasks, and we plan to promote system improvement through a working group that will be held from May.” We plan to operate according to the schedule of, and based on the matters discussed through this, we will come up with an improvement plan, revise the relevant regulations in the second half of the year, and implement them from next year.” A plan to correct the number of drugs related to COVID-19 has also been outlined to some extent. The target drugs are cold medicines and antibiotics that are encouraged to be produced by the Ministry of Food and Drug Safety, and it is explained that they correspond to about 2,600 items based on the 2022 benefit list. As for the correction method, a method of correcting the usage amount was proposed, excluding the period (month) when usage increased sharply during the pandemic, and the director Lee explained that they are currently in final coordination with the pharmaceutical industry. The NHIS plans to finalize the correction plan this month when discussions with the pharmaceutical industry are completed and to apply to monitor for negotiations in April.
- Policy
- Free vaccination of Rotarix·RotaTeq is available
- by Lee, Jeong-Hwan Mar 07, 2023 05:39am
- The Korea Centers for Disease Control and Prevention (KCDC) will start a national vaccination project for Rotavirus vaccines Rotarix and RotaTeq, which are distributed in Korea, from the 6th. From this day, infants aged 2 to 6 months who are subject to vaccination will be able to receive one of the two vaccines free of charge at nationally consigned medical institutions or public health centers. Rotavirus is easily spread through the hands and mouths of infants from contaminants in diapers or toys. Infection can cause vomiting, high fever, and severe diarrhea, leading to dehydration and requiring hospitalization. Even if the 1st rotavirus vaccine was charged for 6 days before the implementation date of the national vaccination program, free vaccination is possible from the remaining 2nd or 3rd vaccination for complete vaccination. Rota vaccination requires 2 or 3 doses depending on the type of vaccine used to obtain the sufficient preventive effect. Rotarix requires a total of 2 doses and RotaTeq requires a total of 3 doses. The current status of the nearest vaccination institution can be checked on the vaccination helper website. Rotarix and RotaTeq are classified into monovalent and pentavalent depending on the number of serotypes included in the vaccine, but both vaccines showed similar efficacy and safety in terms of preventing rotavirus infection and severe disease in Korea. Since cross-inoculation is not allowed, it should be noted that after the first vaccination, all rounds must be completed only with the same manufacturer's vaccine. Director Ji Young-mi of the Agency for Disease Control and Prevention said, “The introduction of this national rotavirus vaccination will lower the cost burden for parents who needed about 200,000 to 300,000 won for vaccination,” and “the incidence of rotavirus infection, which causes acute diarrhea and high fever in infants, will also decrease. I expect that," he said.
