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- 2026-07-01 12:03:09
- Policy
- The regulation for shortening the period will be revised
- by Lee, Hye-Kyung Aug 16, 2022 05:46am
- As announced by the government, if the RSA-applied drugs are subject to PE submission, the registration period will be shortened, and even drugs that have proven improvement in children's quality of life will be excluded. The HIRA will pre-announce the "Partial Amendment Regulations on the Evaluation Standards and Procedures for Medical Care Benefits" containing such information and receive opinions by the 30th of next month. The revised regulations are designed to promote national tasks such as shortening the listing period of drugs related to diseases that threaten survival and strengthening access to patients through the expansion of risk-sharing systems. In accordance with Article 11-2 (1) of the Medical Care Benefit Standard, the legal processing period for insurance registration is within 120 days, and in the case of the world's first new drug approved in Korea, the processing period is within 100 days. However, in the case of drugs that manufacturers under Article 7 (2) of the Decision and Adjustment Standard or drugs that fall under Article 13 of the Medical Care Benefit Standard, the treatment period was 150 days, and the drugs evaluated as Table 2 (b) and (c) of the Decision and Adjustment Standard were shortened by 30 days. The HIRA said, "We have prepared an amended regulation to shorten the legal deadline for insurance registration of PE submission exemptions, which are methods of evaluating expensive anticancer drugs and treatments for severe and rare diseases." In addition, PE-submitted omitting drugs included "when there is no product or treatment that is used in children with equal therapeutic location, and clinically meaningful improvement in quality of life or other committees recognize it." The HIRA explained, "Even drugs to prove the quality of life for children can be omitted to submit PE data, allowing RSA to be expanded."
- Company
- Wakix, a new narcolepsy drug, can be prescribed at Big 5
- by Eo, Yun-Ho Aug 12, 2022 05:58am
- Wakix, a new narcolepsy drug, can be prescribed at the Big 5 General Hospital. According to the industry, it is Mitsubishi Tanabe Pharma's Wakix recently passed the DC of the Big 5, including Samsung Seoul Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Wakix has been on the insurance benefit list since February, forming a confrontation with Nuvigil of Handok Teva. The pay standard for this drug is that in adult patients over the age of 19 who have been confirmed to have narcolepsy, CSF hypocretin-1 immunoreactivity level corresponds to one or more of the patients with hypocretin deficiency measured to be less than 1/3 of the normal level or less than 110 pg/mL. Wakix, a counteracting and antagonist that selectively binds to histamine H3 receptors, is a new mechanism drug that increases histamine concentration in the brain. Nuvigil, an active isomer of sleep seizure treatment Provigil, activates dopamine in the brain to promote awakening and improve the duration of existing drugs. Narcolepsy, a rare and intractable disease, has limited treatment options in Korea. In the United States and Europe, Modafinil, Sodium Oxybate, Solriamfetol, and Pitolisant are used as narcolepsy treatments, but only Modafinil and isomer Armodafinil are permitted in Korea. Narcolepsy is a sleep disorder disease characterized by confusion in the sleep awakening cycle and abnormal expression of REM sleep due to the loss of neurons that produce a neurotransmitter called hypocretin in the brain. Chronic Daytime Sleepiness (EDS) and cataplexy, in which REM sleep is expressed in awakening conditions Cataplexy is known to appear in 70% of narcolepsy patients. Wakix is the first treatment in Korea to be approved for demonstrating clinical efficacy and safety of cataplexy.
- Opinion
- [Reporter’s View] Seek industry opinion before implemention
- by Lee, Tak-Sun Aug 12, 2022 05:58am
- Although the government announced measures to reinforce patient access to high-priced severe disease treatments on the 20th of last month, the pharmaceutical industry’s response to the new measures has been lukewarm at best. Moreover, the industry is ferociously criticizing how the government presented the measure without collecting industry opinion. The main point of implementing the new measure was to reduce the reimbursement period while reinforcing post-marketing management, however, the industry is claiming that the measure will have little effect in reducing the reimbursement period while focusing too much on drug price reduction, ultimately further impeding patient access. The government plans to reduce the reimbursement review period of treatments for life-threatening conditions by 60 days through the concurrent operation of reimbursement evaluation and pricing negotiations, among other measures. On this, the Korean Research-based Pharmaceutical Industry criticized, “Reducing 60 days from a review period that already takes up to 3 to 4 times the actual statutory period (210 days) will be insignificant from the patient’s perspective in feeling any improved access. The industry added, that preparing a pharmacoeconomic evaluation exemption regulation for treatments with a small number of patients and improving the maximum discount rate of the Price-Volume Agreement system from the current 10% will only lower motivation for new drug development or reimbursement. The problem is that the government did not seek the pharmaceutical industry’s opinion before announcing the measure. KRPIA also expressed concern regarding this matter, saying that “It is a shame that the government, which had been emphasizing private-public cooperation, disclosed a major policy that may affect the whole field without conferring it with the biopharmaceutical industry.” Since early last year, the government and pharmaceutical associations have been meeting every month through a private-public consultative body established to improve the drug pricing system. However, the measure for improving access to high-priced drugs that had been announced was found to have never been discussed at the meetings. It is difficult to properly implement or promote a policy that is unilaterally announced without collecting the opinions of its users and suppliers. The ‘Lowering the elementary school entry age to 5 years’ policy that was recently withdrawn due to opposition from the education community, was also aborted due to this non-collection of opinions from the education community. Why the Ministry of Health and Welfare, which lacks a head, made such a hasty decision to announce an important policy without collecting opinions from the industry remains in question. If the government respects the pharmaceutical industry as its future driver of growth, it should not exclude the industry in the process of making such serious policies.
- Policy
- The Price of 4 Xarelto will be cut from the 22nd as planned
- by Kim, Jung-Ju Aug 12, 2022 05:58am
- As the court sided with the government for the four items of the Bayer Korea Xarelto (Rivaroxaban) series, which the government has lowered the insurance drug price through ex officio adjustment and ended the additional application, the drug price cut schedule was set. On the 22nd, the drug price will fall as originally planned by the government. The 11th part of the Seoul High Court recently sided with the Ministry of Health and Welfare in the case of the Xarelto Drug Abatement Cancellation Action (2021-Guhap 65811) filed by the company against the Ministry of Health and Welfare. As the company filed a lawsuit, the price was lowered as the suspension of execution of the drug price cut, which the court accepted, was lifted. Earlier, on May 24, 2021, the Ministry of Health and Welfare lowered the price of four items of the drug series through the revision of the Notice of the Drug Benefit List and the upper limit amount table (Notification No. 2021-147). The government is ex officio adjusting the upper limit price of products with the same administration route, ingredients, and formulations as the first registered products and the lowest registered products when registered as generics. If the first genomic is registered, it is 53.55%, which is added to 70% for one year after adjustment. At that time, the Ministry of Health and Welfare decided to reduce the Xarelto 10mg content, 15mg, 20mg, and 2.5mg content by 30% each, and to drop 23.5~23.6% each as of May 1, 2022, a year later. As a result, the company protested and the suspension of execution has continued for about a year along with the lawsuit. With this close, the price will fall to the official price at the time, and the fixed date will be on the 22nd. However, the Ministry of Health and Welfare said it will inform the company further if there is a change in the price because the possibility of appeal remains, and the court may accept the suspension of execution again.
- Policy
- CKD completes acquiring 3 exclusive licensed items
- by Lee, Tak-Sun Aug 12, 2022 05:58am
- Chong Kun Dang completed the acquisition process for the three items that it signed exclusive sales agreements for with foreign pharmaceutical companies last year. All three items are known to have a prior history with Chong Kun Dang. According to industry sources on the 11th, Chong Kun Dang has been receiving insurance reimbursement for the tranquilizer drug ‘Valium 5mg Tab. (diazepam)’ starting this month. The approval and reimbursement rights for the drug had previously been owned by Roche Korea. However, after the global commercial rights of the drug were transferred from Roche to Pharmanovia, Chong Kun Dang signed an exclusive sales agreement for Valium in Korea with Pharmanovia in August last year. Under the agreement, Chong Kun Dang transferred and acquired the license for Valium Tab. 5mg in Korea, and the reimbursement entity was also changed accordingly. The sales right for the epilepsy treatment Rivotril (clonazepam) in Korea, whose license was also held by Roche Korea, had also been transferred to Chong Kun Dang through a transfer and acquisition process prior to Valium. Accordingly, Rivotril’s reimbursement entity was switched from Roche Korea to Chong Kun Dang in March this year. , whose sales rights was transferred from Roche Korea to Chong Kun Dang In March last year, Chong Kun Dang acquired the exclusive domestic sales right for Rivotril from Cheplapharm, which owns the global commercial rights to Rivotril. Cheplapharm had purchased the global commercial rights for Rivotril from Roche. Both of the drugs had previously been sold by Chong Kun Dang under a joint sales agreement with Roche Korea. Therefore, the interpretation is that the company acquired the exclusive domestic sales right of the two drugs to sell in its pre-established sales networks. In June, the company also completed the transfer and acquisition of the domestic sales right for the anticancer drug ‘Leustatin Inj. (cladribine) ' which had been previously owned by Janssen Korea. Its global commercial rights are also owned by Pharmanovia, and an exclusive domestic sales agreement had been signed for the drug in October last year. This is not the first time Chong Kun Dang had signed exclusive domestic sales agreements with new owners of drugs after the transfer of global commercial rights. The company had previously signed an exclusive sales agreement and acquired the sales rights for the antihypertensive drug ‘Dilatrend’ and obesity treatment ‘Xenical' from Cheplapharm. Chong Kun Dang owns the license and right to reimbursement for the drugs in Korea.
- Policy
- Ceprotin, Takeda's rare dz, gives 11 yrs for reexamination
- by Lee, Hye-Kyung Aug 12, 2022 05:57am
- On the 2nd, Takeda's Ceprotin, which was first approved as a treatment for severe congenital protein C deficiency in Korea, was given an 11-year review period after marketing. Severe congenital protein C deficiency is a rare genetic disease that causes fatal defects in blood clot control due to a lack of protein C, a type of vitamin K-dependent anticoagulant, and is defined when protein C levels are less than 1% (less than 1 IU/dL), and the incidence rate is estimated to be 1 in 4 million newborns. Ceprotin is the first human protein C drug approved for patients with severe congenital C protein deficiency and was approved for "prevention and treatment of venous thrombosis and fulminant purple hemiplegia in patients with severe congenital protein C deficiency in children and adults." Prior to Ceprotin's approval, the Central Pharmaceutical Review Committee's Pharmaceutical Affairs Subcommittee-Rare Medicine Subcommittee discussed the validity of the re-examination period when licensing biopharmaceutical items. On this day, the committee members decided that it was appropriate to set a period under the Rare Disease Control Act in consideration of the prevalence rate as an item prescribed for rare diseases. It also said that 11 years of re-examination, including pediatric indicators, should be given to secure sufficient safety information. It is reasonable to grant a 10-year re-examination period, including a pediatric indication, and a 10-year re-examination period, which was consulted by the central pharmacy, considering the pharmacological law, the re-examination system, and the characteristics of rare diseases. "It is difficult to judge that there is no appropriate treatment for severe congenital protein C deficiency because there are standard treatments," a member said. "However, it is confirmed that there are limitations on standard treatments and risks to be applied to children." The opinion is that it is difficult to evaluate post-marketing safety due to a lack of patients by granting a 4-6 year review period for congenital genetic diseases, which have symptoms mainly in the early stages of newborns and have a very high mortality rate from complications. Considering the nature of special diseases and the characteristics of the domestic medical environment, a total of 11 years of re-examination period, including pediatric diseases, will be given.
- Company
- Verquvo for CHF, aims to enter insurance benefits
- by Eo, Yun-Ho Aug 11, 2022 06:03am
- Verquvo, a new drug for heart failure, aims to enter insurance benefits. dksl According to related industries, Bayer Korea has submitted an application for payment of Verquvo, a water-soluble guanylate cyclase (sGC) promoter that promotes the synthesis of intracellular cyclic Guanosine (cGMP). Verquvo was recently approved in December last year as a combination therapy to reduce the risk of death from cardiovascular disease and hospitalization due to heart failure in patients with symptomatic chronic heart failure, whose left ventricular ejection rate, which experienced intravenous diuretic administration, has decreased to less than 45%. Existing heart failure treatments have been a method of blocking harmful effects from the natural neurohormone system activated by myocardial and vascular dysfunction. Verquvo has a new mechanism to improve myocardial and vascular function by promoting the synthesis of intracellular cyclic monophosphate guanosine (cGMP), which regulates heart contraction, vascular tension, and heart remodeling with a water-soluble sGC stimulant. It was approved as the world's first-in-class chronic heart failure treatment as an sGC promoter. Verquvo demonstrated efficacy through phase 3 clinical VICTORIA The VICTORIA study was conducted in 5, 050 patients with high-risk heart failure with NYHA Class (Grades 2-4) and reduced left ventricular ejection rate to less than 45% who were hospitalized due to heart failure or experienced intravenous diuretic administration outpatient. 59.7% of the patients who participated in the study were undergoing three-drug therapy, and 41% of severely ill patients with NYHA grades 3 and 4. Patients were administered placebo or up to a target maintenance dose of Verquvo 10 mg in combination with other heart failure treatments. As a result, Verquvo had about 10% lower risk of first hospitalization due to cardiovascular disease death or heart failure during 10.8 months (median value) of follow-up, with an annual Absolute Risk Reduction of 4.2%, meeting the primary evaluation variable. The annual absolute risk reduction rate of hospitalization due to heart failure was 3.2%, and as a result of comprehensive evaluation of hospitalization due to death from all causes or heart failure, Verquvo group showed a 10% risk reduction compared to the placebo group. Heart failure is a disease that appears as a final complication of various cardiovascular diseases such as coronary artery disease and high blood pressure without delivering as much oxygen as necessary to the peripheral organs due to structural or functional abnormalities of the heart. Heart failure is a major cause of hospitalization for patients aged 65 or older, and the prevalence of heart failure in Korea has been steadily increasing over the past decade as the population ages. Heart failure is at high risk of worsening over time, and about 50% of patients diagnosed with heart failure have a low survival rate, with death within five years.
- Policy
- Gov is reluctant to demand that infants be exempted from PE
- by Lee, Jeong-Hwan Aug 11, 2022 06:03am
- The government expressed reluctance to apply PE omission to rare drugs for infants, children, and adolescents. They say that it is a matter to be carefully considered in consideration of other drugs. On the 10th, the MOHW responded to a written question by Choi Hye-young of the Democratic Party of Korea, a member of the National Assembly's Health and Welfare Committee. Choi asked if there is a plan to expand rare drugs for infants, children, and adolescents to PE omission even if they are not treated for rare diseases. The Ministry of Health and Welfare expressed its position that it is difficult to exempt PE from rare drugs for infants, children, and adolescents, along with fundamental answers, such as explaining the criteria for omission of PE data. The Ministry of Health and Welfare said, "The submission of PE data can be omitted for rare drugs used for diseases that threaten survival as alternative or therapeutic drugs or anticancer drugs without treatments." The Ministry of Health and Welfare explained, "In addition, the process of revising the regulations of the Korea Appraisal Board, which includes drugs that improve the quality of life of children with anticancer drugs or rare disease treatments, is in progress. In addition, the expansion of rare drugs for infants, children, and adolescents to PE omission is a matter to be carefully considered in consideration of other drugs and equity."
- Policy
- Reyvow, a migraine drug aimed at clinicians
- by Lee, Tak-Sun Aug 11, 2022 06:03am
- Ildong Pharmaceutical, which is seeking to introduce the new migraine drug Reyvow in Korea, has decided not to accept the upper limit offered by the Pharmaceutical Benefit Evaluation Committee of the Health Insurance Review and Assessment Service. The measure was decided in consultation with Lilly, who holds the global copyright of the drug, and they say they will continue to make efforts to register their salaries. On the 7th of last month, the Pharmaceutical Benefit Evaluation Committee of the HIRA Committee reviewed Ildong Pharmaceutical's acute migraine treatment Reyvow 50mg and Reyvow100mg and judged that the benefit was appropriate if it was accepted below the evaluation amount. If Ildong Pharmaceutical accepted less than the evaluation amount, there was a possibility of benefit registration. However, it is said that the amount was not acceptable for pharmaceutical companies. The committee presented a weighted average price of existing treatments, including Tryptan-based drugs, which differed greatly from the price desired by pharmaceutical companies as the prices of existing drugs fell significantly due to the expiration of patents. Reyvow has attracted attention as an expected replacement for Tryptan-based drugs, which are most commonly used to treat migraine headaches. This drug targets serotonin (5-HT) 1F receptors like conventional Tryptane drugs, but it has the advantage of not having cardiovascular side effects by acting selectively. Tryptane-based drugs were limited in their use because they contract blood vessels on the mechanism and cause cardiovascular diseases such as myocardial infarction and stroke. An industry official said, "We needed a migraine treatment that can be used comfortably in clinics because existing drugs have side effects risks," adding, "Reyvow is an oral drug and has a low risk of side effects, so we expected Reyvow to be reimbursed." All procedures were suspended as everyone did not accept the price offered by the HIRA. However, they say they will continue to push for efforts to register benefits in the future. It is known that products will be released in the second half of this year. Reyvow, which was approved by the U.S. FDA in 2019, is a drug that Ildong Pharmaceutical has secured copyrights in eight Asian countries, including domestic sales licenses, in partnership with its developer CoLucid in 2013. When Lilly acquired CoLucid in 2017, the drug's global copyright was also transferred to Lilly. All of them accelerated the introduction of Bridging Study in Korea. Meanwhile, Lilly Emgality and Teva's Ajovy, which are new drugs for the same migraine, are also seeking to register their salaries. In particular, Emgality has completed negotiations with the NHIS and is expected to be listed soon. However, the both are injection typed medication and expensive, so it is not expected to be prescribed much in clinics.
- Policy
- "May bring 60M courses of Omicron-adapted COVID-19 vaccines"
- by Lee, Jeong-Hwan Aug 11, 2022 06:03am
- The disease control authorities announced that they may introduce the adapted, so-called ‘Omicron-specific COVID-19 vaccines’ as newly introduced amounts if the vaccines receive marketing authorization. In other words, if Moderna’s ‘Moderna Spikevax-2 inj.’ and Pfizer’s ‘Comirnaty-2 inj.’ that are being reviewed by the Ministry of Food and Drug Safety are approved, the authorities will bring in these vaccines as newly procured vaccines. On the 9th, the Korea Disease Control and Prevention Agency responded so to a written QA on pending issues related to COVID-19 that was submitted by members of the National Assembly’s Health and Welfare Committee. Adapted vaccines refer to multivalent mRNA vaccines that express antigens for both the original COVID-19 virus (Wuhan strain) and its variant virus (Omicron strain, BA.1) that was developed as a booster vaccine after receiving primary vaccination to be administered in the endemic stage. Moderna Spikevax-2 inj. and Comirnaty-2 inj. are both under review by the MFDS for approval. The KDCA explained that the purchase agreement made with Moderna and Pfizer in 2022 contains the supply of adapted vaccines. If approved, the 60 million courses of vaccines set to be introduced to Korea may all be adapted vaccines. To the question of when the adapted vaccines will be administered, the KDCA said the specific date will be announced at the end of the month after a comprehensive review of the vaccine’s efficacy, development progress, and introduction situation. However, the specific strategies such as vaccination subjects, period, and method would need to be determined based on the variant in circulation at the time of vaccination and the effect of the adapted vaccine against that variant. The KDCA added that it will continue to monitor the development of adapted vaccines in Korea and abroad and cooperate with the MFDS for the prompt introduction of adapted vaccines. Meanwhile, the U.S. companies Pfizer and Moderna are currently developing adapted vaccines that include recently circulating variants. Pfizer is yet to apply for the approval of its vaccine in Korea, and Moderna has completed submitting its application for approval on the 29th of last month.
