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- 2025-12-23 20:03:22
- Policy
- Improvements to exempted calculation of psoriasis are urged
- by Kim, Jung-Ju Jun 07, 2021 06:05am
- #iThe registration for exempted calculation of severe psoriasis is just a year away. Patients have pointed out the difficulties and problems of the system. The point is that there are many unequal and unreasonable conditions, so the system should be improved to ensure quality before re-registration. The Korea Organization For Patient Group issued a press release today (3rd) calling for new and re-registration of special cases for severe psoriasis and improvement of the system. Psoriasis has been included in this list since June 2017. However, the government is applying exempted calculation only for "severe injuries" rather than all psoriasis. At the time, the NHIS estimated that out of a total of 1.5 million psoriasis patients, about 22,000 had severe psoriasis. Four years after the application of the special calculation case, only about 4,500 patients have been registered, and patient groups have called for improvement. The Korea Organization For Patient Group pointed out that compared to other immune diseases such as spondylarthritis ankylopoietica, Crohn's disease, and rheumatoid arthritis, the new registration period and baseline conditions for severe psoriasis are strict, which is equivalent to about 17,500 severe psoriasis patients. They also pointed out, "The fact that the existing treatment, which has been effective in treatment at the time of the five-year re-registration standard for calculation, has been set as a condition for re-registration adds to the difficult situation of psoriasis patients." This organization urged to apply the same special system for exempted calculation of severe psoriasis as ▲spondylarthritis ankylopoietica, Crohn's disease, and rheumatoid arthritis, and,▲it also urged the withdrawal of unreasonable criteria for discontinuing drugs under treatment when re-registration of special cases of calculation after 5 years. The Korea Organization For Patient Group emphasized, "These standard issues have lost equity compared to other diseases, and the pain and difficult situation of patients with severe psoriasis have not been properly identified, so they must be withdrawn."
- Policy
- NA prepares bill to prevent 'price cut lawsuit' gimmicks
- by Lee, Jeong-Hwan Jun 04, 2021 06:06am
- A bill to prevent pharmaceutical companies from filing administrative suits for the purpose of evading or delaying drug price cut dispositions made by the government is expected to be introduced at the National Assembly. The bill will prevent the recurrence of cases similar to the suspended execution of drug price cuts ruling for the brain function enhancer choline alfoscerate, which has been a hot issue since last year’s NA audit. An official from Woni Kim’s office of the NA Health and Welfare Committee explained, “The avoidance of drug price cuts and reimbursement suspensions by companies is an issue that every Health and Welfare Committee member should pay attention to. We are preparing to amend relevant laws.” Woni Kim’s office is not the only place preparing a bill. The bill will aim to recover the reimbursed benefits paid to drugs during the period that the price cuts were avoided using the suspension of execution when the pharmaceutical company that filed the administrative lawsuit in objection to the government’s price cut disposition loses the suit. The key is to impose a penalty and exercise the right to indemnity when a pharmaceutical company deliberately pursues a lawsuit to cancel or delay the government’s justifiable drug price cut disposition. Of course, the bill will also include a provision that compensates for the damage suffered by pharmaceutical companies during the litigation period if the government's unjustifiable drug price cut is proven in court after a pharmaceutical company wins the lawsuit. Also, retroactive application of the bill is also being reviewed in consideration of the fact that many drugs including choline alfoscerate are in litigation to cancel their price cuts. The issue of health insurance finances wasted due to objections to price cut dispositions has been an agenda discussed for many years including at last year’s audit. At the NA audit last year, NA Health and Welfare Committee members Insoon Nam and Jaekeun In of the Democratic Party of Korea had appealed the need to amend the laws, criticizing the cancelation and injunction suit filed by choline alfoscerate makers whose reimbursement reduction and price cuts were set. They pointed out that the administrative suits or suspension of execution filed for the drug price adjustment disposition are being used as a means to preserve or make profit for pharmaceutical companies, or that it is causing unreasonable loss of health insurance finances. In had said that an estimate of 150 billion won of health insurance finances was lost in three years from 2018 to 2020 due to the abuse of drug price reduction cancellation lawsuits by pharmaceutical companies. An official from a member’s office of the NA Health and Welfare Committee said, “Several ruling party members in the committee agree to the validity of such a bill and are coordinating the bill with the Ministry of Health and Welfare. Legislation of this bill requires careful examination in retrospective application, enforcement date, and the supplementary provisions, as the issue on choline alfoscerate is still ongoing.” The official added, “Some have criticized that the drug price reduction cancellation lawsuit and injunctions are being abused as marketing tools by pharmaceutical companies to minimize damage from such price reductions. The Ministry of Health and Welfare and the National Health Insurance Service also agree on the need for the bill, so we expect that a bill will be proposed soon.”
- Policy
- Humira's price cut 30% due to Adalloce Prefilled Pen listing
- by Kim, Jung-Ju Jun 04, 2021 06:06am
- Abbvie Korea’s lead product line Humira is facing an insurance price cut of 30%. This ex officio adjustment by the government is to be made due to the introduction of the two biosimilars earlier this year by Samsung Bioepis, including its Adalloce prefilled pen inj.. The Ministry of Health and Welfare (MOHW) is preparing to amend the 'drug benefit list and price ceiling schedule' to include such adjustments. Once the amendment is finalized, it will take effect from the 7th of this month. Humira is a biologic product approved for rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis, and Crohn’s disease, etc. Humira is facing price adjustments in Korea as Samsung Bioepis' biosimilar of this product, Adalloce Prefilled Syringe inj. 40mg and Adalloce Prefilled Pen inj. 40mg were listed in February. Under the Criteria for Decision or Adjustment on Drugs, the government may reduce the ceiling price of first-listed products, products with the same route of administration/ingredient/formulation, and those in the same class for mixed nutrient solutions to 53.55% of the original price when another company lists a drug with the same route of administration/ingredient/formulation. For narcotics and biologics, the price is adjusted to a 70% level. The MOHW ordered negotiations for Humira, under which the National Health Insurance Service (NHIS) and Abbvie Korea held negotiations from the 11th to 18th last month. However, the terms were not introduced or deliberated by the Health Insurance Policy Deliberation Committee as it missed the deliberation period. The price cuts will be at around 30% for each product in the Humira line. The MOHW is expected to make the final decision soon as the authorities believe that the price cuts are necessary for saving health insurance finances.
- Policy
- Suspension extended due to prolonged lawsuit of Betmiga
- by Kim, Jung-Ju Jun 03, 2021 06:12am
- The price will be temporarily extended again as Astellas Korea, which had been expected to plunge last year due to the government's adjustment to insurance prices, has prolonged its refusal to lower the price of Betmiga PR. The 14th administration of the Seoul Administrative Court has decided to extend the suspension until the 30th day of the ruling on Betmiga PR-related litigation among the "pharmaceutical reimbursed list and upper limit price table" announced by the MOHW on June 23 last year. Suspension means suspending the government's price reduction measures until the lawsuit is closed. Last year, the MOHW included the drug in the list of items that cut the government's authority adjustment, signaling a sharp decline. The government is lowering the upper limit of the first registered generic and products with the same administration path, ingredient, and formulation. Originally, the price would have been lowered due to the adjustment of authority on July 1 last year. According to the suspension, the price will be temporarily maintained at ₩673 per Betmiga PR 50mg and ₩449 per Betmiga PR 25mg. The MOHW will further guide if there is any change later.
- Policy
- Bill to strengthen fines on rebates pass NA plenary session
- by Lee, Jeong-Hwan Jun 03, 2021 06:11am
- A bill to increase the upper limit of the penalty surcharge imposed on drugs caught doing illegal rebates, and allowing the use of the surcharge as a resource for catastrophic health projects passed the plenary session of the National Assembly on the 21st. In the session, the NA passed the bill for the partial amendment of the National Health Insurance Act that was proposed by Yongho Lee as the representative, and the altered bill for the partial amendment to the Catastrophic Health Expenditure Support Act that was submitted as an alternative by the Legislation and Judiciary Committee. Thus, following the government’s promulgation of the laws, the upper limit of the penalty surcharge imposed with the administrative disposition of a ‘reimbursement suspension’ on drugs that have paid illegal rebates will be raised. At the same time, the surcharge can be used for catastrophic health expenditure support projects. The amendment of the National Health Insurance Act that passed the plenary session allows companies to substitute the administrative ‘reimbursement suspension’ disposition to a penalty surcharge. Also, the amendment specified the reasons for substituting the disposition with a penalty surcharge and significantly increased the upper limit of the surcharge compared to before. Under the amended Act, drugs that paid illegal rebates may substitute its suspension disposition with a penalty surcharge up to 200% of the total medical care benefit paid for the drug in cases when the suspension ‘is expected to interfere with public welfare by causing inconvenience in patient care, etc.’ When the surcharge is imposed again for the same drug for rebates within 5 years, the upper limit is increased up to 350%. For the standard that had already existed - ‘special cases when the disposition is expected to cause a serious risk to public health' - the penalty surcharge was set up to 60% of the total medical care benefit paid for the drug. For repeated cases within 5 years, the upper limit is raised to 100%. The amendment to the National Health Insurance Act that passed the plenary session will take effect 6 months after the government’s promulgation. The amendment to the penalty surcharge will start to be applied to rebate cases that were found after the Act goes into effect.
- Policy
- The new rheumatoid oral drug Smyraf was revoked after a year
- by Lee, Tak-Sun Jun 02, 2021 06:10am
- Astellas' Smyraf, which has drawn attention as a treatment for rheumatoid arthritis, withdrew the license in a year. Smyraf is the third domestically licensed inhibitor of Januskinase (JAK) after Xeljanz (Tofacitinib, Pfizer) and Olumiant (Baricitinib, Lilly). However, it failed to complete the registration process and withdrew from the Korean market. The MFDS announced on the 31st that the permits of Smyraf 100mg and Smyraf 50mg from Astellas Korea have been revoked. Smyraf was licensed in January last year as a new drug for rheumatoid arthritis. In particular, although existing rheumatoid arthritis treatments had the disadvantage of injection type, this product was highly anticipated in that it could be taken oral. The oral JAK inhibitor was a third drug following Xeljanz and Olumiant. After the approval, it was reported that this product was negotiated with insurance authorities to register drug prices. JAK inhibitors have mechanisms that inhibit the Jak-STAT pathway involved in the production of cytokines that cause inflammation in the body. In particular, attention has been paid to whether Smyraf will be listed since the fourth JAK inhibitor "Rinvoq (Upadacitinib, AbbVie)" was released in November last year. However, there was no news of listing for Smyraf, and the withdrawal led to Smyraf leaving the Korean market. JAK inhibitors are steadily rising in the domestic market. In the case of Xeljanz, sales of prescription amount outside the market reached ₩12.6 billion last year. In this situation, the news of Smyraf's withdrawal is very disappointing.
- Policy
- Comparing Cellid with Janssen·AZ… SK Bio with Novavax
- by Lee, Tak-Sun Jun 01, 2021 06:11am
- With the Ministry of Food and Drug Safety announcing lowered standards for conducting Phase III clinical trials to promote the development of domestically developed COVID-19 vaccines, commercialization of Korean COVID-19 vaccines is likely to happen sooner than expected. In particular, domestic vaccines that were not able to enter the Phase III stage may be able to enter the market early by conducting comparative effectiveness clinical trials with previously approved products. On the 31st, the MFDS released the “Standard Draft for Covid-19 Vaccine Clinical Investigation Plans" on the 31st. In particular, the draft allows comparative clinical trials (phase 3) with previously approved vaccines. On the 31st, the MFDS released the “Standard Guideline for Covid-19 Vaccine Clinical Trial Plans.” In particular, the guideline allows comparative clinical trials (phase 3) with previously approved vaccines. Until now, clinical trials of COVID-19 vaccines had to demonstrate its efficacy compared to placebo. In the WHO guidelines, the efficacy of the investigational drug is compared with placebo in 150 subjects diagnosed with COVID-19. For example, if 15 out of the 150 patients received the investigational drug and the others received the placebo, the drug’s effect becomes 90%. AstraZeneca, Pfizer, Moderna, and Janssen’s vaccine were all approved through this method. However, issues that administering placebos to patients is ethically wrong as COVID-19 vaccines that are already commercialized do exist, and that an excessive amount of time and money is spent on the developer’s part when conducting placebo studies have been raised. According to MFDS, to conduct a Phase III trial in a country with a COVID-19 incidence rate of 0.4%~1.2%, a minimum of 20,372 to a maximum of 60,112 subjects is needed. However, the guideline presented by MFDS for comparative effectiveness clinical trials only requires an administration record for a minimum of 4,000 subjects. The comparative clinical trial would need to demonstrate that the vaccine is non-inferior or superior to the comparator drug (commercialized drug) at week 4 after vaccination through comparison of their neutralizing antibodies. However, for the safety review, at least 4,000 subjects (≥3,000 in the test group, 1,000≥ in the control group) will need to be enrolled in the trial. MFDS announced that by cohort, approximately 20% of the subjects should be 65 years or older and that over 5,000 participants should initially register for the trial in consideration of the 20% dropout rate. The comparator vaccine should be an item approved in Korea and be produced using the same platform. Currently, 5 domestic pharmaceutical companies have been conducting clinical trials on domestic COVID-19 vaccines. Cellid’s vaccine is being developed using a viral vector platform, SK Biosceincec and EuBiologics are basing their vaccine on a recombinant vaccine platform, and Genexine and GeneOne Life Science are using a DNA vaccine platform to develop the vaccines. The companies have not completed their Phase II trials yet. To be approved to progress to Phase III trials, the companies would need to first submit the results of their Phase II trial and be verified on the dosage and regimen. Under the new guidelines, by platform, Cellid will be able to conduct a comparative effectiveness clinical trial with Janssens or AZ’s vaccine. SK Bioscience and EuBiologics will be able to conduct the trial with Novavx’s vaccine. However, as only items that are approved in Korea may be used as comparators, the Novavax vaccine, which has not been approved in Korea yet, would not be immediately available for use as a comparator. Genexine’s DNA vaccine will not be eligible for the comparative effectiveness clinical trial as there is no DNA platform vaccine currently approved in the world. Therefore, Genexine would need to conduct its Phase III trial in the traditional way. Genexine plans to conduct its Phase III trial in Indonesia and other countries. The comparative effectiveness clinical trials may be conducted in a multinational manner. However, the proportion of domestic subjects must exceed 10%. An MFDS official said, “the long-term safety and immunogenicity data of vaccines are analyzed even after approval. Products approved by MFDS may be used for inoculation purposes in Korea.”
- Policy
- Objections to post-marketing premium reevaluation submitted
- by Lee, Hye-Kyung May 31, 2021 06:02am
- The Health Insurance Review & Assessment Service’s reevaluations of premiums applied to listed drugs are being finalized. On the 28th, HIRA held a post-marketing drug management subcommittee meeting to finalize its decision on the items for which the premiums would be terminated (products for price ceiling recalculation) according to the reorganized drug premium pricing system. 가산재평가 기준 The subcommittee meeting was held to review items that companies submitted objections to, among candidates for reevaluation that was first selected at the Drug Reimbursement Evaluation Committee’s meeting on April 8th. The specific number of items that would undergo re-evaluation will be disclosed after the DREC meeting on the 3rd of next month. HIRA had announced that companies submitted objections to 180 items among the 500 that were first selected during the submission period. After the next DREC meeting, the National Health Insurance Service will conduct a drug pricing negotiation for 60 days under the order of the Minister of Health and Welfare, then implement the notice around August or September after passing the Health Insurance Policy Deliberative Committee meeting. The premium re-evaluation was modified according to the ‘Rules on Criteria for Medical Care Benefits of the National Health Insurance’ and ‘Standards for Decisions and Adjustments for Drugs' that were announced by the Ministry of Food and Drug Safety on November 9th of last year. The rules were modified so that premiums applied to drugs that fall under the following criteria may be terminated after deliberation by DREC: ▲ a biologic that had been applied a premium for 1-2 years that is being manufactured by 4 or more companies; ▲when the premium was applied for 3-5 years; and ▲When the premium was applied for over 5 years HIRA has been receiving data submissions from pharmaceutical companies since January this year to finalize the items subject to reevaluation. In the process, premiums for drugs that had been applied for over 5 years were terminated. For drugs that were applied premiums over 3 years but less than 5 years, the authorities decided to maintain the premium if the drug satisfied at least one of the following criteria: ▲the non-existence of alternative drugs ▲clinical necessity ▲superiority in additional costs incurred ▲listing status of same ingredient drugs ▲IMD (Incrementally modified drug)
- Policy
- Leukemia treatment ‘Venclexta’ to be reimbursed
- by Lee, Hye-Kyung May 31, 2021 06:02am
- ‘Venclexta (venetoclax)’ in combination with ‘MabThera (rituximab)’ will be reimbursed as second-line treatment for patients with chronic lymphocytic leukemia. The Health Insurance Review and Assessment Service (HIRA) has been conducting an opinion inquiry on its proposed revision of the ‘Notices required according to drugs prescribed and administered to cancer patients.’ If no objections are raised during this period, the revision will be applied and enforced from June 7th. Venclexta was approved in combination with rituximab for ‘adult patients with chronic lymphocytic leukemia (CLL) who had at least one prior treatment.’ HIRA reviewed the reimbursement expansion based on information from textbooks, guidelines, and clinical papers. As a result, the combination’s clinical efficacy was demonstrated in the randomly assigned, open-label, Phase III MURANO trial through progression-free survival (PFS), etc., in adult patients with relapsed or refractory chronic lymphocytic leukemia. In addition, the interval required for response evaluation of Afinitor (everolimus), a treatment for central nervous system cancer, was extended. Under general principles, the response of patients with solid cancers and malignant lymphoma should be evaluated every 2-3 cycles or 2-3 months. However, a request had been filed to extend the evaluation interval for Afinitor in tuberous sclerosis complex (TSC) patients who are in need of therapeutic interventions but have a brain tumor called subependymal giant cell astrocytoma (SEGA), in which the tumor cannot be removed completely by surgery. HIRA's textbook review showed that the interval should be 3-6 months for the first 3-5 years, followed by at least once a year. The U.K. guidelines also recommend patients to check responses in 1-3 years if they are asymptomatic, and more frequently so if they have symptoms. Considering the evidence that shows that the imaging tests may be conducted in an interval of 1 year at maximum, HIRA decided to recognize the 3 to 12 month interval as the response evaluation interval for Afinitor depending on the patient's condition.
- Policy
- It's necessary to go through the social consensus
- by Lee, Jeong-Hwan May 28, 2021 06:08am
- It is argued that conflicts between doctors and pharmacists were not be resolved despite government intervention in order to legislate for the activation of the generic substitution, and that they should go through the social consensus process that took place at the time of the separation of prescribing and dispensing. They say that citizens, doctors, pharmacists, and the government should come up with an agreement together because they are divided between doctors and pharmacists and repeatedly make unyielding claims. In particular, the formation of a social consensus is inevitable because the issue of "prescribing active ingredient" is in conflict with the revitalization bill of the generic substitution. The MOHW held a meeting of the KMA, the KHA and the Korean Pharmaceutical Association on the 26th, but failed to agree. Eventually, the first subcommittee of the National Assembly's Health and Welfare Committee reviewed the agenda for revitalizing the generic substitution, which broke down the agreement between doctors and pharmacists. Therefore, the National Assembly reviewed legislation to activate the generic substitution. In 1999, the KMA and the Korean Pharmaceutical Association agreed on a generic substitution and the same level of social consensus that the agreement council had worked on in order to implement the separation of prescribing and dispensing. Furthermore, the bill, which changes the name of the system from generic substitution to "same active patient dispensing" and extends pharmacists from doctors to the HIRA's DUR system, suggests that there is a serious conflict between the division of prescribing and dispensing. It is unreasonable for doctors and pharmacists to simply try to resolve the same active dispensing, separation of prescribing and dispensing bill, which affects social consensus, with parliamentary legislation. "From a doctor's point of view, changing a generic substitution to a same active ingredient dispensing is perceived as generic prescribing. In particular, the generic substitution is a system that is deeply related to the separation of prescribing and dispensing. "If the bill is passed right now, it will be a problem. "How many doctors will agree to the bill that the National Assembly or the government hastily decided without an agreement?" "The general substitution issue is not a matter that can be proposed by a member of Parliament from a pharmacist and decided unilaterally by the National Assembly. "We need to discuss more issues that have differences of opinion between professions." Professor Lee Jae-hyun of Sungkyunkwan University of Medicine said, "The perspective of the generic substitution depends on whether it is a job problem between doctors and pharmacists or a drug inventory problem at pharmacies.If looking at as a matter of doctors and pharmacists to operate a a social consensus on the impossibly difficult. Regardless of the generic substitution, doctors and pharmacists had different opinions," he said, adding, "In terms of pharmacy drug inventory, we can find common ground." The arrangement of a list of local prescriptions was agreed upon at the time of the separation of prescribing and dispensing. "It depends on which issue we focus on." An official from the Korean Pharmaceutical Association said, "The idea of a generic substitution as an active ingredient prescribing is too contradictory. "The goal of the bill is to secure the finances of health insurance and promote national benefits by increasing the use of drugs already licensed through biological equivalence tests," he said. "The general substitution sub-consultation ended without reaching an agreement, and theMOHW plans to report the details to the National Assembly." "It is not a matter of conflict between professional organizations, but a policy that the government should decide for the sake of the people." The official said, "The Ministry of Health and Welfare agreed to a clause that would expand the scope of post-notification. "It is time for the National Assembly to pass even a partial passage of the extension of post-notification clause," he said. "I think the Korean Pharmaceutical Association should join the discussion in that the formation of a social consensus is a division of preservation and dispensing revaluation." But it's going to take too long.
