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- 2025-12-20 20:11:45
- Policy
- Eye drops late to submit test results pass reivew
- by Lee, Hye-Kyung Apr 04, 2024 05:59am
- Amid the ongoing equivalence reevaluations being conducted on eye drops, products that received dispositions for failing to submit equivalence data in time received a final compliant decision. The Ministry of Food and Drug Safety (MFDS) released the results of the ‘2022 drug equivalence reevaluation’ that contained such results on the 3rd. The third list included 4 suspension eye drops, and Daewoo Pharm, which was in charge of the consignment manufacture of the drugs, received a ‘compliant’ judgment, and the other consigned items were also judged compliant and approved. More specifically, the items approved this time are Daewoo Pharm’s ‘Tobeson Eye Drops (exported as Philtobeson Eye Drop, Dextear Eye Drop),’ Hwail Pharm’s ‘Vitodex Eye Drops (exported as Videto Eye Drop, Tosibiam Eye Drop),’ LitePharmTech’s ‘Litetodex Eye Drops),’ and ARI Pharma’s ‘Tobadexa Eye Drops.’ In particular, Daewoo Pharm was suspended from selling Tobeson Eye Drops until April 11 this year for a second violation of failing to submit equivalence reevaluation data in September last year. Results of the 2022 drug equivalence reevaluation results (3rd) Due to delays in completing equivalence reevaluations by their CDMO, Hwail Pharm, LitePharmTech, and ARI Pharma also received sales suspensions last year. On the other hand, the reason why the MFDS’s 2022 equivalence reevaluation results came out 2 years later is because the government granted additional time due to the need to prepare a test method that can accommodate the characteristics of suspension eye drops. The second reevaluation results of the eye drops were released in January, and at the time, only 16 out of 30 products that were reevaluated were deemed suitable. Following the Ministry of Food and Drug Safety’s revision of the 'Rules on the Safety of Pharmaceutical Products, etc,’ and the expansion of the dosage forms subject to submission of equivalence data, the MFDS reevaluated powders and granules in 2021, and eye drops, ear drops, inhalants applied to the lungs, and external preparations in 2022. Items that receive reevaluation notifications will be subject to administrative dispositions such as the first (2-month suspension of sales), second (6-month suspension of sales), and third (revocation of marketing authorization) dispositions if the data is not submitted within the deadline. Also, if the test results do not prove equivalence, the product will be suspended and recalled. This year, 460 tablets (film-coated tablets, etc.) are being reevaluated for equivalence, and next year, oral preparations such as capsules and syrups will be re-evaluated.
- Policy
- K-CAB is in talks to extend refund-type PVA
- by Lee, Tak-Sun Apr 04, 2024 05:59am
- HK inno.N HK inno.N is in talks with the National Health Insurance Service (NHIS) to extend the refund-type price-volume agreement (PVA) for K-CAB (tegoprazan), a drug developed in Korea for gastroesophageal reflux disease. K-CAB is the only drug under the refund-type price-volume agreement (PVA). Since its release in 2019, K-CAB’s claim amount has been on the rise, so the contract extension is highly probable. According to industry sources on April 3, HK inno.N is discussing with the NHIS to extend the refund-type price-volume agreement (PVA) for K-CAB. In 2021, HK inno.N secured the the refund-type price-volume agreement (PVA) for K-CAB with the NHIS. Under the price-volume agreement (PVA) system, a decrease in drug prices can be avoided with the contract. Instead of decreasing a drug price, the pharmaceutical company refunds the portion of the drug’s price to the NHIS. Drugs should meet the standards set by the Health Insurance Review and Assessment Service (HIRA) for impacting healthcare and being developed by innovative pharmaceutical companies to be eligible for the contract. Currently, K-CAB is the only drug under the contract. With the successful extension of the contract, K-CAB will be under the refund-type contract for the next three years. After the initial refund contract, K-CAB was negotiated two times for a price-volume agreement (PVA). Under the refund contract, K-CAB tab 50 mg is set as the initial upper limit price of KRW 1,300 per tablet since its first listing in 2019. The K-CAB products are now three, with K-Cab ODT 50 mg (KRW 1,300 per tablet) listed in May 2022 and K-CAB tab 25 mg listed last January. The products under the price-volume agreement (PVA) are K-CAB tab 50 mg and K-CAB tab 25 mg. According to the last year’s UBIST report, K-CAB’s outpatient prescription amount totaled KRW 158.2 billion, up 20% from KRW 132.1 billion of the previous year. Although K-CAB generic developments are underway, there is still considerable time before any mandatory reduction in the upper limit price due to the entry of subsequent competitors because its patent expires on August 25, 2031.
- Policy
- Novartis’ 'Ilaris' will be reconsidered for the DREC review
- by Lee, Tak-Sun Apr 03, 2024 05:50am
- Novartis The rare disease drug 'Ilaris Injection (canakinumab, Novartis Korea)' will be reconsidered for review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) after two months. Ilaris is a drug used to treat a rare disease called 'periodic fever syndromes (PFS)' for which there are ten patients in South Korea. The drug received domestic approval in August 2018 but has not cleared the reimbursement hurdle. According to industry sources on the 2nd, Ilrais is anticipated to be reconsidered for review by the DREC, which is scheduled for April 4th. According to industry sources on the 2nd, Ilaris will be reconsidered for review by the DREC. In the DREC held in February, the drug was recognized for appropriateness of reimbursement under the condition of submitting additional documents. The DREC decided Ilaris has reimbursement appropriateness for indications in ▲Cryopyrin-Associated Periodic Syndromes (CAPS) ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) ▲Familial Mediterranean Fever (FMF) ▲Active Systemic Juvenile Idiopathic Arthritis (SJIA). However, the DREC required the submission of CAPS, TRAPS, and FMF documents. Yet, Novartis failed to submit related documents within the deadline, so the decision on the appropriateness of reimbursement was postponed. Novartis has requested reevaluation and will be reviewed by the DREC again after two months. Ilaris is an IL-1 inhibitor recommended for the treatment of periodic fever syndromes (PFS) by international guidelines. It is the only drug to receive approval for this treatment from South Korea, the U.S. FDA, and the European EMA. With clinically proven treatment effectiveness and safety, Ilaris is covered by reimbursement in 30 countries. However, Ilaris faced challenges in acquiring reimbursement coverage in South Korea. Its attempts to secure reimbursement were unsuccessful in 2017 and 2022. Now, Ilrais is being considered for the third time. Patients strongly demand reimbursement coverage for the drug, which is highly priced at KRW 20 million per administration. The patients’ families have posted a petition for Ilaris reimbursement listing on the government’s online petition website called, Cheongwon24. Attention is focused on whether the drug will receive the reimbursement appropriateness decision from this DREC review and proceed to the drug price negotiations with the National Health Insurance Service (NHIS). If negotiations for drug pricing succeed, Ilaris will be covered by reimbursement.
- Policy
- 3 more successful Zolgensma treatment cases reported…
- by Lee, Tak-Sun Apr 02, 2024 05:54am
- Zolgensma, a one-shot treatment for spinal muscular atrophy (SMA), is demonstrating a high effect post-reimbursement. The government has been conducting a post-marketing performance evaluation on the drug since its reimbursement in August 2022, and so far, there has been only 1 case of failure reported after its use. The drug costs about KRW 2 billion per dose off-label, but the patient's out-of-pocket cost for the single dose has been lowered to a maximum of KRW 5.98 million (applied the 10% co-payment rate) with insurance reimbursement. According to the performance evaluation results on Zolgensma Inj that were released by the Health Insurance Review and Assessment Service on Sept. 29, all the 3 patient cases reported showed significant improvement. A 20-month-old boy, a 2-month-old girl, and a 2-month-old boy who received treatment with Zolgensma all showed an increase in motor function test scores. As a result, HIRA concluded that a significant improvement occurred after the drug’s administration. Patients who receive Zolgensma are required to be clinically evaluated before administration and every 6 months thereafter for up to 5 years. Objective data such as medical records on the patient need to be submitted to HIRA for clinical evaluations. Failure is defined as a) use of permanent ventilation or death; b) when the CHOP-INTEND score does not improve by at least 4 points from the pre-dose baseline; or c) even if the improvement stated in b) is achieved, the CHOP-INTEND score decreases by at least 4 points or HFMSE decreases by at least 3 points in 2 consecutive response evaluations. However, there has only been 1 case of failure among the performance evaluations disclosed by HIRA so far. The single treatment failure case of a 2-year-old girl was released in the first evaluation data that was disclosed in June of last year. At the time, the patient had respiratory problems due to SMA and died of acute respiratory failure. Other than the single case, patients in all of the other presented outcomes have shown significant improvement. 19 of the 20 cases in the 4 published reports to date have shown meaningful improvement. Zolgensma is evaluated to be superior to its alternative – the intrathecal injection alternative Spinraza (nusinersen) - in terms of administration method, and superior in event-free survival and motor function achievement when indirectly compared to its alternative in patients with rapidly progressive SMY Type 1 patients. Despite its very high price of KRW 2 billion, the drug is proving to be effective, justifying its reimbursement coverage.
- Policy
- Oppo parties also promise 'drug price system reform'
- by Lee, Jeong-Hwan Apr 02, 2024 05:54am
- Following the ruling party’s pledge, the opposition parties also announced their general election pledges to promote Korea’s growth into a pharma-bio powerhouse, by investing in research and development (R&D) and preparing customized drug pricing systems for the global entry of Korea’s new drugs, heralding their intent to foster and develop Korea’s domestic industries. Both the ruling and opposition parties largely accepted most of the policy proposals submitted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, therefore, changes in the pharmaceutical and bio-regulatory administrations and drug pricing policies are expected after the 22nd general election. The following is a summary of the pharmaceutical and bio sector-related policy pledges made by the Democratic Party of Korea in its general election policy manifesto on the 29th. First, in response to KPBMA’s request for the government to strengthen Korea’s R&D environment to become a global key player, the DPK promised to expand national investment and lay the foundation for Korea’s rise into a pharmaceutical bio powerhouse. However, unlike the People Power Party, DPK’s vision is to create a national investment system linked to strengthening the social responsibility of pharmaceutical companies. The DPK also promised to establish a strategic R&D investment system and strengthen outcome-based support, and this is in line with the KPBMA’s request to expand government R&D investment and support the development of blockbuster new drugs. In particular, the DPK also promised to reform the drug pricing system suitable to new drugs seeking to enter the global market. They also pledged to establish a drug price compensation system connected to innovative pharmaceutical companies and their R&D investment rates. It is also expected to affect the drug pricing system for incrementally modified new drugs and generic drugs that serve as a cash cow for new drug development. To address the issue of drugs that have long-term unstable supply, the DPK pledged to establish a public pharmaceutical company and drug distribution corporation, and the opinion on the pledge remains controversial. Proponents argue that the policy would increase the level of state control over out-of-stock drugs, while opponents argue that it would be inefficient and impractical to establish a separate public pharmaceutical company instead of using existing pharmaceutical companies that own the infrastructure. The DPK plans to improve the supply stability of essential medicines and improve the production and investment environment by stockpiling and supporting the establishment of drug production facilities that manufacture essential medicines and drug shortage prevention drugs. The KPBMA called for the establishment of a national measure to realize self-sufficiency of drug substances, and the DPK pledged to expand incentives for drugs using domestic raw materials and support the development of technology for the localization and self-sufficiency of essential medicines and vaccines. Lastly, the DPK’s pledge to build a public big data platform for new drug development and support the utilization of AI is also regarded to be in the same line with the KPBMA’s policy proposal on fostering a digital innovation ecosystem for the pharmaceutical and bio-industry, including the utilization of advanced AI and big data.
- Policy
- Price reduction dilemma for 'Forxiga' set for withdrawal
- by Lee, Tak-Sun Apr 02, 2024 05:53am
- 'Forxiga tab (dapagliflozin, AstraZeneca),' a diabetes treatment that was announced to be withdrawn from the Korean market in the second quarter of this year, has failed to reach an agreement in the price-volume agreement (PVA). Initial negotiations fell apart, so the company is likely to attempt renegotiation. The company hopes to maintain a high drug price before withdrawing Forxiga from the Korean market because other countries reference drug pricing in Korea. According to the industry on the 1st, AstraZeneca Korea negotiated with the National Health Insurance Service (NHIS) for Forxiga’s price-volume agreement (PVA), but they failed to reach an agreement. As a result, AstraZeneca has requested renegotiation. When a pharmaceutical company requests renegotiation for a drug that has not met prior negotiations, it can seek approval for reimbursement by the Drug Reimbursement Evaluation Committee (DREC). Based on the DREC decision, the drug is excluded from subjecting to the reimbursement coverage, or the Ministry of Health and Welfare (MOHW) can mandate a renegotiation once. Forxiga is expected to be considered by the DREC review scheduled for the 4th. Depending on the DREC decision, it may either be excluded from reimbursement or start renegotiations with the NHIS. It seems highly probable that there will be a renegotiation. Forxiga’s upper limit price remained the same before generics entered the market. With generics entering the market last May, the price was expected to reduce by 30%. Due to the court’s suspension of execution, the Forxiga price is maintained at 734 won per tablet. The drug pricing reduction execution is suspended until June 30. It appears that the company may have objected to reducing drug prices through the PVA program. “As other countries reference drug prices in South Korea, it may be necessary to maintain high drug prices in South Korea to continue sales in other countries despite withdrawing from the Korean market,” the industry official explained. As Forxiga would be excluded from reimbursement coverage if an agreement for the upper limit price is not reached during the PVA renegotiation, it is to be watched what decision AstraZeneca makes. Depending on the outcome, Forxiga may be withdrawn in the first half of the year. Despite generics entering the market following the patent expiry of Forxiga last year, Forxiga has recorded an outpatient prescription amount of KRW 55.5 billion, according to UBIST. About 60 generic companies have introduced blockbuster drugs following Forxiga’s patent expiration last April. Affected by generic market entries, AstraZeneca Korea has decided to withdraw from the Korean market in the second half of the year.
- Policy
- K-drugs’ approval in the Philippines to be expedited
- by Lee, Tak-Sun Apr 01, 2024 05:29am
- The Philippine Food and Drug Administration (PH-FDA) has newly listed Korea’s Ministry of Food and Drug Safety as a Reference Drug Regulatory Agency, which is expected to shorten the approval process of domestic drugs that are exported to the Philippines. The MFDS announced that it has been listed as a Reference Drug Regulatory Agency by the PH-FDA on the 30th. The PH-FDA operates a Facilitated Review Pathway (FRP) system, which is a fast-track review pathway that allows rapid review and approval of new drugs and generic drugs already approved by regulator authorities listed as Reference Drug Regulatory Agencies. With the listing, the statutory review period of Korea’s drugs in the Philippines has been significantly reduced from 120-180 days to 30-45 days. The PH-FDA announced the amendment that includes the MFDS as a Reference Drug Regulatory Agency in February, and MFDS-approved drugs will be eligible for fast-track review as of March 30, when the amended regulation takes effect. An MFDS official said, "We expect the listing to further boost the export of Korea’s pharmaceuticals to the Philippines. The MFDS will continue to actively support the entry of our excellent food and drug products into the global market through regulatory diplomacy, including multifaceted cooperation with global regulatory authorities.
- Policy
- Prior approval not required for reimb of Strensiq in KOR
- by Lee, Tak-Sun Apr 01, 2024 05:29am
- Strensiq Inj (asfotase alfa, AstraZeneca), which was subject to prior review by the Health Insurance Review and Assessment Service since it was listed for reimbursement in June 2020, will be converted and be subject to post-review from next month. The drug is a long-term enzyme replacement therapy used to treat bone symptoms in patients with perinatal- and infantile-onset hypophosphatasia and was a drug that previously required prior review from HIRA before administration for coverage. However, starting this month, its reimbursed use will no longer require prior review, expanding access to treatment. HIRA has announced the revisions to the “Detailed Matters on the Procedures for Prior Review, etc” that contained the changes above. The revised standards will take effect as of April 1. According to the revisions, Strensiq Inj will be removed from the list of drugs that require prior review after 4 years upon revision of the reimbursement criteria. Until now, the drug was only approved reimbursement for cases that were pre-applied for and approved – for continued treatment, applications had to be submitted 3 months, 6 months after the start of treatment, then every 6 months thereafter. However, HIRA decided to improve the prior approval system at the end of last year, and HIRA’s Strensiq Inj Subcommittee decided to remove the prior review requirement for Strensiq earlier this year, in accordance with expert opinions. The prior authorization rate for Strensiq Inj has been high until now. Last year, Crysvita, a pediatric hypophosphatemia treatment, was also added to the prior review list. Meanwhile, Samsung Bioepis' Soliris biosimilar ‘Epysqli Inj’ was added to the reimbursement list, adding the Soliris biosimilar Epysqli to the prior authorization list. The indications that require prior authorization are paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The new indication Soliris acquired indication for – neuromyelitis optica spectrum disorder (NMOSD) – will not require prior authorization for reimbursement.
- Policy
- The NHI Trade Union says, 'NHIS should join the DREC'...
- by Lee, Tak-Sun Mar 29, 2024 05:53am
- Kim Cheoljung, the chairman of the National Health Insurance Trade Union. The National Health Insurance Trade Union has criticized the government’s ‘The Second Comprehensive Plan of National Health Insurance’ regarding measures to strengthen patients’ access to new drugs. The union argued that the government formulated the policy referencing the corporate civil complaint. And added, it would be more effective to include the National Health Insurance Service (NHIS) as part of the Drug Reimbursement Evaluation Committee (DREC). During a press conference at the NHIS headquarters on the 26th, Kim Cheoljung, the chairman of the National Health Insurance Trade Union, stated this. Kim maintained a critical standpoint when asked about the union’s stance on the details of the second comprehensive plan of National Health Insurance, which includes strengthening patients’ access to new drugs, reducing listing duration, and expediting the market entry of innovative medical instruments. “The union regards ‘expediting the market entry of innovative medical instruments’ and ‘expanding the scope of the waiver system for new medical technology’ as merely corporate civil complaints and not the interests of the health insurance,” Kim explained. According to the union, the government is pushing measures such as shortening the time it takes to list new drugs for health insurance from 330 days to 150 days via parallel processing of ‘approval-evaluation-negotiation,’ which is the process for drug reimbursement. Additional measures include a comprehensive review and evaluation system to expedite the market entry of innovative medical instruments and an expansion of the waiver system for new medical technology. “Terms like new drug accessibility, innovation, and new technology may sound nice, but the government must base its reimbursement decision on clinical effectiveness and cost-effectiveness, and not on implementing what corporates wish for their quick benefit,” Kim said. The alternative would be to include the NHIS in the DREC of the Health Insurance Review and Assessment Service (HIRA). “Recently, new high-priced drugs were primarily considered for health insurance reimbursement. However, allowing reimbursement of those drugs that have not been evaluated for safety and cost-effectiveness may lead to a waste of finances, along with putting citizens as subjects of clinical experiment,” Kim said. “The government has suggested processing reimbursement evaluation and drug pricing negotiations in parallel. But, our opinion is that including the NHIS in the HIRA's DREC can shorten the duration and reflect on the NHIS’ stance regarding the cost-effectiveness of finances.” The union has strongly criticized the Yoon Suk Yeol government’s retrogressive policy. The government did not release the National Health Insurance's annual insurance coverage cost to the public in 2022. The government is limiting itself as an enforcement agency. Rather than focusing on patient co-payment policy, such as strengthening cost coverage per income level, to aid citizens who cannot receive medical treatments because of the patient co-payment, The government is emphasizing the need for businesses to assist with catastrophic medical expenses, which can be perceived as a charity-like approach by the government. “As an insurer, the government must enforce a policy to strengthen cost coverage or a separate business focusing on public function,” Kim said. “Policies aimed at expanding health insurance big data sharing and legalizing non-face-to-face treatment can be characterized as privatization. In response to the policy of expanding health insurance big data sharing, the union will collaborate with civil society for an action. The union, along with the civil society, will boycott the NHIS’ meeting scheduled for the April 2,” Kim stressed. The union said it will pursue ‘non-reimbursed treatments and reimbursed treatments should not be administered during a single visit’ to prevent national insurance loss. "Every year, the burden of health insurance costs, personal insurance costs, and patient co-payments directly impact the citizens," Kim added. "To address common practices in the medical field, such as recommending non-reimbursed treatments to patients seeking reimbursed treatment or providing unnecessary reimbursed treatments and billing them, as well as treating non-reimbursed instead of reimbursed practices, The union believes that 'mixed medical practices should be prohibited' now to eliminate these issues," Kim explained. Regarding the recent conflicts between the medical community and the government over expanding medical school quotas, Kim expressed deep regret and emphasized the importance of having concrete plans for utilizing medical personnel stationed in regional areas. "I feel really bad about the recent conflict regarding the 'expansion of the medical school enrollment quota,' Kim added. "The biggest problem with this situation is that the government's policy of 'expanding the medical school enrollment quota' and the' doctors' strike' claim focus solely on 'money,' including medical insurance fees. It is concerning that the government is not considering the well-being of citizens," Kim said. “Of course, expanding the medical school enrollment quota is essential. However, concrete plans should be made for the 'station and utilization of medical personnel' who will be responsible for the lives of citizens across the nation,” Kim emphasized. The National Health Insurance Trade Union is affiliated with the Korean Public Service and Transport Workers’ Union (KPTU) under the Korean Confederation of Trade Unions (KCTU). The union has a total of 13,842 members, with a membership rate of approximately 93%. It consists of 13 headquarters, 267 branches, and 345 representatives. The union expresses its opinion regarding the national health insurance policy as an insurer. The union emphasizes the importance of expanding health insurance coverage and reducing citizens’ medical expenses.
- Policy
- "Seek social consensus, shift away from 2,000 quota"
- by Lee, Jeong-Hwan Mar 29, 2024 05:53am
- Lee Jae-myung, the leader of the Democratic Party of Korea (chairman of the standing joint election committee). "How can we persuade and negotiate with the medical community after President Yoon Suk Yeol forced university assignments by pushing through with an excessive fixation on increasing the quota to 2,000? It's time to shift away from this fixation and instead establish a committee proposed by the Democratic Party to facilitate social discussion and reach agreements." On the 27th, Lee Jae-myung, the leader of the Democratic Party of Korea (chairman of the standing joint election committee), proposed operating a consultative body to seek social consensus by questioning President Yoon Suk Yeol and the ruling party about increasing the medical school quota by 2,000 students. Lee pointed out that the fixation of the president and the ruling party with increasing the medical school quota to 2,000 has led to a medical crisis, resulting in hospital doctors overworking and actual harm to patients. During a field press conference at Changwon-gu in Cheongju, Lee said, "There was a similar rumor a month or two ago." He added, "During the Moon Jae-in administration, the Democratic Party government planned to increase the number of doctors by 400 annually for ten years. It was not completely satisfactory, but it was believed to be able to resolve a significant portion of the problem. But, it was postponed due to COVID-19." "However, the Yoon Suk Yeol government's decision to increase the medical school admission quota by five times, to a total of 2000, appears to be an attempt to provoke and forcefully suppress the opposition from the medical community. There was speculation that someone might emerge suddenly and try to create an illusion of resolution, similar to the June 29 Declaration," Lee stated. "During the Democratic Party's highest committee meeting, I raised concerns multiple times and pointed out that we shouldn't approach this strategically," Lee said. Adding, "However, it feels like the situation is becoming similar to gossip. Such critical policy matters should be handled by ministers, vice ministers, prime ministers, and the president. However, the chairman of the ruling party's central committee suddenly meets with former President Park Geun-hye to discuss these matters. This approach raises questions about whether this is part of normal governance," Lee questioned. Regarding the extended conflict between the medical community and the government, Lee stated, "President Yoon's fixation on 2,000 medical school quota and university assignments has made it difficult to persuade the medical community and reach agreements." He highlighted the "fixation on the 2,000 increase" as the cause and said, "Even ruling party candidates agreed." "We must focus on improving public health, which is essential. We need to shift our focus from the fixed number of 2,000 additional admission quotas and instead work on a comprehensive expansion plan that includes establishing public medical schools and regional doctor programs. These programs are essential for maintaining medical services in public and regional areas," Lee said. "As proposed by the Democratic Party, we request the establishment and operation of a consultative body to resolve the issue swiftly," Lee suggested.
