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- 2026-04-28 14:33:04
- Policy
- Orphan drug Ilaris receives conditional pass for reimb again
- by Lee, Hye-Kyung Apr 05, 2024 05:43am
- Although the government restarted reimbursement discussions for Novartis Korea's orphan drug Ilaris Inj (canakinumab) after 2 months, the results were the same. According to the "Results of the 4th 2024 Drug Reimbursement Review Committee Deliberations," which was released on the 4th by the Health Insurance Review and Assessment Service, Ilaris was deemed adequate for reimbursement for the following indications: ▲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), and ▲ Systemic Juvenile Idiopathic Arthritis (SJIA). However, the approval came with a condition. Further evidence for the three indications - CAPS, TRAPS, and FMF - must be submitted for the reimbursed use of the drug. At the DREC meeting in February, Ilaris was deemed adequate for reimbursement subject to submission of further evidence, but Novartis filed an appeal, putting the decision on hold. Novartis then requested a reevaluation and received another DREC review after 2 months, but the results remained unchanged. Ilaris, which was deemed adequate for reimbursement along with Enhertu Inj, is a treatment for a rare disease called periodic fever syndrome, which affects only 13 patients in Korea. It is a drug that HIRA President Jung-Gu Kang said he would make efforts for prompt reimbursement during the National Assembly audit in October last year. Ilaris is the only IL-1 inhibitor recommended by international guidelines for the treatment of hereditary periodic fever syndrome and is approved by both the U.S. FDA and the European EMA. Based on the efficacy and safety of the drug confirmed through clinical studies, it is being reimbursed in a total of 30 countries. However, it is facing difficulties in receiving reimbursement approval in Korea. Novartis made two previous attempts for Ilaris’s reimbursement in 2017 and 2022 but failed both attempts. This is its third attempt. Ilaris is also an expensive drug, costing KRW 8 million to KRW 100 million per year for once every 8-week dose. If Novartis accepts DREC’s decision this time, the reimbursement process for Ilaris will progress rapidly, but if it doesn't, its reimbursement will again be at a standstill. Meanwhile, ‘Orkedia Tab 1mg, 2mg, (Orkedia Tab),’ Kyowa Kirin Korea’s treatment of secondary hyperparathyroidism in patients on maintenance dialysis was deemed adequate for reimbursement by DREC at the same meeting. In the case of Santen Pharm Korea’s ‘Rhopressa Ophthalmic Soln. 0.02% (Netarsudil Mesylate),’ which is a treatment for open-angle glaucoma and ocular hypertension, the drug was deemed adequate for reimbursement if the company accepted a price lower than the evaluated price. Takeda Pharmaceutical Korea’s ovarian cancer treatment ‘Zejula Cap. 100mg (niraparib tosylate monohydrate)’ was reviewed for RSA coverage expansion, but DREC determined its adequacy to be unclear.
- Policy
- HIRA in final stages of preparing expense report survey
- by Lee, Tak-Sun Apr 05, 2024 05:43am
- The Health Insurance Review and Assessment Service is busy preparing a survey and public disclosure of the expenditure reports on economic benefits pharmaceutical companies and medical device companies provided to doctors and pharmacists. As the data submitted by pharmaceutical companies through the survey will be subject to public disclosure, HIRA is also planning to build a system for relevant data collection. However, it plans to receive the data through a temporary system this year and open a formal system next year. According to industry sources on the 3rd, HIRA informed pharmaceutical organizations about the survey on expenditure reports. The survey will be conducted for 2 months from June to July like in the past year. In June, drug wholesalers, and in July, drug licensees, importers, and promoters must submit their previous expenditure reports to HIRA's expenditure report management system, Korea Patient Safety Reporting (KOPS). This year, consignment sales organizations (CSOs), which are entrusted with the sales promotion duties, will also be subject to submit data. CSOs are also required to prepare their own expenditure reports. However, HIRA added that it is advisable for the drug suppliers to manage and supervise the expenditure reports prepared by CSOs. The survey will cover general information such as company information and expenditure report operation status, as well as the 1-year expenditure report prepared from January to December 2023. The expenditure report includes the provision of samples, support for conferences, support for clinical trials, product presentations, post-marketing surveys, and discounts based on payment terms. In last year's survey, pharmaceutical companies uploaded the data in an Excel format, but this year's survey will be conducted in two ways: companies can directly enter the information into the temporary system or upload the data in an Excel format. The results of the survey will be posted on the MOHW website in December, just like last year. Separately, the expenditure reports submitted by pharmaceutical companies in December through KOPS will be made public for 5 years. The disclosed data will be replaced with the data the companies submitted for the expenditure report survey. HIRA plans to database the submitted data and post it according to the open principle. Last month, the Ministry of Health and Welfare announced the 'Operational Guidelines for Public Disclosure of Information,' and explained that the names of recipients, including those of the medical practitioners whose personal information may be leaked, and clinical trial information that contains the companies’ business strategies will be de-identified, then disclosed. HIRA has additionally begun hiring personnel to support the disclosure of expenditure reports and surveys. It announced on Jan. 1 that it would hire 12 people for the service through an emergency bid announcement on 'management staff dispatch service'. A HIRA official said, "This year, we plan to temporarily build an expenditure report management system, and open an official system next year. We plan to make the public disclosure in December, and we will disclose the information after discussing the scope of the disclosure and databasing the data submitted by companies."
- Policy
- Trajenta generics enter reimbursement pricing…
- by Lee, Tak-Sun Apr 05, 2024 05:43am
- DPP-4 diabetes drug Trajenta tab. The generic version of Trajenta (linagliptin), a DPP-4 inhibitor class, has applied for reimbursement pricing ahead of its launch in June. This year, generic market is drawing attention to Trajenta. With the exclusive rights for Trajenta is set to expire, after Forxiga and Januvia last year, the diabetes market is expected to see new competition this year. According to industry reports on the 4th, Trajenta generics applied for reimbursement pricing. Subsequently, the Health Insurance Review and Assessment Service (HIRA) started the pricing process. It is expected that Trajenta generics would be listed on June 9 when the substance patent of the original drug expires. Generic companies have confirmed the release date for June after winning the dispute over Trajenta’s unregistered substance patents. In January, the Intellectual Property Trial and Appeal Board (IPTAB) gave a verdict validating the claims on patent challenges by five generic companies, including Genuonesciences, for invalidating three counts of Boehringer Ingelheim’s use patents for Trajenta. Consequently, when the product patent expires on June 8, the generic companies are expected to enter the market based on the verdict. The DPP4 inhibitor formulation patent, which is set to expire in 2027, remains on the patent list of the Ministry of Food and Drug Safety (MFDS). However, most of the pharmaceutical companies have avoided this patent type. 60 Trajenta monotherapy generics and 204 Trajenta-duo (linagliptin+metformin) combination therapy generics have received approval. Most known domestic pharmaceutical companies are set to enter the market. Notably, generic companies have developed SR tablets unavailable in Trajenta-duo and have completed approval. According to UBIST last year, Trajenta accumulated an outpatient prescription amount of KRW 61.3 billion and Trajenta-duo accumulated an outpatient prescription amount of KRW 62.1 billion. Together, those two generated a KRW 120 billion-worth market. The market size is comparable to Januvia (KRW 34.9 billion), Janumet XR (KRW 41.1 billion), and the Janumet series. Following the expiration of Januvia's patent last year, over 200 products entered the market, and similar interests are observed for Trajenta generics as well. However, Januvia generics occupied the market in advance in September. As many pharmaceutical companies intensify their sales efforts to dominate the market, it is anticipated that they may not be able to put their efforts into Trajenta generics belonging to the same class as Januvia.
- 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.
