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- 2026-04-14 06:57:08
- Policy
- The reasons why Hemlibra's benefit was not recognized?
- by Lee, Hye-Kyung Jul 03, 2021 05:56am
- The HIRA's Central Review and Coordination Committee revealed specific reasons for not recognising benefit of JW Pharma's Hemlibra (Emicizumab). The HIRA released a June review of the Review and Assessment Committee on its portal on Thursday. There are five cases of deliberation, including Hemlibra, Soliris, ventricular assistive therapy, Spinraza, and hematopoietic stem cell transplantation. In the case of Hemlibra, the HIRA unusually disclosed the results on the 8th due to controversy over the standards. Based on the data submitted by the medical institution, the central group said that cases A, B, and C lacked objective data to prove that it was difficult to secure venous blood vessels and to insert and maintain central vein tubes. ▲For pediatric administration, patients with failed Immune Tolerance Induction,▲ If there is a doctor's statement that it meets the requirements subject to Immune Tolerance Induction but is not possible to carry out it,▲ If antibodies are regenerated after the success of Immune Tolerance Induction, the patient must pay the full copayment of Hemlibra. According to the case of disapproval, which was specifically disclosed to the medical institution's business portal, A case was diagnosed with hereditary 8th factor deficiency syndrome in June 2019 and antibodies were found in December 2019 and started administering Hemlibra through clinical trials in March 2020. In February this year, the patient met the criteria for Immune Tolerance Induction benefits, but claimed Hemlibra because it was very difficult to secure venous blood vessels and difficult to insert and maintain central venous tubes as antibodies to factor VIII. However, the HIRA did not acknowledge the benefit, saying that "submitted medical records show insufficient objective data to determine that Hemlibra administration in February 2021 is difficult to secure venous blood vessels and to insert and maintain central venous ducts." Case B is a male (22 months), diagnosed with factor VIII disease in August 2019 and antibody was found in June 2020. The patient also applied for Hemlibra benefits because of the very difficulty in securing venous blood vessels, difficulty in inserting and maintaining central venous tubes due to antibodies to factor VIII, and psychological problems such as fear of intravenous injections, but was not recognized for the same reason as case A. There was also a lack of medical explanation for "stress from a vein injection". Case C was a 4-year-old boy, diagnosed with factor VIII disease in June 2016 and discovered antibodies in July 2016, but had a history of treatment in intensive care due to subgaleal hemorrhage and epidural hemorrhage at birth. The HIRA judged that "the past history of severe bleeding is not the case when immunotherapy cannot be attempted." Case D is a 3-year-old (40 months)-old male diagnosed with factor VIII disease in September 2017 and antibody was discovered in November 2017. In November 2018, chemoport was approved, but three days later, intestinal bleeding failed, and Hemlibra was charged for failing to be administered due to severe intestinal bleeding in February 2021. However, the HIRA ruled that "Immune Tolerance Induction could not be performed due to intestinal bleeding in November 2018, but medical records confirm the application for IImmune Tolerance Inductionagain in January 2019." Meanwhile, the MOHW announced that it would review the benefit standard in consultation with the HIRA as problems with the Hemlibra standard were pointed out at a plenary session of the National Assembly on the 16th.
- Company
- Opdivo+Yervoy's negotiations failed to reach an agreement
- by Jul 01, 2021 05:56am
- Drugs for the combination of the immuno-cancer drugs Opidivo (Nivolumab) and Yervoy (Ipilimumab) in primary treatment for kidney cancer were not negotiated within days. In the end, it is expected to take longer to apply the benefit. According to related industries on the 1st, Ono Pharmaceutical and BMS have extended drug price negotiations with the NHIS for Opdivo and Yervoy kidney cancer primary treatment benefits. Earlier, Opdivo and Yervoy combination therapy was recognized for their benefit adequacy and began drug negotiations with the NHIS for "median or high-risk progressive neocyte cancer treatment" at the HIRA. Pharmaceutical price negotiations run for up to 60 days, and the recent period has expired. The NHIS and pharmaceutical companies never reached an agreement. However, they decided to extend it because they believed that additional negotiations were needed. PD-1 inhibitor immuno-cancer drugs Opdivo and CTLA-4 inhibitor immuno-cancer drugs Yervoy demonstrated excellent effectiveness in primary treatment of kidney cancer. In June 2020, and it passed the HIRA's Cancer Drugs Benefit Appraisal Committee. Later, it took about nine more months for the HIRA's Pharmaceutical Benefits Advisory Committee to recognize the benefit adequacy. In clinical trials of CheckMate-214 compared to the standard treatment of Sutene (Sunitinib Malate) in intermediate and high risk groups, Opdivo and Yervoy combined therapy showed a significant effect compared to the median (mOS) of 48.1 months, compared to 26.6 months. The objective response rate was also significantly higher at 41.9% to 26.8% and the rate of patients maintaining it was higher (65.2% to 49.6%). In particular, 10.4% of patients treated with combination therapy reached full response and received attention. Professor Park Soo-hyung of Kaist GMSE said, "In immune mechanism, CTLA-4 activates priming, which is the first antigen-specific immune response, to induce T-cell reactions, and anti-PD-1 prevents degradation of T-cells, which can create synergies." If Opdivo and Yervoy therapy are listed, the use of immunocancer drugs in kidney cancer is expected to become more active. This is also the first case in which immuno-cancer drug combination therapy is applied in chemotherapy. Both companies are also seeking to expand insurance coverage for Opdivo and Yervoy combined therapy in primary care for non-small cell lung cancer.
- Company
- Yuhan’s Leclaza reimb. held back by companion diagnostics
- by Eo, Yun-Ho Jul 01, 2021 05:56am
- Reimbursement of the novel domestic drug ‘Leclaza’ that was due today (July 1st) was postponed. The listing process of Yuhan Corporation’s new drug which had been progressing at an unprecedented pace came to a full stop due to ‘companion diagnostics.’ Dailypharm found that the Ministry of Health and Welfare had pulled a temporary stop on the enforcement of the notice related to Leclaza (lazertinib). Leclaza was supposed to be listed from July after passing the Health Insurance Policy Deliberative Committee’s review on the 25th of last month. The brakes were pulled by an objection that was registered during the pre-announcement of administration period regarding the lack of a companion diagnostics device Delayed listing of a drug that has already passed the HIPDC deliberations is rare. Since 2018, the Ministry of Food and Drug Safety had regularized a sort of ‘customized use’ of in-vitro companion diagnostics devices through the ‘Guideline on the Review & Approval of companion diagnostic medical devices,’ under which a drug and the companion diagnostics device used as the basis for medications and prescriptions are reflected together in the license. The measure was implemented to precisely screen patients eligible for each prescribed drug target. The problem was that no MFDS-approved diagnostic device existed for the purpose of prescribing Leclaza even though the drug already passed the HIPDC review. Under the current regulations, 3rd generation EGFR TKIs like ‘Tagrisso (Osimertinib)’ and Leclaza may only be prescribed to ‘patients whose EGFR T790M mutation status has been confirmed with an in-vitro diagnostic medical device approved by MFDS.’ In-vitro diagnostic medical devices that are approved and used to identify the EGFR T790M mutation status in Korea include the blood-based ‘Cobas EGFR Mutation Test,’ and ‘PANAMutyper EGFR Kit,’ among others. However, these devices are only approved to be used to screen patients for Tagrisso. In other words, the objection was that Leclaza prescriptions, if made, are all off-label prescriptions, and therefore unfit for reimbursement. As the health authorities have been limiting reimbursement of anticancer therapies with targets such as Tagrisso, the immunotherapy ‘Keytruda (pembrolizumab).’ ‘Tecentriq (atezolizumab),’ the ALK-inhibitor ‘Xalkori (crizotinib), and 'Alubrig (brigatinib)' to those that have used approved diagnostic devices to prescribe the therapies, it was difficult for the government to overlook the objections made regarding this matter. Accordingly, the MFDS had requested the Ministry of Food and Drug Safety to deliberate on whether the in-vitro diagnostic device needed for the prescription of Leclaza should be regarded as a 'companion diagnostics device.' To add an in-vitro companion diagnostic device to a drug's license, additional data that demonstrates that the diagnostic device used in the clinical trial and the device the company wishes to register is equivalent in identifying EGFR T790M mutations need to be submitted. Generally, it takes around 3 to 4 months for the tests to be conducted and the MFDS license to be updated.
- Policy
- Rationalizing ICER threshold requires various considerations
- by Kim, Jung-Ju Jul 01, 2021 05:56am
- Yoon-Seok Yang, Director of MOHW’s Division of Pharmaceutical Benefits Insurance authorities expect the evaluation results of the listed drugs that underwent quality reassessment on the reasonableness of their medical care benefit (re-evaluation of medical benefits of listed drugs) will be applied as early as October this year. This means that the results will pass the Health Insurance Policy Deliberative Committee’s review and be notified in October. Also, regarding the issue of Keytruda’s reimbursement expansion that has been making little progress, the government has pressed for a clear financial sharing scheme with measures such as initial refunds. On lowering the drug price in the detailed evaluation criteria of drugs up for drug pricing negotiations to 80% of the lowest A7 adjusted price, the government plans to continue to hold an ear out to the industry and accept acceptable opinions. This was what Yoon-Seok Yang, Director of Ministry of Health and Welfare’s Division of Pharmaceutical Benefits said in response to the Korea Special Press Association’s questions on pending issues. Director Yang candidly shared the authorities’ positions and concerns over various pharmaceutical policies in his division ranging from reimbursement entry, expansion, improving reimbursement accessibility of ultra-expensive drugs, to ICER thresholds and other various reevaluation issues related to new drug listings. The following is a QA of an interview with Director Yang New drug listings – regarding ICER and PE exemption, RSA, and detailed criteria for drug pricing negations ▶The industry has been requesting rationalization of the ICER threshold in line with the $30,000 GDP per capita era. The ICER threshold is already being flexibly applied on severe and rare diseases, but the industry seems to believe that the threshold should be set at least 3 GDP. “The issue has come up in the NA audit and has also been requested by the industry. As far as I know, HIRA is currently reviewing the issue. Accessibility to new drugs is directly related to drug price, and from the government’s perspective, directly related to NHI finances, so this issue needs to be approached with caution. The fact that you use the term ‘rationalize’ seems to imply that the current ICER threshold is unrealistic. However, there are others who believe that the current threshold is reasonable. We need to gather opinions from various sides before implementing any measures because the drug price also affects reimbursement expenditures. Many drugs have been receiving reimbursement benefits through the PE exemption system without ICER evaluations, so when the government collectively considers its finances, these drugs also need to be taken into account in this discussion. As I said, we need to first gather various opinions. We also need to bear in mind that not many countries use ICER thresholds directly connected to GDP.” ▶There was also talks in the industry that HIRA would lower the PE exemption criteria to 80% of the lowest A7 adjusted price while revising some phrases in HIRA’s evaluation criteria for negotiated drugs. In detail, the criteria would, in principle, set the rate at 80%, and some at 100% according to each drug’s characteristic. Multinational pharmaceutical companies have been greatly opposed to this change, and the question of whether the system and mechanism would become a ‘dead letter’ is also being raised. Is there any room for adjustment on this matter? “We will listen, review, and accept reasonable arguments to the extent possible. The government and HIRA are both aware that the ‘visible’ price listed for most RSA drugs is not the ‘actual price.’ Our focus is on whether the price should be accepted as is, or be adjusted to reflect the real price. The industry will not be able to deny that this is a serious issue. But we will keep an ear out for suggestions from the industry.” ▶Considering that over half of the high-price drugs receive reimbursement through the PE exemption scheme, did the ministry lower the PE exemption criteria to 80% of the lowest adjusted price because the PE exemption scheme is being used more actively than expected?. “Drugs need to be evaluated and given a price according to their value. We know that it is very difficult for rare disease drugs to prepare data for such evaluations, and that’s why we have the existing tools that strengthen post-management measures. HIRA wishes to find measures to strengthen the criteria through discusstions with the industry, but the industry is pushing their opinion. They need to discuss this together. The PE exemption scheme increases payment on HIRA’s part, so HIRA believes in the need to strengthen its management.” Tecentriq and Keytruda ▶Tecentriq applied for reimbursement separately and is up for deliberation by the Cancer Drug Review Committee. I heard that the two drugs will be now discussed together, and the key to Keytruda’s issue is that it lacks a cost-sharing scheme. As the government’s signal would play an important role in the decision, the question that remains is - is the initial refund is crucial?. "Under the premise that the clinical efficacy has been demonstrated, in general, the payer and the pharmaceutical company’s actions are what makes or breaks reimbursement expansions. In other words, the discussion and negotiations on how to share the financial burden are what take up the longest time. A slow progress like Keytruda's is a first for us in our history as well. I cannot disclose specific numbers, but even after CDRC's recommendation to take up the financial sharing request, pre-negotiations fell through. The government's request for a financial sharing scheme similar to those made for other drugs also broke down. The company just increased the scope of its indications and reapplied for reimbursement. This financial-sharing issue is still being discussed, and I hope the company would take a more forward-looking stance regarding this matter. The reason why the authorities emphasize the initial sharing plan is because it allows for a clearer sharing of cost during the initial period where the increase in reimbursement expenses from the expansion is unclear. Initial sharing of cost eliminates financial uncertainty on the government’s part. I know that the company is also seriously considering this matter, and hope that an agreement can be reached in the near future. ▶When will the agenda be introduced?. “The agenda will be introduced sequentially according to HIRA’s order of placement. I believe it will be introduced around July or August.” Premium pricing reevaluation ▶The issue at hand is the premium pricing of single-brand drugs. As brought up during the last pharmaceutical-HIRA roundtable, even when after applying for adjustments, the possibility of accepting the adjusted price is low and it is realistically difficult to reach an agreement, which eventually leads to discussions of taking legal actions. Wouldn't it be resolved by adjusting the timing, by allowing for adjustment applications to be submitted during the 60-day negotiation period set for the stable supply obligation so that they can reach an agreement earlier? “We are reviewing various options. We are trying to adjust the price according to our system, but if the companies say the price is unsuitable for supplying the drug, I think it is right to adjust it to a reasonable price. Some parts of the current standard seem to be strict, and there are other parts where HIRA is not properly carrying out its assessment, and we are determined to address and improve these parts. However, as addressing these issues will increase the drug price, it is natural for the government to be precautious of implementing such price-increasing mechanisms because it will increase the burden on NHI finances, so we are seriously reviewing options with HIRA. Receiving applications during the negotiation period is not being reviewed under current circumstances. However the re-evaluation of premium pricing is being implemented due to a change in the law and system, and I hope the industry would accept this. After the grounds are fully justified, we will seek measures to adjust the price of the drugs.”
- Company
- Hanmi’s Efpeglenatide reduces cardiovascular risk
- by Chon, Seung-Hyun Jul 01, 2021 05:55am
- Sanofi announced a study that reduces the risk of cardiovascular and kidney disease of new diabetes drugs that have returned rights to Hanmi. Hanmi plans to find new opportunities based on research results. According to Hanmi on the 29th, Sanofi held an independent session for Efpeglenatide at the American Diabetes Association (ADA) and announced the results of AMPLITUDE-O on eight subjects through eight researchers for two hours. Efpeglenatide is a GLP-1 family of diabetes drugs that Hanmi transferred technology to Sanofi in November 2015. It is a new bio-drug that extends daily injections from once a week to up to once a month. Sanofi conducts five clinical trials of Efpeglenatide. It finally gave back its rights to Hanmi in September last year. The findings released by Sanofi this time were conducted on more than 4,000 patients, the most among five clinical trials. AMPLITUDE-O Phase 3 clinical trials were given weekly Efpeglenatide or placebo to 4,076 patients with type 2 diabetes or cardiovascular disease in 344 regions in 28 countries. In type 2 diabetes patients, the risk of cardiovascular and kidney disease was significantly reduced when administered in two doses, Efpeglenatide 4mg and Efpeglenatide 6mg. The incidence of major cardiovascular diseases in the Efpeglenatide group compared to the placebo group decreased statistically to 27% and 32% in kidney disease. Professor Naveed Sattar of the University of Glasgow said, "The AMPLITUDE-O clinical trial safely reduced the incidence of major cardiovascular and kidney disease in low-risk and high-risk patients with type 2 diabetes." Major speakers and topics of the independent session for Efpeglenatide conducted by Sanofi (data: Hanmi) "Efpeglenatide has prepared a new opportunity to create another innovation," said Baek Seung-jae, executive vice president of Hanmi Pharmaceutical. "We are focusing our company's capabilities on expanding and materializing the potential of Efpeglenatide, which has been proven through large-scale global clinical trials," he expected. Another global clinical phase 3 (AMPLITUDE-M) result of Efpeglenatide, which was conducted on 406 type 2 diabetes patients whose blood sugar is not controlled by diet and exercise, was also introduced by Dr. Juan Frias, a leading researcher. The clinical trial, which was conducted with double blindness, divided Efpeglenatide into three dose groups (2mg, 4mg, and 6mg) for 56 weeks, compared Glycated hemoglobin with primary evaluation variables for 30 weeks, weight loss, and safety for 56 weeks. Studies have confirmed excellent blood sugar control and weight loss effects when Efpeglenatide is administered to type 2 diabetes patients. Treatment also remained stable for long periods of time. Glycated hemoglobin showed statistically superior improvements in all doses over placebo in Week 30 of treatment. Shortly after the announcement, the New England Journal of Medicine (NEJM) published a paper on Efpeglenatide. "Cardiovascular safety is an important factor that doubles the global competitiveness of drugs in large-scale clinical trials, allowing us to create other innovations and business opportunities," said Kwon Se-chang, CEO of Hanmi Pharmaceutical. Main screen of the New England Journal of Medicine (NEJM) introduced Efpeglenatide (reference: Hanmi)
- Policy
- Targets for PVA in third quarter include Darzalex & Alunbrig
- by Lee, Hye-Kyung Jul 01, 2021 05:55am
- Janssen Korea's (Daratumumab) and Takeda Korea’s Alunbrig (Brigatinib) were included in the Price-Volume Agreement (PVA). Otsuka Pharmaceutical Korea's "Iclusig" and AstraZeneca Korea's "Impinji" (Dubalumab) were also subject to negotiations on drug prices due to increased usage. The NHIS recently introduced "PVA (Type Ka/Na) Monitoring Drugs for 3rd Quarter of 2021" on its website. Targets for monitoring in third quarter of this year are 173 items from 90 pharmaceutical groups. PVA is a method shared by the NHIS and pharmaceutical companies to share the risk of health insurance finances, and the drug price will be reduced through negotiations with the NHIS. Type Ka of PVA corresponds to cases in which claims for the same product group with expected claims agreed with the NHIS have increased by more than 30% from expected claims. Type Na is subject to the same product group, which has been negotiated for type Ka or not negotiated for type Ka, where the previous type has increased by more than 60% or more than 10% or ₩5 billion every year from the end of the analysis period. Drugs with an annual claim of less than ₩1.5 billion, drugs with lower upper limit than the arithmetic average of the same ingredients, low-cost drugs, and drug shortage prevention programs are excluded from PVA. The pharmaceutical groups included Samoh's "Vimizim (Elosulfase Alpha)," Sanofi-Aventis Korea's "Mozobil (Plerixafor)," BL&H's Trisenox(Arsenic Trioxide) and SK Chemical's Migard(Frovatriptan Succinate Monohydrate). The pharmaceutical groups included Samo Pharmaceutical's "Vimizim (Elosulfase Alpha)," Sanofi-Aventis Korea's "Mozobil (Plerixapor)," BL&H's "Arsenic Trioxide" and SK Chemical's "Migard" (Frovat Monochlithinccate).
- Company
- Generics for Pradaxa, Xarelto & Brilinta will be released
- by Kim, Jin-Gu Jun 30, 2021 05:57am
- Material patents of Pradaxa and Xarelto expire in July and October this year, respectively. As a result, 8 generics for Pradaxa and 200 generic for Xarelto are expected to be released early in the second half of this year. In November, 25 generics for Brilinta will be released. Ahn-Gook's generic for Galvus is expected to be released within the year according to the Supreme Court ruling. ◆Generics for Pradaxa & Xarelto in July and October Xarelto and PradaxaAccording to the pharmaceutical industry on the 28th, a total of 82 pharmaceutical patents will expire in the second half of this year. What attracts the most attention is the expiration of the material patent for two NOAC products. Material patent of Pradaxa expires immediately on the 17th of next month. Four companies received generic for exclusivity with a total of eight items. Ajou Pharm's Davitran, Intropharm's Davican, Jinyang Pharmaceutical's Pradabi and Huons' Hubitran can get the exclusivity to sell generics for nine months from July 18 to April 17 next year. Material patent of Xarelto expires in October. 23 companies such as SK Chemical, Chong Kun Dang, and Hanmi have avoided follow-up patents. Two of them received generic for exclusivity. SK Chemical's SK Rivaroxaban 2.5mg and Hanmi Pharmaceutical's Riroxban 2.5mg will be sold exclusively from October 4th to July 3rd next year. 62 companies have been licensed for 195 items. More than 200 generics are expected to be released after October 4, when material patents expire. The early launch of generics for Pradaxa and Xarelto contrasts with the withdrawal of Eliquis' generic market. Earlier, six to seven companies, including Chong Kun Dang, won the first trial on material patent of Elyquis. Thus, it has released generic early since June 2019. They have accumulated more than ₩10 billion in prescription performance through the first quarter of this year. In April this year, however, the Supreme Court sided with the original company, BMS. Generics voluntarily withdrew their products from the market. The early launch of generis of Pradaxa and Xarelto is expected to lead to a reorganization of the NOAC market. In the case of the two items, judgment of the decision to avoid the follow-up patent has been confirmed. As of last year, Pradaxa had ₩14.3 billion and Xarelto had ₩50 billion in outpatient prescription performance. Considering that generic for Eliquis has previously increased its market share around Clinics, generics for Pradaxa and Xarelto are also expected to be in the market. ◆25 generics for Brillinta are expected to be launched simultaneously after November The patent for the anti-platelet drug Brilinta expires in November. It is predicted that 25 generics will be launched at the same time as the patent expires. 25 items, including Boryung Ticagrelor by Boryung from November 21 this year to August 20 next year have acquired generic for exclusivity. Attention is also focusing on whether Ahn-Gook will be able to release Novartis' GPP-4 inhibitor family of diabetes drugs early on. The generic for exclusivity for generic for Galvus is the sole acquisition of Ann-Gook. The period is from 30 August to 29 May next year. In 2019, Ahn-Gook succeeded in invalidating some of the extended periods of material patents for the first time in Korea. As a result, it succeeded in pushing forward the expiration of material patent of Galvus, which was originally scheduled to expire in March next year, by about six months (187 days). However, Novartis appealed, and the Patent Court ruled that 55 days were invalid, not 187 days. The release date of generic for Galvus will be pushed back to January next year. The case now awaits the Supreme Court's final ruling. The Supreme Court's decision determines the timing of Ahn-Gook's generic for Galvus. If it accepts the judgment of the Patent Tribunal, it can be released in August. If the patent court accepts the ruling, it is expected to be released in January next year. If it accepts Novartis' claim, it can only be released after March of next year.
- Policy
- 2 indications deleted for choline alfoscerate, changes label
- by Lee, Tak-Sun Jun 30, 2021 05:56am
- Authorities have ordered companies to delete the No.2 and No.3 indication of the brain function enhancer choline alfoscerate, for which the clinical re-evaluations have started recently. Accordingly, the indication must be removed from the label from the 28th of next month. Also, the Ministry of Food and Drug Safety requested doctors and pharmacists to review the need to prescribe and dispense substitute drugs for patients that use choline alfoscerate during the labeling change period. On the 28th, the MFDS ordered a label change for 144 choline alfoscerate products. After a review of the clinical trial protocols for the reevaluation of these products, the ministry determined that that trial will be unable to assess the efficacy of choline alfoscerate’s second and third indications and decided to remove the two indications. As a result, only the first and main indication, for ‘Secondary symptom caused by cerebrovascular defects or degenerative brain-organic psychiatric syndrome by cerebrovascular deficiency: reduced memory, derangement, disorientation by reduced willingness and spontaneity, reduced willingness and spontaneity, reduced concentration’ will be left approved for choline alfoscerate. The second indication, for ‘Emotional and behavioral change: emotional insecurity, sensitive to stimulation, indifferent to surrounding,’ and the third indication for’ Senile pseudodepression’ will be deleted. However, whether the first indicating will remain intact depends on the results of the domestic clinical reevaluation that will be conducted. The MFDS had ordered companies to submit clinical trial results for Alzheimer's patients by December 9th, 2025, and the same for patients with mild cognitive disorder by March 9th, 2025. 57 companies including Daewoong Pharmaceutical and Chong Kun Dang that will lead the clinical trial will be participating in the clinical reevaluation. With the order to change labels issued, choline alfoscerate products that will be produced a month from the indication change, from July 28th, must reflect the new efficacy and effect on the product box and label. Administrative sanctions will be imposed on the companies that do not comply with the order by the said date. In 2019, the prescription sales amount of choline alfoscerate for the deleted two indications (No.2, No.3) amounted to 39.3 billion won and accounted for 11.1% of total prescription sales for the drug. Therefore, pharmaceutical companies are not expected to suffer huge performance losses from the change of indications. The companies are more intently focused on negotiations with the government on the amount they may have to give back in case the reevaluations for the first indication fall through. The National Insurance Health Service had recently proposed a retrieval rate of 30% of the insurance claims amount to make progress in the fruitless negotiations.
- Opinion
- [Reporter’s view] Confusion by 1+3 bill must be minimized
- by Lee, Tak-Sun Jun 30, 2021 05:56am
- Sharing the results of the biological equivalence test with other companies and obtaining permission is restricted by the revision of the law. The National Assembly passed the pharmaceutical affairs law amendment on the 29th, which included 1+3 bill. Accordingly, a trustee who manufactures medical supplies may share permitted data and supply medical supplies only within three consignment companies. Therefore, it is expected that this will greatly reduce generic items that are easily licensed only by data sharing. Trustees are expected to suffer a setback in their projects due to a decrease in consignment production. Overall spending costs are also expected to increase as the number of medicines manufactured by pharmaceutical companies increases. The 1+3 bill was revised by the MFDS in 2019 by reflecting it in the screening regulations due to numerous generic drugs. However, the office for government policy coordination's Regulatory Reform Committee decided to withdraw the system, and the regulations were not amended. The National Assembly said that the number of generics should be limited when impurities were detected in preparations such as Ranitidine following Valsartan. As a result, it was re-promoted with the Pharmaceutical Affairs law, and despite opposition from small and medium-sized pharmaceutical companies, the MFDS, the KPBMA, and lawmakers from the ruling and opposition parties were generally in favor. Now, when the law is promulgated in July, it will be restricted from new medicines received from the future. Since the law takes effect immediately, pharmaceutical companies may suffer unfair damage due to the application of products prepared before that. Regulations can be avoided by proving joint development within one month of the enforcement date of the law. However, there may be complaints over the targets of exceptions, evidence, and procedures. Consequently, failure to make the exception correctly can be confusing. The MFDS should establish detailed rules after passing the law to minimize complaints from pharmaceutical companies and to ensure that the law is settled quickly. The 1+3 bill was effective and any debate became meaningless. The MFDS, which is in charge of ensuring that the law is applied fairly and quickly. It is up to the MFDS now.
- Company
- JW Pharma acquires domestic license for fostamatinib
- by Chon, Seung-Hyun Jun 30, 2021 05:56am
- On the 28th, JW Pharmaceutical Corporation announced that it has entered into a licensing agreement with Kissei Pharmaceutical Co., Ltd for the development and commercialization rights in Korea of fostamatinib, a thrombocytopenia treatment. Under the licensing agreement, JW Pharmaceutical may develop, obtain regulatory approval, and market fostamatinib in the domestic market. Fostamatinib was originally developed by Rigel Pharmaceuticals, Inc., and Kissei acquired exclusive development and commercialization rights for fostamatinib in Japan, China, Korea, and Taiwan from Rigel in 2018. Immune Thrombocytopenic Purpura (ITP) is a condition in which the body’s immune system attacks platelets, causing the platelet count to become lower than normal. Patients with ITP are easily bruised, bleed easily, and have difficulty stopping bleeding. In severe cases, it can lead to cerebral hemorrhage or upper gastrointestinal tract bleeding, and therefore is a rare blood condition with a high unmet need. Fostamatinib is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of ITP in adult patients. Contrary to existing treatments that boost blood platelet production, this first-in-class drug suppresses the destruction of platelets by macrophages and suppresses platelet depletion. Fostamatinib was approved by the U.S. FDA in 2018 for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatment, and is sold under the name ‘Tavalisse.’ According to post hoc analysis results of Phase III clinical trial presented at the 2019 American Society of Hematology (ASH) Annual Meeting, the use of fostamatinib as second-line therapy after treatment with corticosteroid showed a high treatment response rate in patients who have been diagnosed within a year. Also, fostamatinib has less dietary interference and drug-drug interactions than other oral formulations and may be taken regardless of food intake or other medications. JW Pharmaceutical plans to receive the orphan drug designation for fostamatinib in Korea to expand treatment opportunities for adult patients with thrombocytopenia. An official from JW Pharmaceutical said, “The company was able to add a new drug for a rare disease in our lineup through the agreement. We will work to progress the domestic approval process without any delay to provide treatment for patients suffering from chronic ITP.”
