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- 2025-12-26 16:58:19
- Policy
- Doctors consider 'efficacy' over cost on anticancer Rx
- by Lee, Hye-Kyung Nov 15, 2019 06:29am
- Domestic oncologists have considered more efficacy and safety than the medicne expense when they prescribe anticancer drugs It implies that health authorities need to mix the ratio of anticancer efficacy and toxicity when applying the valuation tools of the European Society for Medical Oncology(ESMO) and the American Society of Clinical Oncology(ASCO). Korean Cancer Study Group (KCSG) has been conducting researches on 'Analysis of valuation tools for foreign cancer drugs and their application in Korea' as a service project of the HIRA (Health Insurance Review & Assessment Service) since June. KCSG conducted perception survey of 17 oncologists (1st), 165 stakeholders(2nd), and 20 specialists in hematology and oncology(3rd) in order to explore Wertform model of Korean anticancer drugs to evaluate the value of high-priced anticancer drugs using ESMO and ASCO. Prof. Ryu, Min-hee Prof Ryu, Min-hee, trustee of KCSG director presented the results of the 1st, 2nd and 3rd perceptions at the public hearing on Oct 23, and many respondents responded positively to using the value evaluation tool as an anticancer health insurance benefit or afterlife assessment criteria. In the first survey of 17 oncologists, efficacy was considered ranked first when prescribing general anticancer drugs and immune chemotherapy, 94.1% and 75%, respectively. Only 1 (5.9%) responded that the MD considered costs for generic anticancer drugs, while 3 (18.75%) answered that they considered costs for immune chemotherapy. Anticancer drug evaluation items of ASCO and ESMO consists of efficacy and toxicity. When asked about the appropriate ratio in Korea, 58.8% of respondents answered that 70% efficacy and 30% toxicity. The other 23.5% said 60% efficacy and 40% toxicity, and the remaining 17.6% said 80% efficacy and 20% toxicity. The ASCO anti-cancer drug value evaluation reflects additional scores in improving the quality of life (QoL) besides efficacy and toxicities. If the sum of the importance of anticancer efficacy and toxicity is 100, 47.4% answered 20% of the appropriate quality of life ratio. the remaining 37.5% chose 10%, and 6.3% over 30%. As a result of asking the oncologist about the cost of drugs that are not included in the two valuation tools, 43.8% of the respondents consider it to be 60% to 80%. Domestic clinicians are also considering the burden of drug costs. When the Korean anti-cancer drug value evaluation tool developed by the government is developed, 50% of respondents said 'use it as evaluation standard when applying health insurance', and 31.3% said 'use it for evaluating the efficacy of anti-cancer drug after marketing' and the rest ‘ used by MD to decide on patient treatments.'' The second perception survey was conducted by oncologists, nurses, and pharmacists at the ASCO in Busan in last August. Occupation rate was 49.4% of doctors, 35.5% of nurses, and 11.4% of the pharmaceutical industry. The rest chose a duplicate with the others. In the survey of stakeholders, more than half of the respondents said that more than half of the respondents chose to choose generic anticancer drugs or immunocancer drugs with the most importance of efficacy. In addition, 97.6% of the respondents said that it is necessary to develop an anti-cancer drug clinical evaluation tool for the Korean situation. In particular, the majority of opinions that the valuation tool should be used as a standard of health insurance benefits or afterlife assessment. 90.4% of respondents said that value evaluation tools that reflect clinical effects, toxicity, and quality of life should be used as criteria for determining health insurance benefits. 93.4% of respondents said they needed to use a value evaluation tool as a post-registration evaluation tool for conditionally listed anticancer drugs. The third recognition survey was conducted with 20 hematological oncologists from MM working party. More than 90% of the respondents consider the effects of selecting general anticancer drugs and immunocancer drugs. The drug costs were 5% and 10%, respectively. Respectively 80%, 90% of the respondents commented on the need to use a value evaluation tool as a basis for reimbursement decision and afterlife assessment. Prof. Ryu said, "The results showed that they takes count of the efficacy the most when prescribing general anticancer drugs and immunocancer drugs. Education and seminars were needed to utilize and apply the research tools." The response was positive for being used as reimbursement standards or fterlife assessment standards” Prof. Ryu said, "New Bio drugs such as anticancer drugs are shifting the paradigm of disease treatment with new treatment mechanisms and improved effects. However, some high-cost anticancer drugs raise questions about the uncertainty of cost effectiveness compared to the therapeutic effect." "We need to consider introducing an objective and standardized drug valuation tool for fiscal integrity and sustainability."
- Policy
- 4200 items subject to ATP-based price reduction by 1%
- by Lee, Hye-Kyung Nov 15, 2019 06:28am
- Korean regulators have decided to reduce drug prices of about 4,200 items based on actual transaction price (ATP) from Jan. 1 next year. Until Nov. 11, Health Insurance Review and Assessment Service (HIRA) informed details of price reduction to pharmaceutical companies with already-listed drugs subject to the reduction, and allowed them to visit and confirm the result. HIRA plans to accept their appeals until the end of the month, and to start re-evaluating the items from Nov. 30. The updated lists of reimbursed drugs and their upper limit price are to be in effect from Jan. 1, 2020. At a correspondent’s workshop held on Nov. 14, Director of Pharmaceutical Management Department at HIRA, Kim San stated, “Except for the exempted 4,398 items, weighted average price of 17,702 items, out of 21,732 reimbursement listed drugs, has been calculated. According to the first result, average reduction rate is about 1.3 percent, and it would be modified down to around 1 percent after the appeal review”. “Last year’s overall drug expenditure reached about 17.8 trillion won, and the figure would be decreased by around 90 billion to 100 billion won with price reduction rate around 1 percent. To provide reduced drug price from the beginning of next year, the span of National Health Insurance (NHI) benefit claim bill collection was shortened from three months to two months,” Director Kim added. This year’s ATP survey delved into NHI benefit claim made from July 1 of 2018 to June 30 of 2019, but 3,773 public healthcare institutes, four special veteran hospitals, and 40 military hospitals were excluded from 94,183 subject healthcare institutes. Price reduction subject drugs are to determine weighted average price based on healthcare institutes’ NHI reimbursement claim made on 17,702 listed drugs to HIRA during the surveyed period. Total of 4,398 items are exceptions to the upper limit price adjustment, which consists of 1,167 low-priced drugs, 638 shortage prevention drugs, 394 narcotics and orphan drugs, and 1,837 drugs newly listed during the survey period. Last year, overall 3,619 items had their prices lowered by average rate of 1.3 percent due to ATP-based price reduction, which apparently saved 80.8 billion won of drug coverage expenditure.
- Policy
- Pharmaceutical spending structure needs to be reorganized
- by Lee, Jeong-Hwan Nov 14, 2019 05:40pm
- We need to increase the expenditure of new drugs in drug costs far more than now. Patent expiration drugs must be left out of the market and replaced by generics for health insurance to be kept. However, since the structure could not be broken, the reform of the generic drug price system, which is a transitional measure, has started. It is solved only by redrawing the spending structure itself. There is often a conflict between estimating drug pricing and increasing reimbursement reflecting the social value of expensive innovative new drugs and the rational expenditure and management of limited health insurance financing. The government is trying to come up with a variety of tools to evaluate the value of innovative new drugs, but it is not easy to close the gap between regulators and profit-generating companies. Eventually, it was the government and experts' view that a massive restructuring of the financial spending structure in health insurance would be necessary to resolve this conflicting agenda. At the National Assembly Library on Nov 7, experts from the government, industry, and patients organization gathered in an open policy debate to solve the difficult task of balancing new drug?s social values and health finances. A panel discussion was held after the presentation of JiHong Bu, senior vice president of IQVIA Korea, which aims to increase the supply of new drugs by regulating the excessive use of chronic disease drugs. The discussion was attended by Myungseop Kwak, Director of insurance and pharmaceutical affairs at MOHW, Jinok Byun, director of the Center for Institutional Finance Research, Korea Institute for Health Insurance Policy, Prof.Lee, Wonbok, Graduate School of Law, Ewha Womans University, Sungjoo Kim, a member of Lee & Ko, and Representative Kijong Ahn , Korea alliance of patients organization ▲ Professor Wonbok Lee (left), Director of Jinok Byun he discussion was based on whether it would be reasonable to create a health budget for new drug benefits by regulating the use of mild and chronic disease drugs, and how to improve the expenditure structure of drugs cost. Prof. Lee, Wonbok, school of law of Ewha Womans University pointed to the lack of statistical or objective evidence that reducing the use of mild and chronic diseases and increasing new drug benefits would contribute to health and financial health. In particular, he introduced many cases where the cost-effectiveness of treatment for severe rare diseases was low and mentioned the risk of unconditional expansion of new drug benefits. Prof. Lee said, "Because the high-income countries except Japan and Korea are spending aggressively on new drugs, there is no justification for the expansion of new drug benefits." Prof. Lee said, "It must be accompanied by practical evidence. We need to provide quantitative indicators of what will help us in terms of health finance and public health." In particular, if the new cap expenditures are unconditionally increased due to the fiscal cap, there is a need for a solution to the backlash against the decrease in stakes in other sectors. � Jinok Byun, head of the Korea Institute for Health Policy Research, said people should not misunderstand that the government will not save or use health finances. Health insurance finances, after all, exist in order to be well spent, explaining that they are doing their best to meet the characteristics of medicines. In particular, the initial drug pricing negotiation of the original new drug is important in terms of financial financing. "The chronic leukemia drug Gleevec was the first targeted drug, called magic bullet because of its superior effect. When it was first introduced, the number of patients was 500," she said. "We have tens of thousands of patients a year and the Gleevec market is still active.� "This is the hallmark of the innovative new drug market. It is the case that Gleevec?s reimbursement was not stopped even after the Novatis?s rebate is caught." "If the new drug lie Gleevec is not managed by the government, it becomes a problem. It is the decision or adjustment process on drugs to agree on a reasonable basis for price in terms of overall price management." ▲ Sungjoo Kim (left) and Myungseop Kwak Sung-Joo Kim, Expert in Lee & Ko , said that the level of drug prices in Korea is not high compared to overseas, and that the application of innovative new drugs should be expanded quickly. "I agree with the significant improvement in the new drug registration rate, but the reimbursement approval is still limited. Cancer immunotherapy is a good example of this, we need to increase reimbursement level and expand the reimbursement drugs" said Kim. Mr. Kim said, ?In particular, we have to worry about creating surplus in financial fields other than pharmaceutical expenses. According to the analysis of the Health Insurance Review & Assessment Service bill data, The number of visits by the most visited clinics in Korea for one year was 300 times. It means that the patient went to clinics more than once per day, so we need to improve the efficiency of health finance. " Myungseop Kwak, the ministry's director of welfare, said that the drug expenditure structure should be redesigned for the social value of new drugs and sustainable health finance. The purpose of this study is to analyze the current spending structure and to rationalize as soon as possible to spend more on new drugs and to reduce the amount of money spent on patent expiration drugs and generics to secure sustainability of health and financial finance. However, since it is virtually impossible to break the spending structure at once, it is implementing measures that can be reformed, such as the reform of the generic drug system, which is a transitional stage. He said, ?Patients and the industry do not require reimubursement for patent expiring drugs. We pay only for new drugs.??We have established a rationalization plan and started research on expenditure structure analysis. We initiated expenditure structure analysis research, results will be released in the first half of next year.� He also said, "If you don't change the expenditure structure in the end, the answer will be microscopic. It's difficult to solve it without drawing a new macroscopic cost chart and digging into the details one by one." Sustainability can only be achieved if the patent expiry is released from the market and generics are replaced. " ?We started with the reorganization of the generic drug pricing system, which is a transitional measure because it is difficult to realize in the five-year health insurance guarantee plan. We plan to use the resources obtained through the reevaluation of patent expired drugs and non-payment drugs for high-cost anticancer drugs, rare incurable diseases treatments, and serious treatments."
- Policy
- Zejula max reimbursed price 76,400 won from Dec. 1
- by Kim, Jung-Ju Nov 14, 2019 09:08am
- From December, Takeda Pharmaceutical Korea’s ovarian cancer treatment, Zejula 100mg capsule (niraparib) would be on the insured drug list at a price of 76,400 won. Although it is more cost-effective than the alternative option Lynparza, Zejula received the same price cap because Lynparza was listed via pharmaceoeonomics (PE)-exempted risk sharing agreement (RSA). Zopista would also be listed from next month at a price of 108 won per 1mg tablet. Health Insurance Policy Deliberation Committee (HIPDC) convened a meeting on Oct. 30, and decided to revise the list of reimbursed drug and upper limit reimbursement rates. Ministry of Health and Welfare (MOHW) explained the reimbursement listing schedule reflects the actual supply schedule of each listed drug, for instance, Zopista from Nov. 1, Zejula from Dec. 1 and Velphoro chewable tablets (sucroferric oxyhydroxide) from Jan. 1, 2020. ◆ Zejula 100mg capsule: Zejula 100mg capsule was approved as an oral maintenance therapy for platinum-sensitive adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Reaching an agreement with National Health Insurance Service (NHIS) on drug pricing negotiation, Zejula’s reimbursed price was set at 76,400 won per capsule. The drug was passed with expenditure cap as its alternative drug Lynparza was passed with a case of PE-exempted expenditure cap type RSA. Takeda released Zejula in Korean market after Ministry of Food and Drug Safety (MFDS) approved it on Mar. 22. On Mar. 25, the company submitted an insurance reimbursement listing application. The application was deliberated by Severe and Cancer Disease Deliberation Committee and Drug Reimbursement Evaluation Committee on June 12 and July 25, respectively, and the drug’s price was negotiated from Aug. 13 to Oct. 10. MOHW official explained patient’s burden on the drug is expected to be lowered significantly as the drug’s daily cost for patient reimbursement the cost is now at 7,640 won, whereas without reimbursement was at 152,800 won before. ◆ Velphoro chewable tablet: Velphoro is a new drug used to control serum phosphorus levels in patients with chronic kidney disease on dialysis, and HIPDC passed the drug at a reimbursed price of 1,697 won per tablet. The tablet was approved by MFDS on Mar. 20 last year, and it applied for reimbursement on Oct. 24 the same year. DREC deliberated and passed the drug on Apr. 25 this year, and NHIS conducted a pricing negotiation from May 22 to July 19. ◆Zopista tablet: An insomnia treatment, Zopista was approved by MFDS on last May 3, and it applied for reimbursement on May 31. The treatment was passed by DREC on Aug. 29 and reached an agreement with NHIS on pricing negotiation from Sept. 24 to Oct. 21. The tablet’s reimbursed cap price was set to 108 won, 162 won and 203 won for 1mg, 2mg and 3mg tablets, respectively. Director Kwak Myeong-Seop of Pharmaceutical Benefits Division stated “The updated reimbursed drug list has expanded insurance coverage on recurrent ovarian cancer treatment, and accordingly enhanced treatment access but lessened patient’s financial burden. The updated list would be officially in effect from Dec. 1, providing National Health Insurance reimbursement on newly added Zejula, Velphoro and Zopista”.
- Policy
- 62 DI including Belviq® and CONTRAVE®,added to DUR
- by Lee, Tak-Sun Nov 14, 2019 09:07am
- The MFDA(Ministry of Food and Drug Safety) has announced additional contraindicated DI(Drug Interaction) medicines that will be updated in the DUR (Drug Utilization Review). Especially, one of the antiobesity medicines, Contrave®(Bupropion-Naltrexone) is contraindicated with Belviq® (Locaserine HCl), and , Cough®, one of expectorants was added Category X which means highly unsafe in pregnant woman. MFDA announced on Nov 11 the partial amendment proposal of 'Regulations on Designation of Contamination of etc.'. This amendment will be implemented immediately after the opinion submission period and will be reflected in the DUR. The revised contents includes 62 DI medicines including Bupropion & Naltrexone-Locaserin, which are considered necessary for contraindication DI. The Bupropion / Naltrexone preparations are generic for Contrave® recently approved. It was added to DUR not to take with Belviq®. Also Belviq® is anti-obesity medicine. 42 contraindicated drugs for pregnany women including Dihydrocodein tartrate was added to DUR, too. Cough® and Codaewon-Forte® are the main medicines including Dihydrocodein tartrate. Remarks have been changed and added to Fentanyl and other ingredient, which are designated as category X. Fosfomycin, on the other hand, was lifted from category X. 10 contraindicated drugs for certain age criteria like Atomoxetine added age-specific contraindications and dosage forms. In addition, the age criteria for 4 ingredients including Bicalutamide were changed. The ingredient name and dosage forms for 4 components including Mesalazine were changed. MFDA officer said, “This amendment will be implemented after the opinion submission period and will be reflected in the DUR immediately” and added “ The amendment was based on the information in the drug insert".
- Policy
- Ultomiris®, follow-up Soliris® to set with clinical trial
- by Lee, Tak-Sun Nov 14, 2019 03:21am
- Follow-up medicine after Soliris® which is a very expensive Orphan drug and ₩40 billion sales in domestic market reached out the end of clinical trials. That’s what the medicine named Ultomiris®, and Phase III clinical trials was approved for PNH and Myasthenia gravis patients. There is high probability of becoming available in the domestic market the end of next year. The MFDS(Ministry of Food and Drug Safety) approved Ravulizumab’s (generic for Ultomiris®) multi-state models in clinical trials. The Clinic trial is proceeded in SNUH, Severance Hospital, SMC. And, The test client is INC Research. Domestic subjects are 8 patients, and it will progress clinical test on until next September. Prior to this, multi-state models in clinical trials for myasthenia gravis patients without administering C5 complement inhibitor evaluating saftey and efficacy in was approved. Domestic subjects are 7 patients, and the Clinic trial is proceeded in 6 medical institutions including SMC. Handok retains the reimbursement and dometic approval for Ultomiris®. Also, the company imports and sell Soliris®, PNH treatment. Alexion, original developer is targeting domestic approval of Ultomiris® by the end of next year. Alexion received FDA approval forUltomiris® last December, and EMA approval this July, too. Ultomiris® improved medication compliance compared to Soliris®. Ultomiris® is injected every 8 weeks, while Soliris® is injected every 2weeks. Soliris®is very expensive, and the RSA(Risk Sharing Agreement) was ended in last October. The pharmaceutical price is ₩5,130,000 per 300mg /30ml bottle. It costs ₩5 billion annually per patient, and IQVIA’s Standard sales was ₩41.5 billion last year. It seems that they put a high price on Ultomiris®. Reimbursement negotiation is expected to be the key to market release.
- Policy
- DREC passes Imfinzi, Liporaxel ‘conditional'
- by Kim, Jung-Ju Nov 11, 2019 10:41pm
- AstraZeneca AstraZeneca’s immunotherapy Imfinzi (durvalumab) passed the first threshold to receive its insurance reimbursement in Korea. The treatment is soon to initiate its negotiation with National Health Insurance Service (NHIS) under the order of drug pricing negotiation by Ministry of Health and Welfare (MOHW). On the other hand, Daehwa Pharmaceutical’s stomach cancer treatment Liporaxel (paclitaxel) received a conditional right to initiate a drug pricing negotiation with NHIS, when the drugmaker accepts proposed evaluated price (weighted average) by Health Insurance Review and Assessment Service (HIRA). In the morning of Nov. 8, HIRA published results of Drug Reimbursement Evaluation Committee (DREC) meeting convened on Nov. 7, deliberating insurance reimbursement feasibility review applications. First, Imfinzi is approved for the treatment of locally-advanced non-small cell lung cancer following chemotherapy and radiation therapy. Unlike other immunotherapy, Imfizi specifically targets Stage III lung cancer. DREC reviewed reimbursement feasibility of the treatment and passed it, 11 months after the application was submitted. Liporaxel is a new anticancer treatment, improving inconvenience of Taxol as an oral regimen. But the Korean regulator once denied reimbursement on the treatment last year. In the latest deliberation, Liporaxel was granted with conditional non-reimbursement status. The treatment’s efficacy was well noted but it came down to the issue of relatively high cost than other alternative drugs. When the pharmaceutical company proposes a price lower than HIRA’s feasibility-evaluated price, the drug is to receive reimbursement.
- Policy
- World's most expensive drug Zolgensma to challenge Spiranza
- by Lee, Hye-Kyung Nov 11, 2019 06:11am
- Launching of the most expensive drug in the world, Zolgensma (onasemnogene abeparvovec-xioi), with a price tag of 2.5 billion won per dosage, has gotten Korean health authority and pharmaceutical industry anxious. Although the drug had an allegation of data manipulation from animal testing two months after the U.S. Food and Drug Administration’s (FDA) approval, the industry experts see Zolgensma would enter Korean market soon as the allegation is unlikely to cancel its approval. In last May, the U.S. FDA approved Zolgensma, indicated for the treatment of pediatric patients less than two years of age with spinal muscular atrophy (SMA) with bi-allelic mutation in the survival motor neuron-1 (SMN1) gene. Also, its applications for Fast Track, Breakthrough Therapy, Priority Review and orphan drug were granted. But the treatment has not been introduced to Korean market, yet. The drug is a gene therapy designed to target the genetic root cause of the Type 1 SMA through one single session of therapy. Meaning, one injection of the therapy replaces the function of the missing or nonworking SMN 1 gene with a new, working copy of a human SMN gene and prolongs patient’s overall survival. Institute for Clinical and Economic Review (ICER), a U.S. based organization reviewing drug’s cost-effectiveness, set Zolgensma’s price at USD 90,000 (about 95 million won), but the drugmaker claimed it should be four million to five million dollars (about 5 billion won), because it is an one-time treatment. Currently, Zolgensma is sold in the U.S. for 2.1 million dollars (about 2.5 billion won), and the pharmaceutical company provides an option of five-year installment with an yearly payment of 425,000 dollars, with partial refunds if it does not perform as expected. Followings are major motor milestones of the final result of clinical study on 12 SMA Type 1 patients with the onset of clinical symptoms before six months of age (average age of 3.9 years, as of March 8, 2019); all patients at the 24-month study closeout, survived and are free of permanent ventilation; 11 patients were able to hold their head erect for three seconds and longer, and sit without support for five seconds and longer; ten patients were able to sit without support for ten seconds and longer; nine patients were able to sit without support for 30 seconds and longer; two patients were able to stand alone, walk with assistance and walk alone. The key results resemble that of Spinraza, listed on Drug Reimbursement List in Korea as of April 8, this year. In 2016, the US FDA granted approval on Spinraza, an antisense oligonucleotide (ASO), for treating SMA caused by mutations in chromosome 5q. At the point of approval, ICER evaluated price of first year Spinraza therapy to be 750,000 dollars (about 800 million won), and 350,000 dollars (about 400 million won) from second year and on. As of now, Spinraza is covered by National Health Insurance (NHI) in Korea with risk sharing agreement (RSA), and its price cap for a single vial (5ml) is at 92,359,131 won, and patient copayment is about 9.23 million won, a ten percent of the full price. Reimbursement is granted for patients with SMA caused by mutations in chromosome 5q satisfying all conditions of preliminary review. The conditions include, patients diagnosed with absence or mutation of SMN1 gene, having onset clinical symptoms of SMA from age of three or less, and not using permanent ventilation (more than 16 hours a day continuously for more than 21 days). Spinraza is an intrathecal injection, administering four loading doses of 12mg (5ml) into cerebrospinal fluid. The first three loading doses should be administered at 14-day intervals. The fourth loading dose should be administrated 30 days after the third dose. A maintenance dose should be administered once every four month thereafter. In July, Spinraza published an interim report of 60-month long-term Phase 2 NURTURE clinical trial. NURTURE is an ongoing Phase 2 study of 25 infants with the genetic mutation of SMN, who received their first dose of the drug in a pre-symptomatic stage and before six weeks old. 45.4 months into the trial, all 25 patients have survived without permanent ventilation and are able to sit without support. Apparently, 88 percent (22 patients) can walk without support, suggesting the drug could be effective for infants not showing SMA symptoms, yet. SMA is a rare recessive neuromuscular disorder caused by bi-allelic mutation in the SMN1 gene’s chromosome 5q. The disorder causes a deficiency of motor neuron protein called SMN, and about 95 percent of people with SMA have onset symptoms when SMN1 gene mutates. SMN1 gene mutation reduces production of SMN protein as downstream processing from DNA to RNA cannot develop enough SMN gene, and also it induces apoptosis of anterior horn cell causing degenerative change in motor neurons, which leads to a relatively fast progression and symmetrical muscle weakness resulting in early death. Reported estimated incidence rate of the condition is one in 6,000 to one in 10,000 live births and carrier frequency is about 1/40-1/50. Infants with symptoms are unable to independently move as they lose motor function due to muscle degeneration. Infants with SMA have the highest severity and frequency, which their symptoms are prevalent from birth or around six months after the birth. These patients with severe case rapidly lose motor neuron, in control of activities like breathing, swallowing, speaking and walking, and without a treatment their muscles weaken fast and die from respiratory failure, as even their respiratory root loses its function by the age of two. Currently Spinraza and Zolgensma are only two SMA treatments available. Spinraza is a SMN2-directed ASO, approved to treat 5q SMA with its results of ENDEAR study. Whereas Zolgensma is a gene therapy that replaces missing or mutated SMN 1 gene, and was approved to treat children less than two years of age having bi-allelic mutation in SMN1 with results demonstrated in STR1VE study. Zolgensma had a comparatively small-size clinical trial than Spinraza, which demonstrated its efficacy in Type 1 patient before the age of six months and Type 2 and 3 patients at the age of two to 12 with onset symptoms from six months after birth. On the other hand, Zolgensma can only be used for SMA patients before the age of two. As for their pricing, Spinraza is priced at around 100 million won per injection and needs continuous administration, but a single-administration therapy Zolgensma is priced at around 2.13 million dollars (about 2.52 billion won) per injection. Zolgensma currently holds the title of the most expensive drug in the world for the price of single dosage. However, Spinraza and Zolgensma still need more research and follow-up monitoring on the drugs’ efficacy and safety through long-term clinical trials. There are also needs for more reasonable pricing for better treatment access.
- Policy
- On a mission to eradicate KOEDC’s deep-rooted ill practice
- by Lee, Jeong-Hwan Nov 10, 2019 10:00pm
- Sources confirmed Korea Orphan and Essential Drug Center (KOEDC) submitted the National Assembly (NA) a plan to resolve its issue of redirecting profit made from drug expense gap, as it was pointed out at the latest NA Annual Audit. The center is committed to eradicate its deep-rooted practice of making profit from drug price difference and reusing it as the center’s budget. However, some point out the center would eventually need significantly increased budget approved by the center’s affiliated government body, Ministry of Food and Drug Safety (MFDS) and Ministry of Economy and Finance (MOEF). On Nov. 6, NA Health and Welfare Committee lawmaker, In Jae-Keun’s office explained “KOEDC submitted a proposal to cease their ill practice of redirecting unfairly made profit”. By the end of the year, KOEDC plans to compile ‘Evidences for Drug Pricing Readjustment Application’, needed to remove profit from drug price differences. Until February next year, KOEDC is to initiate a negotiation with Health Insurance Review and Assessment Service (HIRA) on modifying drug pricing, and in March, it would execute a lump-sum reevaluation on drug price gap. The center claims it would be done with redirecting drug pricing gap profit to budget use after HIRA completes drug reimbursement listing procedure by December next year. Newly appointed KOEDC Chairperson Yun Young Mi is reportedly determined to eradicate unethical practice within the center and normalize its internal management. As a matter of fact, KOEDC has been under a criticism for last five year on re-utilizing 6.5 billion won, made from differences in orphan drug’s actual transaction price and National Health Insurance Service (NHIS) billing price, as the center’s budget. The center official explained the practice actually has been a solution to MFDS’ insufficient budget support rate of average 37 percent. Although the center has consistently confessed of abnormal use of drug price differences and urged MFDS to boost its budget support, KOEDC did not get any answer. So in the end, it is up to MFDS to allocate budget support for the center to ultimately resolve the budget redirecting practices, according to the plan submitted to the NA. Apparently, the center used drug price differences of about one billion won every year as their organizational operation expense. But after HIRA’s adjustment on the drug pricing, the center would lose budget of one billion won. However, it is not going to be an easy ride. KOEDC has already asked for next year’s budget of 14.03 billion won, but the government only passed about 17 percent of the requested amount, 2.39 billion won. The NA is already reviewing the government’s next year budget plan, but the Health and Welfare Committee’s ‘Budget and Accounting Evaluation Subcommittee’ and ‘Budget Deliberation Special Committee’ have not yet made a decision on whether or not to increase KOEDC’s budget. Even after the committees decide to increase the overall budget, the key to the problem is then passed to MFDS and MOEF’s decision to provide the center’s requested budget. KOEDC official said, “A number of lawmakers at the NA Health and Welfare Committee audit session demanded the government to work on the center’s drug price gap profit redirecting issue, insufficient budget and low government support funding rate. For the center to operate properly, the addressed issues have to be resolved completely, and it ultimately comes down to the matter of budget allocation. The center would do its best waiting for the NA make a decision.” “For now, Health and Welfare Committee is to request Budget Deliberation Special Committee to consider increasing budget for KOEDC basic operation expense, personnel expense, and regional center operation expense. As the center’s issue of redirecting profit from drug price difference has been addressed, the lawmakers have asked MFDS to submit a solution to KOEDC’s problems,” an official from Lawmaker In Jae-Keun’s office commented.
- Policy
- Eliquis faces 42 generics after patent invalidated
- by Lee, Tak-Sun Nov 10, 2019 10:00pm
- The list of generics launched in the New Oral Anticoagulant (NOAC) Eliquis (apixaban) market is getting longer by the day. Especially after generic manufacturing companies won the case invalidating Eliquis’ patent in last March, number of regulator-approved generics has skyrocketed. Ministry of Food and Drug Safety (MFDS) confirmed that the total number of MFDS-approved apixaban medicine products as of Nov. 6, including the original Eliquis by BMS, is 84 supplied by 42 companies. 19 companies supplying 38 items have been approved by the ministry after the patent was invalidated at a court decision. Daewoong Bio and GC Pharma are a few of latest additions. At the moment, 38 items by 19 companies are listed with reimbursement and competing in the same market. After winning the patent invalidation case, Chong Kun Dang, Alvogen Korea, Huons and Yuhan immediately applied for reimbursement listing and entered the market from last June. Other freeloading pharmaceutical companies did not participate in the patent litigation, but decided to launch their generics expecting the patent to be invalidated. More generics are projected to be released in the future based on the number of approved products. Currently, an appeal against the patent invalidation decision has been filed but is pending at the Supreme Court. But as generic companies won both first and second trials, the Supreme Court would likely to rule in favor of the generics. On Oct. 18, the Supreme Court dismissed a trial on a medicine patent invalidation case, finalizing the previous judiciary decision to invalidate the patent. In other words, the generics sales would not have any legal barrier against sales, when the Supreme Court decides to invalidate the medicine patent. As for apixaban market, even the preferential sales approval period on the patent challenger, banning sales of other equivalent generic, has passed already. Three items, including Yuhan Apixaban, were granted with preferential sales period from May 12, 2018, to Apr. 2, 2019, but their actual sales were suspended as BMS’ sales ban application was accepted. Sales ban injunction was lifted only after the Patent Court invalidated apixaban patent. Now the key is on how well generic companies would expand the trending NOAC market. Among all NOAC medicine, only Eliquis has generic competitors. As NOACs are mostly used in general hospitals, Korean generic companies are focusing on the clinic market instead. But it seems like it would take some time for NOAC generic market to fully flourish. Since its sales started from June, Chong Kun Dang’s Liquisia made disappointing sales of 178.35 million won (Source by UBIST) until September. Meanwhile, the original Eliquis reaffirmed its market leadership by making accumulated prescription sales of 31.3 billion won by September, hiking up 32.1 percent from the year before.
