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- 2025-12-26 13:07:30
- Policy
- Janssen prepares to close Hyangnam plant, renewing licenses
- by Lee, Tak-Sun Jan 29, 2020 06:27am
- Janssen Korea is to close Hyangnam plant in 2021 and the company is speeding up the process of transferring items manufactured in Hyangnam to other facilities. Apparently some of them would be transferred to other Korean manufacturing companies, whereas some would be manufactured abroad and imported to Korea. As of Jan. 28, Korea’s Ministry of Food and Drugs Safety (MFDS) cleared Janssen Korea’s antipsychotic medicine, Invega (paliperidone) ER tablet in 3 mg, 6 mg, and 9 mg doses. These items are the same items approved back in April 2010. But the newly approved items would be imported to Korea, unlike the previously approved ones manufactured in Hyangnam plant. Janssen Korea has preemptively notified the change to drug distribution channels in Korea and forewarned the drug supply would be suspended until coming May. With the new license in Korea as an imported drug, Invega is expected to be listed for reimbursement from April. UBIST reported Invega has generated 2.3 billion won in Korea for outpatient prescription last year. The drug manufacturing plant is reportedly moving to Italy from Hyangnam, Korea. And the global company would obtain more new drug import licenses, as Janssen has notified Jurnista SR tablet and Topamax springkle capsule would also be manufactured abroad and imported back to Korea. The existing license on Invega has been returned as of passed Jan. 17. Janssen Korea canceling the license and leaving void period in between licenses are inevitable at the moment. Regardless, Invega Sustenna injection would be supplied without a break. Invega Sustenna, unlike the tablet form, was approved as an imported drug in July 2010. Janssen has already registered the injection’s DMF with Irish and Belgian plants as manufacturer of active ingredient paliperidone. Some items are transferring to other Korean manufacturers. Pain reliever Ultracet is transferred to Handok, and gastro-oesophageal reflux disease treatment Pariet is running bioequivalence test for approval to be transferred to Kolmar Korea. And Tyrenol 8-hour ER tablet is highly likely to be transferred to Handok. Janssen’s Hyangnam plant, built in 1983, would stop its production life of 38 years after a year. As it was the center of global drug manufacturing plant in Korea, the Korean pharmaceutical industry is left with bittersweet sentiment of the plant.
- Policy
- Korea-Switzerland promulgated an AMR on GMP
- by Lee, Jeong-Hwan Jan 29, 2020 06:26am
- The AMR (Agreement on Mutual Reliance) on GMP (Good Manufacturing Practice) between Korea and Switzerland was promulgated on the 23rd. It is a follow-up after the MFDS (Ministry of Food and Drug Safety) signed a GMP agreement with the SWISSMEDIC (Swiss Drug Agency) on December 18 last year. The agreement promulgated the mutual recognition that strengthening cooperation between Korea and Switzerland would mitigate trade barriers and create mutual benefits. Above all, it reaffirmed its importance in promoting international trade between the Republic of Korea and Switzerland and ensuring the global supply chain integrity of pharmaceuticals and the production of high quality pharmaceuticals. In conclusion, the results of the GMP survey between the MFDS and the SWISSMEDIC can be replaced by a GMP certificate issued in the country. Trust article in the GMP agreement between Korea &Switzerland This shortens the registration period for domestic pharmaceutical and bio companies by exempting GMP evaluation from the SWISSMEDIC. The GMP requirements apply to all human medicines, including investigational medicinal products (IMPs), active pharmaceutical ingredients (APIs), chemicals, biologics (including biologicals) or herbal preparations. Switzerland is one of the strongest pharmaceutical groups in A7 countries, and Korea's GMP system and management level is equivalent to that of Switzerland, which means that Korea's regulatory capacity and pharmaceutical industry are internationally recognized. The A7 countries are the United States, the United Kingdom, France, Germany, Italy, Switzerland, and Japan, which are advanced pharmaceutical countries that are used when deciding or reassessing domestic drug prices. As the ratification takes effect, Korean pharmaceutical companies are exempt from GMP due diligence when exported to Switzerland, and it is expected that market entry will be easier due to cost reduction and shortening of the permit period. In particular, as pharmaceutical quality management and regulatory levels are recognized by Switzerland, the possibility of equal treatment in the European market increases. so it will be a good opportunity for Korean pharmaceuticals to enter the European market.
- Policy
- Hanmi’s salt-modifying drug for Galvus was approved
- by Lee, Tak-Sun Jan 29, 2020 06:25am
- A salt alteration drug of Galvus(Vildagliptin) by Hanmi, a DPP-4 inhibitor for diabetes was approved. But one indication in the original drug is excluded. It is understood as a strategy to avoid patent The Ministry of Food and Drug Safety approved the generic product (50mg) for Galvus by Hanmi. Unlike the original galvus, this generic has the HCl of the main ingredient, Vildagliptin. There are four efficacy and effectivess (indications) of Vildagle tablet 50mg including ▲monotherapy as an adjunct to diet and exercise therapy to improve glycemic control in patients with type II diabetes, ▲combination with Metformin if no prior diabetes medication has been received and monotherapy is not enough to control blood sugar, ▲concomitant use with Vildagle if Sulfonylureas and Metformin combinations do not provide sufficient glycemic control, ▲and combination with Vildagle when Insulin (Insulin alone or with Metformin) therapy does not provide sufficient glycemic control. One indication, which is concomitant use in case of Sulfonylurea, Metformin or Thiazolidinediones monotherapy does not provide sufficient blood sugar control, is missing compared to the original Galvus 50 mg. This is due to the fact that the Galvus’ Material Patent received an extension of its duration (2 years 2 months 23 days). One of the indications is excluded that Concomitant use is possible for insulin-independent diabetic patients (type II), if diet and exercise therapy are not sufficient to control glycemic control with Metformin, Sulfonylurea, or Thiazolidinedione alone. In other words, with the exception of the indication, it seems to be a strategy to circumvent the scope of rights of the extended patent for material and to release the product at the time of expiration of the material patent (December 9 2019). Hanmi requested a passive judgment on the scope of the rights of Galvus in December last year. If the claim is quoted, the reimbursement process can be used to bring the product to market immediately. This is a different strategy from Ahn-gook Pharm, which was previously approved for the same ingredient. Ahn-gook obtained the same indication as the original Galvus 50mg with Ahn-gook’s generic drug. Instead, due to the problem of extending the life of the material patent, it succeeded to invalidate 187 days of the extended 2 years 2 months 23 days. Thus, it became the sales base from August 30 2021. In addition, the company obtained a successful patent challenge and a generic monopoly 'generic exclusivity' granted to the first applicant. In order for Hanmi to release its products earlier than Ahn-gook, it must be cited by the passive jurisdiction checker who claimed at the end of last year. Hanmi also co-sold Galvus with Novartis in 2014. It is important to note whether the company will compete as a competitor in the former peer market through patent evasion.
- Policy
- Tarlige, pain reliever & Smyraf, RA treatment approved
- by Lee, Tak-Sun Jan 28, 2020 06:13am
- New drugs such as Tarlige (Mirogabalin besylate by Daiichi Sankyo, Korea) used for the treatment of peripheral neuropathic pain and Smyraf (Peficitinib hydrobromide, Korea Astellas Pharmaceutical) for rheumatoid arthritis received domestic permission at the same time . They are expected to compete with existing products of the same family. The Ministry of Food and Drug Safety approved two new drugs on the 23rd, including 2.5mg, 5mg, 10mg, 15mg and 50mg of Tarlige, & 100mg of Smyraf. Both drugs were made by Japanese global pharmaceutical companies. Tarlige has the efficacy(indication) of treatment of peripheral neuropathic pain. The dosage and dose is usually administered orally 5mg/day twice daily for adults. Multi-national trials showed that 824 patients with diabetic peripheral neuropathy (DPNP) had double-blind, phase III trials performed in Asia for 14 weeks (1 to 2 weeks of dosing and 12 to 13 weeks of fixed dose). In the clinical trials, the group of 30 mg of Mirogabalin/day (15mg twice daily) showed a statistically significant improvement in the pain score at week 14 compared to the placebo group. The main ingredient, Mirogabalin, is a Gabapentinoid-based drug that acts on the calcium channel apa2-delta ligand and reduces the secretion of neurotransmitters involved in pain. Pfizer's Neurontin capsules (Gabapentin) and Lyrica capsules (Pregabalin) have the same mechanism. As a result, Mirogabalin is likely to compete with them. However, it is expected in the medical field for new drugs, since both Neurontin and Lyrica are patent expired drugs. According to the drug market researcher UBIST, in 2019, Neurotin recorded ₩ 19.5 billion and Lyrica recorded ₩62.7 billion in outpatient prescriptions. Smyraf is a JAK inhibitor, such as Pfizer's Xeljanz (Tofacitinib). JAK inhibitor is a drug that blocks the arthritis molecule and improves symptoms by inhibiting the enzyme neurons, Januskinase (JAK), and it is an oral rather than injection as a treatment for rheumatoid arthritis. Currently, there are two items in the same category, including Xeljanz and Lilly's Olumiant (Baricitinib). Smyraf is used to treat moderate to severe active rheumatoid arthritis in adults who do not adequately respond or tolerate one or more anti-rheumatic agents (DMARDs) and may be co-administered with Methotrexate or other abiotic rheumatic agents (DMARDs). However, it should not be combined with potent immunosuppressive agents (except topical therapies) such as biological antirheumatic agents or other Janukinase (JAK) inhibitors. It has a recommended dose of 100mg once a day after meals, and it seems to be more competitive than Xeljanz administered twice a day. However, Lilly's Olumiantis is also once daily use. In a multi-regional phase III trial in 500 patients with rheumatoid arthritis that did not respond properly to existing anti-rheumatic (cDMARDs) formulations including Methotrexate, Smyraf had a higher treatment rate compared to placebo and a statistically significant difference. According to last year's JAK inhibitors, Xeljanz recorded outpatient prescriptions of ₩4.3 billion based on UBIST and ₩500 million of Olumiantis. However, due to the rapid growth of this category of drugs, the market size is expected to expand further with the emergence of Smyraf.
- Policy
- Finally a complete revision of PE guideline after 8 years?
- by Lee, Hye-Kyung Jan 28, 2020 06:12am
- After long eight years, the Korean health authority seems to finally accept the pharmaceutical industry’s demand to amend the pharmacoeconomic analysis guideline. Health Insurance Review and Assessment Service (HIRA) recently unveiled a final report on the cosigned research regarding ‘Pharmacoeconomic (PE) Analysis Guideline Revision Plan (Principal investigator: Professor Lee Tae-jin of Seoul National University Health Science Department and Professor Bae Eun Young of Gyeongsang National University College of Pharmacy).’ Aiming for a ‘complete revision’ of the PE analysis, HIRA has started the research from last year. The research report, disclosed on Jan. 22, found countries the Korean PE analysis guideline refers to, such as the U.K., Australia and Canada, have entirely amended their guidelines after 2011. And it claimed the Korean PE analysis guideline should also reflect the developed PE analysis methodology and precedents that the other countries have based since 2011. The research team conducted a survey on stakeholders like pharmaceutical industry organization, patient and civic group, and related scholars, from July to September last year. The team convened consultative meeting with Korean Research-based Pharmaceutical Industry Association (KRPIA), Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA), Korea Biomedicine Industry Association (KoBIA), Korea National Council of Consumer Organization, National Council of the Green Consumers Network, Korea Consumer Agency, National Health Insurance Policyholder Forum, Korean Association of Health Technology Assessment (KAHTA) and other experts. The survey helped the research team to limit the scope of guideline revision down to perspective of revision, analysis period, analysis subject and population group, analytic techniques, comparison subject selection, data source (indirect comparison), items of cost, utility (health related quality of life), discount rate, model construction, and uncertainty. The team recommended the guideline to remove ‘financial impact’ article, but to add ‘statistical consideration (estimated long-term effect, treatment switching (cross over) and etc.)’ and ‘analysis guideline for laboratory test drug.’ ◆ Cost: As the article of cost in PE analysis depends on the perspective, the researchers recommended using healthcare perspective instead of the existing limited societal perspective, as well as only including direct medical expense and excluding non-medical expense (transportation cost, time cost, nursing guardian cost and etc.) for the basic analysis. In the PE analysis material submitted to this date, expert’s opinion takes up the majority of data source with seven cases (14 percent) in diagnostic cost and five cases (ten percent) in treatment cost. Compared to data-focused referential material, expert opinion or cost and resource use quoted from hospital investigation have limited credibility or consistency. Therefore, referencing expert opinion should require official statement of an academic society, or stipulated minimum number of expert panel to improve credibility and consistency. Although the existing guideline does not mention drug wastage, the researchers suggested stating the cost of wastage volume, because it generates noticeable amount of expense. ◆ Utility, the healthcare related quality of life: Rounding up the recommendations made by HIRA, pharmaceutical companies, and civic groups, the researchers said following articles in the guideline about ‘utility’ should be revised; prioritization of utility measuring techniques; Health-related quality of life (HRQL) indicating tool and reviewing tariff selection; detailed guideline on mapping; detailed guideline of direct measuring; and additional review on minimal clinically important difference of utility. Recommending the revised guideline to clarify preference of indirect measurement based on the Health Technology Assessment (HTA) of many other countries, the researchers also suggested using health state vignette-based direct measuring, calculating weighted value of quality of life via mapping, or quoting a value proposed in a published literature, as an option when lacking or having limited data quoted from preference-based measuring tool. About reviewing and selecting HRQL tool and tariff, they argued the health authority should select a single set of tool and tariff to ensure consistency in policy-making process. ‘Tariff’ means the value that converts utility value in foreign country to fit the Korean landscape. The primary recommendation is to select EQ-5D-3L, a tool used the most home and abroad so far, as a single tool and to select tariff developed in the most recent study ‘Lee et al. (2009)’ with the largest sample as a standard tariff. However, the team also proposed keeping the existing guideline as a secondary option, because a proper comparison study or qualitative evaluation on HRQL tool and tariff in Korea has not been conducted, yet, and related empirical data are insufficient. ◆ Discount rate: According to 50 cases of PE analysis material submitted to HIRA, 45 cases (90 percent) have been discounted and five cases (10 percent) have not been discounted. The analysis period of the five cases was apparently under a year. The researchers stated the discount rate for PE analysis should be reduced as well, because the social discount rate continues to descend due to changes in socio-economic conditions. Hence, the report suggested the revised guideline should set 4.5 percent as an adequate level of discount rate, equivalent to the discount rate applied on preliminary feasibility assessment. About applying the same discount rate on the cost and result, the report tried to persuade applying the unchanged rate, but applying either zero percent for no discount or three percent discount rate to analyze sensitivity. Applying the discount rate of 4.5 percent for the entire period of basic analysis was suggested in case the period of PE analysis for the healthcare sector is longer than three decades. But also as a sensitivity analysis, 3.5 percent could be applied after 30 years in case the applicant drug is essential for pediatric treatment. ◆ Perspective: Taking in account the state and realistic environment of reimbursement decision making, the researchers argued the analytic perspective should be amended. Keeping in mind the interest of reimbursement listing reviewer is on the impact on the healthcare sector, the research team first recommended shifting the perspective from limited societal perspective to healthcare perspective and excluding items applicable for direct medical cost from the basic analysis. So the cost should cover items centering the direct medical expense, but it should include nursing if the cost is reimbursed from long-term nursing insurance, whereas the effect should reflect benefit of health on the patient. The secondary proposal suggested was maintaining the current guideline. ◆ Analysis period: The current guideline recommends the analysis to be conducted long enough to confirm major clinical endpoints. The research team studied deliberation cases of similar diseases and contemplated on patient age (cohort joining age), expected life expectancy of general population group, patient’s survival rate, analysis period of similar drugs, clinical trial outcome (median OS), monitoring period, clinical consulting, and uncertainty for calculating analysis period. The team advised to maintain the principal approach of the existing guideline, but to consider validity of calculated analysis period. Also the team elaborated the revision, when comparing with other countries’ guidelines, should take in account the age of applicable population, life expectancy, survival rate based on epidemiological data, median OS observed from clinical trial, difference in survival rate between cohorts, monitoring period, numerous uncertainties inserted in model, similar drug evaluation case or cases in referential countries and expert consulting. ◆ Analytic techniques: The current guideline recommends using cost-utility analysis when quality of life is a crucial aspect or the health outcome is demonstrated in various indicators. But the research team claims the guideline should provide more specific standard or analytic techniques to distinguish equivalence of effect. They first advised offering more detailed guideline on selecting subject for cost-minimization analysis, expense item and submission data to be considered when conducting the cost-minimization analysis. Regarding subject for cost-minimization analysis, the researchers recommended clarifying the cases of the drug effect is non-inferior (or superior) and recognizing the non-inferiority of the applicant drug in safety profile. As for the cost estimation, the guideline should set equi-effective doses and provide cost of comparing options’, as well as other costs estimated from monitoring, adverse reaction relief, and others. The secondary recommendation is to exclude cost-minimization analysis from the analytic techniques. The researchers explained it would theoretically eliminate the issues of effect equivalence and uncertainty. ◆ Subject of comparison: The existing guideline stipulates selecting alternative treatment option with the highest market share as a reference. When there are multiple drugs with similar market share, multiple options can be selected for comparison, and other therapy and surgery can be used as reference if there is no other alternative option. The referential option selection has been an issue raised by the pharmaceutical industry for a long while. The Korean guideline clearly states to select a substitutable option with the highest market share, but many of other countries’ guideline does not specify “the highest market share.” As a primary recommendation, the researchers suggested keeping the basic principal of selecting the ‘most used’ drug for comparison, but to loosen the description of ‘highest market share’ to prioritize replaceability when selecting a referential treatment option. The majority of the researchers were negative about providing a range of options like in Australia or limiting the option to reimbursed treatment, but they agreed on having government committee to discuss or negotiate with pharmaceutical companies based on submitted PE analysis material and market status. However, the team put down a precondition that comparing with existing treatment option, which fails to treat health condition but has no other option, is ‘not automatically neglected from referential candidate list.’ ◆ Data source: The HIRA’s guideline barely mentions of indirect comparison, but a separate indirect comparison guideline is used to accommodate, and the government agency has already opened up about possibly accepting simple comparison of drugs as they reflected stakeholders’ demands, since the 2014 revision. The researchers elaborated “It could be seen that it was actually more lenient than other countries’ guidelines,” and advised that the revised guideline should edit the detailed guideline and supplementary explanation in a wider sense.
- Policy
- Unfair profit of orphan drugs will be readjusted
- by Lee, Jeong-Hwan Jan 23, 2020 06:15am
- The KOEDC (Korea Orphan & Essential Drug Center) took the first step toward improving the 'profit for difference' of urgently imported drugs, which had been disputed for over 20 years. The KOEDC will soon discuss the detailed procedures for drug price adjustments with the Ministry of Health and Welfare & the HIRA, for the purpose of permanently eliminating the profits from urgently imported drugs. In particular, The KOEDC are considering not only one-time drug price adjustment, but also regularizing the re-adjustment system every six months or one year. An official of the KOEDC said on the 20th, “We are currently selecting drugs that need to adjust the price due to the large difference in profits, and apply for collective price adjustment by next month after meeting with the Ministry of Welfare and the HIRA”. The problem of unfair profit of orphan drugs is regarded as chronic disease. If the KOEDC unveils the policy of price restructuring, the illegal disputed earnings will soon disappear. In last year's National Assembly audit, many members of the parliament have pointed out that the KOEDC spent about ₩6.5 billion on unfair profits for the past five years and spent it on institutional expenses. In response, Young-mi Yoon, the president of the KOEDC, embarked on a discussion on rebalancing of drug costs with the HIRA to fundamentally solve the problem of drug price gaps and delivered a plan to eliminate the proceeds. Proceeds will be generated when the center purchases insurance contracts of emergency drugs from abroad and imports them into Korea. For example, the profit generated when the center buy ₩10,000 abroad for a orphan drug with a domestic insurance price of ₩20,000 is ₩10,000. Indeed, the difference between the import price of a drug and the high insurance price is the profit, but there is a problem that the national budget and national tax, the cost of health and pharmaceutical drugs, are unnecessarily wasted. There are a total of 17 insurance-listed items in Korea. The KOEDC will select the item with the largest drug price difference, apply for the drug price adjustment to the Ministry of Health and Welfare and is to eliminate controversial proceeds. In detail, the center plans to complete the request for price re-adjustment next month after a selection of drug price-adjusted items reflecting the changes in the total price of drugs and the VAT for each item through the meeting with the HIRA related officials. Drug rebalancing is the process by which the KOEDC re-adjust urgent import drug prices that is out of the range. In addition, the center also planned to regularize the drug price adjustment system. It is a policy to enforce the price adjustment repeatedly for all of the urgent imported drugs handled every six months or one year. The center official said, "We will re-adjust drug prices sequentially from items with large difference in profits as discussed with the Ministry of Health and Welfare, and currently reorganizing the entire 17 listed urgent imported drugs, as well as planning regular realignment procedures for 6 months or 1 year".
- Policy
- SK Chemicals’ hemophilia drug Afstyla wins MFDS approval
- by Lee, Tak-Sun Jan 23, 2020 06:15am
- Hemophilia treatment Afstyla, developed by SK Chemicals, has won an approval for sales in Korea. The drug has licensed out its technology to Australia-based CSL in 2009. Ministry of Food and Drug Safety (MFDS) has authorized commercialization of Afstyla (lonoctocog Alfa (recombinant Factor VIII)) on Jan. 20. The licenser is Zanovex Korea, a subsidiary of global pharmaceutical distributor Zuellig Pharma. SK Chemicals’ blood product-manufacturing subsidiary, SK Plasma would be in charge of the sales in Korea. The U.S. Food and Drug Administration (FDA) granted approval on Afstyla in May 2015, and European Medicines Agency (EMA) also approved the treatment in January 2017. In Australia, where CSL is based, the treatment received the approval in April 2017. The Korean-developed treatment was approved first in overseas and entering the Korean market later. The drug is a recombinant factor VIII single-chain therapy for hemophilia A, developed by SK Chemicals. After the preclinical phase, the technology was licensed to Australia’s biotechnology firm CSL for all clinical trials. Existing hemophilia A treatments had two separate proteins combined, but Afstyla forms one whole structure with two proteins that improves stability of the treatment significantly and provides an option of twice-weekly dose. Compared to existing treatment options, the treatment apparently has enhanced productivity by ten-fold and doubled the stability. Specifically, Afstyla has doubled the duration of action of alternative options, and shows effect with only administration of twice or three times a week. Most of other hemophilia treatments are administered three to four times a week. However, some say Afstyla’s launch in Korea is late in the game as a once-weekly subcutaneously injected hemophilia treatment was approved in Korea last year and other Korean pharmaceutical companies like GC Pharma are developing investigational drugs. The hemophilia A treatment market in Korea is estimated to be around 150 billion won. While CSL is in charge of Afstyla’s global sales, SK Chemicals receives royalty on global sales and payment for agreed sales milestones. The Korean company is estimated to have earned approximately 6.5 billion won from Afstyla royalty last year.
- Policy
- Pfizer, challenges Velcade’s generic market
- by Lee, Tak-Sun Jan 22, 2020 10:47pm
- Pfizer will show anticancer generics (Pfizer Bortezomib, generic for Velcade) used in multiple myeloma. It is expected to compete with the original drug by Janssen and six domestic generics. The MFDS approved the Pfizer Bortezomib 3.5 mg of Pfizer Korea on the 21st. It is the same ingredient of Janssen Korea’s Velcade (Bortezomib). The difference is that the velcade is attached to the trimer, while the Pfizer’s Bortezomib has monohydrate attached to the main component. In conclusion, the same effectiveness is shown for multiple myeloma and mantle cell lymphoma. The original 'Velcade' is a blockbuster drug that generates about ₩10 billion in sales in Korea. In December 2015, the generic market was opened due to patent expiration, but it has maintained its market share due to the characteristics of the cancer drug market that prefers the original. Moreover, it is licensed as a first-line treatment for patients with multiple myeloma. About 8000 patients with multiple myeloma are known in Korea. Multiple myeloma is a type of blood cancer that occurs in plasma cells, the final stage of maturation of B lymphocytes, a type of white blood cell. Symptoms such as bone pain, and symptoms caused by bone marrow dysfunction. Janssen's Darzalex and Celgene’s Revlimid are available. As Velcade's patent expired in December 2015, generics for Belcade by Chong Kun Dang and Samyang Biofarm launched at a low price. Since then, generics for Boryung, ACE Pharma, Korea United Pharm, and Alvogen Korea have been approved. Seven companies are competing, including the original Janssen. Although there are few competitors, generic sales are still small enough to compete the original. An official of the related company said, "Even if there are few competitors because of the original loyalty in the anticancer drug market, there is no room for generics to enter the market." In this situation, Pfizer has challenged the generic market with imported products. Pfizer is showing a variety of anticancer drugs such as Sutene, Xalkori and Ibrance, and is expected to show its competitiveness as a generic because of the high reliability of domestic medical institutions. It is noteworthy that Pfizer will use the success story as generics in the anticancer market.
- Policy
- The leukemia drug 'Venclexta', formulary approved
- by Lee, Hye-Kyung Jan 22, 2020 06:27am
- Venclexta (Venetoclax), a drug used to treat chronic lymphocytic leukemia (CLL) that by Abbvie Korea, got formulary approval. The HIRA announced in December last year that Venclexta 10 mg, 50 mg and 100 mg were adequate for their benefits. Abbvie received Venclexta’s permission from the Ministry of Food and Drug Safety on May 29, and filed a formulary request with the HIRA. Venclexta has been approved as a monotherapy for the treatment of patients with chronic lymphocytic leukemia who are relapsed or refractory to chemoimmunotherapy and B cell receptor pathway inhibitors. CLL is a blood cancer caused by abnormally increased lymphocytes in the blood. In the West, CLL is the most prevalent leukemia, but in Korea, it is a rare disease that accounts for only 0.4-0.5% of all leukemias. On the other hand, the HIRA evaluates the reimbursement adequacy of drugs after deliberation by the drug reimbursement and evaluation committee in accordance with Article 11-2 of the regulation for criteria for providing reimbursed services in the NHI. The final evaluation result may be changed in the event of changes in the specific reimbursement range and standard items of the drug, changes in the permission of the item requested for decision, and withdrawal (cancellation).
- Policy
- Naglazyme RSA ends, 20.6% price cut from March
- by Kim, Jung-Ju Jan 22, 2020 06:27am
- Insurance prices have fallen by more than 20% since March, when Naglazyme (Galsulfaze) by Samoh Pharmaceutical has concluded a risk-sharing contract (RSA) agreement. According to pharmaceutical companies' strategies, such as price competition, there are a total of eight products that will be lowered on their own benefits next month. According to the industry on the 19th, the Ministry of Health and Welfare is pursuing ‘the revision of drug reimbursement list and the upper price limits’. The criteria for application are as follows, but the timing of application differs depending on the product. ◆Naglazyme’s RSA terminated= Samoh’s Naglazyme with the end of the RSA, is applied as regular reimbursement. The drug was not easily covered because it was expensive until now. In the past, the government increased the accessibility by registering the drug in insurance as a refund pharmacy negotiation pilot project, and introduced the RSA in Korea, and maintained the drug access on the RSA track in March 2016 after the end of the project. The RSA contract lasted for four years, and in preparation for the termination of the drug contract, the NHIS negotiated a drug price on a general track with the company. Negotiations were priced at ₩1,492,815 per 5mg/ml, 20.6% lower than RSA price. The new drug price starts in March shortly after the RSA contract expires. ◆Lowered the upper limit due to the price-volume agreement negotiation conclusion= This time, there are a total of 1 drug for which the price is lowered after negotiating with the NHIS. The government is conducting post management of drug prices through Price-Volume agreement linkage, which lowers drug prices by re-negotiating drugs with higher anticipated dosages and claims compared to those listed on drug insurance. Samoh's Vimizim is a new drug that is listed as a drug price negotiation, and the same product group charges are more than 30% higher than the expected billing amount. Price-Volume agreement system(Type Ka) has been applied. Here, the same product group means a drug having the same company name, route of administration, ingredient, and dosage form. The closing price of the negotiations was ₩995,661, 2.3% lower than the previous price. New drug price will be effective from June 1. ◆Voluntary upper limit adjustment (voluntary lowering)= A total of eight items will be lowered as the pharmaceutical company voluntarily decides to lower its insurance price. The government calculates and re-adjusts a manufacturer, a consigned manufacturer, or an importer to apply for a price cut at a price lower than the listed maximum drug price. In general, it is a measure of cuts in line with its policies following market competition. Looking at the items, Chong Kun Dang's Esoduo 40/800mg drops by 14.7% from ₩1,078 to ₩920, and Huon's Cinacal from ₩2,267 to ₩2,020 by 10.9%, respectively. Celltrion’s Truxima dropped 6.1% from ₩871,323 to ₩817,823, and Jinyang Pharmaceutical's Jinicough drops 2.9% from ₩102 to ₩99. New drug pricing will begin next month. ◆Preservation of production cost of shortage prevention drugs= A total of two drugs are designated as shortage prevention drugs or the price has been preserved. The government designates drugs that are necessary for patient care or are not profitable and that manufacturers, consigned manufacturers, or importers avoid production or import, drugs that require the preservation of production and import costs as a shortage prevention drug and preserves production costs. Myung In Pharm’s Vivaquin is the drug that raised the upper limit due to the conservation of production cost, It is up 21.2% from ₩255 to ₩309. In addition, Shin Poong’s Malafree was designated as a cost-preserving drug. The drug price is ₩309 per tablet. New drug prices will be applied from next month.
