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- 2026-05-17 17:30:44
- Opinion
- [Reporter's view] Improving guidelines excluding PVA
- by Lee, Hye-Kyung Dec 09, 2021 05:58am
- The NHIS announced the revision of Article 6 (1) and (2) of the Price-Volume Agreement (PVA) detailed operation guidelines for "Article 6 (Drugs Excluding Negotiations)." According to the policy, The NHIS guidelines will be implemented immediately after the revision is made, but this time, they will be applied from January 1 next year after inquiring opinions as opposition from the pharmaceutical industry is expected. The revision calls for expanding the "same product group with an annual claim of less than 1.5 billion won" to "less than 2 billion won" in Paragraph 1, Paragraph 2, "items with an upper limit of less than the arithmetic average of the main component code." The NHIS unveiled a plan to improve the PVA (excluding) system at the 10th public-private consultative body held on the 2nd. The reason is that PVA has been reserved for drugs with small insurance financial savings in consideration of the burden of the pharmaceutical industry and administrative costs required to conduct drug price negotiations, but guidelines have been improved due to various problems. When the health authorities made the guidelines in 2014, the standard for making the exclusion clause for PVA was a drug with a small effect on insurance financial savings. While operating PVA for 7 years and 4 months, drugs with a large effect of reducing insurance finances were often excluded from negotiations for reasons below the arithmetic average, or they voluntarily cut drug prices to avoid PVA. These drugs included blockbuster drugs with an annual claim of more than 80 billion won, which went against the PVA system. As a result of the NHIS' analysis of drugs that have avoided PVA negotiations with voluntary cuts within the past two years, a total of 39 drugs have been cut by 1 won, and some of them have exceeded the arithmetic average price. If the NHIS suddenly lowers its arithmetic average exclusion standard from 100% to 90%, the pharmaceutical industry will face a backlash. The NHIS said it has set the PVA negotiations to be omitted if it accepts a 10% drop in drug prices according to the "weighted average of alternative drugs 90%" of the new drug negotiations criteria. Like new drugs, it means to voluntarily cut 10% of the usage, or otherwise proceed with the NHIS and PVA. PVA will be able to proceed smoothly if it is a pharmaceutical company that makes a trick at the arithmetic average price, but it is also understandable that the pharmaceutical industry will protest if the arithmetic average price is reduced by 1%. There is no reason for the pharmaceutical industry to oppose the expansion of claims for the same product group under paragraph (1) 1. If the NHIS' simulation results raise the billing amount from 1.5 billion won to 2 billion won, 23 out of 59 items under the same regulation that completed PVA negotiations this year will be excluded from the list. The NHIS will receive opinions from the pharmaceutical industry on the PVA guidelines containing such information. KPBMA, KRPIA, and KOBIA, which have already participated in public-private consultations, have opposed the revision of the guidelines. There are two main contents of this amendment. The pharmaceutical industry may want only the criteria for expanding the amount of claims to be reflected and the criteria for reducing the arithmetic average to be not reflected. However, the NHIS may not be meaningful in improving the PVA guidelines with just one thing. The association's opinion is important during the opinion inquiry period, but it is also important to reflect the opinions of individual pharmaceutical companies according to their size. This is why it is important for pharmaceutical companies to express their opinions on improving PVA guidelines during this period.
- Policy
- 6 cases of Ultomiris & 1 case of Spinraza were pre-approved
- by Lee, Hye-Kyung Dec 09, 2021 05:58am
- Benefits for pre-approval of six new PNH patients for Ultomiris administration were approved and four cases were rejected. There were no applications for new salary administration for Soliris, but two applications for pre-approval for new aHUS patients were not accepted. In the case of Spinraza, a treatment for Spinal Muscular Atrophy (SMA), one application for new patient benefits and two data supplementations were decided. Of the 25 monitoring reports, 23 were approved and 2 were disapproved. The HIRA conducted deliberation on six items, including Soliris and Ultomiris, and whether hospitalization fees were recognized. According to the results of the deliberation on the 2nd, Soliris decided to approve 33 PNH monitoring applications, to disapprove 2 new aHUS cases, to disapprove 1 retrial, to approve 2 monitoring cases, and to disapprove 1 case. Ultomiris has approved 6 out of 10 new patient approval applications for PNH, 4 disapproval, 3 re-deliberation, and 1 monitoring approval. Soliris is 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price per year alone is 400 million won. Ultomiris was listed at 5,598,942 won per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris and Ultomiris are ultra-high-priced new drugs, so they implement a pre-approval system to determine whether they are eligible for medical care benefits, and the agency must administer Soliris or Ultomiris within 60 days from the date of notification of the results of the deliberation. If it is intended to be administered after 60 days, it must be re-applied. In one case, data supplementation was requested, and in the other case, data supplementation was required as it was necessary to confirm whether the patient could receive spinal canal injection stably due to the long course of the disease. Spinraza is an ultra-high-priced new drug of 92.35 million won per bottle of 5ml, and medical institutions that want to take it must apply for pre-approval and submit a monitoring report every four months after approval of salary. Details of the deliberation can be found in the case of www.hira.or.kr or biz.hira.or.kr > Comprehensive Review Standards Service> Criteria> Review Standards> Public Deliberation.
- Policy
- Patients fume over non-deliberation of Kymriah·Keytruda
- by Lee, Jeong-Hwan Dec 09, 2021 05:58am
- Patients have set out to demand PBAC's prompt deliberation of the new reimbursement listing for Novartis Korea’s cancer immunotherapy Kymriah in acute lymphoblastic leukemia and diffuse large B-cell lymphoma and reimbursement expansion for MSD Korea’s non-small cell lung cancer treatment Keytruda to first-line in NSCLC. The patients expressed strong regrets after it was found that the agenda related to the reimbursement of Kymriah and Keytruda was not put up for deliberation by the Pharmaceutical Benefit Assessment Committee on the 2nd, the last meeting set for this year. On the 1st, the Korea Alliance of Patient Organizations (KAPO) said, “The non-deliberation of the agenda at the PBAC meeting reduces the will to fight the disease and threatens the lives of leukemia, lymphoma, and NSCLC patients in Korea." Novartis had applied for the reimbursement of its leukemia and lymphoma treatment, the CART-T therapy Kymriah, on March 3rd this year through the ‘approval-reimbursement review linkage system,’ and received a conditional nod from the Cancer Disease Deliberation Committee deliberation 7 months later on October 13th. Keytruda, which was listed for reimbursement as a second-line treatment, applied to extend its reimbursement to first-line monotherapy in NSCLC in September 2017 but failed 9 times. After 4 years and numerous attempts, the agenda had finally received a conditional nod at the CDDC meeting on July 14th, 2021. The life expectancy of recurrent·refractory leukemia and lymphoma patients that need treatment with Kymriah is only 3 to 6 months. In other words, patients who cannot bear the non-reimbursed 460 million won cost of the drug are dying waiting for the reimbursement listing. Also, Stage 4 NSCLC patients had borne the 70 million to 100 million won drug cost of Keytruda for the past 4 years to receive treatment or received partial support with their indemnity medical insurance or MSD's non-reimbursement drug cost support program. Others received treatments from hospitals that have been pilot operating the new DRG system or received treatment with another anticancer drug then used Keytruda as second-line with disease progression. KAPO said, “Deliberations on Kymriah and Keytruda have barely passed the CDDC on condition and are being delayed, but this is not due to the clinical efficacy of the drugs. Kymriah and Keytruda are representative drugs that are directly related to life, and there is little controversy about their therapeutic effect. It is just that the drugs’ prices are very expensive and patients so many. The concern over the increased burden on NHI finances, the drug price, and fiscal concerns are what has been delaying the listing of these drugs.” The patient organization stressed that the access to treatments that are directly related to life should not be obstructed due to administrative procedures for reimbursement listing. It said, “Patients who meet the MFDS indication can even now receive non-reimbursed treatment with Kymriah or Keytruda. The harsh reality is that the late-stage patient’s life or death, and extension of life depends on their economic ability, on whether they have the ability to pay for the high priced non-reimbursement cost for their treatments. For new drugs directly related to life such as Kymriah and Keytruda, the government should spend NHI finances to save the patients’ lives first, then decide on how to list and set their drug price through formal procedures as they are doing now.” Currently, no system in Korea allows for the priority use of NHI finances even if the new drugs are directly related to life. Therefore, KAPO demanded that the government and the National Assembly introduce a constitutionally guaranteed 'rapid NHI listing system for new drugs directly related to life'. The organization also plans to propose the introduction of this system as a presidential campaign to presidential candidates. It added, "Pharmaceutical companies develop and market new drugs to save the lives of patients. Also, the nation operates a NHI system to ensure that no citizen is left untreated due to reasons of cost if there are drugs available. To fulfill this objective, we need to quickly complete Kymriah’s reimbursement listing process that has been ongoing for 9 months and Keytruda’s first-line reimbursement that is being discussed for over 4 years.”
- Policy
- Impurity detected Cozaar is excluded from recovery
- by Lee, Tak-Sun Dec 08, 2021 06:01am
- In the case of a single drug in Losartan formulation where impurities were detected, it is interpreted that only the original drug was excluded from recovery, exposing the risk of domestic generics again. It is analyzed that the reason why the original drug was excluded from the collection list is because the raw material process is different. The MFDS announced on the 7th that it will recover 295 items (98 companies) of Losartan drugs that have been excessively detected with Azido-based impurities. The majority of the 306 (99 companies) items in circulation are included. As impurities were confirmed to be within the daily intake allowance, 11 items were excluded from the collection, 5 items from foreign pharmaceutical companies and 6 domestic pharmaceutical companies. In particular, in the case of Losartan potasium, only "Cozaar" and "Cozaar 100mg" of Organon, Korea were excluded from the recovery list. All of the remaining identical generic drugs were included in the recovery list. An official from the MFDS explained, "We estimate that this impurity was caused by unintended residue from the use of Azide during the raw material process," adding, "However, we know that the original did not use Azide." However, the official explained that there are products that are currently shipped below the standard by improving the raw material synthesis process for generic drugs. The original and generic materials are the same ingredients, but there was a difference in the synthesis process. Finished drugs were included in the collection list one after another due to consignment. There are 16 factories in Korea that produce Losartan single 5-mg finished products. These 16 places are connected by consignment and consignment structures supplied to 88 pharmaceutical companies. As a result, if a problem occurs in one finished product factory, products from various companies will also be recovered. This consignment structure has also been problematic in the Valsartan formulation, where the NDMA impurity crisis first occurred. Accordingly, the government has been implementing a policy since last year to discriminate against generic items entrusted with biological equivalence tests for consignment production when registering drug prices. In addition, from July this year, a revision to the Pharmaceutical Affairs Act was implemented to require one trustee to supply products to only three consignment companies to restrict consignment production through sharing of biological equivalence tests. As a result, it can be seen that the Losartan impurity incident also showed generic risks. However, experts say that it is dangerous to interpret that there is a difference in quality between the original and generic in that the generic raw material process was initially approved by the MFDS.
- Policy
- No recall crisis expected to arise from losartan impurities
- by Lee, Tak-Sun Dec 08, 2021 06:00am
- Although 295 antihypertensive treatments that were found with impurities were ordered recalled, due to the low risk and specificity of the targeted items, no disruption is expected from the exchange, re-prescriptions, or re-dispensing of such drugs. The Ministry of Food and Drug Safety announced on the 7th that 295 losartan items that were found to contain azido impurities that exceed the allowed daily intake of 1.5㎍/day (1.7~88.7㎍/day) will be recalled. However, the ministry emphasized that the risk of its harm to the human body is very low and that the patients should not discontinue taking the drugs. The azido impurities that were detected this time occur specifically in the losartan ingredient, and although the properties of genetic mutations have been confirmed in the ingredient carcinogenicity has not been yet identified. In particular, an assessment of its health effect on the majority of patients who took losartan that had an excess amount of impurities than the allowed daily intake showed that the added risk of cancer from the impurities was 0.54 out of 100,000, which was a very low and negligible level. An MFDS official said, “The evaluation was based on the representative value (median value) that was set with losartan drugs that had impurities exceeding the amount allowed for daily intake. We also took into account the possibility that the drugs that had a higher amount of impurities will be taken for life (70 years).” As a result, the MFDS emphasized that even if one takes losartan drugs that contain an excess amount of impurities, it has little effect on one’s health, and that patients who were prescribed the product should not arbitrarily discontinue taking the drugs. However, the exchange, re-prescriptions, or re-dispensing measures were prepared to resolve anxiety for patients with health concerns. The exchange, re-prescriptions, or re-dispensing of the drugs can be done at no out-of-pocket cost on the patient’s part. However still, the number of re-prescriptions or re-dispensing is not expected to be high. Although all lot numbers of 241 items will be fully recalled, only some lot numbers of 54 items and none from 11 items are recalled, and identifying the drugs that are subject to recall is also a complicated process. Also, some of the items for which full recalls are being conducted for all lot numbers, some are being re-released as normal items, and may only be exchanged at hospitals rather than be re-prescribed or re-dispensed at hospitals. In fact, only 4 cases of consumer exchanges arose for sartan drugs that were recalled due to excess impurities in September. Due to this, there had been some criticism that the authorities had wasted too much time on the consumer exchange process that did not have many actual cases, delaying the recall period for the harmful drugs in business.
- Company
- Hanmi’s poziotinib enters final phase for commercialization
- by Kim, Jin-Gu Dec 08, 2021 06:00am
- ‘Poziotinib,’ a drug licensed out by Hanmi Pharmaceuticals, is entering its last phase for authorization in the US. The variables that remain to approval are the US FDA’s interpretation of the clinical trial results and the on-site investigations on the company’s production and manufacturing facilities. If these progress as planned, Hanmi Pharmaceuticals will be able to achieve its first global commercialization landmark with the new drug technology export earlier next year. On the 6th (local time), the US company Spectrum Pharmaceuticals submitted a new drug application (NDA) for poziotinib. It is indicated for the treatment of locally advanced and metastatic HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) in patients who have previous treatment experience. Poziotinib received the fast-track designation in March from the FDA. Drugs that receive the fast-track designation receive various support from the FDA in the stages of its development. Also, when applying for marketing authorization, the drugs are allowed to submit data sequentially under a rolling review as soon as data is available and are allowed to be discussed for priority review, etc. In particular, the priority review would shorten the FDA's marketing authorization review period from 10 months to 6 months. Considering the circumstances, Spectrum expects poziotinib to be approved in the US by the first half of next year. If poziotinib receives FDA approval, it would be a first for Hanmi to succeed in the global commercialization of a new drug that it had exported technology for. The variables that remain to approval now are poziotinib’s clinical trial data and on-site investigation. Spectrum submitted the NDA based on the cohort 2 results of the ‘ZENITH20’ clinical trial. Trial results showed that the objective response rate (ORR) of patients with HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) with treatment experience was 27.8%, the median duration of response (mDOR) 5.1 months, and the median progression-free survival (PFS) 5.5 months. However, the drug showed somewhat less encouraging results in a clinical trial that was independently conducted in Europe. Professor Arsela Prelaj of the IRCCS National Cancer Institute Foundation in Italy compared data of 30 patients who were administered poziotinib to 28 that did not. No significant difference was found, with the overall survival (OS) of the poziotinib-treated group being 19.2 months compared to the 18.2 months in the control group. However, when matched by propensity score and calculated by Cox's proportional hazard regression model, the risk of death in patients who took ‘poziotinib’ was reduced by 34% at the most. Although no significant OS improvement was demonstrated in the study, the study still had meaning as it identified the possibility that the drug can reduce the risk of death. The results were announced at the ESMO virtual congress in September. The study was an investigator-led study without sponsorship from Hanmi or Spectrum. The other variable that remains is the on-site investigation. In the case of ‘Rolontis,’ another one of Hanmi’s technology export new drugs that Spectrum applied marketing authorization for, the on-site investigation had deferred what was on the brink of approval. The FDA determined that there were some problems with Hanmi’s factory in Pyeongtaek and sent a complete response letter (CRL) to Spectrum. Although Rolontis was expected to be approved in October last year, the FDA’s CRL has pushed back the schedule by over a year. Hanmi believes such an issue will not arise for poziotinib because the two drugs have different manufacturing facilities. An official from Hanmi said, “Rolontis is manufactured at Hanmi’s Pyeongtaek plant, whereas poziotinib is manufactured in the US. Also, most of the FDA’s requests for supplementation have been now addressed.” Therefore, the industry’s eyes are focused on whether Hanmi will be able to overcome its two previous failures and succeed in its third attempt. The FDA had deferred approval of Hanmi’s two technology export new drugs ‘Oraxol’ and ‘Rolontis’ in March and August this year. The company had licensed out the technology for its metastatic breast cancer drug Oraxol to Athenex but the FDA deferred its approval due to neutropenia concerns.
- Company
- Hanmi's lung cancer drug Poziotinib has been applied for NDA
- by Kim, Jin-Gu Dec 08, 2021 06:00am
- The U.S. FDA marketing approval process for Poziotinib, a new lung cancer drug developed by Hanmi Pharmaceutical, has begun. Hanmi Pharmaceutical's partner Spectrum announced on the 6th (local time) that it has submitted an NDA to the U.S. Food and Drug Administration (FDA). This indication is NSCLC with local progression and metastatic HER2 Exon 20 insertion mutation with treatment experience. This NDA submission is based on the positive cohort 2 results of the ZENITH20 clinical trial that evaluated the safety and efficacy of Poziotinib. Poziotinib was designated as FastTrack by the FDA. As a result of this indication, there are no FDA-approved treatments so far. Spectrum President Joe Turgon said, "HER2 Exon 20 insertion mutation has reached an important stage for achieving the first treatment for lung cancer patients. We thank researchers, patients, and spectrum executives and employees for their passionate efforts to achieve important milestones in areas with high unmet medical demand."
- Company
- The kit for precocious puberty in Korea has been stopped
- by Moon, sung-ho Dec 08, 2021 06:00am
- The increase in the number of precocious puberty patients in Korea is unusual. As the number of patients, which was 80,000 in 2015, exceeded 130,000 in 2020, there are opinions that it should now be recognized as a social problem. In response, some in the medical community and clinical sites predict that the number of precocious puberty patients will increase further as outdoor activities decrease due to the prolonged COVID-19 pandemic. Amid this situation, it has been confirmed that confusion is occurring at front-line medical sites due to the recent suspension of the supply of "diagnostic reagents" that can identify patients with precocious puberty. With the suspension of the supply of diagnostic reagents, which were the only health insurance coverage targets, even the diagnosis of precocious puberty patients, which is rapidly increasing due to prolonged COVID-19, is developing. According to the medical and pharmaceutical industries on the 4th, clinical doctors are suffering from the suspension of supply of injection items that are prescribed precocious puberty as a "diagnostic reagent" since March. The item is Relefact LH-RH supplied by Handok in Korea. As Sanofi, the original developer, decided to suspend the supply of this item in March, stock of reagents for diagnosing precocious puberty has disappeared in Korea. According to the MFDS, the import performance of Relefact LH-RH in 2020 is about 1.132.26 billion won. Considering that it was 650.58 million won in 2015, the performance has increased, but it is lower than expected. The problem is that Relefact LH-RH is the only item as a diagnostic reagent for precocious puberty. Lutrelef of Perring Pharmaceutical Korea, which can be said to be the same ingredient, has already been withdrawn from the domestic market due to the expiration of its validity period. For this reason, medical sites are unable to diagnose precocious puberty patients due to a lack of diagnostic reagents. In the diagnosis of precocious puberty, LH and FSH are measured in the blood for 2 hours at intervals of 15 to 30 minutes after administration of "sexual stimulation hormone secretion hormone." If the maximum concentration of sulfonation hormone is 5 IU/L or higher, it is judged to be activated and diagnosed with precocious puberty. , that is, "sexual stimulation hormone secretion hormone" plays a role in the diagnosis process of precocious puberty, and it is Relefact that diagnoses it. As Relefact has not been imported into Korea, it is difficult to diagnose precocious puberty nationwide, said a professor of pediatrics in a province who asked for anonymity. "As the number of precocious puberty patients has already increased rapidly through the COVID-19 pandemic, I wonder what preparation the health authorities have made." It is prescribed as an "off label" for precocious puberty, which has become difficult to diagnose. If so, how is the medical field responding to the suspension of the supply of diagnostic reagents? As a result of the coverage, it was found that some hospitals and clinics are prescribing other drugs offline as the supply of Relefact has been stopped. In fact, it has been confirmed that some hospitals and clinics apply for approval for excessive use of Ferring's Decapeptyl Depot and use it as a reagent for diagnosing precocious puberty. Decapeptyl is a specialized drug licensed for hormone-dependent prostate cancer, endometriosis and uterine myoma, central puberty early onset in girls under the age of 9 and boys under the age of 10. Another professor who runs a clinic said, "As papers have been presented that they have obtained good results in Thailand, some hospitals in Korea are already receiving health insurance benefits by submitting approval to the HIRA for the use of non-reimbursed drugs beyond the scope of reporting." In fact, the HIRA official also said, "As the supply of Relefact injections has been suspended, off-label use through Decapeptyl is being carried out. Currently, we are considering approving the use of hospitals and clinics that submit overseas papers." It was found that the seriousness of the problem was recognized and countermeasures began to be prepared, focusing on related societies such as the Korean Society of Pediatric Endocrinology. If it is no longer possible to secure Relefact, the use of off-label for Decapeptyl is suggested as an alternative, and some pharmaceutical companies are requesting the re-import of related items. It is only hoped that the suspension of supply will end in a short period of time as a pharmaceutical company that resupplies the drug to Korea.
- Company
- Dire need for a rational pricing system for new drugs
- by Nho, Byung Chul Dec 07, 2021 05:57am
- Improving the drug pricing system through social consensus has been proposed as a prerequisite for the government to achieve the 60 trillion won export and 300,000 job creation in the biohealth industry as one of its 3 new growth engine industries. In addition to the primary purpose of fostering the biopharmaceutical industry to create national wealth, there is no disagreement on the fact that the localization of vaccines and treatments as the nation’s key industry is essential to address the national need and respect and realize the right to life of the citizens in Korea in the COVID-19 pandemic. In particular, the emphasis Yong-Ik Kim, the President of the National Health Insurance Service, made at special lectures, in raising the will for R&D among biopharmaceutical companies through appropriate pricing of new drugs and the joint growth of the nation and its companies, has been interpreted as an exemplary blueprint for the soft landing of Mooncare. Seong-min Park, a lawyer from HnL law firm said, " An irrational pricing system for new drugs may infringe the Korean patients’ access to treatment as well as adversely affect the fostering of a health drug ecosystem with fair competition.” Essentially, 4 rational drug pricing measures were considered eligible for review/introduction through communication with the Ministry of Health and Welfare, as well as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and other industry pricing managers: ▲ reducing the scope of alternative drugs ▲flexible application of negotiations(diversifying types of pricing negotiations allowed to include refund system, etc) ▲price discount accumulation system ▲pricing premium for new drugs that have conducted Phase III trials on Koreans First, the system to reduce the scope of alternative drugs was proposed to improve the standards for selecting alternative drugs so that new drugs can be compared with each other. According to the industry, one issue in setting prices for new drugs is that the price of originals and generic drugs that have been discounted 53.55% due to patent expiry are all included in the standard used to set new drug prices and are continuing to be discounted due to post-marketing measures. If this intensifies, the price of new drugs could be set at a lower level than alternative generics, reducing the will for companies to research or develop new drugs and also inducing voluntary withdrawal of licenses due to loss of cost. In other words, Korea will not be able to leap forward and become a pharmaceutical powerhouse if the virtuous cycle of ‘R&D-new drug discovery- national wealth creation’ is broken. On this, Park said, “Special measures such as excluding patent-expired products from alternative drugs is necessary. Global competitiveness can be secured only when practical standards are established for the selection of alternative drugs such as those with therapeutic equivalence and the price set at 80-120% of the price in foreign countries.” Under the price discount accumulation system, pricing discounts that are accumulated during a new drug’s patent period after term expiry, effectively preserving the R&D value of a new drug to allow faster recovery of R&D expenses and induce reinvestment. The system does not provide preferential treatment by exempting drug price discounts but defers it, therefore retaining the effect of reducing insurance finances. The irrationality of lowering drug prices of new drugs that are more cost-effective than its alternatives with the price-volume linkage system and the discount applied when a drugs attempts to add indications that are within the scope held by its alternatives, has been constantly raised. For example, compared to other drugs of the same class, Zemiglo had been subject to numerous more price-volume linkage discounts than its number of sales since it was released in 2012. Its price had been discounted a total of 6 times. The pricing premium system for new drugs that have provided Phase III trials on Koreans allows the price of new drugs that conducted Phase III trials on local patients to be set at 95-100% of the market price of substitute drugs rather than at 90% when omitting pricing negotiations. The system does not conflict with international trade as it allows new drugs from multinational pharmaceutical companies that conduct multinational clinical trials to receive benefits while local new drugs that did not conduct Phase III trials of a certain size in Korea to become ineligible for such benefits. The system is already being applied and operated abroad. For example, in Taiwan, a 10% premium is provided for new drugs that conducted clinical trials over a certain size to demonstrate safety and efficacy. In Japan, a new drug that was first-ever to be approved in Japan receives a premium of 10-20% for early introduction (new drugs that explicitly include dosage regimens for pediatric patients area are applied a 5-20% premium, however, the premium is not applied if the clinical trial conducted in Japan do not include pediatric patients). The greatest advantage of the 'pricing premium system for new drugs that have conducted Korean Phase III trials’ is that it provides base data on the safety, efficacy, clinical utility of a drug in Koreans. It is also easy to track and manage, improves R&D ability by the full step of the trial being conducted domestically, provides a performance upgrade for domestic clinical trial institutions, creates jobs, and contributes to new drug development fit to match the condition and diseases of Koreans.
- Industry is nervous about strengthening quarantine guideline
- by Kim, Jin-Gu Dec 07, 2021 05:57am
- Private gatherings in the Seoul metropolitan area are limited to 6 people. With COVID-19 (step-by-step daily recovery) was suspended after a month of implementation due to the re-proliferation of COVID-19. The pharmaceutical bio industry is also nervous about the worsening COVID-19 situation. On the 6th, the government tightened quarantine guidelines again by reducing the limit on the number of private gatherings to six in the metropolitan area and eight in the non-metropolitan area. In fact, it is the suspension of With Corona. The strengthened quarantine guidelines will be applied until the 2nd of next month. The period can be adjusted depending on the trend situation. The pharmaceutical bio industry has also strengthened internal guidelines in line with these measures. In particular, it is recommended to refrain from public gatherings, including informal private gatherings, as the end of the year is approaching. Yuhan Corporation again urged executives and employees to conduct remind-level retraining and comply with personal quarantine rules. The company's rule is to wear a mask at all times while working and refrain from multi-use facilities and private gatherings. End-of-the-year events such as workshops will be refrained from as much as possible and will be held non-face-to-face only if inevitable. Efforts are also made to minimize contact within the company. The time to use the cafeteria is set differently for each department, and lunch boxes are provided to some. Last month, Yuhan Corporation changed its guidelines to work as all of them finished working from home before and after the implementation of With Corona. In the case of Hanmi Pharmaceutical, it is discussing whether to reapply telecommuting due to the re-proliferation of COVID-19. The results of the discussion are expected to come out as early as today (7th). Hanmi Pharmaceutical, like Yuhan Corporation, has terminated telecommuting since last month. Separately, all year-end official events will be canceled or replaced online. In the case of other private gatherings, executives and employees were informed to follow government guidelines. Most of the other domestic pharmaceutical companies, including Chong Kun Dang, Dong-A ST, and Ildong Pharmaceutical, have a similar rules. It is said that guidelines have been issued to replace year-end events such as year-end parties and closing ceremonies online only if necessary, and to refrain from small workshops and dinners by department. An official from a large pharmaceutical company said, "There are no separate guidelines. However, there is an atmosphere among most employees to refrain from private gatherings such as year-end dinners, he said. Another pharmaceutical company official said, "We did not prepare an official event at the end of the year. It will also be replaced online so that workshops that were planned on a small scale by each department can be used, he said. Multinational pharmaceutical companies maintain quarantine guidelines such as telecommuting, official meetings, and refraining from outside events regardless of the implementation of With Corona. Pfizer Pharmaceutical Korea, Novartis Korea, and AstraZeneca Korea plan to continue working from home, which have been doing since the beginning of COVID-19. Likewise, year-end workshops and seminars are held non-face-to-face. It is recommended to refrain from official gatherings or outside events as before. Since the implementation of With Corona, MSD has switched to allowing all employees to work from home twice a week. Since the government's quarantine guidelines have been strengthened, it has been recommended that in-office workers can voluntarily decide to work, and outside workers should refrain from visiting except in unavoidable cases.
