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- 2025-12-21 23:26:11
- Policy
- Reimbursement extended for 18 Factor VIII hemophilia drugs
- by Kim, Jung-Ju Jul 24, 2023 05:26am
- The reimbursement for recombinant factor VIII therapies that are used to treat hemophilia is expected to be extended soon. The government accepted the requests of related medical societies and patients and analyzed its fiscal impact, and the pharmaceutical companies with relevant products accepted the government’s request and will share the fiscal burden of the reimbursement extensions with the government. Starting next month, the drug price of the recombinant factor VIII therapies will be cut in line with the reimbursement extensions. According to industry sources, the Ministry of Health and Welfare is working to revise its ‘drug reimbursement list and reimbursement ceiling price table’ to apply the abovementioned changes. The revised list and table will become effective as of the 1st of next month. There has been a constant demand for reimbursement extensions on Factor VIII therapies in Korea. Patients can only maintain daily life when the patient’s factor activity is maintained at 1% or higher during pharmacokinetic tests. Patients whose factor activity is less than 1%, have a high possibility of experiencing complications due to repeated joint bleeding and spontaneous bleeding. Thus, the Korean Society of Hematology had asked the government to grant reimbursement when patients receive the maximum dose allowed within the range approved in the indication to maintain their coagulation factor activity level at 1% or higher. Acknowledging the need, the government held a financial subcommittee to analyze the fiscal impact of the reimbursement extensions. At the June meeting, the subcommittee analyzed that the additional budget required annually will be in the KRW 6.57 billion range. However, the government’s ex officio adjustment on the price of the drugs would not be significant due to the small number of items that can be adjusted and the small amount of financial savings that would follow. Therefore, the government sought another way to extend reimbursement. Among pharmaceutical companies with related products, the MOHW requested 4 major pharmaceutical companies to share the fiscal burden, and 3 accepted and submitted a voluntary price-cut proposal to the authorities. As a result, the price of 18 items of 4 ingredients will be voluntarily reduced. The government expects that increasing the administered dose of the Factor VIII therapies will delay the timing of Hemlibra administration. Also, as the patients that benefit from the new reimbursement extensions may overlap with those already receiving reimbursement through the current standards, the MOHW believes the budget impact may be less than expected. The affected 18 products are Takeda Pharmaceuticals Korea’s Advate Inj and Adynovate Inj, Pfizer Korea’s Xyntha Solofuse Prefilled Inj, Sanofi-Aventis Korea’s Eloctate Inj. The companies decided to voluntarily reduce the price of their items from 0.1% to up to 5.6% each.
- Policy
- BMS makes 2nd voluntary price cut for Baraclude this year
- by Lee, Tak-Sun Jul 24, 2023 05:26am
- BMS Korea made the decision to carry out a second voluntary price cut on its flagship hepatitis B treatment ‘Baraclude’ this year. It is rare for an original drug to undergo two voluntary price cuts in one year. The industry analysis is that the company is using the price cut of its off-patent drug Baraclude as leverage to list new drugs. According to industry sources on the 21st, BMS Korea voluntarily reduced the insurance ceiling price for its 0.5mg dose Baraclude (entecavir) from KRW 3,030 to KRW 3,006, and its 1mg dose from KRW 3,430 to KRW 3,403, effective as of August 1st. As a result, Baraclude’s price is now placed in the mid-range among same ingredient drugs. Eighteen 0.5mg dose and eight 1mg dose generic drugs are now more expensive than the original Baraclude. The company had already voluntarily reduced the price of Baraclude once in June. The 0.5mg dose’s price had been reduced from KRW 3,064 to KRW 3,030 at the time, and the price of the 1mg dose from KRW 3,470 to KRW 3,430 then. Coincidentally, a new drug from BMS was listed a month after the company carried out the voluntary price cut. In June, the myelofibrosis treatment Inrebic Cap (fedratinib) was listed for reimbursement, and in August, the acute myeloid leukemia treatment Onureg Tab is set to be listed for reimbursement through the RSA system. This is why the industry believes that BMS has carried out a 'trade-off' twice – lowering the price of its off-patent drug to list a new drug under the pretext of sharing the government’s financial burden. Such trade-offs are not revealed on the surface due to a confidentiality clause made during negotiations between the NHIS and pharmaceutical companies. However, there is a definite possibility that the company made trade-offs as the company made the voluntary price cuts for its off-patent drug the same month a new drug was listed. Recently, pharmaceutical companies are known to be the first to propose such trade-offs to the NHIS to list new drugs. Baraclude has remained in the top rank ever since its patent expired in 2015. Last year, it had made outpatient prescriptions of KRW 71 billion and ranked second to Viread (tenofovir disoproxil fumarate, Gilead), which had recorded KRW 89.5 billion. However, Baraclude’s sales had fallen 3%p last year due to the release of Vemlidy (tenofovir alafenamide hemiFumarate, Gilead), and the strong inflow of generics.
- Policy
- Original for Parkinson's dz tx released are withdrawn
- by Lee, Tak-Sun Jul 21, 2023 05:41am
- Decisions are being made to withdraw from Korea one after another, citing the weakening profitability of Parkinson's disease original treatment drugs, for which generics have appeared. Early this year, following Roche Korea's Madopar, Boehringer Ingelheim Korea's Mirapex ER also decided to stop supplying. The problem is that existing patients have a distrust of generic drugs, so there is a concern about a treatment gap if the supply of the original drug is discontinued. According to the industry on the 19th, Boehringer Ingelheim Korea recently informed the retailer that it would stop supplying Mirapex ER. Accordingly, Mirapex ER 0.375mg is expected to be sold out by July 31 next year, Mirapex ER 1.5mg by February 28 next year, and Mirapex ER 0.75mg by July 31 next year. However, Boehringer Ingelheim decided to maintain the supply of Mirapex. Mirapex is taken three times a day and Mirapex ER is taken once a day. Discontinuation of the supply of Mirapex ER, which is highly convenient, seems to be related to the entry of generics. Mirapex ER started with Hyundai Pharm's Mirap ER in 2014, followed by Samil Pharm's Prapexole ER and Myeongin Pharm's PD-Pexol ER. As three generic companies compete fiercely to preoccupy the market, drug prices are also falling. Each generic company is widening the gap with the original drug by voluntarily lowering the drug price. The profitability of original drugs has fallen due to drug price cuts following the introduction of generics, and market share is also in an emergency due to the generic offensive. In the case of Pramipexole ER 0.75mg, a component of Mirapex ER, the lowest price for generics has fallen from 740 won to 707 won. There is a difference of 74 won from the original price of 781 won. Due to the price reduction of Mirapex ER, Mirapex taken three times a day is better than Mirapex ER in terms of profitability. For this reason, some analyze that Behringer withdrew Mirapex ER and left Mirapex in the market. Roche Korea's Madopar also decided to discontinue supply in January of this year after the drug price was reduced when the generic was first released in August 2021. However, patients are requesting the resupply of Madopar through national petitions because generic drugs have side effects. Accordingly, Roche Korea and the Ministry of Health and Welfare are seeking a way out of the controversy by extending the insurance deletion grace period from July 31 to December 31. Roche has yet to make an official statement about resupply. CNS drugs such as Parkinson's disease drugs are highly dependent on drugs, so there is a high preference for existing prescribed original drugs. In this situation, patients' dissatisfaction is growing as original drugs are withdrawn from Korea due to profitability problems. Accordingly, while some argue that drug price hikes should be considered to maintain the supply of original drugs, others oppose that the government should step forward and implement policies to increase the reliability of generic drugs.
- Policy
- How Scemblix received reimb without negotiations
- by Lee, Tak-Sun Jul 21, 2023 05:40am
- The chronic myeloid leukemia treatment Scemblix (asciminib, Novartis) was passed the Drug Reimbursement Evaluation Committee review for costing the same as another 3rd generation CML treatment, Iclusig (ponatinib, Otsuka), The company agreed to set its price at 100% or below the weighted average price of its therapeutic alternative to waive the drug pricing negotiation process and succeeded in being listed within one year since it applied for reimbursement on July 27 last year. According to industry sources on the 20th, the DREC’s evaluation results on Scemblix were recently disclosed by the Health Insurance Review and Assessment Service showed that the cost of Scemblix, which was the same as that of Iclusig, was the decisive factor that prompted the committee to accept the adequacy of Scemblix’s reimbursement. Scemblix is a treatment for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs). For Scemblix’s review, DREC selected Iclusig as the therapeutic alternative in consideration of the drug’s label, literature, academic opinion, and reimbursement standards. The committee explained, “The NCCN guidelines recommend the drug that submitted the application at the same level as ponatinib (Iclusig generic name), and as the drug’s improvement in effect over its therapeutic alternative is unclear in various variables, the two drugs are appropriate comparators in terms of drug administration cost.” In other words, the committee determined that Iclusig’s price will be the key factor that determines the adequacy of Scemblix’s reimbursement. In response, Novartis accepted a price that is 100% or lower than the weighted average price of its alternative. Accordingly, DREC determined Scemblix’s reimbursement appropriate and cost-effective because its effect was similar to its alternative, and the cost was the same. In particular, the company was able to waive the NHIS drug pricing negotiations as it accepted a price below the set standard. The drug price negotiation waiver system is applied to drugs that are deemed to have reimbursement adequacy, have similar effects to their alternative, and are cost-effective as they cost less or are equivalent to their therapeutic alternative. Scemblix is one example of how a company accepted a price at 100% or below the weighted average price and only underwent negotiations for the estimated claims amount. However, Scemblix had to overcome its share of obstacles to reimbursement listing. Most of all, the fact the approval can increase NHI financial spending as switching between Iclusig and Scemblix is allowed served as a major obstacle. This was why the Cancer Disease Deliberation Committee failed to set Scemblix’s reimbursement standards at its meeting last December. Reflecting this, Novartis applied for reimbursement again on January 12 this year. The DREC also acknowledged the adequacy of Scemblix’s reimbursement but added the condition that it would be necessary to consider the fiscal impact of switching. Accordingly, the company would have dealt with the switching issue during negotiations with the NHIS on the expected claims amount. Meanwhile, Scemblix 20mg’s reimbursement ceiling price was set at KRW 50,914, and Scemblix 40mg at KRW 76,371. Iclusig 15mg’s reimbursement ceiling price is KRW 60,400, and Iclusig 45mg is KRW 152,742. When considering how the recommended dose of Scemblix is 80mg, and Iclusig 45mg, the price of the two drugs are comparable.
- Policy
- Evrysdi also subject to prior authorization for reimb
- by Lee, Tak-Sun Jul 20, 2023 05:35am
- Pic of SMA treatments (from the left) Spinraza, Evrysdi, Zolgensma The Health Insurance Review and Assessment Service is expected to require the oral SMA (spinal muscular atrophy) treatment ‘Evrysdi Dry Syrup (risdiplam, Roche)’ to receive prior authorization for reimbursement. Also, HIRA is planning to reflect the prior authorization experience it has accumulated from Spinraza for Evrysdi. HIRA’s Healthcare Review and Assessment Committee announced so at a special press corps meeting with industry reporters on the 18th. Jin-Su Lee, Chair of the Healthcare Review and Assessment Committee, said, ”After literature review and reflection of overseas cases, we have prepared an announcement on the revised measures for prior authorization drugs based on the RWD (Real World Data) data we obtained from the prior authorization for Spinraza. The revised standards will be applied to the prior authorization review of the oral SMA treatment Evrysdi that was recently granted reimbursement. Jin-Su Lee, Chair of HIRA’s Healthcare Review and Assessment Committee is answering questions at a special press corp meeting on the 18th Currently, Roche is having pricing negotiations with the National Health Insurance Service for Evrysdi, after which reimbursement listing is expected. Also, the company for Spinraza Inj, a drug already listed for reimbursement, is negotiating to expand the use age for the drug with NHIS. The reimbursement standards for the two drugs are prepared after completing pricing negotiations, and the measure HIRA presented on the 18th will be reflected then. Lee said, “We expect the new measure to contribute to saving finances unnecessarily spent on SMA patients who are judged to have no effect with Spinraza Inj.” Based on the comment, it is likely that the Healthcare Review and Assessment Committee will be disapproving reimbursement of the drug to patients who are judged to have no effect. Spinraza is a high-priced drug that costs KRW 554 million per patient in the first year, then KRW 277 million every year thereafter. A HIRA official explained, "We cannot conclusively say that Evrysdi will be subject to prior authorizations as its reimbursement standards have not been announced yet. However, as the other existing SMA treatments are also required to receive prior authorizations, it is true that the drug’s chances of being subject to the same conditions are high.” Currently, the SMA treatments Spinraza and Zolgensma are subject to prior authorizations for reimbursement. Lee also added that just as in Spinraza's reimbursement standards, the committee will be reflecting the experience accumulated from other prior authorizations in the reimbursement review process as well. Lee stressed, “We will continue to sequentially analyze the data of other prior authorization drugs in addition to Spinraza inj. Although the purpose and content analyzed may differ by item, we will be assessing the possibility and need for the subject drugs to switch to general review drugs and identify whether there is a need to improve the reimbursement standards for others.” He added, "If the committee judges that it is necessary to improve the reimbursement standard based on data analysis, and there is valid evidence to support the change, we will closely work with relevant departments to make the necessary improvements." SMA is a rare condition in which the SMN1 gene is innately deficient or mutated to result in progressive muscle atrophy. In the case of SMA Type 1, the most common and severe form of SMA, if left untreated, over 95% of the motor neurons are damaged within 6 months, and 90% die before the age of 2 or require permanent respiratory support devices. Also, 30% of SMA Type 2 patients can die before the age of 25 and requires lifelong treatment. The reimbursement decision for the SMA treatment Spinraza has been subject to prior authorization ever since it was listed for reimbursement in April 2019. Also, ‘Zolgensma Inj,’ better known as the one-shot treatment for SMA, has been added as a prior authorization drug.
- Policy
- The more applications for pre-screening drugs, the higher
- by Lee, Tak-Sun Jul 20, 2023 05:34am
- .. Lee Jin-soo, chairman of the Medical Review and Evaluation Committee, "If the number of applications increases, the understanding of the benefit standards also increases." It was found that the higher the number of applications for pre-screening drugs, the higher the approval rate. It is an interpretation that the approval rate increases as the understanding of the salary standards accumulates. However, there is an interpretation that the salary standard is strict in the first place, so there is a high probability of disapproval of the salary in the pre-screening. Among pre-screening drugs, Soliris, which treats 'atypical hemolytic uremic syndrome (aHUS)', has a meager initial approval rate. The Health Insurance Review and Assessment Service presented an interpretation at the Korea Special Press Association meeting on the 18th that the understanding of the benefit standard was poor. In response to a question about the cause of Soliris' aHUS initial review approval rate and improvement plans, Chairman Lee Jin-soo explained, "I think the approval rate will increase if the clinical site fully understands the benefit standard and applies for it." He explained, “When we analyzed the status of approvals by the institution by 2022, we confirmed that the more cumulative applications there are, the more often they are approved.” According to the table released by the Clinical Review and Evaluation Committee, a total of 47 institutions applied for prior approval of Soliris in aHUS disease, and 51 cases (20.3%) out of 251 cases were approved. However, agency A, which applied the most, was approved for 10 out of 35 cases, with an approval rate of 28.6%, higher than the average. On the other hand, all 15 institutions that applied for prior approval were rejected. Regarding this, Chairman Lee explained, "As the number of applications for Solily increases, the understanding of the salary standard increases." Even so, it is pointed out that the approval rate of Soliris aHUS is too low compared to other drugs with an initial approval rate of more than 50%. In response, the Medical Review and Assessment Committee also said, "The expansion of the Soliris reimbursement standard was discussed at a recent advisory meeting, and the review results have been reported to the Ministry of Health and Welfare." In fact, it is pointed out that the Soliris aHUS salary standard is more difficult than overseas. In Korea, the benefit is approved only when all four criteria are satisfied: platelet count, mitotic red blood cell count, hemoglobin, and LDH, but the medical community says that the standard is higher than overseas. The Korean Society of Nephrology also submitted an opinion asking for relief standards to be relaxed. In March, Yoo Mi-young, head of the drug management office at HIRA, said, "A number of academic societies, including the Society for Nephrology, have submitted proposals for revising the reimbursement standards (for Soliris aHUS), including discontinuation of administration, administration standards, and evaluation methods." "We are currently reviewing the salary standards by identifying the reasons for pre-approval and disapproval and referring to expert opinions," she explained. It is noteworthy whether the pre-examination approval rate of Soliris will increase through the improvement of the benefit standard.
- Policy
- MFDS organizes a Clinical Trial Consultative Body
- by Lee, Tak-Sun Jul 19, 2023 05:20am
- The Ministry of Food and Drug Safety announced on the 17th that it has organized and is operating a ‘Clinical Trial Consultative Body’ with the industry to hold an ear out to the domestic clinical trial industry’s opinion and facilitate the smooth operation of the systems that are being newly introduced. The consultative body will consist of 14 members, experts in the bio-industry, including pharmaceuticals, vaccines, and cell therapies recommended by associations (Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korean Research-based Pharmaceutical Industry Association, Korea Biomedicine Industry Association), and the 1st meeting of the body was held on the 13th (Thurs) at the KRPIA head office. At the meeting, the MFDS discussed ▲the main improvements required for the factual survey on Good Clinical Practice and disclosure of the main results of the factual survey ▲ mandatory up-to-date Development Safety Update Reporting, and also ▲ shared and guided the system for the therapeutic use of investigational drugs overseas and discussed related standards, producers, and subjects in depth. In addition, the committee members proposed the ▲activation of a central IRB, ▲simplification of data reported to MFDS, etc. An MFDS official said, “The 'Clinical Trial Consultative Body' requested that we continue to propose reasonable system improvements in all areas related to clinical trials. Also, the members asked for the MFDS’s active support and utilization of the body so that it can play its role in developing regulations for clinical trials in Korea.’ The MFDS will continue to support the rapid development of safe and effective new products and the expansion of patient treatment opportunities through active communication between the public and private sectors based on the 'Clinical Trial Consultative Body'.
- Policy
- 22 items that exploded in use during COVID-19,
- by Lee, Tak-Sun Jul 19, 2023 05:20am
- While negotiations are underway for PVA Type Da items, 22 items are said to have undergone correction due to increased usage due to Corona 19 last year. The NHIS plans to finalize the negotiations by this month, including these items, and report the results of the negotiations to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare next month. According to the industry on the 17th, the government is negotiating by correcting the number of drugs that have increased usage due to Corona 19 last year and selecting a target for negotiation. Items subject to PVA Type Da are drugs that have not been negotiated at the time of initial registration, and if the billing amount increases by 60% or more compared to the previous year, by 10% or more, or by 5 billion won or more, the upper limit is reached through negotiation from the 4th year of registration. adjust the amount. The problem is that the demand for respiratory medicines such as cold medicine has increased significantly as the number of Corona 19 patients exploded last year. Drugs whose bills have increased significantly from the previous year are likely to have their upper limit reduced according to PVA, so the pharmaceutical industry suggested making an exception for drugs used for Corona 19. It is difficult for NHIS to exclude all drugs used for COVID-19 from the negotiation target, and instead decided to negotiate only those drugs that meet the standard by correcting the amount used. This is in accordance with Article 10 (2) of the PVA Negotiation Guidelines, which stipulates an exception to the application of PVA in the case of drugs used to support the treatment of infectious diseases. It is known that the NHIS, which has monitored about 2,600 items, including cold medicines and antibiotics that the Ministry of Food and Drug Safety has encouraged to produce since the beginning of this year, selected 22 items among them and proceeded with negotiations. The total number of Type Da negotiation items is known to be 60 items and 138 items in the same product group. The NHIS plans to complete the negotiations this month and submit the results of the negotiations to the Health Policy Deliberation Committee to be held next month to reflect the drug price adjustments in the reimbursement list in September. The NHIS explained that it lowered the upper limit on a total of 175 items according to the Type Da negotiations last year, resulting in a total of 44.7 billion won in financial savings.
- Policy
- No need to fear for the lack of Sabril after recall
- by Lee, Hye-Kyung Jul 19, 2023 05:20am
- The supply of Handok’s ‘Sabril Tab’ that was recalled by the company is expected to smoothen up soon. Its recall was issued by the health authorities due to the discovery of a small amount of an active pharmaceutical ingredient for a different drug, ‘tiapride,’ in its main active pharmaceutical ingredient, ‘vigabatrin.’ The Ministry of Food and Drug Safety (Minister Yu-Kyung Oh) said on the 18th, “We are aware of the concerns over the lack of epilepsy and infantile spasm treatment Sabril being raised by the industry. We have been discussing measures with Korea’s Children's Hospital Association, seeking expert advice, and meeting with the industry to closely understand the need and supply status in the field, and encouraged Handok, its domestic manufacturer, to promptly supply Sabril.” As a result, Handok decided to import 980,000 tablets (an amount that can be used for 5 months) of active ingredient (bulk tablets) that was scheduled to be imported in December in July, and its customs clearance is scheduled for July 21. Handok is known to be hastening its overseas import as there is no drug that can replace Sabril in Korea. The MFDS explained, “We have acquired information overseas on the discovery of another drug’s active pharmaceutical ingredient tiapride in some batches of Sabril’s active pharmaceutical ingredient, vigabatrin. Although the possibility of side effects is low, considering the fact that the safety of the detected ingredient for children has not been established, the MFDS recommended that the company recall a product with a specific lot number manufactured using the raw material on July 14 as a precautionary measure." Tiapride is an active pharmacuetical ingredient used to treat a variety of neurological and psychiatric disorders including movement disorders, neuromuscular pain, aggression, agitation, etc. The MFDS said, “ We have issued the recall recommendation as a preemptive measure for patient safety in comprehensive consideration of the potential distribution amount owned by the company (92,000 tablets that are not subject to recall) and the additional amount set to be supplied within July (980,000 tablets).”
- Policy
- Multiple Rxs for newly reimbursed drugs
- by Lee, Tak-Sun Jul 17, 2023 05:30am
- Pfizer Korea’s atopic dermatitis drug New drugs such as Cibinqo Tab (Pfizer Korea), a treatment for atopic dermatitis, and Newmaco S, a treatment for high triglycerides, which were listed in July, were included in the list of cost-effective, high-dose oral drugs. If multiple prescriptions are made for low content, the cost of claiming benefits can be reduced by exceeding the upper limit for high-content products. Cibinqo Tab, a treatment for atopic dermatitis in adolescents and adults that inhibits JAK1, was listed as reimbursement through NHIS negotiations on July 1. As for the JAK1 inhibitor, it is the second drug to be covered after AbbVie's Rinvoq ER 15mg for the treatment of atopic dermatitis in adolescents aged 12 years and older. Three doses of 50mg, 100mg, and 200mg are listed for this drug, but you should pay attention to multiple prescriptions for 50mg and 100mg products. In the case of Cibinqo 50mg, the upper limit is 11,087 won, which exceeds the upper limit of 100mg (17,739 won) and 200mg (25,942 won) when prescribed twice or 4 times. If 100mg is prescribed twice, it exceeds the upper limit of 200mg and is subject to reduction. Yuyu Pharmaceutical's 500mg product 'Newmaco S 500mg', which was first introduced among omega-3 preparations, should also be careful of multiple prescriptions. This is because multiple prescriptions exceed the upper limit of the previously listed 1000mg product Newmaco S. The upper limit of Newmaco S Soft Cap 500mg is 198 won, and the upper limit of Newmaco Soft Cap is 297 won. These items are reviewed and adjusted by the difference in drug price that occurs when they are replaced with the upper limit price for high content. Along with this, Gabape Capsule 100mg of Hanpoong, Kuhnletal SR Cap 100mg (Cilostazol) of Kunil Biopharmaceuticals, Prelin 25mg of Myungmoon, and Tamsu SR of Youngpoong are also added to the target items for cost-effective oral medications, so multiple prescriptions should be taken into consideration.
