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- 2026-04-09 21:05:43
- Opinion
- [Reporter's view] A groundbreaking policy is needed
- by Lee, Tak-Sun Jul 24, 2023 05:26am
- Controversy is in full swing over Madopar, a Parkinson's disease drug that withdrew from the Korean market early this year due to profitability issues. Patients want Madopar again, saying that the only remaining generic drug after Madopar was withdrawn has severe side effects. Furthermore, it raises the question of calculating the drug price of the original drug. First of all, the government extended the grace period for Madopar's insurance benefit deletion from July 31st to December 31st. During this period, benefits can be applied even if Madopar is prescribed in stock. However, extending the grace period is only a short-term solution. After December 31st, it is clear that patients' dissatisfaction will increase. Accordingly, some are discussing ways to recall Madopar within the current drug pricing policy. It is said that the upper limit amount will be raised through the drug ceiling amount adjustment system so that the Ministry of Food and Drug Safety must obtain re-permission. The Ministry of Health and Welfare also said that it would speed up the related procedures if it applied for reimbursement after re-permission by the Ministry of Food and Drug Safety. But even this is not a fundamental solution. In the future, such a situation may arise again in the market where the original is withdrawn and only the generic remains. This has a problem in that it is difficult to maintain order in the drug price system, and above all, it can further accelerate distrust of generic drugs. We need the best way to calm patients' dissatisfaction right away, but we also need to come up with measures to cut off distrust of generics in the long term. If patients cannot trust generics because of side effects, health authorities should consider verifying their effectiveness through various data and patient interviews. Through this, it is necessary to verify whether some side effects are inflated or whether side effects actually appear only in generic drugs. If side effects appear only in generic drugs, the background should be found and reflected in the improvement of the approval system. This is because the Ministry of Food and Drug Safety may miss something just by verifying the equivalence of drug efficacy. The measures currently put forward by the authorities are only short-term prescriptions aimed at calming patients and public opinion. Even if things become complicated, we must take a broader perspective and respond preemptively. That's the only way for generic trust.
- 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.
- Company
- CDK4/6 anticancer drug is very active in early breast cancer
- by Jung, Sae-Im Jul 24, 2023 05:25am
- The activity of CDK4/6 inhibitors in early breast cancer is not limited to Verzenio. Kisqali also presented data on adjuvant therapy after successful surgery at ASCO held in June. Although they are the same class of drugs, the clinical designs of the two drugs in early breast cancer are different in many ways. First, Verzenio was targeted for high-risk patients with lymph node metastasis. On the other hand, Kisqali did not limit the presence of lymph node metastases. Relatively less risky patient groups were also included in the clinical trial. The dose and duration of administration are also different. Verzenio uses the same dose as for metastatic breast cancer, and after two years of administration, only endocrine therapy is continued. On the other hand, Kisqali lowered the dose by two-thirds and set the duration of administration to 3 years while conducting clinical trials. It appears to be intended to lower the risk of side effects by reducing the dose. CDK4/6 inhibitor options are increasing in early breast cancer, but their use in the field is still limited. This is because there are no drugs that have entered the right to benefit. HIRA reviewed Verzenio's early breast cancer reimbursement standards in May but did not set standards. There is also a prejudice against early cancer. It is a view that the patient group is wider than terminal cancer and that life is not in a relatively dangerous situation. At the same time, there are practical questions about whether it would be cost-effective to spend significant drug costs on all 100 people to reduce the risk of recurrence in several people. Dailypharm listened to changes and improvements in treatment strategies for early breast cancer through a conversation with Professor Nadia Harbeck, head of the breast center at Munich University, Germany, and Professor Lim Seok-ah, Department of Hematology and Oncology, Seoul National University Hospital. Professor Lim Seok-ah -There are increasing cases of CDK 4/6 inhibitors spreading to early breast cancer. How to expect to meet the prognosis and unmet needs of early breast cancer patients in terms of quality of life. =Professor Lim Seok-ah: Korea has a well-operated breast cancer screening system, so there are many early breast cancer cases. About 80% of breast cancers are of the HR+ type, and the number of patients with this type is relatively high among young people between the ages of 45 and 55. In the West, premenopausal female patients account for 20-30% of all breast cancer patients, but in Korea, they account for almost half. Young women's breast cancer has a slightly more aggressive characteristic, especially among the HR+ types, the luminal B type has a faster tumor growth rate than the luminal A type. In light of treatment experience, the proportion of patients with Luminal B type is higher in HR+ breast cancer among women in their 40s and 50s in Korea. In these patients, relapse is quite common during the first 2 to 3 years of endocrine therapy for 5 years after surgery. Personally, I believe that reducing the recurrence rate by using Verzenio for 2-3 years, when the recurrence frequency is high, can yield important results that increase the patient's chance and possibility of a full recovery. Korea has recently started to use ovarian function inhibitors and aromatase inhibitors as adjuvant therapy for HR+/HER2- breast cancer. Now, with the addition of Verzenio, we believe that the treatment strategy will proceed in the direction of improving the prognosis by reducing the recurrence rate of early breast cancer patients, including premenopausal women. =Professor Nadia Harbeck: Patients with HR+/HER2- early breast cancer had significant unmet needs in the past. Even if patients underwent endocrine therapy or chemotherapy, the data in terms of survival were not good. It is very encouraging that Verzenio can now be used in early patients to increase the chances of a full recovery. This is because cure is the ultimate treatment goal in early breast cancer. Professor Nadia Harbeck -Recently, following Verzenio, other CDK 4/6 inhibitors also released new data in the field of early breast cancer. What are the prospects for the use of CDK 4/6 inhibitors in the field of early breast cancer in the future? Along with this, there are opinions that administering drugs to 100 patients to prevent the risk of recurrence in about 3 patients is not cost-effective. What do you think? =Professor Lim: The appearance of CDK 4/6 inhibitors is providing hope to early breast cancer patients who have been fearful of recurrence due to limited treatment options. In addition, as clinical trials were conducted for patients with a high risk of recurrence, it plays an important role in preventing high-risk early breast cancer patients from spreading to recurrent and metastatic breast cancer. If other clinical studies are successfully completed, the use of CDK 4/6 inhibitors in reducing the risk of recurrence of early breast cancer will be broadened. Treatment for early breast cancer has a fixed duration. If the recurrence of a patient can be prevented through active therapeutic intervention in the early stage of breast cancer for a certain period of time, the social and economic medical costs of the patient in the stage of metastatic and advanced breast cancer can be reduced. When reviewing cost-effectiveness, these factors should also be considered. - Since Verzenio was approved in Germany last year, reimbursement was applied immediately. What are the criteria for determining the salary? What are the effects experienced in actual clinical settings? =Professor Harbeck: In Germany, reimbursement starts immediately for drugs approved by the European Medicines Agency (EMA). Verzenio's prescription and reimbursement are conducted according to the monarchE research standards, and overall, both medical staff and patients are having a fairly positive experience. As a participant in one of the actual monarchE clinical research sites, following the experience in the research process, prescriptions are being routinely conducted in the real world. In actual clinical settings, there are patients who need dose adjustment due to some diarrhea or fatigue at the beginning of treatment, but most of them are satisfied with the treatment and have excellent treatment compliance. Because patients know that they are at high risk of recurrence, they are very satisfied that there is a new treatment available to them that can protect them from the risk of recurrence.
- Company
- The synergy between strengths & strengths
- by Kim, Jin-Gu Jul 21, 2023 05:41am
- The number of domestic pharmaceutical companies collaborating to jointly sell drugs has increased significantly. In the past, drug co-promotion contracts were mainly concluded between multinational pharmaceutical companies and domestic pharmaceutical companies. In the pharmaceutical industry, it is interpreted as a result in which the needs of both sides are well-matched. Companies with relatively weak sales power can enjoy the effect of increasing sales and securing customers by collaborating with companies that have expertise in a specific area. Companies entering the market through joint sales can expect the effect of expanding their product lineup. Here, it is analyzed that it can be relatively advantageous to enter the market through joint sales instead of selling products at low drug prices as generics. According to the pharmaceutical industry on the 4th, there are more than 10 cases of marketing and sales collaboration, such as co-promotion contracts for joint sales of drugs between domestic pharmaceutical companies this year. Last month ▲MOU for domestic sales and marketing of Insulin Glargine, a Lantus biosimilar between Dongkuk and GC Pharma ▲MOU between Dongkuk and Korea Pharmbio for intestinal sales co-promotion of Orafang ▲CCB series 3 between Samjin and Ilsung Four contracts were signed, including a co-promotional agreement for Azelblock, a first-generation hypertension treatment, and a co-promotional agreement between Anguk Pharm and CMG Pharmaceutical for rosuvastatin + omega 3 combination drug 'Mega M Dual Soft Cap'. Last month ▲ Dongkuk Pharm and GC Pharma's domestic sales and marketing business agreement for Lantus biosimilar Insulin Glargine, ▲ Dongkuk Pharm and Korea Pharmbio's booklet payment Orafang's hospital sales co-promotion business agreement, ▲ Samjin Pharm and Ilsung New Drug's CCB A co-promotion agreement was signed for Azelblock, a third-generation high blood pressure treatment affiliate, and ▲Mega M Dual Soft Cap, a rosuvastatin + omega-3 combination drug between Anguk Pharmaceutical and CMG Pharmaceutical. In January, ▲an exclusive sales contract between Kwangdong Pharm and Hanlim Pharm for the highly concentrated liquid nutritional tonic 'Horban', ▲an extension contract for joint sales of Edarbi and Edarbyclor between Donga ST and Celltrion Pharm, ▲HK Innoen and Samyang Holdings' domestic sales of Paclitaxel-based anticancer drug Genexol ·Marketing joint sales contract, and ▲Amortan-R' co-promotion contract between Anguk Pharm and CMG Pharmaceutical, a three-drug combination drug for hypertension and hyperlipidemia. Anguk and CMG Pharmaceuticals also signed a co-promotion for Lacbio, an intestinal medicine, in December last year. In the same month, SK Chemicals also signed an exclusive sales and distribution contract with Mothers Pharmaceuticals for Acerisone, a non-steroidal anti-inflammatory drug. (From left) K-CAB, Zemiglo, Shinbaro. It is regarded as an example of a successful co-promotion contract between domestic companies Since the end of last year, at least 13 domestic pharmaceutical companies have signed joint sales contracts in the past half year. It is evaluated that the cases of collaboration between domestic companies have increased significantly compared to the past. In the pharmaceutical industry, there is an analysis that collaboration between domestic companies is becoming a new trend. In the past, most of the co-promotional contracts in the domestic pharmaceutical bio-industry were in the form of multinational pharmaceutical companies borrowing the local area sales force of domestic pharmaceutical companies. It was mainly a method in which multinational companies were in charge of general hospitals and domestic companies were in charge of local clinics. The drug co-promotion between domestic pharmaceutical companies is interpreted as a result of the needs of the two contracting parties matching well. Pharmaceutical companies with relatively weak sales power can seek to increase sales by collaborating with companies that have expertise in a specific area. Even in the opposite case, it is an analysis that the pharmaceutical company can create synergy by expanding its lineup in the treatment area. Taking the Glarzia case of Dongkuk and GC Pharma as an example, Dongkuk is actively seeking to expand into the diabetes field. Dongkuk received approval for Daflzin, Tenelikan, Sitakan, and Sitakandapeul one after another from the end of last year. In April, a relay symposium was held for 500 medical staff in five regions across the country ahead of full-fledged sales promotion. Dongkuk Pharmaceutical's plan is to strengthen its diabetes treatment lineup by adding Glarzia, an insulin injection. GC Pharma plans to reverse the sluggish sales flow after the introduction of the product through collaboration with Dongkuk Pharmaceutical. GC Pharma introduced Glarzia from Indian pharmaceutical company Biocon and launched it in November 2018. At the time, Handok was in charge of domestic sales and marketing, but sales continued to be sluggish at around 1 billion won a year. It shows a big difference from the original Lantus, which generates sales of more than 20 billion won a year. Like K-CAB and Zemiglo, we also accumulated positive results from joint sales. It is analyzed that the steady accumulation of positive co-promotion results also contributed to the expansion of cooperation between domestic companies. A representative example is the joint sale of K-CAB by HK inno.N and Chong Kun Dang. HK inno.N signed a joint marketing contract with Chong Kun Dang and K-CAB in January 2019. As a result, K-CAB expanded its annual prescription amount to more than 130 billion won in four years of collaboration between the two companies. HK inno.N took on the challenge with P-CAB-type drugs at a time when PPI-type drugs were leading the market. It is an analysis that HK inno.N was able to quickly settle K-CAB in the market through collaboration with Chong Kun Dang. Chong Kun Dang has also established K-CAB as a product that greatly contributes to corporate performance. Daewoong and LG Chem jointly sold Zemiglo, GC Pharma and Daewon Pharm jointly sold Shinbaro, and Boryung and GC Pharma jointly sold Neulapeg. In the pharmaceutical industry, analysis is raised that there will be some impact from the stepped drug pricing system that took effect in July 2020. This system is a structure in which the drug price is reduced starting with the 21st registered drug. It means that the generic means that the drug price is lower. For generic companies, it may be more beneficial to jointly sell products that have already been released rather than belatedly developing generics and entering the market.
- 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.
- Company
- Exports of botulinum in the first half rose by 26%
- by Kim, Jin-Gu Jul 21, 2023 05:41am
- In the first half of last year, exports of domestic botulinum toxin increased by 26% compared to the previous year. In particular, exports to Brazil increased significantly. In the pharmaceutical industry, analysts say that Brazil is emerging as a major exporter of domestic botulinum toxin along with China and the United States. According to the Korea Customs Service on the 19th, the export of domestic botulinum toxin in the first half of last year was 166.1 million dollars (about 210 billion won). It increased by 26.4% compared to $131.4 million in the first half of last year. By country, exports to China and the United States still account for a large proportion. In the first half of the year, botulinum toxin exports to China amounted to US$23.55 million, accounting for 14.2% of the total. Exports to the US account for 13.9% at $23.01 million. Following China and the United States, Brazil has the third-highest export performance of botulinum toxin. In the first half of the year, exports of botulinum toxin to Brazil were $21.07 million. Compared to $13.32 million in the first half of last year, it increased by 58.1% in one year. The share of total exports increased by 2.6%p from 10.1% to 12.7% over the same period. If the period is extended, the increase in botulinum toxin exports to Brazil becomes even more remarkable. In the first half of 2020, three years ago, the export of botulinum toxin to Brazil was only $5.57 million. Its share of the total was 6.1%. In just three years, the amount of exports has increased nearly four times, and the share has more than doubled. In this process, it is similar to China and the United States, which are existing major exporters, and their share in total exports has increased. An official from the pharmaceutical industry explained, "It seems that interest in Korean botulinum toxin is growing in the South American market, especially in Brazil." “Recently, botulinum toxin exports are diversifying not only to South America but also to emerging markets such as Southeast Asia and the Middle East,” he said.
- Company
- Korean pharmas busy recruiting talent from global pharmas
- by Lee, Seok-Jun Jul 21, 2023 05:41am
- Korea's pharmaceutical and bio businesses are busy recruiting talents from multinational pharmaceutical companies to further accelerate their global entry. Handok appointed Miyeon Kim (56) as the new CEO as of July 1st. At Pfizer, the new CEO Kim worked as the Strategic Planning Manager, Product Manager, Marketing Manager, and as the BU Lead of the company’s Established Products Business Unit. Afterward, she was appointed VP of Pfizer’s Established Products Business Unit at Pfizer US and led the US Brands Team. Kim also has served as the Cardiovascular Metabolic Franchise Head and Country General Manager of Alcon. In June, Handok had appointed Yoon-Mi Kim as Executive Director to head its ETC business unit. Executive Director Kim started her career in 2001 as a sales and marketing manager at Handok. At Pfizer Korea, she served as the Marking Manager for Viagra and Champix, and as Director of Business Operations and Strategy, Oncology at Pfizer APAC Region. Until recently, she had served as a Hematology & Oncology BU Lead at BMS before returning to Hanok. Hana Pharm appointed Tae-Hong Choi (66) as its new President/CEO. President Choi had previously served as the CEO of Boryung Pharmaceutical from January 2013 to March 2019, then as CEO of Daewon Pharmaceutical from June 2019 to 2022. Choi has extensive experience in multinational pharmaceutical companies before leading various Korean pharmaceutical companies. He joined Janssen Korea in 1987 and served as the VP of the Korean and Hong Kong Janssen and as the Head of the North Asian region, etc. Anterogen will hold a special shareholders meeting on September 4th to discuss the appointment of Hong-Ki Ryu (66) as the full-time auditor. After working as a marketing and planning executive at various domestic and multinational pharmaceutical companies including AstraZeneca, Novartis, JW Pharmaceutical, etc., Rhu joined AbbVie (then Abbott) in 2004 and rose to the position of CEO in 2008. Rhu continued to lead the company until early 2019 even after Abbott separated into the current AbbVie and Abbott in 2013. Also, Shaperon has appointed former GSK executive Yeon-Sam Oh as Head of Business Development, and Lotte Biologics appointed former Roche and Genentech executive Hyungduk Yoo as Chief Operation Officer (COO) this year. Global business expansion The domestic pharma and bio companies’ recruitment of personnel from multinational companies is interpreted as the companies’ move to advance into the global market. Hana Pharm is one example. The company had posted annual sales of KRW 210.8 billion last year. Among them, exports amounted to KRW 1.3 billion, less than 1% of the total sales. The company’s sales depend on domestic demand. It had posted no overseas sales in the Q1 this year. President Tae-Hong Choi is well-versed in global affairs to the extent that he served as the General Manager of the North Asian region at Janssen Korea. While serving at Boryung Pharmaceutical, he demonstrated his overseas proficiency by winning several export contracts for Kanarb (high blood pressure drug). Most of Boryung Pharmaceutical's exports of Kanarb occurred after President Choi was appointed in 2013. Choi is expected to focus on the global business at Hana Pharm. He expects to create synergy with Director Yerim Cho (43, second daughter of the owner), who is in charge of the global business. The preliminary preparations for the global advancement are complete. Last year, Hana Pharm completed the construction of a production plant to produce the new anesthetic drug ‘Byfabo Inj.’ In 2020, the company acquired the right to sign exclusive contracts in 6 Southeast Asian countries to expand overseas sales of its new anesthetic drug. The company recently received approval in the Philippines, one of 6 countries, and is preparing to release Byfabo there in Q4. Also, the company is aiming to sign consignment manufacturing (CMO) export agreements in Europe and Japan.
- Company
- NHIS starts RSA reevaluations for AD drug Dupixent
- by Eo, Yun-Ho Jul 21, 2023 05:40am
- Sanofi has started reevaluation negotiations for its atopic dermatitis treatment ‘Dupixent,' which has been receiving reimbursement under the RSA (Risk Sharing Agreement). According to industry sources, Dupixent’s RSA term ends on December 31st, therefore, the drug is undergoing reevaluation negotiations with the National Health Insurance Service. In other words, the company needs to renew the RSA contract within the year to allow the drug to be applied for reimbursement without any issue. Of course, no company has failed to renew its RSA until now. However, the mechanism of the RSA makes it so that every time a reevaluation is conducted, the price is further reduced, raising tensions. In Korea, unlike general drugs that are listed after demonstrating cost-effectiveness through pharmacoeconomic evaluations, RSA drugs are required to receive additional evaluations for clinical utility and cost-effectiveness every time the contract term expires. The cost-effectiveness evaluations are inevitably affected by the price of its alternatives at the time of evaluation. And during the 5-year RSA term, the price of the alternative drug is also reduced through various follow-up measures (reduction in original drug price due to generic listing, price-volume price linkage system, ceiling price cut due to reimbursement extensions, etc). Furthermore, the revisions in the announcement made in 2020 allowed latecomers to receive reimbursement through RSA, allowing the price of the latecomers to directly affect the cost-effectiveness of the first entrants. This has added to the already long list of issues that have been constantly raised about RSA renewals in the industry. However, the entry of latecomer drugs to the RSA scheme has been a long-awaited wish come true from the industry’s perspective, and the government expanded its benefits after various considerations Also, it is not unreasonable for price adjustments to be made for drugs that have alternatives with the same mechanism of action, even if the indications are not identical. Meanwhile, reimbursement extensions for Dupixent to cover severe asthma and pediatric AD are also in progress. Whether Sanofi Korea can reach an agreement and receive reimbursement extensions remains to be seen.
- 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.
