- by Lee, Tak-Sun Dec 7, 2023 05:47am
The final results of the 2023 reimbursement adequacy reevaluations will be released on the 7th. On the day, the Health Insurance Review and Assessment Service’s Drug Reimbursement Evolution Committee will deliberate on the final reevaluation results that reflect the appeals made by pharmaceutical companies on the first results.
In general, the pharmaceutical industry is not expecting the results to differ greatly from the first results, given the lack of appeals that were filed.
However, in the case of hyaluronic acid eye drops, the committee discussed revising the reimbursement standards regarding the use amount after releasing the initial results, so industry eyes are on whether DREC will make a final decision on this on the 7th.
The initial results announced at the end of DREC’s September 6 meeting concluded that rebamipid and levosulfiride were reimbursable.
However, limaprostalpha-dex for improving ischemic symptoms of Berger's disease, such as ulcers, arterial pain, and coldness, was not considered to be adequate for reimbursement.
Also, loxoprofen’s use to reduce fever and pain related to acute upper respiratory tract infection was not considered to be adequate for reimbursement.
In the case of hyaluronic acid eye drops, which attracted the most attention, the committee deemed reimbursement inadequate for its use for exogenous diseases caused by surgery, drugs, trauma, or contact lens wear.
Although its use for endogenous diseases such as Sj&246;gren's syndrome, mucocutaneous ocular syndrome, and dry eye syndrome were deemed adequate, the committee determined that its reimbursement standards such as the number of prescriptions per patient visit and the total number of prescriptions per patient per year would need to be established for its appropriate use.
The industry generally expressed pleasure about the initial results because the indications that were deemed non-reimbursable were not the drugs’ primary indications. However, as antipyretic and analgesic indications for loxoprofen have been heavily used during the COVID-19 pandemic, there was some pushback regarding its non-reimbursement in the medical community.
In the case of the hyaluronic acid eye drops, there were fewer appeals from pharmaceutical companies because s its use for exogenous diseases is relatively low. The approved use for endogenous diseases accounts for the absolute majority of hyaluronic acid eye drop prescriptions, with over an 80% share.
However, the industry is keeping a keen eye on restrictions that may be made on its use volume. Although there has been an opinion that its annual use should be restricted to 60 eyedrops (4 boxes), it has been reported that the committee had difficulty coming up with a unified plan due to strong opposition from the medical community and the pharmaceutical industry.
Nevertheless, the industry prospects are that HIRA will report the results of its discussion to DREC to make a final decision. However, it is unlikely that DREC will come to an easy conclusion, therefore the reimbursement standards for restricting the volume is likely to be discussed beyond the year, according to industry analysis.
If revisions to the reimbursement standards are postponed for this reason, it is expected that sodium hyaluronate eye drops’ reimbursement standards for exogenous diseases will first be removed and be granted reimbursement use only for endogenous diseases from January next year.
An industry official said, "In the case of sodium hyaluronate eye drops, restricting its usage may greatly affect performance. We are waiting to see what decision DREC will make on this tomorrow."
- 'Janssen’s strong in autoimmune diseases for a reason'
- by Eo, Yun-Ho Dec 7, 2023 01:28pm
Most pharmaceutical companies have one business unit that represents the company. These units, which usually own specialized cardiovascular, anticancer, or antiviral products, or have flagship products that lead their respective markets, are often revered within the company as well.
Janssen Korea’s Immunology Business Unit is one such unit. The company, which had been leading the central nervous system (CNS) area until the mid-2000s, made its way into the immunology business with ‘Remicade (infliximab)’ and provided various treatment options including ‘Stelara (ustekinumab),’ ‘Tremfya (guselkumab),’ and ‘Simponi (golimumab),’ rising to lead the immunology treatment paradigm. The drugs are also the top revenue contributor.
This business unit welcomed a new head earlier this year. SungHee Yoon, Director of the Immunology Business Unit at Janssen, is credited with developing the portfolio strategies for Stelara and Inflammatory Bowel Disease (IBD) for the Asia Pacific region, solidifying Janssen's autoimmune disease leadership.
Dailypharm met Director Yoon to seek insight into the vision and future of Janssen’s Immunology Business Unit
- Janssen Korea and you played a leading role in adding an indication for Remicade
After joining Medical Affairs, I led Remicade’s clinical trial for Behcet's colitis, an indication that had not been studied globally, and received approval for the indication. As Remicade's patent was about to expire at the time, it wasn't easy to convince the headquarters to carry out and design a clinical trial for an additional indication from a product’s lifecycle perspective.
However, I could not give up because of the many Behcet's disease patients who do not have many treatment options. From a macro perspective, I believe that improving the treatment experience for those patients would contribute to strengthening Janssen's market leadership.
After much effort, including active discussions with the MFDS and the medical community, Remicade was approved for Behcet's colitis indication in 2020.
-Janssen owns 4 of the top 10 autoimmune disease specialty drugs in Korea. As head of the Immunology BU, how has your BU performed and strategized during the past year to deal with the ever-intensifying competition in the market?
Competition has been intensifying in the autoimmune disease market with the entry of many new drugs, so we believed it was important to deliver differentiated value. We are focusing on market segmentation to understand patient characteristics and unmet needs to match them to our product characteristics.
We are also focusing on diversifying the ways we communicate with healthcare providers as well. As dynamic as the market is, the spectrum of experience we can enjoy as a commercial unit is also appealing. Our unit holds a sense of mission and pride as a high-revenue Business Unit, and we are serious about encouraging our employees to devise and execute their strategies to feel rewarded.
-You have key products that drive growth. What have you achieved with each product and what are your plans for the future?
Stelara is an interleukin-12 and 23 inhibitor with a focus on inflammatory bowel diseases, and we are strengthening communication with HCPs in the area based on our clinical data that shows the drug’s rapid symptom improvement and long-term efficacy. The drug is a global blockbuster that’s nearing patent expiry, and as the producer of the original drug, we are committed to working more closely with HCPs to foster a better treatment environment.
As the first interleukin-23 inhibitor, Tremfya has been leading the market. As the first-in-class drug, the company's strategy is to deliver its value as a best-in-class product with a long track record of clinical data compared to its competitors. In psoriasis, a chronic inflammatory disease, long-term improvement is critical, and we have been delivering treatment benefits based on scientific evidence, including longer treatment duration in patients after achieving PASI 90 and PASI 100 than the competitors. Tremfya is the only interleukin inhibitor in the market with three indications: plaque psoriasis, psoriatic arthritis, and palmoplantar pustulosis.
Simponi is a TNF alpha inhibitor that has a lower antibody production rate than other TNF alpha inhibitors. This is one of Janssen Korea's flagship products, with sales growing by about 10% this year as well. In particular, Simponi was approved as a monotherapy, unlike other TNF-a inhibitors that are typically used in combination with methotrexate (MTX). The drug was first approved as a monotherapy (100mg) without MTX in Japan and was approved as monotherapy based on the same clinical data last year. The company has completed the approval and reimbursement listing process for Simponi since then and started full-scale marketing activities in Korea as well.
- What is your outlook on the autoimmune disease market and what plans do Janssen and your BU have for the future?
One of the important characteristics of the autoimmune disease market is that one product can have multiple indications. Due to the nature of the immune system, the causes of many autoimmune diseases are often interconnected. Therefore, after a product is released for one indication, the companies tend to expand the indications for their drug. In the case of Stelara, it started off as a dermatology treatment and then moved into gastroenterology.
When it comes to expanding indications, Janssen actively looks to address conditions with a high unmet need. I think there is a high unmet need for lupus in the Asian region. Due to a poor understanding of its mechanism of action, a lot of R&D effort still needs to be made for the disease.
Also, combination therapies using biologics will be an important area of research, although this is not common yet. Improving patient convenience will also be important due to the nature of chronic diseases that require lifelong management. Varying formulations for the same target substance to improve adherence will also be an interesting area of research.
- JW Pharm Hemlibra's sales tops KRW 10 bil for the 1st time
- by Chon, Seung-Hyun Dec 7, 2023 05:47am
- Annual sales of JW Pharmaceutical's Hemlibra has surpassed the 10 billion won mark for the first time since its launch in Korea. The expanded reimbursement significantly boosted sales, by threefold.
According to the pharmaceutical research agency IQVIA, Hemlibra's Q3 sales reached 6.8 billion won, a 261.3% increase from 1.9 billion won in the same period last year.
Hemlibra is a prophylactic treatment for Type A hemophilia, which is caused by the deficiency of blood clotting Factor VIII. It utilizes a dual-specific antibody technology that binds simultaneously to clotting Factors IX and X. Unlike traditional Factor VIII treatments, Hemlibra is the first non-Factor VIII medication that can be administered subcutaneously at intervals of up to four weeks.
Hemlibra was developed by Chugai Pharmaceutical, a subsidiary of Roche. JW Pharmaceutical secured the domestic development and sales rights for Hemlibra in 2017 and received approval from the Ministry of Food and Drug Safety in 2019.
Hemlibra had been released with reimbursement in 2020, and its sales remained at mere 2.1 billion won range in Q1. However, its sales rose to 3.6 billion won in Q2, up by 68.4% from the previous quarter, and showed an even steeper increase in Q3.
The surge in Hemlibra's Q2 sales was due to the expanded reimbursement. Since May, Hemlibra has been reimbursed for patients over the age of one with Type A hemophilia who do not have Factor VIII antibodies.
In May 2020, Hemlibra was initially reimbursed for severe Type A hemophilia patients with inhibitors. Three years later, the reimbursement was expanded to non-antibody patients. JW Pharmaceutical reports that there are approximately 1,700 Type A hemophilia patients in Korea, with about 70% being severe cases. Among them, a significant majority are non-antibody patients. Over 60% of Type A hemophilia patients in Korea fall under Hemlibra reimbursement group.
Hemlibra's sales last year reached 7.6 billion won. The quarterly sales alone nearly matched the previous year's annual sales, marking significant growth due to the reimbursement expansion. For the first time since its launch in Korea, Hemlibra topped the annual sales of 10 billion won, amounting to 12.5 billion won in Q3 sales.
JW Pharmaceutical expects Hemlibra to provide substantial treatment benefits to patients based on its efficacy and safety proven through large-scale clinical trials.
In the HAVEN 1 trial that was conducted on patients with inhibitors, Hemlibra showed a 79% reduction in annualized bleeding rate (ABR) to 3.3 compared to prior prophylaxis with a bypassing agent. or patients without inhibitors, the HAVEN3 trial demonstrated a 68% reduction in ABR to 1.5 compared to factor VIII prophylaxis.
Research comparing the effects of Hemlibra on both inhibitor and non-inhibitor patients yielded similar results and confirmed long-term efficacy. The goal of prophylaxis (bypassing therapy) for hemophilia patients is to maintain a certain level of factor VIII activity to prevent bleeds. Hemlibra has shown sustained plasma concentrations.
According to the company, the clinical trial demonstrated a favorable safety profile. Results from HAVEN 1 - 4 trials had shown that side-effects observed in patients treated with Hemlibra were minor injection site reactions.
Hemlibra’s global sales last year were 3.823 billion Swiss francs (approx. 5.7 trillion won), up 27% from the 3.022 billion Swiss francs YoY. Currently, over 20,000 patients in 144 countries worldwide are using Hemlibra.
- [Reporter’s View] CSO is a double-edged sword
- by Kim, Jin-Gu Dec 7, 2023 05:47am
- Over the past few years, small mid-sized pharmaceutical companies and contract sales organizations (CSOS) have developed a strong symbiotic relationship. Small and mid-sized pharmaceutical companies have provided work for CSOs, and CSOs have repaid the companies by improving their performance.
Due to this, many companies, especially small- and mid-sized companies, have partnered with CSOs. Over the past few years, CSOs have become "the trend" for small- and mid-sized pharma companies, as their performance varied depending on whether they used CSOs.
Also, CSOs have expanded their role by specializing in sales for specific products or regions. They have been praised for improving cost-effectiveness and profitability through flexible sales activities, but they have also been criticized that it has become a ‘breeding ground for rebates.’ It was constantly pointed out that CSOs were being utilized as a rebate delivery channel, hiding in the blind spots of the system.
Then, the CSO Reporting System emerged to address this issue. A bill to amend the Pharmaceutical Affairs Act to require CSOs to report to the government and local governments passed the National Assembly in the first half of this year. The revised Pharmaceutical Affairs Act will come into effect on October 19 next year
Once implemented, the government will be able to hold pharmaceutical companies that signed contract sales agreements with CSOs accountable for the CSO’s deviant activities. This means when rebates are made, not only the CSO but also the pharmaceutical company involved could be criminally punished as an "accomplice".
Even if the company avoids criminal penalties, it will be difficult to avoid administrative penalties because criminal penalties and administrative penalties are imposed separately. The administrative penalty imposed on a Korean pharmaceutical company that was finalized in July this year is a good example. Although the company was acquitted by the prosecution due to insufficient evidence for the rebate case that was discovered in 2016, the Supreme Court made the final ruling to impose a 3-month suspension on the sales of 14 items.
Therefore, cases of rebates made through CSOs may also be judged similarly. Even if the companies avoid criminal penalties, they may still face strong administrative penalties. Moreover, if multiple rebate cases are found at the same time, the administrative penalties may be accrued or raised. For small- and mid-sized pharmaceutical companies, such rulings will be a hard blow.
In this sense, CSOs are now a double-edged sword for small- and mid-sized pharmaceutical companies. They can improve performance but the companies will have to also bear the risk. The time has come for pharmaceutical companies that have already built a symbiotic relationship with CSOs to make a choice. Will the companies continue to work with CSOs that deliver high performance, or reduce the role of CSOs to mitigate risk? The companies will need to make their decision quickly, as just over 10 months remain until the CSO reporting system comes into effect.
- Bemarituzumab is granted ODD status in Korea
- by Eo, Yun-Ho Dec 7, 2023 05:47am
- The new gastric cancer drug bemarituzumab received an orphan drug status in Korea.
The Ministry of Food and Drug Safety (MFDS) recently announced so through the orphan drug designation notice. Specifically, the drug is indicated to treat patients with fibroblast growth factor receptor 2b (FGFR2b) overexpression and unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma.
Amgen’s bemarituzumab is a first-in-class investigational FGFR2b targeted antibody. And, Amgen gained access to the drug as part of its acquisition of Five Prime Therapeutics in 2021. In the same year, the FDA has granted bermarituzumab a Breakthrough Therapy designation (BTD).
Bermarituzumab is a humanized IgG1 monoclonal antibody that targets the binding of FGFR2b. It blocks FGFR2b&160;activation and slows cancer progression.
The data from the its Phase 2 FIGHT clinical trial was been released in October 2022.
For patients with HER2-negative FGFR2b-overexpressing tumor, bemarituzumab plus combination chemotherapy demonstrated clinically significant results in progression free survival (9.5 months vs 7.4 months), overall survival (19.2 months vs 13.5 months), and response rate (53% vs 40%).
Based on the previous results, the company has been conducting FORTITUDE-101 and FORTITUDE-102 Phase 3 trials to further evaluate bemarituzumab in FGFR2b overexpression gastric cancer patients.
In the Phase 1 trial, bemarituzumab showed no dose-limiting toxicities and a had confirmed objective response rate (ORR) of 18% in patients with refractory FGFR2b-positive gastric cancer.
- Dong-A and Pfizer win Industry Ad-PR Awards
- by Kim, Jin-Gu Dec 7, 2023 05:47am
- Dong-A Pharmaceutical's ‘Bacchus’ and Pfizer Korea's 'Green Move Campaign' won the grand award in the advertising and PR categories of the 2023 Korea Pharmaceutical and Bio-Industry Advertising and PR Awards.
On the 6th, Dailypharm (CEO: Jeong Seok Lee) held the ‘2023 Korea Pharmaceutical and Bio-Industry Advertising and PR Awards Ceremony’ at the K-room of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association heqdquarters.
Now celebrating its 11th year, the competition for the award had been stronger than ever, with 77 entries from 39 pharmaceutical companies.
The awards were divided into advertising and PR categories. In the advertising category, 1 grand prize, 1 best excellence prize, and 1-3 excellence prizes were given in each of the 3 areas: ▲TV-CF, ▲print-radio, and ▲Internet-SNS. In the PR category, one grand prize, 1 best excellence prize, and 2 excellence prizes were awarded given in 2 areas: ▲social contribution and disease promotion campaigns, and ▲corporate and product promotion.
Dong-A Pharmaceutical's ‘Bacchus’ seized the grand prize in the advertisement category. Among the 49 entries that were made in the category, Dong-A’s advertisement received the highest scores for message clarity, novelty, and consumer trust. The grand prize awardee received a trophy and a cash prize of KRW 5 million.
Sang-Hyun Han, Advertisement Team Lead at Dong-A Pharmaceutical, said, “This year marks the 60th anniversary of Bacchus’s launch. We prepared an ad that looked back on the past 60 years of Korea with Bacchus and is pleased that our ad received good reviews as a result.”
Han said, “We plan to release a more youthful and dynamic ad next year that celebrates Bacchus’s 60 years to come. We are planning an innovative and fresh advertisement that can lift the public's fatigue like our product.”
In the TV-CF field, Dong Wha Pharm’s ‘Pancol’ received the best excellence prize, and was awarded a trophy and a cash prize of KRW 3 million. Boryung Consumer Healthcare’s ‘Younggaksan Cool,’ Johnson & Johnson Korea’s ‘Tylenol,’ and Samjin Pharm’s ‘Anjung Sol’ received excellence prizes and a cash prize of KRW 2 million.
In the Internet and SNS field, Yuhan Corp’s ‘Contac Gold’ received the best excellence prize. Ahn-gook Pharm’s ‘Tobicom’ and Daewon Pharm’s ‘Newbein’ received excellence prizes. In the Print-Radio field, Daewoong Pharmaceuticals ‘Impactamin’ received the best excellence prize, and Kukje Pharm’s ‘Company PR ad’ received the excellence prize.
In the PR category, 28 entries on the company’s CSR activities and company promotion were submitted by companies. Among the 28, Pfizer won the grand prize in the PR category with its ‘Green Move Campaign.’ As the grand prize awardee, Pfizer received a trophy and a cash prize of KRW 5 million.
Oh Hye-min, Policy & Public Affairs Lead at Pfizer Korea, said, “Corporate ESG activities are no longer an option &8211; it is an obligation. As our company is already engaged in various ESG activities at the headquarters level, we decided to start the Green Move campaign after long discussions on what Pfizer Korea could additionally provide to society. We want to make it a mid-to-long-term project rather than just a one-time event. We look forward to your interest."
In the CSR and disease awareness campaign, area Sinsin Pharm’s ‘Shinshin H2O Life’ won the best excellence prize. The runners-up were Withus Pharmaceutical's ‘Sponsorship of the Korea Ssireum Association’ and Korea United Pharm’s ‘Global Talent Development Program.’
In Company PR and product promotion area, Hanmi Pharm’s ‘50th Anniversary History Discovery Campaign’ won the best excellence prize, while Geo-Young’s " Zyrtec 10mg for Allergic Rhinitis" and Boehringer Ingelheim's ‘Trajenta’ received excellence prizes.
Dae-Chun Ahn, former president of the Korea Advertising Society (Inha University) served as the head of the judging panel for this year’s event, and Jae-Hoon Cheong, professor of Pharmacy at Sahmyook University, and Jae-Kook Lee, executive director of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association served as expert judges.
Ahn said, "In the Advertising category, the judges focused on the delivery and clarity of the theme and message, how novel and original the ideas and expressions were, and how credible the message was beneficial to the consumers’ public interests."
He added, "In the corporate PR category, we focused on how timely the message was from a long-term perspective and how it contributed to the consumers’ public interest. For CSR activities, an area that was
newly introduced this year, we focused on the authenticity of the message, the degree of reflection into society, and the continuity and consistency of the campaign activities."
The Korea Pharma & Bio Industry Advertising-PR Award was launched in 2013 to encourage advertisers to add new value to the pharmaceutical industry and drugs, and to encourage the creation of advertisements that resonate with pharmacists, the primary consumers of pharmaceutical advertisements."
Jeong Seok Lee, CEO of Dailypharm, said, "I would like to congratulate the 17 pharmaceutical company officials that won today's awards. The awards are one recognition of the hard promoting and marketing work and efforts companies made throughout the year. We look forward to seeing more great work next year."