- by Eo, Yun-Ho Sep 25, 2020 06:06am
A third generation targeted therapy Tagrisso is getting back on its track to seek reimbursement as a first-line treatment for patients with lung cancer.
The pharmaceutical industry sources confirmed, AstraZeneca Korea has submitted an application to expand reimbursement on its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) as a first-line treatment. After failing to pass the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee in last May, the company is resuming the process in five months.
Adding the first-line treatment indication in December 2018, Tagrisso sought after the reimbursement expansion in 2019, but the South Korean health regulators deferred the decision by claiming the decision should be made when the Phase III FLAURA study reveals full data on overall survival (OS) as a first-line therapy.
Although the company handed in additional data from the FLAURA study and accepted the government-proposed financial burden sharing plan, the Cancer Deliberation Committee members argued the treatment demonstrated issues in clinical efficacy and denied the reimbursement expansion.
AstraZeneca’s new weapon of choice is the FLAURA China extension cohort study unveiled as a poster presentation at European Society for Medical Oncology (ESMO) conference convened online recently. The study provides specific OS data in Asian race.
The toughest barrier that hindered Tagrisso from expanding the reimbursement was the Asian subset analysis. The study found Tagrisso’s OS was at 38.6 months, which improved OS in Iressa (gefitinib) and Tarceva (erlotinib) by 6.8 months. The findings were encouraging as Tagrisso was the first EGFR TKI, and the researchers counted even the cross over prescription on patients with confirmed T790M mutation.
However, the subset analysis on Asian race showed skeptical hazard ratio (HR). Among the Asian participants, the HR was only around 0.995. The figure was basically within the margin of error from the value 1, which meant the targeted therapy failed to show meaningful improvement compared to the controls.
Based on the unsatisfying result, the scholars claimed “The Tagrisso OS in Asian race, also covering the South Koreans, is not credible,” and the claim eventually influenced the Cancer Deliberation Committee’s decision.
Now that Tagrisso has prepared the study results from China, the previous decision on reimbursement expansion could be overturned.
The FLAURA China study incorporated a total of 71 participants using Tagrisso and 65 participants using control in China cohorts. The control group participants were allowed to cross over to Tagrisso as a second-line treatment, once they advanced as T790m-positive, in which 22 out of 65 patients were the case.
As a result, Tagrisso group’s OS median reached 33.1 months, or 7.4 months longer compared to the control group with 25.7 months, while the risk of death was reduced by 15.2 percent.
- More than 20 companies, to apply for Atozet's generics
- by Lee, Tak-Sun Sep 25, 2020 06:05am
- It is reported that more than 20 pharmaceutical companies have contracted to produce generics for Atozet (Ezetimibe/Atorvastatin) with Chong Kun Dang.
Accordingly, it is expected that the number of drugs applied for permission after PMS through bioequivalence test will be lowered by about 15% compared to Chong Kun Dang products.
Chong Kun Dang signed contracts with consignment companies on the 22nd. According to the industry, contrary to the concerns of the participating companies, it is reported that more than 20 companies have signed contracts.
In the new cascaded drug price system, up to 20 items in the order of listing will receive 53.55% of the drug price compared to the original if the condition of DMF-self-biological equivalence is satisfied. On the other hand, starting from 21st generics, drug prices are calculated at 85% of the lowest price, so generics are more advantageous the sooner they are listed.
If there are no more than 20 contractors entrusted to Chong Kun Dang, including the original company and Chong Kun Dang, the companies applying for permission after the end of the PMS in January of next year could receive the drug price at the same level.
Accordingly, some of the consignment companies that undertake Chong Kun Dang's contracts also commented that it would be better to entrust the same drug price to a bioequivalence generic company that has low production costs. However, it is reported that Chong Kun Dang responded to the consignment company to not worry because there are more than 20 contractors.
Chong Kun Dang's drugs for data-based re-evaluation are expected to be approved next month, and the consignees are planning to apply within this week. From September 30, when applying for permission, it is mandatory to submit data on the possibility of causing genotoxicity of impurities. The evaluation data on the possibility of inducing genotoxicity of impurities is a system introduced by the MFDS in order to strengthen management in the subsequent NDMA incidents of carcinogenic substances.
An industry official said, "In consideration of the MFDS’ confirmation schedule, Chong Kun Dang's consignment companies decided to apply for a permit within 25 days at the latest. It is likely that the exact number of consignment contractors will be disclosed after applying for permission."
If more than 20 Atozet consignment contractors are confirmed, the demand for the restriction on the number of delegated generic licenses is expected to increase. This is because generics that have been tested for bioequivalence may suffer damage from the drug price due to late listing. Therefore, some in the industry have come up with an opinion that the number of delegated generic licenses should be limited.
- The post-assessment system has many problems
- by Lee, Hye-Kyung Sep 25, 2020 06:05am
- The necessity of introducing post-assessment system for prior registration was raised to expand patient access to new drugs, but the government said it needed complex concerns.
Choi Gyeong-ho, an official at the insurance pharmaceutical department of the MOHW, said at the 'Non-face-to-face discussion for enhancing patient accessibility of new drugs in the era of COVID-19' held at 2 p.m. on the 23rd hosted by member of the National Assembly, Lee Yong-ho and hosted by the Future Health Network. "The post-admission evaluation system is theoretically very good, but there are a lot of concerns."
In the process of reducing Choline alfoscerate’s benefit, the notice was suspended due to lawsuits, etc., and Choi said, "we tried to subtract the ineffective Choline alfoscerate from reimbursement, but it is suspended."
He said, "The post-admission evaluation system may have complex problems such as what to do with patients who have been taking it if there is a situation where they have to leave." "I have no choice but to have doubts whether pre-listing at temporary prices is a system that can actually work."
Lee Hyung-ki, a professor of clinical pharmacology at Seoul National University Hospital, who was in charge of the topic presentation on the day, said that there is no simple approach to the increase of the ICER threshold.
He said, “If we raise the price of ICER, it will help with positive aspects and high-priced new drugs or listings, etc. in terms of reinforcement of security, However, it is bound to be accompanied by an increase in drug prices. Therefore, there are many opinions, and there are opinions that the current value is okay, so a lot of discussion is needed.”
It was also said that the law will be revised sooner or later regarding the listing of drugs after risk sharing (RSA).
He said, "There are plans to improve the RSA system, such as generic drugs system, but it is a matter that needs to be revised and linked in practice and it will be implemented soon."
- Better new drug access with pre-listing reimbursement
- by Lee, Hye-Kyung Sep 25, 2020 06:04am
- Pharmaceutical affairs expert argues, to enhance patients’ access to new drugs, the government should induce pharmaceutical companies to voluntarily set and lower generic pricing on their own, while also considering flexible ICER threshold and pre-listing reimbursement.
And the expert criticizes the upcoming pilot program, effective from October to provide coverage on Korean herbal medicine, as ‘medical service coverage without sound evidence of cost-effectiveness,’ and urges the government to revisit the matter and review appropriately allocating the National Health Insurance (NHI) finance.
The said claims were made at a non-contact discussion panel on enhancing access to new drug amid COVID-19, convened by Lawmaker Lee Yongho and ‘Future Health Network’ on Sept. 23.
Professor Howard Lee at Seoul National University Hospital Department of Clinical Pharmacology presented his analytic findings on recommended policies to improve patients’ access to new drugs.
Professor Lee proposed four policies on reinforcing the accessibility to new drugs.
First, the professor urged the incremental cost-effectiveness ratio (ICER) threshold should be based off of the national income level, disease severity and properties, and patients’ need for the treatment.
Currently, the Health Insurance Review and Assessment Service’ (HIRA) ‘Detailed Evaluation Standards of New Drug and Negotiating Drugs’ do not clearly state ICER threshold, but it refers to GDP per capita (36 million won as of 2019).
Professor Lee said, “If the reference subject is used in combination with a high-cost standard therapy or other drugs, it is difficult to prove the cost-effectiveness,” and “ICER threshold should be flexibly applied in brackets for pharmaceuticals challenged to conduct pharamacoeconomic (PE) analysis, or cancer or severe disease treatments.”
The second proposal is to seek alternatives for PE analysis.
Professor Lee pointed out, “The risk sharing agreement (RSA) system was initially introduced, because proving cost-effectiveness was difficult,” but “these new drugs still take 746 days until the listing and 729 days with RSA, making not much of a difference. Nevertheless, there is no alternative option other than RSA.”
Based on his criticism, he argued the mindset on enhancing new drug accessibility should be shifted and suggested adopting ‘pre-listing reimbursement.’
The third recommendation is to adequately appropriate NHI finance.
His argument is that the price competition-induced generic pricing reduction and coverage on medical service, which cannot prove cost-effectiveness, should be taken into account again.
The professor reprimanded, “South Korea’s generics are usually expensive but their markets generate more than sufficient sales. It means the true market functions is missing,” and “in case of Japan, where drug pricing controlled, its government decides the generic pricing preventing the price competition. But South Korea is different.”
Regardless of the government’s pricing control, the generic sales are high, as well as the sales profit. So the professor stated, “Rather than the government-forced pricing control, voluntary generic pricing by companies is more effective to motivate generic pricing reduction.”
The fourth proposal was opening a separate fund for the new drugs.
He emphasized the government should seek for the social consensus to create an independent fund for the new drug coverage that can be operated regardless of NHI financial status.
- The generic competition of Circadin PR is intensifying
- by Lee, Tak-Sun Sep 25, 2020 06:04am
- Generics for Circadin PR, a melatonin-based insomnia treatment drug, began to be approved on the 22nd. Kuhnil's Circadin PR was removed from data protection due to the expiration of PMS in June. With the end of PMS, applications for permission for generic drugs were followed, and product approval was finally received this month. Prior to the release of generics, the entrusted generics, which signed a contract with Kuhnil, were pre-released, and attention is focused on the competitive structure.
On the 22nd, the MFDS approved generics of the same ingredients as Circadin PR, such as SK Chemicals' Raton 2mg. Seven companies were approved on the 22nd and more companies are expected to receive approval for generic drugs within this month.
On the 22nd, generic drugs produced by Inist and Mothers Pharm were approved. The original, Kuhnil's Circadin PR, obtained an item approval in June 2014. It is an item developed by NEURIM, headquartered in Israel, and imports and sells items produced by SwissCo Services AG located in Switzerland.
In a domestic clinical trial for insomnia patients over 55 years of age, Kuhnil said that after taking Circadin, the quality of sleep, time to fall asleep, total sleep time, sleep efficiency and activity during the day were improved, but no special side effects occurred.
In addition, while existing sleeping pills are limited to 3-4 weeks per time as psychotropic drugs, Circadin PR is a non-psychotic drug that can be prescribed for up to 13 weeks at a time.
Circadin PR which was released as a non-reimbursement drug in July of that year, continued to increase in sales, but last year, it was evaluated that it successfully settled in the market at &8361;6.5 billion based on IQVIA.
However, with the end of PMS, which releases new drug data protection this year, it has become difficult to maintain market share due to the entry of generic drugs.
Accordingly, Kuhnil has devised a strategy to increase its side through delegated generics. In February and March, before the expiration of the PMS, Kuhnil provided data to four companies, including Jeil, Penmix, Hanlim, CMG pharm and helped with the authorization of the delegated generic type. These four delegated generics, like the original, are drugs produced by SwissCo Services AG.
The intention is to preoccupy the generic market with delegated generics manufactured in the same producer before generics are released. Sales of delegated generics released six months earlier are still not good.
The fact that this drug is a non-reimbursement Rx drug, but it is an unpredictable indicator of how the market competition will flow. It is noteworthy how well domestically produced generic generics will perform.
- Janssen MA Director Lim Kyunghwa promoted to Janssen APAC
- by Eo, Yun-Ho Sep 24, 2020 11:59am
- Market Access (MA) Director Lim Kyunghwa at Janssen Korea is to be promoted to Janssen Asia Pacific.
The pharmaceutical industry sources reported, Director Lim would be appointed as a new MA Director at Janssen Asia Pacific from coming October. Temporarily, Lim would be remotely working from South Korea amid COVID-19, but she would be working at the Asia Pacific Region Office later.
Director Lim, currently leading the MA at Janssen Korea, has earned her master’s and doctorate degrees from Sookmyung Women’s University, as well as MBA from Korea University. Her career in MA started when she joined Chong Kun Dang, and she gained rich MA experiences from Boehringer Ingelheim and Novartis.
Moreover, Director Lim is currently serving as a Co-chair of MA Committee at Korean Research-based Pharmaceutical Industry Association (KRPIA). Due to her promotion, KRPIA is to appoint a new co-chair on Sept. 28.
KRPIA is also readying for a series of new personnel changes in Board of Directors, as the current Chairman Avi BenShoshan and Vice-Chair Julien Samson are returning back to the headquarters.