- by An, Kyung-Jin Oct 23, 2020 09:46am
On Oct. 23, a pharmaceutical market research firm UBIST reported a dyslipidemia treatment Lipitor defended its top spot again in the outpatient prescription market this third quarter reaching a cumulative prescription volume of 140.1 billion won. Compared to the third quarter last year at 143.1 billion won, the figure dipped 2 percent, but its prescription volume doubled Daewoong Bio’s Gliatamin’s.
In 1999, Pfizer Pharmaceutical Korea launched a hyperlipidemia treatment Lipitor (atorvastatin) in the South Korean market. After its patent expired, about 130 generics were released but it has never fell below second place in the prescription drug market for over a decade.
Daewoong Bio’s cognitive function enhancing choline alfoscerate, Gliatamin generated a cumulative prescription volume of 73.8 billion won and stayed at the second spot. Compared to the previous year at 70.2 billion won, the prescription volume grew by 5.1 percent. During the same time, another competitor Chog Kun Dang Gliatirin marked 63.3 billion won this third quarter and leapt by 12.4 percent. Regardless of the controversy on the choline alfoscerate efficacy and the novel coronavirus (COVID-19), the two drugs were able to maintain their prescription volume.
Among the top products in the prescription drug market, Hanmi Pharmaceutical’s Rosuzet had the highest growth. For nine months, Rosuzet generated f 72.8 billion won and had a 24.3-percent surge compared to last year. Basically, the average monthly volume was over 8 billion won.
Launched in the Korean market in late 2015, Rosuzet is a dyslipidemia treatment consisting of rosuvastatin and ezetimibe. Hanmi Pharmaceutical licensed in the use of ezetimibe from the patent owner MSD and allowed itself to take the generic market faster than other competitors. While the competition among rosuvastatin plus ezetimibe combination drug market is intensifying day by day, Rosuzet has been on the top of the charts with a significant gap from the competitors.
Despite the difficulties in the sales and marketing activity amid COVID-19, Rosuzet’s quarterly prescription volume showed over 20 percent growth every quarter and marked a record high prescription volume. The drug kept a steady prescription volume in the second and third quarters, when the confirmed cases of COVID-19 exploded. The industry experts predict the drug’s annual prescription volume could break through the 100 billion won line.
Meanwhile, the off-patent drugs had contrasting results. Boehringer Ingelheim’s hypertension combination drug Twynsta had prescription volume of 70.6 billion won and grew by 2.0 percent from last year same time, but Sanofi’s anticoagulant Plavix had a 1.2-percent dip. AstraZeneca’s dyslipidemia treatment Crestor also stepped down by 5.5 percent. But the market experts claim the fluctuating growth is not too concerning as the government has ordered stricter social distancing measures from last August and the country’s general economy was stagnant.
AstraZeneca’s anticancer treatment Tagrisso (osimertinib) placed itself on the sixth place after climbing up 4.8 percent from last year and generated 65.9 billion won. The anticancer treatment is prescribed to non-small cell lung cancer patients who have developed tolerance on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as Iressa (gefitinib), Tarceva (erlotinib) and Giotrif (afatinib). Its prescription volume has been skyrocketing since its National Health Insurance (NHI) listing green lit in December 2017. Although its price is still high at 120,000 won with the reimbursement, the convenient oral drug is the only anticancer treatment found among the top prescribed drugs for outpatients.
A hepatitis B treatment Viread (tenofovir disoproxil fumarate) that used to top the prescription drug market took a steep 25.9-percet fall in just within a year, raising 64.9 billion won. In the same year, the prescription volume of Bristol-Myers Squibb (BMS) Pharmaceutical Korea’s hepatitis B treatment Baraclude (entecavir) was brought down by 10.8 percent from 39 billion won to 34.8 billion won.
- Rinvoq is in the process of prescribing general hospitals
- by Eo, Yun-Ho Oct 23, 2020 09:44am
- The third JAK inhibitor Rinvoq was received for prescription in general hospital. The synergy is expected as the application of insurance benefits became visible from November.
According to related industries, AbbVie Korea recently concluded a drug price negotiation between the NHIS and the oral autoimmune disease treatment Rinvoq (Upadacitinib), and listed. Applications of DC to major general hospitals including Big 5 are in progress from October.
It recently concluded a drug price negotiation with the NHIS, and listed. AbbVie focused on the pace of Rinvoq's listing by accepting the weighted average price of alternative drugs because Pfizer's Xeljanz (Tofacitinib citrate) and Lilly's Olumiant (Baricitinib), which have the same mechanism, are already listed.
Rinvoq's permit-reimbursement linkage system was also very useful. As a result, the drug, which was approved in Korea in June, was put on the reimbursement list in about five months.
Janus kinase (JAK) inhibitors, such as Xeljanz, Olumiant, and Rinvoq, were the first oral options that proved equivalent to anti-TNF drugs in the area of &8203;&8203;autoimmune diseases, and have received a lot of attention.
However, it has not yet exerted as much influence as biological agents in the market. Anti-TNF drugs and anti-interleukin drugs are also active, but the indications for JAK inhibitors were relatively narrow in areas other than rheumatoid arthritis.
JAK inhibitors have potential. Xeljanz, which was first developed last year, secured additional indications such as ulcerative colitis and psoriatic arthritis, and generics, including Rinvoq, are also conducting research to expand indications for autoimmune diseases such as atopic dermatitis, Crohn's disease, and ankylosing spondylitis.
Rinvoq proved its effectiveness through five phase III SELECT clinical trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE, SELECT-EARLY) in which 4,443 patients with moderate to severe active rheumatoid arthritis participated.
In phase III clinical results, Rinvoq showed lower disease activity and improved clinical response rate compared to placebo, MTX or Humira(Adalimumab) group when used alone or in combination with a conventional synthetic antirheumatic drug (csDMARD).
Seong-Hwan Park, a professor of rheumatology at Seoul St. Mary's Hospital, said, "Rinvoq shows a 20% higher remission rate compared to MTX at week 12 in SELECT-COMPARE, a phase III clinical trial administered in combination with MTX, which is a standard therapy. and he said that it will be used as a new treatment option that provides an opportunity to improve the quality of life.
- Hanmi’s generic for Galvus is aiming for release next year
- by Lee, Tak-Sun Oct 23, 2020 09:44am
- Hanmi applied for item approval again three months after withdrawal of the DPP-4 inhibitory diabetes treatment 'Galvus' (Novartis, Vildagliptin) salt-modifying drug.
Indications were not removed unlike existing products, and combination drugs were applied for permission.
According to the MFDS and pharmaceutical industry on the 21st, Hanmi applied for item approval for a single drug for Vildagliptin HCl on the 29th of last month and a combination drug for Vildagliptin HCl /Metformin HCl on the 16th of this month.
In January, Hanmi obtained an item license for Vildagliptin HCl. At the time, it was licensed to exclude two of the original drug uses.
The company tried to obtain insurance benefits, but the Intellectual Property Trial and Appeal Board dismissed the request from Hanmi. Accordingly, as of July 6, Hanmi voluntarily withdrew the item.
The item applied for permission this time contains the same six original uses unlike the previous case. It seems that it is now aiming for release on August 30th next year.
Although it failed to split the indications, Hanmi and Ahn-Gook succeeded in invalidating Galvus' material patent duration extension period of 187 days. Accordingly, the product can be released on August 30 next year.
However, in response to the Intellectual Property Trial and Appeal Board trial decision, Novartis has filed a lawsuit to cancel the trial decision to the Patent Court of Korea. The judgment of this lawsuit is scheduled for the 29th this month. It will be difficult to launch in August next year if the court takes the side of Novartis, then, it will be available only in March 2022, a year later.
Hanmi applied for permission for the Metformin combination drugs at this time. Currently, Hanmi is the only generic company that has applied for a combination drug.
Although it failed to launch this year, it can dominate the market with Ahn-Gook even if it is released next year. However, Ahn-Gook did not apply for a combination drug. It is analyzed that if Hanmi introduces a single drug and a combination drug at the same time, it will be more advantageous in the competition for market share of generic companies.
According to UBIST in the first half of this year, the outpatient prescription sales of the original, Galvus and the combination drug, Galvusmet were &8361;4 billion and &8361;17.9 billion, four times larger in the combination drug market.
- Saxenda must be prescribed thru outpatient Rx
- by Lee, Jeong-Hwan Oct 23, 2020 09:44am
- The MFDS stated that the principle is to issue outpatient Rx by applying the principle of separation of prescribing and dispensing drugs for self-injectable medicines such as obesity drug, Saxenda.
Unless a doctor directly injects, according to the purpose of separation of prescribing and dispensing drugs, medical institutions such as hospitals and clinics should not directly prescribe or dispense self-injection drugs, but rather must dispense them at a pharmacy.
On the 20th, the MFDS unveiled an agreement with the MOHW regarding self-injectable medicines in a written inquiry by Nam In-soon, a member of Democratic Party of Korea.
She inquired about the need for safety management and prevention of drug abuse for self-injectable medicines.
It was pointed out that self-injectable medicines should be reinforced during the national audit last year that the safe use measures for patients should be strengthened due to side effects such as bleeding, infection, and pain.
In particular, she asked about the results of consulting the MFDS’ Central Pharmaceutical Affairs Review Committee in January this year to support measures to support the safe use of self-injectable medicines and the contents of consultations with the MOHW regarding the mandatory outpatient Rx.
She clarified that self-injectable medicines is subject to separation of prescribing and dispensing drugs, and urged that the outpatient Rx be made mandatory and consulted with the MOHW so that the public can use it safely.
The MFDS stated that based on the discussion of the MOHW, self-injectable medicines should be prescribed through outpatient Rx, unless the doctor injects directly. She said that she would discuss the details of outpatient Rx with the MOHW.
The MFDS said, "To support the safe use of self-injectable medicines, we have created patient-participated information and planned patient education with experts." Saxenda has improved the packaging unit from the current 5 packaging to unit packaging."
She added, “I confirmed the position of the MOHW that Issuing outpatient Rx for self-injectable medicines is a principle unless the doctor injects directly.” And she also said that outpatient Rx for self-injectable medicines is a task under the jurisdiction of the MOHW, and I will discuss the details in the future."
- NA audit talks about pre-listing coverage on anticancer
- by Lee, Hye-Kyung Oct 23, 2020 09:44am
- At the National Assembly annual audit, a healthcare provider suggested the ‘pre-listing reimbursement and post-evaluation’ should be implemented and ‘incremental cost-effectiveness ratio (ICER) threshold’ should be adjusted to practically improve access to new drugs.
Professor Kang Jin-hyoung at the Catholic University of Korea Seoul St. Mary’s Hospital, treating cancer patients at the clinical treatment scene, elaborated about the patients struggling to receive treatment due the delayed new drug reimbursement listing. However, the insurer, or the National Health Insurance Service (NHIS) and Health Insurance Review and Assessment Service (HIRA) expressed a reserved view on the suggestion.
At the NHIS-HIRA National Assembly annual audit session on Oct. 20, Professor Kang Jin-hyoung was summoned as a witness and stated, “A novel anticancer treatment takes a long time to receive NHI reimbursement even after getting approved for the market by the Ministry of Food and Drug Safety (MFDS),” and “Patients are in immense pain as an immunotherapy for lung cancer could not pass HIRA for three years.”
Regardless of how greatly effective a new drug is, it is not easy for the patients to actually use those drugs without the reimbursement.
Professor Kang explained, “MOHW and HIRA say the anticancer treatment listing takes 350 days, but it excludes the time for requesting and submitting supplementary evidence. The time should be shortened to within 180 days for the patients and healthcare providers to actually feel the improvement.”
The professor also noted although the risk sharing agreement system (RSA) introduced in 2014 contributed in speeding up the new drug listing procedure initially, the effect of RSA implementation on shortening the time has been insignificant due to expensive anticancer treatment entering the market.
The professor stressed, “The social controversy is that most of immunotherapies can hardly get to RSA signing. After RSA was implanted, a half of anticancer treatments were listed through RSA, but the actual effect of shortening the listing period was weak,” and “The new drug listing speed has slowed down due to scarce review meetings amid COVID-19. If RSA were the only supplementary boost for the positive listing system, we need to pursue new options from now on.”
Professor Kang recommended the following agenda to improve the new drug accessibility; providing pre-listing reimbursement and post-evaluation option, adjusting ICER threshold, and seeking means to secure additional source of NHI income to enhance public-private access.
Regarding the ICER threshold for severe and rare disease treatments, the professor noted the threshold should be flexibly adjusted in a ‘bracket’ range, instead of basing it on GDP per capita.
An independent Lawmaker Lee Yongho, who summoned Professor Kang, commented that “The patients would be desperate to access those new drugs,” and “Only controlling the NHI finance would not grant a solution. We need a balanced approach.”
Instead of clearly giving their opinion, however, NHIS President Kim Yong-Ik and HIRA President Kim Sun-min both claimed implementing a new system should be approached, carefully..
President Kim stated, “We can only be cautious when listing a new drug. Negotiating with a pharmaceutical company from a disadvantageous position can put NHIS and the government at risk when setting the drug pricing. And higher drug price can then put the patients in a worse situation. This is why the problem is difficult to solve.”
On introducing the pre-listing reimbursement and post-evaluation, President Kim said, “We would review the suggestion, but we would not make any hasty decision as with have imminent issues regarding drug pricing and NHI finance.”
HIRA President Kim Sun-min also said the accessibility issue is regrettable from the point of patients, but the suggested agenda would be difficult to execute without a social consensus.
President Kim explained, “ICER threshold has to be effective when adding more cost. Recently listed anticancer treatments require cost of over 1 billion won to extend life expectancy by average one year,” so “We need to consider other patients and pursue the social consensus through thorough discussions.”
“Although we would further make efforts to expand access to new drugs for severe and rare disease patients, we are already providing pharmacoeconomic evaluation exemption system and pricing negotiation exemption system,” nevertheless, “We would continue to improve the access,” said President Kim.
After hearing from Lawmaker Lee Yongho’s witness, People Power Party Lawmaker Lee Jongseong spoke to President Kim Yong-ik, “You sounded negative about providing support to access the novel immunotherapy, but the administration promised, with the Moon Care, that no one would be neglected from accessing treatments. The government needs more forward-looking review. It should consider making a cancer fund and other options.”
President Kim then answered, “We are absolutely not negative about expanding access to new drugs. Surely the alternative options should be considered, but the previous answer was concerned more of the pricing negotiation.”
- Patients taking more than 10 drugs exceeded 2 million
- by Lee, Jeong-Hwan Oct 22, 2020 06:45am
- The number of multi-drug-drug patients who took more than 10 drugs at once exceeded 2 million last year.
Korea ranks the highest among seven OECD countries that submitted statistics on multi-drug consumption, and the situation is serious. On the 20th, In Jae-keun, a member of Democratic Party of Korea, analyzed the national control data submitted by the NHIS and made this announcement. When taking multi-drugs, there is a high risk of drug effects or side effects due to drug interactions.
According to a study by the NHIS, if older people 65 years of age or older take 5 or more drugs, they increase their risk of hospitalization by 18% and death by 25% compared to taking 1 to 4 drugs. The reality of taking multi-drug drugs in Korea is at a serious level.
Last year, the OECD published the percentage of 75-year-old patients (as of 2017) who chronically take five or more drugs for 90 days or more, and Korea was the highest among the seven countries that submitted statistics. The proportion of Korea was 68.1%, and the average of 7 countries was 48.3%.
The multi-drug prescription rate in Korea is increasing every year from 3.3% in 2016 to 3.5% in 2017, 3.8% in 2018, and 4.2% in 2019.
The higher the age, the higher the multi-drug prescription rate was, and as of 2019, the multi-drug prescription rate of the 75-year-old or older population reached 23.6%. The multi-drug prescription rate is the number of people who took 10 or more drugs for 60 days or more in the year divided by the number of people who received the prescription at least once in the year.
The number of patients taking multi-drugs is also increasing. The number of multi-drugs users from 1,548,000 in 2016 increased every year to 2,012,000 last year. During the same period, the multi-drug taking rate also increased from 3.0% to 3.8%.
Looking at multi-drugs users by age, as of 2019, 841,000 people aged 75 and over (22.4% dose rate), 600,000 people aged 65-75 (12.2% dose rate), and 401,000 people aged 55-65 (4.8%), 127,000 people aged 45 to 55 (1.4%), and 43,000 people under the age of 45 (0.2%).
There was also a difference in the status of multi-drugs users by income. As of last year, the first quintile was the highest at 5.8%, followed by the 10th (4.2%) and the ninth (3.7%).
The 2nd to 8th quartiles showed similar figures around 3.0%. This means that those with higher income levels than those with intermediate income levels and those with the lowest income level than those with higher income levels had a higher rate of taking multi-drugs.
In particular, in the case of medical benefits, the multi-drugs use rate reached 19.4%, requiring special attention.
She said, "The current state of multi-drugs use in Korea is another aspect of an excellent pharmaceutical system," and pointed out that "the government needs attention for improvement." She stressed that it is urgent to manage multi-drug products for the elderly and low-income groups, including medical care recipients, to promote it as an official project.