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- 2025-12-27 12:04:08
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- Targeted therapy and immunotherapy as new TNBC options
- by Eo, Yun-Ho Feb 05, 2020 05:59am
- 린파자와 티쎈트릭 Sources say one of highly unmet medical need, triple negative breast cancer, now has two more treatment options. The pharmaceutical industry reported on Feb. 5 that AstraZeneca’s targeted therapy Lynparza (olaparib) and Roche’s immunotherapy Tecentriq (atezolizumab) respectively received new indication in last October and January, to treat patients with triple negative breast cancer (TNBC) in Korea. The Korean health regulator has indicated poly ADP ribose polymerase (PARP) inhibitor Lynparza for patients with TNBC and gBRCA mutation, who has been treated with chemotherapy before. Lynparza’s new indication was approved based on the key endpoints demonstrated in Phase III OlympiAD study. The trial confirmed patient group treated with Lynparza showing 42 percent lower risk of disease progression and death than a group treated with standard of care. The Lynparza arm’s median progression-free survival (mPFS) was 7.0 months, whereas the standard of care arm’s was 4.2 months. Respective groups had general response rate of 59.9 percent and 28.8 percent. And a sub-analysis found olaparib-treated patient group with TNBC demonstrated benefit of reducing risk of disease progression and death by 57 percent than in chemotherapy-treated group. PD-L1 inhibitor Tecentriq was approved as a first-line treatment in combination with paclitaxel to treat patients with PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer. The Tecentriq combination therapy indication was approved based on Phase III Impassion130 trial outcome. During the trial, PD-L1 positive patient group treated with Tecentriq plus albumin-bound paclitaxel combination therapy achieved mPFS of 7.5 months, about 40 percent lower risk of disease progression and death than the placebo group. And Tecentriq combination therapy reached median overall survival (OS) of over two years in PD-L1 positive patient group, while the group’s objective response rate (ORR) was 58.9 percent when the placebo group was at 42.6 percent. 15 percent of overall breast cancer patients are diagnosed with TNBC, which is a kind of breast cancer with all negative receptors (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2)). Showing a mix of various properties of cancer, TNBC is the most complicated and more aggressive type of breast cancer usually found in young patients. However, for a long while, chemotherapy has been the only treatment option for TNBC. Although Roche’s targeted therapy Avastin (bevacizumab) received the indication first in Korea, it has remained as non-reimbursed option to this day.
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- Lazertinib by Yuhan launches global phase III clinical trial
- by An, Kyung-Jin Feb 05, 2020 05:59am
- (From left) Professor Kyung-Hee Lee, Youngnam University Hospital, Jin-Hyung Kang, Seoul St. Mary Global Phase III clinical trial of anticancer drug candidate 'Lazertinib' by Yuhan is in full swing. On the 3rd, Yuhan Corporation announced that it will hold an initiation meeting for each institution after receiving the Lazertinib phase III clinical trial approval (IND) from the MFDS in December last year, and will soon begin recruiting patients. So far, Serbia and Malaysia have completed application for the approval of Lazertinib for Phase III clinical trials and plan to gradually expand the clinical process to 17 countries worldwide. The research name was set to 'LASER301'. The Phase III trial aims to evaluate the potential of Lazertinib as a primary treatment in 380 patients with epidermal growth factor receptor (EGFR) mutant-positive non-small cell lung cancer (NSCLC). After randomization, the subjects were divided into four groups, and then the Lasertinib and AstraZeneca's target anticancer drugs 'Iressa (brand name for Gefitinib)' or placebo were used to compare efficacy and safety. In Korea, which has the fastest pace, 27 hospitals, including Severance Hospital, Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, and Seoul Asan Hospital, confirmed the participation. More than 100 researchers and officials attended the research conference held by Yuhan Corporation for domestic participating organizations. Lazertinib is a targeted anticancer agent being developed for primary treatment of EGFR mutant positive non-small cell lung cancer patients or secondary treatment of EGFR T790M mutant non-small cell lung cancer patients. Yuhan Corporation received $ 50 million in November 2018 from Janssen Biotech, with no obligation to return Lasertinib to technology transfer. Successful commercialization requires up to $1.25 billion, including a tiered technology fee (milestone). In phase I/II clinical trial in patients with EGFR T790M mutant-positive non-small cell lung cancer, a dose of 120 mg or more resulted in 12.3 months of progression free survival (PFS) and safety. Byung-cheol Cho, a professor at Severance Hospital, who is leading the global phase III of Lasertinib, said, “The Lazertinib study paper, which proved safety and anti-tumor effect in the Phase I/II trial of non-small cell lung cancer patients, was recognized for its value in October last year at the Lancet Oncology, and we will do our best to be a good treatment alternative for patients with high prevalence of EGFR mutation-positive non-small cell lung cancer in our country”. An official of Yuhan Corporation said, "Korea is the first country in this multinational clinical trial phase III. We will make every effort to ensure that many countries enter the clinical trial phase III successfully in the future".
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- Last to join HCV treatment game Mavyret tops in 1 year
- by Kim, Jin-Gu Feb 05, 2020 05:59am
- 마비렛 제품사진. Taking up 81 percent of the market share, Mavyret has been prominently leading the hepatitis C treatment market making 40.3 billion won last year. However, the prescription volume fell for two consecutive quarters due to reduced number of patients. Pharmaceutical market research firm UBIST on Feb. 3 said eight of direct-acting antiviral (DAA) treatments for hepatitis C generated 49.9 billion won for outpatient prescription last year, which was increased by ten percent than at 45.2 billion won in 2018. ◆ Mavyret dominates the market at 81 percent market share Mavyret has been predominant in the market. Owning 81 percent of the overall hepatitis C-treating DAA market pie, the treatment generated 40.3 billion won last year alone. Considering its prescription volume and market share in 2018 were respectively at 4.5 billion won and ten percent, Mavyret’s growth has basically skyrocketed exponentially. The treatment’s quarterly prescription volume started from 300 million won in third quarter 2018, which steeply soared to 4.2 billion won in following fourth quarter, 8.2 billion won in first quarter 2019, and 12 billion won in second quarter, but climbed down to 10.9 billion won in the next third quarter and 9.2 billion won in the fourth quarter. In the same period, it took up the market share of three percent, 44 percent, 71 percent, 84 percent, 83 percent and 85 percent, respectively. Mavyret is the first pan-genotypic treatment for chronic hepatitis C to be available in Korea. As other existing treatments targeted limited genotypes (type 1 to 6), it was easy for Mavyret to take over the others’ pie. Besides, the treatment’s strength of reducing about a month of treatment period than other DAA has been evaluated as its key to rapid growth. Quarterly prescription volume of 8 hepatitis C treatments (Unit: KRW 100 million) Source: UBIST ◆ Prescription volume dips for two consecutive quarters Although Mavyret seems to be at its height, no one can clearly predict how long it would last. The biggest reason is the unique quality of hepatitis C. The prevalence rate of the blood-borne virus in Korea is relatively lower than in other countries. The exceptionally outstanding effect of the drug is also affecting the descending prescription volume. DAA for hepatitis C has significantly high response rate and has short treatment period. The number of patients fell more and more, as most of the patients administered with the treatment have recovered. Quarterly prescription volume of Mavyret (Unit: KRW 100 million) Source: UBIST In fact, the overall prescription volume of all eight drug products has decreased since the third quarter of 2016. The overall volume went up for a short while from the fourth quarter in 2018, but it bounced back down since last second quarter. The trend was not so different for Mavyret, either. In last second quarter, the drug volume peaked at 12 billion won, but it kept on dropping down to 10.9 billion won in the following quarter and 9.2 billion won in the next. The fall got steeper as well. The volume fell from the second to third quarter last year by nine percent, but it took a 16-percent fall from the third to fourth quarter. ◆ Prescription volume of Harvoni, Sunvepra and Zepatier plunges As Mavyret’s market share soared, the former market leaders from Gilead Sciences, Harvoni and Sovaldi’s prescription volume took a rapid fall. Harvoni generated 4.2 billion won last year, whereas Sovaldi only generated 2.2 billion won. Compared to their golden age in 2017 respectively making 61.8 billion won and 10.7 billion won, Harvoni and Sovaldi’s pie in the market have vastly shriveled. Yearly prescription volume of 8 hepatitis C treatments (Unit: KRW 100 million) Source: UBIST Other treatments in the same market are not too far off. Bristol-Myers Squibb’s Daklinza and Sunvepra each generated 300 million won and 100 million won last year. First ones to be released as DAA for hepatitis C, the two treatments used to top the market making 36.8 billion won and 9.3 billion won, respectively. But soon after, the market was engulfed by follow-on drugs with evolved effects. Reportedly, their monthly prescription volumes (Sunvepra: 7.65 million won; Daklinza: 1.94 million won) did not even reach ten million won in last December. They would soon become the drugs of the olden days. Zepatier by MSD has made 2.6 billion won last year. Blocked by Harvoni around the launch and then by Mavyret, the MSD’s treatment has never shined through the market and is now sliding down the slope. Other hepatitis C treatment by AbbVie, Exviera and Viekira, have not been prescribed for even once from July last year. Mavyret presumably absorbed the entire pie of those two treatments. ◆ Accumulated prescription volume, Harvoni tops followed by Daklinza and Mavyret Then which company profited the most from the DAA for hepatitis C? Gilead Sciences accumulated total of 162.2 billion won up to year 2019—Harvoni generated 133.9 billion won and Sovaldi generated 28.3 billion won. Accumulated prescription volume of 8 hepatitis C treatments (Unit: KRW 100 million) Source: UBIST Bristol-Myers Squibb then followed with 74.3 billion won. The company’s Daklinza made 62.0 billion won and Sunvepra made 12.3 billion won. All three DAA by AbbVie, Mavyret, Viekira and Exviera made 49.2 billion won together. Mavyret made 44.8 billion won, and Viekira and Exviera made 4.1 billion won and 400 million won, respectively. At the bottom of the rank, MSD made 14.5 billion won for four years with Zepatier.
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- Heated argument over Botulinum lawsuit in USA is expected
- by Kim, Jin-Gu Feb 05, 2020 05:58am
- A trial of the controversial botulinum toxin strain between Medytox and Daewoong Pharmaceutical began in the United States. According to the pharmaceutical industry, the US International Trade Commission (ITC) entered a trial on the 4th of the case against Daewoong Pharmaceutical and Medytox. The trial lasts four days until the 7th. The final decision was announced in October. However, on June 5, it is expected that it will be possible to determine which prevails in the form of 'preliminary judgment'. The issue is whether Daewoong Pharmaceutical's Nabota infringed the patent between Meditoxin·Allergan. The controversial use of Daewoong Pharmaceutical's strain is also likely to be revealed in this process. Daewoong Pharm and Medytox both saved their breath. Officials from both companies said in a call to the Dailypharm, "We will carefully watch the progress". Whatever the conclusion, Party defeated is predicted that a lot of damage is inevitable. The two companies have already invested nearly ₩10 billion in litigation costs. According to the financial statements of the two companies, Medytox used ₩7.8 billion and Daewoong Pharm used ₩10.4 billion as litigation costs. Further civil proceedings will be burdened by the trial results. Both Daewoong Pharmaceutical and Medytox are reportedly planning to file a civil lawsuit in Korea based on the results of the trial. Daewoong Pharmaceutical also raises concerns that Nabota's export path to the US will be blocked. According to Evolus, which is responsible for Nabota's U.S. sales, last year's cumulative sales of Jeuveau (US brand name for Nabota) was up to ₩ 39.9 billion. If Daewoong Pharm loses, the immediate sales loss of ₩40 billion is inevitable. In addition, there is no guarantee of civil action in the United States from Evolus. If a preliminary decision is made in June, the results will be served to both parties. The final decision is in October. In most cases, the results are the same as the preliminary judgment, but the opposite may be the case. The preliminary decision is made by the administrative judge and the final decision is made by the committee. There is, of course, an appeal after the final decision. They may appeal to the Federal Circuit Court of Appeals within 60 days. However, the CAFC decides whether to accept the appeal.
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- DC passes second PARP option Zejula fast with reimbursement
- by Eo, Yun-Ho Feb 04, 2020 06:32am
- After winning National Health Insurance reimbursement, anticancer treatment Zejula has been quick to get listed on general hospital prescription list. According to the pharmaceutical industry on Jan. 4, Takeda Pharmaceuticals Korea’s Zejula (niraparib) has been passed by drug committees of 16 major hospitals nationwide, including Seoul National University Hospital, Korea University Anam Hospital, Pusan National University Hospital, Hanyang University Guri Hospital, and CHA Bundang Medical Center. The Big Fives with Samsung Medical Center, Seoul St. Mary’s Hospital and Seoul Asan Medical Center are currently in process of landing the code. A DNA repairing poly ADP ribose polymerase (PARP) inhibitor, Zejula, was indicated as maintenance treatment of adult patients with recurrent epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer), who are in a complete or partial response to platinum-based chemotherapy from last July and earned reimbursement in last December. During a key clinical trial, the drug has improved median progression-free survival (mPFS) exceptionally, regardless of BRCA mutation, compared to the placebo arm. The patient group with ovarian cancer and BRCA mutation, who were treated with Zejula, has demonstrated mPFS of 21.0 months, about four times longer than the placebo group with 5.5 months. Even in the group without BRCA mutation, Zejula-treated group had mPFS of 9.3 months, showing clinically meaningful improvement than the placebo group with 3.9 months. In a recent PRIMA study, Zejula also confirmed efficacy as a first-line therapy for ovarian cancer, regardless of BRCA mutation. However, its reimbursed indication is limited to patients with BRCA mutation. President Kim Seung Cheol of Korean Gynecologic Oncology Group (Professor at Gynecologic Cancer Center of Ewha Womans University Hospital) stated, “Zejula is the first PARP inhibitor used regardless of BRCA mutation. Two to three tablets conveniently taken once daily, the drug also showed satisfying safety profile in adverse reaction as it could be managed by adjusting dose taken.” The first PARP inhibitor to be approved in Korea was AstraZeneca’s Lynparza (olaparib), and it received reimbursement in October 2017 with expenditure cap type risk sharing agreement (RSA) negotiated under pharmacoeconomic analysis exemption route. Apparently, Pfizer’s Talzenna (talazoparib) is preparing for Ministry of Food and Drug Safety’s approval as a third PARP inhibitor in Korea.
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- Salespersons, working at home due to Wuhan virus
- by Kim, Jin-Gu Feb 04, 2020 06:31am
- Hospitals and pharmaceutical companies took action in the aftermath of the new corona virus (Wuhan pneumonia). It is advisable to refrain from entering the hospital for the sales person for a while until the situation calms down. Some pharmaceutical companies have even started working full-time at home. According to the pharmaceutical industry, on the 31st, Konkuk University Hospital sent a text message to a pharmaceutical company sales representative and asked for cooperation to "restrict access to representatives of pharmaceutical companies for the management of new corona infection". Seoul Paik Hospital and Daejeon Konyang University Hospital are recently reported that the salesperson refrained from entering. It is expected to apply until the release of the infectious disease crisis alarm. Clinic-level medical institutions also refrain from accessing salespersons for the time being. A pharmaceutical salesman said, "Some clinics asked me to refrain from access for the time being." In some cases, all employees have been working from home. Amgen Korea has been working from home since 31st last month. Unless absolutely necessary, salespersons' visits to the hospital or business trips are prohibited. It is said that until the end of the notice, and it is possible to close the deadline until the warning of the infectious disease crisis is released. Email sent to employees from Amgen Korea Pfizer Korea will also work from home next week. MSD recently recommends 14-day telecommuting regardless of whether the person has recently been to China, who has related symptoms, or who has been to Wuhan, China. Even people who have not been to China recommended working from home if they have any symptoms. Some multinational pharmaceutical companies canceled overseas workshops, which were planned earlier this year. Roche Korea planned to go to Bali in February, but decided to cancel on the 31st. Novartis Korea is also said to have canceled the workshop plan for Thailand recently. Likewise, this is due to the new coronavirus. It is confirmed that domestic companies have also taken action. Hanmi internally ordered to avoid face-to-face meetings whenever possible. An official of Hanmi said, "Unless there is a special reason, We decided to refrain from meetings or face-to-face meetings and to handle the work by phone call whenever possible". In addition, several pharmaceutical companies are now preparing to counter the spread of new coronaviruses. A pharmaceutical industry official said, "We have not made any official recommendations yet, but we are considering various options, including refraining from visits (clinicians) under the judgment that the situation in Korea is serious and the company will make official recommendations as in the last MERS outbreak".
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- Bayer to withdraw Levitra from Korean market
- by Kim, Jin-Gu Feb 04, 2020 06:31am
- Bayer Korea has decided to withdraw Levitra (vardenafil) from Korean market and leave Chong Kun Dang Pharmaceutical’s Yaila as the only erectile dysfunction treatment in Korea with vardenafil. Bayer Korea has notified respective drug distributing vendors that the supply of Levitra would be suspended from coming April. Superficially, the company stated the ‘upgrade process of manufacturing facility in Leverkusen, Germany’ is the reason for the withdrawal, but the pharmaceutical industry insiders see otherwise and suspect the recently fallen demand on the drug has affected the decision. In fact, the sales volume of Levitra has been mediocre. The pharmaceutical market research firm, IQVIA said the drug has only generated 800 million won, 600 million won, 500 million won and 300 million won from year 2015 to 2018, respectively. The drug’s gap with other competitors Viagra and Cialis is significant, considering they have generated 9.9 billion won and 7.4 billion won in 2018, respectively. The market share shriveled even more when Chong Kun Dang challenged the drug’s patent from 2018. The Korean company has filed a negative scope confirmation on Levitra in January, 2018, and won the case in November of the year. Immediately following the winning case, Chong Kun Dang released erectile dysfunction treatment Yaila with the same active ingredient from November, 2018. Yaila ended up generating 300 million won that year, and has also generated 700 million until third quarter last year. Considering Levitra has barely made over 100 million until third quarter last year, Yaila presumably has absorbed most of Levitra’s pie. ◆ Ending the Bayer-Chong Kun Dang partnership after seven years together Chong Kun Dang actually has co-marketed Levitra with Bayer from 2007 to 2014. It was technically a two-track strategy to each sell vardenafil drug under different brand name of Levitra by Bayer and Yaila by Chong Kun Dang. In the first year of the launch, the drug has earned more than five billion won. But the sales volume gradually fell as the competitors Viagra and Cialis consumed the market aggressively. From 2012, many of Viagra generics have been released. In the following year, Yaila’s sales volume plunged to around 400 million won. In the end, Chong Kun Dang canceled the license on Yaila in 2014. Basically the company stepped out of the erectile dysfunction treatment market as they had not launched the Viagra generic, yet. Shortly after in 2015, when Cialis’ patent was expired, Chong Kun Dang released the generic Cendom and got back into the market. Cendom has been performing well and followed right after the market leader, Hanmi Pharmaceutical’s PalPal. ◆Re-release after four years, Chong Kun Dang is the only one with three-substance line-up Gaining confidence with Cendom, Chong Kun Dang launched Viagra generic Cengla in 2017. And in the following year, the company released Yaila again as vardenafil generic and completed the full erectile dysfunction treatment line-up. It did not sign a co-marketing deal with Bayer this time, however. Moving on from a partnership, now the two companies are in competitive relationship. But as the original Levitra is leaving the Korean market for good, Yaila would be the sole erectile dysfunction treatment with vardenafil. And Chong Kun Dang is the only company in Korea to have all three substances of erectile dysfunction treatment. Chong Kun Dang official said, “Each active ingredient has unique advantages. Yaila’s biggest strength is its powerful effect compared to other treatments. It can be prescribed to patients, who did not see the effect with sildenafil.” “Marketing the products with three substances would create a favorable synergy effect as it could better accommodate each individual patient’s needs,” the official added.
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- Tae-han Kim, CEO of BioLogics will be reappointed
- by Lee, Seok-Jun Jan 31, 2020 06:36am
- Samsungbioepis will operate the system of two vice presidents, and Tae-han Kim, CEO of SamsungbioLogics has confirmed that it is four consecutive years. The two companies made such key positions on January 30. The figures reflect results from last year's performance. Sang-Jin Park, Vice President of SamsungbioepisSeven people were promoted. Another vice president was appointed. Sang-jin Park, 50-year-old general manager, was promoted to vice president. Park is a physician and joined Samsungbioepis in July 2018 after serving as head of the German GSK and representative of AstraZeneca Korea. As a result, Samsungbioepis has two vice presidents. Until Sang-jin Park was appointed, Chang-hoon Choi(60) was Vice President . In addition to Sang-jin Park, Samsungbioepis has appointed Kyung-A Kim, QE (Quality Evaluation) Team Manager, and Young-Pil Lee. PD (Process Development) Team. Hyung-ki Park, CMC Group Head of RA (Regulatory Affairs), Won-young Yoo, Cell Line 1 Group Head of Development Division , Soyoung Lee, Head of SCM Team of Production Division, and Jinhan Jung ,Head of Production Management Group of were promoted. The promotions reflected achievements. Samsungbioepis expects its first profit in eight years. Samsungbioepis posted operating loss of ₩102.7 billion in 2017. The market revenue is expected to reach ₩1 trillion. Samsungbioepis entrusts global distribution to partner companies, and only a certain proportion of ₩ 1 trillion will be captured. Samsungbioepis had sales of ₩368.7 billion in 2018 and last year exceeded it in the third quarter. Tae-han Kim, CEO of Samsung BioLogics Kim Tae-han, CEO of Samsung Biologics, 63 years old, has virtually confirmed his term. If there is no change in the position of the representative on promotion on January 30, he will be reappointed on March 23. Samsung Biologics announced the promotion on the 30th, including promotion to the executive director of C & C Center, Ho-yeol Yoon. Four executives including Eun-young Yang, head of CDO project team, Se-kang Park, DS2 culture part process manager, Yong-hwan Jin, DS2 MSAT team leader, and Ki-jung Kim, executive director of global customer support team, were appointed as executive directors. There was no change in the position of representative in this performance assessment. Tae-han Kim , CEO of Samsung Biologics, is expected to be re-elected at the general shareholders' meeting on March 23. If he is re-elected, it is his fourth term. In general, Samsung affiliates' promotions are conducted after the presidents' appointments. Resignation of Kim's position as a CEO was a concern. Mr. Kim is the oldest and longest CEO of Samsung Group's listed subsidiaries, and he is at the center of controversy over the issue of fraudulent accounting. Samsung BioLogics posted ₩701.6 billion in sales last year. This is a 30.9% increase from the previous year (₩535.8 billion). Operating profit came in at ₩917.7 billion, up 64.8% from the previous year (₩55.7 billion).
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- Resumed supply of Terramycin delayed from Feb to July
- by Jung, Hye-Jin Jan 31, 2020 06:35am
- The supply resumption date of Pfizer Korea’s Terramycin ophthalmic ointment has been pushed back. On Jan. 28, Pfizer Korea notified distributors, pharmacies and hospitals that Terramycin supply would resume around July. Apparently, the delayed production schedule is pushing down the resumption date. In last November, the company has notified the ointment is out of stock and informed the stock would be supplied around February 2020. Terramycin has struggled with a long-term shortage for 20 months previously, and is now considered as a frequently used drug with frequent shortage problem. Priced at 385 won with reimbursement, Terramycin ophthalmic ointment 3.5 g is commonly used to treat a vast variety of superficial ocular infections like corneal ulcer and conjectivitis. According to pharmaceutical market research firm UBIST, the ointment has generated 354.76 million won from over 920,000 outpatient prescriptions last year.
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- Keytruda awaits Cancer Committee’s nod in February
- by Eo, Yun-Ho Jan 30, 2020 06:34am
- The pharmaceutical industry is keeping their eyes close to the Korean government and MSD’s tug-of-war over expanding reimbursement on immunotherapy Keytruda. The industry reported on Jan. 30, the Cancer Disease Deliberation Committee is scheduled to deliberate reimbursement on Keytruda’s five indications including first-line treatment for non-small cell lung cancer (NSCLC) in February. As recommended by the Cancer Committee, MSD Korea had two sessions of preliminary negotiation with Ministry of Health and Welfare (MOHW), each in May and September last year, but their talks fell through. Besides the indications of first-line treatment for NSCLC, bladder cancer, and Hodgkin’s disease, MSD is anticipating for the Cancer Committee to green light the reimbursement expansion in February on additional indications to treat metastatic non-squamous NSCLC as a first-line combination therapy with pemetrexed and platinum chemotherapy, and to treat metastatic squamous NSCLC as a first-line combination therapy with carboplatin and paclitaxel. So far, the key issues addressed at the attempted but failed negotiation were the conditions of granting reimbursement. The conditions are to limit to ‘patients showing response to the treatment,’ and the trade off card the government is pushing on to recognize the value of new drug while compensating the cost with reduced pricing of off-patent drugs. Considering the cards on the table, MSD has reportedly prepared somewhat of middle ground proposal to persuade the government at the next round of reimbursement deliberation. The global company official stated, “Over the span of two years, the company has been negotiating and narrowing the gap with the government over expanding Keytruda’s reimbursement, and we think the two parties have been engaged enough to have better understanding of each other. Based on the experience, the company is making sure to receive the expanded reimbursement this time.” Keytruda has been listed in August 2017 with a combination of risk sharing agreement (RSA) refund and expenditure cap types under the condition of PD-L1 expression rate. As immunotherapy alone, the drug is even trying to replace chemotherapy for first-line treatment. This holds a great meaning to the anticancer treatment scene. When the reimbursement expands on the drug’s indications, a patient diagnosed with stage IV lung cancer, but cannot be treated with targeted therapy due to EGFR mutation, could be instead prescribed with Keytruda.
