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- 2026-03-18 10:27:55
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- MSD virtually prohibits one-on-one product presentations
- by Apr 27, 2021 06:04am
- MSD Korea has proposed new rules for one-on-one product presentations with doctors. Product presentations that are not for business purposes are minimized, and the limit for meals is lowered from ₩100,000 per person to a maximum of ₩70,000. It is expected that the labor-management conflict will intensify as a counter-argument has been raised within the business that it is a'substantially banned rule'. On the 23rd, MSD Korea announced the reorganized guidelines for product presentations to its employees. According to this, from this coming May ▲Meetings with speakers scheduled to lecture ▲Details that require a lot of time, such as changes in new drugs, indications, and guideline changes ▲One-on-one products under the approval of NSM only when in-depth details are needed for important business purposes. The pre-lecture meeting with the speaker is when in-depth discussions about products and diseases are necessary to determine and prepare the contents of the lecture. Details that take a lot of time include new drug launches, new indications, adverse reaction issues, supply-related, insurance benefits, and important clinical data updates. An important business purpose refers to business-related discussions after product presentations and Q&A, or when additional discussions on other business-related topics such as marketing, insurance benefits, supply, etc. are necessary in relation to products or diseases.If this is not the case above, one-on-one product presentations must be approved by the business unit director (BUD). The limit on food and beverages that can be provided at product presentations has also been lowered. From ₩100,000 per person, lunch is limited to ₩40,000 and dinner is ₩70,000 (excluding VAT). The company said, "We hope that the product briefing sessions conducted one-on-one with the doctor will be conducted as a simple PRE. When a product briefing with meals is absolutely necessary, it is conducted with the approval of the executive, and the approval authority carefully reviews the reason why this activity must be conducted as a general briefing rather than a simple product briefing, and additional reasons are recognized..” Simple product presentations refer to light meals that are less than ₩10,000, such as coffee or sandwiches. There is a backlash from inside the business that it is a measure that effectively bans one-on-one product presentations. This is because the scope of the provisions allowed by the company is narrow and ambiguous. An official from the MSD Korea union said, "The speakers scheduled to lecture are only for some professors at general hospitals, and there are few new drugs available." "Because the important business purpose is ambiguous, there is a difference in the position between the field staff and the company. It is expected to be large.” He added, "In the end, the three provisions proposed by the company seem to be in most cases that are not possible in the field, so it is actually interpreted to mean that one-on-one meetings should not be held." Employees pointed out that the company is pushing for a unilateral change of regulations that does not take into account the business environment, which is a stronger measure than that of the pharmaceutical affairs law and the KRPIA. Earlier, MSD Korea said, "We regularly review whether the communication method with customers is appropriate and update internal regulations if necessary." It said that it will derive an appropriate plan by collecting opinions from employees
- Company
- Hankook Korus Pharm is preparing for Sputnik V
- by Kim, Jin-Gu Apr 26, 2021 05:51am
- Hankook Korus Pharm announced on the 23rd that it has begun preliminary work for domestic approval of Sputnik V, COVID-19 vaccine developed by Russia. According to Hankook Korus Pharm, the company has recently requested documents related to the permit from the Russian Direct Investment Fund (RDIF) and is preparing the necessary materials for the permit. An official from Hankook Korus Pharm said, "We have inquired the MFDS for other domestic permits and necessary matters. We are preparing for it as the recent discussion on the introduction of Sputnik V in Korea has progressed." In particular, President Moon Jae-in ordered the inspection. There are steps that must be taken to introduce Sputnik V in Korea. First, it is a contract with the Russian Direct Investment Fund (RDIF). As with other vaccines, the amount and timing of introduction should be negotiated with the supplier. Formal approval from the MFDS is also required. The approval of the MFDS is expected to be the key to approval by the European Medicines Agency (EMA). Currently, the EMA is undergoing formal review of Sputnik V. It is expected that the evaluation results will be announced as early as May. If the EMA approves Sputnik V, it is expected to speed up domestic introduction. In Korea, Hankook Korus Pharm and Huons Global each have signed a contract for consignment production of Sputnik V. Hankook Korus Pharm has decided to produce 500 million doses. Huons decided to build a facility capable of producing more than 100 million doses per month.
- Company
- Ninlaro can be prescribed at general hospitals
- by Eo, Yun-Ho Apr 26, 2021 01:34am
- Ninlaro, an oral multiple myeloma treatment that solves the problem of insurance benefits, is prescribed at general hospitals. According to related industries, Ninlaro (Ixazomib), an oral medication option in the field of multiple myeloma (MM), is used in Korea, including Samsung Medical Center, Seoul National University Hospital, the Catholic University of Korea Seoul St. Mary's Hospital, Hwasun Chonnam National University Hospital, Kyungpook National University Hospital, Pusan National University Hospital, and Chungnam National University Hospital. it has passed the drug commitee (DC) of major medical institutions nationwide. Ninlaro was designated as an orphan drug in May 2017 and was listed last month. This is because the risk sharing agreement (RSA) could not be used due to the selection of competing drugs. Takeda Korea, a supplier, has also provided free domestic supply since October 2019. This drug, a proteasome inhibitor, proved its efficacy in the TOURMALINE-MM1 study, a phase 3 clinical trial in 722 patients with relapsed or refractory multiple myeloma. According to the results of the study, Ninlaro, Revlimid (Lenalidomide), and Dexamethasone therapy had an average progression-free survival (PFS) of 20.6 months, which was higher than that of placebo, Lenalidomide and dexamethasone combination therapy at 14.7 months. Meanwhile, three-drug therapy including Revlimid for multiple myeloma is recommended as a major treatment option in the NCCN guidelines and ESMO. Reblimide's 'R' is the backbone of these three-drug therapies. Amgen's Kyprolis (Carfilzomib) is used as KRd (Kyprolis, Revlimid, dexamethasone) therapy, BMS' Empliciti (Elotuzumab) is used as ERd therapy, Ninlaro is used as IRd therapy, Janssen's Darzalex (Daratumumab) is used as DRd therapy. Deok-Hyun Yoon, professor of oncology at Asan Medical Center, said, "Multiple myeloma with many elderly patients and frequent recurrence will gradually increase in number of patients and increase the socioeconomic burden as the population ages. In the treatment of relapsed and refractory multiple myeloma patients for a long period of time," "The treatment strategy that keeps this from progressing is important, and one of the factors to consider for this is patient compliance." He added, “The combination therapy of oral three-drugs through Ninlaro is a treatment option that lowers the patient's treatment burden for outpatient and administration time and increases medication convenience. It is recommended for patients first.”
- Company
- The market share of Hanmi & Chong Kun Dang's is 16%
- by Kim, Jin-Gu Apr 26, 2021 01:29am
- BetmigaCompetition for the generic drug Betmiga (Mirabegron), an overactive bladder treatment, is intensifying in the outpatient prescription market. According to the drug market research agency UBIST on the 20th, the Mirabegron market scale in the first quarter reached ₩18.3 billion. It increased by 9% compared to ₩16.7 billion in the same period last year (1st quarter of 2020). It is an analysis that the addition of generics has contributed to the expansion of the market size. Hanmi Pharm and Chong Kun Dang released Mirabek and Selebeta consecutively in June and July of last year through the avoidance of Betmiga patents. The sales of both items totaled ₩1.4 billion in the third quarter of 2020. The prescription amount for the two items increased to ₩2.3 billion in the fourth quarter, then to ₩2.9 billion in the first quarter of this year. In half a year, prescription performance more than doubled. Generic market share also doubled from 8% to 16% during this period. It is possible to exceed ₩10 billion in annual prescriptions. The prescription amount of the original Betmiga in the first quarter was ₩15.4 billion, down 8% from ₩16.7 billion a year earlier. As the drug price of Betmiga remains almost the same as before, it is interpreted that generic drugs have a direct effect on the decline in original performance. Astellas has postponed the government's disposition of drug price cuts following the release of generics to filing an administrative lawsuit. However, from March this year, the upper limit price was cut by 5.5% according to the price-volume agreement. From 2Q, competition in the Mirabegron market is expected to intensify. This is because Mirabek and Selebeta's generic for exclusivity period ended in February of this year. According to the MFDS, 26 companies in addition to Hanmi and Chong Kun Dang have received the generic for Betmiga license. Betmiga is an overactive bladder treatment launched by Astellas in October 2015. It became a representative item at the same time as it was released. The annual prescription amount is ₩28.8 billion in 2016, ₩41.9 billion in 2017, ₩54.8 billion in 2018, ₩64.7 billion in 2019, and ₩65.1 billion in 2020. About 40 domestic companies challenged the patent. Since 2015, it has filed a request for an invalidation trial and a negative trial for confirming the scope of rights for material patents, formulation patents, crystalline patents, and use patents. Hanmi and Chong Kun Dang won generic for exclusivity. The generic for exclusivity period was from May 4 last year to February 3 this year.
- Company
- Domestic drug Rosuzet/K-CAB sales performance is very good
- by An, Kyung-Jin Apr 26, 2021 01:28am
- Lipitor Lipitor, a treatment for hyperlipidemia, kept the lead in outpatient prescription sales. Drugs developed with domestic technology such as Rosuzet and Zemiglo, led by HK inno.N's K-CAB, increased sales despite prolonged COVID-19. Original drugs are on a decreasing trend after patent expiration. According to UBIST, a drug research institute on the 20th, Pfizer's Lipitor took the lead in overall outpatient prescriptions with ₩43 billion in the first quarter. Lipitor is an Atorvastatin-based treatment for hyperlipidemia, which Pfizer Korea introduced to the domestic market in 1999. After the expiration of the patent, the insurance drug price has dropped to half, and more than 130 generics have been poured out, but except for 2017 alone, it has maintained the lead in prescription sales for the past 10 years. However, the uptrend has slowed. Lipitor reduced the size of quarterly prescriptions by 8.5% compared to ₩47 billion a year earlier. In January and February, prescriptions decreased by 9.9% and 11.2%, respectively. The prescription amount in March was ₩15.3 billion, recovering to the previous year's level. Hanmi's Rosuzet ranked second in prescriptions with an outpatient prescription amount of ₩26.6 billion, up 16.3% year-on-year. Rosuzet is a hyperlipidemia complex consisting of two ingredients: Rosuvastatin Calcium and Ezetimibe. Since its launch at the end of 2015, it has been ranked No. 1 in the same ingredient market. It is analyzed that the strategy of entering the market before competitors while securing the right to use Ezetimibe from the patent holder MSD was effective. Rosuzet recorded an increase of more than 10% each month compared to the previous year, even when there were many restrictions on face-to-face sales marketing activities due toCOVID-19 incident last year. Rosuzet surpassed Gliatamin in the second half of last year, exceeding ₩8 billion in monthly prescriptions. In March, it set its own highest prescription record at ₩9.4 billion and the monthly prescription amount exceeded ₩10 billion. Daewoong's Gliatamin amounted to ₩23.2 billion in outpatient prescriptions in the first quarter of last year, down 1.7% from the same period last year. Gliatamin is generic containing Choline alfoscerate, a brain function improvement agent. As the government imposed two sanctions, including reduction in reimbursement and negotiations for redemption, and pharmaceutical companies protested, an unprecedented legal battle is expected, but the market impact of prescription drugs is still strong. During the same period, the competitive item CKD Gliatilin Soft Cap is ranked 9th overall with outpatient prescription performance of ₩19.8 billion, up 1.2% from the same period last year. HK inno.N's K-CAB showed an unrivaled growth rate, rising 54.7% year-on-year to ₩22.5 billion in prescriptions in the first quarter of last year. K-CAB (Tegoprazan 50mg) is a P-CAB-based anti-ulcer drug released by HK inno.N in March 2019. In gastric parietal cells, it represents a new mechanism of action that inhibits gastric acid secretion by competitively binding the proton pump and potassium ions located in the final stage of acid secretion. The monthly prescription for K-CAB in the first year of its release rose from ₩1.7 billion to ₩5 billion. After securing the indication for GERD as the first indication, the amount of prescriptions increased further with the addition of the indication for gastric ulcer treatment in July of the same year. In January and February this year, when most pharmaceuticals were sluggish, the prescription ranking rose by two steps in the first quarter. It is evaluated that the joint sales strategy with Chong Kun Dang, which has differentiated mechanisms compared to the existing PPI and strong sales power in the digestive system field, created synergy. LG Chem's diabetes combination drug Zemimet's outpatient prescription for the first quarter was ₩20.8 billion. It changed its own prescription record, rising 12.2% from the same period last year. Zemimet is a combination drug that combines Metformin with Zemiglo, a new diabetes drug based on DPP-4 inhibitors developed by LG Chem. Since 2016, it has signed a co-promotion contract with Daewoong and has been selling it jointly. Eutropin, a growth-promoting hormone developed by LG Chem, doubled from the same period last year as it was prescribed ₩17.9 billion worth in the first quarter. Since it was listed on the list of selective benefits at the end of 2018, it has grown rapidly in the prescription drug market. Patent expiration drugs, which are copyrighted by global pharmaceutical companies, still rank at the top of the outpatient prescription market, but the uptrend did not show the same trend as in previous years. The quarterly prescription size of the top 10 outpatient prescription drugs with expired patents such as Boehringer Ingelheim's high blood pressure combination drug Twynsta, Sanofiaventis' antithrombotic drug Plavix, Gilead Science's hepatitis B treatment Viread, and AstraZeneca's hyperlipidemia treatment Crestor declined. Twynsta's outpatient prescription amount fell 7.7% YoY to W21.8bn in 1Q. Twynsta is a hypertensive combination drug that combines ARB-based Telmisartan and CCB-based Amlodipine Besylate. Yuhan Corporation has been selling jointly since 2010, but sales have declined compared to K-CAB since the third quarter of last year. The two hepatitis B treatments that once dominated the prescription drug market had poor prescription performance. Viread barely maintained ₩20 billion, with prescriptions falling 5% in the first quarter. Baraclude by BMS Pharmaceutical, a rival drug, was ₩16.3 billion, down 5.1% from the previous year, ranking 20th in the prescription ranking. For Plavix and Crestor, the amount of prescriptions decreased by 7.5% each. For dementia treatment Handok Aricept, the quarterly prescription amount decreased by 7.3%. Aricept developed by Eisai was changed from Daewoong to Handok in Korea for some items such as Aricept and Aricept Evess in May of last year. The quarterly prescriptions for MSD's diabetes combination drug JANUMET and Astellas Pharmaceutical's prostatic hypertrophy treatment Harnal fell 3.5% and 6.2% respectively.
- Company
- Big 5 Hospitals actively prepare CAR-T ‘Kymria' centers
- by Eo, Yun-Ho Apr 22, 2021 05:53am
- The ‘Big-5’ tertiary hospitals in Korea are working fast to introduce the first CAR-T therapy ‘Kymriah’ to their institutions. According to industry officials, among the Big-5s, Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, and Severance Hospital are in the process of acquiring the ‘human cell management business approval’ from the Ministry of Food and Drug Safety, and Samsung Medical Center (SMC) already obtained the approval. In Seoul National University Hospital, Kymriah (tisagenlecleucel) passed the drug committee (DC) review in April, and the drug is also expected to land in Samsung Medical Center in May. Kymriah developer Novartis has allowed general hospitals to be paid for the ancillary costs by establishing Kymriah centers in their institutions. SMC and SNUH will open their Kymriah centers in May, and other tertiary hospitals are expected to follow. To establish the center, hospitals are first required to receive a permit for the human cell management business under the newly implemented ‘Advance Regernative Bio Act.’ Kymriah is the first CAR-T therapy and the most expensive drug in Korea up to date. The drug is indicated for adult patients with diffuse large B cell lymphoma (DLBCL) and young adult and pediatric patients with acute lymphoblastic leukemia (ALL). Both indications are for late-stage patients that are in relapse post-transplant or in second or later relapse after two or more lines of therapy. CAR-T therapy takes a different approach in its method of treatment. Unlike conventional drugs that are produced as finished products, for CAR-T, the hospital first collects T cells from the patient's white blood cells, then freezes and sends them to a manufacturing facility. At the facility, the T cells are genetically engineered to express the chimeric antigen receptors (CARs) that allow the T cells to recognize tumor cells, cultivated, then sent back to the hospital. In other words, after the hospital sends the raw material (patient’s T cells) to the company, the company makes the finished ‘Kymriah’ product with the raw material and sends it back to the hospital. The hospital maximizes the effect of Kymriah by using lymphodepleting chemotherapy to reduce the white blood cell count in advance. After 4-5 weeks, the processes are all complete, and Kymriah is finally infused into the patient. “Kymriah is an innovative, personalized treatment for each patient with a new mechanism of action that allows the patient to complete treatment with just ‘one shot.' It is a treatment that has never been seen in the history of anticancer treatment.,” said Sung-soo Yoon, professor of Hemato-Oncology at the Seoul National University Hospital. “Patients with relapsed∙refractory DLBCL who failed two or more lines of treatment or transplant that are left with a life expectancy of only three to six months can reach complete remission after a single treatment and increase their rate of survival.” “Relapsed∙refractory ALL patients are very rare in Korea, however, these few young patients that are diagnosed every year are in the fight for their lives,” Said Chuhl Joo Lyu, professor of pediatric Hematology-Oncology at Severance Hospital said. “The government, pharmaceutical company, and the medical community should work together to create an environment for these young patients to enable timely treatment with Kymriah.”
- Company
- Tremfya reimbursement approved for palmoplantar pustulosis
- by Apr 22, 2021 05:53am
- Janssen’s interlukin-23 (IL-23) inhibitor ‘Tremfya (guselkumab)’ will be reimbursed from May 1st for the treatment of palmoplantar pustulosis. The reimbursement will apply to patients over the age of 18 years who were diagnosed with moderate to severe palmoplantar pustulosis that has lasted for more than 6 months that ▲ have a Palmoplantar Pustulosis Area and Severity Index (PPPASI) score of 12 or higher and have no response to Acitretin for at least 3 months or had to discontinue treatment due to side effects(medical report required); or ▲have a PPPASI score of 12 or higher and show no response to phototherapy for at least three months or had to discontinue treatment due to side effects; Tremfya is the first and only biological treatment in Korea available for patients with palmoplantar pustulosis. In a Phase III clinical trial, the patient group treated with Tremfya significantly lowered their PPPASI score compared to the placebo group. At 52 weeks, patients in the Tremfya treatment group still showed continuous improvement, and achieved a PPPASI-50(≥50% improvement) and PPPASI-75(≥75% improvement) response of 83.3% and 55.6%, respectively. “With the reimbursement approval, we are pleased to be able to provide a new treatment option to palmoplantar pustulosis patients in Korea," said TaeYun Jung, Director of the Immunology Business Unit at Janssen. "Starting with the TNF-a blocker Remicade to Stelara, Janssen has been in the forefront of providing new treatment options for patients suffering from psoriasis. We will continue to spare no effort for our patients that suffer from immune disorders, including psoriatic diseases.” Palmoplantar pustulosis is a chronic inflammatory skin disorder that presents as sterile pustules or red patches on one's palms and soles.
- Company
- Sanofi to sell Hanmi's AmosartanQ' in Russia
- by An, Kyung-Jin Apr 22, 2021 05:53am
- AmosartanQHanmi's IMD AmosartanQ will be launched in the Russian market through Sanofi. Hanmi announced on the 20th that Sanofi has obtained marketing approval from the MOH for AmosartanQ under the product name Tristanium. AmosartanQ is a combination drug that combines Amlodipine Camsylate, a component for treating hypertension of CCB, and Losartan potassium, a component for treating hypertension of ARB, and Rosuvastatin Calcium, a component for treating hyperlipidemia. Sanofi is in charge of local licensing, sales marketing, and sales in Russia by receiving the right to use exclusive Russian license materials for AmosartanQ from Hanmi. This time, with the marketing approval, it is planning to establish a sales marketing strategy for AmosartanQ and launch it officially. Hanmi produces finished products at the Paltan Smart Plant in Gyeonggi Province and exports them to Russia. According to Hanmi, Russia is the second largest pharmaceutical market in Europe. In particular, the hypertension treatment market is evaluated for its high potential growth rate. According to the European Society of Cardiology, the incidence of hypertension in Russia is as high as 4 out of every 10 people, but only about 20% are actively treated. AmosartanQ (Amlodipine, Losartan, and Rosuvastatin) is ganerating market sales of about ₩400 billion ($3.9 billion) in Russia. Amosartan (Amlodipine and Losartan) has been on sale in Russia with Sanofi since 2017. It has grown at an annual average rate of 21% over the past four years. Hanmi expects that AmosartanQ will receive a positive response in the Russian market as well. AmosartanQ is an important product of the Amosartan Family, which records annual prescription sales of ₩100 billion in Korea," said Jongsoo Woo, CEO of Hanmi. He said, "Starting with Russia, we will do our best to accelerate entry into the global market."
- Company
- Schingles is expected to be released in the end of the year
- by Apr 21, 2021 05:50am
- GSK's Schingles, which boasts the highest efficacy among the existing shingles vaccines, is expected to receive product approval at the end of the year as soon as possible. When Schingles is released in Korea, fierce competition is expected with Zostavax and Sky Zoster. According to the pharmaceutical industry on the 21st, GSK applied for Schingles item approval from the MFDS in January and is currently undergoing review. Approval is expected within the year, considering the period of time it normally takes for a permit review. It is expected that it will be able to obtain a permit at the latest early next year. Schingles was first approved in the United States in October 2017 and in Europe and Japan. In the US, the market share reached 98% a year after the launch of Schingles. Worldwide sales amounted to ￦1.1 trillion in 2018, ￦2.5 trillion in 2019, and ￦3 trillion in 2020. The defense rate is stronger than other products. In a clinical trial involving adults 50 years and older (ZOE-50), Schingles demonstrated a 97.2% ERA at 3.2 years of follow-up. Those over 70 years old (ZOE-70) showed 89.8% efficacy after 3.7 years of follow-up. The conventional vaccine, MSD's Zostavax, showed 51% protection in patients over 50 years of age. It was 41% of those over 70 years old. SK Bioscience's Sky Zoster has no known ERA figures. With a non-inferiority test against Zostavax, it can be assumed that the ERA is similar. Schingles is an inactivated vaccine, unlike the live attenuated vaccine Zostavax, and is particularly recommended for patients with weakened immunity. Accordingly, the CDC recommended Schingles first over existing products as a shingles vaccine for adults over 50 years of age. People who had previously been vaccinated with Zostavax also recommended Schingles re-vaccination. Schingles has two doses and is a bit more expensive. Zostavax and Sky Zoster are given a single dose, whereas Schingles requires two doses at intervals of 2 to 6 months. The price is also expected to be higher than the two products. Concerns over Schingles' supply shortages are reported to be largely resolved. At the time of launch, there was a shortage of supply due to failure to keep up with demand. Accordingly, GSK is continuously expanding its production capacity and increasing its supply. Currently, the domestic shingles vaccine market includes Zostavax and Sky Zoster. Originally, Zostavax was the only one, but with the launch of Sky Zoster in October 2017, it quickly eroded the market. Market sales of Zostavax and Sky Zoster based on IQVIA last year were ￦43.2 billion and ￦29.1 billion, respectively. Competition between the three products will be fierce from next year when Schingles sales are in full swing.
- Company
- Lynparza tablet to be prescribed at Big 5 hospitals
- by Eo, Yun-Ho Apr 21, 2021 05:49am
- The tablet formulation of the anticancer drug ‘Lynparza’ can now be prescribed at the Big-5 tertiary hospitals. Industry sources reported that AstraZeneca’s poly ADP ribose polymerase (PARP) inhibitor Lynparza (olaparib) passed the review of drug committees (DC) in the five major hospitals, the ‘Big-5s,’ which include the Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary’s Hospital, Asan Medical Center, and Severance Hospital. With Severance Hospital’s DC giving the last nod, Lynparza has now landed in all five hospitals as well as 25 other medical institutions nationwide. As the company received approval from HIRA's Drug Review Evaluation Committee (DREC) to reimburse Lynparza for the ‘first- and second-line maintenance treatment of patients with BRCA-mutated ovarian cancer,’ prescriptions are expected to be made soon after being listed for reimbursement. The company had submitted an application to expand Lynparza tablet's reimbursement to ▲first-line maintenance treatment for patients with BRCA-mutated advanced ovarian cancer; ▲second-line or higher maintenance monotherapy for patients with recurrent platinum-sensitive advanced epithelial ovarian cancer; and ▲HER-2 negative metastatic breast cancer; however, reimbursement for second-line treatment of mBRCA-negative ovarian cancer and breast cancer patients were rejected in the listing process. The addition of the tablet formulation also signifies an improvement in the convenience of oral administration for patients. In the SOLO-2 trial, which investigated the efficacy of the tablet formulation of Lynparza, the 300mg of the tablet formulation taken twice a day met the primary efficacy endpoint. The recommended dose of the Lynparza tablet is two 150mg tablets (300 mg) taken orally twice daily, while the dose for the Lynparza capsule is eight 50mg capsules (400mg) taken orally twice daily. The total number of pills to take is reduced from 16 to 4 per day with the tablet formulation. Lynparza was listed for ovarian cancer in October 2017 as an expenditure cap type under the Risk Sharing Agreement (RSA) through the PE exemption policy. However, the coverage only applied for its use as maintenance therapy for 15 months following chemotherapy. Due to the period limit, cases of patients being discontinued reimbursement started to arise from January 2019. To resolve the issue, the government and AstraZeneca discussed expanding the reimbursement and lifted the period limit set on the drug.
