- LOGIN
- MemberShip
- 2026-05-21 01:11:53
- Company
- Kisqali joins reimbursement race as Faslodex combination
- by Eo, Yun-Ho Nov 13, 2019 01:11am
- A third CDK4/6 inhibitor in the Korean market, Kisqali now stands next to the first two drugs, Ibrance and Verzenio, as it applies for National Health Insurance (NHI) reimbursement listing. Novartis Korea recently submitted a reimbursement listing application of Kisqali (ribociclib) after its approval by Ministry of Food and Drug Safety (MFDS) on last Oct. 30. Accordingly, Ibrance and Verzenio are to face another competitor, while they are already fighting over insurance benefit under an indication as a combination therapy with Faslodex (fulvestrant),. Currently both Pfizer’s Ibrance (palbociclib) and Lilly’s Verzenio (abemaciclib) are waiting for deliberation by Drug Reimbursement Evaluation Committee (DREC), after Health Insurance Review and Assessment Service’ (HIRA) Severe and Cancer Disease Deliberation Committee has passed them as a combination therapy with Faslodex. And now with Kisqali joining the race, the three pharmaceutical companies are to compete intensely against each other for the first-in class indication as ‘second-line combination therapy with Faslodex’. All three of them are in the same class of cyclin-dependent kinase (CDK) 4 and 6. But reportedly, their reimbursement listing applications vary in strategy. In November 2017, Ibrance has already been listed as a first-line therapy in combination with Letrozole via refund type risk sharing agreement (RSA). And now it is in process of expanding the indication. Verzenio, on the other hand, is applying for reimbursement listing for the first time. The treatment has simultaneously applied for reimbursement not only as a second-line therapy, but also as a first-line therapy in combination with aromatase inhibitor. But under its current circumstances, Verzenio’s only option is RSA. However, a follow-on drug is not yet eligible for RSA. And because its indication as a combination therapy with faslodex targets wider range of patients with prior experience of treatment regardless of menopause, the drug maker Lilly is highly likely to apply as a second-line treatment before any other product applies for it. But, Kisqali is also likely to apply for the second-line treatment indication as well. Kisqali was approved by the regulator based on a meaningful improvement of prolonging progression free survival (PFS) demonstrated in its clinical trial. Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as first-line treatment for pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer, and proved the drug’s effect of significantly extending patient’s overall survival (OS). Compared to the existing endocrine-based single therapy, Kisqali’s result in the Phase 3 MONALEESA-3 extended OS longer and improved treatment efficacy when used as initial endocrine-based therapy in combination with fulvestrant for postmenopausal women with locally advanced or metastatic breast cancer.
- Company
- Takeda provides free supply of MM treatment Ninlaro
- by Eo, Yun-Ho Nov 13, 2019 01:09am
- Takeda Pharmaceutical started providing free supply of oral multiple myeloma treatment, Ninlaro. According to industry insider, Takeda Pharmaceutical has decided to provide free supply the only oral option for multiple myeloma treatment, Ninlaro (ixazomib), last month and recently entered general hospital’s list of drug codes. Currently, the Big Five general hospitals including, Seoul National University Hospital, Severance Hospital, and Samsung Seoul Medical Center, have coded in the treatment for prescription. The decision was made as a temporary arrangement due to the delayed insurance reimbursement listing procedure. The treatment was designated as an orphan drug in May of 2017, and was approved in July same year. But its reimbursement application is pending in the hands of Drug Reimbursement Evaluation Committee (DREC) of Health Insurance Review and Assessment Service (HIRA) to this date. Ninlaro also expanded its indication as a combination therapy with lenalidomide and dexamethasone for multiple myeloma patients who have not responded to at least one standard therapy. The proteasome inhibitor drug demonstrated its efficacy and safety from Phase III TOURMALINE-MM1 clinical trial in patients with relapsed or refractory multiple myeloma. The study found triplet regimen of ixazomib, lenalidomide, and dexamethasone had significantly improved the length of progression free survival (PFS) to average 20.6 months, longer than 14.7 months of PFS recorded by a combination of placebo, lenalidomide and dexamethasone. Meanwhile, a triple combination therapy with Revlimid is the most recommended multiple myeloma treatment option according to the U.S. National Comprehensive Cancer Network (NCC) guideline and the European Society for Medical Oncology (ESMO). And Revlimid (lenalidomide) is the backbone for all triple combination therapies. Following are some of major triple combination therapy options for second line and later treatments; Amgen’s Kyprolis (carfilzomib) KRd combination (Kyprolis, Revlimid, dexamethasone); BMS’ Empliciti (elotuzumab) ERd combination (Empliciti, Revlimid, dexamethasone); Takeda’s Ninlaro (ixazomib) IRd combination (ixazomib, Revlimid, dexamethasone); and Janssen’s Darzalex (daratumumab) DRd combination (Darzalex, Revlimid, dexamethasone).
- Opinion
- [Column] Imposing fine enough to prevent rebate?
- by Kim, Jung-Ju Nov 13, 2019 01:09am
- Korean government’s plan to revise illegal rebate penalty regulation and replace insurance reimbursement suspension with fine on an accused drug product came under fire. However, the government is committed to protect drug access considering patient’s safety and convenience. For the justification of rebate regulation against rebate, the government points its finger on financial factor, other than pure objective of treatment, intervening the process of selecting and purchasing drug products, and negatively affecting on patient’s health, National Health Insurance (NHI) and general medical expense. The objective of rebate regulation is to induce adequate use of drug and transparent trading. The execution of rebate regulation should be able to achieve the objective, and the regulators should maintain fairness when executing it. The existing penalty against rebate is to revoke NHI reimbursement listing and to impose fine depending on the number of committed offenses. The proposed revision of the regulation starts from lowering of upper limit healthcare expense (drug price) to suspension of healthcare reimbursement, as well as imposing of fine, depending on the number of committed offenses. The major differences are utilization of drug price reduction, increase in amount of fine, and excluding revocation of reimbursement listing. It seems appropriate not to remove the responsible drug product from reimbursement listing for the sake of patient’s stable drug access, because it would be far-fetched to correlate illegal practice and quality of the drug. Furthermore, the regulators should contemplate on how effective the revised penalties would be to eradicate the illegal practice, compared to the revocation of reimbursement listing. The purpose of the regulation should not only stress on punitive aspect, but also stress on preventive aspect. Reduction of drug price and increased fine are undeniably punitive. However, the issue is the severity level of the penalty sufficient enough to bring preventive effect. When the level of penalty is bearable, then companies with agenda would rather take the chance of committing offense. Other issues are drug price reduction, reimbursement suspension period and the unclear definition of the ‘period’ when imposing fine. Positively speaking, they could be seen as ‘flexibility’ in administrative measure, but negatively speaking, ‘voluntariness’ of the administrative measures are questionable. It is easy to predict who would exploit and abuse the regulatory standard (interpretation of the term). Also, the term ‘one year-worth of reimbursement cost’ addressed in the regulation summing the amount of fine is ambiguous. Depending on the point of the ‘year’, the accused company’s absolute amount of fine and countermeasure differ vastly. At the moment, dual penalty system is applied on the rebate giver, a pharmaceutical company, and the receiver, a doctor or healthcare institute. But the off-balance between regulations against the giver and the receiver, as addressed by the National Health Insurance Act, are under fire. The regulators are reinforcing financial penalty on rebate-giving product, instead of imposing regulation on the product itself to maintain access to the treatment. On the other hand, regulators suspends license of the rebate-receiving healthcare provider, and also confiscates illegally obtained financial gain. How about some more attention on re-evaluating the fairness between reimbursement revocation on a drug product and suspension of doctor’s license? Or between drug price reduction and reimbursement cost refund, and financial gain confiscated from healthcare providers? Effective execution and fair penalties of rebate regulation should be revisited at this point in time. Moreover, we should not forget to contemplate on revising the regulation to prevent rebate practice in long-term and fundamental fashion, taking the unique qualities of the pharmaceutical industry’s rebate practice and distribution environment into account. Although the ultimate consumer of a drug product is patient, it is undeniable that doctors are in control over the pharmaceutical options. Keeping in mind that a drug is also a commercial product, the regulators would also have to face the reality of marketing without some form of rebate. The point is to bring down healthcare provider’s openness of receiving rebate and the level of rebate provision. Besides the problem within rebate practice, National Health Insurance’ payment system and healthcare provision system should be reformed to achieve fair and good healthcare.
- Company
- Doctors choose PPI to replace ranitidine alternative
- by Nho, Byung Chul Nov 12, 2019 06:26am
- Apparently, healthcare providers are in favor of proton pump inhibitor (PPI), as an alternative to ranitidine after confirmed contamination of carcinogen N-nitrosodimenthylamine (NDMA) in some of ranitidine products. Doctor Ville, an online community exclusive to healthcare providers, recently conducted a survey on 1,664 doctors about alternatives to ranitidine. The survey studied which medicine would healthcare providers prescribe in place of ranitidine, due to the sales suspension on ranitidine products. 1,664 doctor members of the online community, who prescribes ranitidine, participated in the latest survey. 33.4 percent, 20.7 percent, 4.4 percent, 3.6 percent, and 3.6 percent of survey participants were from internal medicine, family medicine, neurology, surgical, and dermatology departments, respectively. Apparently, the overall 796 doctors are prescribing ranitidine for about ten patients a day. The study found the most number of doctors (48.7 percent) are considering on prescribing PPI instead of ranitidine, and other options like H2RA (35 percent) and mucosal protective agent (15.1 percent) followed. On a questionnaire confirming doctor’s preference order of single agent treatment alternative to ranitidine, 82.9 percent of survey participants ‘agreed’ with the order of ‘PPI, H2RA and mucosal protective agent’ as preferred options in the order. Among the group of doctors who chose PPI for an alternative option, 70.6 percent of them particularly picked esomeprazole as their primary option in mind. Lansoprazole (11.6 percent), rabeprazole (9.8 percent) and pantoprazole (8 percent) followed the list of preferred options of PPI. 43.2 percent of the group of doctors who chose H2RA answered they are contemplating on famotidine, and others chose lafutidine (29 percent), cimetidine (14.9 percent) and nizatidine (12.9 percent), in the order of preference. The survey also reported doctors’ preference order of mucosal protective drug was rebamipide (64.5 percent), artemisia asiatica medicine (27.1 percent), sucralfate (4.4 percent) and bismuth (4.0 percent). As for ranitidine combination therapy, 40.6 percent of doctors answered ‘combination of esomeprazole and Mosapride’, and other combinations of ‘esoeprazole and rebamipide (27.2 percent)’, ‘famotidine and rebamipide (18.5 percent)’ and ‘famotidine and Mosapride (13.6 percent)’ followed the list. 86.4 percent of the survey participants said they ‘agree’ on top three preferred prescription option of alternative ranitidine combination therapy to be ‘PPI and mucosal protective agent,’ ‘PPI and PKT’ and ‘H2RA and mucosal protective agent’, in the respective order. On the other hand, 58.2 percent of doctors said the most crucial factors affecting ranitidine-alternative option are ‘acid blocking and mucosal protective effects,’ and other 18.2 percent of doctors said ‘safety’.
- Policy
- DREC passes Imfinzi, Liporaxel ‘conditional'
- by Kim, Jung-Ju Nov 11, 2019 10:41pm
- AstraZeneca AstraZeneca’s immunotherapy Imfinzi (durvalumab) passed the first threshold to receive its insurance reimbursement in Korea. The treatment is soon to initiate its negotiation with National Health Insurance Service (NHIS) under the order of drug pricing negotiation by Ministry of Health and Welfare (MOHW). On the other hand, Daehwa Pharmaceutical’s stomach cancer treatment Liporaxel (paclitaxel) received a conditional right to initiate a drug pricing negotiation with NHIS, when the drugmaker accepts proposed evaluated price (weighted average) by Health Insurance Review and Assessment Service (HIRA). In the morning of Nov. 8, HIRA published results of Drug Reimbursement Evaluation Committee (DREC) meeting convened on Nov. 7, deliberating insurance reimbursement feasibility review applications. First, Imfinzi is approved for the treatment of locally-advanced non-small cell lung cancer following chemotherapy and radiation therapy. Unlike other immunotherapy, Imfizi specifically targets Stage III lung cancer. DREC reviewed reimbursement feasibility of the treatment and passed it, 11 months after the application was submitted. Liporaxel is a new anticancer treatment, improving inconvenience of Taxol as an oral regimen. But the Korean regulator once denied reimbursement on the treatment last year. In the latest deliberation, Liporaxel was granted with conditional non-reimbursement status. The treatment’s efficacy was well noted but it came down to the issue of relatively high cost than other alternative drugs. When the pharmaceutical company proposes a price lower than HIRA’s feasibility-evaluated price, the drug is to receive reimbursement.
- Company
- Mavyret’s 8-week indication approved in Korea
- by Eo, Yun-Ho Nov 11, 2019 10:40pm
- A hepatitis C treatment Mavyret is to soon be available as an eight-week treatment in Korea, after its approval in the U.S. After receiving an approval from the U.S. Food and Drug Administration (FDA) first, AbbVie received an approval from Korean Ministry of Food and Drug Safety (MFDS) last month for another indication as an eight-week once-daily treatment for chronic hepatitis C virus (HCV) patients across all genotypes (GT 1 to 6) with compensated cirrhotic, who has never been treated before. However, the drug is planning to follow a separate approval procedure for genotype 3 HCV. Moreover, Mavyret now can be prescribed to treat pediatric patients over age of 12 with HCV. The drug has been approved in the U.S. as an eight-week pan-genotypic treatment for treatment-naïve patients without cirrhosis in August, 2017. The indication expansion got a nod from the regulators based on evidence resulted in the Phase 3b EXPEDITION-8 study, a single-arm, open-label clinical trial evaluating the safety and efficacy of Mavyret in treatment-naïve adult patients with all six genotypes of chronic HCV and compensated cirrhosis. In the study, an overall 98 percent (n=335/343) of patients achieved a sustained virologic response 12 weeks after treatments (SVR12). The EXPEDITION-8 study had one reported case, out of 336 patients treated, for relapse, and found none of them discontinued treatment due to adverse reaction. The indication expansion on adolescent patient from age 12 to 18 was based on results from Part 1 of DORA study, a single-arm, open-label clinical trial assessing the safety and efficacy of Mavyret in pediatric patients treated for eight or 16 weeks. The study demonstrated 100 percent SVR12 in the adolescent patient group, proving the efficacy of the treatment successfully. Professor Kim Ji Hoon of Korea University Guro Hospital stated, “With the launch of Mavyret last year, eight-week treatment for HCV of all genotypes is now a prevalent option for the disease. But now with the new approval shortening the treatment duration from 12 weeks to eight weeks, patients with all genotypes of HCV, except for genotype 3, who has no experience of treatment can have a shorter treatment of eight weeks, regardless of cirrhosis.” Meanwhile, drug committees of all five major general hospitals in Korea, including Seoul National University Hospital, Severance Hospital, Samsung Seoul Hospital, Asan Seoul Medical Center and Seoul St. Mary’s Hospital, passed Mavyret for prescription. Similar to hepatitis B and alcohol, hepatitis C virus is a main cause of liver cancer. About 70 to 80 percent of HCV cases progress to chronic hepatitis, and 30 to 40 percent of such case get worsen to cirrhosis and liver cancer. Up to three or four years ago, only option for HCV treatment was combination therapy of injection and oral antiviral. For the long treatment duration of six to 12 months, patients had to endure many adverse events, and even so, the treatment success rate was just around 50 percent. The treatment success rate reached 90 percent and treatment duration was shortened to 12-to-24 weeks after orally taken direct-acting antiviral (DAA) was launched in the market.
- Opinion
- [Reporter's view] DC the absolute power behind hospital
- by Eo, Yun-Ho Nov 11, 2019 11:08am
- When each hospital’s Drug Committee (DC) is convened, pharmaceutical companies starts a fierce war to land a favorable drug deal. Just like any war in the world, the ‘DC war’ has a winner and a loser. Unfortunately, not always do the winners deserve a win or the losers deserve their defeat. To land a ‘drug code-in’ deal at some general hospitals, ‘inappropriate backdoor dealing’ is more important than outstanding evidences of a drug’s indication and efficacy. Such phenomenon is prevalent when an original’s patent is expired and new generic is released. A hospital’s DC mostly consists of doctors from each department and chief pharmacist. However, sometimes unheard-of drugs get their codes in and push out existing drugs, thanks to hospital foundation’s influence. To this date, a hospital with significantly influential DC brings in representative of a pharmaceutical company and demands for so-called ‘drug code maintenance fee’ on an original drug with expired patent. In fact, the hospital removed well-known original hypertension, hyperlipidemic and antithrombotic items for last two to three years. Their codes were removed, simply because the drug companies refused to pay the ‘maintenance fee’. The illegal rebate paid by drug companies is never handed straight to the foundation. Pharmaceutical industry insiders hint that the money is rerouted and laundered through separate corporations owned by the foundation or distribution companies with a close relationship, and finally gets to the foundation. DC lobbying exists between originals when there is a new generation or type of drug is launched. So for pharmaceutical companies to get a drug code-in deal, they need to coax foundation and doctors. Of course, the effort of Dual Penalty System and Fair Competition Agreement has brought some fairness to the business. Unless solid evidence of a drug is available, growing numbers of hospitals are not guaranteeing DC’s approval, regardless of a good connection between a healthcare provider and a pharmaceutical company. However, hospitals still associate DC with an absolute power. Even though it should be given that hospital’s drug coding depends on fair evaluation.
- Policy
- World's most expensive drug Zolgensma to challenge Spiranza
- by Lee, Hye-Kyung Nov 11, 2019 06:11am
- Launching of the most expensive drug in the world, Zolgensma (onasemnogene abeparvovec-xioi), with a price tag of 2.5 billion won per dosage, has gotten Korean health authority and pharmaceutical industry anxious. Although the drug had an allegation of data manipulation from animal testing two months after the U.S. Food and Drug Administration’s (FDA) approval, the industry experts see Zolgensma would enter Korean market soon as the allegation is unlikely to cancel its approval. In last May, the U.S. FDA approved Zolgensma, indicated for the treatment of pediatric patients less than two years of age with spinal muscular atrophy (SMA) with bi-allelic mutation in the survival motor neuron-1 (SMN1) gene. Also, its applications for Fast Track, Breakthrough Therapy, Priority Review and orphan drug were granted. But the treatment has not been introduced to Korean market, yet. The drug is a gene therapy designed to target the genetic root cause of the Type 1 SMA through one single session of therapy. Meaning, one injection of the therapy replaces the function of the missing or nonworking SMN 1 gene with a new, working copy of a human SMN gene and prolongs patient’s overall survival. Institute for Clinical and Economic Review (ICER), a U.S. based organization reviewing drug’s cost-effectiveness, set Zolgensma’s price at USD 90,000 (about 95 million won), but the drugmaker claimed it should be four million to five million dollars (about 5 billion won), because it is an one-time treatment. Currently, Zolgensma is sold in the U.S. for 2.1 million dollars (about 2.5 billion won), and the pharmaceutical company provides an option of five-year installment with an yearly payment of 425,000 dollars, with partial refunds if it does not perform as expected. Followings are major motor milestones of the final result of clinical study on 12 SMA Type 1 patients with the onset of clinical symptoms before six months of age (average age of 3.9 years, as of March 8, 2019); all patients at the 24-month study closeout, survived and are free of permanent ventilation; 11 patients were able to hold their head erect for three seconds and longer, and sit without support for five seconds and longer; ten patients were able to sit without support for ten seconds and longer; nine patients were able to sit without support for 30 seconds and longer; two patients were able to stand alone, walk with assistance and walk alone. The key results resemble that of Spinraza, listed on Drug Reimbursement List in Korea as of April 8, this year. In 2016, the US FDA granted approval on Spinraza, an antisense oligonucleotide (ASO), for treating SMA caused by mutations in chromosome 5q. At the point of approval, ICER evaluated price of first year Spinraza therapy to be 750,000 dollars (about 800 million won), and 350,000 dollars (about 400 million won) from second year and on. As of now, Spinraza is covered by National Health Insurance (NHI) in Korea with risk sharing agreement (RSA), and its price cap for a single vial (5ml) is at 92,359,131 won, and patient copayment is about 9.23 million won, a ten percent of the full price. Reimbursement is granted for patients with SMA caused by mutations in chromosome 5q satisfying all conditions of preliminary review. The conditions include, patients diagnosed with absence or mutation of SMN1 gene, having onset clinical symptoms of SMA from age of three or less, and not using permanent ventilation (more than 16 hours a day continuously for more than 21 days). Spinraza is an intrathecal injection, administering four loading doses of 12mg (5ml) into cerebrospinal fluid. The first three loading doses should be administered at 14-day intervals. The fourth loading dose should be administrated 30 days after the third dose. A maintenance dose should be administered once every four month thereafter. In July, Spinraza published an interim report of 60-month long-term Phase 2 NURTURE clinical trial. NURTURE is an ongoing Phase 2 study of 25 infants with the genetic mutation of SMN, who received their first dose of the drug in a pre-symptomatic stage and before six weeks old. 45.4 months into the trial, all 25 patients have survived without permanent ventilation and are able to sit without support. Apparently, 88 percent (22 patients) can walk without support, suggesting the drug could be effective for infants not showing SMA symptoms, yet. SMA is a rare recessive neuromuscular disorder caused by bi-allelic mutation in the SMN1 gene’s chromosome 5q. The disorder causes a deficiency of motor neuron protein called SMN, and about 95 percent of people with SMA have onset symptoms when SMN1 gene mutates. SMN1 gene mutation reduces production of SMN protein as downstream processing from DNA to RNA cannot develop enough SMN gene, and also it induces apoptosis of anterior horn cell causing degenerative change in motor neurons, which leads to a relatively fast progression and symmetrical muscle weakness resulting in early death. Reported estimated incidence rate of the condition is one in 6,000 to one in 10,000 live births and carrier frequency is about 1/40-1/50. Infants with symptoms are unable to independently move as they lose motor function due to muscle degeneration. Infants with SMA have the highest severity and frequency, which their symptoms are prevalent from birth or around six months after the birth. These patients with severe case rapidly lose motor neuron, in control of activities like breathing, swallowing, speaking and walking, and without a treatment their muscles weaken fast and die from respiratory failure, as even their respiratory root loses its function by the age of two. Currently Spinraza and Zolgensma are only two SMA treatments available. Spinraza is a SMN2-directed ASO, approved to treat 5q SMA with its results of ENDEAR study. Whereas Zolgensma is a gene therapy that replaces missing or mutated SMN 1 gene, and was approved to treat children less than two years of age having bi-allelic mutation in SMN1 with results demonstrated in STR1VE study. Zolgensma had a comparatively small-size clinical trial than Spinraza, which demonstrated its efficacy in Type 1 patient before the age of six months and Type 2 and 3 patients at the age of two to 12 with onset symptoms from six months after birth. On the other hand, Zolgensma can only be used for SMA patients before the age of two. As for their pricing, Spinraza is priced at around 100 million won per injection and needs continuous administration, but a single-administration therapy Zolgensma is priced at around 2.13 million dollars (about 2.52 billion won) per injection. Zolgensma currently holds the title of the most expensive drug in the world for the price of single dosage. However, Spinraza and Zolgensma still need more research and follow-up monitoring on the drugs’ efficacy and safety through long-term clinical trials. There are also needs for more reasonable pricing for better treatment access.
- Policy
- On a mission to eradicate KOEDC’s deep-rooted ill practice
- by Lee, Jeong-Hwan Nov 10, 2019 10:00pm
- Sources confirmed Korea Orphan and Essential Drug Center (KOEDC) submitted the National Assembly (NA) a plan to resolve its issue of redirecting profit made from drug expense gap, as it was pointed out at the latest NA Annual Audit. The center is committed to eradicate its deep-rooted practice of making profit from drug price difference and reusing it as the center’s budget. However, some point out the center would eventually need significantly increased budget approved by the center’s affiliated government body, Ministry of Food and Drug Safety (MFDS) and Ministry of Economy and Finance (MOEF). On Nov. 6, NA Health and Welfare Committee lawmaker, In Jae-Keun’s office explained “KOEDC submitted a proposal to cease their ill practice of redirecting unfairly made profit”. By the end of the year, KOEDC plans to compile ‘Evidences for Drug Pricing Readjustment Application’, needed to remove profit from drug price differences. Until February next year, KOEDC is to initiate a negotiation with Health Insurance Review and Assessment Service (HIRA) on modifying drug pricing, and in March, it would execute a lump-sum reevaluation on drug price gap. The center claims it would be done with redirecting drug pricing gap profit to budget use after HIRA completes drug reimbursement listing procedure by December next year. Newly appointed KOEDC Chairperson Yun Young Mi is reportedly determined to eradicate unethical practice within the center and normalize its internal management. As a matter of fact, KOEDC has been under a criticism for last five year on re-utilizing 6.5 billion won, made from differences in orphan drug’s actual transaction price and National Health Insurance Service (NHIS) billing price, as the center’s budget. The center official explained the practice actually has been a solution to MFDS’ insufficient budget support rate of average 37 percent. Although the center has consistently confessed of abnormal use of drug price differences and urged MFDS to boost its budget support, KOEDC did not get any answer. So in the end, it is up to MFDS to allocate budget support for the center to ultimately resolve the budget redirecting practices, according to the plan submitted to the NA. Apparently, the center used drug price differences of about one billion won every year as their organizational operation expense. But after HIRA’s adjustment on the drug pricing, the center would lose budget of one billion won. However, it is not going to be an easy ride. KOEDC has already asked for next year’s budget of 14.03 billion won, but the government only passed about 17 percent of the requested amount, 2.39 billion won. The NA is already reviewing the government’s next year budget plan, but the Health and Welfare Committee’s ‘Budget and Accounting Evaluation Subcommittee’ and ‘Budget Deliberation Special Committee’ have not yet made a decision on whether or not to increase KOEDC’s budget. Even after the committees decide to increase the overall budget, the key to the problem is then passed to MFDS and MOEF’s decision to provide the center’s requested budget. KOEDC official said, “A number of lawmakers at the NA Health and Welfare Committee audit session demanded the government to work on the center’s drug price gap profit redirecting issue, insufficient budget and low government support funding rate. For the center to operate properly, the addressed issues have to be resolved completely, and it ultimately comes down to the matter of budget allocation. The center would do its best waiting for the NA make a decision.” “For now, Health and Welfare Committee is to request Budget Deliberation Special Committee to consider increasing budget for KOEDC basic operation expense, personnel expense, and regional center operation expense. As the center’s issue of redirecting profit from drug price difference has been addressed, the lawmakers have asked MFDS to submit a solution to KOEDC’s problems,” an official from Lawmaker In Jae-Keun’s office commented.
- Policy
- Eliquis faces 42 generics after patent invalidated
- by Lee, Tak-Sun Nov 10, 2019 10:00pm
- The list of generics launched in the New Oral Anticoagulant (NOAC) Eliquis (apixaban) market is getting longer by the day. Especially after generic manufacturing companies won the case invalidating Eliquis’ patent in last March, number of regulator-approved generics has skyrocketed. Ministry of Food and Drug Safety (MFDS) confirmed that the total number of MFDS-approved apixaban medicine products as of Nov. 6, including the original Eliquis by BMS, is 84 supplied by 42 companies. 19 companies supplying 38 items have been approved by the ministry after the patent was invalidated at a court decision. Daewoong Bio and GC Pharma are a few of latest additions. At the moment, 38 items by 19 companies are listed with reimbursement and competing in the same market. After winning the patent invalidation case, Chong Kun Dang, Alvogen Korea, Huons and Yuhan immediately applied for reimbursement listing and entered the market from last June. Other freeloading pharmaceutical companies did not participate in the patent litigation, but decided to launch their generics expecting the patent to be invalidated. More generics are projected to be released in the future based on the number of approved products. Currently, an appeal against the patent invalidation decision has been filed but is pending at the Supreme Court. But as generic companies won both first and second trials, the Supreme Court would likely to rule in favor of the generics. On Oct. 18, the Supreme Court dismissed a trial on a medicine patent invalidation case, finalizing the previous judiciary decision to invalidate the patent. In other words, the generics sales would not have any legal barrier against sales, when the Supreme Court decides to invalidate the medicine patent. As for apixaban market, even the preferential sales approval period on the patent challenger, banning sales of other equivalent generic, has passed already. Three items, including Yuhan Apixaban, were granted with preferential sales period from May 12, 2018, to Apr. 2, 2019, but their actual sales were suspended as BMS’ sales ban application was accepted. Sales ban injunction was lifted only after the Patent Court invalidated apixaban patent. Now the key is on how well generic companies would expand the trending NOAC market. Among all NOAC medicine, only Eliquis has generic competitors. As NOACs are mostly used in general hospitals, Korean generic companies are focusing on the clinic market instead. But it seems like it would take some time for NOAC generic market to fully flourish. Since its sales started from June, Chong Kun Dang’s Liquisia made disappointing sales of 178.35 million won (Source by UBIST) until September. Meanwhile, the original Eliquis reaffirmed its market leadership by making accumulated prescription sales of 31.3 billion won by September, hiking up 32.1 percent from the year before.
