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- 2026-04-29 14:23:45
- Policy
- ‘Hypertension·hyperlipidemia generics are pricier in KOR'
- by Lee, Jeong-Hwan Jun 26, 2024 05:46am
- According to a government study, generic drugs for some indications, such as those for the gastrointestinal system, hypertension, and hyperlipidemia, are more expensive in Korea than in major overseas countries other than the United States, such as the United Kingdom, Switzerland, and Japan. As of 2022, Korean generic hyperlipidemia drugs were more than 10 times more expensive than those in the UK and 3 times more expensive than those in Japan, while those for hypertension were 2 times more expensive than those in the UK and 3 times more expensive than those in Japan. Based on such findings, the study concluded that the government may directly reduce the price of hypertension and hyperlipidemia drugs with more than 20 generic listings. The researchers proposed the government consider a policy that collectively reduces the price of hypertension and hyperlipidemia drugs to 85% of the lowest price when 20 or more items are listed at the same time. In addition, it was suggested that the domestic generic drug price system should be converted to an indirect price reduction structure, in which the drug price is reduced when the number of listed items increases above a certain level. "Domestic generic drugs for gastrointestinal system-hypertension-hyperlipidemia are more expensive than in overseas" The Ministry of Health and Welfare compared the generic drug prices in South Korea with the "A8" countries (the United States, the United Kingdom, Germany, France, Japan, Italy, Canada, and Switzerland) for 323 ingredient-dose drugs that contain 160 ingredients in 5 efficacy groups Specifically, the study compared the Price-to-Consumer (PTC) price rather than the Price-to-Pharmacists (PTP) price as PTPs in countries abroad include pharmacy dispensing fees and are not comparable to domestic prices. When comparing the PTC price based on the buying power index, the A8 countries' drug price index in 2022 ranged between 0.52 to 0.86 and was lower than Korea's index except for diabetes drugs and antibiotics which were 1.66 times and 1.81 times higher, respectively. Excluding diabetes drugs and antibiotics, generics for gastrointestinal drugs, hypertension drugs, and hyperlipidemia drugs were about 14% to 48% more expensive in Korea than in the A8 countries. In particular, the study looked at the drug prices of the 7 individual countries other than the U.S., given that the U.S. has a relatively high drug price among the A8 countries. Results showed that generics in 3 out of 5 therapeutic classes in Canada were more expensive than in South Korea, while in Germany antibiotics, in Switzerland antibiotics, and UK gastrointestinal drugs and antibiotics were more expensive than in South Korea. Except for these, the price of hyperlipidemia drugs in most countries was 0.09 to 0.41 times less expensive than those in Korea. This means that hyperlipidemia drugs were priced at 9% to 41% of the price of the same in Korea. In addition, the ratio of original to generic drug prices was below 0.5 in most countries, whereas it was closer to 1 in Korea. "20 product criteria for differential pricing of generic drugs is adequate" The study analyzed the market share of the top products by drug market segment and found that the top 20 products accounted for more than 90% of the market in most cases, and 60% in the lowest cases, indicating that the top 20 products dominate the market. This means that the current threshold of 20 products set for differential pricing of generics is sufficient to motivate companies to enter the generic market and to maintain the generic market within an ingredient. In addition, the researchers added that the market share of the top 10 products ranges from 50% to 80%, which accounts for a significant portion of the market but is not considered sufficient to maintain the market. Therefore, according to market logic, the price of ingredients with multiple products should be allowed to be reduced, and policy mechanisms should be put in place to compensate for the market failure of ingredients that no longer enter the market. "For drugs that have 20 or more generics listed simultaneously, setting its price at 85% of the lowest drug price should be reviewed" The study concluded that the comparison of domestic generic prices with those of A8 countries showed price differences by drug class and ingredient and that there are limitations to applying a one-size-fits-all approach. Since the domestic generic drug price level is not unilaterally higher or lower than foreign countries across all efficacy groups and varies by efficacy group, the research diagnosed that the generic policy currently in place should be observed so it could show effect, then be reviewed again and modified. Nevertheless, in terms of maintaining the appropriateness of the generic drugs’ price level, the study suggested the government introduce price-reducing measures for multiple listed ingredients. In particular, the study pointed out that hypertension and hyperlipidemia drugs have many products listed and are expensive compared to foreign countries, so the price of items with more than 20 listed products can be directly reduced. The study suggested the government consider a policy that unilaterally reduces the price of hypertension and hyperlipidemia drugs to 85% of the lowest price when “20 or more products are listed at the same time.”
- Policy
- Fasenra·Idelvion, Ajovy·Emgality receive reimb in KOR
- by Lee, Jeong-Hwan Jun 25, 2024 05:47am
- AstraZeneca's severe eosinophilic asthma treatment Fasenra (benralizumab) and CSL Behring's hemophilia B drug Idelvion (albutrepenonacog alfa) will be reimbursed by the national health insurance starting on the 1st of next month. Also, the anti-malignant tumor agent rituximab (original brand name: MabThera) and the migraine drug Ajovy (fremanezumab) and Emgality(galcanezumab) will receive expanded reimbursement coverage. In addition, the reimbursement standards for psoriasis and macular degeneration treatments will be improved. The Ministry of Health and Welfare recently issued a pre-announcement of an administrative notice on the ’Partial Amendment of Details Regarding the Standards and Methods for Applying Medical Care Benefits (drugs)’ that contained the details stated above. The MOHW plans to collect opinions until the 25th and implement the amended standards from the 1st of next month. New reimbursement standards set for Fasenra·Idelvion Fasenra, a severe eosinophilic asthma drug that contains benralizumab, and Idelvion, a hemophilia B treatment that contains albutrepenonacog alfa, will be newly granted reimbursement in July. Fasenra will be granted reimbursement for use in adult patients with severe eosinophilic asthma who are not adequately controlled despite the use of high-dose inhaled corticosteroids-long-acting inhaled beta2-agonists (ICS-LABAs) and long-acting muscarinic antagonists (LAMA). More specifically, ▲ patients with a baseline blood eosinophil count of 300 cells/μL or greater and have experienced four or more acute asthma exacerbations requiring systemic corticosteroids within 12 months prior to treatment initiation, or received continuous use of oral corticosteroids at a dose equivalent to prednisolone 5 mg/day or greater for 6 months prior to starting treatment; or ▲patients with a blood eosinophil counts of 400 cells/㎕ or greater who have experienced 3 or more acute asthma exacerbations requiring systemic corticosteroids within 12 months prior to starting treatment, will be eligible for reimbursement. Patients will be evaluated every year before and after Fasenra’s use, and those who showed overall asthma control, such as ▲ those who showed a 50% or greater reduction in the frequency of acute asthma exacerbations from baseline, and ▲those requiring ongoing oral corticosteroid therapy who showed a 50% or greater reduction in the oral corticosteroid dose from baseline while improving or maintaining asthma symptom control, that submit a doctor’s note will be eligible for continued use of Fasenra with reimbursement. However, in patients for whom the drug’s effect is deemed insufficient based on clinical symptoms, the effectiveness of the treatment can be evaluated before one year. Patients who co-administer biological agents for severe asthma will not be granted reimbursement. Also, reimbursement will not be granted for patients switching between Nucala, Fasenra, and Cinqair, or switching from Fasenra to Xolair. However, patients switching to Fasenra after Xolair may be reimbursed on a case-by-case basis if the patient has been on Xolair for at least 3-6 months and is unable to continue taking Xolair due to inadequate efficacy, side effects, or the need to improve adherence. Such patients would need to submit a doctor’s note and satisfy the Fasenra reimbursement eligibility standards to receive reimbursement. Idelvion will be granted reimbursement as a routine prophylactic therapy for the control and prevention of bleeding, pre-and post-operative management, and reduction in the frequency of bleeding episodes in patients with hemophilia B, at 23 IU/kg (30 IU/kg in children) per dose. However, for patients with moderate or severe bleeding, up to 39 IU/kg (up to 50 IU/kg for children) may be reimbursable, based on the physician's medical judgment. For patients who need to be hospitalized but receive outpatient treatment and require dose escalation, their use of the increased dose can be reimbursed with the submission of a doctor’s note. In terms of dosing interval, up to 2 doses at the first visit and 1 dose (2 doses for severe patients) at the second visit every 4 weeks will be granted reimbursement, which totals to 3 doses every 4 weeks (up to 4 doses for severe patients with a coagulation factor activity of less than 1%). If the patient's condition is stable, up to a total of 3 doses per visit every 4 weeks (4 doses for severe patients) may be reimbursed at the doctor’s discretion, and if bleeding occurs after being administered 3 doses every 4 weeks (4 doses for severe patients), up to 1 dose per visit is granted reimbursement, and a doctor's note must be attached. If the dose is administered in the hospital, the administered dose is included in the calculation of the allowable number of reimbursed doses. Reimbursement expanded for Ajovy-Emgality Reimbursement for the migraine drugs Ajovy and Emgality had been previously limited to patients who had failed treatment with three or more migraine prevention drugs within one year, but the period limit has been lifted, expanding coverage. The anti-malignant tumor agent rituximab will additionally be reimbursable as maintenance therapy for patients with severe refractory pemphigus vulgaris and pemphigus foliaceus. Two doses of 500 mg/day every 6 months, 12 months after initiation will be granted reimbursement. In addition, the reimbursement exclusion phrase for macular degeneration treatments such as abatacept (original brand name: Eylea), brolucizumab (original brand name: Beovu), faricimab (original brand name: Vabysmo), and ranibizumab (original brand name: Lucentis) has been clarified. Also, the expected adverse events in the psoriasis-specific reimbursement standards for dimethyl fumarate (original brand name: Skilarence), guselkumab (original brand name: Tremfya), ixekizumab (original brand name: Taltz), Risankizumab (original brand name: Skyrizi), secukinumab (original brand name: Cosentyx), ustekinumab (original brand name: Stelara), adalimumab(original brand name: Humira), etanercept (original brand name: Enbrel), Infliximab (original brand name: Remicade) have been further specified.
- Policy
- LG Chem and Samsung Bioepis's biosimilars are reimbursed
- by Lee, Tak-Sun Jun 25, 2024 05:46am
- LG Chem and Samsung Bioepis’ biosimilar products will be listed for reimbursement in July. LG Chem is launching a biosimilar of the autoimmune disease treatment Humira, and Samsung Bioepis is launching a biosimilar of Stelara. Both are aiming to list at the lowest price to compete with their respective original products. According to industry sources on the 23rd, LG Chem's Humira biosimilar Xelenka Autoinjector Inj 40mg/0.4L and Xelenka Prefilled Syringe Inj 40mg/0.4mL will be listed at KRW 220,390 from month. Samsung Bioepis' Stelara biosimilars Epyztek Prefilled Inj and Epyztek Intravenous Inj will also be listed the same month at KRW 1,292,890 and KRW 1,355,393, respectively. These are the first Stelara biosimilars to be reimbursed in Korea. Humira is a TNF-a inhibitor used for 13 autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, ulcerative colitis, and adult Crohn's disease. The drug confirmed an effect in various diseases through its mechanism of action that inhibits TNF-α (tumor necrosis factor-alpha), which affects immune diseases. As of last year, its sales amounted to KRW 86.6 billion based on IQVIA. The domestic market for Humira biosimilars opened in earnest with Samsung Bioepis launching Adaloce with reimbursement in May 2021 and Celltrion launching Yuflyma in March 2022. According to IQVIA sales, Adaloce sold KRW 13.1 billion and Yuflyma sold KRW 1.8 billion last year. Sales of the biosimilars are fiercely chasing the original. LG Chem’s Xelenka was approved in December last year. It took 7 months for the drug to be listed for reimbursement after approval. Like other biosimilars, it is a high-concentration formulation that offers improved patient convenience. As a latecomer to the market, the company also paid attention to the price of Xelenka. Currently, for the 40mg/0.4mL dose, the original Humira is priced at KRW 280,891, and the biosimilars Adaloce and Yuflyma at KRW 248,877. LG Chem’s Xelenka is priced lower than these and will be listed at KRW 223,900. It is about KRW 20,000 cheaper than other biosimilars and KRW 60,000 cheaper than the original. Samsung Bioepis, the first company to introduce a Stelara biosimilar, also significantly reduced its product’s price from the estimated price. While biosimilars are usually priced at 80 percent of the original, Samsung Bioepis’s product will be listed at 50 to 60% of the original price. Stelara Prefilled Syringe Inj is priced at KRW 2,182,000, while Epyztek Prefilled Inj is priced at about KRW 900,000 cheaper at KRW 1,298,290. Also, when comparing the IV injection versions, Stelara IV Inj is priced at KRW 2,261,500, compared with EpyztekIV, which is priced at KRW 1,345,593. Stelara generated sales of KRW 47.4 billion last year based on IQVIA. Stelara is indicated and reimbursed for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older, active psoriatic arthritis in adults, active Crohn's disease in adults, and moderate-to-severe ulcerative colitis in adults. Following Samsung Bioepis’s footsteps, Celltrion received approval for Steqeyma PFS on March 12. Samsung Bioepis is believed to have adopted a lowest-price strategy to occupy the market before Celltrion's product is listed. Biosimilars are products approved after demonstrating equivalence and effectiveness to the original product. As biosimilar companies sell their products at a significantly reduced price compared with the original product, the financial burden borne by patients is greatly reduced upon the introduction of biosimilars.
- Policy
- Combinatory drugs with linagliptin+dapagliflozin
- by Lee, Tak-Sun Jun 25, 2024 05:46am
- Following the patent expiration of DPP-4 inhibitor Trajenta (linagliptin), combinatory drugs containing linagliptin have been released. Next month, a combinatory drug containing linagliptin combined with SGLT-2 inhibitory dapagliflozin will enter the market. It is a combinatory drug with a new combination being introduced in South Korea. According to the industry sources on June 24th, Aju Pharm’s 'Dapalina Tab,' containing dapagliflozin propanediol hydrate combined with linagliptin, will be listed for reimbursement on July 1st. It is a combinatory drug with a new combination of SGLT-2 inhibitory dapagliflozin with DPP-4 inhibitor linagliptin. The Ministry of Food and Drug Safety (MFDS) categorized Dapalina Tab as an incrementally modified drug (IMD). Therefore, Dapalina Tab’s drug price was credited 59.5% instead of an adjusted amount of 53.55% for a year. Aju Pharm’s Dapalina Tab will be priced KRW 883 per tablet. However, companies receiving CMO products from Aju Pharm have not received IMD approvals. Therefore, the drug prices were calculated based on adjusted amounts. This has affected the prices of drugs such as Hutex Korea Pharmaceutical’s Traxiga Tab 10/5 mg, Boyung’s Trudapa L Tab 10/5 mg, Whan In Pharm’s Posarina Tab 10/5mg, Hanlim Pharm’s Daparo L Tab 10/5 mg, Ilhwa’s Posijenta Tab, GC Biopharma’s Linadapa G Tab, and HK inno. N’s Dapa N Jenta Tab 10/5mg. The prices of these drugs were calculated as KRW 795 per tablet. According to Aju Pharm, phase 3 trials of Dapalina Tab were conducted in 30 university hospitals in South Korea. The results showed a 0.88% reduction in HbA1c at 24 weeks compared to the placebo group (MET+linagliptin). There were no significant differences in drug-related adverse reactions observed. Combinatory drugs containing SGLT-2 inhibitor and DPP-4 inhibitor have been released after the reimbursement criteria for these drugs were established in April of last year. The Ministry of Health and Welfare (MOHW) approves reimbursement of prescriptions for combinations of these two classes of drugs with metformin. Drugs with SLGT-2 inhibitory and DPP-4 inhibitory mechanisms of action are commonly used to treat diabetes. Due to the complementary mechanisms of the two drugs, a combinatory drug is expected to have a superior effect on regulatory blood glucose levels. After the patent expiration of SGLT-2 inhibitor Forxiga (dapagliflozin propanediol hydrate) in April of last year and DPP-4 inhibitor Januvia (sitagliptin phosphate hydrate), pharmaceutical companies in South Korea have launched combinatory drugs containing Forxiga and Januvia. As the patent for DPP-4 inhibitor Trajenta (linagliptin) expires this month, combinatory drugs containing linagliptin will be introduced.
- Policy
- Will GMP One-strike-out be loosened?...MFDS, 'negative'
- by Lee, Hye-Kyung Jun 24, 2024 05:47am
- While pharmaceutical companies advocate for loosening the 'Cancellation of the GMP compliance decision' act, the Ministry of Food and Drug Safety (MFDS) says it will start a discussion once it receives an official submission of opinions. This is in response to biopharmaceutical companies’ submission of a statement last month regarding the necessity of improving the 'Cancellation of the GMP compliance decision' act. The groups have continuously voiced concerns over the policy. According to industry sources on June 24th, the MFDS’ GMP One strike-out was applied to Korea Syntex Pharmaceutical earlier this year, following Hutecs Korea Pharmaceutical at the end of last year. After the court suspended execution due to administrative claims, opinions were gathered to rediscuss the policy. “We are open to meeting regarding the issue,” Kim Sang Bong, Director of the Pharmaceutical Safety Bureau, said. “To our knowledge, there is an official committee within the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), and we would like them to submit an official statement of opinions.” According to a statement from biopharmaceutical companies, if non-compliance with GMP has been unintentional, a different set of measures should be applied instead of one strike-out. "The National Assembly legislation has enacted a policy for the cancellation of the GMP compliance decision,” Kim said. “As this policy is not part of the MFDS’ administrative rules, MFDS is simply carrying out the legislative body’s policy.” As a result, even if companies request that the policy be loosened within the law, MFDS has nothing to offer because it is a regulatory agency. “We acknowledge that the pharmaceutical industry regards the one-strike-out policy as a significant issue, we are open to meeting when they request discussion through the Quality Committee,” Kim said. “When there is an agenda, we will visit the KPBMA for a discussion.” On December 11, 2022, the MFDS initiated a GMP one-strike-out act. According to this act, when a company is found to violate the Good Manufacturing Practices (GMP) for medicinal products, such as falsely receiving GMP approvals or falsely documenting GMP repeatedly, their GMP compliance approval may be revoked. Hutecs Korea Pharmaceutical was the first target of this act and received a disposition, and their plant was suspended and then re-opened after the suspension of execution. Korea Syntex Pharmaceutical was in the process of canceling the GMP compliance decision, but it has been put on hold. Dongkoo Bio&pharma is expected to be the third target for canceling the GMP compliance decision. An official from the MFDS said, “In general, the details of disposition are posted through the website, and we cannot provide answers to a matter under review.” “We have released the first case details of Hutecs Korea Pharmaceutical through a press release to inform the industry of GMP adherence. We reviewed the scope of the disposition and criteria,” an official added. The MFDS states that apart from Hutecs Korea Pharmaceutical, other companies that receive the cancellation will not be disclosed when there is a suspension of the act through trials. Once the cancellation is confirmed, it will be posted on the website.
- Policy
- Price of BI’s diabetes drug Trajenta is cut 30% from July
- by Lee, Tak-Sun Jun 24, 2024 05:46am
- Price of Boehringer Ingelheim’s flagship diabetes drugs ‘Trajenta’ and ‘Jardiance’ will both be cut in July. Trajenta will receive an ex officio price cut due to the entry of its generic while Jardiance will see a price cut after completing price-volume agreement (PVA) negotiations. According to industry sources on the 21st, the insurance ceiling price of Boehringer Ingelheim’s diabetes drug brands Trajenta and Jardiance will be adjusted as of July 1st. Trajenta is a DPP-4 (dipeptidyl peptidase-4) inhibitor class, and Jardiance is an SGLT-2 (sodium-glucose co-transporter 2) inhibitor for diabetes. Based on UBIST, Trajenta generated KRW 61.3 billion in outpatient prescriptions, and Trajenta Duo, which is a combination of Trajenta and metformin, generated KRW 62.1 billion. In the same period, Jardiance generated outpatient sales of KRW 58.1 billion. The two are leading products in the diabetes drug market. Trajenta’s drug price cut is being made ex officio with its generic versions being listed for reimbursement from the 9th. 15 single-agent Trajenta generics and 108 combination Trajenta Duo generics are currently listed. As a result, the price of the single-agent Trajenta Tab will be reduced 30% from KRW 750 to KRW 525. In addition, the price of the 3 combination Trajenta Duo Tab products will be reduced from KRW 387 to KRW 338 for the 2.5/500mg and 2.5/850mg dose (12.7%p price cut), and to KRW 344 for the 2.5/1000 mg (11.1%p price cut) dose. Jardiance’s price ceiling was adjusted under Type B of the Price-Volume Agreement. Type B negotiations are initiated when a product’s insurance claims amount increases by more than 60% from the previous year, or when the product’s claims amount increases by more than 10% and the amount exceeds KRW 5 billion. Accordingly, the price of Jardiance Tab 10mg will be reduced from KRW 650 to KRW 618 and Jardiance Tab 25mg will be reduced from KRW 839 to KRW 798. The price reduction rate is 4.9% each. Jardiance is the only foreign SGLT-2 inhibitor class brand being used in Korea. Other SGLT-2 inhibitor class single agent drugs from abroad such as Forxiga, Steglatro, and Suglat withdrew from the Korean market. Among domestic brands, Daewoong Pharmaceutical's ‘Envlo Tab’ is available as an SGLT-2 inhibitor class drug.
- Policy
- Low-dose 'nicergoline' is increasingly becoming available
- by Lee, Hye-Kyung Jun 21, 2024 05:47am
- Il Dong’s Sermion, the original drug containing nicergoline. Old drugs containing the active ingredient 'nicergoline' are on the rise for substituting 'choline alfoscerate,' which is under reassessment of clinical and reimbursement. The lower doses are also being approved. Previously, companies mostly received approvals for items containing 30 mg doses, which obtained indications for the first-line treatment of symptoms associated with dementia. However, Hanmi Pharm, Chong Kun Dang Pharm, and Whan In Pharm have also secured 10 mg doses, following in the footsteps of the original 'Sermion' by Il Dong. According to the Ministry of Food and Drug Safety (MFDS), Whan In Pharm received approval for its 'Niceon Tab 10 mg' on June 19th. Low-dose items containing 5 mg and 10 mg nicergoline have the efficacy and effectiveness in ▲ improving cerebral infarction cerebral circulation ▲ migraine in elderly associated with arteriosclerosis ▲ adjuvant therapy for high blood pressure. For adults, 5-10 mg of these drugs can be taken orally 2-3 times per day, before each meal. After Il Dong Pharm received approval for 'Sermion Tab 10 mg' in 1986, the second approval came 27 years later with Hanmi Pharm’s 'Nicegoline Tab 10 mg.' In January of last year, Hanmi Pharm obtained approval for two doses of nicergoline: 10 mg and 30 mg. After that, pharmaceutical companies considered nicergoline as a potential substitute for choline alfoscerate and began releasing products containing 30 mg doses. There are now 35 products approved as nicergoline 30 mg, and 26 products simultaneously became reimbursed last month. Nicergoline is an antagonist of alpha-1 adrenoreceptors, leading to the dilation of blood vessels and increased artery blood flow. It then improves neurotransmitter functions, inhibits platelet aggregation, and increases metabolic activities. According to the market research firm QYResearch Korea, the global market size for nicergoline will likely grow by 16.6% annually on average, reaching US$2.35 billion (approximately KRW 3.14 trillion) by 2029.
- Policy
- DLBCL treatment Epkinly is approved in Korea
- by Lee, Hye-Kyung Jun 21, 2024 05:47am
- The Ministry of Food and Drug Safety(Minister: Yu-Kyoung Oh) announced that it had approved the orphan drug 'Epkinly (epcoritamab)' that is being imported by Abbvie Korea on the 20th. Epkinly is a bispecific monoclonal antibody that binds to both the CD3 on the surface of T-cells and CD20 on the surface of B-cells and is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after 2 or more lines of systemic therapy. As one of the most common blood cancers, DLBCL is a type of non-Hodgkin's lymphoma it spreads out over a large area (diffuse) and is characterized by its rapid progression. Epcoritamab binds to CD3 to activate T cells and binds to CD20 to bring B cells to the side of activated T cells and induce T-cell–mediated killing of CD20+ malignant B cells. The MFDS said, “We expect Epkinly’s approval to prove new treatment opportunities to patients with relapsed or refractory DLBCL who have received two or more prior therapies. We will continue to build on our regulatory science expertise to ensure that new therapies are promptly supplied to expand treatment opportunities for patients with rare and intractable diseases.”
- Policy
- When will 'Paxlovid' become reimbursable?
- by Lee, Tak-Sun Jun 20, 2024 05:48am
- Pfizer The review of 'Paxlovid (nirmatrelvir‧ritonavir, Pfizer),' a COVID-19 drug, for reimbursement has been prolonged. It has been over eight months since the submission of the reimbursement application last October, yet it has not been considered for the Drug Reimbursement Evaluation Committee (DREC) review. Because the Paxlovid free-of-charge program ended in May and is now available with co-payment, there are postulations that this has caused delays in the reimbursement listing. The Paxlovid item was not considered for review during the 6th meeting for 2024 of the DREC of the Health Insurance Review and Assessment Service (HIRA), held on June 13th. The drug reimbursement application for Paxlovid was submitted in early October of last year. After that, HIRA initiated the reimbursement review, including seeking academic opinions. The government and Pfizer expected a reimbursement decision to be made within the first half of the year. However, since the item was not considered for the DREC review in June, it is unlikely to become reimbursable in July. Pfizer Korea, the distributor of Paxlovid, submitted a response letter to HIRA five times. However, HIRA appears to have requested additional supplementary documents. The industry postulates that the two parties have different opinions about setting the drug pricing. The free-of-charge program has ended, and Paxlovid is now available through co-payment. Patients are required to pay KRW 50,000, which is approximately 5% of the drug price, for the drug. However, it is still provided free of charge for medical reimbursement benefit recipients and those eligible for co-payment reduction due to having the second-lowest income. Since the free-of-charge program ended, the government has been under less financial burden. Analysis suggests that this may have reduced the need for the government to quickly make Paxlovid reimbursable. Furthermore, with the co-payment for the drug, there may be a decrease in its usage. Additionally, if Pfizer continues to advocate high drug pricing, the reimbursement listing process may take much longer. However, the demand for COVID-19 treatment remains high due to its ongoing occurrence and the spread of COVID-19 variants. Experts say that Paxlovid should become reimbursable shortly to lessen patient burden and improve treatment access. Meanwhile, researchers at Stanford University disclosed that a 15-day course of Paxlovid did not provide relief for 'long COVID' symptoms. In a study conducted for 15 weeks enrolling 155 patients with long COVID who have not recovered from COVID-19 for over 16 months on average, Paxlovid treated for 15 days did not significantly improve symptoms, including fatigue, difficulty breathing, feeling sick, stomach aches, and heart symptoms, compared to placebo. However, researchers additionally demonstrated that taking Paxlovid, which is a 5-day course of treatment, for 15 days is safe.
- Policy
- 'Approvals-Reimbursement Reviews-Price Negotiations' pilot
- by Lee, Hye-Kyung Jun 20, 2024 05:48am
- The government is preparing to commence “The 2nd Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations” The pilot system is intended to concurrently process applications to the Ministry of Food and Drug Safety (MFDS), reimbursement assessment, and drug price negotiations. Following the first pilot program last year, the government initiated a demand survey to commence the second pilot program in the second half of the year. According to the industry sources on June 19th, the Ministry of Health and Welfare (MOHW)’s Pharmaceutical Benefits is conducting a demand survey for drugs to participate in the second approval-assessment-negotiations pilot program. This program aims to improve patient access to treatments for severe diseases and strengthen reimbursement management. “The 2nd Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations” in preparation. The 'approval-assessment package system' is now in effect to strengthen patient access to reimbursable treatments. This system has been designed to handle the marketing approval from the MFDS and reimbursement appropriateness assessment of HIRA at the same time. By expediting the drug price negotiations stage, the goal is to shorten the time it takes for the entire process, ensuring prompt drug reimbursement. The drug can be applied to HIRA’s insurance listing after receiving marketing approval by passing the safety and efficacy review from the MFDS. The course of the process is that once a reimbursement appropriateness decision is made and selected as a drug price negotiation or reimbursable drug, the drug can be reimbursable. The approval-assessment-negotiation packages will handle all three tracks simultaneously. Drugs that are eligible for approval-assessment-negotiation packages must meet the following conditions. For a drug to be considered for the second pilot program, ▲The drug must be eligible for approval and decision application by the end of June next year. ▲It should be a drug intended for treating life-threatening diseases (with a life expectancy of less than 1 year) or rare diseases with sufficient efficacy. ▲The drug must demonstrate clinically significant improvements in efficacy compared to existing treatments or be for conditions without current treatments. ▲It must meet the prerequisites for designation under the MFDS's Expedited Review and Approval (GIFT) program or be eligible for application. Required documents must include the planned date of application for approval, product name, ingredients, classification, indication, approval alignment (domestic/foreign), drug pricing application system, life expectancy, 5-year survival rate, clinical stage, presence of placebo, reimbursement status in South Korea for placebo, evaluation criteria, substitute drug, current treatment, degree of improvement, and number of subjects. Additionally, the document must include the estimated per capita and overall estimated financial requirements, excluded country reimbursement evaluation results, number of countries where pricing is listed, names of countries where pricing is listed, and company name. This document will be used as a reference for selecting drugs for the pilot program. The registration deadline is August 12th, and the documents can be submitted to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA). Meanwhile, two items of treatments for pediatric rare diseases have been designated for the first pilot system and are under assessment for approval, reimbursement assessment, and drug pricing negotiations simultaneously.
