The National Drug Formulary Listing Process for Orphan Drugs in South Korea: narrative review focused on pricing and reimbursement pathways

This study aimed to analyze four current pathways affecting the listing and post-listing prices of new orphan drugs (ODs) in South Korea. These mechanisms were: (1) essential OD, (2) pharmacoeconomic evaluation (PE) waiver OD, (3) weighted average price OD, and (4) PE OD. We analyzed the ratio of the listing price of 48 new ODs to the average adjusted price (AAP) of seven advanced countries and examined the change in the post-listing price. Descriptive statistics were used to analyze the listing and post-listing price changes. The mean and median ratios of the listing price of total new OD to AAP were calculated to be 69.4% and 65.4%, respectively. Essential OD showed the highest mean (93.8%) and median (80.8%) ratios. The mean cumulative price discount rate of the new OD was 7.2% in the third year and 5.7% in the fifth year. The rarity of diseases impacts the listing price of OD, but the political effects of the benefits of OD on the post-listing price of these drugs could not be verified. Further research should be conducted to develop measures that facilitate the practical sharing of budget risks and increase patient access to new ODs.

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Review of Insulin Listing in the National Drug Formulary of Malaysia

Value in Health ◽

10.1016/j.jval.2016.09.1927 ◽

2016 ◽

Vol 19 (7) ◽

pp. A682

Author(s):

YV Yong ◽

WS Kua ◽

R Lajis ◽

FA Md Yusof

Keyword(s):

Drug Formulary ◽

National Drug

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VP74 Orphan Black Box: Explanatory Principles

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462319003295 ◽

2019 ◽

Vol 35 (S1) ◽

pp. 92-93

Author(s):

George Wang ◽

Richard Macaulay

Keyword(s):

Market Access ◽

Economic Value ◽

Orphan Drugs ◽

Regulatory Approval ◽

Marketing Authorization ◽

European Medicines Agency ◽

Reimbursement Mechanisms ◽

Regulatory Pathways ◽

Small Patient ◽

Pricing And Reimbursement

IntroductionOrphan legislations over the past thirty years have successfully increased the number of drugs receiving marketing authorization for rare diseases. However, for a therapy to be accessible to most patients, it requires not only marketing authorization, but market access via public reimbursement. In many major markets, the pricing and reimbursement of new therapies is based on an assessment by a national Health Technology Assessment (HTA) body, for which economic value is typically a key consideration. This research evaluates the outcome of HTAs of orphan drugs in Europe.MethodsHTA decision data (to 31/08/2017) was extracted from Gemeinsame Bundesausschuss (G-BA), Haute Autorité de Santé (HAS), National Institute for Health and Care Excellence (NICE), Pharmaceutical Benefits Advisory Committee (PBAC), and Scottish Medicines Consortium (SMC) websites. EC-approval data was extracted from the European Medicines Agency (to 31/08/2017).ResultsOnly a small minority of drugs for orphan diseases received full recommendations for their licensed indication(s) by NICE (3/35, 9%), SMC (8/66, 12%) and PBAC (1/44, 2%). 37% (26/70) of drugs assessed received positive HTA outcome by HAS (ASMR I-III). In Germany, all approved orphan drugs (100/100) received automatic additional benefit post regulatory approval by G-BA.ConclusionsThere have been significant challenges for manufacturers in converting regulatory approval of orphan drugs into commercial success and optimised market access. Attaining positive HTA appraisals for these drugs, which have been approved under expedited regulatory pathways on a less than fully mature dataset, whilst also having high prices, due to small patient populations, limiting commercial returns, may necessitate increased utilisation of alternative reimbursement mechanisms.

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The Economic Impact of Introducing Serotonin-Noradrenaline Reuptake Inhibitors into the Brazilian National Drug Formulary

PharmacoEconomics ◽

10.2165/00019053-200725110-00007 ◽

2007 ◽

Vol 25 (11) ◽

pp. 979-990 ◽

Cited By ~ 8

Author(s):

Márcio Machado ◽

Michael Iskedjian ◽

Inés A Ruiz ◽

Thomas R Einarson

Keyword(s):

Economic Impact ◽

Drug Formulary ◽

Noradrenaline Reuptake ◽

National Drug

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National Drug Formulary of the Ministry of Health in Saudi Arabia

Pharmacology Toxicology and Biomedical Reports ◽

10.5530/ptb.2018.4.10 ◽

2019 ◽

Vol 4 (3) ◽

pp. 28-30

Author(s):

Yousef Ahmed Alomi ◽

Saeed Jamaan Alghamdi ◽

Radi Abdullah Alattyh

Keyword(s):

Saudi Arabia ◽

Drug Formulary ◽

Ministry Of Health ◽

National Drug

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Preparation of Nifedipine Push-Pull Osmotic Pump Tablets

VNU Journal of Science Medical and Pharmaceutical Sciences ◽

10.25073/2588-1132/vnumps.4284 ◽

2020 ◽

Vol 36 (4) ◽

Author(s):

Tran Quang Trung ◽

Nguyen Thi Dao ◽

Nguyen Thanh Hai ◽

Trinh Van Lau

Keyword(s):

Drug Delivery ◽

Extended Release ◽

Oral Drug Delivery ◽

The United States ◽

Osmotic Pump ◽

Oral Drug ◽

Drug Formulary ◽

National Drug ◽

Osmotic Agent ◽

Formulation Factors

This study aims to investigate the influence of the formulation factors on the drug release kinetics, thereby selecting the compositions of extended-release nifedipine tablet based on the similarity coefficient f2 obtained when compared with Adalat LA tablet. The formulation factors such as: molecular weight of the polyethylene oxide (PEO) and osmotic agent amount in drug layer and push layer, semi permeable membrane thickness (estimated by coating weight gain), orifice size, type of plasticizers and ratios of coating polymer to plasticizer in semipermeable membrane were evaluated. It was found that developed tablets were able to deliver nifedipine in an approximate zero-order manner up to 20 hours and drug release profile of developed tablets was similar to that from Adalat LA tablets. The developed tablet contained: PEO N10, PEO 303 in drug layer and push layer, respectively; percentages of osmotic agent in drug layer and push layer were 10% and 30%, respectively; weight gain of semipermeable coating was 12%; and orifice size was 0.8 mm. Keywords Nifedipine, GPKD, push-pull osmotic pump, PEO, Tlag. References [1] Vietnamese National Drug Formulary Council, Nifedipine, Vietnamese National Drug Formulary, 2nd edition, Medical Publising House, Hanoi, 2018, pp. 1056-1058 (in Vietnamese).[2] A. Nokhodchi, M.N. Momin, J. Shokri, et al., Factors affecting the release of nifedipine from a swellable elementary osmotic pump, Drug Delivery, 15 (1) (2008) 43-48. https://doi.org/10.1080/10717540701829028[3] R.K. Verma, D.M. Krishna, S. Garg, Formulation aspects in the development of osmotically controlled oral drug delivery systems, Journal of controlled release 79 (1-3) (2002) 7-27. https://doi.org/10.1016/s0168-3659(01)00550-8.[4] The United States Pharmacopeial Convention, Nifedipine Extended-Release Tablets, The United States Pharmacopeia, 41st edition, United Book Press, Baltimore, 2018, pp. 2938 - 2944.[5] V. Malaterre, J. Ogorka, N. Loggia, et al., Approach to design push–pull osmotic pumps, International Journal of Pharmaceutics 376 (1–2) (2009) 56-62. http://dx.doi.org/10.1016/j.ijpharm.2009.04.015.[6] S. Missaghi, P. Patel P, Farrell T. P., et al., Investigation of critical core formulation and process parameters for osmotic pump oral drug delivery, AAPS PharmSciTech 15 (1) (2014) 149-160. http://doi.org/10.1208/s12249-013-0040-4.[7] V. Malaterre, H. Metz, J. Ogorka , et al., Benchtop-magnetic resonance imaging (BT-MRI) characterization of push-pull osmotic controlled release systems, J Control Release 133 (1) (2009) 31-36. http://doi.org/10.1016/j.jconrel.2008.09.007.[8] Z. Zhang, W. Li, S. Nie, et al., Overcome side identification in PPOP by making orifices on both layers, International journal of pharmaceutics 371 (1-2) (2009) 1-7. http://dx.doi.org/10.1016/j.ijpharm.2008.12.006[9] C. Wu, Z. Zhao, Y. Zhao, et al., Preparation of a push–pull osmotic pump of felodipine solubilized by mesoporous silica nanoparticles with a core–shell structure, International Journal of Pharmaceutics,475 (1-2) (2014) 298 - 305 . http://dx.doi.org/10.1016/j.ijpharm.2014.08.033.[10] V. Patel, A. Chudasama, M. Nivsarkar, et al., Push-pull osmotic pump for zero order delivery of lithium carbonate: Development and in vitro characterization, Pharmaceutical development and technology, 17 (3) (2012) 375-382. http://doi.org/10.3109/10837450.2010.542577.[11] C.N. Patra, S. Swain, J. Sruti, et al., Osmotic drug delivery systems: Basics and design approaches, Recent Patents on Drug Delivery & Formulation 7(2) (2013) 1 - 12. http://doi.org/10.2174/1872211311307020007.

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The current status of chronic obstructive pulmonary disease awareness, treatments, and plans for improvement in South Korea: a narrative review

Journal of Thoracic Disease ◽

10.21037/jtd-21-172 ◽

2021 ◽

Vol 13 (6) ◽

pp. 3898-3906

Author(s):

Yong Bum Park ◽

Kwang Ha Yoo

Keyword(s):

Chronic Obstructive Pulmonary Disease ◽

South Korea ◽

Pulmonary Disease ◽

Narrative Review ◽

Current Status ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Disease Awareness

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How can we improve patients’ access to new drugs under uncertainties? : South Korea’s experience with risk sharing arrangements

BMC Health Services Research ◽

10.1186/s12913-021-06919-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Boram Lee ◽

Eun-Young Bae ◽

SeungJin Bae ◽

Hyun-Jin Choi ◽

Kyung-Bok Son ◽

...

Keyword(s):

South Korea ◽

Risk Sharing ◽

Pharmaceutical Expenditure ◽

Developed Countries ◽

Orphan Drugs ◽

Drug Coverage ◽

New Drugs ◽

Current Status ◽

Time Gap ◽

The Uk

Abstract Background New drugs including cancer drugs and orphan drugs are becoming increasingly more expensive. Risk sharing arrangements (RSAs) could manage the risk based on both financial impact and the health outcome of new drugs if reimbursed. To improve patients’ access to new drugs under uncertainties, many developed countries have adopted RSAs. In this study, we aimed to understand the effects of RSAs in South Korea on patients’ access. Methods We reviewed current status of RSA drugs in South Korea. The number of appraisals and time gap between market approval and reimbursement per RSA drug were considered to quantify improvement of patients’ access as they showed how rapidly decisions on reimbursement of RSA drugs were derived. Then, we applied a comparative analysis to determine whether the RSA drugs in South Korea were reimbursed in the UK, Italy, and Australia. Most data for this study were obtained from websites of the governmental department/agencies responsible for appraisal of drug reimbursement in each country. And literatures related to RSAs were investigated as well. Results The eligibility for Korean RSAs had two key components - drugs for cancer and rare diseases and not having other alternative treatments. As of the first half of 2019, there were 39 RSA drugs reimbursed in South Korea, the majority of which were financial-based schemes. Refund and expenditure cap were the representative types (89.7%). After introduction of RSAs, the time gap and number of appraisals were decreased. Based on the indications of RSA drugs, the level of drug coverage in South Korea was found lower than Italy, similar to the UK, and higher than Australia. Conclusions RSAs in South Korea significantly enhanced patients’ access to new drugs and led to the alleviation of patients’ out-of-pocket expenses. The drug coverage of South Korea had a level comparable to that of other countries. This study provides implications for countries that have a dual mission of containing pharmaceutical expenditure and improving access to new drugs.

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