Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System

Yoo, Seung‐Hyun; Kim, Dae Jung; Lee, Seung-Mi; Kang, Won-Gu; Kim, Sang Yoon; Lee, Jong Hyuk; Suh, Dong‐Churl

doi:10.3390/ijerph16020288

Cited by 30 publications

(31 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The Korean government implemented a risk-sharing agreement, which is only applicable to anticancer drugs and orphan drugs that lack alternatives, to improve patient access to new drugs since December 2013. However, only 33 drugs have been listed under the risk-sharing agreement; 32 drugs were contracted with finance-based agreements such as refunds or expenditure caps, and one drug was contracted with a performance-based agreement [ 42 ].…”

Section: Discussionmentioning

confidence: 99%

International Price Comparisons of Anticancer Drugs: A Scheme for Improving Patient Accessibility

Jung

Kim

Suh

et al. 2021

IJERPH

Self Cite

View full text Add to dashboard Cite

Background: The demand for implementing a new listing scheme to expedite patient access to novel oncology drugs has increased in South Korea. This study was conducted to compare the prices of anticancer drugs between eight countries and to explore the feasibility of a ‘pre-listing and post-evaluation’ scheme to expedite patient access to oncology drugs. Methods: This study included 34 anticancer drugs, which were reimbursed between 1 January 2007 and 31 December 2017. The unit price and sales volume of the study drugs were collected from eight countries and IQVIA data, respectively. The prices were adjusted to estimate the ex-factory prices using the discount/rebate rate suggested by the Health Insurance Review Agency (HIRA). The four price indices of Laspeyres, Paasche, Fisher, and the unweighted index were calculated using the price in each country, the average price, and lowest price among the study countries. Each currency was converted using the currency exchange rate and purchasing power parity (PPP). The budget impact of implementing the proposed pre-listing and post-evaluation scheme on payers was calculated. Results: Based on the currency exchange rate, anticancer drug prices were higher in other countries (index range: 1.05–2.78) compared to Korea. The prices in Korea were similar to countries with the lowest prices. When the PPP was applied, prices were higher in the US, Germany, Italy, and Japan than in Korea (range: 1.10–2.13); however, the prices were lower in the UK, France, and Switzerland than in Korea (range: 0.72–0.99). The financial burden of implementing the pre-listing and post-evaluation scheme was calculated at 0.83% of the total anticancer drug sales value in Korea from 2013–2017. Conclusions: The prices of anticancer drugs in Korea were similar to the lowest prices among the seven other study countries. A pre-listing and post-evaluation scheme should be considered to improve patient access to novel anticancer drugs by reducing the reimbursement review time and uncertainties.

show abstract

Section: Discussionmentioning

confidence: 99%

International Price Comparisons of Anticancer Drugs: A Scheme for Improving Patient Accessibility

Jung

Kim

Suh

et al. 2021

IJERPH

Self Cite

View full text Add to dashboard Cite

show abstract

“…For biologics, market growth after patent expiration was 4.0% in the first year and remained the same thereafter due to the lack of biosimilar sales data for proxy cases. In addition, the impact of the confidential rebate magnitude of originators, which contracted with the risk-sharing scheme, on the robustness of budget savings was analyzed by assuming a 25% rebate [ 20 ].…”

Section: Methodsmentioning

confidence: 99%

Use of budget savings from patent expiration of cancer drugs to improve affordability and accessibility

Lee

Kim

Suh

et al. 2021

BMC Health Serv Res

Self Cite

View full text Add to dashboard Cite

Background The introduction of generics after the loss of patent exclusivity plays a major role in budget savings by significantly decreasing drug prices. The aims of this study were to estimate the budget savings from off-patent cancer drugs in 2020–2024 and to inform decision makers on how these savings could be used to improve the affordability of innovative cancer treatments in South Korea. Methods A model was developed to calculate budget savings from off-patent cancer drug use in Korea over 5 years (2020–2024). Cancer drugs with one or more valid patents that expire between 2020 and 2024 in Korea were selected. Key input parameters in the model included market share of generics, market growth, and prices of originators and generics. To reflect market dynamics after patent expiration, the trends of the off-patent market were estimated using historical sales volume data of IQVIA from 2012 to 2018. The study assumed that the prices of off-patent drugs decreased according to the price regulations set by the Korean government and that the off-patent market sales volume did not grow. Sensitivity analyses were performed to investigate the uncertainty in model input parameters. Results A total of 24 cancer drugs which met selection criteria were identified. In the base case analysis, patent expiration of cancer drugs between 2020 and 2024 could lead to a spending reduction of ₩234,429 million ($203 million), which was 20% of the cancer drug expenditure in the 5-year period. The savings ranged from ₩157,633 million ($136 million) to ₩434,523 million ($376 million) depending on the scenarios in sensitivity analyses. Conclusions The findings indicate that patent loss of cancer drugs could lead to a 20% reduction in spending on cancer drugs over the next 5 years in South Korea. The savings could be used to improve the affordability of innovative, advanced cancer drugs for 94,000 cancer patients by reallocating the budget savings from patent expiration.

show abstract

“…The determination of reimbursement is based on the price in seven countries (the so-called A7 countries: USA, Japan, Germany, France, Switzerland, UK, and Italy) as the external reference price without cost-effectiveness verification (without CE pathway). In this case, RSA may be applied to spread financial risk related to uncertain clinical usefulness and budget impact [30,31].…”

Section: New Drug Pricing and Reimbursement Review System In South Koreamentioning

confidence: 99%

Price-Cutting Trends in New Drugs after Listing in South Korea: The Effect of the Reimbursement Review Pathway on Price Reduction

Kim¹,

Lee

2020

Healthcare

View full text Add to dashboard Cite

This study aims to analyze the trends of post-listing price changes for new drugs listed from 2007, when the health technology assessment (HTA) was introduced in South Korea, until 2017. We analyzed 135 products that have undergone price cuts. These products were analyzed by their respective review pathways, namely, pharmaco-economic study (PE), weighted average price (WAP), and the without a cost-effectiveness (CE) pathway. Prices were discounted faster in PE than in WAP (p = 0.002 in a comparison between PE and WAP). In addition, the median discount rate of the first price cut was 5.0% (range: 0.1–20.0) for PE, 3.0% (range: <0.1–30.0) for WAP, and 5.0% (range: 0.6–10.9) without a CE pathway. The median cumulative discount rate of PE and WAP showed that the PE pathway products’ discount rates were higher: 10.4% for PE and 6.0% for WAP (p = 0.025 for comparison between PE and WAP). It is necessary to discuss the practical effects of the price-cutting system from a myriad of perspectives, including insurance finance, the value of new drugs, and the accessibility of new drugs to patients.

show abstract

Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System

Cited by 30 publications

References 26 publications

International Price Comparisons of Anticancer Drugs: A Scheme for Improving Patient Accessibility

International Price Comparisons of Anticancer Drugs: A Scheme for Improving Patient Accessibility

Use of budget savings from patent expiration of cancer drugs to improve affordability and accessibility

Price-Cutting Trends in New Drugs after Listing in South Korea: The Effect of the Reimbursement Review Pathway on Price Reduction

Contact Info

Product

Resources

About