Abstract
BackgroundThe 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.MethodsA 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.ResultsA 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.ConclusionsThe 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.
Highlights
The introduction of generics after the loss of patent exclusivity plays a major role in budget savings by significantly decreasing drug prices
Several scenarios were examined in sensitivity analyses by varying model parameters such as inclusion of different cancer drug groups, delay in generic/biosimilar entrance, the price level of originators and generics/biosimilars, adjustment for proportion of reimbursement, the growth of the offpatent cancer drug market, the risk sharing scheme rebate, and the new generic pricing policy across a range of relevant values
The results showed that uncertainty in savings was mainly driven by the changes in the list of drugs depending on the drug group, followed by the order of timing of generic entrance, price level of originators, adjustment for proportion of reimbursement, the growth of the off-patent cancer drug market, and manufacturers’ rebate percentage in the risk-sharing agreement
Summary
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. The estimated global incidence of cancer was 18.1 million cases with 9.6 million deaths in 2018. The most commonly diagnosed cancer was lung cancer, accounting for 11.6% of the incidence, closely followed closely by breast cancer (11.6%) and prostate cancer (7.1%) [1]. Cancer incidence in South Korea was 232,000 with 78,000 deaths in 2017. The most commonly diagnosed cancer was stomach (12.8%), followed by colorectal (12.1%), lung (11.6%), thyroid (11.3%), breast (9.6%), and liver (6.6%) [4]. Cancer drug expenditures for these six major cancers accounted for 37% of the US$2658 million expenditures in 2015, and the annual cancer drug cost per person was US$2149 [5]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
