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Market Exclusivity of the Originator Drugs in South Korea: A Retrospective Cohort Study.

ABSTRACT: Introduction: Generic entry is a well-known driver of competition and cost containment. Objectives: We aim to measure the market exclusivity of originator drugs and to determine what influences the entry of generics in South Korea. Methods: A list of originator drugs approved by the authority from 2000 to 2013 and their corresponding generics were paired. An event history model was applied for a statistical estimation for the duration until generic entry and to identify abbreviating or prolonging factors on the duration. Results: A total of 2,061 pairs of originator and generics were identified. The market exclusivity for the originator drugs, including NDAs and non-NDAs, has not notably changed. However, competition among non-NDAs was less common than we expected. We found delayed time to entry of generics in the long run, particularly for non-NDAs in injection forms and biologics, and this finding is partially associated with market attractiveness. Conclusion: The authority should address the delayed availability of certain types of generic drugs. The government could provide information on off-patent pharmaceuticals with no generic competition, designate their corresponding submissions as prioritized in the review process, and provide additional market exclusivity when entering the market via a long period of exclusivity.

SUBMITTER: Son KB

PROVIDER: S-EPMC8056004 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:We evaluated the survival rates and medical expenditure in patients with lung cancer using a nationwide claims database in South Korea. A retrospective observational cohort study design was used, and 2,919 lung cancer patients and their matched controls were included. Medical expenditures were analyzed with the Kaplan-Meier sample average method, and patients were categorized into 4 groups by operation and primary treatment method (i.e. Patients with operation: OP = surgery, OP+CTx/RTx = surgery with anti-cancer drugs or radiotherapy; Patients without operation: CTx/RTx = anti-cancer drugs or radiotherapy, Supportive treatment). The 5-year medical expenditure per case was highest in the OP+CTx/RTx group ($36,013), followed by the CTx/RTx ($23,134), OP ($22,686), and supportive treatment group ($3,700). Lung cancer-related anti-cancer drug therapy was the major cost driver, with an average 53% share across all patients. Generalized linear regression revealed that monthly medical expenditure in lung cancer patients, after adjustment for follow-up month, was approximately 3.1-4.3 times higher than that in the control group (cost ratio for OP = 3.116, OP+CTx/RTx = 3.566, CTx/RTx = 4.340, supportive treatment = 4.157). The monthly medical expenditure at end of life was estimated at $2,139 for all decedents, and approximately a quarter of patients had received chemotherapy in the last 3 months. In conclusion, this study presented the quantified treatment costs of lung cancer on various aspects compared with matched controls according to the treatment of choice. In this study, patients with operation incurred lower lifetime treatment costs than patients with CTx/RTx or supportive treatment, indicating that the economic burden of lung cancer was affected by treatment method. Further studies including both cancer stage and treatment modality are needed to confirm these results and to provide more information on the economic burden according to disease severity.

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Market Exclusivity of the Originator Drugs in South Korea: A Retrospective Cohort Study.

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