Health Intervention and Technology Assessment Program (HITAP), Department of Health, Ministry of Public Health, Nonthaburi, Thailand.
Value Health. 2012 Jan-Feb;15(1 Suppl):S95-9. doi: 10.1016/j.jval.2011.11.016.
To assess the budget impact of the government use licenses policy, a form of compulsory licensing used by the government, on seven patented drugs, namely, efavirenz, lopinavir/ritonavir combination, clopidogrel, letrozole, docetaxel, erlotinib, and imatinib, in Thailand between 2006 and 2008.
By using government's perspective, budget impact was estimated within a 5-year period after the introduction of the policy. The number of patients who need treatment with each drug and the costs of treatments by both original and generic versions were obtained from Thai government agencies. Probabilistic sensitivity analysis was used to determine the impact of uncertainty surrounding parameters such as the numbers of patients and the health-care costs.
The study indicated that the use of generic drugs under the policy could save the government budget approximately $370 million over 5 years. It was also found that each drug had a different effect on budget saving depending on the number of patients treated, the difference in drug costs between original and generic drugs, and the lag time from the introduction of the policy to the availability of the generic drugs on the market.
The study showed that the introduction of the government use licenses policy in Thailand would provide significant benefits for the study timeframe; however, there are several issues that should be taken into account when the government use licenses policy is adopted.
评估政府实施强制许可政策（一种政府强制许可形式）对七种专利药品（依非韦伦、洛匹那韦/利托那韦复方制剂、氯吡格雷、来曲唑、多西他赛、厄洛替尼和伊马替尼）在泰国 2006 年至 2008 年的预算影响。
采用政府视角，在政策实施后 5 年内估算预算影响。从泰国政府机构获得每种药物的治疗患者数量和原研药及仿制药治疗成本。采用概率敏感性分析来确定患者数量和医疗保健成本等参数的不确定性对结果的影响。
研究表明，实施该政策使用仿制药在 5 年内可节省政府预算约 3.7 亿美元。研究还发现，每种药品对预算节省的影响因治疗患者数量、原研药和仿制药之间的药物成本差异以及政策实施到仿制药上市之间的时滞长短而有所不同。
研究表明，泰国政府实施强制许可政策将在研究时间段内为政府提供显著的效益；然而，在实施政府强制许可政策时，应考虑到几个问题。
