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HTA in Pharmaceutical regulation

HTA in Pharmaceutical regulation. Yot Teerawattananon M.D., Ph.D. Outline. Mechanisms for health sector/pharmaceutical regulation Involvement of HTA in pharmaceutical regulation: examples from Thailand and Korea Discussion and conclusions. Conceptual framework of health sector regulation.

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HTA in Pharmaceutical regulation

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  1. HTA in Pharmaceutical regulation Yot Teerawattananon M.D., Ph.D.

  2. Outline • Mechanisms for health sector/pharmaceutical regulation • Involvement of HTA in pharmaceutical regulation: examples from Thailand and Korea • Discussion and conclusions

  3. Conceptual framework of health sector regulation Source: Teerawattananon et al. Health sector regulation in Thailand. Health Policy 2003;63;323-338

  4. Pharmaceutical regulation and regulators • Market authorization • FDA • Price control (direct and indirect methods) • FDA, Department/Ministry of Health, Ministry of Commerce • Reimbursement and financial control policy • Third party payers (national health insurance) with the support from HTA organizations • Procurement/diffusion • Local authorities e.g. hospital drug formulary committee • Post-marketing monitoring • FDA

  5. Evidences and approaches used

  6. Evidence used and approaches

  7. are all HTA information! • Safety • Efficacy/Effectiveness • Value for money • Drug accessibility • Adverse consequences

  8. Reasons for decisions not to reimburse new medicines of Republic of Korea Orange indicates “Lack of evidence on cost-effectiveness”, blue “Lack of evidence on clinical effectiveness”, and green “Contradiction to the principle of insurance.” Source: HIRA

  9. Cost-effectiveness league table of selected interventions in Thailand

  10. Example of using HTA in price negotiationthe analysis of pricing threshold of the HPV vaccine against the WTP threshold Vaccine price in Thai Baht In Fab 09 a company announced a price reduction of the vaccine to 7,000 Baht 10 Source: HITAP 2008

  11. Utilization of statins in Thailand

  12. Problems related to HTA in Pharmaceutical regulation • Current attention focuses mainly on market authorization and reimbursement and lack of HTA on procurement/diffusion and post-marketing monitoring • Although there are many stakeholders involved in the regulation, lack of knowledge and skills on HTA among stakeholders esp. decision makers, health professionals, the media and the public

  13. Factors influencing decision making about health technology adoption by Thai decision makers (N=450) 13 Chaikledkaew et al. A national survey on human capacity for health technology assessment in Thailand (a draft manuscript for submissionto international journal)

  14. Knowledge of selected technical terms used in HTA among Thai decision makers (N=450) never heard ever heard known (understood) able to use ICER Sensitivity analysis Discounting QALY CMA Marginal cost CUA CBA CEA Indirect cost Direct cost Unit cost 0% 20% 40% 60% 80% 100% 14 Chaikledkaew et al. A national survey on human capacity for health technology assessment in Thailand (a draft manuscript for submissionto international journal)

  15. Conclusions • HTA is a useful tool in every aspect of pharmaceutical regulation • Greater attention need to be given to the use of HTA in other aspects of pharmaceutical regulation (apart from reimbursement ) extensive consultation and prioritization of HTA topics are important • Capacity building on HTA is crucial esp. for those decision makers, professionals, the media and the public so that they are aware and/or be able to use the tool

  16. Thank you

  17. Who are producers of the HTA evidence?

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