Assessment of the therapeutic value of new medicines marketed in Australia

The determination of a new medicine’s therapeutic benefit and value currently lies in the realm of the HTA agencies such as the PBAC than in the realm of the regulators such as the TGA. Vitry et al. claim that this is a role for the TGA; “another limitation of this study is the lack of gold standard methodology for the evaluation of the therapeutic value of new medicines. Regulatory agencies do not currently use standardized processes but mostly rely on expert judgment.” The current role of the TGA does not include the determination a new medicine’s therapeutic value. I am not aware that the TGA is seeking to usurp the role of the PBAC

The determination of a new medicine’s therapeutic benefit and value currently lies in the realm of the HTA agencies such as the PBAC than in the realm of the regulators such as the TGA. Vitry et al. claim that this is a role for the TGA; “another limitation of this study is the lack of gold standard methodology for the evaluation of the therapeutic value of new medicines. Regulatory agencies do not currently use standardized processes but mostly rely on expert judgment.” The current role of the TGA does not include the determination a new medicine’s therapeutic value. I am not aware that the TGA is seeking to usurp the role of the PBAC