CIRS Agenda_2015

HTA and Market Access Programme Research

Assessing the Interactions Between Regulatory Approval and HTA Recommendations

The doctoral research programme of Senior Research Fellow Dr Iga Lipska, entitled The quality of industry health technology assessment (HTA) submissions for medicines and their review by HTA agencies, sought to determine the correlations between the regulatory approval process and health technology assessment recommendations in European countries.

The objectives of the first study were to find the association between duration of the process of marketing authorisation reviews at European Medicines Agency and subsequent HTA recommendations in selected European Union countries. The research hypothesis was that length of the EMA approval process might be an indicator of the complexity of and potential issues in the dossier and therefore would be associated with more restrictive HTA recommendations.

Data were analysed for a cohort of drugs approved by the EMA between 2007 and 2011. There were three methods of coding the data analysed.

  • In the first coding recommendations were grouped as positive; positive with minor restrictions; positive with economic restrictions; positive with clinical restrictions; positive with economic and clinical restrictions; negative for economic reasons; negative for clinical reasons; negative for economic and clinical reasons; negative for other reasons and not assessed.
  • In the second coding, recommendations were grouped as positive; positive with minor restrictions; positive with major restrictions; and not assessed.
  • In the third coding, HTA recommendations were grouped as positive; positive with restrictions, negative or not assessed.

Results of the analysis showed that there were negative correlations between HTA recommendations in the second and the third coding and EMA approval time in Netherlands; that is, a longer EMA approval time was correlated with less beneficial HTA recommendations.  All of the correlations were marginally significant (Figure 1).

 

Figure 1. There were negative correlations between HTA recommendations and EMA approval time in Netherlands.