- In an effort to speed the assessment of new medicines while maintaining the quality of the regulatory review, facilitated regulatory pathways (FRPs) have been introduced in many countries. In this study, the effects of FRPs (expedited and conditional reviews) were investigated in terms of their influence on timing.
- First health technology assessment (HTA) recommendations issued between 2014 and 2016 were collected from the Canadian Agency for Drugs and Technology in Health (CADTH), Haute Autorité de santé (HAS; France), Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWIG; Germany), Scottish Medicine Consortium (SMC) and Tandvårds-och läkemedelsförmånsverket (TLV; Sweden) for 90 internationalised medicines (new active substances approved between 2012 and 2016 by all five regulatory agencies).
- Of this cohort of internationalised medicines that received a HTA recommendation, 31% in Canada and 28% in Europe were approved via a FRP. With the exception of Scotland, expedited medicines were more likely to be appraised within a year from regulatory approval and had a shorter median time between regulatory approval to HTA recommendation than standard medicines. The largest difference was seen in Sweden, where medicines undergoing expedited regulatory review received a first HTA recommendation 66.5 days faster than those using standard pathways.
- Medicines designated for an expedited review pathway show a reduced time from regulatory approval to first HTA recommendation. Although this finding suggests an alignment between regulators and health technology assessors regarding the identification of medicines for which there is a need to expedite HTA recommendation, it cannot be assessed from these data whether the reduced time from approval to HTA recommendation is attributed to the sponsoring company strategy, HTA review time or both and further investigation would be required.
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