OBJECTIVES

: Internationalised medicines are often a marker of therapies that address important unmet medical needs. In this study, the evaluation of internationalised new active substances (NAS) and their timing from 1^st regulatory submission to jurisdictional HTA recommendation was conducted to study differences in timing or outcome in key therapeutic areas.

METHODS

: Twenty four internationalised NAS, (NAS which had been approved between 2012 and 2017 in all the studied jurisdictions (Australia, Canada and Europe) and have also received their first HTA recommendation between 2014 and 2017 in Australia, Canada, France, Germany, Scotland and Sweden) were identified. The data evaluated were: therapeutic area, timing (regulatory date of submission and approval, HTA recommendation date), HTA outcome (positive, positive with restrictions, negative and multiple) and use of expedited regulatory pathways.

RESULTS

: Anti-cancer and immunomodulators (12 NASs) and Anti-infectives (7 NASs) made up the majority of internationalised NAS identified with the remaining 5 NASs being a mix of other therapeutic areas. Anti-infectives showed the shortest median times for regulatory review and the gap between regulatory approval and HTA recommendation (median time ranged from -28 days in Australia to 314 days in England). When comparing anti-infectives to anticancer and immuomodulators; the largest difference was seen in France where time to recommendation from regulatory approval for anti-infectives was 119 days faster; There was also a higher proportion of positive and positive with restriction recommendations for anti-infectives. Interestingly, this cohort of anti-infectives were also 63% and 69% more likely to undergo expedited regulatory pathways in Canada and Europe respectively.

CONCLUSIONS

: Although most internationalised drugs are anti-cancer and immunomodulators, for the time period studied in this analysis indicates that anti-infectives when evaluated as an aggregate are getting to HTA recommendation faster following regulatory approval. This may relate to fact that in this time period the new medicines for Hepatitis C were being introduced.