OBJECTIVES: FDA breakthrough therapy designation was created in 2012 to expedite the registration of new health care technologies for use by patients with serious or life-threatening diseases/conditions.  Breakthrough therapies are eligible for other FDA regulatory programs such as fast track designation, accelerated approval and priority review.  We sought to determine whether other regulators and HTA agencies/payers also sought to expedite access to these therapies. METHODS: The FDA website was examined to identify breakthrough therapy medicines that had been approved up to 31 December 2014.  The websites of the EMA (EU), Health Canada and TGA (Australia) were examined to determine their corresponding registration status.  The NICE (England), IQWiG (Germany), TC (France), CADTH/pCODR (Canada) and PBAC (Australia) websites were examined to determine if and when the medicines had been considered for reimbursement/coverage. RESULTS: The FDA approved 14 breakthrough medicines as at 31 December 2014 for use in 16 unique patient populations (i.e. pairings).  The mean time from submission to approval was 164 days.  Twelve pairings are orphan drugs and 9 are for patients with cancer.  As of 20 June 2015, 13 had been registered in the EU (mean time 326 days), 8 in Canada (275 days) and 9 in Australia (N/A).  Four of the 15 pairings had been assessed by NICE (all recommended), 5 by IQWiG (4 additional benefit not quantifiable, 1 minor additional benefit), 6 by the TC (ASMR rating = II (2), III (1), IV (1), V (2)), 8 by CADTH/pCODR (6 recommended, 2 not recommended) and 7 by the PBAC (all recommended). CONCLUSIONS: Most of the 16 pairings were registered first in the US.  The FDA evaluation period was shorter compared to other regulatory agencies.  Some HTA agencies are yet to consider many pairings whilst others have dissimilar views on their additional clinical benefit.