OBJECTIVES: A growing number of medicines are approved in the US and EU using at least one expedited pathway, but approval based on more limited clinical data may undermine the ability to achieve successful pricing and reimbursement (P&R) outcomes. This study examines whether expedited-pathway drugs are penalised in terms of price level, length of P&R review and likelihood of being subjected to a risk sharing (RS) scheme.

METHODS: Secondary research was conducted to identify medicines approved for marketing in 2013-2017 under the FDA's Fast Track-designation, Accelerated Review, or Breakthrough Therapy-designation or the EMA's Conditional Approval or Accelerated Assessment procedure. Product launch price, time to pricing, and time to reimbursement were investigated in the US and EU-5, along with existence of an RS scheme.

RESULTS: On average, compared to standard-review drugs, expedited-pathway drugs launched 39, 76, 106 and 122 days faster in the US, Italy, UK and Germany respectively, but did not launch faster in France and Spain. The mean time to reimbursement was 58 days longer for expedited-pathway drugs in France and 57 days longer in Spain compared to standard-review drugs. In Germany, expedited-pathway drugs completed the reimbursement process in 74 days – less than half the time for standard-review medicines. Only 3% of expedited-pathway medicines were subject to RS in the US, but accounted for 18.4% of all RS agreements in the country. Conversely, 43% of expedited-review drugs were subject to RS in at least one EU country.

CONCLUSIONS: Expedited-review drugs are not penalised in terms of list price and tend to reach the market quicker than their standard-review counterparts. However, the P&R review in countries conducting a full assessment before granting a price takes longer than for standard-review drugs, and the likelihood of an RS scheme is relatively high for expedited-review medicines.