OBJECTIVES: In this follow-up study, we take a look at the market access delays caused by lengthy pricing and reimbursement negotiations in the EU5 and compare the outcomes of those results to the US.

METHODS: We examined over 40 oncology NMEs with EMA approval between 2011-2017 and looked at the date of initial price publication in each market, HTA agency outcomes (where available), and price level at launch to compare the length of the price negotiation and price levels across EU markets as well as with the United States.

RESULTS: Timing for coming to a negotiated agreement for reimbursement in France, Italy, and Spain can vary between as little as two months up to as much as two years. In addition, oncology pricing in the EU5 has been found to be significantly lower than the US by an average of 40-50% and this gap seems to be getting larger and larger from year-to-year. Lastly, we re-confirmed that HTA agencies such as in France or Germany very often conduct sub-group analysis and find a lack of benefit in some sub-populations.

CONCLUSIONS: For oncology products, the European market remains less rewarding to pharmaceutical manufacturers than the US market due to the long negotiation period, much lower prices, and lack of perceived value for some subpopulations. The number of oncology launches over the past years have left payers scrutinizing the added value of new products and we are seeing payers demonstrating little interest in making those drugs available to patients quickly or at an attractive price. Further realignment towards a more high risk, but high reward, approach of looking for true innovation will hopefully lead to better patient outcomes and higher rewards for pharmaceutical and biotech manufacturers, but “me-too” products with incremental improvements can expect long waits for market access and lower price potentials.