Abstract

In this study, we look at the market access delays caused by lengthy pricing and reimbursement negotiations in the EU5. In addition, we look at the results of those pricing negotiations compared to the US, and the outcome with regards to access for specific subpopulations. We examined over 20 oncology NMEs with EMA approval over the last three years 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. Coming to a negotiated agreement for reimbursement in France, Italy, and Spain typically takes over a year, but there is no recognizable trend by market. In addition, oncology pricing in the EU5 has been found to be significantly lower than the US by an average of 30-40%. Lastly, we found that HTA agencies such as in France or Germany increasingly look at sub-group analysis and find a lack of benefit in some patient sub-populations. The secret to good pulled pork is low temperatures and long cooking time. With low prices and long negotiations, EU payers have found a recipe that is working well for them, but likely giving oncology manufacturers indigestion. An explosion in 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. A realignment towards a more high risk but high reward approach of looking for true innovation will hopefully lead to better patient outcomes and higher profits for pharmaceutical and biotech manufacturers.

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