In France, the pricing and reimbursement landscape is certainly changing. Take for instance the case of Gilead’s Hepatitis C blockbuster, Sovaldi. According to clinical trial data, 90% of patients for whom this drug is indicated for are for all intents and purposes cured upon treatment completion. A few years ago, Sovaldi would have likely been awarded a premium price in France, which has traditionally only considered the therapeutic benefit of new drugs to inform pricing decisions. It would have also entered the French market at a high price point relative to other European Union Five markets, including the cost-conscientious United Kingdom.

However, the need for the government to continue providing universal healthcare coverage to an aging population, along with increasing drug prices and shrinking budgets, recently drove the country to introduce pharmacoeconomic analysis as part of its pricing process. Due in part to a more economically focused health technology assessment process, in late 2014, the French government was able to get Sovaldi at the lowest list price in Europe. The government also secured a volume-based tax and performance-based discount in exchange for 100% reimbursement. Based on the limited number of pharmacoeconomic analyses that have been published to date, manufacturers can expect to face tougher negotiations with the pricing committee, with a final price potentially below expectations.

In addition to pricing pressures, manufacturers face other challenges in France including the government’s mounting focus on driving the use of generic drugs and biosimilars, which may restrict market growth. This article explores some of the recent developments in the French pharmaceutical market, identifies pricing and reimbursement challenges, and discusses strategies manufacturers should consider for sustainable success.