The Montaigne Institute, an independent think tank dedicated to public policy in France and Europe, published a report on innovative medicines on 19 September 2019, strongly recommending acceleration in market access and the renewal of the medical and economic evaluation of medicines.
In France, a reimbursed innovative medicine can only be marketed after the High Health Authority (HAS) assesses the interest of the medicine and provides its opinion on whether the medicinal product should be included in the lists of medicinal products covered by the health insurance system. Based on this opinion, the Economic Committee for Health Products (CEPS) sets a price for the product. According to the Report, for marketing new medicines in France, excluding generics and unsuccessful marketing authorisation (MA) applications, it takes 213 days in France from the date of submission of an application to the HAS and the medicine inscription in the Official Journal. This is more than the maximum 180 days set by the EU Transparency Directive (89/105/EEC).
The report suggests marketing innovative medicines as soon as they are granted MA, as in Germany. The report proposes that the price set would be provisional and would correspond to the average of European prices, or comparable medicines, and the HAS and CEPS would then have one year to evaluate the effectiveness of the medicine and negotiate a price. In return, the pharmaceutical company would be expected to reimburse the difference if the final price was lower than the initial price. During the process, the company would commit to collect “real-life” data from patients to refine the assessment.
The system proposed by the report notably requires the strengthening of the HAS by allowing it to carry out evaluations grouped by therapeutic class, in line with market developments, instead of re-evaluating medicines every five years. In addition, the HAS would need to better value its experts by creating positions for clinical practitioners. Above all, the HAS should extend medico-economic analysis to all new treatments, even if this means outsourcing studies, and monitor through “real life” data for one to three years to inform policy decisions.
In return, the HAS budget would benefit from some of the savings generated by innovative medicines, such as lower hospitalisation costs. An increase in filing fees charged to pharmaceutical companies could also assist in the implementation of the new system.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2019 Issue (Thomson Reuters).