Abstract

Vaccination is one of medicine’s greatest achievements—but patient access remains a challenge. Navigating the complex pricing and reimbursement processes for vaccines across Europe can cause delays and therefore limit patient access to life-saving immunization. This analysis compared the national evaluation processes and times to market in France, Germany, Italy, and the UK. We analyzed the National Immunization Technical Advisory Group (NITAG) assessment processes and the duration from market authorization through to price negotiations for 6 new vaccines approved in the past 5 years by the European Medicines Agency (EMA). Time to patient access can be delayed by the processes involved in creating vaccine recommendations by the NITAGs. In France, the Technical Commission for Vaccination (CTV) provides their recommendations before the vaccine is re-assessed by the Transparency Commission (CT) for reimbursement. In the UK, the Joint Committee on Vaccination and Immunisation (JCVI) makes recommendations and then advises the Department of Health and Social Care (DHSC) on the use of vaccines. In Italy NITAG manages new or updated recommendations regarding vaccines and relevant indications through the publication of the National Plan for Vaccine Prevention. In Germany, the Standing Committee on Vaccination (STIKO) only provides recommendations for vaccines that are not yet reimbursed and in specific indications, which considerably accelerates patient access. The French NITAG assessment took approximately 14.8 months versus just 5.8 and 11.6 months in Germany and in the UK, respectively. No data were available for Italy as the Italian NITAG assessments are not published. Regarding the price negotiation timelines, the product price was on average available in 5.8 months in Germany versus 17.3 months in France and 16.3 months in Italy. This assessment showed that pricing and reimbursement processes and timelines differed between the European countries. Companies must plan ahead to ensure timely patient access.

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