Abstract

The global market for therapeutic vaccines has witnessed significant growth in the last decade (e.g. anti-cancer, hepatitis B); however, the overall cost, stringent regulatory policies and initial capital investment associated with therapeutic vaccines present a challenge to payers. This research was completed to understand the key drivers affecting reimbursement for therapeutic vaccines in EU5 countries and potential solutions to current challenges. A web-based survey was administered through the Rapid Payer Response™ online portal (RPR®) to 25 payers with experience in HTA and reimbursement decision-making for vaccines in France, Germany, Italy, Spain and the UK, 5 payers per country. Payer profiles included former members of the department of Health and JCVI (Joint Committee of Vaccine and Immunization) in the UK, ex-CEPS and ex-TC payers in France, ex-GBA and SHI payers in Germany and both national and regional level payers in Italy and Spain. Responses were collected through RPR® in 5 days and analysed via Microsoft™ Excel. Cost-effectiveness studies, use of biomarkers and real world evidence demonstrating patient outcomes in clinical practice were identified as being highly supportive in facilitating successful reimbursement outcomes alongside clinical drivers such as the magnitude of efficacy benefit, long-term safety data and improvement in quality of life. With recent approvals of therapeutic vaccines, payers are concerned about the potentially high cost of treatment, therefore identifying the most appropriate patient population for vaccination is likely to become increasingly important to payers in order to reduce the overall budget impact and ensure favourable HTA and formulary outcomes.

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