MARKET ACCESS CHALLENGES FOR VACCINE LAUNCHES

Objectives: Vaccine launch from a market access perspective could be more complex than launching general drugs. The study was conducted to assess the complexities of launching various types of vaccines and differences in market access pathways. Factors of modes to include in the National Immunization program (NIM), procurement dynamics, evidence requirements, value elements influencing access were assessed. The project was focussed in selected European countries including France, Italy, Germany, UK, Spain, Norway and Belgium. Methods: The project was conducted through in depth secondary research including assessment of pathways and critical analysis of HTA outcomes of selected vaccines through analogue analysis. Results: The analysis confirmed that there are several stakeholder institutions in addition to those involved in general drug assessments who influence the success of a vaccine. Most importantly NITAG (national immunisation technical advisory groups) in various countries play an important role. There is variance in how different countries approach the inclusion of vaccines in the national immunisation program. Not all countries have clearly defined criteria making it difficult for vaccine manufactures to understand how to develop a market access strategy for vaccines. They could follow either a vaccine pathway, generally defined by national immunisation program or a therapeutic pathway, which is similar to the standard drug access pathway. Also the modes of procurement vary including direct purchase by hospitals to national or regional tendering. Elements such as efficacy of the vaccine, its influence on the individual and global population, schedule, target population, price, unmet need and target disease carry different weightings influencing the success of vaccine from a market access perspective. Conclusions: The study gave clear strategy for a pharmaceutical company wanting to launch a vaccine. HTA agencies in general have a positive perspective towards vaccines and have support systems that could be explored for their successful market access launch.