CO4 An Evaluation of the Differences in Vaccine Approval and Procurement Processes between Healthcare Systems during a Pandemic
Most countries have well established pricing and reimbursement pathways for vaccines which differ from the pathway for other pharmaceutical products The review, purchasing, and distribution of vaccines varies between healthcare systems in high income countries During global viral pandemics, such as that caused by H1N1pdm09 in 2009 or more recently SARS CoV 2;countries adapt their appraisal pathways to allow for expedient approval and distribution of vaccines Understanding such adaptions is important to enable rapid market access for COVID 19 vaccines as well as providing the opportunity to identify possibilities to establish more global approaches to the challenges of such diseases For this evaluation, a targeted review was undertaken to identify reimbursement pathways for both seasonal and pandemic vaccines in four markets with different underlying healthcare systems: nationalised (UK) social insurance based (Germany) decentralised (Italy) and private insurance based (USA) The H1N1 vaccine was used as an analogue for a pandemic vaccine and the seasonal influenza vaccine for standard processes The two pathways were compared across key variables including: relevant stakeholders, evidence requirements, pricing strategies, and procurement and distribution Despite considerable differences in the pathways used for seasonal vaccines, the emergent pathway used during the H1N1pdm09 pandemic was almost identical in each market All four markets accelerated the appraisal process and used a centralised procurement pathway National governments relied on licensing authorities to provide the initial review of quality and safety data on new vaccines Governments then directly oversaw tender processes, supplier selection, financial agreements and contracting, in order to purchase vaccines directly from manufacturers and distribute them to regional healthcare providers European markets all used advance purchasing agreements and the USA negotiated a sole source direct purchase The parallels in pandemic vaccine processes between the markets indicates opportunities for greater international co ordination to accelerate both the technical reviews of new vaccines and implementation of vaccination programmes
Value in Health