Assessment of Vaccines in Europe, the HPV Example: Can the EU Joint Clinical HTA Regulation Result in More Consistent Vaccine Evaluations and Improve Access Across EU Countries?

OBJECTIVES: Assess how inconsistencies in vaccine assessments explain cross-country differences in national HPV vaccination programmes. Explore how proposed methodologies for EU Joint Clinical Assessment (JCA) can address disparities in vaccine access across EU countries.

METHODS: Publicly-available information relating to clinical guidelines for the three HPV vaccines in EU27 and the UK was extracted from web searches. Decision-analysis frameworks for National Immunisation Technical Advisory Groups (NITAGs) and HTA bodies were analysed and mapped against the proposed methods for conducting JCAs published by the EUnetHTA 21 Consortium.

RESULTS: All three vaccines are indicated for those aged nine and above, however most countries do not recommend vaccination until 11 years old, and some do not include boys in their national immunisation programmes (NIP). HPV vaccines are not funded or are only partially funded by national health systems in two countries (Romania and Czech Republic).

NITAGs recommend vaccine inclusion in NIPs and funding in all countries except Romania, whilst 12/28 countries require HTA input. Most countries base recommendations on clinical and economic aspects; 9 also factor in public health impact. Vaccines are assessed similarly to therapeutic drugs, although long-term vaccination benefits are not captured in clinical studies. Evaluations rely on modelling which tends to be complex and subject to a higher degree of uncertainty.

CONCLUSIONS: EUnetHTA guidelines recommend that outcomes relevant for HTA should be long-term or final where possible, and redefine the controversial use of surrogate endpoints which are particularly relevant for vaccine trials. The proposed inclusion of a PICO (population, intervention, control, and outcomes) survey in the scoping process would allow each member state to provide national needs with input from clinical experts and patients, ensuring that vaccines’ direct and indirect impact on individuals, society and public health are accounted for and that the scope reflects policy questions from the different healthcare systems.