Landscape assessment for gender neutral human papillomavirus vaccination recommendations including head and neck cancer burden data.

INTRODUCTION: Head and neck cancers (HNC) accounted for over 450,000 deaths and 900,000 cases in 2018 worldwide. Of those, 38,000 cases were attributable to human papillomavirus (HPV). HNC is two to four times more prevalent in men than in women. The incidence of oropharyngeal cancers (OPC) and oral cavity cancers caused by HPV has increased in recent decades. Given the substantial burden of HPV-related HNC in males, this study aimed to assess whether and how national agencies included HPV-related HNC when evaluating HPV genderneutral vaccination (GNV) programs. METHODS: A systematic literature review was conducted in MEDLINE® and EMBASE®, and on the websites of selected national agencies. RESULTS: Searches identified a potential 205 records; seventeen were eligible for the review. Seventy percent of assessments were published by European countries and most were recent (2014-2019). Eleven (65%) reports considered OPC when discussing HNC, and a few included other anatomic sites. All reports that considered incidence data were in consensus that incidence of OPC was higher in men and showed that the mortality rates for HPV-related HNC were also higher in men. When looking at the economic impact, the incremental cost-effectiveness ratios in the assessments varied widely, as the inputs into the analyses were heterogeneous. However, several reports concluded GNV programs were likely to be cost-effective versus not vaccinating males. CONCLUSION: The burden of HPV-related HNC in the general male population has been recognized by several Heatlth Technology Assessment (HTA) agencies and National Immunization Technical Advisory Groups (NITAGs) when evaluating HPV GNV programs. The assessments identified on GNV programs strongly indicate a cost-effective clinical benefit. Nevertheless, the epidemiological burden of HNC may have been underestimated in some countries due to limited data. Further research is crucial to obtain more robust data that will help address the information gap in epidemiological and economic burden of HPV-associated HNC in men.

A multi-stakeholder approach in optimising patients' needs in the benefit assessment process of new metastatic breast cancer treatments.

There is a growing understanding as science evolves that different cancer types require different approaches to treatment evaluation, especially in the metastatic stages. The introduction of new metastatic breast cancer (MBC) treatments may be hindered by several elements, including the availability of relevant evidence related to disease-specific outcomes, the benefit assessment process around the evaluation of the clinical benefit and the patients' need of new treatments. The Steering Committee (SC) found that not all issues relevant to MBC patients are consistently considered in the current benefit assessment process of new treatments. Among these are overall survival, time-to-event endpoints (e.g. progression-free survival), patients' priorities, burden of disease, MBC-specific quality of life, value in delaying chemotherapy, route of administration, side effects and toxicities, treatment adherence and the benefit of real-world evidence. This paper calls on decision makers to (1) Include MBC-specific patient priorities and outcomes in the overall benefit assessments of new MBC treatments; (2) Enhance multi-stakeholder collaboration in order to improve MBC patient outcomes.