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Introduction: Access to medicines is a shared goal across healthcare stakeholders. Since health technology assessment (HTA) informs funding decisions, it shapes access to medicines. Despite its wide implementation, significant access variations due to HTA are observed across Europe. This paper elicited the opinions of European stakeholders on how HTA can be improved to facilitate access. Methods: A scoping review identified HTA features that influence access to medicines within markets and areas for improvement, while three access dimensions were identified (availability, affordability, timeliness). Using the Delphi method, we elicited the opinions of European stakeholders to validate the literature findings. Results: Nineteen participants from 14 countries participated in the Delphi panel. Thirteen HTA features that could be improved to optimise access to medicines in Europe were identified. Of these, 11 recorded a positive impact on at least one of the three access dimensions. HTA features had mostly a positive impact on timeliness and a less clear impact on affordability. 'Early scientific advice' and 'clarity in evidentiary requirements' showed a positive impact on all access dimensions. 'Established ways to deal with uncertainty during HTA' could improve medicines' availability and timeliness, while more 'reliance on real-world evidence' could expedite time to market access. Conclusions: Our results reiterate that increased transparency during HTA and the decision-making processes is essential; the use of and reliance on new evidence generation such as real-world evidence can optimise the availability of medicines; and better collaborations between regulatory institutions within and between countries are paramount for better access to medicines. [ABSTRACT FROM AUTHOR]

Midlife, beginning at 40 years and extending to 65 years, a range that encompasses the late reproductive to late menopausal stages, is a unique time in women's lives, when hormonal and physical changes are often accompanied by psychological and social evolution. Access to sexual health and sexual well-being (SHSW) services, which include the prevention and management of sexually transmitted infections, contraception and the support of sexual function, pleasure and safety, is important for the health of midlife women, their relationships and community cohesion. The objective was to use the socio-ecological model to synthesise the barriers and enablers to SHSW services for midlife women in high-income countries. A systematic review of the enablers and barriers to women (including trans-gender and non-binary people) aged 40–65 years accessing SHSW services in high-income countries was undertaken. Four databases (PubMed, PsycINFO, Web of Science and Google Scholar) were searched for peer-reviewed publications. Findings were thematically extracted and reported in a narrative synthesis. Eighty-one studies were included; a minority specifically set out to study SHSW care for midlife women. The key barriers that emerged were the intersecting disadvantage of under-served groups, poor knowledge, about SHSW, and SHSW services, among women and their healthcare professionals (HCPs), and the over-arching effect of stigma, social connections and psychological factors on access to care. Enablers included intergenerational learning, interdisciplinary and one-stop women-only services, integration of SHSW into other services, peer support programmes, representation of minoritised midlife women working in SHSW, local and free facilities and financial incentives to access services for under-served groups. Efforts are needed to enhance education about SHSW and related services among midlife women and their healthcare providers. This increased education should be leveraged to improve research, public health messaging, interventions, policy development and access to comprehensive services, especially for midlife women from underserved groups. Plain language summary: Sexual health and sexual wellbeing services for midlife women in high income countries Midlife, beginning at 40 years and extending to 65 years, a range that encompasses the late reproductive to late menopausal stages, is a unique time in women's lives. Access to Sexual Health and Sexual Wellbeing (SHSW) services, which include the prevention and management of sexually transmitted infections, contraception and the support of sexual function, pleasure and safety, is important for the health of midlife women, their relationships and community cohesion. The objective of this systematic review was to use the socio-ecological model to synthesise the barriers and enablers to SHSW services for midlife women in high income countries. Eighty-one studies were included; a minority specifically set out to study SHSW care for midlife women. The key barriers that emerged were the intersecting disadvantage of under-served groups, poor knowledge, about SHSW, and SHSW services, among women and their HealthCare Professionals (HCPs), and the over-arching effect of stigma, social connections, and psychological factors on access to care. Enablers included intergenerational learning, interdisciplinary and one-stop women-only services, integration of SHSW into other services, peer support programmes, representation of minoritised midlife women working in SHSW, local and free facilities, and financial incentives for under-served groups to access services. The appetite for education about SHSW and SHSW services among midlife women and their HCPs should be capitalised upon, and utilised to improve research, public health messaging, interventions and access to holistic services, particularly for midlife women from under-served groups. [ABSTRACT FROM AUTHOR]

Recent evidence brought by novel anti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugates is leading to significant changes in HER2-negative breast cancer (BC) best practices. A new targetable category termed 'HER2-low' has been identified in tumors previously classified as 'HER2-negative'. Daily practice in pathology and medical oncology is expected to align to current recommendations, but patient access to novel anticancer drugs across geographies might be impeded due to local challenges. An expert meeting involving ten regional pathology and oncology opinion leaders experienced in BC management in four Central and Eastern Europe (CEE) countries (Bulgaria, Croatia, Serbia, Slovenia) was held. Herein we summarized the current situation of HER2-low metastatic BC (mBC), local challenges, and action plans to prevent delays in patient access to testing and treatment based on expert opinion. Gaps and differences at multiple levels were identified across the four countries. These included variability in the local HER2-low epidemiology data, certification of pathology laboratories and quality control, and reimbursement conditions of testing and anticancer drugs for HER2-negative mBC. While clinical decisions were aligned to international guidelines in use, optimal access to testing and innovative treatment was restricted due to significant delays in reimbursement or limitative reimbursement conditions. Preventing delays in HER2-low mBC patient access to diagnosis and novel treatments is crucial to optimize outcomes. Multidisciplinary joint efforts and pro-active discussions between clinicians and decision makers are needed to improve care of HER2-low mBC patients in CEE countries. [ABSTRACT FROM AUTHOR]