Health democracy in Europe: Cancer patient organization participation in health policy.

BACKGROUND: Patient organization participation in health policy decision making is an understudied area of inquiry. A handful of qualitative studies have suggested that the growing number of patient organizations in Europe and their increasing involvement in policy issues do not result in high political effectiveness. However, existing research is largely country-specific. OBJECTIVE: To examine the degree and impact of cancer patient organization (CPO) participation in health policy decision making in EU-28 and to identify their correlates. METHODS: A total of 1266 members of CPOs participated in this study, recruited from a diversity of sources. CPO participation in health policy was assessed with the Health Democracy Index, a previously developed instrument measuring the degree and impact of patient organization participation in various realms of health policy. Additional questions collected information about participants' and the CPO's characteristics. Data were gleaned in the form of an online self-reported instrument. RESULTS: The highest degree of CPO participation was observed with respect to hospital boards, reforms in health policy and ethics committees for clinical trials. On the contrary, the lowest was discerned with regard to panels in other important health-related organizations and in the Ministry of Health. The reverse pattern of results was observed concerning the Impact subscale. As regards the correlates of CPO participation, legislation bore the strongest association with the Degree subscale, while organizational factors emerged as the most important variables with regard to the Impact subscale. CONCLUSIONS: Research findings indicate that a high degree of CPO participation does not necessarily ensure a high impact. Efforts to promote high and effective CPO participation should be geared towards the establishment of a health-care law based on patient rights as well as to the formation of coalitions among CPOs and the provision of training to its members.

Variation in Health Technology Assessment and Reimbursement Processes in Europe.

BACKGROUND: It has been suggested that differences in health technology assessment (HTA) processes among countries, particularly within Europe, have led to inequity in patient access to new medicines. OBJECTIVES: To provide an up-to-date snapshot analysis of the present status of HTA and reimbursement systems in select European countries, and to investigate the implications of these processes, especially with regard to delays in market and patient access. METHODS: HTA and reimbursement processes were assessed through a review of published and gray literature, and through a series of interviews with HTA experts. To quantify the impact of differences among countries, we conducted case studies of 12 products introduced since 2009, including 10 cancer drugs. RESULTS: In addition to the differences in HTA and reimbursement processes among countries, the influence of particular sources of information differs among HTA bodies. The variation in the time from the authorization by the European Medicines Agency to the publication of HTA decisions was considerable, both within and among countries, with a general lack of transparency as to why some assessments take longer than others. In most countries, market access for oncology products can occur outside the HTA process, with sales often preceding HTA decisions. CONCLUSIONS: It is challenging even for those with considerable personal experience in European HTA processes to establish what is really happening in market access for new drugs. We recommend that efforts should be directed toward improving transparency in HTA, which should, in turn, lead to more effective processes.

Personalized medicine in Europe: not yet personal enough?

BACKGROUND: Personalized medicine has the potential to allow patients to receive drugs specific to their individual disease, and to increase the efficiency of the healthcare system. There is currently no comprehensive overview of personalized medicine, and this research aims to provide an overview of the concept and definition of personalized medicine in nine European countries. METHODS: A targeted literature review of selected health databases and grey literature was conducted to collate information regarding the definition, process, use, funding, impact and challenges associated with personalized medicine. In-depth qualitative interviews were carried out with experts with health technology assessment, clinical provisioning, payer, academic, economic and industry experience, and with patient organizations. RESULTS: We identified a wide range of definitions of personalized medicine, with most studies referring to the use of diagnostics and individual biological information such as genetics and biomarkers. Few studies mentioned patients' needs, beliefs, behaviour, values, wishes, utilities, environment and circumstances, and there was little evidence in the literature for formal incorporation of patient preferences into the evaluation of new medicines. Most interviewees described approaches to stratification and segmentation of patients based on genetic markers or diagnostics, and few mentioned health-related quality of life. CONCLUSIONS: The published literature on personalized medicine is predominantly focused on patient stratification according to individual biological information. Although these approaches are important, incorporation of environmental factors and patients' preferences in decision making is also needed. In future, personalized medicine should move from treating diseases to managing patients, taking into account all individual factors.

[Determinants of the cost of initiation of insulin therapy type 2 diabetic patients in France: possible approaches to optimization]. / Déterminants des coûts du passage à l’insuline en France chez le patient diabétique de type 2 : quelles pistes d’optimisation ?

Increased costs cannot be exclusively attributed to the consequences of insulin prescription. Any initiative designed to accelerate acquisition of patient autonomy would be likely to reduce the costs observed after switching to insulin, provided this initiative is adapted to the patient’s health profile, diabetes history and available medical resources..

Challenges in the implementation of trastuzumab biosimilars: an expert panel's recommendations.

Trastuzumab has transformed the treatment of HER2-positive breast cancer. Because of impending European patent expiry in 2017, numerous trastuzumab biosimilars are currently undergoing comparability exercises for marketing authorization. Although biosimilar products have been approved in Europe since 2006, many obstacles are expected for trastuzumab, resulting from its nature as a monoclonal antibody, its impact on overall survival, and its extensive biochemical complexities. Unsolved questions need to be addressed for the evaluation of biosimilars' activity in terms of appropriate clinical endpoint definitions for such anticancer drugs, specific assessment pathways and comparative testing of biosimilars, untested ensuing de facto combination of trastuzumab biosimilars with cytotoxics, and immunogenicity monitoring among immunocompromised patients. In such a context of uncertainties, the recent approval by the French parliament of biosimilar substitution, which would allow dispensing trastuzumab biosimilars in place of the originator, should interrogate the oncological community. A think tank of experts was created to delineate specificities and challenges stemming from trastuzumab biosimilars.

Web-based analysis of adherence to influenza vaccination among French healthcare workers.

BACKGROUND: Influenza is recognized as a public health threat. However, vaccine hesitancy and poor vaccine uptake have been seen in French healthcare workers (HCWs). As a result, authorities have considered implementing mandatory influenza vaccination for HCWs. OBJECTIVES: This study aimed to describe factors associated with influenza vaccine adherence or non-adherence in French HCWs and to collect their perception about mandatory influenza vaccination. STUDY DESIGN: In February 2017, during the influenza season, a standardized questionnaire was sent electronically to the professional email addresses of French HCWs. Analyses were performed having collected 3000 responses. RESULTS: Between February 1 and 16, 2017, a 14-question survey was sent to HCWs professional email addresses. After a two week period had elaspsed, 3000 answers were collected for analysis. Overall, 45.7% of responders reported they had received influenza vaccination in 2016-2017, with statistical differences relating to professional status, age and practice. In addition, 92.2% reported caring for at-risk patients and 62.9% had a community-based practice. Finally, accepting mandatory influenza vaccination was statistically associated with higher age, a higher socio-professional category, and seasonal influenza vaccine uptake, but not with management of at-risk patients. CONCLUSIONS: Electronically submitted questionnaires are a rapid and easy tool that can be used to describe factors associated with influenza vaccine uptake in HCWs. In our study, differences in receiving influenza vaccination related to age, practice and professional categories, and provided an insight into potential adherence to mandatory influenza vaccination in HCWs. If repeated, these surveys may also monitor the evolution of vaccine uptake by professional categories.

Cancer patients' organisation participation in heath policy decision-making: a snapshot/cluster analysis of the EU-28 countries.

OBJECTIVES: Even though patient involvement in health policy decision-making is well documented, studies evaluating the degree and impact of this participation are scarce. This is even more conspicuous in the case of cancer. There is evidence showing that patients with the same type of cancer and at the same stage of the disease will receive different treatments in different countries. Therefore, it is crucial to assess the degree of patient participation in health policy decision-making across Europe, as it may result in health inequalities across countries. In a response to this research call, the present study aimed to provide a snapshot of cancer patients' organisation (CPO) participation in health policy processes in European Union (EU)-28 countries. SETTING: CPOs from the EU-28 countries. PARTICIPANTS: Primary and secondary outcome measures: information about participants' sociodemographic characteristics and their involvement in their CPO was collected as well as data about the CPO. A 17-item index containing questions about the type and impact of participation in various facets of health policy decision-making was used to assess the degree of CPOs participation in health policy decision-making processes and its impact.

Assessing Patient Organization Participation in Health Policy: A Comparative Study in France and Italy.

BACKGROUND: Even though there are many patient organizations across Europe, their role in impacting health policy decisions and reforms has not been well documented. In line with this, the present study endeavours to fill this gap in the international literature. To this end, it aims to validate further a previously developed instrument (the Health Democracy Index - HDI) measuring patient organization participation in health policy decision-making. In addition, by utilizing this tool, it aims to provide a snapshot of the degree and impact of cancer patient organization (CPO) participation in Italy and France. METHODS: A convenient sample of 188 members of CPOs participated in the study (95 respondents from 10 CPOs in Italy and 93 from 12 CPOs in France). Participants completed online a self-reported questionnaire, encompassing the 9-item index and questions enquiring about the type and impact of participation in various facets of health policy decisionmaking. The psychometric properties of the scale were explored by performing factor analysis (construct validity) and by computing Cronbach α (internal consistency). RESULTS: Findings indicate that the index has good internal consistency and the construct it taps is unidimensional. The degree and impact of CPO participation in health policy decision-making were found to be low in both countries; however in Italy they were comparatively lower than in France. CONCLUSION: In conclusion, the HDI can be effectively used in international policy and research contexts. CPOs participation is low in Italy and France and concerted efforts should be made on upgrading their role in health policy decision-making.